U.S. patent application number 09/940468 was filed with the patent office on 2002-03-21 for subcutaneous electrode for transthoracic conduction with improved installation characteristics.
Invention is credited to Bardy, Gust H., Cappato, Riccardo, Rissmann, William J., Sanders, Gary H..
Application Number | 20020035379 09/940468 |
Document ID | / |
Family ID | 25474892 |
Filed Date | 2002-03-21 |
United States Patent
Application |
20020035379 |
Kind Code |
A1 |
Bardy, Gust H. ; et
al. |
March 21, 2002 |
Subcutaneous electrode for transthoracic conduction with improved
installation characteristics
Abstract
One embodiment of the present invention provides a lead
electrode assembly for subcutaneous implantation including an
electrode; and an appendage coupled to the electrode for
positioning the lead electrode assembly.
Inventors: |
Bardy, Gust H.; (Seattle,
WA) ; Cappato, Riccardo; (Ferrara, IT) ;
Rissmann, William J.; (Coto de Caza, CA) ; Sanders,
Gary H.; (Rancho Santa Margarita, CA) |
Correspondence
Address: |
EDWARD O. KRUESSER
BROBECK PHLEGER & HARRISON
12390 EL CAMINO REAL
SAN DIEGO
CA
92130
US
|
Family ID: |
25474892 |
Appl. No.: |
09/940468 |
Filed: |
August 27, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09940468 |
Aug 27, 2001 |
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09663607 |
Sep 18, 2000 |
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09940468 |
Aug 27, 2001 |
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09663606 |
Sep 18, 2000 |
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Current U.S.
Class: |
607/4 |
Current CPC
Class: |
A61N 1/3975 20130101;
A61N 1/3756 20130101; A61N 1/375 20130101; A61N 1/05 20130101; A61N
1/3968 20130101; A61N 1/3956 20130101; A61N 1/3906 20130101; A61N
1/37512 20170801 |
Class at
Publication: |
607/4 |
International
Class: |
A61N 001/39 |
Claims
What is claimed is:
1. A lead electrode assembly for use with an implantable
cardioverter-defibrillator subcutaneously implanted outside the
ribcage between the third and twelfth ribs comprising: an
electrode; and an appendage coupled to the electrode for
positioning the lead electrode assembly.
2. The lead electrode assembly of claim 1, wherein the appendage is
substantially fin-shaped.
3. The lead electrode assembly of claim 2, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom of the appendage.
4. The lead electrode assembly of claim 1, wherein the appendage is
substantially planar.
5. The lead electrode assembly of claim 4, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
6. The lead electrode assembly of claim 4, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
7. The lead electrode assembly of claim 1, wherein the appendage
has an eyelet therein.
8. The lead electrode assembly of claim 1, wherein the appendage is
substantially loop-shaped.
9. The lead electrode assembly of claim 1, wherein the appendage is
substantially tube-shaped.
10. The lead electrode assembly of claim 9, wherein a proximal end
of the substantially tube-shaped appendage is closed.
11. The lead electrode assembly of claim 9, wherein the appendage
is substantially cylindrical.
12. The lead electrode assembly of claim 1, wherein the appendage
comprises a polymeric material.
13. The lead electrode assembly of claim 12, wherein the polymeric
material is selected from the group consisting essentially of a
polyurethane, a polyamide, a polyetheretherketone (PEEK), a
polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a
silicone, and mixtures thereof.
14. The lead electrode assembly of claim 1, wherein the electrode
is substantially planar.
15. The lead electrode assembly of claim 14, wherein the electrode
is substantially rectangular in shape.
16. The lead electrode assembly of claim 15, wherein the electrode
has rounded corners.
17. The lead electrode assembly of claim 14, wherein the electrode
comprises a top surface, a bottom surface and at least one
side.
18. The lead electrode assembly of claim 17, wherein the appendage
is substantially fin-shaped.
19. The lead electrode assembly of claim 18, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom appendage.
20. The lead electrode assembly of claim 17, wherein the appendage
is substantially planar.
21. The lead electrode assembly of claim 20, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
22. The lead electrode assembly of claim 20, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
23. The lead electrode assembly of claim 20, wherein the appendage
is substantially perpendicular to the top surface of the
electrode.
24. The lead electrode assembly of claim 20, wherein the appendage
is less than 10 mm in height.
25. The lead electrode assembly of claim 20, wherein the appendage
is flexible.
26. The lead electrode assembly of claim 25, wherein the appendage
is substantially perpendicular to the top surface of the electrode
and wherein the appendage is capable of flexing when force is
applied to it, so that the appendage is no longer substantially
perpendicular to the top surface of the electrode.
27. The lead electrode assembly of claim 26, wherein the appendage
is capable of flexing when force is applied to it, so that the
appendage lies substantially parallel to the top surface of the
electrode.
28. The lead electrode assembly of claim 23, wherein the appendage
is rigid.
29. The lead electrode assembly of claim 28, wherein the lead
electrode assembly further comprises flexible joining material,
wherein the flexible joining material is coupled between the
appendage and the electrode.
30. The lead electrode assembly of claim 29, wherein the flexible
joining material is capable of allowing the appendage to fold such
that the appendage lies parallel to the top surface of the
electrode.
31. The lead electrode assembly of claim 20, wherein the appendage
is coupled to the electrode and extends from the at least one side
of the electrode.
32. The lead electrode assembly of claim 31, wherein the appendage
is substantially parallel to the top surface of the electrode.
33. The lead electrode assembly of claim 1, wherein the electrode
comprises a mesh of metallic material.
34. The lead electrode assembly of claim 33, wherein the metallic
material is selected from the group consisting essentially of
titanium, nickel alloys, stainless steel alloys, platinum, platinum
iridium, and mixtures thereof.
35. The lead electrode assembly of claim 1, wherein the electrode
comprises a substantially flat sheet of metallic material.
36. The lead electrode assembly of claim 35, wherein the metallic
material is selected from the group consisting essentially of
titanium, nickel alloys, stainless steel alloys, platinum, platinum
iridium, and mixtures thereof.
37. The lead electrode assembly of claim 33, wherein the appendage
is substantially fin-shaped.
38. The lead electrode assembly of claim 37, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom appendage.
39. The lead electrode assembly of claim 33, wherein the appendage
is substantially planar.
40. The lead electrode assembly of claim 39, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
41. The lead electrode assembly of claim 39, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
42. The lead electrode assembly of claim 39, wherein the appendage
extends substantially perpendicular to the electrode.
43. The lead electrode assembly of claim 39, wherein the appendage
extends substantially parallel to the electrode.
44. The lead electrode assembly of claim 33, wherein the appendage
is substantially loop-shaped.
45. The lead electrode assembly of claim 33, wherein the appendage
is substantially tube-shaped.
46. The lead electrode assembly of claim 45, wherein a proximal end
of the substantially tube-shaped appendage is closed.
47. The lead electrode assembly of claim 45, wherein the tube is
substantially cylindrical.
48. The lead electrode assembly of claim 1, wherein the lead
electrode assembly further comprises a lead coupled to the
electrode.
49. The lead electrode assembly of claim 48, wherein the lead
comprises one or more electrical conductors electrically coupled to
the electrode.
50. The lead electrode assembly of claim 49, wherein the lead
further comprises an electrically insulating sheath, enclosing the
one or more electrical conductors.
51. The lead electrode assembly of claim 48, wherein the lead
electrode assembly further comprises a connector coupled to the
lead.
52. The lead electrode assembly of claim 51, wherein the connector
is electrically coupled to the electrode.
53. The lead electrode assembly of claim 48, wherein the lead is
between approximately 5 cm and approximately 52 cm in length.
54. The lead electrode assembly of claim 53, wherein the lead is
between approximately 5 cm and approximately 30 cm in length.
55. The lead electrode assembly of claim 54, wherein the lead is
between approximately 10 cm and approximately 20 cm in length.
56. The lead electrode assembly of claim 53, wherein the lead
length is one of a plurality of pre-set lengths.
57. The lead electrode assembly of claim 56, wherein the pre-set
lengths vary by approximately 10 cm.
58. The lead electrode assembly of claim 48, wherein the lead has a
proximal end and a distal end and wherein the proximal end of the
lead is coupled to the electrode.
59. The lead electrode assembly of claim 58, wherein the lead
electrode assembly further comprises a lead fastener coupled
between the proximal end of the lead and the electrode.
60. The lead electrode assembly of claim 59, wherein the appendage
is coupled to the electrode along an interface line intersecting
the lead fastener.
61. The lead electrode assembly of claim 60, wherein the appendage
is substantially fin-shaped.
62. The lead electrode assembly of claim 61, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom appendage.
63. The lead electrode assembly of claim 60, wherein the appendage
is substantially planar.
64. The lead electrode assembly of claim 63, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
65. The lead electrode assembly of claim 63, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
66. The lead electrode assembly of claim 63, wherein the appendage
has an eyelet therein.
67. The lead electrode assembly of claim 63, wherein the appendage
is substantially tube-shaped.
68. The lead electrode assembly of claim 67, wherein a proximal end
of the substantially tube-shaped appendage is closed.
69. The lead electrode assembly of claim 67, wherein the tube is
substantially cylindrical.
70. The lead electrode assembly of claim 59, wherein the appendage
is coupled to the electrode along an interface line and wherein the
lead is coupled to the lead fastener along a line of the lead that
is substantially parallel to the interface line.
71. The lead electrode assembly of claim 70, wherein the appendage
is substantially fin-shaped.
72. The lead electrode assembly of claim 71, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom appendage.
73. The lead electrode assembly of claim 71, wherein the appendage
is substantially planar.
74. The lead electrode assembly of claim 73, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
75. The lead electrode assembly of claim 73, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
76. The lead electrode assembly of claim 71, wherein the appendage
has an eyelet therein.
77. The lead electrode assembly of claim 71, wherein the appendage
is substantially tube-shaped.
78. The lead electrode assembly of claim 77, wherein a proximal end
of the substantially tube-shaped appendage is closed.
79. The lead electrode assembly of claim 77, wherein the tube is
substantially cylindrical.
80. The lead electrode assembly of claim 70, wherein the interface
line and the line of the lead are the same line.
81. The lead electrode assembly of claim 80, wherein the appendage
is substantially fin-shaped.
82. The lead electrode assembly of claim 81, wherein the appendage
comprises proximal edge, a distal edge, a top and a bottom and
wherein the proximal edge is closer to the distal edge at the top
of the appendage than at the bottom appendage.
83. The lead electrode assembly of claim 80, wherein the appendage
is substantially planar.
84. The lead electrode assembly of claim 83, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the top
of the appendage than at the bottom of the appendage.
85. The lead electrode assembly of claim 83, wherein the appendage
comprises first face, a second face, a top and a bottom and wherein
the first face and the second face are closer together at the
bottom of the appendage than at the top of the appendage.
86. The lead electrode assembly of claim 81, wherein the appendage
has an eyelet therein.
87. The lead electrode assembly of claim 59, wherein the appendage
is substantially tube-shaped.
88. The lead electrode assembly of claim 87, wherein a proximal end
of the substantially tube-shaped appendage is closed.
89. The lead electrode assembly of claim 87, wherein the tube is
substantially cylindrical.
90. The lead electrode assembly of claim 1, wherein the length of
the appendage is between approximately 2 mm and approximately 6
cm.
91. The lead electrode assembly of claim 1, wherein the length of
the appendage is less than the length of the electrode.
92. The lead electrode assembly of claim 91, wherein the appendage
length is less than 6 cm.
93. The lead electrode assembly of claim 91, wherein the appendage
is coupled to the electrode along an interface line and the length
of the appendage and the length of the electrode are measured along
the interface line.
94. The lead electrode assembly of claim 93, wherein the electrode
has a proximal end and a distal end and wherein the appendage is
closer to the proximal end of the electrode than the distal end of
the electrode.
95. The lead electrode assembly of claim 94, wherein the lead
electrode assembly further comprises a lead, wherein the lead is
coupled to the electrode closer to the distal end of the electrode
than the proximal end of the electrode.
96. The lead electrode assembly of claim 94, wherein the appendage
is positioned less than 20 mm from the proximal end of the
electrode.
97. The lead electrode assembly of claim 1, wherein the appendage
is attached directly to the electrode.
98. The lead electrode assembly of claim 1, wherein the electrode
is flexible.
99. The lead electrode assembly of claim 1, where in the lead
electrode assembly further comprises a plurality of adjacent
backing layers, wherein the plurality of adjacent backing layers
includes a layer positioned furthest from the electrode and a layer
positioned closest to the electrode, wherein the layer positioned
furthest from the electrode is attached to the appendage and
wherein the layer positioned closest to the electrode is attached
to the electrode.
100. The lead electrode assembly of claim 1 further comprising a
backing layer coupled between the appendage and the electrode.
101. The lead electrode assembly of claim 100, wherein the backing
layer comprises a polymeric material.
102. The lead electrode assembly of claim 101, wherein the
polymeric material is selected from the group consisting
essentially of a polyurethane, a polyamide, a polyetheretherketone
(PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene
(PTFE), a silicone, and mixtures thereof.
103. The lead electrode assembly of claim 100, wherein the
electrode is flexible and wherein the backing layer is
flexible.
104. The lead electrode assembly of claim 100, wherein the backing
layer comprises an inside face and an outside face, wherein the
backing layer is coupled to the electrode such that at least part
of the inside face of the backing layer faces and is parallel to
the electrode, and wherein the appendage is coupled to the outside
face of the backing layer.
105. The lead electrode assembly of claim 104, wherein the
appendage is substantially planar.
106. The lead electrode assembly of claim 104, wherein the backing
layer comprises a first section of material and a second section of
material, wherein a portion of the inside face of the first section
of material is coupled to the electrode, wherein a portion of the
inside face of the second section of material is coupled to the
electrode, and wherein a portion of the inside face of the first
section of material is coupled to a portion of the inside face of
the second section of material such that an appendage is
formed.
107. The lead electrode assembly of claim 106, wherein the
appendage is substantially fin-shaped.
108. The lead electrode assembly of claim 107, wherein the
appendage comprises proximal edge, a distal edge, a top and a
bottom and wherein the proximal edge is closer to the distal edge
at the top of the appendage than at the bottom appendage.
109. The lead electrode assembly of claim 104, wherein the
appendage is attached to the backing layer by stitching.
110. The lead electrode assembly of claim 100, wherein the lead
electrode assembly further comprises a molded cover covering the
backing layer and appendage.
111. The lead electrode assembly of claim 110, wherein the molded
cover comprises a polymeric material.
112. The lead electrode assembly of claim 111, wherein the
polymeric material is selected from the group consisting
essentially of a polyurethane, a polyamide, a polyetheretherketone
(PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene
(PTFE), a silicone, and mixtures thereof.
113. The lead electrode assembly of claim 110, wherein the
electrode comprises a front face, a back face, a periphery and a
center, wherein the front face faces away from the backing layer,
wherein the molded cover covers the periphery of the front face and
wherein the cover does not cover the center of the front face.
114. The lead electrode assembly of claim 1, wherein the electrode
has a curved shape.
115. The lead electrode assembly of claim 114, wherein the
electrode is curved with a radius between approximately 5 cm and
approximately 35 cm.
116. The lead electrode assembly of claim 115, wherein the radius
is one of a plurality of pre-set radii.
117. The lead electrode assembly of claim 116, wherein the pre-set
radii vary by approximately 10 cm.
118. An implantable cardioverter-defibrillator for subcutaneous
positioning between the third rib and the twelfth rib within a
patient, the implantable cardioverter-defibrillator comprising: a
housing; and a lead electrode assembly coupled to the housing,
wherein the lead electrode assembly comprises: an electrode; and an
appendage coupled to the electrode for positioning the lead
electrode assembly.
119. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage is substantially fin-shaped.
120. The implantable cardioverter-defibrillator of claim 119,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom of the
appendage.
121. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage is substantially planar.
122. The implantable cardioverter-defibrillator of claim 121,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
123. The implantable cardioverter-defibrillator of claim 121,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
124. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage has an eyelet therein.
125. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage is substantially loop-shaped.
126. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage is substantially tube-shaped.
127. The implantable cardioverter-defibrillator of claim 126,
wherein a proximal end of the substantially tube-shaped appendage
is closed.
128. The implantable cardioverter-defibrillator of claim 126,
wherein the appendage is substantially cylindrical.
129. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage comprises a polymeric material.
130. The implantable cardioverter-defibrillator of claim 129,
wherein the polymeric material is selected from the group
consisting essentially of a polyurethane, a polyamide, a
polyetheretherketone (PEEK), a polyether block amide (PEBA), a
polytetrafluoroethylene (PTFE), a silicone, and mixtures
thereof.
131. The implantable cardioverter-defibrillator of claim 118,
wherein the electrode is substantially planar.
132. The implantable cardioverter-defibrillator of claim 131,
wherein the electrode is substantially rectangular in shape.
133. The implantable cardioverter-defibrillator of claim 132,
wherein the electrode has rounded corners.
134. The implantable cardioverter-defibrillator of claim 131,
wherein the electrode comprises a top surface, a bottom surface and
at least one side.
135. The implantable cardioverter-defibrillator of claim 134,
wherein the appendage is substantially fin-shaped.
136. The implantable cardioverter-defibrillator of claim 135,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
137. The implantable cardioverter-defibrillator of claim 134,
wherein the appendage is substantially planar.
138. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
139. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
140. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage is substantially perpendicular to the top
surface of the electrode.
141. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage is less than 10 mm in height.
142. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage is flexible.
143. The implantable cardioverter-defibrillator of claim 142,
wherein the appendage is substantially perpendicular to the top
surface of the electrode and wherein the appendage is capable of
flexing when force is applied to it, so that the appendage is no
longer substantially perpendicular to the top surface of the
electrode.
144. The implantable cardioverter-defibrillator of claim 143,
wherein the appendage is capable of flexing when force is applied
to it, so that the appendage lies substantially parallel to the top
surface of the electrode.
145. The implantable cardioverter-defibrillator of claim 140,
wherein the appendage is rigid.
146. The implantable cardioverter-defibrillator of claim 145,
wherein the lead electrode assembly further comprises flexible
joining material, wherein the flexible joining material is coupled
between the appendage and the electrode.
147. The implantable cardioverter-defibrillator of claim 146,
wherein the flexible joining material is capable of allowing the
appendage to fold such that the appendage lies parallel to the top
surface of the electrode.
148. The implantable cardioverter-defibrillator of claim 137,
wherein the appendage is coupled to the electrode and extends from
the at least one side of the electrode.
149. The implantable cardioverter-defibrillator of claim 148,
wherein the appendage is substantially parallel to the top surface
of the electrode.
150. The implantable cardioverter-defibrillator of claim 118,
wherein the electrode comprises a mesh of metallic material.
151. The implantable cardioverter-defibrillator of claim 150,
wherein the metallic material is selected from the group consisting
essentially of titanium, nickel alloys, stainless steel alloys,
platinum, platinum iridium, and mixtures thereof.
152. The implantable cardioverter-defibrillator of claim 118,
wherein the electrode comprises a substantially flat sheet of
metallic material.
153. The implantable cardioverter-defibrillator of claim 152,
wherein the metallic material is selected from the group consisting
essentially of titanium, nickel alloys, stainless steel alloys,
platinum, platinum iridiuma, and mixtures thereof.
154. The implantable cardioverter-defibrillator of claim 150,
wherein the appendage is substantially fin-shaped.
155. The implantable cardioverter-defibrillator of claim 154,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
156. The implantable cardioverter-defibrillator of claim 150,
wherein the appendage is substantially planar.
157. The implantable cardioverter-defibrillator of claim 156,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
158. The implantable cardioverter-defibrillator of claim 156,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
159. The implantable cardioverter-defibrillator of claim 156,
wherein the appendage extends substantially perpendicular to the
electrode.
160. The implantable cardioverter-defibrillator of claim 156,
wherein the appendage extends substantially parallel to the
electrode.
161. The implantable cardioverter-defibrillator of claim 150,
wherein the appendage is substantially loop-shaped.
162. The implantable cardioverter-defibrillator of claim 150,
wherein the appendage is substantially tube-shaped.
163. The implantable cardioverter-defibrillator of claim 162,
wherein a proximal end of the substantially tube-shaped appendage
is closed.
164. The implantable cardioverter-defibrillator of claim 162,
wherein the tube is substantially cylindrical.
165. The implantable cardioverter-defibrillator of claim 118,
wherein the lead electrode assembly further comprises a lead
coupled between the electrode and the housing.
166. The implantable cardioverter-defibrillator of claim 165,
wherein the lead comprises one or more electrical conductors
electrically coupled to the electrode.
167. The implantable cardioverter-defibrillator of claim 166,
wherein the lead further comprises an electrically insulating
sheath, enclosing the one or more electrical conductors.
168. The implantable cardioverter-defibrillator of claim 165,
wherein the lead electrode assembly further comprises a connector
coupled to the lead.
169. The implantable cardioverter-defibrillator of claim 168,
wherein the connector is electrically coupled to the electrode.
170. The implantable cardioverter-defibrillator of claim 165,
wherein the lead is between approximately 5 cm and approximately 52
cm in length.
171. The implantable cardioverter-defibrillator of claim 170,
wherein the lead is between approximately 5 cm and approximately 30
cm in length.
172. The implantable cardioverter-defibrillator of claim 171,
wherein the lead is between approximately 10 cm and approximately
20 cm in length.
173. The implantable cardioverter-defibrillator of claim 170,
wherein the lead length is one of a plurality of pre-set
lengths.
174. The implantable cardioverter-defibrillator of claim 173,
wherein the pre-set lengths vary by approximately 10 cm.
175. The implantable cardioverter-defibrillator of claim 165,
wherein the lead has a proximal end and a distal end and wherein
the proximal end of the lead is coupled to the electrode.
176. The implantable cardioverter-defibrillator of claim 175,
wherein the lead electrode assembly further comprises a lead
fastener coupled between the proximal end of the lead and the
electrode.
177. The implantable cardioverter-defibrillator of claim 176,
wherein the appendage is coupled to the electrode along an
interface line intersecting the lead fastener.
178. The implantable cardioverter-defibrillator of claim 177,
wherein the appendage is substantially fin-shaped.
179. The implantable cardioverter-defibrillator of claim 178,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
180. The implantable cardioverter-defibrillator of claim 177,
wherein the appendage is substantially planar.
181. The implantable cardioverter-defibrillator of claim 180,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
182. The implantable cardioverter-defibrillator of claim 180,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
183. The implantable cardioverter-defibrillator of claim 180,
wherein the appendage has an eyelet therein.
184. The implantable cardioverter-defibrillator of claim 180,
wherein the appendage is substantially tube-shaped.
185. The implantable cardioverter-defibrillator of claim 184,
wherein a proximal end of the substantially tube-shaped appendage
is closed.
186. The implantable cardioverter-defibrillator of claim 184,
wherein the tube is substantially cylindrical.
187. The implantable cardioverter-defibrillator of claim 176,
wherein the appendage is coupled to the electrode along an
interface line and wherein the lead is coupled to the lead fastener
along a line of the lead that is substantially parallel to the
interface line.
188. The implantable cardioverter-defibrillator of claim 187,
wherein the appendage is substantially fin-shaped.
189. The implantable cardioverter-defibrillator of claim 188,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
190. The implantable cardioverter-defibrillator of claim 188,
wherein the appendage is substantially planar.
191. The implantable cardioverter-defibrillator of claim 190,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
192. The implantable cardioverter-defibrillator of claim 190,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
193. The implantable cardioverter-defibrillator of claim 188,
wherein the appendage has an eyelet therein.
194. The implantable cardioverter-defibrillator of claim 188,
wherein the appendage is substantially tube-shaped.
195. The implantable cardioverter-defibrillator of claim 194,
wherein a proximal end of the substantially tube-shaped appendage
is closed.
196. The implantable cardioverter-defibrillator of claim 194,
wherein the tube is substantially cylindrical.
197. The implantable cardioverter-defibrillator of claim 187,
wherein the interface line and the line of the lead are the same
line.
198. The implantable cardioverter-defibrillator of claim 197,
wherein the appendage is substantially fin-shaped.
199. The implantable cardioverter-defibrillator of claim 198,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
200. The implantable cardioverter-defibrillator of claim 197,
wherein the appendage is substantially planar.
