Implantable Hermetically Sealed Structures

• US 20080312726A1
• Filed: 12/22/2005
• Published: 12/18/2008
• Est. Priority Date: 12/22/2004
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark, Costello, Benedict J., Jensen, Marc, Gelfandbein, Vladimir, Frank, Jeremy
• Granted Patent: US 8,195,308 B2
• Time in Patent Office: Days
• US Class Current: 607/122
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Implantable hermetically sealed structures and methods for making the same are provided. Also provided are devices, systems and kits including the hermetically sealed structures, as well as methods of using such devices and systems.

Claims

1. An implantable hermetically sealed structure dimensioned to be placed inside a lead.

2. The implantable hermetically sealed structure according to claim 1, wherein said structure comprises an effector.

3. The implantable hermetically sealed structure according to claim 2, wherein said effector comprises an integrated circuit.

4. The implantable hermetically sealed structure according to claim 3, wherein said effector comprises an actuator.

5. The implantable hermetically sealed structure according to claim 4, wherein said actuator comprises an electrode.

6. The implantable hermetically sealed structure according to claim 3, wherein said effector comprises a sensor.

7. The implantable hermetically sealed structure according to claim 1, wherein said hermetically sealed structure is configured to remain hermetically sealed in a saline environment for at least 10 years.

8. The implantable hermetically sealed structure according to claim 7, wherein structure comprises:

an in vivo corrosion resistant holder having at least one conductive feedthrough; and

a sealing layer;

wherein said sealing layer and holder are configured to define a hermetically sealed volume.

9. The implantable hermetically sealed structure according to claim 8, wherein said conductive feedthrough is a metal.

10. The implantable hermetically sealed structure according to claim 8, wherein said conductive feedthrough is an alloy of metal and a semiconductor.

11. The implantable hermetically sealed structure according to claim 8, wherein said conductive feedthrough is a nitride.

12. The implantable hermetically sealed structure according to claim 8, wherein said conductive feedthrough is a semiconductor.

13. The implantable hermetically sealed structure according to claim 8, wherein said corrosion resistant holder comprises silicon.

14. The implantable hermetically sealed structure according to claim 8, wherein said corrosion resistant holder comprises a ceramic.

15. The implantable hermetically sealed structure according to claim 8, wherein said corrosion resistant holder is fabricated using a planar processing protocol.

16. The implantable hermetically sealed structure according to claim 8, wherein said sealing layer is metallic.

17. The implantable hermetically sealed structure according to claim 8, wherein said structure further comprises an insulative material present in said hermetically sealed volume.

18. The implantable hermetically sealed structure according to claim 1, wherein said structure is electrically coupled to at least one elongated conductive member.

134. An implantable medical device comprising a hermetically sealed structure according to claim 1.

135. The implantable medical device according to claim 134, wherein said structure comprises an effector.

136. The implantable medical device according to claim 135, wherein said effector comprises an integrated circuit.

137. The implantable medical device according to claim 134, wherein said structure is present in a lead.

138. The implantable medical device according to claim 137, wherein said lead is a cardiovascular lead.

139. The implantable medical device according to claim 138, wherein said lead is a left ventricular lead.

140. The implantable medical device according to claim 138, wherein said lead is an epicardial lead.

141. The implantable medical device according to claim 134, wherein said structure is present in an implant.

142. The implantable medical device according to claim 141, wherein said implant is a cardiovascular implant.

143. The implantable medical device according to claim 134, wherein said device is chosen from a neurological device, a muscular device, a gastrointestinal device, a skeletal device, a pulmonary device, an opthalmic device and an auditory device.

144. The implantable medical device according to claim 134, wherein said structure is electrically coupled to at least one elongated conductive member.

145. The implantable medical device according to claim 144, wherein said at least one conductive member is electrically coupled to a control unit.

146. The implantable medical device according to claim 145, wherein said control unit is present in a pacemaker can.

147. The implantable medical device according to claim 146, wherein said device is a cardiovascular pacing device.

148. The implantable medical device according to claim 134, wherein said device comprises two or more of said hermetically sealed structures.

149. A method comprising:

implanting an implantable medical device according to claim 135 into a subject; and

using said effector of said implanted medical device.

150. The method according to claim 149, wherein said effector is a sensor and said using comprises obtaining signals from said sensor.

151. The method according to claim 149, wherein said effector is a sensor and said using comprises obtaining data from said sensor.

152. The method according to claim 149, wherein said effector is an actuator.

153. The method according to claim 152, wherein said actuator is coupled to an electrode and said using comprises actuating said electrode to deliver an electrical energy to said subject.

154. A system comprising:

a hermetically sealed structure according to claim 1; and

a control unit.

155. The system according to claim 154, wherein said structure and control unit are electrically coupled by an elongated conductive member.

156. The system according to claim 154, wherein said hermetically sealed structure is present in an implant.

157. The system according to claim 154, wherein said system comprises two or more hermetically sealed structures according to claim 1.

158. The system according to claim 156, wherein said implant is a lead.

159. The system according to claim 158, wherein said lead is a left ventricular lead.

160. The implantable medical device according to claim 158, wherein said lead is an epicardial lead.

161. A kit comprising:

a hermetically sealed structure according to claim 1; and

a control unit.

