U.S. patent application number 11/194544 was filed with the patent office on 2005-12-08 for neural interface system and method for neural control of multiple devices.
Invention is credited to Capachione, L. Renee, Caplan, Abraham H., Flaherty, J. Christopher, Guillory, K. Shane, Morris, Daniel S., Saleh, Maryam.
Application Number | 20050273890 11/194544 |
Document ID | / |
Family ID | 34636530 |
Filed Date | 2005-12-08 |
United States Patent
Application |
20050273890 |
Kind Code |
A1 |
Flaherty, J. Christopher ;
et al. |
December 8, 2005 |
Neural interface system and method for neural control of multiple
devices
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.
Inventors: |
Flaherty, J. Christopher;
(Topsfield, MA) ; Capachione, L. Renee; (Acton,
MA) ; Morris, Daniel S.; (Stanford, CA) ;
Caplan, Abraham H.; (Cambridge, MA) ; Saleh,
Maryam; (Providence, RI) ; Guillory, K. Shane;
(Salt Lake City, UT) |
Correspondence
Address: |
Leslie I. Bookoff
FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, L.L.P.
901 New York Ave., N.W.
Washington
DC
20001-4413
US
|
Family ID: |
34636530 |
Appl. No.: |
11/194544 |
Filed: |
August 2, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11194544 |
Aug 2, 2005 |
|
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10992111 |
Nov 19, 2004 |
|
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60524969 |
Nov 25, 2003 |
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Current U.S.
Class: |
600/544 ;
901/50 |
Current CPC
Class: |
A61B 5/24 20210101; A61B
2560/0223 20130101; A61B 2560/045 20130101; A61B 5/0031 20130101;
A61B 2562/08 20130101 |
Class at
Publication: |
901/050 |
International
Class: |
B25J 011/00; G06K
009/46 |
Claims
1-167. (canceled)
168. A system for collecting multicellular signals from a central
nervous system of a patient and for transmitting processed signals
to a plurality of controlled devices, the system comprising: a
sensor comprising a plurality of electrodes configured to detect
the multicellular signals; and 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 plurality of controlled devices;
wherein the plurality of controlled devices comprises a first
controlled device configured to receive the processed signals and a
second controlled device configured to receive the processed
signals.
169. 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.
170. The system of claim 168, wherein both the first and second
controlled devices are medical therapeutic devices.
171. The system of claim 168, wherein at least one of the first and
second controlled devices is configured to perform a therapy to
treat a neurological disorder.
172. The system of claim 168, wherein at least one of the first and
second controlled devices is controlled by processed signals
produced under voluntary control of the patient.
173. The system of claim 168, wherein at least one of the first and
second controlled devices is controlled by processed signals not
produced under voluntary control of the patient.
174. The system of claim 168, wherein the first controlled device
is controlled by processed signals produced under voluntary control
of the patient, and the second controlled device is controlled by
processed signals not produced under voluntary control of the
patient.
175. The system of claim 168, wherein both the first and second
controlled devices are joysticks.
176. The system of claim 168, wherein both the first and second
controlled devices are computers.
177. The system of claim 168, wherein the first controlled device
is a robot, and the second controlled device is not a robot.
178. The system of claim 168, wherein the first controlled device
is a medical therapeutic or diagnostic device, and the second
controlled device is not a medical device.
179. The system of claim 168, wherein the first controlled device
and the second controlled device are included in a single discrete
component.
180. The system of claim 179, wherein the single discrete component
is implanted within the body of the patient.
181. The system of claim 168, wherein the system comprises multiple
discrete components, the multiple discrete components comprising a
first discrete component and a second discrete component.
182. The system of claim 181, wherein the first controlled device
is included in the first discrete component, and the second
controlled device is included in the second discrete component.
183. The system of claim 181, wherein the first discrete component
is implanted within the body of the patient, and the second
discrete component is placed external to the patient.
184. The system of claim 181, further comprising a unique
electronic identifier embedded in one or more information
transmissions between the first discrete component and the second
discrete component.
185. The system of claim 184, 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.
186. The system of claim 184, 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.
187. The system of claim 184, wherein the unique electronic
identifier is stored in at least one of the following: at least one
of the first and second discrete components, the sensor, and the
processing unit.
188. The system of claim 184, wherein the unique electronic
identifier is stored in at least one of the first and second
discrete components that is partially implanted within the body of
the patient and partially external to the body of the patient.
189. The system of claim 184, wherein the unique electronic
identifier is programmable.
190. The system of claim 189, wherein the unique electronic
identifier is programmable one or more times.
191. The system of claim 189, wherein the unique electronic
identifier is programmable by an operator.
192. The system of claim 191, wherein the operator comprises one or
more of: a clinician, a technician, a caregiver, and a patient.
193. The system of claim 184, wherein the unique electronic
identifier comprises a hardwired connection to one or more discrete
components.
194. The system of claim 184, wherein the unique electronic
identifier is embedded in a transcutaneous connector implanted in
the patient.
195. The system of claim 184, wherein the unique electronic
identifier is embedded in a wireless communication between two or
more discrete components of the system.
196. The system of claim 184, 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.
197. The system of claim 184, wherein the unique electronic
identifier is linked to a previously recorded neural signature of
the patient.
198. The system of claim 197, wherein the previously recorded
neural signature includes a characterization of the patient's
multicellular signals.
199. The system of claim 198, wherein the multicellular signals
comprise one or more of neuron spikes, electrocorticogram signals,
local field potential signals, electroencephalogram signals, and
other physiologic electrical activity.