201. The implantable cardioverter-defibrillator of claim 200,
wherein the appendage comprises first face, a second face, a top
and a bottom and wherein the first face and the second face are
closer together at the top of the appendage than at the bottom of
the appendage.
202. The implantable cardioverter-defibrillator of claim 200,
wherein the appendage comprises first face, a second facea, a top
and a bottom and wherein the first face and the second face are
closer together at the bottom of the appendage than at the top of
the appendage.
203. The implantable cardioverter-defibrillator of claim 198,
wherein the appendage has an eyelet therein.
204. The implantable cardioverter-defibrillator of claim 176,
wherein the appendage is substantially tube-shaped.
205. The implantable cardioverter-defibrillator of claim 204,
wherein a proximal end of the substantially tube-shaped appendage
is closed.
206. The implantable cardioverter-defibrillator of claim 204,
wherein the tube is substantially cylindrical.
207. The implantable cardioverter-defibrillator of claim 118,
wherein the length of the appendage is between approximately 2 mm
and approximately 6 cm.
208. The implantable cardioverter-defibrillator of claim 118,
wherein the length of the appendage is less than the length of the
electrode.
209. The implantable cardioverter-defibrillator of claim 208,
wherein the appendage length is less than 6 cm.
210. The implantable cardioverter-defibrillator of claim 208,
wherein the appendage is coupled to the electrode along an
interface line and the length of the appendage and the length of
the electrode are measured along the interface line.
211. The implantable cardioverter-defibrillator of claim 210,
wherein the electrode has a proximal end and a distal end and
wherein the appendage is closer to the proximal end of the
electrode than the distal end of the electrode.
212. The implantable cardioverter-defibrillator of claim 211,
wherein the lead electrode assembly further comprises a lead,
wherein the lead is coupled to the electrode closer to the distal
end of the electrode than the proximal end of the electrode.
213. The implantable cardioverter-defibrillator of claim 211,
wherein the appendage is positioned less than 20 mm from the
proximal end of the electrode.
214. The implantable cardioverter-defibrillator of claim 118,
wherein the appendage is attached directly to the electrode.
215. The implantable cardioverter-defibrillator of claim 118,
wherein the electrode is flexible.
216. The implantable cardioverter-defibrillator of claim 118, where
in the lead electrode assembly further comprises a plurality of
adjacent backing layers, wherein the plurality of adjacent backing
layers includes a layer positioned furthest from the electrode and
a layer positioned closest to the electrode, wherein the layer
positioned furthest from the electrode is attached to the appendage
and wherein the layer positioned closest to the electrode is
attached to the electrode.
217. The implantable cardioverter-defibrillator of claim 118
further comprising a backing layer coupled between the appendage
and the electrode.
218. The implantable cardioverter-defibrillator of claim 217,
wherein the backing layer comprises a polymeric material.
219. The implantable cardioverter-defibrillator of claim 218,
wherein the polymeric material is selected from the group
consisting essentially of a polyurethane, a polyamide, a
polyetheretherketone (PEEK), a polyether block amide (PEBA), a
polytetrafluoroethylene (PTFE), a silicone, and mixtures
thereof.
220. The implantable cardioverter-defibrillator of claim 217,
wherein the electrode is flexible and wherein the backing layer is
flexible.
221. The implantable cardioverter-defibrillator of claim 217,
wherein the backing layer comprises an inside face and an outside
face, wherein the backing layer is coupled to the electrode such
that at least part of the inside face of the backing layer faces
and is parallel to the electrode, and wherein the appendage is
coupled to the outside face of the backing layer.
222. The implantable cardioverter-defibrillator of claim 221,
wherein the appendage is substantially planar.
223. The implantable cardioverter-defibrillator of claim 221,
wherein the backing layer comprises a first section of material and
a second section of material, wherein a portion of the inside face
of the first section of material is coupled to the electrode, where
in a portion of the inside face of the second section of material
is coupled to the electrode, and wherein a portion of the inside
face of the first section of material is coupled to a portion of
the inside face of the second section of material such that an
appendage is formed.
224. The implantable cardioverter-defibrillator of claim 223,
wherein the appendage is substantially fin-shaped.
225. The implantable cardioverter-defibrillator of claim 224,
wherein the appendage comprises proximal edge, a distal edge, a top
and a bottom and wherein the proximal edge is closer to the distal
edge at the top of the appendage than at the bottom appendage.
226. The implantable cardioverter-defibrillator of claim 221,
wherein the appendage is attached to the backing layer by
stitching.
227. The implantable cardioverter-defibrillator of claim 217,
wherein the lead electrode assembly further comprises a molded
cover covering the backing layer and appendage.
228. The implantable cardioverter-defibrillator of claim 227,
wherein the molded cover comprises a polymeric material.
229. The implantable cardioverter-defibrillator of claim 228,
wherein the polymeric material is selected from the group
consisting essentially of a polyurethane, a polyamide, a
polyetheretherketone (PEEK), a polyether block amide (PEBA), a
polytetrafluoroethylene (PTFE), a silicone, and mixtures
thereof.
230. The implantable cardioverter-defibrillator of claim 227,
wherein the electrode comprises a front face, a back face, a
periphery and a center, wherein the front face faces away from the
backing layer, wherein the molded cover covers the periphery of the
front face and wherein the cover does not cover the center of the
front face.
231. The implantable cardioverter-defibrillator of claim 118,
wherein the electrode has a curved shape.
232. The implantable cardioverter-defibrillator of claim 231,
wherein the electrode is curved with a radius between approximately
5 cm and approximately 35 cm.
233. The implantable cardioverter-defibrillator of claim 232,
wherein the radius is one of a plurality of preset radii.
234. The implantable cardioverter-defibrillator of claim 233,
wherein the pre-set radii vary by approximately 10 cm.
235. A method for surgically implanting a lead electrode assembly
comprising an appendage for positioning the lead electrode assembly
subcutaneously outside a patient's ribcage, the method comprising
the steps of: providing a hemostat; creating a subcutaneous path
outside the ribcage; grasping the appendage of the lead electrode
assembly with the hemostat; moving the lead electrode assembly
through the path; and releasing the appendage of the lead electrode
assembly from the hemostat.
236. The method of claim 235, wherein the step of creating a
subcutaneous path outside the ribcage further comprises the steps
of: creating an incision in the thoracic region of the patient; and
creating the subcutaneous path by moving the hemostat between the
ribcage and the skin.
237. The method of claim 236, wherein the step of creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin further comprises the step of: moving the hemostat
laterally and posteriorly around the side of the patient until the
subcutaneous path terminates at a termination point such that if a
straight line were drawn from the incision to the termination
point, the line would intersect the heart of the patient.
238. The method of claim 236, wherein the step of creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin further comprises the step of: moving the hemostat
laterally and posteriorly around the side of the patient until the
subcutaneous path terminates at a termination point within 10 cm of
the spine of the patient between the third and twelfth rib.
239. The method of claim 236, wherein the incision in the thoracic
region of the patient is in the anterior of the thorax.
240. The method of claim 235, wherein the hemostat has a curved
shape.
241. A method for surgically implanting a lead electrode assembly
with a fin-shaped appendage comprising an eyelet for positioning
the lead electrode assembly subcutaneously outside a patient's
ribcage, comprising the steps of: providing a hemostat comprising
two prongs and a pin on at least one prong; creating a subcutaneous
path outside the ribcage; placing the pin on said at least one
prong of the hemostat through the eyelet on the fin-shaped
appendage of the lead electrode assembly; moving the lead electrode
through the path; and moving the hemostat until the pin comes out
of the eyelet in the fin-shaped appendage.
242. The method of claim 241, wherein the step of creating a
subcutaneous path outside the ribcage further comprises the steps
of: creating an incision in the thoracic region of the patient;
introducing the hemostat into the incision; creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin; and retracting the hemostat.
243. The method of claim 241, wherein the step of creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin further comprises the step of: moving the hemostat
laterally and posteriorly around the side of the patient.
244. The method of claim 241, wherein the step of creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin further comprises the step of: moving the hemostat until
the subcutaneous path terminates at a termination point such that
if a straight line were drawn from the incision to the termination
point, the line would intersect the heart of the patient.
245. The method of claim 241, wherein the step of creating the
subcutaneous path by moving the hemostat between the ribcage and
the skin further comprises the step of: moving the hemostat until
the subcutaneous path terminates at a termination point near the
patient's spine between the third and twelfth rib.
246. The method of claim 241, wherein the incision in the thoracic
region of the patient is in the anterior of the thorax.
247. The method of claim 241, wherein the hemostat has a curved
shape.
248. A method of providing effective energy via subcutaneous
electrodes in the thorax of a patient, the method comprising the
steps of: providing an implantable cardioverter-defibrillator
comprising: a housing comprising a housing electrode, a lead
comprising a proximal and distal end, and a lead electrode assembly
comprising a lead electrode assembly electrode, wherein the housing
is connected to the proximal end of the lead and the lead electrode
assembly is connected to the distal end of the lead; implanting the
housing subcutaneously in the posterolateral thorax; implanting the
lead electrode assembly in a position approximately lateral to the
tip of the left inferior portion of the scapula; and implanting the
lead circumferentially around the thorax.
249. The method of claim 248, further comprising the step of:
releasing effective energy via the housing electrode and the lead
electrode assembly electrode.
250. A subcutaneous implantable cardioverter-defibrillator kit for
use in surgically implanting a subcutaneous implantable
cardioverter-defibrillat- or and lead electrode assembly within a
patient comprising: a tray; and a lead electrode assembly
comprising an appendage for positioning the lead electrode assembly
within the patient stored in the tray.
251. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising a hemostat stored in the tray.
252. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising a hemostat with two prongs comprising
a pin on at least one prong stored in the tray.
253. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising a subcutaneous implantable
cardioverter-defibrillator stored in the tray.
254. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising a medical adhesive stored in the
tray.
255. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising an anesthetic stored in the tray.
256. The subcutaneous implantable cardioverter-defibrillator kit of
claim 250, further comprising a tube of mineral oil stored in the
tray.
257. A lead electrode assembly manipulation tool for use in
surgically implanting a lead electrode assembly with an appendage
containing an eyelet for positioning the lead electrode assembly
within a patient comprising: a hemostat comprising a first prong, a
second prong and a pin attached to the first prong for hooking into
the eyelet of the appendage.
258. The lead electrode assembly manipulation tool of claim 257,
wherein the first prong and the second prong are curved.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
patent application entitled "SUBCUTANEOUS ONLY IMPLANTABLE
CARDIOVERTER-DEFIBRILLATOR AND OPTIONAL PACER," having Ser. No.
09/663,606, filed Sep. 18, 2000, pending, and U.S. patent
application entitled "UNITARY SUBCUTANEOUS ONLY IMPLANTABLE
CARDIOVERTER-DEFIBRILLATO- R AND OPTIONAL PACER," having Ser. No.
09/663,607, filed Sep. 18, 2000, pending, of which both
applications are assigned to the assignee of the present
application, and the disclosures of both applications are hereby
incorporated by reference.
[0002] In addition, the present application is filed concurrently
herewith U.S. patent application entitled "DUCKBILL-SHAPED
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND METHOD OF USE," U.S.
patent application entitled "CERAMICS AND/OR OTHER MATERIAL
INSULATED SHELL FOR ACTIVE AND NONACTIVE S-ICD CAN," U.S. patent
application entitled "SUBCUTANEOUS ELECTRODE WITH IMPROVED CONTACT
SHAPE FOR TRANSTHORACIC CONDUCTION," U.S. patent application
entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH
HIGHLY MANEUVERABLE INSERTION TOOL," U.S. patent application
entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH
LOW-PROFILE INSTALLATION APPENDAGE AND METHOD OF DOING SAME," U.S.
patent application entitled "SUBCUTANEOUS ELECTRODE FOR
TRANSTHORACIC CONDUCTION WITH INSERTION TOOL," U.S. patent
application entitled "METHOD OF INSERTION AND IMPLANTATION FOR
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR CANISTERS," U.S. patent
application entitled "CANISTER DESIGNS FOR IMPLANTABLE
CARDIOVERTER-DEFIBRILLATORS," U.S. patent application entitled
"RADIAN CURVED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR CANISTER,"
U.S. patent application entitled "CARDIOVERTER-DEFIBRILLATOR HAVING
A FOCUSED SHOCKING AREA AND ORIENTATION THEREOF," U.S. patent
application entitled "BIPHASIC WAVEFORM FOR ANTIBRADYCARDIA PACING
FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR," U.S.
patent application entitled "BIPHASIC WAVEFORM FOR ANTI-TACHYCARDIA
PACING FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,"
and U.S. patent application entitled "POWER SUPPLY FOR A
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR," the
disclosures of which applications are hereby incorporated by
reference.
FIELD OF THE INVENTION
[0003] The present invention relates to an apparatus and method for
performing electrical cardioversion/defibrillation and optional
pacing of the heart via a totally subcutaneous non-transvenous
system.
BACKGROUND OF THE INVENTION
[0004] Defibrillation/cardioversion is a technique employed to
counter arrhythmic heart conditions including some tachycardias in
the atria and/or ventricles. Typically, electrodes are employed to
stimulate the heart with electrical impulses or shocks, of a
magnitude substantially greater than pulses used in cardiac
pacing.
[0005] Defibrillation/cardioversion systems include body
implantable electrodes and are referred to as implantable
cardioverter/defibrillators (ICDs). Such electrodes can be in the
form of patches applied directly to epicardial tissue, or at the
distal end regions of intravascular catheters, inserted into a
selected cardiac chamber. U.S. Pat. Nos. 4,603,705, 4,693,253,
4,944,300, 5,105,810, the disclosures of which are all incorporated
herein by reference, disclose intravascular or transvenous
electrodes, employed either alone or in combination with an
epicardial patch electrode. Compliant epicardial defibrillator
electrodes are disclosed in U.S. Pat. Nos. 4,567,900 and 5,618,287,
the disclosures of which are incorporated herein by reference. A
sensing epicardial electrode configuration is disclosed in U.S. Pat
No. 5,476,503, the disclosure of which is incorporated herein by
reference.
[0006] In addition to epicardial and transvenous electrodes,
subcutaneous electrode systems have also been developed. For
example, U.S. Pat. Nos. 5,342,407 and 5,603,732, the disclosures of
which are incorporated herein by reference, teach the use of a
pulse monitor/generator surgically implanted into the abdomen and
subcutaneous electrodes implanted in the thorax. This system is far
more complicated to use than current ICD systems using transvenous
lead systems together with an active can electrode and therefore it
has o practical use. It has in fact never been used because of the
surgical difficulty of applying such a device (3 incisions), the
impractical abdominal location of the generator and the
electrically poor sensing and defibrillation aspects of such a
system.
[0007] Recent efforts to improve the efficiency of ICDs have led
manufacturers to produce ICDs which are small enough to be
implanted in the pectoral region. In addition, advances in circuit
design have enabled the housing of the ICD to form a subcutaneous
electrode. Some examples of ICDs in which the housing of the ICD
serves as an optional additional electrode are described in U.S.
Pat. Nos. 5,133,353, 5,261,400, 5,620,477, and 5,658,321 the
disclosures of which are incorporated herein by reference.
[0008] ICDs are now an established therapy for the management of
life threatening cardiac rhythm disorders, primarily ventricular
fibrillation (V-Fib). ICDs are very effective at treating V-Fib,
but are therapies that still require significant surgery.
[0009] As ICD therapy becomes more prophylactic in nature and used
in progressively less ill individuals, especially children at risk
of cardiac arrest, the requirement of ICD therapy to use
intravenous catheters and transvenous leads is an impediment to
very long term management as most individuals will begin to develop
complications related to lead system malfunction sometime in the
5-10 year time frame, often earlier. In addition, chronic
transvenous lead systems, their reimplantation and removals, can
damage major cardiovascular venous systems and the tricuspid valve,
as well as result in life threatening perforations of the great
vessels and heart. Consequently, use of transvenous lead systems,
despite their many advantages, are not without their chronic
patient management limitations in those with life expectancies of
>5 years. The problem of lead complications is even greater in
children where body growth can substantially alter transvenous lead
function and lead to additional cardiovascular problems and
revisions. Moreover, transvenous ICD systems also increase cost and
require specialized interventional rooms and equipment as well as
special skill for insertion. These systems are typically implanted
by cardiac electrophysiologists who have had a great deal of extra
training.
[0010] In addition to the background related to ICD therapy, the
present invention requires a brief understanding of automatic
external defibrillator (AED) therapy. AEDs employ the use of
cutaneous patch electrodes to effect defibrillation under the
direction of a bystander user who treats the patient suffering from
V-Fib. AEDs can be as effective as an ICD if applied to the victim
promptly within 2 to 3 minutes.
[0011] AED therapy has great appeal as a tool for diminishing the
risk of death in public venues such as in air flight. However, an
AED must be used by another individual, not the person suffering
from the potential fatal rhythm. It is more of a public health tool
than a patient-specific tool like an ICD. Because >75% of
cardiac arrests occur in the home, and over half occur in the
bedroom, patients at risk of cardiac arrest are often alone or
asleep and can not be helped in time with an AED. Moreover, its
success depends to a reasonable degree on an acceptable level of
skill and calm by the bystander user.
[0012] What is needed therefore, especially for children and for
prophylactic long term use, is a combination of the two forms of
therapy which would provide prompt and near-certain defibrillation,
like an ICD, but without the long-term adverse sequelae of a
transvenous lead system while simultaneously using most of the
simpler and lower cost technology of an AED. What is also needed is
a cardioverter/defibrillator that is of simple design and can be
comfortably implanted in a patient for many years.
SUMMARY OF THE INVENTION
[0013] One embodiment of the present invention provides a lead
electrode assembly for subcutaneous implantation including an
electrode; and an appendage coupled to the electrode for
positioning the lead electrode assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] For a better understanding of the invention, reference is
now made to the drawings where like numerals represent similar
objects throughout the figures where:
[0015] FIG. 1 is a schematic view of a Subcutaneous ICD (SICD) of
the present invention;
[0016] FIG. 2 is a schematic view of an alternate embodiment of a
subcutaneous electrode of the present invention;
[0017] FIG. 3 is a schematic view of an alternate embodiment of a
subcutaneous electrode of the present invention;
[0018] FIG. 4 is a schematic view of the S-ICD and lead of FIG. 1
subcutaneously implanted in the thorax of a patient;
[0019] FIG. 5 is a schematic view of the S-ICD and lead of FIG. 2
subcutaneously implanted in an alternate location within the thorax
of a patient;
[0020] FIG. 6 is a schematic view of the S-ICD and lead of FIG. 3
subcutaneously implanted in the thorax of a patient;
[0021] FIG. 7 is a schematic view of the method of making a
subcutaneous path from the preferred incision and housing
implantation point to a termination point for locating a
subcutaneous electrode of the present invention;
[0022] FIG. 8 is a schematic view of an introducer set for
performing the method of lead insertion of any of the described
embodiments;
[0023] FIG. 9 is a schematic view of an alternative S-ICD of the
present invention illustrating a lead subcutaneously and
serpiginously implanted in the thorax of a patient for use
particularly in children;
[0024] FIG. 10 is a schematic view of an alternate embodiment of an
S-ICD of the present invention;
[0025] FIG. 11 is a schematic view of the S-ICD of FIG. 10
subcutaneously implanted in the thorax of a patient;
[0026] FIG. 12 is a schematic view of yet a further embodiment
where the canister of the S-ICD of the present invention is shaped
to be particularly useful in placing subcutaneously adjacent and
parallel to a rib of a patient; and
[0027] FIG. 13 is a schematic of a different embodiment where the
canister of the S-ICD of the present invention is shaped to be
particularly useful in placing subcutaneously adjacent and parallel
to a rib of a patient.
[0028] FIG. 14 is a schematic view of a Unitary Subcutaneous ICD
(US-ICD) of the present invention;
[0029] FIG. 15 is a schematic view of the US-ICD subcutaneously
implanted in the thorax of a patient;
[0030] FIG. 16 is a schematic view of the method of making a
subcutaneous path from the preferred incision for implanting the
US-ICD.
[0031] FIG. 17 is a schematic view of an introducer for performing
the method of US-ICD implantation; and
[0032] FIG. 18 is an exploded schematic view of an alternate
embodiment of the present invention with a plug-in portion that
contains operational circuitry and means for generating
cardioversion/defibrillation shock waves.
