Neural interface system with embedded id

• US 20050267597A1
• Filed: 11/19/2004
• Published: 12/01/2005
• Est. Priority Date: 11/25/2003
• Status: Active Grant

• Current Assignee: Braingate Incorporated
• Original Assignee: Braingate Co., LLC
• Inventors: Capachione, L. Renee, Flaherty, J. Christopher, Saleh, Maryam, Morris, Daniel S., Caplan, Abraham H., Guillory, K. Shane
• Granted Patent: US 7,751,877 B2
• Time in Patent Office: Days
• US Class Current: 623/24
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof

Abstract

A system and method for a neural interface system with a unique identification code includes a sensor including a plurality of electrodes to detect multicellular signals, an processing unit to process the signals from the sensor into a suitable control signal for a controllable device such as a computer or prosthetic limb. The unique identification code is embedded in one or more discrete components of the system. Internal and external system checks for compatibility and methods of ensuring safe and effective performance of a system with detachable components are also disclosed.

Claims

1-167. -167. (canceled)

168. A system for collecting multicellular signals from a central nervous system of a patient and for transmitting processed signals to a controlled device, the system comprising:

a sensor comprising a plurality of electrodes configured to detect the multicellular signals;

a processing unit configured to receive the multicellular signals from the sensor, process the multicellular signals to produce processed signals, and transmit the processed signals to the controlled device; and

the controlled device for receiving the processed signals,

wherein the sensor, processing unit, and controlled device are contained in two or more discrete components, one of the discrete components transmitting electronic information to another of the discrete components, and

wherein a unique electronic identifier is embedded in one or more transmissions of the electronic information.

169. The system of claim 168, wherein the sensor and at least a portion of the processing unit are implanted in the body of the patient.

170. The system of claim 168, wherein the controlled device is implanted in the body of the patient.

171. The system of claim 168, wherein the sensor and processing unit are connected with one or more physical cables, the cables comprise at least one of electrically conductive wire and optical fiber.

172. The system of claim 168, wherein at least one of the sensor and the processing unit comprises a wireless transmission mechanism.

173. The system of claim 168, wherein at least one of the discrete components is implanted within the body of the patient, and at least one of the discrete components is positioned external to the body of the patient.

174. The system of claim 173, wherein the unique electronic identifier is embedded in at least one of the discrete components implanted within the body of the patient.

175. The system of claim 173, wherein the unique electronic identifier is embedded in at least one of the discrete components positioned external to the body of the patient.

176. The system of claim 175, wherein at least one of the discrete components positioned external to the body of the patient is detachable from another discrete component.

177. The system of claim 173, wherein the unique electronic identifier is embedded in all of the discrete components positioned external to the body of the patient.

178. The system of claim 177, wherein all of the discrete components positioned external to the body of the patient are detachable from the patient.

179. The system of claim 173, wherein the processing unit is external to the body of the patient.

180. The system of claim 173, wherein a first portion of the processing unit is external to the body of the patient, and a second portion of the processing unit is implanted within the body of the patient.

181. The system of claim 173, wherein one or more of the discrete components comprises a calibration module.

182. The system of claim 181, wherein the calibration module comprises multiple calibration routines, and at least one of the calibration routines is linked with the system by the unique electronic identifier.

183. The system of claim 173, wherein the controlled device is included in a discrete component external to the body of the patient.

184. The system of claim 168, wherein the patient is a human being.

185. The system of claim 168, wherein the multicellular signals emanate directly from the central nervous system.

186. The system of claim 168, wherein the multicellular signals comprise one or more of neuron spikes, electrocorticogram signals, local field potential signals, and electroencephalogram signals.

187. The system of claim 168, wherein the sensor comprises a multi-electrode array.

188. The system of claim 168, wherein the sensor comprises multiple wires or wire bundle electrodes.

189. The system of claim 168, wherein the sensor comprises electrodes incorporated in a subdural grid.

190. The system of claim 168, wherein the sensor comprises two or more discrete components, and each of the discrete components comprises one or more electrodes.

191. The system of claim 190, wherein the discrete components of the sensor comprise two or more of the following components:

multi-electrode array, multiple wires or wire bundles, subdural grids, and scalp electrodes.

192. The system of claim 190, wherein the electrodes of the discrete components of the sensor are placed in the brain.

193. The system of claim 190, wherein at least one of the electrodes is placed in the brain, and at least one of the sensors is placed at an extracranial location.

194. The system of claim 190, wherein at least one of the discrete components of the sensor has a maximum of one electrode.

195. The system of claim 168, wherein the electrodes of the sensor are implanted near the central nervous system.

196. The system of claim 168, wherein the electrodes of the sensor are implanted within the brain.

197. The system of claim 196, wherein the electrodes of the sensor are implanted within the motor cortex portion of the brain.