162. The kit according to claim 160, wherein said kit further includes an elongated conductive member.

163. The kit according to claim 160, wherein said hermetically sealed structure is present in a lead.

164. The kit according to claim 163, wherein said lead is a cardiovascular lead.

165. The kit according to claim 162, wherein said hermetically sealed structure is present in an implant.

166. The kit according to claim 165, wherein said implant is a cardiovascular implant.

19-92. -92. (canceled)

93. An implantable hermetically sealed structure comprising:

an in vivo corrosion resistant integrated circuit holder having at least one conductive feedthrough;

at least one integrated circuit present in said holder and electrically coupled to said at least one feedthrough; and

a sealing layer;

wherein said sealing layer and holder are configured to define a hermetically sealed volume comprising said at least one integrated circuit.

94. The implantable hermetically sealed structure according to claim 93, wherein said integrated circuit is part of an effector.

95. The implantable hermetically sealed structure according to claim 94, wherein said effector comprises an actuator.

96. The implantable hermetically sealed structure according to claim 94, wherein said effector comprises a sensor.

97. The implantable hermetically sealed structure according to claim 93, wherein said conductive feedthrough is metallic.

98. The implantable hermetically sealed structure according to claim 97, wherein said metallic conductive feedthrough comprises platinum.

99. The implantable hermetically sealed structure according to claim 97, wherein said metallic conductive feedthrough comprises iridium.

100. The implantable hermetically sealed structure according to claim 93, wherein said conductive feedthrough comprises an alloy of a metal and a semiconductor.

101. The implantable hermetically sealed structure according to claim 93, wherein said corrosion resistant holder comprises walls that are at least about 1 μ

m thick.

102. The implantable hermetically sealed structure according to claim 93, wherein said corrosion resistant holder comprises walls that are at least about 50 μ

m thick.

103. The implantable hermetically sealed structure according to claim 93, wherein said corrosion resistant holder comprises walls that range from about 1 to about 125 μ

m thick.

104. The implantable hermetically sealed structure according to claim 93, wherein said corrosion resistant holder comprises silicon.

105. The implantable hermetically sealed structure according to claim 93, wherein said corrosion resistant holder comprises a ceramic.

106. The implantable hermetically sealed structure according to claim 93, wherein said sealing layer is metallic.

107. The implantable hermetically sealed structure according to claim 106, wherein said metallic sealing layer comprises platinum.

108. The implantable hermetically sealed structure according to claim 93, wherein said sealing layer comprises a noble metal or alloy thereof.

109. The implantable hermetically sealed structure according to claim 93, wherein said sealing layer is at least about 0.5 μ

m thick.

110. The implantable hermetically sealed structure according to claim 93, wherein said sealing layer is at least about 2.0 μ

m thick.

111. The implantable hermetically sealed structure according to claim 93, wherein said sealing layer is at least about 20 μ

m thick.

112. The implantable hermetically sealed structure according to claim 93, wherein said structure further comprises an insulating material present in said hermetically sealed volume.

113. The implantable hermetically sealed structure according to claim 93, wherein said hermetically sealed volume ranges from about 1 pl to about 1 ml.

114. The implantable hermetically sealed structure according to claim 93, wherein said integrated circuit is electrically coupled via said conductive feedthrough to at least one elongated conductive member.

115. The implantable hermetically sealed structure according to claim 114, wherein said elongated conductive member is electrically coupled to a control unit.

116. The implantable hermetically sealed structure according to claim 115, wherein said control unit is present in a pacemaker can.

117. A method of making a hermetically sealed structure, said method comprising:

positioning an effector through an opening in an in vivo corrosion resistant holder; and

fabricating a sealing layer over said opening to seal said effector in said holder in a hermetically sealed volume;

wherein said method further comprises producing one or more conductive feedthroughs in said holder that is electrically coupled to said effector.

118. A method according to claim 117, wherein said holder comprises two or more conductive feedthroughs insulated from each other.

119. The method according to claim 117, wherein said producing comprises filling a passage in said holder with a conductive material.

120. The method according to claim 119, wherein said producing further comprises melting a solder material positioned between said effector and said conductive feedthrough.

121. The method according to claim 117, wherein said producing comprises filling a passage in said holder with a conductive material and contacting said effector with said conductive material in a single process step.

122. The method according to claim 117, wherein said conductive feedthrough is metallic.

123. The method according to claim 122, wherein said metallic material comprises platinum.

124. The method according to claim 117, wherein said conductive feedthrough comprises an alloy of a metal and a semiconductor.

125. The method according to claim 117, wherein said effector comprises an integrated circuit.

126. The method according to claim 117, wherein said method further comprises fabricating said holder.

127. The method according to claim 126, wherein said holder is fabricated using a planar processing protocol.

128. The implantable hermetically sealed structure according to claim 117, wherein said holder comprises silicon.

129. The implantable hermetically sealed structure according to claim 117, wherein said holder comprises a ceramic.

130. The method according to claim 117, wherein said method further comprises placing an insulating material into said volume.

131. The method according to claim 117, wherein said method further comprises planarizing said holder prior to producing said sealing layer.

132. The method according to claim 117, wherein said sealing layer is fabricated using a planar processing protocol.

133. The method according to claim 117, wherein said holder is present in a structure comprising multiple chip holders and said method further comprises separating said multiple chip holders to produce said hermetically sealed structure.