[0033] FIG. 14 (a) is a side plan view of an embodiment of a lead
electrode assembly with a top-mounted fin;
[0034] FIG. 14(b) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted fin;
[0035] FIG. 14(c) is a side plan view of a section of the lead in
an embodiment of the lead electrode assembly;
[0036] FIG. 14(d) is a cross-sectional view of a filar in the lead
in an embodiment of the lead electrode assembly;
[0037] FIG. 14(e) is a cross-sectional view of the lead fastener of
an embodiment of a lead electrode assembly;
[0038] FIG. 14(f) is an exploded view of the lead fastener of an
embodiment of a lead electrode assembly;
[0039] FIG. 15(a) is a cross-sectional front plan view of an
embodiment of a lead electrode assembly with a top-mounted fin;
[0040] FIG. 15(b) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted fin;
[0041] FIG. 16(a) is a perspective view of an embodiment of a lead
electrode assembly with a top-mounted fin;
[0042] FIG. 17(a) is a cross-sectional side plan view of an
embodiment of a lead electrode assembly with a top-mounted fin and
a molded cover;
[0043] FIG. 17(b) is a cross-sectional side plan view of an
embodiment of a lead electrode assembly with a top-mounted fin that
is slope-shaped and a molded cover;
[0044] FIG. 17(c) is cross-sectional front plan view of an
embodiment of a lead electrode assembly with a top-mounted fin and
a molded cover;
[0045] FIG. 17(d) is an exploded top plan view of the lead fastener
in an embodiment of a lead electrode assembly with a top-mounted
fin and a molded cover;
[0046] FIG. 17(e) is a bottom plan view of an embodiment of a lead
electrode assembly with a top-mounted fin and a molded cover;
[0047] FIG. 17(f) is a side plan view of an embodiment of a lead
electrode assembly with a top-mounted fin and a molded cover;
[0048] FIG. 17(g) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted fin and a molded cover;
[0049] FIG. 18(a) is a side plan view of an embodiment of a lead
electrode assembly with an elongated top-mounted fin and a molded
cover;
[0050] FIG. 18(b) is a top plan view of an embodiment of a lead
electrode assembly with an elongated top-mounted fin and a molded
cover;
[0051] FIG. 18(c) is a bottom plan view of an embodiment of a lead
electrode assembly with an elongated top-mounted fin and a molded
cover;
[0052] FIG. 19 is a side plan view of a lead electrode assembly
demonstrating the curvature of the electrode;
[0053] FIG. 20(a) is a top plan view of the backing layer and
electrode of an embodiment of a lead electrode assembly with a
side-mounted fin;
[0054] FIG. 20(b) is a side plan view of the backing layer and
electrode of an embodiment of a lead electrode assembly with a
side-mounted fin;
[0055] FIG. 20(c) is a bottom plan view of an embodiment of a lead
electrode assembly with a side-mounted fin;
[0056] FIG. 20(d) is a bottom plan view of an embodiment of a lead
electrode assembly with a side-mounted fin with a slope-shape;
[0057] FIG. 21(a) is a side plan view of a lead electrode assembly
with a top-mounted loop;
[0058] FIG. 21(b) is a cross-sectional rear plan view of a lead
electrode assembly with a top-mounted loop;
[0059] FIG. 21(c) is a top plan view of a lead electrode assembly
with a top-mounted loop;
[0060] FIG. 22(a) is a top plan view of a backing layer for use in
an embodiment of a lead electrode assembly with a top-mounted fin
formed as part of the backing layer;
[0061] FIG. 22(b) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted fin formed as part of the
backing layer;
[0062] FIG. 22(c) is a side plan view of an embodiment of a lead
electrode assembly with a top-mounted fin formed as part of the
backing layer;
[0063] FIG. 22(d) is a front plan view of an embodiment of a lead
electrode assembly with a top-mounted fin formed as part of a
backing layer;
[0064] FIG. 22(e) is a side plan view of an embodiment of a lead
electrode assembly with a top-mounted fin formed as part of a
two-piece backing layer;
[0065] FIG. 22(f) is a front plan view of an embodiment of a lead
electrode assembly with a top-mounted fin formed as part of a
two-piece backing layer;
[0066] FIG. 23(a) is a front plan view of the embodiment of the
lead electrode assembly of FIG. 22(e) and (f) in an upright
position;
[0067] FIG. 23(b) is a front plan view of the embodiment of the
lead electrode assembly of FIG. 22(e) and (f) illustrating the
ability of the fin to fold;
[0068] FIG. 24(a) is a front plan view of an embodiment of a lead
electrode assembly with a top-mounted tube formed as part of a
backing layer;
[0069] FIG. 24(b) is a side plan view of an embodiment of a lead
electrode assembly with a top-mounted tube formed as part of a
backing layer;
[0070] FIG. 24(c) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted tube formed as part of a
backing layer;
[0071] FIG. 25(a) is a front plan view of an embodiment of a lead
electrode assembly with a top-mounted fin connected with flexible
joining material in an upright position;
[0072] FIG. 25(b) is a front plan view of an embodiment of a lead
electrode assembly with a top-mounted fin connected with flexible
joining material in a folded position;
[0073] FIG. 25(c) is a top plan view of an embodiment of a lead
electrode assembly with a top-mounted fin connected with flexible
joining material in an upright position;
[0074] FIG. 26 is a perspective view of an embodiment of a lead
electrode assembly in which the appendage is a cylindrical
tube;
[0075] FIG. 27 is a perspective view of an embodiment of a lead
electrode assembly in which the appendage is a tube with a
substantially triangular cross section;
[0076] FIGS. 28(a)-(d) are top plan views of embodiments of lead
electrode assemblies illustrating shapes of the electrode and the
lines of the lead;
[0077] FIGS. 28(e)-(h) are bottom plan views of embodiments of lead
electrode assemblies illustrating shapes of the electrode;
[0078] FIG. 29 is a perspective view of a custom hemostat for lead
electrode assembly implantation;
[0079] FIG. 30(a) is a perspective view of a patient's ribcage
showing the orientation of the components in an implanted S-ICD
system;
[0080] FIG. 30(b) is a cross-sectional side plan view of a
patient's rib cage, skin, fat and the lead of the lead electrode
assembly;
[0081] FIG. 31 is a front plan view illustrating the incision point
for the surgery to implant the lead electrode assembly;
[0082] FIG. 32(a) is a cross-sectional bottom plan view of a
patient along line 32(a) of FIG. 31 illustrating the creation of a
subcutaneous path for implantation of the lead electrode assembly
of an S-ICD system;
[0083] FIG. 32(b) is a perspective view of a lead electrode
assembly captured by a custom hemostat;
[0084] FIG. 32(c) is a cross-sectional bottom plan view of a
patient along line 32(a) of FIG. 31 illustrating the implantation
of a lead electrode assembly via the subcutaneous path;
[0085] FIG. 32(d) is a top view of a lead electrode assembly
captured by a custom hemostat;
[0086] FIG. 33(a) is a perspective view of a rail of an embodiment
of the lead electrode assembly;
[0087] FIG. 33(b) is a cross-sectional front plan view of an
embodiment of the lead electrode assembly where the appendage is a
rail;
[0088] FIG. 33(c) is a top plan view of an embodiment of the lead
electrode assembly where the appendage is a rail;
[0089] FIG. 34 is a top view of an embodiment of the lead electrode
assembly where the appendage is a rail;
[0090] FIG. 35(a) is a perspective view of a lead electrode
assembly manipulation tool with a rail fork;
[0091] FIG. 35(b) is a top plan view of a lead electrode assembly
manipulation tool with a rail fork;
[0092] FIG. 35(c) is a side plan view of a lead electrode assembly
manipulation tool with a rail fork;
[0093] FIG. 35(d) is a top plan view of a lead electrode assembly
having a rail captured by a lead electrode assembly manipulation
tool with a rail fork;
[0094] FIG. 36(a) is a cross-sectional side plan view of a lead
electrode assembly with a pocket;
[0095] FIG. 36(b) is a top plan view of a lead electrode assembly
with a pocket;
[0096] FIG. 36(c) is a cross-sectional side plan view of a lead
electrode assembly with a pocket and a fin;
[0097] FIG. 37(a) is a bottom plan view of a lead electrode
assembly with a pocket;
[0098] FIG. 37(b) is a top plan view of a lead electrode assembly
with a pocket;
[0099] FIG. 38(a) is a top plan view of a lead electrode assembly
manipulation tool with a paddle;
[0100] FIG. 38(b) is a side plan view of a lead electrode assembly
manipulation tool with a paddle;
[0101] FIG. 38(c) is a top plan view of a lead electrode assembly
with a pocket captured by a lead electrode assembly manipulation
tool with a paddle;
[0102] FIG. 39(a) is a cross-sectional rear plan view of a lead
electrode assembly with a first channel guide and a second channel
guide;
[0103] FIG. 39(b) is a top plan view of a lead electrode assembly
with a first channel guide and a second channel guide;
[0104] FIG. 40(a) is a top plan view of a lead electrode assembly
manipulation tool with a channel guide fork;
[0105] FIG. 40(b) is a top plan view of a lead electrode assembly
with a first channel guide and a second channel guide captured by a
lead electrode assembly manipulation tool with a channel guide
fork;
[0106] FIG. 41(a) is a perspective view of a subcutaneous
implantable cardioverter-defibrillator kit; and
[0107] FIG. 41(b) is a perspective view of a hemostat illustrating
the length measurement.
DETAILED DESCRIPTION
[0108] Turning now to FIG. 1, the S-ICD of the present invention is
illustrated. The S-ICD consists of an electrically active canister
11 and a subcutaneous electrode 13 attached to the canister. The
canister has an electrically active surface 15 that is electrically
insulated from the electrode connector block 17 and the canister
housing 16 via insulating area 14. The canister can be similar to
numerous electrically active canisters commercially available in
that the canister will contain a battery supply, capacitor and
operational circuitry. Alternatively, the canister can be thin and
elongated to conform to the intercostal space. The circuitry will
be able to monitor cardiac rhythms for tachycardia and
fibrillation, and if detected, will initiate charging the capacitor
and then delivering cardioversion/defibrillation energy through the
active surface of the housing and to the subcutaneous electrode.
Examples of such circuitry are described in U.S. Pat. Nos.
4,693,253 and 5,105,810, the entire disclosures of which are herein
incorporated by reference. The canister circuitry can provide
cardioversion/defibrillation energy in different types of
waveforms. In the preferred embodiment, a 100 uF biphasic waveform
is used of approximately 10-20 ms total duration and with the
initial phase containing approximately 2/3 of the energy, however,
any type of waveform can be utilized such as monophasic, biphasic,
multiphasic or alternative waveforms as is known in the art.
[0109] In addition to providing cardioversion/defibrillation
energy, the circuitry can also provide transthoracic cardiac pacing
energy. The optional circuitry will be able to monitor the heart
for bradycardia and/or tachycardia rhythms. Once a bradycardia or
tachycardia rhythm is detected, the circuitry can then deliver
appropriate pacing energy at appropriate intervals through the
active surface and the subcutaneous electrode. Pacing stimuli will
be biphasic in the preferred embodiment and similar in pulse
amplitude to that used for conventional transthoracic pacing.
[0110] This same circuitry can also be used to deliver low
amplitude shocks on the T-wave for induction of ventricular
fibrillation for testing S-ICD performance in treating V-Fib as is
described in U.S. Pat. No. 5,129,392, the entire disclosure of
which is hereby incorporated by reference. Also the circuitry can
be provided with rapid induction of ventricular fibrillation or
ventricular tachycardia using rapid ventricular pacing. Another
optional way for inducing ventricular fibrillation would be to
provide a continuous low voltage, i.e., about 3 volts, across the
heart during the entire cardiac cycle.
[0111] Another optional aspect of the present invention is that the
operational circuitry can detect the presence of atrial
fibrillation as described in Olson, W. et al. "Onset And Stability
For Ventricular Tachyarrhythmia Detection in an Implantable
Cardioverter and Defibrillator," Computers in Cardiology (1986) pp.
167-170. Detection can be provided via R-R Cycle length instability
detection algorithms. Once atrial fibrillation has been detected,
the operational circuitry will then provide QRS synchronized atrial
defibrillation/cardioversion using the same shock energy and
waveshape characteristics used for ventricular
defibrillation/cardioversion.
[0112] The sensing circuitry will utilize the electronic signals
generated from the heart and will primarily detect QRS waves. In
one embodiment, the circuitry will be programmed to detect only
ventricular tachycardias or fibrillations. The detection circuitry
will utilize in its most direct form, a rate detection algorithm
that triggers charging of the capacitor once the ventricular rate
exceeds some predetermined level for a fixed period of time: for
example, if the ventricular rate exceeds 240 bpm on average for
more than 4 seconds. Once the capacitor is charged, a confirmatory
rhythm check would ensure that the rate persists for at least
another 1 second before discharge. Similarly, termination
algorithms could be instituted that ensure that a rhythm less than
240 bpm persisting for at least 4 seconds before the capacitor
charge is drained to an internal resistor. Detection, confirmation
and termination algorithms as are described above and in the art
can be modulated to increase sensitivity and specificity by
examining QRS beat-to-beat uniformity, QRS signal frequency
content, R-R interval stability data, and signal amplitude
characteristics all or part of which can be used to increase or
decrease both sensitivity and specificity of S-ICD arrhythmia
detection function.
[0113] In addition to use of the sense circuitry for detection of
V-Fib or V-Tach by examining the QRS waves, the sense circuitry can
check for the presence or the absence of respiration. The
respiration rate can be detected by monitoring the impedance across
the thorax using subthreshold currents delivered across the active
can and the high voltage subcutaneous lead electrode and monitoring
the frequency in undulation in the waveform that results from the
undulations of transthoracic impedance during the respiratory
cycle. If there is no undulation, then the patent is not respiring
and this lack of respiration can be used to confirm the QRS
findings of cardiac arrest. The same technique can be used to
provide information about the respiratory rate or estimate cardiac
output as described in U.S. Pat. Nos. 6,095,987, 5,423,326,
4,450,527, the entire disclosures of which are incorporated herein
by reference.
[0114] The canister of the present invention can be made out of
titanium alloy or other presently preferred electrically active
canister designs. However, it is contemplated that a malleable
canister that can conform to the curvature of the patient's chest
will be preferred. In this way the patient can have a comfortable
canister that conforms to the shape of the patient's rib cage.
Examples of conforming canisters are provided in U.S. Pat. No.
5,645,586, the entire disclosure of which is herein incorporated by
reference. Therefore, the canister can be made out of numerous
materials such as medical grade plastics, metals, and alloys. In
the preferred embodiment, the canister is smaller than 60 acc
volume having a weight of less than 100 gms for long term
wearability, especially in children. The canister and the lead of
the S-ICD can also use fractal or wrinkled surfaces to increase
surface area to improve defibrillation capability. Because of the
primary prevention role of the therapy and the likely need to reach
energies over 40 Joules, a feature of the preferred embodiment is
that the charge time for the therapy, intentionally e relatively
long to allow capacitor charging within the limitations of device
size. Examples of small ICD housings are disclosed in U.S. Pat Nos.
5,597,956 and 5,405,363, the entire disclosures of which are herein
incorporated by reference.
[0115] Different subcutaneous electrodes 13 of the present
invention are illustrated in FIGS. 1-3. Turning to FIG. 1, the lead
21 for the subcutaneous electrode is preferably composed of
silicone or polyurethane insulation. The electrode is connected to
the canister at its proximal end via connection port 19 which is
located on an electrically insulated area 17 of the canister. The
electrode illustrated is a composite electrode with three different
electrodes attached to the lead. In the embodiment illustrated, an
optional anchor segment 52 is attached at the most distal end of
the subcutaneous electrode for anchoring the electrode into soft
tissue such that the electrode does not dislodge after
implantation.
[0116] The most distal electrode on the composite subcutaneous
electrode is a coil electrode 27 that is used for delivering the
high voltage cardioversion/defibrillation energy across the heart.
The coil cardioversion/defibrillation electrode is about 5-10 cm in
length. Proximal to the coil electrode are two sense electrodes, a
first sense electrode 25 is located proximally to the coil
electrode and a second sense electrode 23 is located proximally to
the first sense electrode. The sense electrodes are spaced far
enough apart to be able to have good QRS detection. This spacing
can range from 1 to 10 cm with 4 cm being presently preferred. The
electrodes may or may not be circumferential with the preferred
embodiment. Having the electrodes non-circumferential and
positioned outward, toward the skin surface, is a means to minimize
muscle artifact and enhance QRS signal quality. The sensing
electrodes are electrically isolated from the
cardioversion/defibrillation electrode via insulating areas 29.
Similar types of cardioversion/defibrillation electrodes are
currently commercially available in a transvenous configuration.
For example, U.S. Pat. No. 5,534,022, the entire disclosure of
which is herein incorporated by reference, disclosures a composite
electrode with a coil cardioversion/defibrillation electrode and
sense electrodes. Modifications to this arrangement is contemplated
within the scope of the invention. One such modification is
illustrated in FIG. 2 where the two sensing electrodes 25 and 23
are non-circumferential sensing electrodes and one is located at
the distal end, the other is located proximal thereto with the coil
electrode located in between the two sensing electrodes. In this
embodiment the sense electrodes are spaced about 6 to about 12 cm
apart depending on the length of the coil electrode used. FIG. 3
illustrates yet a further embodiment where the two sensing
electrodes are located at the distal end to the composite electrode
with the coil electrode located proximally thereto. Other
possibilities exist and are contemplated within the present
invention. For example, having only one sensing electrode, either
proximal or distal to the coil cardioversion/defibrillation
electrode with the coil serving as both a sensing electrode and a
cardioversion/defibrillation electrode.
[0117] It is also contemplated within the scope of the invention
that the sensing of QRS waves (and transthoracic impedance) can be
carried out via sense electrodes on the canister housing or in
combination with the cardioversion/defibrillation coil electrode
and/or the subcutaneous lead sensing electrode(s). In this way,
sensing could be performed via the one coil electrode located on
the subcutaneous electrode and the active surface on the canister
housing. Another possibility would be to have only one sense
electrode located on the subcutaneous electrode and the sensing
would be performed by that one electrode and either the coil
electrode on the subcutaneous electrode or by the active surface of
the canister. The use of sensing electrodes on the canister would
eliminate the need for sensing electrodes on the subcutaneous
electrode. It is also contemplated that the subcutaneous electrode
would be provided with at least one sense electrode, the canister
with at least one sense electrode, and if multiple sense electrodes
are used on either the subcutaneous electrode and/or the canister,
that the best QRS wave detection combination will be identified
when the S-ICD is implanted and this combination can be selected,
activating the best sensing arrangement from all the existing
sensing possibilities. Turning again to FIG. 2, two sensing
electrodes 26 and 28 are located on the electrically active surface
15 with electrical insulator rings 30 placed between the sense
electrodes and the active surface. These canister sense electrodes
could be switched off and electrically insulated during and shortly
after defibrillation/cardioversion shock delivery. The canister
sense electrodes may also be placed on the electrically inactive
surface of the canister. In the embodiment of FIG. 2, there are
actually four sensing electrodes, two on the subcutaneous lead and
two on the canister. In the preferred embodiment, the ability to
change which electrodes are used for sensing would be a
programmable feature of the S-ICD to adapt to changes in the
patient physiology and size (in the case of children) over time.
The programming could be done via the use of physical switches on
the canister, or as presently preferred, via the use of a
programming wand or via a wireless connection to program the
circuitry within the canister.
[0118] The canister could be employed as either a cathode or an
anode of the S-ICD cardioversion/defibrillation system. If the
canister is the cathode, then the subcutaneous coil electrode would
be the anode. Likewise, if the canister is the anode, then the
subcutaneous electrode would be the cathode.
[0119] The active canister housing will provide energy and voltage
intermediate to that available with ICDs and most AEDs. The typical
maximum voltage necessary for ICDs using most biphasic waveforms is
approximately 750 Volts with an associated maximum energy of
approximately 40 Joules. The typical maximum voltage necessary for
AEDs is approximately 2000-5000 Volts with an associated maximum
energy of approximately 200-360 Joules depending upon the model and
waveform used. The S-ICD of the present invention uses maximum
voltages in the range of about 700 to about 3150 Volts and is
associated with energies of about 40 to about 210 Joules. The
capacitance of the S-ICD could range from about 50 to about 200
micro farads.
[0120] The sense circuitry contained within the canister is highly
sensitive and specific for the presence or absence of life
threatening ventricular arrhythmias. Features of the detection
algorithm are programmable and the algorithm is focused on the
detection of V-FIB and high rate V-TACH (>240 bpm). Although the
S-ICD of the present invention may rarely be used for an actual
life threatening event, the simplicity of design and implementation
allows it to be employed in large populations of patients at modest
risk with modest cost by non-cardiac electrophysiologists.
Consequently, the S-ICD of the present invention focuses mostly on
the detection and therapy of the most malignant rhythm disorders.
As part of the detection algorithm's applicability to children, the
upper rate range is programmable upward for use in children, known
to have rapid supraventricular tachycardias and more rapid
ventricular fibrillation. Energy levels also are programmable
downward in order to allow treatment of neonates and infants.
[0121] Turning now to FIG. 4, the optimal subcutaneous placement of
the S-ICD of the present invention is illustrated. As would be
evidence to a person skilled in the art, the actual location of the
S-ICD is in a subcutaneous space that is developed during the
implantation process. The heart is not exposed during this process
and the heart is schematically illustrated in the figures only for
help in understanding where the canister and coil electrode are
three dimensionally located in the left mid-clavicular line
approximately at the level of the inframammary crease at
approximately the 5th rib. The lead 21 of the subcutaneous
electrode traverses in a subcutaneous path around the thorax
terminating with its distal electrode end at the posterior axillary
line ideally just lateral to the left scapula. This way the
canister and subcutaneous cardioversion/defibrillation electrode
provide a reasonably good pathway for current delivery to the
majority of the ventricular myocardium.
[0122] FIG. 5 illustrates a different placement of the present
invention. The S-ICD canister with the active housing is located in
the left posterior axillary line approximately lateral to the tip
of the inferior portion of the scapula. This location is especially
useful in children. The lead 21 of the subcutaneous electrode
traverses in a subcutaneous path around the thorax terminating with
its distal electrode end at the anterior precordial region, ideally
in the inframammary crease. FIG. 6 illustrates the embodiment of
FIG. 1 subcutaneously implanted in the thorax with the proximal
sense electrodes 23 and 25 located at approximately the left
axillary line with the cardioversion/defibrillatio- n electrode
just lateral to the tip of the inferior portion of the scapula.
[0123] FIG. 7 schematically illustrates the method for implanting
the S-ICD of the present invention. An incision 31 is made in the
left anterior axillary line approximately at the level of the
cardiac apex. This incision location is distinct from that chosen
for S-ICD placement and is selected specifically to allow both
canister location more medially in the left inframammary crease and
lead positioning more posteriorly via the introducer set (described
below) around to the left posterior axillary line lateral to the
left scapula. That said, the incision can be anywhere on the thorax
deemed reasonably by the implanting physician although in the
preferred embodiment, the S-ICD of the present invention will be
applied in this region. A subcutaneous pathway 33 is then created
medially to the inframmary crease for the canister and posteriorly
to the left posterior axillary line lateral to the left scapula for
the lead.
[0124] The S-ICD canister 11 is then placed subcutaneously at the
location of the incision or medially at the subcutaneous region at
the left inframmary crease. The subcutaneous electrode 13 is placed
with a specially designed curved introducer set 40 (see FIG. 8).
The introducer set comprises a curved trocar 42 and a stiff curved
peel away sheath 44. The peel away sheath is curved to allow for
placement around the rib cage of the patient in the subcutaneous
space created by the trocar. The sheath has to be stiff enough to
allow for the placement of the electrodes without the sheath
collapsing or bending. Preferably the sheath is made out of a
biocompatible plastic material and is perforated along its axial
length to allow for it to split apart into two sections. The trocar
has a proximal handle 41 and a curved shaft 43. The distal end 45
of the trocar is tapered to allow for dissection of a subcutaneous
path 33 in the patient. Preferably, the trocar is cannulated having
a central Lumen 46 and terminating in an opening 48 at the distal
end. Local anesthetic such as lidocaine can be delivered, if
necessary, through the lumen or through a curved and elongated
needle designed to anesthetize the path to be used for trocar
insertion should general anesthesia not be employed. The curved
peel away sheath 44 has a proximal pull tab 49 for breaking the
sheath into two halves along its axial shaft 47. The sheath is
placed over a guidewire inserted through the trocar after the
subcutaneous path has been created. The subcutaneous pathway is
then developed until it terminates subcutaneously at a location
that, if a straight line were drawn from the canister location to
the path termination point the line would intersect a substantial
portion of the left ventricular mass of the patient. The guidewire
is then removed leaving the peel away sheath. The subcutaneous lead
system is then inserted through the sheath until it is in the
proper location. Once the subcutaneous lead system is in the proper
location, the sheath is split in half using the pull tab 49 and
removed. If more than one subcutaneous electrode is being used, a
new curved peel away sheath can be used for each subcutaneous
electrode.
[0125] The S-ICD will have prophylactic use in adults where chronic
transvenous/epicardial ICD lead systems pose excessive risk or have
already resulted in difficulty, such as sepsis or lead fractures.
It is also contemplated that a major use of the S-ICD system of the
present invention will be for prophylactic use in children who are
at risk for having fatal arrhythmias, where chronic transvenous
lead systems pose significant management problems. Additionally,
with the use of standard transvenous ICDs in children, problems
develop during patient growth in that the lead system does not
accommodate the growth. FIG. 9 illustrates the placement of the
S-ICD subcutaneous lead system such that he problem that growth
presents to the lead system is overcome. The distal end of the
subcutaneous electrode is placed in the same location as described
above providing a good location for the coil
cardioversion/defibrillation electrode 27 and the sensing
electrodes 23 and 25. The insulated lead 21, however is no longer
placed in a taught configuration. Instead, the lead is
serpiginously placed with a specially designed introducer trocar
and sheath such that it has numerous waves or bends. As the child
grows, the waves or bends will straighten out lengthening the lead
system while maintaining proper electrode placement. Although it is
expected that fibrous scarring especially around the defibrillation
coil will help anchor it into position to maintain its posterior
position during growth, a lead system with a distal tine or screw
electrode anchoring system 52 can also be incorporated into the
distal tip of the lead to facilitate lead stability (see FIG. 1).
Other anchoring systems can also be used such as hooks, sutures, or
the like.
[0126] FIGS. 10 and 11 illustrate another embodiment of the present
S-ICD invention. In this embodiment there are two subcutaneous
electrodes 13 and 13' of opposite polarity to the canister. The
additional subcutaneous electrode 13' is essentially identical to
the previously described electrode. In this embodiment the
cardioversion/defibrillation energy is delivered between the active
surface of the canister and the two coil electrodes 27 and 27'.
Additionally, provided in the canister is means for selecting the
optimum sensing arrangement between the four sense electrodes 23,
23', 25, and 25'. The two electrodes are subcutaneously placed on
the same side of the heart. As illustrated in FIG. 6, one
subcutaneous electrode 13 is placed inferiorly and the other
electrode 13' is placed superiorly. It is also contemplated with
this dual subcutaneous electrode system that the canister and one
subcutaneous electrode are the same polarity and the other
subcutaneous electrode is the opposite polarity.
[0127] Turning now to FIGS. 12 and 13, further embodiments are
illustrated where the canister 11 of the S-ICD of the present
invention is shaped to be particularly useful in placing
subcutaneously adjacent and parallel to a rib of a patient. The
canister is long, thin, and curved to conform to the shape of the
patient's rib. In the embodiment illustrated in FIG. 12, the
canister has a diameter ranging from about 0.5 cm to about 2 cm
without 1 cm being presently preferred. Alternatively, instead of
having a circular cross sectional area, the canister could have a
rectangular or square cross sectional area as illustrated in FIG.
13 without falling outside of the scope of the present invention.