198. The system of claim 168, wherein the electrodes of the sensor are placed at an extracranial site or above the patient'"'"'s scalp.

199. The system of claim 168, wherein the electrodes of the sensor are configured to detect multicellular signals from clusters of neurons and provide signals midway between single neuron and electroencephalogram recordings.

200. The system of claim 168, wherein each electrode is capable of recording a plurality of neurons.

201. The system of claim 168, wherein the processing unit comprises two or more discrete components.

202. The system of claim 201, wherein at least one of the discrete components of the processing unit is implanted within the patient.

203. The system of claim 202, wherein at least one of the discrete components of the processing unit is positioned external to the body of the patient.

204. The system of claim 201, wherein at least one of the discrete components of the processing unit is positioned external to the skull.

205. The system of claim 204, wherein at least one of the discrete components of the processing unit is positioned external to the body of the patient.

206. The system of claim 168, wherein at least one discrete component of the processing unit is configured to receive or send signals via a physical cable.

207. The system of claim 168, wherein at least one discrete component of the processing unit is configured to receive or send signals via wireless communication mechanism.

208. The system of claim 207, wherein the wireless communication passes through the skull of the patient.

209. The system of claim 168, wherein the processing unit comprises an integrated neuron spike sorting function.

210. The system of claim 168, wherein the processing unit comprises an element to amplify the multicellular signals.

211. The system of claim 168, wherein the processing unit utilizes neural net software routines to map neural signals into desired controlled device control.

212. The system of claim 168, wherein the processing unit utilizes one or more neural signals that is under voluntary control of the patient.

213. The system of claim 168, wherein the processing unit utilizes two or more neural signals that are mathematically combined to create the processed signals.

214. The system of claim 168, wherein the processed signals are used in a calibration routine for producing calibration output parameters.

215. The system of claim 214, wherein the calibration routine comprises selection and deselection of specific neural signals over time.

216. The system of claim 214, wherein the calibration routine comprises setting one or more of the following calibration output parameters:

electrode selection, neural signal selection, neuron spike selection, electrocorticogram signal selection, local field potential signal selection, electroencephalogram signal selection, sampling rate by signal, sampling rate by group of signals, amplification by signal, amplification by group of signals, filter parameters by signal, and filter parameters by group of signals.

217. The system of claim 214, wherein the calibration output parameters are stored in memory and linked with the unique electronic identifier.

218. The system of claim 214, wherein the calibration routine is performed on a periodic basis.

219. The system of claim 214, wherein the calibration routine selects a subset of the multicellular signals received from the sensor to be processed by the processing unit.

220. The system of claim 214, wherein the calibration routine utilizes one or more calibration input parameters to determine the calibration output parameters.

221. The system of claim 220, wherein the calibration input parameters comprises system performance criteria or controlled device performance criteria.

222. The system of claim 220, wherein the calibration input parameters are stored in memory and linked with the unique electronic identifier.

223. The system of claim 220, wherein the calibration input parameters comprise properties associated with the multicellular signals, the properties comprising one or more of the following:

signal to noise ratio, frequency of signal, amplitude of signal, neuron firing rate, average neuron firing rate, standard deviation in neuron firing rate, modulation of neuron firing rate, and modulation of other signal parameters.

224. The system of claim 220, wherein the calibration input parameters comprise one or more of:

system performance criteria, controlled device electrical time constants, controlled device mechanical time constants, other controlled device criteria, types of electrodes, number of electrodes, patient activity during calibration, target number of signals required, patient disease state, patient condition, patient age, and other patient parameters.

225. The system of claim 168, wherein the controlled device comprises at least one of:

a computer, a computer display, a mouse, a cursor, a joystick, a Functional Electrical Stimulator device or system, an artificial or prosthetic limb, a robot or robotic device, a computer controlled device, a teleoperated device, a vehicle, a remote control device, a medical therapeutic and diagnostic equipment, a communication device, and any combination thereof.

226. The system of claim 168, wherein the at least one of the discrete components comprises an information transfer mechanism for both transmitting and receiving information to and from another discrete component.

227. The system of claim 226, wherein the information transfer mechanism comprises a wireless transceiver.

228. The system of claim 226, wherein the information transfer mechanism comprises a physical cable comprising at least one of an electrically conductive wire and an optical fiber.

229. The system of claim 168, wherein the discrete component comprises, at least partially, one or more of the following:

the sensor, the processing unit, the controlled device, a display monitor, a calibration or system configuration module, a memory storage device, a telemetry device, a physical cable connecting device, a power supply module, a recharging module, an information recall and display unit, and a system diagnostic unit.