The length of the canister can vary depending on the size of the
patient's thorax. Currently the canister is about 5 cm to about 15
cm long with about being presently preferred. The canister is
curved to conform to the curvature of the ribs of the thorax. The
radius of the curvature will vary depending on the size of the
patient, with smaller radiuses for smaller patients and larger
radiuses for larger patients. The radius of the curvature can range
from about 5 cm to about 35 cm depending on the size of the
patient. Additionally, the radius of the curvature need not be
uniform throughout the canister such that it can be shaped closer
to the shape of the ribs. The canister has an active surface, 15
that is located on the interior (concave) portion of the curvature
and an inactive surface 16 that is located on the exterior (convex)
portion of the curvature. The leads of these embodiments, which are
not illustrated except for the attachment port 19 and the proximal
end of the lead 21, can be any of the leads previously described
above, with the lead illustrated in FIG. 1 being presently
preferred.
[0128] The circuitry of this canister is similar to the circuitry
described above. Additionally, the canister can optionally have at
least one sense electrode located on either the active surface of
the inactive surface and the circuitry within the canister can be
programmable as described above to allow for the selection of the
best sense electrodes. It is presently preferred that the canister
have two sense electrodes 26 and 28 located on the inactive surface
of the canisters as illustrated, where the electrodes are spaced
from about 1 to about 10 cm apart with a spacing of about 3 cm
being presently preferred. However, the sense electrodes can be
located on the active surface as described above.
[0129] It is envisioned that the embodiment of FIG. 12 will be
subcutaneously implanted adjacent and parallel to the left anterior
5th rib, either between the 4th and 5th ribs or between the 5th and
6th ribs. However other locations can be used.
[0130] Another component of the S-ICD of the present invention is a
cutaneous test electrode system designed to simulate the
subcutaneous high voltage shock electrode system as well as the QRS
cardiac rhythm detection system. This test electrode system is
comprised of a cutaneous patch electrode of similar surface area
and impedance to that of the S-ICD canister itself together with a
cutaneous strip electrode comprising a defibrillation strip as well
as two button electrodes for sensing of the QRS. Several cutaneous
strip electrodes are available to allow for testing various bipole
spacings to optimize signal detection comparable to the implantable
system.
[0131] FIGS. 14 to 18 depict particular US-ICD embodiments of the
present invention. The various sensing, shocking and pacing
circuitry, described in detail above with respect to the S-ICD
embodiments, may additionally be incorporated into the following
US-ICD embodiments. Furthermore, particular aspects of any
individual S-ICD embodiment discussed above, may be incorporated,
in whole or in part, into the US-ICD embodiments depicted in the
following figures.
[0132] Turning now to FIG. 14, the US-ICD of the present invention
is illustrated. The US-ICD consists of a curved housing 1211 with a
first and second end. The first end 1413 is thicker than the second
end 1215. This thicker area houses a battery supply, capacitor and
operational circuitry for the US-ICD. The circuitry will be able to
monitor cardiac rhythms for tachycardia and fibrillation, and if
detected, will initiate charging the capacitor and then delivering
cardioversion/defibrillation energy through the two
cardioversion/defibrillating electrodes 1417 and 1219 located on
the outer surface of the two ends of the housing. The circuitry can
provide cardioversion/defibrillation energy in different types of
waveforms. In the preferred embodiment, a 100 uF biphasic waveform
is used of approximately 10-20 ms total duration and with the
initial phase containing approximately 2/3 of the energy, however,
any type of waveform can be utilized such as monophasic, biphasic,
multiphasic or alternative waveforms as is known in the art.
[0133] The housing of the present invention can be made out of
titanium alloy or other presently preferred ICD designs. It is
contemplated that the housing is also made out of biocompatible
plastic materials that electronically insulate the electrodes from
each other. However, it is contemplated that a malleable canister
that can conform to the curvature of the patient's chest will be
preferred. In this way the patient can have a comfortable canister
that conforms to the unique shape of the patient's rib cage.
Examples of conforming ICD housings are provided in U.S. Pat. No.
5,645,586, the entire disclosure of which is herein incorporated by
reference. In the preferred embodiment, the housing is curved in
the shape of a 5.sup.th rib of a person. Because there are many
different sizes of people, the housing will come in different
incremental sizes to allow a good match between the size of the rib
cage and the size of the US-ICD. The length of the US-ICD will
range from about 15 to about 50 cm. Because of the primary
preventative role of the therapy and the need to reach energies
over 40 Joules, a feature of the preferred embodiment is that the
charge time for the therapy, intentionally be relatively long to
allow capacitor charging within the limitations of device size.
[0134] The thick end of the housing is currently needed to allow
for the placement of the battery supply, operational circuitry, and
capacitors. It is contemplated that the thick end will be about 0.5
cm to about 2 cm wide with about 1 cm being presently preferred. As
microtechnology advances, the thickness of the housing will become
smaller.
[0135] The two cardioversion/defibrillation electrodes on the
housing are used for delivering the high voltage
cardioversion/defibrillation energy across the heart. In the
preferred embodiment, the cardioversion/defibrillation electrodes
are coil electrodes, however, other cardioversion/defibrillation
electrodes could be used such as having electrically isolated
active surfaces or platinum alloy electrodes. The coil
cardioversion/defibrillation electrodes are about 5-10 cm in
length. Located on the housing between the two
cardioversion/defibrillation electrodes are two sense electrodes
1425 and 1427. The sense electrodes are spaced far enough apart to
be able to have good QRS detection. This spacing can range from 1
to 10 cm with 4 cm being presently preferred. The electrodes may or
may not be circumferential with the preferred embodiment. Having
the electrodes non-circumferential and positioned outward, toward
the skin surface, is a means to minimize muscle artifact and
enhance QRS signal quality. The sensing electrodes are electrically
isolated from the cardioversion/defibrillation electrode via
insulating areas 1423. Analogous types of
cardioversion/defibrillation electrodes are currently commercially
available in a transvenous configuration. For example, U.S. Pat.
No. 5,534,022, the entire disclosure of which is herein
incorporated by reference, discloses a composite electrode with a
coil cardioversion/defibrillation electrode and sense electrodes.
Modifications to this arrangement is contemplated within the scope
of the invention. One such modification is to have the sense
electrodes at the two ends of the housing and have the
cardioversion/defibrillation electrodes located in between the
sense electrodes. Another modification is to have three or more
sense electrodes spaced throughout the housing and allow for the
selection of the two best sensing electrodes. If three or more
sensing electrodes are used, then the ability to change which
electrodes are used for sensing would be a programmable feature of
the US-ICD to adapt to changes in the patient physiology and size
over time. The programming could be done via the use of physical
switches on the canister, or as presently preferred, via the use of
a programming wand or via a wireless connection to program the
circuitry within the canister.
[0136] Turning now to FIG. 15, the optimal subcutaneous placement
of the US-ICD of the present invention is illustrated. As would be
evident to a person skilled in the art, the actual location of the
US-ICD is in a subcutaneous space that is developed during the
implantation process. The heart is not exposed during this process
and the heart is schematically illustrated in the figures only for
help in understanding where the device and its various electrodes
are three dimensionally located in the thorax of the patient. The
US-ICD is located between the left mid-clavicular line
approximately at the level of the inframammary crease at
approximately the 5.sup.th rib and the posterior axillary line,
ideally just lateral to the left scapula. This way the US-ICD
provides a reasonably good pathway for current delivery to the
majority of the ventricular myocardium.
[0137] FIG. 16 schematically illustrates the method for implanting
the US-ICD of the present invention. An incision 1631 is made in
the left anterior axillary line approximately at the level of the
cardiac apex. A subcutaneous pathway is then created that extends
posteriorly to allow placement of the US-ICD. The incision can be
anywhere on the thorax deemed reasonable by the implanting
physician although in the preferred embodiment, the US-ICD of the
present invention will be applied in this region. The subcutaneous
pathway is created medially to the inframammary crease and extends
posteriorly to the left posterior axillary line. The pathway is
developed with a specially designed curved introducer 1742 (see
FIG. 17). The trocar has a proximal handle 1641 and a curved shaft
1643. The distal end 1745 of the trocar is tapered to allow for
dissection of a subcutaneous path in the patient. Preferably, the
trocar is cannulated having a central lumen 1746 and terminating in
an opening 1748 at the distal end. Local anesthetic such as
lidocaine can be delivered, if necessary, through the lumen or
through a curved and elongated needle designed to anesthetize the
path to be used for trocar insertion should general anesthesia not
be employed. Once the subcutaneous pathway is developed, the US-ICD
is implanted in the subcutaneous space, the skin incision is closed
using standard techniques.
[0138] As described previously, the US-ICDs of the present
invention vary in length and curvature. The US-ICDs are provided in
incremental sizes for subcutaneous implantation in different sized
patients. Turning now to FIG. 18, a different embodiment is
schematically illustrated in exploded view which provides different
sized US-ICDs that are easier to manufacture. The different sized
US-ICDs will all have the same sized and shaped thick end 1413. The
thick end is hollow inside allowing for the insertion of a core
operational member 1853. The core member comprises a housing 1857
which contains the battery supply, capacitor and operational
circuitry for the US-ICD. The proximal end of the core member has a
plurality of electronic plug connectors. Plug connectors 1861 and
1863 are electronically connected to the sense electrodes via
pressure fit connectors (not illustrated) inside the thick end
which are standard in the art. Plug connectors 1865 and 1867 are
also electronically connected to the cardioverter/defibrillator
electrodes via pressure fit connectors inside the thick end. The
distal end of the core member comprises an end cap 1855, and a
ribbed fitting 1859 which creates a water-tight seal when the core
member is inserted into opening 1851 of the thick end of the
USICD.
[0139] The core member of the different sized and shaped USICD will
all be the same size and shape. That way, during an implantation
procedures, multiple sized US-ICDs can be available for
implantation, each one without a core member. Once the implantation
procedure is being performed, then the correct sized US-ICD can be
selected and the core member can be inserted into the US-ICD and
then programmed as described above. Another advantage of this
configuration is when the battery within the core member needs
replacing it can be done without removing the entire US-ICD.
[0140] FIG. 14(a) illustrates an embodiment of the subcutaneous
lead electrode or "lead electrode assembly" 100. The lead electrode
assembly 100 is designed to provide an electrode 107 to be
implanted subcutaneously in the posterior thorax of a patient for
delivery of cardioversion/defibrillation energy. The lead electrode
assembly 100 is further designed to provide a path for the
cardioversion/defibrillation energy to reach the electrode 107 from
the operational circuitry within the canister 11 of an S-ICD such
as the embodiment shown in FIG. 1.
[0141] The lead electrode assembly 100 comprises a connector 111, a
lead 21, a lead fastener 146, an electrode 107 and an appendage
118. The connector 111 is connected to the lead 21. The lead 21 is
further connected to the electrode 107 with the lead fastener 146.
The appendage 118 is mounted to the electrode 107.
[0142] The connector 111 provides an electrical connection between
the lead 21 and the operational circuitry within the canister 11 of
an S-ICD such as the embodiment shown in FIG. 1. Connector 111 is
designed to mate with the connection port 19 on the canister 11. In
the embodiment under discussion, the connector 111 meets the IS-1
standard.
[0143] The lead 21 of the lead electrode assembly 100 provides an
electrical connection between the connector 111 and the electrode
107. The lead 21 comprises a distal end 101 and a proximal end 102.
The distal end 101 of the lead 21 is attached to the connector 111.
The proximal end 102 of the lead 21 is attached to electrode 107
with the lead fastener 146.
[0144] The lead 21 has a lead length, l.sub.Lead, measured from the
connector 111 along the lead 21 to the lead fastener 146 of the
electrode 107. The length of the lead 21 is approximately 25 cm. In
alternative embodiments, the lead lengths range between
approximately 5 cm and approximately 52 cm.
[0145] The lead fastener 146 provides a robust physical and
electrical connection between the lead 21 and the electrode 107.
The lead fastener 146 joins the proximal end 102 of the lead 21 to
electrode 107.
[0146] The electrode 107 comprises an electrically conductive
member designed to make contact with the tissue of the patient and
transfer cardioversion/defibrillation energy to the tissue of the
patient from the S-ICD canister 11.
[0147] The electrode 107 illustrated is generally flat and planar,
comprising a top surface 110, a bottom surface 115, a distal end
103 and a proximal end 104. The lead fastener 146 is attached to
the top surface 110 of the distal end 103 of the electrode 107.
[0148] The electrode 107 may have shapes other than planar. In an
alternate embodiment, the electrode 107 is shaped like a coil.
[0149] The appendage 118 is a member attached to the electrode 107
that can be gripped and used to precisely locate the lead electrode
assembly 100 during its surgical implantation within the
patient.
[0150] The appendage 118 has a first end 105, a second end 106, a
distal edge 121 and a proximal edge 129. The second end 106 of the
appendage 118 is attached to the top surface 110 of the electrode
107. The appendage 118 is positioned such that its proximal edge
129 is within approximately 20 mm of the proximal end 104 of the
electrode 107. In alternate embodiments, the appendage 118 is
attached to the electrode 107 in other positions.
[0151] It is useful at this point, to set out several general
definitions for future reference in discussing the dimensions and
placement of appendages 118.
[0152] The appendage height, h.sub.Appendage, is defined as the
distance from the point of the appendage 118 most distant from the
electrode 107 to a point of the appendage 118 closest to the
electrode 107 measured along a line perpendicular to the top
surface 110 of the electrode 107. The appendage height of the
appendage 118 illustrated, for example, would be measured between
the first end 105 of the appendage 118 and the second end 106 of
the appendage 118.
[0153] The appendage height of the appendage 118 illustrated is
approximately 5 mm. In alternative embodiments, the appendage
heights range between approximately 1 mm and approximately 10
mm.
[0154] The appendage interface is defined as the part of the
appendage 118 that joins it to the electrode 107. The appendage
interface of the appendage 118 illustrated, for example, would be
the second end 106 of the appendage 118.
[0155] The appendage length, l.sub.Appendage, is the length of the
appendage 118 along the appendage interface. The appendage
interface of the appendage 118 illustrated, for example, would be
the length of the second end 106 of the appendage 118.
[0156] The appendage length of the appendage 118 illustrated in
FIG. 14 is approximately 1 cm. In alternative embodiments,
appendage lengths range between approximately 2 mm and
approximately 6 cm. In an alternate embodiment, the appendage 118
is substantially as long as the electrode 107.
[0157] More particularly, the appendage 118 of the embodiment
illustrated is a fin 120 comprising a fin core 122 (phantom view)
and a coating 125.
[0158] The fin core 122 generally provides support for the fin 120.
The fin core 122 has a first end 126 and a second end 127. The
second end 127 of the fin core 122 is attached to the top surface
110 of the electrode 107.
[0159] The fin core 122 comprises a metal selected from the group
consisting essentially of titanium, nickel alloys, stainless steel
alloys, platinum, platinum iridium, and mixtures thereof. In other
embodiments, the fin core 122 comprises any rugged material that
can be attached to the first surface 110 of the electrode 107.
[0160] The coating 125 is disposed around the fin core 122. The
coating 125 provides a surface for the fin 120 that can be easily
gripped during the implantation of the lead electrode assembly 100.
The coating 125 covering the fin core 122 is composed of molded
silicone. In an alternative embodiment, the coating 125 may be any
polymeric material. In this specification, the term polymeric
material includes the group of materials consisting of a
polyurethane, a polyamide, a polyeteretherketone (PEEK), a
polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a
silicone and mixtures thereof.
[0161] In one embodiment, the fin 120 is reinforced with a layer of
Dacron.RTM. polymer mesh attached to the inside of the coating 125.
Dacron.RTM. is a registered trademark of E.I. du Pont de Nemours
and Company Corporation, Wilmington, Del. In another embodiment,
the Dacron.RTM. polymer mesh attached to the outside of the coating
125. In another embodiment, the fin 120 is reinforced with a layer
of any polymeric material.
[0162] FIG. 14(b) illustrates a top view of the lead electrode
assembly 100. The electrode 107 is substantially rectangular in
shape, comprising a first pair of sides 108, a second pair of sides
109 and four corners 112. In an alternative embodiment the
electrode 107 has a shape other than rectangular. In this
embodiment, the corners 112 of the electrode 107 are rounded. In an
alternative embodiment the corners 112 of the electrode 107 are not
rounded.
[0163] The first pair of sides 108 of the electrode 107 are
substantially linear, substantially parallel to each other and are
approximately 1 cm in length. The second pair of sides 109 of the
electrode 107 are also substantially linear, substantially parallel
with each other and are approximately 5 cm in length. The bottom
surface 115 of the electrode 107 has an area of approximately 500
square mm. In alternative embodiments, the first pair of sides 108
and the second pair of sides 109 of the electrode 107 are neither
linear nor parallel.
[0164] In alternative embodiments, the length of the first pair of
sides 108 and second pair of sides 109 of the electrode 107 range
independently between approximately 1 cm and approximately 5 cm.
The surface area of the bottom surface 115 of the electrode 107
ranges between approximately 100 sq. mm and approximately 2000 sq.
mm. In one embodiment, the first pair of sides 108 and second pair
of sides 109 of the electrode 107 are linear and of equal length,
such that the electrode 107 is substantially square-shaped.
[0165] The electrode 107 comprises a sheet of metallic mesh 114
further comprised of woven wires 119. The metallic mesh 114
comprises a metal selected from the group consisting essentially of
titanium, nickel alloys, stainless steel alloys, platinum, platinum
iridium, and mixtures thereof. In other embodiments, the metallic
mesh 114 comprises any conductive material.
[0166] In an alternate embodiment, the electrode 107 comprises a
solid metallic plate. The metallic plate comprises a metal selected
from the group consisting essentially of titanium, nickel alloys,
stainless steel alloys, platinum, platinum iridium, and mixtures
thereof. In other embodiments, the solid plate comprises any
conductive material.
[0167] The metallic mesh 114 is approximately a 150 mesh, having
approximately 150 individual wires 119 per inch. In alternative
embodiments, the metallic mesh 114 ranges between approximately a
50 mesh and approximately a 200 mesh. In this embodiment, the
diameter of the wires 119 of the mesh is approximately 1 mil. In
alternative embodiments, the diameter of the wires 119 ranges
between approximately 1 and approximately 5 mils.
[0168] The metallic mesh 114 is first prepared by spot welding
together the wires 119 located along the first pair of sides 108
and second pair of sides 109 of the metallic mesh 114. The excess
lengths of wires are then ground or machined flush, so as to
produce a smooth edge and to form a smooth border 113. In an
alternate embodiment, the wires 119 located along the first pair of
sides 108 and second pair of sides 109 of the metallic mesh 114 are
bent in toward the metallic mesh 114 to form a smooth border
113.
[0169] The fin 120 is attached to the top surface 110 of the
electrode 107 in a position centered between the first pair of
sides 108 of the electrode 107. In other embodiments, the fin 120
is not centered between the first pair of sides 108 of the
electrode 107.
[0170] The fin 120 is planar shape comprising a first face 191 and
a second face 192. The first face 191 and the second face 192 of
the fin 120 are substantially parallel to the first pair of sides
108 of the electrode 107. In other embodiments, the first face 191
and the second face 192 of the fin 120 are positioned in
orientations other than parallel to the first pair of sides 108 of
the electrode 107.
[0171] The first face 191 and the second face 192 of the fin 120
extend from and substantially perpendicular to the top surface 110
of the electrode 107. In an alternative embodiment, the first face
191 and the second face 192 of the fin 120 extend from the top
surface 110 of the electrode 107 at other than right angles.
[0172] The fin core 122 of the fin 120 is spot welded to the
metallic mesh 114 comprising the electrode 107. In another
embodiment, the fin 120 may be composed entirely of a polymeric
material and attached to the electrode 107 by means known in the
art.
[0173] FIG. 14(c) illustrates in detail a section of the lead 21 of
this embodiment. The lead 21 comprises an electrically insulating
sheath 141 and an electrical conductor 142.
[0174] The electrically insulating sheath 141 is disposed around
the electrical conductor 142 (phantom view). The electrically
insulating sheath 141 prevents the cardioversion/defibrillation
energy passing through the electrical conductor 142 to the
electrode from passing into objects surrounding the lead 21. The
electrically insulating sheath 141, comprises a tube 149 disposed
around the electrical conductor 142. The tube is composed of either
silicone, polyurethane or composite materials. One skilled in the
art will recognize that the tube 149 could alternately be composed
of any insulating, flexible, biocompatible material suitable to
this purpose.
[0175] In this embodiment, the electrical conductor 142 comprises
three highly-flexible, highly-conductive coiled fibers known as
filars 147 (phantom view). These fibers are wound in a helical
shape through the electrically insulating sheath 141. In an
alternate embodiment, the filars lie as linear cables within the
electrically insulating sheath 141. In another alternate
embodiment, a combination of helically coiled and linear filars lie
within the electrically insulating sheath 141.
[0176] FIG. 14(d) illustrates a cross-section of a filar 147. The
filars 147 of the embodiment illustrated comprise a metal core 144,
a metal tube 143 and an insulating coating 140. The metal tube 143
is disposed around the metal core 144. The insulating coating 140
is disposed around the metal tube. The metal core 144 is made of
silver and the metal tube 143 is made of MP35N stainless steel, a
product of SPS Technologies of Jenkintown, Pa. The insulating
coating 140 is made of teflon. The filars 147 of this structure are
available as DFT.TM. (drawn filled tube) conductor coil, available
from Fort Wayne Metals Research Products Corp. of Fort Wayne,
Ind.
[0177] In an alternative embodiment, the filars 147 further
comprise an intermediate coating (not shown) disposed between the
metal tube 143 and the insulating coating 140. This intermediate
coating is made of platinum, iridium ruthenum, palladium or an
alloy of these metals.
[0178] In another alternative embodiment, the filars 147 comprise
DBS.TM. (drawn braised strands) also available from Fort Wayne
Metals Research Products Corp. of Fort Wayne, Ind.
[0179] Turning now to FIG. 14(e), a cross section of the lead
fastener 146 is shown in detail. The lead fastener 146 provides a
robust physical and electrical connection between the lead 21 and
the electrode 107.
[0180] In this embodiment, the lead fastener 146 comprises a metal
strip 157, a crimping tube 154 and a crimping pin 156. The metal
strip 157 has a first end 150, a second end 151, and a middle
portion 152. The first end 150 and second end 151 of the metal
strip 157 are separated by the middle portion 152. The first end
150 and second end 151 of the metal strip 157 are attached to the
electrode 107. In this embodiment, the first end 150 and second end
151 of the lead fastener 146 are spot welded to the top surface 110
of the metallic mesh 114 comprising the electrode 107. In other
embodiments, other fastening methods known in the art can be
used.
[0181] The middle portion 152 of the metal strip 157 is raised away
from the electrode 107 to permit the crimping tube 154 and
electrically insulating sheath 141 of the lead 21 to fit between
the metal strip 157 and the electrode 107.
[0182] The middle portion 152 of the metal strip 157 contains a
crimp point 148. The crimp point 148 squeezes the crimping tube 154
and electrically insulating sheath 141 of the lead 21 thereby
gripping it, and thereby providing a robust structural connection
between the lead 21 and the electrode 107.
[0183] The filars 147 of the lead 21 are situated between the
crimping tube 154 and crimping pin 156. The crimping tube 154 has a
crimping point 155 which causes the filars 147 to be squeezed
between crimping tube 154 and crimping pin 156. A gap 159 in the
electrically insulating sheath 141 allows the crimping tube 155 to
make contact the electrode 107, thereby forming a robust electrical
connection.
[0184] The metal strip 157, the crimping tube 154 and crimping pin
156 are each made of platinum iridium. In an alternative
embodiment, the metal strip 157, crimping tube 154 and crimping pin
156 are each made of a metal selected from the group consisting
essentially of titanium, nickel alloys, stainless steel alloys,
platinum, platinum iridium, and mixtures thereof. In an alternative
embodiment, the metal strip 157, crimping tube 154 and crimping pin
156 are each made of any conductive material.
[0185] FIG. 14(f) illustrates an exploded view of the lead fastener
146. In other embodiments, other types of lead fasteners 146 known
in the art are used.
[0186] FIG. 15(a) illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the lead electrode assembly 100 illustrated in FIGS. 14(a)-14(f).
In this embodiment, however, the appendage 118 lacks a fin core
122. Moreover, as seen in FIG. 15(a) the lead electrode assembly
100 of this embodiment further comprises a backing layer 130 and
stitching 139. The backing layer 130 acts to insulate the electrode
107 so that cardioversion/defibrillation energy may not pass to the
tissue of the patient that surrounds the top surface 110 of the
electrode 107. This has the effect of focusing the
cardioversion/defibrillation energy toward the heart of the patient
through the bottom surface 115 of the electrode 107.