230. The system of claim 229, wherein the discrete component comprises a calibration or system configuration module.

231. The system of claim 230, wherein the system configuration module includes data representing multiple systems, and each datum is linked with the unique electronic identifier of a corresponding system.

232. The system of claim 231, wherein the system configuration module is configured to upload the unique electronic identifier from the system and segregate the data of the system configuration module from the unique electronic identifier.

233. The system of claim 168, wherein the electronic information is wirelessly transmitted between one or more discrete components.

234. The system of claim 233, wherein the unique electronic identifier is included in an initial wireless transmission.

235. The system of claim 234, wherein the unique electronic identifier is included in multiple wireless transmissions.

236. The system of claim 168, further comprising an information transfer cable attached to one or more discrete components for transfer of the electronic information between the discrete components.

237. The system of claim 236, wherein the information transfer cable comprises one or more of:

an electrically conductive wire and an optical fiber.

238. The system of claim 237, wherein the information transfer cable comprises operator accessible information correlating to the unique electronic identifier.

239. The system of claim 238, wherein the operator accessible information comprises at least one selected from the group consisting of:

color codes, bar codes, brail and other tactile patterns, visual patterns or symbology, text information, and any combination thereof.

240. The system of claim 238, wherein the operator accessible information comprises instructions for attachment of the information transfer cable to a specific discrete component of the system.

241. The system of claim 168, wherein the unique electronic identifier includes one or more of:

patient information, system information, implant information, number of sensor components or electrodes implanted, implant location, software revisions of one or more discrete components, clinician information, date of implant, date of calibration, manufacturing codes, and hospital information.

242. The system of claim 168, wherein the unique electronic identifier is linked to one or more of:

patient information, system information, implant information, number of sensor components or electrodes implanted, implant location, software revisions of one or more discrete components, clinician information, date of implant, date of calibration, manufacturing codes, and hospital information.

243. The system of claim 168, wherein the unique electronic identifier is stored in at least one of the following:

one or more of the discrete components, the sensor, and the processing unit.

244. The system of claim 168, wherein the unique electronic identifier is stored in a discrete component, the discrete component being partially implanted within the body of the patient and partially external to the body of the patient.

245. The system of claim 168, wherein the unique electronic identifier is programmable.

246. The system of claim 245, wherein the unique electronic identifier is programmable one or more times.

247. The system of claim 245, wherein the unique electronic identifier is programmable by an operator.

248. The system of claim 247, wherein the operator comprises one or more of:

a clinician, a technician, a caregiver, and a patient.

249. The system of claim 168, wherein the unique electronic identifier comprises a hardwired connection to one or more discrete components.

250. The system of claim 168, wherein the unique electronic identifier is embedded in a transcutaneous connector implanted in the patient.

251. The system of claim 168, wherein the unique electronic identifier is embedded in a wireless communication between two or more discrete components of the system.

252. The system of claim 168, wherein the unique electronic identifier is embedded in a wireless communication from one or more discrete components to a separate device external to the system.

253. The system of claim 168, wherein the unique electronic identifier is linked to a previously recorded neural signature of the patient.

254. The system of claim 253, wherein the previously recorded neural signature includes a characterization of the patient'"'"'s multicellular signals.

255. The system of claim 253, wherein the previously recorded neural signature is based on one or more of:

channels that have spike activity, autocorrelation shapes on each channel, firing rates on each channel, and correlation patterns between channels.

256. The system of claim 253, wherein the previously recorded neural signature is compared to current multicellular signals utilizing one or more of:

a linear filter, a maximum likelihood estimator, or a neural network.

257. The system of claim 256, wherein the system enters an alarm state when the current multicellular signals do not adequately match the previously recorded neural signature.

258. The system of claim 257, wherein the alarm state includes displaying an alarm condition on one or more of the discrete components.

259. The system of claim 257, wherein the alarm state produces one or more of:

an audible alarm, a visual alarm, and a tactile alarm.

260. The system of claim 168, wherein the unique electronic identifier is changeable over time.

261. The system of claim 168, wherein the unique electronic identifier corresponds to a state of the system.

262. The system of claim 261, wherein the state of the system comprises one or more of:

processed signal stability, processed signal performance, and processed signal requirements.

263. The system of claim 261, wherein the state of the system comprises one or more of:

software revision, hardware revision, controlled device compatibility list, patient permissions list, and calibration status.

264. The system of claim 168, further comprising a library of system specific values that are linked to the unique electronic identifier.

265. The system of claim 264, wherein the library of system specific values are stored in a component other than the sensor, the processing unit, and the controlled device.

266. The system of claim 265, wherein the library of system specific values are stored in a computer network based platform.

267. The system of claim 266, wherein the computer network based platform comprises one or more of:

a local area network, a wide area network, and the Internet.

268. The system of claim 264, wherein the library of system specific values is stored in one or more of:

the sensor, the processing unit, and the controlled device.