[0187] The backing layer 130 comprises a base portion 158 and an
integrated fin 120. The base portion 158 of the backing layer 130
comprises a first surface 131, a second surface 132, a first side
133 and a second side 134.
[0188] The base portion 158 of the backing layer 130 is attached to
the electrode 107 such that the second surface 132 of the backing
layer 130 lies directly adjacent to the top surface 110 of the
electrode 107.
[0189] The base portion 158 of the backing layer 130 is formed so
that the first side 133 and the second side 134 are substantially
parallel and of substantially the same size as the first pair of
sides 108 of the electrode 107.
[0190] FIG. 15(b) illustrates a top view of the lead electrode
assembly 100 of this embodiment. The base portion 158 of the
backing layer 130 further comprises a distal end 137 and a proximal
end 138.
[0191] The distal end 137 and proximal end 138 of the backing layer
130 are parallel to and of substantially the same size as the
second pair of sides 109 (hidden) of the electrode 107. The backing
layer 130 contains a notch 136 on its distal end 137, through which
the lead fastener 146 rises.
[0192] The base portion 158 of the backing layer 130 is attached to
the electrode 107 with stitching 139. The stitching is composed of
nylon. In alternate embodiments, the stitching is composed of any
polymeric material.
[0193] The backing layer 130 is composed of polyurethane. In an
alternative embodiment, the backing layer is composed of molded
silicone, nylon, or Dacron.RTM.. In alternative embodiments, the
backing layer is composed of any polymeric material.
[0194] The integrated fin 120 of the backing layer 130 is formed
from the same piece of material as the backing layer 130. The
integrated fin 120 has the same shape and dimensions as the fin 120
of the embodiment in FIG. 14.
[0195] In one embodiment, the integrated fin 120 is reinforced with
a layer of Dacron.RTM. polymer mesh attached to the integrated fin
120. In another embodiment, the integrated fin 120 is reinforced
with a layer of any polymeric material.
[0196] FIG. 16(a) illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the lead electrode assembly 100 illustrated in FIGS. 14(a)-14(e).
In this embodiment, however, the fin 120 has a different
construction.
[0197] Here, fin 120 comprises a first fin section 165, a second
fin section 160 and stitching 168. The first fin section 165 is a
rectangular sheet of polymeric material comprising an inside face
167, an outside face 166, a first side 175 and a second side 174.
The first side 175 and second side 174 of the first fin section 165
are substantially parallel and of substantially the same size.
[0198] A line 173 divides the first fin section 165 into a first
half 171 and a second half 172. The line 173 runs parallel to the
first side 175 of the first fin section 165. The first half 171 of
the first fin section 165 lies on one side of line 173. The second
half 172 of the first fin section 165 lies on the other side of the
line 173.
[0199] The second fin section 160 is a rectangular sheet of
polymeric material of the same size as the first fin section 165
comprising an inside face 162 and an outside face 161. The second
fin section 160 is divided in half substantially similarly to the
first fin section 165, thereby forming a first half 163 and a
second half 164 of the second fin section 160.
[0200] In an alternate embodiment, the first fin section 165 and
second fin section are not rectangular in shape. In an alternate
embodiment, the first fin section 165 and second fin section have
an oval shape.
[0201] The first half 171 of the first fin section 165 is fastened
to the first half 163 of the second fin section 160. The inside
face 167 of the first half 171 of the first fin section 165 faces
the inside face 162 of the first half 163 of the second fin section
160. The first fin section 165 is fastened the second fin section
160 with stitching 168.
[0202] The fin 120 is attached to the top surface 110 of the
electrode 107. To accomplish this, the second half 172 of the first
fin section 165 is attached to the top surface 110 of the electrode
107 with the stitching 169. The second half 164 of the second fin
section 160 is similarly attached to the top surface 110 of the
electrode 107 with stitching (not shown).
[0203] In one embodiment, the fin 120 is reinforced with a layer of
Dacron.RTM. polymer mesh positioned between the first fin section
165 and the second fin section 160 of the integrated fin 120. In
another embodiment, the Dacron.RTM. polymer mesh is attached only
to the first fin section 165 or the second fin section 160. In
other embodiments, the integrated fin 120 is reinforced with a
layer of any polymeric material attached to either or both fin
sections.
[0204] The appendage height of the fin 120 in this embodiment is
approximately 5 mm. In alternative embodiments, the appendage
heights range between approximately 1 mm and approximately 10 mm.
The appendage length of the fin 120 in this embodiment is
approximately 1 cm. In alternative embodiments, appendage lengths
range between approximately 2 mm and approximately 6 cm.
[0205] In one embodiment, the appendage length of the fin 120 is
such that the fin 120 is substantially as long as the electrode
107.
[0206] FIG. 17(a) illustrates a side plan view of an alternative
embodiment of the lead electrode assembly 100. The lead electrode
assembly 100 comprises a connector 111, a lead 21, a lead fastener
146, an electrode 107, a backing layer 130 with an integrated fin
tab 180, a molded cover 220 and an appendage 118.
[0207] The connector 111 is connected to the lead 21. The lead 21
is further connected to the electrode 107 with the lead fastener
146. The backing layer 130 is positioned over the electrode 107.
The fin tab 180 protrudes from the backing layer 130. The molded
cover 220 is disposed around the lead fastener 146 and the backing
layer 130. The molded cover 220 is further disposed around the fin
tab 180 of the backing layer 118 to form the appendage 118. The
molded cover 220 also partially envelops the electrode 107.
[0208] The connector 111 and the lead 21 are substantially similar
to the connector 111 and the lead 21 described with reference to
FIGS. 14(a)-14(f). The lead comprises a distal end 101 and a
proximal end 102. The distal end 101 of the lead 21 is attached to
the connector 111. The proximal end 102 of the lead 21 is connected
to the electrode 107 by the lead fastener 146.
[0209] In this embodiment, the lead fastener 146 comprises a first
crimping tube 200, a crimping pin 202 and a second crimping tube
201. The first crimping tube 200 connects the proximal end 102 of
the lead 21 to the crimping pin 202. The second crimping tube 201
connects the crimping pin 202 to the electrode 107.
[0210] The electrode 107 comprises a distal end 103 (phantom view),
a proximal end 104, a top surface 110 and a bottom surface 115. The
electrode further comprises three sections: a main body 217, a
mandrel 219 and a mandrel neck 218.
[0211] The main body 217 of the electrode 107 is the region of the
electrode 107 that makes contact with the tissue of the patient and
transfers the cardioversion/defibrillation energy to the patient.
This region is substantially rectangular, comprising a first pair
of sides 108 (not shown) and a second pair of sides 109. The first
pair of sides 108 of the electrode 107 are substantially parallel
to each other. The second pair of sides 109 of the electrode 107
are also substantially parallel to each other. In another
embodiment, the first pair of sides 108 and the second pair of
sides 109 of the electrode 107 are non-parallel. The main body 217
of the electrode 107 is positioned under the backing layer 130, so
that the top surface 110 of the electrode faces the backing layer
130.
[0212] The mandrel 219 is a region of the electrode 107 shaped to
facilitate the connection of the electrode 107 to the lead 21 via
the lead fastener 146. The mandrel of the electrode is crimped onto
to the crimping pin 202 of the lead fastener 146 with the second
crimping tube 201, so that a robust physical and electrical
connection is formed. The main body 217 of the electrode 107 is
connected to the mandrel 219 of the electrode 107 via the mandrel
neck 218 of the electrode 107.
[0213] The backing layer 130 comprises a base portion 158 and an
integrated fin tab 180. The base portion 158 of the backing layer
130 comprises a first surface 131, a second surface 132, a distal
end 137 and a proximal end 138.
[0214] The base portion 158 of the backing layer 130 is positioned
such that its second surface 132 is adjacent to the top surface 110
of the electrode 107. The base portion 158 of the backing layer 130
is sized and positioned so that the distal end 137 and proximal end
138 of the base portion 158 of the backing layer 130 overlay the
second pair of sides 109 of the main body 217 of the electrode 107.
The distal end 137 and proximal end 138 of the are also
substantially parallel and of substantially the same size as the
second pair of sides 109 of the electrode 107.
[0215] The integrated fin tab 180 of the backing layer 130 is
formed from the same piece of material as the base portion 158 of
the backing layer 130. The integrated fin tab 180 is formed on the
first surface 131 of the base portion 158 of the backing layer
130.
[0216] The integrated fin tab 180 comprises a proximal edge 183, a
distal edge 184, a top 185 and a bottom 186. The bottom 186 of the
integrated fin tab 180 is joined to the first surface 131 of the
base portion 158 of the backing layer 130. The proximal edge 183
and the distal edge 184 of the integrated fin tab 180 extend from,
and substantially perpendicular to the first surface 131 of the
base portion 158 of the backing layer 130. The proximal edge 183
and distal edge 184 of the integrated fin tab 180 are parallel with
each other. The integrated fin tab 180 is positioned so that its
proximal edge 183 is substantially flush with the proximal end 138
of the base portion 158 of the backing layer 130.
[0217] The backing layer 130 is composed of polyurethane. In an
alternative embodiment, the backing layer 130 is composed of
silicone. In another alternative embodiment, the backing layer 130
is composed of any polymeric material.
[0218] The molded cover 220 envelops and holds together the
components of the lead electrode assembly 100. The molded cover 220
also provides rigidity to the lead electrode assembly 100. The
molded cover 220 envelops the lead fastener 146 and the backing
layer 130. The fin 120 is formed when the molded cover 220 covers
the fin tab 180. The thickness of the resulting fin 120 is
approximately 2 mm. In alternate embodiments, the thickness of the
fin 120 is between approximately 1 mm and approximately 3 mm.
[0219] The appendage height of the fin 120 in this embodiment is
approximately 5 mm. In alternative embodiments, the appendage
heights range between approximately 1 mm and approximately 10 mm.
The appendage length of the fin 120 in this embodiment is
approximately 1 cm. In alternative embodiments, appendage lengths
range between approximately 2 mm and approximately 6 cm. In one
embodiment, the appendage length of the fin 120 is such that the
fin is as long as the backing layer. In one embodiment, the
appendage length of the fin 120 is such that the fin is as long as
the electrode 107. In one embodiment, the appendage length of the
fin 120 is such that the fin is as long as the molded cover
220.
[0220] The molded cover 220 also partially covers the bottom
surface 115 of the electrode 107. In this way, the molded cover 220
attaches the backing layer 130 to the electrode 107.
[0221] The molded cover 220 in this embodiment is made of silicone.
In an alternate embodiment, the molded cover 220 is made of any
polymeric material. Stitching 360 holds the molded cover 220, the
electrode 107 and the backing layer 130 together.
[0222] In one embodiment, the fin 120 is reinforced with a layer of
Dacron.RTM. polymer mesh positioned between the molded cover 220
and the integrated fin tab 180. In another embodiment, the
Dacron.RTM. polymer mesh is attached only to the molded cover 220.
In other embodiments, the fin 120 is similarly reinforced with a
layer of any polymeric material.
[0223] As shown in FIG. 17(b), the fin 120 of the embodiment
illustrated in FIG. 17(a) can alternately have a sloped shape. The
sloped shape can reduce the resistance offered by the tissue of the
patient as it slides against the fin 120 during the insertion of
the lead electrode assembly 100 into the patient. The slope-shaped
fin 120 is constructed so that the proximal edge 183 and distal
edge 184 of the integrated fin tab 180 are not parallel with each
other. Instead, proximal edge 183 of the integrated fin tab 180 can
be curved so that the proximal edge 183 of the integrated fin tab
180 is closer to the proximal edge 184 at the top 185 of the
integrated fin tab 180, than at the bottom 186 of the integrated
fin tab 180. In alternate embodiments, the proximal edge 183 of the
integrated fin tab 180 is not curved. Instead, the proximal edge
183 of the integrated fin tab 180 is straight, and forms an acute
angle with the first surface 131 of the backing layer 130. In one
alternate embodiment, the proximal edge 183 of the integrated fin
tab 180 forms a 45 degree angle with the first surface 131 of the
backing layer 130. In alternate embodiments, the distal edge 184 of
the integrated fin tab 180 is curved. In alternate embodiments, the
distal edge 184 of the integrated fin tab 180 is straight and
shaped so that it forms an acute angle with the first surface 131
of the backing layer 130.
[0224] FIG. 17(c) illustrates a front plan view of the lead
electrode assembly 100 seen in FIG. 17(a). The base portion 158 of
the backing layer 130 further comprises a first side 133 and second
side 134. The first side 133 and second side 134 of the base
portion 158 of the backing layer 130 are substantially parallel. In
an alternate embodiment, the first side 133 and second side 134 of
the backing layer 130 are not parallel. The base portion 158 of the
backing layer 130 is sized so that it is substantially the same
size and shape as the main body 217 of the electrode 107.
[0225] The integrated fin tab 180 of the backing layer 130 is
planar, comprising a first face 181 and a second face 182. The
first face 181 and second face 182 of the fin tab 180 are
substantially parallel with each other and with the first side 133
and second side 134 of the backing layer 130. The first face 181
and second face 182 of the fin tab 180 extend from, and
substantially perpendicular to the first surface 131 of the backing
layer 130. In another embodiment, the first face 181 and second
face 182 of the fin tab 180 extend from the first surface 131 of
the backing layer 130 at angles other than a right angle.
[0226] In an alternate embodiment, the first face 181 and a second
face 182 of the integrated fin tab 180 of the backing layer 130 are
not substantially parallel to each other. Instead, they are angled,
such that they are closer together at the top 185 than they are at
the bottom 186 of the integrated fin tab 180. This shape can reduce
the resistance offered by the tissue of the patient as it slides
against the fin 120 during the insertion of the lead electrode
assembly 100 into the patient.
[0227] In another embodiment, the first face 181 and a second face
182 of the integrated fin tab 180 of the backing layer 130 are
angled, such that they are further apart at the top 185 than they
are at the bottom 186 of the integrated fin tab 180. This shape can
make the fin 120 easier to grip with a tool, such as a
hemostat.
[0228] The fin tab 180 extends from the backing layer 130 at a
position centered between the first side 133 and the second side
134 of the backing layer 130. In an alternate embodiment, the fin
tab 180 is not centered between the first side 133 and the second
side 134 of the backing layer 130.
[0229] An eyelet 301 is formed in the fin 120 of this embodiment.
The eyelet can be used to facilitate the capture of the lead
electrode assembly by a tool. The eyelet is formed as a hole 225
through the molded cover 220 and between the faces 181 and 182 of
fin tab 180. In an alternate embodiment, no eyelet is formed in the
fin 120.
[0230] The bottom surface 115 of the electrode 107 comprises a
periphery 213 and a center 211. The molded cover 220 forms a skirt
222 around the periphery 213 of the bottom surface 115 of the
electrode 107. The skirt 222 of the molded cover 220 covers the
periphery 213 of the bottom surface 115 of the electrode 107.
[0231] The skirt 222 of the molded cover 220 can act to focus
cardioversion/defibrillation energy emitted from the electrode 107
of the lead electrode assembly 100 toward the heart of the patient.
Because the thorax of a patient is surrounded by a layer of fat
that is somewhat conductive, the cardioversion/defibrillation
energy may tend to arc through this layer to reach the active
surface 15 of the canister 11 (seen in FIG. 1) without passing
through the patient's heart. The skirt 222 of the lead electrode
assembly 100 acts to minimize the loss of cardioversion
defibrillation energy to surrounding body tissues, or from being
diverted away from the patient's heart.
[0232] The center 211 of the bottom surface 115 of the electrode
107 is not covered by the molded cover 220 and is left exposed. The
width of the periphery 213 of the bottom surface 115 of the
electrode 107 covered by the molded cover 220 is approximately
0.125 cm.
[0233] The area of the exposed center 211 of the bottom surface 115
of the electrode 107 is approximately 500 square mm. In alternative
embodiments, the length of the first pair of sides 108 and the
second pair of sides 109 of the electrode 107 vary, such that the
area of the center 211 of the bottom surface 115 of the electrode
has a surface area between approximately 100 sq. mm. and
approximately 2000 sq. mm.
[0234] FIG. 17(d) illustrates an exploded top view of the lead
fastener 146 of the embodiments illustrated in FIGS. 17(a)-17(c).
The lead fastener connects the proximal end 102 of the lead 21 and
the distal end 103 of the electrode 107.
[0235] In this embodiment, the lead fastener 146 comprises a first
crimping tube 200, a crimping pin 202 and a second crimping tube
201. The crimping pin 202 comprises a first side 203 and a second
side 204.
[0236] The crimping tube 200 crimps the filars 147 of the lead 21
(here, only one representative filar 147 is shown) to the first
side 203 of crimping pin 202. The mandrel 219 of the electrode 107
is then wrapped around the second side 204 of the crimping pin 202.
Crimping tube 201 crimps the mandrel 219 to the second side 204 of
the crimping pin 202.
[0237] The first crimping tube 200, the second crimping tube 201
and the crimping pin 202 are each made of platinum iridium. In an
alternative embodiment, the first crimping tube 200, the second
crimping tube 201 and the crimping pin 202 are each made of a metal
selected from the group consisting essentially of titanium, nickel
alloys, stainless steel alloys, platinum, platinum iridium, and
mixtures thereof. In other embodiments, the first crimping tube
200, the second crimping tube 201 and the crimping pin 202 each
comprise any conductive material.
[0238] The electrode 107 in this embodiment comprises a sheet of
metallic mesh 206 prepared by the process described with reference
to FIG. 14. The electrode 107 has a width measured parallel to the
second pair of sides 109 of the electrode 107. The width of the
mandrel neck 218 of the electrode 107 is approximately 3 mm wide.
The width of the mandrel of the electrode 107 is approximately 5 mm
wide.
[0239] The first pair of sides 108 of the electrode 107 are
approximately 5 cm in length. The second pair of sides 109 of the
electrode 107 are approximately 1.9 cm in length. In alternative
embodiments, the length of the first pair of sides 108 and the
second pair of sides 109 of the electrode 107 range independently
from approximately 1 cm to approximately 5 cm.
[0240] The electrode 107 of this embodiment further comprises four
corners 112. The corners 112 of the electrode 107 are rounded. In
an alternate embodiment, the corners 112 of the electrode 107 are
not rounded.
[0241] FIGS. 17(e)-17(g) illustrate the size and position of the
fin 120 on the molded cover of the lead electrode assembly 100.
[0242] FIGS. 18(a)-18(c) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiments illustrated in FIGS. 17(a)-17(g). In
this embodiment, however, the appendage height of the fin 120 is
approximately 1 cm. The appendage length of the fin 120 in this
embodiment is approximately 3.5 cm.
[0243] As shown in FIG. 18(a), stitching 302 is placed through the
molded cover 220 and the fin 120 to prevent the molded cover 220
from sliding off the fin tab 180 when the molded cover 220 is
subjected to a force directed away from the electrode 107.
[0244] As shown in FIG. 18(c), the fin 120 (phantom view) extends
approximately two thirds of the length of the electrode 107.
[0245] FIG. 19 illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the embodiments illustrated in FIGS. 17(a)-17(g). In this
embodiment, however, the backing layer 130 (not shown) inside the
molded cover 220 is curved. This results in an electrode 107 that
has a curvature of radius r, such that the bottom surface 115 of
the electrode 107 is concave.
[0246] Because a curved electrode 107 may more closely approximate
the curvature of the patient's ribs, this curvature may have the
effect of making the lead electrode assembly 100 more comfortable
for the patient. In one embodiment, the radius r of the curvature
varies throughout the electrode 107 such that it is intentionally
shaped to approximate the shape of the ribs. Lead electrode
assemblies 100 can be custom manufactured with an electrode 107
with a curvature r that matches the curvature of the intended
patient's ribcage in the vicinity of the ribcage adjacent to which
the electrode 107 is to be positioned.
[0247] In an alternative embodiment, lead electrode assemblies 100
are manufactured with an electrode 107 with a radius r that matches
the curvature of the ribcage of a statistically significant number
of people.
[0248] In another embodiment, lead electrode assemblies 100 with
electrodes 107 of varying curvatures can be manufactured to allow
an electrode radius r to be selected for implantation based on the
size of the patient. Smaller radii can be used for children and for
smaller adult patients. Larger radii can be used for larger
patients. The radius r of the curvature can range from
approximately 5 cm to approximately 35 cm depending on the size of
the patient.
[0249] In an alternative embodiment, the electrode 107 of the lead
electrode assembly 100 is flexible, such that it can be bent to
conform to the curvature of the intended patient's rib cage at the
time of implantation.
[0250] FIGS. 20(a)-20(c) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiments illustrated in FIGS. 17(a)-17(g). In
this embodiment, however, the backing layer 130 lacks an integrated
fin tab 180 mounted on the first surface 131 of the backing layer
130. Moreover, this embodiment further comprises a backing layer
400 having a fin tab 405.
[0251] FIGS. 20(a) and 20(b) illustrate only the backing layer 400,
the fin tab 405 and the electrode 107 of this embodiment as they
are positioned relative to each other in the complete embodiment.
Other components of the embodiment are not shown. FIG. 20(c) shows
the embodiment in a complete form.
[0252] FIG. 20(a) illustrates a top plan view of the backing layer
400 and the electrode 107. The backing layer 400 is positioned over
the electrode 107. The electrode 107 of this embodiment is
substantially similar to the electrode 107 of the embodiment
illustrated in FIG. 17(d). In the complete embodiment, the mandrel
219 of the electrode 107 is joined to the lead 21 (not shown) by a
lead fastener 146 (not shown) as shown in FIG. 17(a).
[0253] The backing layer 400 is a flat, planar member comprising a
distal end 137 and a proximal end 138. The backing layer 400
further comprises a first side 133, a second side 134, a first
surface 131, and a second surface 132 (not shown). The backing
layer 400 further comprises a width, W, measured as the distance
between the first side 133 and the second side 134.
[0254] The backing layer 400 includes a fin tab 405 that is formed
from the same piece of material as the backing layer 400. The first
side 133 of the backing layer 400 lies over one of the first pair
of sides 108 of the electrode 107 except over a fin tab region 407.
In the fin tab region 407, the backing layer 400 is wider than the
electrode 107. In the fin tab region 407, the first side 133 forms
a fin tab 405 that protrudes from part of the first side 133 of the
backing layer 400 outside the fin tab region 407. The fin tab 405
extends from the first side 133 of the backing layer 400 in an
orientation substantially parallel to the top surface 110 of the
electrode 107, beyond the first side 108 (phantom view) of the
electrode 107.
[0255] The fin tab 405 comprises a first face 410 and a second face
411 (not shown). The first face 410 of the fin tab 405 is an
extension of the first surface 131 of the backing layer 400. The
second face 411 of the fin tab 405 is an extension of the second
surface 132 of the backing layer 400.
[0256] Aside from the fin tab 405, the backing layer 405 is formed
so that it is of substantially the same size and shape as the main
body 217 of the electrode 107.
[0257] The backing layer 400, including the fin tab 405, is
composed of polyurethane. In an alternate embodiments the backing
layer 400 and fin tab 405 are composed of any polymeric
material.
[0258] FIG. 20(b) is a side plan view of the backing layer 400 and
the electrode 107. The backing layer 400 is positioned over the
electrode 107 such that the second surface 132 of the backing layer
400 is placed adjacent to the top surface 110 of the electrode
107.
[0259] FIG. 20(c) illustrates a bottom plan view of the complete
embodiment, in which the backing layer 400 (not shown), the lead
fastener 146 (not shown) and the fin tab 405 (phantom view) are
coated with a molded cover 220. When the molded cover 220 is
applied over the backing layer 400, a fin 424 is formed over the
fin tab 405 (phantom view). The fin 424 comprises a proximal end
404 and a distal end 403.
[0260] In one embodiment, the fin 424 is reinforced with a layer of
Dacron.RTM. polymer mesh positioned between the molded cover 220
and the fin tab 405. In another embodiment, the Dacron.RTM. polymer
mesh is attached only to the molded cover 220. In other
embodiments, the fin 424 is similarly reinforced with a layer of
any polymeric material.
[0261] The appendage height, h.sub.Appendage, of the fin 424 of
this embodiment is approximately 5 mm. In alternative embodiments,
the appendage heights range between approximately 1 mm and
approximately 10 mm. The appendage length, L.sub.Appendage, of the
fin 424 of this embodiment is measured between the proximal end 404
and the distal end 403 of the fin 424. L.sub.Appendage is measured
where the fin 424 joins the rest of the lead electrode assembly
100. In this embodiment, the appendage length is approximately 1
cm. In alternative embodiments, the appendage lengths range between
approximately 2 mm and approximately 6 cm. In one embodiment, the
appendage length of the fin 424 is such that the fin 424 runs the
length of the electrode 107. In one embodiment, the appendage
length of the fin 424 is such that the fin 424 runs the length of
the backing layer 130 (not shown). In one embodiment, the appendage
length of the fin 424 is such that the fin 424 runs the length of
the molded cover 220.
[0262] FIG. 20(d) illustrates a bottom plan view of an alternate
embodiment of the lead electrode assembly 100. This embodiment is
substantially similar to the lead electrode assembly 100
illustrated in FIGS. 20(a)-20(c) In this embodiment, however,
proximal end 404 of the fin 424 is sloped. The slope shape of the
fin 424 is formed by the shape of the fin tab 405 (phantom view)
inside the fin 424. The backing layer 400 gradually widens in the
fin tab region 407 (not shown) with distance from the proximal end
138 (not shown) to the distal end 137 (not shown) of the backing
layer 130 (not shown) until the appendage height is reached. The
proximal end 404 of the fin 424 is straight and forms an acute
angle with the first side 133 of the base portion 158 of the
backing layer 130 (not shown). In an alternate embodiment, the
proximal end 404 of the fin 424 forms a 45 degree angle with the
first side 133 of the base portion 158 of the backing layer 130
(not shown). In another embodiment, the proximal end 404 of the fin
424 is curved slope.
[0263] In alternate embodiments, the distal end 403 of the fin 424
is straight and shaped so that it forms an acute angle with the
first side 133 of the base portion 158 of the backing layer 130
(not shown). In alternate embodiments, the distal end 403 of the
fin 424 is curved.
[0264] FIGS. 21(a)-21(c) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 15(a)-15(b). The
integrated fin 120 is absent, however, from the backing layer
130.
[0265] The lead electrode assembly 100 of this embodiment further
comprises a cylindrical rod 500 having a loop 515 formed therein.
The loop 515 comprises the appendage 118 of this embodiment. The
loop 515 is a member attached to the electrode 107 that can be
gripped and used to precisely locate the electrode 107 during its
surgical implantation within the patient.
[0266] FIG. 21(a) illustrates a side plan view of the embodiment.
The cylindrical rod 500 comprises a first straight portion 510, a
second straight portion 512 and a portion formed into a loop 515.
The first straight portion 510 is separated from the second
straight portion 512 by the loop 515.
[0267] The rod 500 is made of platinum iridium. In an alternative
embodiment, the rod 500 is made of titanium or platinum.
[0268] The first straight portion 510 and second straight portion
512 are spot welded to the top surface 110 of the electrode 107.
The loop 515 in the rod 500 extends away from the top surface 110
of the electrode 107.
[0269] The backing layer 130 is similar to the backing layer 130
illustrated in FIGS. 15(a)-15(b). The backing layer 130 is disposed
over the electrode 107. The first straight portion 510 and second
straight portion 512 of the rod 500 are positioned between the
second surface 132 of the backing layer 130 and the top surface 110
of the electrode 107.
[0270] FIG. 21(b) illustrates a cross-sectional rear plan view of
the embodiment of the lead electrode assembly shown in FIG. 21(a).
The first straight portion 510 and second straight portion 512 are
positioned such that they are parallel to the first pair of sides
108 of the electrode 107. The first straight portion 510 and second
straight portion 512 are both centered between the first pair of
sides 108 of the electrode 107. In an alternative embodiment, the
first straight portion 510 and second straight portion 512 are not
parallel to and centered between the first pair of sides 108 of the
electrode 107.
[0271] FIG. 21(c) illustrates a top plan view of the embodiment of
the lead electrode assembly shown in FIG. 21(a). An aperture 517 is
formed in the backing layer 130. The aperture 517 in the backing
layer is positioned such that the loop 515 extends through and
beyond the aperture 517 in a direction away from the top surface
110 of the electrode 107. The backing layer 130 is attached to the
electrode 107 with stitching 139.
[0272] FIGS. 22(a)-22(d) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 15(a)-15(b). This
embodiment comprises a backing layer 610, however, that lacks the
integrated fin 120 illustrated in FIGS. 15(a)-15(b).
[0273] FIG. 22(a) illustrates a top plan view of the backing layer
610 of this embodiment prior to its attachment to the rest of the
lead electrode assembly 100. The backing layer 610 is cut in a
pattern as shown. The backing layer comprises a first surface 131,
a second surface 132 (not shown), a distal end 137, a proximal end
138, a first side 133, a second side 134 and an indented
fin-forming region 620. The indented fin-forming region 620
comprises a first edge 690 and a second edge 691.
[0274] The backing layer 610 is formed so that the first side 133
and the second side 134 are substantially parallel and of
substantially the same size as the first pair of sides 108 of the
electrode 107. The proximal end 138 is formed so that it is
substantially perpendicular to the first side 133 and the second
side 134 of the backing layer 610. The proximal end 138 is longer
than the second pair of sides 109 of the electrode 107 by a length
A. The backing layer 610 has a varying width C measured from its
distal end 137 to its proximal end 138 along a line parallel to its
first side 133.
[0275] The backing layer is divided into three sections. A first
backing section 693, a second backing section 692 and an indented
fin-forming region 620 of length A. The length of the fin-forming
region 620, A, is approximately 10 mm. In other embodiments, the
length of the fin-forming region 620, A, ranges between
approximately 2 mm and approximately 20 mm.
[0276] The area within the indented fin-forming region 620 is
equally divided into a first fin area 612 and a second fin area
615. The dividing line 617 between the first fin area 612 and the
second fin area 615 is substantially parallel to the first side
133.
[0277] The width, C, of the backing layer 610 is equal to the
distance between the second pair of sides 109 of the electrode 107
except in the indented fin-forming region 620. In the indented
fin-forming region 620, the width, C, of the backing layer 610 is
B. The width, B, of the backing layer 610 in the fin-forming region
620, is approximately 1 cm. In alternate embodiments, the width, of
the backing layer 610 in the fin-forming region 620 ranges between
approximately 2 mm and approximately 6 cm. In other embodiments,
however, the fin-forming region 620 ranges between 2 mm and the
width, C, of the backing layer 610. In other embodiments, the
fin-forming region 620 is longer than the width, C, of the backing
layer 610.
[0278] The variation in width between the areas inside and outside
the indented fin-forming region 620, forms the first edge 690 and a
second edge 691 of the fin-forming region 620.
[0279] A first notch 136(a) is formed on the distal end 137 the
first edge 690 of the fin-forming region 620 of the backing layer
130. A second notch 136(b) is formed on the distal end 137 the
second edge 691 of the fin-forming region 620 of the backing layer
130.
[0280] The backing layer 610 in this embodiment is formed of
flexible silicone. In alternative embodiments the backing layer 610
is formed of any bio-compatible, flexible polymeric material.
[0281] FIG. 22(b) illustrates a top plan view of the lead electrode
assembly 100 of this embodiment. The backing layer 610 is attached
to the electrode 107, so that the first edge 690 and a second edge
691 of the fin-forming region 620 of the backing layer 610 meet.
This causes the backing layer 610 in the first fin area 612 and the
second fin area 615 to fold together to form a fin 120.
[0282] The first notch 136(a) and second notch 136(b) formed on the
distal end 137 the first edge 690 and second edge 691 of the
fin-forming region 620 of the backing layer 130 meet to form a
notch 136 on the distal end 137 of the backing layer, through which
the lead fastener 146 rises. Stitching 660 holds the backing layer
to the electrode 107.
[0283] FIG. 22(c) illustrates a side plan view of the lead
electrode assembly 100 of this embodiment. Stitching 660 holds the
first fin area 612 and a second fin area 615 of the backing layer
610 together to form the fin 120.
[0284] FIG. 22(d) illustrates a front plan view of the lead
electrode assembly 100 of this embodiment. In one embodiment, the
fin 120 is reinforced with a layer of Dacron.RTM. polymer mesh
positioned between the first fin area 612 and a second fin area
615. In another embodiment, the Dacron.RTM. polymer mesh is
attached only to either first fin area 612 or the second fin area
615. In other embodiments, the fin 120 is similarly reinforced with
a layer of any polymeric material.
[0285] FIGS. 22(e) and 22(f) illustrate an alternative embodiment
of the lead electrode assembly 100. This embodiment is
substantially similar to the embodiment illustrated in FIGS.
22(a)-22(d). The backing layer 610 is substantially similar to the
backing layer 610 illustrated in FIG. 22(a). The backing layer 610
in this embodiment, however, is cut along line 617. The fin 120 of
this embodiment comprises a proximal edge 129. The proximal edge
129 of the fin 120 is slope-shaped. The sloped shape can reduce the
resistance offered by the tissue of the patient as it slides
against the fin 120 during the insertion of the lead electrode
assembly 100 into the patient.
[0286] FIGS. 23(a) and 23(b) illustrate a property of the
embodiment of the lead electrode assembly 100 illustrated in FIGS.
22(e) and 22(f). The backing layer 610 is flexible, such that the
substantially planar fin 120 formed therefrom is flexible and able
to fold. Because the ability of the fin 120 to fold effectively
reduces its appendage height, it may make the fin more comfortable
to the patient after it is implanted.
[0287] FIG. 23(a) shows fin 120 in an upright condition. When
pressure is applied perpendicular to the first surface 131 of
backing layer in the first fin area 612, along line 677 for
example, the fin 120 folds as shown in FIG. 23(b). When the fin 120
folds, its appendage height, H.sub.Appendage, is reduced. This can
be seen by a comparison between FIG. 23(a) and FIG. 23(b).
[0288] The backing layer 610 in this embodiment is formed of a
polymeric material. In an alternative embodiment, the backing layer
610 is formed of any bio-compatible, flexible polymeric
material.
[0289] FIGS. 24(a)-24(c) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 22(a)-22(d).
[0290] As shown in FIG. 24(a), however, the material from the first
fin area 612 and the second fin area 615 of the backing layer 610
is not fastened together with stitching 660 in this embodiment. The
resulting appendage 118 is formed in the shape of a tube.
[0291] In alternate embodiments, the backing layer 610 is coupled
to the electrode 107 such that the material from the first fin area
612 and the second fin area 615 of the backing layer 610 does not
touch except at the dividing line 617 between the first fin area
612 and the second fin area 615. The separation between the first
fin area 612 and the second fin area 615 of the backing layer 610
can allow the appendage 118 of this embodiment to be highly
flexible. This flexibility can reduce the resistance offered by the
tissue of the patient as it slides against the appendage 118 during
the insertion of the lead electrode assembly 100 into the
patient.
[0292] FIG. 24(b) illustrates a side plan view of the embodiment
illustrated in FIG. 24(a). The appendage 118 of this embodiment
comprises a proximal edge 129. The proximal edge 129 of the
appendage 118 is slope-shaped. The sloped shape can reduce the
resistance offered by the tissue of the patient as it slides
against the appendage 118 during the insertion of the lead
electrode assembly 100 into the patient.
[0293] In alternate embodiments, the proximal edge 129 of the tube
formed by the appendage 118 is closed. In one embodiment, the
proximal edge 129 of the appendage 118 is closed by a cap (not
shown). In another embodiment, the proximal edge 129 of the
appendage 118 is closed with stitching placed between the first fin
area 612 and the second fin area 615 only at the proximal edge 129
of the appendage 118. In another embodiment, the proximal edge 129
of the appendage 118 is closed by any other means known in the art
for this purpose.
[0294] FIG. 24(b) illustrates a top plan view of the embodiment
illustrated in FIGS. 24(a)-24(b).
[0295] FIGS. 25(a)-25(d) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 15(a)-15(b). The
backing layer 130 of this embodiment, however, lacks an integrated
fin 120.
[0296] FIG. 25(a) illustrates a front plan view of the lead
electrode assembly. The fin 120 in this embodiment comprises a fin
head 700 and flexible joining material 702.
[0297] The fin head 700 comprises a rectangular sheet having a
first face 705, a second face 706, a first end 710 and a second end
712. The fin head 700 further comprises a height measured along the
first face 705 between the first end 710 and the second end 712 and
a length measured perpendicular to its height.
[0298] The fin head 700 is made of rigid silicone, which has a high
durometer. In alternate embodiments, the fin head 700 is composed
of any rigid bio-compatible material, such as a rigid
bio-compatible polymeric material.
[0299] The flexible joining material 702 comprises a rectangular
sheet having a first face 720, a second face 721, a first end 718
and a second end 719. The flexible joining material 702 further
comprises a height measured along the first face between the first
end 718 and the second end 719. The flexible joining material 702
also comprises a length measured perpendicular to its height. The
length of the flexible joining material 702 is the same as the
length of fin head 700.
[0300] The second end 712 of the second face 706 of the fin head
700 is attached to the first end 718 of the first face 720 of the
flexible joining material 702. The fin head 700 is attached to the
flexible joining material 702 with stitching 725. The second end
719 of the first face 720 of the flexible joining material 702 is
attached to the first surface 131 of the backing material 130. The
flexible joining material 702 is attached to the backing material
130 with stitching 730.
[0301] The flexible joining material 702 is made of flexible
silicone. It will be recognized by one skilled in the art, however,
that the flexible joining material 702 may be made from many other
flexible materials, such as a flexible polymeric material.
[0302] FIG. 25(b) illustrates a property of the fin 120. When
pressure is applied perpendicular to the first surface 705 of the
fin head 205, the fin 120 folds as shown. When the fin 120 folds,
its appendage height, H.sub.Appendage, is reduced. This can be seen
by a comparison between FIG. 25(a), which shows the fin 120 in an
upright position and FIG. 25(b) which shows the fin 120 in a folded
position.
[0303] FIG. 25(c) illustrates a top planar view of the lead
electrode assembly 110 of the embodiment illustrated in FIGS. 25(a)
and 25(b). Neither the corners of the electrode 107 nor the corners
735 of the backing layer 130 of this embodiment are rounded. In an
alternate embodiment, both the corners of the electrode 107 and the
corners 735 of the backing layer 130 of this embodiment are
rounded.
[0304] FIG. 26 illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the embodiment illustrated in FIGS. 25(a)-25(d). The backing layer
130 of this embodiment, however, lacks a fin head 700 and flexible
joining material 702.
[0305] Moreover, the appendage 118 in this embodiment comprises a
tube 740 having an interior 755, an exterior 756, a proximal end
757 and a distal end 758. The tube comprises a sheet of material
750. The sheet of material 750 is substantially rectangular having
a first pair of sides 751, a second pair of sides 752, a first
surface 753 and a second surface 754.
[0306] The sheet of material 750 is folded so that its first pair
of sides 751 abut each other. The folded sheet of material 750
forms a tube 740. The first surface 753 of the sheet of material
750 faces the interior 755 of the tube 740. The second surface 754
of the sheet of material 750 faces the exterior of the tube 756. In
folding the sheet of material 750 so that the first pair of sides
751 abut each other, the second pair of sides 752 of the sheet of
material 750 are folded in a circular shape to form the proximal
end 757 and distal end 758 of the tube 740. This results in the
tube 740 having a cylindrical shape. The diameter of the circular
proximal end 757 and distal end 758 of the tube 756 is
approximately 5 mm. In alternate embodiments, the diameter range
between approximately 1 mm and approximately 10 mm. The length of
the tube 756 as measured between the proximal end 757 and distal
end 758 of the tube 756 is approximately 1 cm. In alternate
embodiments, length of the tube 756 ranges between approximately 2
mm and approximately 6 cm. In one embodiment, the tube 756 is
substantially as long as the electrode 107.
[0307] The second surface 754 of the sheet of material 750 is
attached to the first surface 131 of the backing layer 130. The
first pair of sides 751 of the sheet of material 750 are attached
to the backing layer 130 with stitching 760.
[0308] In alternate embodiments, the proximal end 757 of the tube
740 is closed. In one embodiment, the proximal end 757 of the tube
740 is closed by a cap (not shown). In another embodiment, the
proximal end 757 of the tube 740 is closed by holding one of the
second pair of sides 752 of the sheet of material 750 closed with
stitching. In another embodiment, the proximal end 757 of the tube
740 is closed by any other means known in the art for this
purpose.
[0309] It should be noted that the appendage 118 in some
alternative embodiments comprises a tube with a shape other than a
cylinder. An example of a tube with a shape other than cylindrical
is illustrated below in FIG. 27.
[0310] FIG. 27 illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the embodiment illustrated in FIG. 26. The tube 740 comprising a
sheet of material 750, however, is absent from this embodiment.
[0311] Moreover, the appendage 118 of this embodiment comprises a
tube 770 having an interior 755 an exterior 756, a proximal end 757
and a distal end 758. The tube comprises a first sheet of material
775, a second sheet of material 776 and a third sheet of material
777. The first sheet of material 775, the second sheet of material
776 and the third sheet of material 777 are all substantially
rectangular in shape. Each comprises a first pair of sides 784, a
second pair of sides 786, a first surface 788 and a second surface
789. The first pair of sides 784 of each sheet of material are
parallel to each other. In another embodiment, the first pair of
sides 784 of each sheet of material are non-parallel. The second
pair of sides 786 of each sheet of material are parallel to each
other. In another embodiment, the second pair of sides 786 of each
sheet of material are non-parallel.
[0312] The first pairs of sides 784 of each sheet of material are
attached to the first pair of sides 784 of the other sheets of
material. In this way the second pair of sides 786 of the first
sheet of material 775, the second sheet of material 776 and the
third sheet of material 777 form a triangular shaped proximal end
757 and distal end 758 of the tube 770. The sheets of material are
attached to each other such that the second surface 789 of each
sheet of material faces the interior 755 of the tube 770. The
sheets of material are attached to each other with stitching
791.
[0313] The height of the tube 770 is approximately 5 mm. In
alternate embodiments, the height ranges between approximately 1 mm
and approximately 10 mm. The length of the tube 770 as measured
between the proximal end 757 and distal end 758 of the tube 770 is
approximately 1 cm. In alternate embodiments, length of the tube
770 ranges between approximately 2 mm and approximately 6 cm. In
one embodiment, the tube 770 is substantially as long as the
electrode 107.
[0314] The second sheet of material 776 is attached to the backing
layer 130 with stitching 790. The first surface 788 of the second
sheet of material 776 is positioned next to the first surface 131
of the backing layer 130.
[0315] In alternate embodiments, some or all of the sheets of
material are reinforced with a layer of Dacron.RTM. polymer mesh.
In one embodiment, the Dacron.RTM. polymer mesh is attached to the
first surface 788 of each sheet of material. In another embodiment,
the Dacron.RTM. polymer mesh is attached to the second surface 789
of each sheet of material. In another embodiment, the sheets of
material are similarly reinforced with a layer of any polymeric
material.
[0316] In alternate embodiments, the proximal end 757 of the tube
770 is closed. In one embodiment, the proximal end 757 of the tube
770 is closed by a cap. In another embodiment, the proximal end 757
of the tube 770 is closed by holding the sides 786 of the first
sheet of material 775, the second sheet of material 776 and the
third sheet of material 777 that form the proximal end 757 of the
tube 770 together with stitching. In another embodiment, the
proximal end 757 of the tube 770 is closed by any other means known
in the art for this purpose.
[0317] FIGS. 28(a)-28(d) illustrate various possible positions for
the appendage 118 relative to the lead 21 of the lead electrode
assembly 100. Additionally, up to this point, all embodiments of
the electrode 107 illustrated and discussed have had a rectangular
shape. These figures illustrate alternative embodiments with
electrodes 107 of different shapes.
[0318] At this point, it is useful to set out two definitions in
order to discuss the possible orientation of appendages 118.
[0319] The interface line is defined as the center line of the
appendage 118 as traced on the electrode 107. FIG. 28(a)
illustrates the interface line 800 of the appendage 118 of a lead
electrode assembly 100.
[0320] The line of the lead is defined as the line along which the
lead 21 of the lead electrode assembly 100 enters the lead fastener
146. The line of the lead 805 of line 21 is shown as it enters the
lead fastener 146 (in phantom). As the lead 21 approaches the lead
fastener 146, the closest section 807 of the lead 21 forms the line
of the lead. When the lead 21 is not bent, the entire lead 21 lies
along the line of the lead.
[0321] FIG. 28(b) illustrates an embodiment wherein the lead 21 is
not bent and the entire lead 21 lies along the line of the lead
805.
[0322] The electrode length, L.sub.Electrode, is the length of the
electrode 107 as measured along the interface line 800.
[0323] In the embodiments of the lead electrode assembly 100 shown
in FIGS. 28(b) and 28(c), the interface line 800 is the same line
as the line of the lead 805. In the embodiment shown in FIG. 28(a)
the interface line 800 is parallel with the line of the lead
805.
[0324] In the embodiment of the lead electrode assembly 100 shown
in FIG. 28(d), the interface line 800 intersects the lead fastener
146 (phantom view).
[0325] FIGS. 28(e)-28(h) show various additional electrode shapes
disposed in various lead electrode assemblies 100. The electrode
shapes are not limited, however, to the shapes specifically
illustrated.
[0326] The electrode 204 depicted in FIG. 28(e) has a "thumbnail"
shape. The proximal end 104 of this electrode 107 is generally
rounded. As the electrode 107 moves distally along its length, the
conductive surface terminates at the distal end 103 of the
electrode 107.
[0327] An ellipsoidal shaped electrode 107 is depicted in FIG.
28(f). The proximal end 104 of the ellipsoidal shaped electrode 107
is generally rounded. As the ellipsoidal shaped electrode 107 moves
distally along its length, the conductive surface terminates in a
rounded distal end 103.
[0328] A circular shaped electrode 107 is illustrated in FIG.
28(g).
[0329] A triangular shaped electrode 107 is depicted in FIG. 28(h).
Triangular shaped electrodes 107 also incorporate electrodes that
are substantially triangular in shape. In particular to FIG. 28(h),
the corners of the triangular shaped electrode 107 are rounded.
[0330] Several lead electrode assembly manipulation tools 927 have
been developed to manipulate the lead electrode assemblies during
their surgical implantation.
[0331] FIG. 29 illustrates an embodiment of a lead electrode
assembly manipulation tool 927. The lead electrode assembly
manipulation tool 927 comprises an enhanced hemostat 930 used to
manipulate lead electrode assemblies 100 comprising an eyelet
during their implantation in patients.
[0332] The enhanced hemostat 930 comprises the following
components: a hemostat having a first prong 931, a second prong
932, a hinge 939 and an eyelet pin 940. The first prong 931 is
attached to the second prong 932 by the hinge 939. The eyelet pin
is attached to the second prong 932.
[0333] The first prong 931 comprises a first end 933 and a second
end 934. The second prong 932 comprises a first end 935 and a
second end 936. The first prong and second prong are approximately
75 cm long and curved with a radius of approximately 30 cm. In
alternate embodiments, the curvature of the hemostat does not have
a radius of approximately 30 cm, but instead approximates the
curvature of the thorax of a patient. In one embodiment, the
curvature of the hemostat approximates the curvature of the thorax
of a patient along a subcutaneous path taken from the anterior
axillary line, posteriorly toward the spine.
[0334] The first prong 931 is pivotally attached to the second
prong 932 by the hinge 939. The hinge is attached to the first
prong 931 approximately 10 cm from the first end 933. In this
embodiment, the hinge is attached to the second prong 932
approximately 10 cm from the second end 935.
[0335] The eyelet pin 940 can be inserted through the eyelet 301 of
a fin 120 of the lead electrode assembly 100 such as the lead
electrode assembly 100 discussed with reference to FIG. 17(a)-17(g)
as a means of capturing the lead electrode assembly 100 prior to
its implantation in a patient.
[0336] The eyelet pin 940 is a cylindrical member having a first
end 941 and a second end 942. In an alternate embodiment, the
eyelet pin 940 is a hook-shaped member. The diameter of the
cylinder is approximately 2 mm. In alternate embodiments, the
diameter of the cylinder ranges from approximately 1 mm to
approximately 5 mm. The length of the eyelet pin 940 is
approximately 8 mm. In alternate embodiments, the length of the
eyelet pin 940 ranges from approximately 4 to approximately 15
mm.