269. The system of claim 264, wherein the library of system specific values includes a list of controlled devices compatible with the system.

270. The system of claim 168, further comprising a discrete component compatibility check routine that is configured to check for an appropriate unique electronic identifier existing in multiple discrete components.

271. The system of claim 270, wherein the discrete component compatibility check is accomplished with wireless transmission of the unique electronic identifier from the one of the discrete components to the other of the discrete components.

272. The system of claim 270, further comprising one or more information transfer cables coupling one or more discrete components for transfer of the electronic information.

273. The system of claim 272, wherein the discrete component compatibility check is implemented when the information transfer cable is connected between the one of the discrete components to the other of the discrete components.

274. The system of claim 270, wherein the discrete component compatibility check is activated on a periodic basis or each time a connection is made to a discrete component.

275. The system of claim 270, wherein the discrete component compatibility check outputs a pass or fail value.

276. The system of claim 275, wherein a fail value causes the system to deactivate transmission of the processed signal to the controlled device.

277. The system of claim 275, wherein a fail value causes the system to deactivate a subset of control parameters from transmitting to the controlled device.

278. The system of claim 168, further comprising an information recall unit for obtaining the unique electronic identifier from one or more discrete components.

279. The system of claim 278, wherein the information recall unit is included in one or more of the discrete components.

280. The system of claim 279, wherein the information recall unit is included in the controlled device.

281. The system of claim 280, wherein the controlled device is a computer.

282. The system of claim 279, wherein the information recall unit is a separate device.

283. The system of claim 282, wherein the information recall unit is a personal data assistant.

284. The system of claim 279, wherein the information recall unit communicates with the one or more discrete components with wireless communication.

285. The system of claim 279, wherein the information recall unit communicates with the one or more discrete components with a physical connection.

286. The system of claim 285, wherein the physical connection comprises one or more of:

electrically conductive wire and optical fiber.

287. The system of claim 168, further comprising an alarm transducer.

288. The system of claim 287, wherein the alarm transducer comprises one or more of:

an audio transducer, a visual transducer, an olfactory transducer, and a tactile transducer.

289. The system of claim 287, wherein the system comprises multiple discrete components, and the alarm transducer is activated when the unique electronic identifier contained in the one of the discrete components is not compatible with the unique electronic identifier contained in the other of the discrete components.

290. The system of claim 168, further comprising a memory storage module for storing the unique electronic identifier.

291. The system of claim 290, further comprising an additional memory storage module for storing the unique electronic identifier.

292. The system of claim 291, wherein system information is stored in the memory storage module and linked with the unique electronic identifier.

293. A method of confirming discrete component compatibility in a system for collecting multicellular signals from a central nervous system of a patient and for transmitting processed signals to a controlled device, the method comprising:

providing the system comprising;

a sensor comprising a plurality of electrodes configured to detect the multicellular signals;

a processing unit configured to receive the multicellular signals from the sensor, process the multicellular signals to produce processed signals, and transmit the processed signals to the controlled device; and

the controlled device for receiving the processed signals,

wherein the sensor, processing unit, and controlled device are contained in first and second discrete components, the first discrete component transmitting electronic information to the second discrete component, and

comparing a unique electronic identifier embedded in the first discrete component to a unique electronic identifier embedded in the second discrete component.

294. The method of claim 293, wherein the first discrete component is detachable from the second discrete component.

295. The method of claim 293, wherein the first discrete component transmits the electronic information to the second discrete component with wireless communication means.

296. A system for collecting multicellular signals from a central nervous system of a patient and for transmitting processed signals to a controlled device, comprising:

a sensor comprising a plurality of electrodes configured to detect the multicellular signals;

a processing unit configured to receive the multicellular signals from the sensor, process the multicellular signals to produce processed signals, and transmit the processed signals to the controlled device; and

the controlled device for receiving the processed signals,

wherein the processing unit creates a neural signature representing a reproducible derivative of one or more multicellular signals detected.

297. The system of claim 296, wherein the neural signature is based on one or more of:

specific channels that have spike activity, spike activity pattern shapes on multiple channels, firing rates on multiple channels, and correlation patterns between channels.

298. The system of claim 296, wherein a current derivative of the multicellular signals is compared to the neural signature as a check for system compatibility.

299. The system of claim 298, wherein the comparison is performed with one or more of:

a linear filter, a maximum likelihood estimator, and a neural network.

300. The system of claim 296, wherein the neural signature is created while the patient is shown a specific visual stimulus.

301. The system of claim 300, wherein a current derivative of the multicellular signals is generated using the specific visual stimulus.

302. The system of claim 301, wherein the current derivative of the multicellular signals is compared to the neural signature as a check for system compatibility.