[0337] The first end of the eyelet pin 940 is attached to the
second prong 932, approximately 8 mm from the second end 936 of the
second prong 932. In alternate embodiments, the eyelet pin 940 is
attached to the second prong 932 at various lengths from the second
end 936 of the second prong 932.
[0338] The eyelet pin 940 is attached to the second prong 932 in an
orientation perpendicular to the length of the second prong 932.
The eyelet pin 940 is attached to the second prong 932 so that it
extends away from the second end 934 of the first prong 931.
[0339] In this embodiment, all of the components are made of
stainless steel. In an alternative embodiment, some or all of the
components are composed metals other than stainless steel or are
composed of a polymeric material.
[0340] We now turn to a discussion of the positions of the
components that comprise an entire S-ICD system including the lead
electrode assembly 100 when it is implanted in a patient.
[0341] FIGS. 30(a) and 30(b) illustrate an embodiment of the S-ICD
system implanted in a patient as a means of providing
cardioversion/defibrillati- on energy.
[0342] FIG. 30(a) is a perspective view of a patient's ribcage with
an implanted S-ICD system. The S-ICD canister 11 is implanted
subcutaneously in the anterior thorax outside the ribcage 1031 of
the patient, left of the sternum 920 in the area over the fifth rib
1038 and sixth rib 1036. The S-ICD canister 11, however, may
alternately be implanted anywhere over the area between the third
rib and the twelfth rib. The lead 21 of the lead electrode assembly
100 is physically connected to the S-ICD canister 11 where the
transthoracic cardiac pacing energy or effective
cardioverion/defibrillation shock energy (effective energy) is
generated. The term "effective energy" as used in this
specification can encompass various terms such as field strength,
current density and voltage gradient.
[0343] The lead 21 of the lead electrode assembly 100 travels from
the S-ICD canister 11 to the electrode 107, which is implanted
subcutaneously in the posterior thorax outside the ribcage 1031 of
the patient in the area over the eighth rib 1030 and ninth rib
1034. The electrode 107, may alternately be implanted
subcutaneously anywhere in the posterior thorax outside the ribcage
1031 of the patient in the area over the third rib 1030 and the
twelfth rib 1034. The bottom surface 115 of the electrode 107 faces
the ribcage. The electrode or active surface 15 (phantom view) of
the canister 11 also faces the ribcage.
[0344] FIG. 30(b) is a cross-sectional side plan view of the
patient's rib cage. Here it is seen that the lead 21 travels around
the circumference of the thorax, in the subcutaneous layer beneath
the fat 1050 between the outside of the ribcage 1031 and the skin
1055 covering the thorax.
[0345] We now turn to a discussion of a method by which the lead
electrode assembly 100 of the S-ICD system is implanted in a
patient using a standard hemostat as well as the enhanced hemostat
described above. FIG. 31 and FIGS. 32(a)-32(d) illustrate aspects
of this method.
[0346] In operation, as seen in FIG. 31, an incision 905 is made in
the patient 900 in the anterior thorax between the patient's third
and fifth rib, left of the sternum 920. The incision can
alternately be made in any location between the patient's third and
twelfth rib. The incision can be made vertically (as shown),
horizontally or angulated. In order to minimize scarring, the
incision can be made along Langher's lines.
[0347] FIG. 32 (a) shows a bottom view cross-section of the patient
900, along the line 32 (a) shown in FIG. 31. A hemostat 930, with
prongs 932 is introduced into the incision 905. The hemostat 930 is
inserted with its prongs together without anything gripped between
them. The prongs 932 of the hemostat 930 are pushed through the fat
1050 between the skin 1055 of the thorax and the ribcage 1031 to
create a subcutaneous path 1090. The prongs 932 of the hemostat 930
can alternately be pushed beneath the fat 1050 that lies between
the skin 1055 of the thorax and the ribcage 1031 to create a
subcutaneous path 1090 between the fat 1050 and the ribcage
1031.
[0348] The hemostat is moved around the ribcage 1031 until the
subcutaneous path 1090 reaches within approximately 10 cm of the
spine 1035 between the eighth rib 1030 and ninth rib 1034 (this
location is best seen in FIG. 30(a)) between the skin 1055 and the
ribcage 1031. The subcutaneous path 1090 can alternately be made to
reach any location between the skin 1055 and the ribcage 1031
between the patient's third and twelfth rib. The hemostat 930 is
then withdrawn. Alternately, the hemostat 930 can be moved around
the ribcage 1031 until the subcutaneous path 1090 terminates at a
termination point 1085 at which a line 1084 drawn from the
termination point 1085 to the incision 905 would intersect the
heart 910.
[0349] Next, as shown in FIG. 32(b), the appendage 118 of a lead
electrode assembly 100, is squeezed between the tongs 932 of a
hemostat 930.
[0350] As shown in FIG. 32(c), the lead electrode assembly 100 and
hemostat tongs 932 are introduced to the subcutaneous path 1090 and
pushed through the subcutaneous path until the lead electrode
assembly 100 reaches the termination point 1085 of the path. The
appendage 118 of the lead electrode assembly 100 is then released
from the tongs 932 of the hemostat 930. The hemostat 930 is then
withdrawn from the subcutaneous path 1090.
[0351] In an alternative method, the enhanced hemostat 930 seen in
FIG. 29 is used to introduce the lead electrode assembly 100 into
the subcutaneous path 1090 created as discussed above. After the
subcutaneous path 1090 is created, the lead electrode assembly 100
is attached to the enhanced hemostat 930 as shown in FIG. 32 (d).
Eyelet pin 1108 is inserted through the eyelet 301 in the fin 120
of the lead electrode assembly 100. The enhanced hemostat 930 is
then used to introduce the lead electrode assembly 100 into the
subcutaneous path 1090, as shown in FIG. 32(c). The lead electrode
assembly 100 is then moved through the subcutaneous path 1090 until
the electrode 107 reaches the end of the path 1085. The enhanced
hemostat 930 is then moved until the lead electrode assembly 100 is
released from the eyelet pin 940. The enhanced hemostat 930 is then
withdrawn from the subcutaneous path 1090.
[0352] FIGS. 33(a)-33(c) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiments illustrated in FIGS. 17(a)-17(g). The
backing layer 130 of this embodiment, however, lacks an integrated
fin tab 180. Moreover, the appendage 118 of the lead electrode
assembly 100 of this embodiment comprises a rail 1100.
[0353] FIG. 33(a) illustrates the rail 1100 of the lead electrode
assembly 100 of this embodiment. The rail 1100 is a member attached
to the electrode 107 that can be captured by a lead electrode
assembly manipulation tool and used to precisely locate the
electrode 107 during its surgical implantation within the patient.
The rail 1100 comprises three sections: a foundation 1105, a riser
1110 and a head 1115. The foundation 1105 is separated from the
head 1115 by the riser 1125.
[0354] The foundation 1105 comprises a flat, substantially planar
member, comprising a first pair of sides 1106 and a second pair of
sides 1107. The first pair of sides 1106 of the foundation 1105 are
substantially linear and substantially parallel. In an alternate
embodiment, the first pair of sides 1106 of the foundation 1105 are
neither linear nor parallel. The length of the first pair of sides
1106 of the foundation 1105 is approximately 2 cm. In alternate
embodiments, the length of the first pair of sides 1106 of the
foundation 1105 ranges from approximately 2 mm to approximately 6
cm. In an alternate embodiment, the first pair of sides 1106 of the
foundation 1105 are as long as the electrode 107 (not shown) of the
lead electrode assembly 100 (not shown).
[0355] The second pair of sides 1107 of the foundation 1105 are
substantially linear and substantially parallel. In an alternate
embodiment, the second pair of sides 1107 of the foundation 1105
are neither linear nor parallel. The length of the second pair of
sides 1107 of the foundation 1105 is approximately 1 cm. In
alternate embodiments, the length of the second pair of sides 1107
of the foundation 1105 ranges from approximately 0.5 cm to
approximately 3 cm.
[0356] The foundation 1105 further comprises a top surface 1120 and
a bottom surface 1121. The foundation 1105 has a thickness,
measured as the distance between the top surface 1120 and the
bottom surface 1121. The thickness of the foundation 1105 is 2 mm.
In alternate embodiments, the thickness of the foundation 1105
ranges between approximately 1 mm and approximately 5 mm.
[0357] Turning now to the riser 1110, the riser 1110 comprises a
flat, substantially planar protrusion from the top surface 1120 of
the foundation 1105 of the rail 1100. The riser comprises a first
face 1125, a second face 1126, a top 1127, a bottom 1128, a
proximal end 1123 and a distal end 1124. The first face 1125 and
second face 1126 are parallel to each other and perpendicular to
the top surface 1120 of the foundation 1105. The first face 1125
and a second face 1126 of the riser 1110 are parallel to the first
pair of sides 1106 of the foundation 1105. The bottom 1128 of the
riser 1110 joins the foundation 1105 in a position centered between
the first pair of sides 1106 of the foundation 1105. The proximal
end 1123 of the riser 1110 and the distal end 1124 of the riser
1110 are parallel to each other and perpendicular to the top
surface 1120 of the foundation 1105. In other embodiments, the
proximal end 1123 of the riser 1110 and the distal end 1124 of the
riser 1110 are not parallel to each other.
[0358] In one embodiment, the proximal end 1123 of the riser 1110
is not perpendicular the top surface 1120 of the foundation 1105.
Instead, the proximal end 1123 of the riser 1110 is sloped, so that
the proximal end 1123 and the distal end 1124 of the riser 1110 are
closer at the top 1127 of the riser 1110 than at the bottom 1128 of
the riser. A slanted proximal end 1123 make the rail 1100 of the
lead electrode assembly 100 offer less resistance against the
tissues of the patient during insertion into the patient.
[0359] The height of the riser, H.sub.Riser, is measured as the
distance between the top surface 1120 of the foundation 1105 to the
head 1115, perpendicular to the top surface 1120 of the foundation
1105. The height of the riser is approximately 5 mm. In alternate
embodiments, the height of the riser ranges from approximately 1 mm
to approximately 10 mm.
[0360] The riser 1110 has a width, measured as the distance between
the first face 1125 and the second face 1126. The width of the
riser 1110 is 2 mm. In alternate embodiments, the width of the
riser 1110 ranges from approximately 1 mm to approximately 6
mm.
[0361] Turning now to the head 1115, the head 1115 is a flat,
substantially planar member. The head 1115 comprises a first pair
of sides 1136, a second pair of sides 1137, a top surface 1116 and
a bottom surface 1117 (not shown). The first pair of sides 1136 and
the second pair of sides 1137 of the head 1115 are substantially
linear and substantially parallel. In an alternate embodiment, the
first pair of sides 1136 of the head 1115 are neither linear nor
parallel. In an alternate embodiment, the second pair of sides 1137
of the head 1115 are neither linear nor parallel.
[0362] The length of the first pair of sides 1136 of the head 1115
is equal to the length of the first pair of sides 1106 of the
foundation 1105. In alternate embodiments, the length of the first
pair of sides 1136 of the head 1115 is unequal to the length of the
first pair of sides 1106 of the foundation 1105. The length of the
second pair of sides 1137 of the head 1115 is approximately 5 mm.
In alternate embodiments, the length of the second pair of sides
1137 of the head 1115 ranges from approximately 3 mm to
approximately 10 mm.
[0363] The bottom surface 1117 of the head 1115 joins the top 1127
of the riser 1110 opposite the foundation 1105 of the rail 1100.
The top surface 1116 and the bottom surface 1117 of the head 1115
are parallel to the top surface 1120 of the foundation 1105. In an
alternate embodiment, the top surface 1116 and the bottom surface
1117 of the head 1115 are not parallel to the top surface 1120 of
the foundation 1105.
[0364] The head 1115 has a thickness, measured as the distance
between the top surface 1116 and the bottom surface 1117 of the
head 1115. The thickness of the head 1115 is approximately 2 mm. In
alternate embodiments, the thickness of the head ranges between
approximately 2 mm and approximately 10 mm.
[0365] The foundation 1105, the head 1115 and the riser 1110 are
made of stainless steel. In alternate embodiments, some or all of
the sections of the rail 1100 are made of metals other than
stainless steel. In alternate embodiments, some or all of the
sections of the rail 1100 are made of a polymeric material 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.
[0366] The foundation 1105, the head 1115 and the riser 1110 are
machined from the same piece of material. In an alternate
embodiment, some or all of the sections are formed independently
and welded to the others.
[0367] Turning in detail to FIG. 33(b), the position of the rail
1100 within the lead electrode assembly 100 will be discussed. The
rail 1100 is positioned so that its bottom surface 1121 is adjacent
to and covers a region of the first surface 131 of the backing
layer 130. The rail is centered between the first side 133 and
second side 134 of the backing layer 130. In an alternate
embodiment, the rail is not centered between the first side 133 and
second side 134 of the backing layer 130.
[0368] In an alternate embodiment, there is no backing layer 130
and the rail 1100 is positioned so that its bottom surface 1121 is
adjacent to the top surface 110 of the electrode 107.
[0369] Turning now to the electrode 107 of this embodiment, the
electrode 107 is the same shape and size as the electrode 107
discussed with reference to FIGS. 17(a)-(g) In alternative
embodiments, the length of the first pair of sides 108 (not shown)
and second pair of sides 109 (not shown) of the electrode 107 range
independently between approximately 1 cm and approximately 5
cm.
[0370] Turning now to the molded cover 220, the skirt 222 of the
molded cover 220 partially covers the bottom surface 115 of the
electrode 107 as discussed with reference to FIG. 17(d). The molded
cover 220 further substantially covers the first surface 131 of the
backing layer 130. The molded cover 220 does not cover the first
surface 131 of the backing layer 220 in the region in which the
bottom surface 1121 of the rail 1100 is adjacent to the backing
layer 130. Instead, the molded cover 220 in this region
substantially covers the top surface 1120 of the rail 1100.
[0371] The molded cover 220 abuts the first face 1125 and second
face 1126 of the riser 1110 of the rail 1100.
[0372] Turning to FIG. 33(c), the position of the lead 21 and the
appendage 118 will now be discussed. The interface line 800 of the
appendage 118 and the line of the lead 805 are the same line. In an
alternate embodiment, interface line 800 of the appendage 118 and
the line of the lead 805 are not the same line. The line of the
lead 805 is centered between the first pair of sides 108 (phantom
view) of the electrode 107 (phantom view). In an alternate
embodiment, the line of the lead 805 is not centered between the
first pair of sides 108 of the electrode 107.
[0373] FIG. 34 illustrates an alternative embodiment of the lead
electrode assembly 100. This embodiment is substantially similar to
the embodiment illustrated in FIGS. 33(a)-33(c). In this
embodiment, however, the dimensions of the electrode 107 are
different from those of the embodiment illustrated in FIGS.
33(a)-33(c).
[0374] The first pair of sides 108 of the electrode 107 (phantom
view) are approximately 2.4 cm in length. The second pair of sides
109 of the electrode 107 are approximately 4 cm in length. In
alternative embodiments, the length of the first pair of sides 108
and second pair of sides 109 of the electrode 107 range
independently between approximately 1 cm and approximately 5
cm.
[0375] The interface line 800 of the rail 1100 is parallel to the
line of the lead 805. In an alternate embodiment, the interface
line 800 of the rail 1110 is not parallel to the line of the lead
805. The interface line 800 of the rail 1100 is centered between
the first pair of sides 108 of the electrode 107. In an alternate
embodiment, the interface line 800 of the rail 1100 is not centered
between the first pair of sides 108 of the electrode 107.
[0376] The line of the lead 805 is not centered between the first
pair of sides 108 of the electrode 107. Because the lead 805 is not
centered between the first pair of sides 108 of the electrode 107,
the lead rail 1110 may be more easily accessed by a lead electrode
manipulation tool (not shown). In an alternate embodiment, the line
of the lead 805 is centered between the first pair of sides 108 of
the electrode 107.
[0377] FIG. 35 illustrates a lead electrode assembly manipulation
tool 927 useful for manipulating a lead electrode assembly (not
shown) having an appendage 118 comprising a rail 1100 during the
implantation of the lead electrode assembly 100 in a patient.
Examples of such lead electrode assembly 100 embodiments are shown
in FIGS. 33(a)-33(c) and 34.
[0378] The lead electrode assembly manipulation tool 927 comprises
a handle 1142, a rod 1144 and a rail fork 1146. The handle 1142 is
connected to the rod 1144. The rail fork 1146 is also connected to
the rod 1144.
[0379] The rod 1144 is a cylindrical member with a diameter of
approximately 4 mm, approximately 25 cm in length, having a
proximal end 1147 and a distal end 1148. The rod 1144 is curved
with a radius of approximately 20 cm.
[0380] The rod is made of steel. In other embodiments, the rod is
composed of titanium, a polymeric material or any other material
suitable for this purpose.
[0381] The handle 1142 is a cylindrical member with a diameter
sized to fit comfortably in the palm of a surgeon's hand. The rod
is connected to the proximal end 1147 of the rod 1144. In an
alternate embodiment, the handle 1142 is not cylindrical. In an
alternate embodiment, the handle 1142 has ergodynamic contours.
[0382] The handle is made of polyurethane. In an alternate
embodiment, the handle is made of any metal, or any polymeric
material suitable for this purpose.
[0383] Turning now to FIG. 35(b), the rail fork 1146 is attached to
the distal end 1148 of the rod 1144. The rod further comprises a
slot 1162 in its distal end. The rail fork comprises a pair of
tines 1151 separated by a gap 1153 and a tine base 1160 having a
tang 1161.
[0384] Each of the pair of tines 1151 has a proximal end 1154 and a
distal end 1155. The proximal ends 1154 of the pair of tines 1151
are attached to the tine base 1160. Each of the pair of tines 1151
has a substantially rectangular form with straight inner sides 1156
and straight outer sides 1157. The distal ends 1155 of each of the
pair of tines 1151 are rounded. The length of the pair of tines
1151, measured from the distal end 1155 to the proximal end 1154,
is substantially equal to the length of the first pair of sides
1106 of the rail 1100 of the lead electrode assembly 100. In
alternate embodiments, the length of the pair of tines 1151 is
substantially greater than or less than the length of the first
pair of sides 1106 of the rail 1100.
[0385] The pair of tines 1151 are separated by a gap 1153 formed by
the inner sides 1156 of the pair of tines 1151 and the tine base
1160.
[0386] The pair of tines 1151 and the tine base 1160 comprising the
rail fork 1146 are punched from a single sheet of steel having a
thickness of approximately 3 mm. In other embodiments, the rail
fork 1146 is composed of titanium, a polymeric material or any
other material suitable for this purpose. In one embodiment, the
handle 1142, the rod 1144 and the rail fork 1146 are all made from
the same piece of material.
[0387] FIG. 35(c) illustrates a side plan view of the lead
electrode assembly manipulation tool 927. The rod 1144 further
comprises a slot 1162 in its distal end 1148. The tine base 1160
connects the pair of tines 1151 to the distal end 1148 of the rod
1144. The tine base 1160 comprises a tang 1161 (phantom view). The
tang 1161 is inserted in the slot 1162 in the rod 1144. The tang
1161 is welded in the slot 1162 of the rod 1144.
[0388] We now turn to a description of the use of the lead
electrode assembly manipulation tool 927 in the implantation of a
lead electrode assembly 100 into a patient.
[0389] As discussed with reference to FIG. 31, an incision 905 is
made in the patient 900. As discussed with reference to FIG. 32(a),
a subcutaneous path 1090 is created in the patent 900 with a
hemostat 932.
[0390] As shown in FIG. 35(d), the lead electrode assembly 100 is
then captured by the lead electrode assembly manipulation tool 927.
The rail 1110 of the lead electrode assembly 100 is inserted into
the rail fork 1146 of the lead electrode assembly manipulation tool
927. The riser 1110(phantom view) of the rail is placed into the
gap 1153 between the pair of tines 1151 of the rail fork 1146. The
pair of tines 1151 fit between the bottom surface 1117 of the head
1115 of the rail 1100 and the molded cover 220. The rail 1100 is
slid toward the proximal end 1155 of the pair of tines 1151 until
the riser 1110 of the rail 1100 reaches the tine base 1160 of the
rail fork 1146. The lead 21 of the lead electrode assembly 100 can
then be pulled in toward the handle 1142 of the lead electrode
assembly manipulation tool 927 until it is taught. This acts to
prevent the rail 1100 of the lead electrode assembly 100 from
sliding toward the distal end 1151 of the pair of tines 1151 of the
rail fork 1146.
[0391] As discussed with reference to FIG. 32(c), the lead
electrode assembly manipulation tool 927 may then be used to place
the lead electrode assembly 100 into the incision 905 of the
patient 900 and used to move the electrode 107 to the termination
point 1085 of the subcutaneous path 1090.
[0392] The lead electrode assembly 100 is then released from the
lead electrode assembly manipulation tool 927. To achieve this, the
lead 21 of the lead electrode assembly 100 is released so that the
pair of tines 1151 of the rail fork 1146 of the lead electrode
assembly manipulation tool 927 can slide relative to the rail 1100
of the lead electrode assembly 100. The lead electrode assembly
manipulation tool 927 may then be extracted from the subcutaneous
path 1090, leaving the lead electrode assembly 100 behind.
[0393] FIGS. 36(a)-36(b) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiments illustrated in FIGS. 17(a)-17(g). The
backing layer 130 of this embodiment, however, lacks an integrated
fin tab 180. Moreover, the lead electrode assembly 100 of this
embodiment further comprises a pocket 1300.
[0394] FIG. 36(a) illustrates a cross-sectional side plan view of
this embodiment. The pocket 1300 comprises a layer of material 1315
and stitching 360. The pocket further comprises an interior 1305
and an opening 1310. The layer of material 1315 is attached to the
molded cover 220 with the stitching 360. The molded cover 220 is,
in turn, attached to the electrode 107.
[0395] The molded cover 220 comprises an outer surface 1330 and a
top surface 1331. The outer surface 1330 of the molded cover 220 is
the surface of the molded cover 220 that does not lie adjacent to
the backing layer 131 or the electrode 107. The top surface 1331 of
the molded cover 220 faces away from, and parallel to the electrode
107.
[0396] The layer of material 1315 of the pocket 1300 comprises an
inner face 1316 and an outer face 1317. The layer of material 1315
is attached to the top surface 1331 of the molded cover 220 so that
the inner face 1316 of the layer of material 1315 faces the top
surface 1331 of the molded cover 220. The inner face 1316 of the
layer of material 1315 also faces the top surface 110 of the
electrode 107.
[0397] The layer of material 1315 is made of polyurethane. In other
embodiments, the layer of material 1315 is made of any
bio-compatible material suitable for this purpose. In other
embodiments, the layer of material 1315 is made of any
bio-compatible polymeric material.
[0398] The stitching 360 fastening the layer of material 1315 to
the top surface 1331 of the molded cover 220 is comprised of nylon.
In alternate embodiments, the stitching 360 comprises any polymeric
material.
[0399] FIG. 36(b) illustrates a top plan view of the lead electrode
assembly 100 of FIG. 36(a). The top surface 1331 of the molded
cover 220 has a first side 1333, a second side 1334, a distal end
1336, a proximal end 1337, a length and a width.
[0400] The distal end 1336, proximal end 1337, first side 1333 and
second side 1334 of the top surface 1331 of the molded cover 220
are positioned substantially over the distal end 137 (phantom
view), proximal end 138 (phantom view), first side 133 (not shown)
and second side 134 (not shown) of the backing layer 130 (phantom
view) respectively.
[0401] The width of the top surface 1331 of the molded cover 220 is
measured as the distance between the first side 1333 and second
side 1334 of the back surface. The length of the top surface 1331
of the molded cover is measured as the distance between the distal
end 1336 and proximal end 1337 of the molded cover 220.
[0402] The layer of material 1315 comprises a periphery 1318 and a
middle portion 1319. More particularly, the layer of material 1315
comprises a distal end 1320, a proximal end 1321, a first side 1322
and a second side 1323. The periphery 1318 of the layer of material
1315 comprises the distal end 1320, the proximal end 1321, the
first side 1322 and the second side 1323 of the layer of material
1315. The middle portion 1319 of the layer of material 1315
comprises the area between the distal end 1320, the proximal end
1321, the first side 1322 and the second side 1323 of the layer of
material 1315.
[0403] The pocket 1300 formed by the layer of material 1315 further
comprises a bounded region 1325 and a center 1326. The bounded
region 1325 of the pocket 1300 is attached to the back face 1317 of
the molded cover 220. The center 1326 of the pocket 1300 is not
attached to the back face 1317 of the molded cover 220. Stitching
360 in the bounded region 1325 is used to attach the layer of
material 1315 to the molded cover 220.
[0404] In the embodiment under discussion, the bounded region 1325
of the pocket 1300 comprises a portion of the periphery 1318 of the
layer of material 1315. The bounded region 1325 of the pocket 1300
comprises the proximal end 1321, the first side 1322 and the second
side 1323 of the layer of material 1315. In this embodiment, the
bounded region 1325 of the pocket 1300 does not comprise the distal
end 1320 of the layer of material 1315. The center 1326 of the
pocket 1300 comprises the middle portion 1319 of the layer of
material 1315. The bounded region 1325 is curved around the center
1326 of the pocket 1300 in a "U" shape. The bounded region 1325 of
the pocket 1300 does not completely enclose the center 1326 of the
pocket 1300.
[0405] In this embodiment, the bounded region 1325 of the pocket
comprises a contiguous portion of the periphery 1318 of the layer
of material 1315. In an alternate embodiment, the bounded region
1325 of the pocket comprises a plurality of segmented portions of
the periphery 1318 of the layer of material 1315.
[0406] In an alternate embodiment the bounded region 1325 of the
pocket 1300 does not comprise any portion of the periphery 1318 of
the layer of material 1315. In alternate embodiments, the bounded
region 1325 comprises any shape that could be traced on the layer
of material 1315 that partially encloses a center 1326. In one
embodiment, the bounded region 1325 of the pocket 1300 is a portion
of a circle's circumference (not shown) that does not touch the
periphery 1318 of the layer of material 1315. The center 1326 is
the area inside the circle.
[0407] In an alternate embodiment, the pocket 1300 comprises a
sheet of molded silicone. The molded silicone is fused to the
molded cover 220 in the bounded region 1325.
[0408] The opening 1310 of the pocket 1300 comprises the area
between the distal end 1320 of the layer of material 1315 and the
top surface 1331 of the molded cover 220. The interior 1305 of the
pocket 1300 comprises the area between the middle portion 1319 of
the layer of material 1315 and the top surface 1331 of the molded
cover 220.
[0409] The layer of material 1315 is positioned so that its first
side 1322 and second side 1323 are positioned over the first side
1333 and second side 1334 of the top surface 1331 of the molded
cover 220 respectively. The layer of material 1315 is positioned so
that its proximal end 1321 is positioned over the proximal end 1337
of the top surface 1331 of the molded cover 220.
[0410] The layer of material 1315 is sized so that its length is
shorter than the length of the top surface 1331 of the molded cover
220. In alternate embodiments, the layer of material 1315 is sized
so that its length is equal to, or longer than the length of the
top surface 1331 of the molded cover 220.
[0411] The proximal end 1321 of the layer of material 1315 is sized
so that its width is substantially equal to the width of the
proximal end 1337 of the top surface 1331 of the molded cover 220.
The layer of material 1315 is sized so that its width steadily
increases toward its distal end 1320.
[0412] The first side 1318 of the distal end 1320 of the layer of
material 1315 is fastened to the first side 1333 of the top surface
1331 of the molded cover 220. The second side 1323 of the distal
end 1320 of the layer of material 1315 is fastened to the second
side 1334 of the top surface 1331 of the molded cover 220.
[0413] Since the first end 1322 of the layer of material 1315 is
wider than the top surface 1331 of the molded cover 220, the layer
of material 1315 separates from the top surface 1331 of the molded
cover 220 to form the interior 1305 of the pocket 1300.
[0414] In an alternate embodiment, the lead electrode assembly 100
lacks a molded cover 220 and the pocket 1300 is attached directly
to the backing layer 130. In another alternate embodiment the lead
electrode assembly 100 lacks a molded cover 220 and a backing layer
130 and the pocket 1300 is attached directly to the electrode 107.
In a further alternate embodiment, the pocket 1300 is molded as
part of the molded cover 220.
[0415] FIG. 36(c) illustrates a cross-sectional side plan view of
an alternative embodiment of the lead electrode assembly 100. This
embodiment is substantially similar to the embodiment illustrated
in FIGS. 36(a)-36(b). The backing layer 130 of this embodiment,
however, further comprises a fin 120 positioned in the interior
1305 of the pocket 1300. The fin 120 of this embodiment is
substantially similar to the fin 120 of the embodiment illustrated
in FIG. 17 (b).
[0416] The fin 120 comprises an integrated fin tab 180 formed on
the backing layer 130. The molded cover 220 covers the integrated
fin tab 180 to form the fin 120. The integrated fin tab 180 has a
slope-shaped proximal edge 183. The sloped-shape of the resulting
fin 120 permits a the fin 120 to fit deeply into the interior 1305
of the pocket 1300. The hood can act to reduce the resistance
presented by the tissues of the patient against the fin 120 and any
tool used to grasp the fin 120 during insertion of the lead
electrode assembly 100. Such a hood can be placed over any fin
discussed in the specification to perform this function or any
other function.
[0417] In alternate embodiments, appendages other than a fin are
positioned between the pocket 1300 and the electrode 107, in the
interior 1305 of the pocket 1300. In one embodiment, a loop such as
that discussed with reference to FIGS. 21(a)-21(c) is positioned in
the interior 1305 of the pocket 1300. In another embodiment, a tube
such as that discussed with reference to FIG. 26 is positioned in
the interior 1305 of the pocket 1300.
[0418] FIG. 37(a) and 37(b) illustrates an alternate embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 36(a)-36(b).
[0419] FIG. 37(a) illustrates a bottom plan view of the lead
electrode assembly 100 of this embodiment. In this embodiment, the
electrode 107 is thumbnail shaped.
[0420] FIG. 37(b) illustrates a top plan view of the lead electrode
assembly 100 of this embodiment. The top surface 1331 of the molded
cover 220 is shaped to accommodate the thumbnail shaped electrode
107.
[0421] Like the embodiment discussed with reference to FIGS. 36(a)
and 36(b), the pocket 1300 comprises a layer of material 1315. In
this embodiment, however, the layer of material 1315 has a roughly
triangular shape. The layer of material 1315 comprises a periphery
1318 and a middle portion 1319. More particularly, the layer of
material comprises a first side 1340, a second side 1341 and a
third side 1342 of the layer of material 1315. The periphery 1318
of the layer of material comprises the first side 1340, the second
side 1341 and the third side 1342 of the layer of material 1315.
The middle portion 1319 of the layer of material 1315 comprises the
area between the first side 1340, the second side 1341 and the
third side 1342 of the layer of material 1315.
[0422] In this embodiment, the bounded region 1325 of the pocket
1300 comprises a portion of the periphery 1318 of the layer of
material 1315. The bounded region 1325 of the pocket 1300 comprises
the first side 1340 and the second side 1341 of the layer of
material 1315. The center 1326 of the pocket 1300 comprises the
middle portion 1319 of the layer of material 1315. The opening 1310
of the pocket 1300 comprises the third side 1342 of the layer of
material 1315 and the top surface 1331 of the molded cover 220. The
bounded region 1325 of the pocket 1300 is curved around the center
1326 of the pocket 1300. The bounded region 1325 of the pocket 1300
does not completely enclose the center 1326.
[0423] In this embodiment, the bounded region 1325 of the pocket
comprises a contiguous portion of the periphery 1318 of the layer
of material 1315. In an alternate embodiment, the bounded region
1325 of the pocket comprises a plurality of segmented portions of
the periphery 1318 of the layer of material 1315.
[0424] In an alternate embodiment the bounded region 1325 of the
pocket 1300 does not comprise any portion of the periphery 1318 of
the layer of material 1315.
[0425] FIG. 38(a)-38(c) illustrates a lead electrode assembly
manipulation tool 927. The lead electrode assembly manipulation
tool 927 illustrated is useful for manipulating a lead electrode
assembly 100 having a pocket 1300 during the implantation of the
lead electrode assembly 100 in a patient. Examples of such a lead
electrode assembly 100 embodiments are shown in FIGS. 36(a), 36(b),
37(a) and 37(b).
[0426] FIG. 38(a) is a top view of the lead electrode assembly
manipulation tool 927 of this embodiment. The lead electrode
assembly manipulation tool 927 comprises a handle 1142 (not shown),
a rod 1144 and a paddle 1350.
[0427] The rod 1144 and handle 1142 are substantially similar to
the rod 1144 and handle 1142 of the lead electrode assembly
manipulation tool 927 illustrated in FIGS. 35(a)35(d). The handle
1142 is connected to the rod 1144.
[0428] The paddle 1350 is attached to the distal end 1148 of the
rod 1144. The paddle 1350 comprises a disk 1351 and a tang 1161
(phantom view).
[0429] FIG. 38(b) is a side view of the lead electrode assembly
manipulation tool 927 of this embodiment. The tang 1161 is inserted
in the slot 1162 in the rod 1144. The tang 1161 is welded into the
slot 1162 of the rod 1144.
[0430] The disk 1351 and the tang 1161 are punched from a single
sheet of steel having a thickness of approximately 3 mm. In other
embodiments, the disk 1351 and tang 1161 are composed of titanium,
a polymeric material or any other material suitable for this
purpose. In one embodiment, the handle 1142, the rod 1144 and the
paddle 1350 are all made from the same piece of material.
[0431] We now turn to FIG. 38(c) for a description of the use of
the lead electrode assembly manipulation tool 927 in the
implantation of a lead electrode assembly 100 into a patient.
[0432] As discussed with reference to FIG. 31, an incision 905 is
made in the patient 900. As discussed with reference to FIG. 32(a),
a subcutaneous path 1090 is created in the patient 900 with a
hemostat 932.
[0433] The lead electrode assembly 100 is then captured by the lead
electrode assembly manipulation tool 927. The paddle 1350 of the
lead electrode assembly manipulation tool 927 is inserted into the
pocket 1300 of the lead electrode assembly 100. The paddle 1350 is
slid into the interior 1305 of the pocket via the opening 1310 of
the pocket until it can go no further. At this point, the paddle
1350 touches the inner surface 1316 of the proximal end 1321 of the
layer of material 1315.
[0434] The lead 21 of the lead electrode assembly 100 can then be
pulled toward the handle 1142 of the lead electrode assembly
manipulation tool 927 until it is taught. This acts to prevent the
paddle 1350 of the lead electrode assembly manipulation tool 927
from sliding out of the pocket 1300 of the lead electrode assembly
100.
[0435] The lead electrode assembly manipulation tool 927 may then
be used to place the lead electrode assembly 100 into the incision
905 of the patient as seen in FIG. 31. The lead electrode assembly
manipulation tool 927 may then be used to move the electrode 107 to
the termination point 1085 of the subcutaneous path 1090 created as
discussed with reference to FIG. 32(c).
[0436] The lead electrode assembly 100 is then released from the
lead electrode assembly manipulation tool 927. To achieve this, the
lead 21 of the lead electrode assembly 100 is released so that the
paddle 1350 can slide relative to the pocket 1300 of the lead
electrode assembly 100. The lead electrode assembly manipulation
tool 927 may then be extracted from the subcutaneous path 1090
leaving the lead electrode assembly 100 behind.
[0437] Alternately, a curved hemostat, such as the hemostat 930
discussed with reference to FIG. 32(b) could be inserted in the
pocket 1300 of the lead electrode assembly 100. The hemostat could
then be used to move the electrode 107 to the termination point
1085 of the subcutaneous path 1090 as discussed above.
[0438] Alternately, a curved hemostat, such as the hemostat 930
discussed with reference to FIG. 32(b) could be used to grip the
pocket 1300 of the lead electrode assembly 100, and used to move
the electrode 107 to the termination point 1085 of the subcutaneous
path 1090 as discussed above.
[0439] FIGS. 39(a)-39(b) illustrate an alternative embodiment of
the lead electrode assembly 100. This embodiment is substantially
similar to the embodiment illustrated in FIGS. 38(a)-38(c). The
backing layer 130 of this embodiment, however, lacks a pocket 1300.
Moreover, the lead electrode assembly 100 of this embodiment
further comprises a first channel guide 1401 and a second channel
guide 1402.
[0440] FIG. 39(a) illustrates a cross-sectional rear plan view of
the lead electrode assembly 100 of this embodiment. The first
channel guide 1401 and a second channel guide 1402 each have an
interior 1403 and an opening 1404.
[0441] The first channel guide 1401 and the second channel guide
1402 each comprise a strip of material 1406 attached to the molded
cover 220.
[0442] The strip of material 1406 comprising the first channel
guide 1401 is substantially rectangular in shape. The strip of
material 1406 comprises a first side 1410 and a second side 1412.
The first side 1410 and the second side 1412 of the strip of
material 1406 are parallel to each other. In another embodiment,
the first side 1410 of the strip of material 1406 is not parallel
to the second side 1412.
[0443] The strip of material 1406 further comprises an inner
surface 1417 and a outer surface 1416. The strip of material is
positioned so that the inner surface 1417 of the first side 1410
faces the outer surface 1330 of the molded cover 220. The first
side 1410 of the strip of material is attached to the first side
1333 of the top surface 1331 of the molded cover 220. The second
side 1412 of the strip of material 1406 is attached to the skirt
222 of the molded cover 220.
[0444] The interior 1403 of the first channel guide is formed
between the inner face 1417 of the strip of material 1406 and the
outer surface 1330 of the molded cover 220.
[0445] The second channel guide is formed in substantially the same
way on the second side 1334 of the molded cover 220.
[0446] FIG. 39(b) illustrates a top plan view of the lead electrode
assembly of the embodiment of FIG. 39(a). The strip of material
1406 comprising the first channel guide 1401 is substantially
rectangular in shape having a distal end 1413 and a proximal end
1414. The distal end 1413 and the proximal end 1414 of the strip of
material 1406 are parallel to each other. In another embodiment,
the distal end 1413 of the strip of material 1406 is not parallel
to the proximal end 1414 of the strip of material 1406.
[0447] The opening 1404 of the first channel guide 1401 is formed
by the distal end 1413 of the strip of material 1406 and the outer
surface 1330 of the molded cover 220.
[0448] The first side 1410 and the second side 1412 (not shown) of
the strip of material 1406 comprising the first channel guide 1401
are positioned so that they lie parallel to the first side 1333
(phantom view) of the molded cover 220.
[0449] The second channel guide 1402 is formed and mounted to the
lead electrode assembly 100 in substantially the same way as the
first channel guide 1401. The first side 1410 and the second side
1412 (not shown) of the strip of material 1406 comprising the
second channel guide 1402 are positioned so that they lie parallel
to the second side 1333 (phantom view) of the molded cover 220.
[0450] The strips of material 1406 are composed of polyurethane. In
an alternate embodiment, the strips of material 1406 are composed
of any polymeric material. The strips of material 1406 are fastened
to the molded cover 220 with stitching 360.
[0451] In an alternate embodiment, the strips of material 1406 are
made of molded silicone and attached to the molded cover 220 by
fusing them to the molded cover 220. In an alternate embodiment,
the first channel guide 1401 and the second channel guide 1402 are
formed as part of the molded cover 220.
[0452] FIG. 40(a)-40(b) illustrates a lead electrode assembly
manipulation tool 927. The lead electrode assembly manipulation
tool 927 illustrated is useful for manipulating a lead electrode
assembly 100 having a first channel guide 1401 and a second channel
guide 1402 during the implantation of the lead electrode assembly
100 in a patient. Examples of such a lead electrode assembly 100
embodiments are shown in FIGS. 39(a)-39(b).
[0453] FIG. 40(a) illustrates a top plan view of a lead electrode
assembly manipulation tool 927. The lead electrode assembly
manipulation tool 927 in this embodiment comprises a handle 1142
(not shown), a rod 1144 and a channel guide fork 1446.
[0454] The rod 1144 and handle 1142 are substantially similar to
the rod 1144 and handle 1142 of the lead electrode assembly
manipulation tool 927 illustrated in FIGS. 35(a)35(d). The handle
1142 is connected to the rod 1144.
[0455] The channel guide fork 1446 is attached to the distal end
1148 of the rod 1144. The channel guide fork 1446 comprises a pair
of tines 1451 separated by a gap 1455 and a tine base 1450 having a
tang 1161.
[0456] The pair of tines 1451 each have a proximal end 1452 and a
distal end 1453. The proximal ends 1452 of the pair of tines 1451
are attached to the tine base 1450. The pair of tines 1451 have a
substantially cylindrical form. The distal end 1453 of each of the
pair of tines 1451 is rounded.
[0457] The length of the pair of tines 1451 is substantially equal
to the length of the first side 1410 of the strips of material 1406
comprising the first channel guide 1401 and second channel guide
1402. In alternate embodiments, the length of the tines 1451 is
substantially greater than or less than the length of the first
side 1410 of the strips of material 1406 comprising the first
channel guide 1401 and second channel guide 1402.
[0458] The tines are separated by a gap 1455 between the proximal
ends 1452 of the pair of tines 1451. The pair of tines 1451 are
substantially straight and substantially parallel to each
other.
[0459] The tine base 1450 connects the pair of tines 1451 to the
distal end 1148 of the rod 1144. The tine base 1450 comprises a
tang 1161 (phantom view). The tang 1161 is inserted in a slot 1162
in the rod 1144. The tang 1161 is welded in the slot 1162 of the
rod 1144.
[0460] The pair of tines 1451 comprising the channel guide fork
1446 are composed of steel and have a diameter of approximately 3
mm. The tine base 1450 comprising the channel guide fork 1446 is
punched from a single strip of steel having a thickness of
approximately 3 mm. The pair of tines 1451 are welded to the tine
base 1450.
[0461] In other embodiments, the channel guide fork 1446 is
composed of metal, a polymeric material, or any other material
suitable for this purpose. In one embodiment, the handle 1142, the
rod 1144 and the channel guide fork 1446 are all made from the same
piece of material.
[0462] We now turn to FIG. 40(b) for a description of the use of
the lead electrode assembly manipulation tool 927 in the
implantation of a lead electrode assembly 100 into a patient.
[0463] As discussed with reference to FIG. 31, an incision 905 is
made in the patient 900. As discussed with reference to FIG. 32(a),
a subcutaneous path 1090 is created in the patent 900 with a
hemostat 932.
[0464] The lead electrode assembly 100 is then captured by the lead
electrode assembly manipulation tool 927. The pair of tines 1451 of
the lead electrode assembly manipulation tool 927 is inserted into
the openings 1404 in the first channel guide 1401 and second
channel guide 1402.
[0465] The electrode 107 is placed into the gap 1455 between the
tines of the channel guide fork 1446. The tines 1451 fit into the
interior 1403 of the first channel guide 1401 and second channel
guide 1402. The molded cover is slid toward the proximal end 1452
of the tines until it can go no further. The lead 21 of the lead
electrode assembly 100 can then be pulled in toward the handle 1142
of the lead electrode assembly manipulation tool 927 until it is
taught. This acts to prevent the lead electrode assembly 100 from
sliding toward the distal end 1453 of the pair of tines 1451 of the
channel guide fork 1446.
[0466] The lead electrode assembly manipulation tool 927 may then
be used to place the lead electrode assembly 100 into the incision
905 of the patient as seen in FIG. 31. The lead electrode assembly
manipulation tool 927 may then be used to move the electrode 107
through the termination point 1085 of the subcutaneous path 1090
created as discussed with reference to FIG. 32(c).
[0467] The lead electrode assembly 100 is then released from the
lead electrode assembly manipulation tool 927. To achieve this, the
lead 21 of the lead electrode assembly 100 is released so that the
pair of tines 1451 of the channel guide fork 1446 of the lead
electrode assembly manipulation tool 927 can slide relative to the
first channel guide 1401 and second channel guide 1402 of the lead
electrode assembly 100. The lead electrode assembly manipulation
tool 927 may then be extracted from the subcutaneous path 1090
leaving the lead electrode assembly 100 behind.
[0468] FIG. 41(a) illustrates a subcutaneous implantable
cardioverter-defibrillator kit 1201 of the present invention.
[0469] The kit comprises a group of items that may be used in
implanting a S-ICD system in a patient. The kit 1201 comprises a
group of one or more of the following items: an S-ICD canister 11,
a lead electrode assembly 100, a hemostat 1205, a lead electrode
assembly manipulation tool 927, a medical adhesive 1210, an
anesthetic 1215, a tube of mineral oil 1220 and a tray 1200 for
storing these items.
[0470] In one embodiment, the S-ICD canister 11 is the S-ICD
canister 11 seen in, and discussed with reference to FIG. 1.
[0471] The lead electrode assembly 100 is the lead electrode
assembly 100 with a rail 1100, and discussed with reference to
FIGS. 33(b) and 33(c). In alternate embodiments, the lead electrode
assembly 100 is any lead electrode assembly 100 including an
electrode 107 with an appendage 118; a pocket; or a first and
second channel guide for positioning the electrode 107 during
implantation.
[0472] The hemostat 1205 is a curved hemostat made of steel having
a first end 1240 and a second end 1241. The hemostat 1205 has a
length, measured between the first end 1240 and the second end 1241
as shown in FIG. 41(b) by dimension L.sub.Hemostat. The length of
the hemostat 1205, L.sub.Hemostat, is approximately 75 cm. In an
alternate embodiments, the hemostat 1205 is a length other than 75
cm. In an alternate embodiment, the hemostat 1205 is the enhanced
hemostat seen in, and discussed with reference to FIG. 31.
[0473] The lead electrode assembly manipulation tool 927 is the
lead electrode assembly manipulation tool 927 with a rail fork
1146. In alternate embodiments, the lead electrode assembly
manipulation tool 927 is any lead electrode assembly manipulation
tool 927 including a paddle or a channel guide fork.
[0474] The medical adhesive 1210 comprises a roll of clear, 1-inch
wide medical adhesive tape. As will be recognized, the medical
adhesive could be a liquid adhesive, or any other adhesive
substance.
[0475] The anesthetic 1215 is a one ounce tube of lidocaine gel.
This can be used as a local anesthetic for the introduction of the
lead electrode assembly 100 as discussed below. As will be
recognized, the anesthetic could be any substance that has a
pain-killing effect. Alternatively, one could use an injectable
form of anesthetic inserted along the path of the lead.
[0476] The tube of mineral oil 1220 is a one ounce tube of mineral
oil. This can be used for oiling parts of the electrode connector
block 17 seen in FIG. 1.
[0477] The tray 1200 is a box sized to fit the items of the kit
1201. The tray 1200 is composed of molded plastic. In another
embodiment, the tray 1200 is a cardboard box. One skilled in the
art will recognize that the tray 1200 may comprise any container
capable of containing the items of the kit. In one embodiment, the
tray is formed with recessed partitions 1230 that generally follow
the outline of the items of the kit 1201 to be stored in the tray.
In one embodiment, the tray 1200 has packaging material 1225
disposed over it, wherein the packing material 1225 provides a
sanitary cover for the items of the kit 1201. The packaging
material 1225 further acts to contain the items of the kit
1201.
[0478] In an alternate embodiment the kit 1201 comprises ten lead
electrode assemblies 100 each comprising a lead 21 having a lead
length, l.sub.Lead different from the others. In one embodiment,
the lead lengths range between approximately 5 cm and approximately
52 cm with approximately a 10 cm difference between the lead length
of each lead electrode assembly 100.
[0479] In an alternative embodiment, the kit 1201 comprises an
S-ICD canister 11, a hemostat 1205 and an assortment of lead
electrode assemblies 100 each comprising a lead 21 having a lead
length, l.sub.Lead, different from the others.
[0480] In one embodiment, the kit 1200 further comprises a tray
1201 and an assortment of lead electrode assemblies 100, each with
an electrode 107 curved at a radius r different from the
others.
[0481] In another embodiment, the kit 1200 includes components
sized for surgery on a patient of a particular size. A kit 1200 for
a 10 year old child, for example, includes an S-ICD canister 11
with a length of approximately 10 cm, a lead electrode assembly 100
with a lead length, L.sub.Lead of approximately 12 cm and a radius
r of approximately 10 cm and hemostat 1205 with a hemostat length,
L.sub.Hemostat, of approximately 12 cm.
[0482] The S-ICD device and method of the present invention may be
embodied in other specific forms without departing from the
teachings or essential characteristics of the invention. The
described embodiments are therefore to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description and all changes which come within the meaning
and range of equivalency of the claims are therefore to be embraced
therein.
* * * * *