200. The system of claim 197, 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.
201. The system of claim 197, 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.
202. The system of claim 201, wherein the system enters an alarm
state when the current multicellular signals do not adequately
match the previously recorded neural signature.
203. The system of claim 202, wherein the alarm state includes
displaying an alarm condition on one or more of the discrete
components.
204. The system of claim 202, wherein the alarm state produces one
or more of: an audible alarm, a visual alarm, and a tactile
alarm.
205. The system of claim 184, wherein the unique electronic
identifier is changeable over time.
206. The system of claim 184, wherein the unique electronic
identifier corresponds to a state of the system.
207. The system of claim 206, wherein the state of the system
comprises one or more of: processed signal stability, processed
signal performance, and processed signal requirements.
208. The system of claim 206, 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.
209. The system of claim 168, further comprising a first
calibration routine for calibrating the system with the first
controlled device, and a second calibration routine for calibrating
the system with the second controlled device.
210. 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.
211. The system of claim 168, wherein the first controlled device
is implanted in the body of the patient.
212. 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.
213. The system of claim 168, wherein at least one of the sensor
and the processing unit comprises a wireless transmission
mechanism.
214. The system of claim 168, wherein the system comprises multiple
discrete components, at least one of the multiple discrete
components is implanted within the body of the patient, and at
least one of the multiple discrete components is positioned
external to the body of the patient.
215. The system of claim 214, wherein a unique electronic
identifier is embedded in at least one of the discrete components
implanted within the body of the patient.
216. The system of claim 214, wherein a unique electronic
identifier is embedded in at least one of the discrete components
positioned external to the body of the patient.
217. The system of claim 214, wherein at least one of the discrete
components positioned external to the body of the patient is
detachable from another discrete component.
218. The system of claim 214, wherein a unique electronic
identifier is embedded in all of the discrete components positioned
external to the body of the patient.
219. The system of claim 218, wherein all of the discrete
components positioned external to the body of the patient are
detachable from the patient.
220. The system of claim 214, wherein the processing unit is
external to the body of the patient.
221. The system of claim 214, 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.
222. The system of claim 214, wherein one or more of the discrete
components comprises a calibration module.
223. The system of claim 222, wherein the calibration module
comprises multiple calibration routines, and at least one of the
calibration routines is linked with the system by a unique
electronic identifier.
224. The system of claim 214, wherein the controlled device is
included in a discrete component external to the body of the
patient.
225. The system of claim 168, wherein the patient is a human
being.
226. The system of claim 168, wherein the multicellular signals
emanate directly from the central nervous system.
227. 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.
228. The system of claim 168, wherein the sensor comprises a
multi-electrode array.
229. The system of claim 168, wherein the sensor comprises multiple
wires or wire bundle electrodes.
230. The system of claim 168, wherein the sensor comprises
electrodes incorporated in a subdural grid.
231. 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.
232. The system of claim 231, 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.
233. The system of claim 231, wherein the electrodes of the
discrete components of the sensor are placed in the brain.
234. The system of claim 231, 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.
235. The system of claim 231, wherein at least one of the discrete
components of the sensor has a maximum of one electrode.
236. The system of claim 168, wherein the electrodes of the sensor
are implanted near the central nervous system.
237. The system of claim 168, wherein the sensor electrodes are
implanted within the brain.
238. The system of claim 237, wherein the electrodes of the sensor
are implanted within the motor cortex portion of the brain.
239. The system of claim 168, wherein the electrodes of the sensor
are placed at an extracranial site or above the patient's
scalp.
240. 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.
241. The system of claim 168, wherein each electrode is capable of
recording a plurality of neurons.
242. The system of claim 168, wherein the processing unit conducts
adaptive processing of the multicellular signals so that the system
responds to changes in the multicellular signals.
243. The system of claim 168, wherein the processing unit includes
two or more discrete components.
244. The system of claim 243, wherein at least one of the discrete
components of the processing unit is implanted within the
patient.
245. The system of claim 244, wherein at least one of the discrete
components of the processing unit is positioned external to the
body of the patient.
246. The system of claim 243, wherein at least one of the discrete
components of the processing unit is positioned external to the
skull.
247. The system of claim 246, wherein at least one of the discrete
components of the processing unit is positioned external to the
body of the patient.
248. The system of claim 168, wherein an at least one discrete
component of the processing unit is configured to receive or send
signals via a physical cable.
249. The system of claim 168, wherein an at least one discrete
component of the processing unit is configured to receive or send
signals via a wireless communication mechanism.
250. The system of claim 249, wherein the wireless communication
passes through the skull of the patient.
251. The system of claim 168, wherein the processing unit comprises
an integrated neuron spike sorting function.
252. The system of claim 168, wherein the processing unit comprises
an element to amplify the multicellular signals.
253. The system of claim 168, wherein the processing unit utilizes
neural net software routines to map neural signals into desired
controlled device control.
254. The system of claim 168, wherein the processing unit utilizes
one or more neural signals that is under voluntary control of the
patient.
255. The system of claim 168, wherein the processing unit utilizes
two or more neural signals that are mathematically combined to
create the processed signals.
256. The system of claim 168, wherein the processed signals are
used in a calibration routine for producing calibration output
parameters.
257. The system of claim 256, wherein the calibration routine
comprises selection and deselection of specific neural signals over
time.
258. The system of claim 256, 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.
259. The system of claim 256, wherein the calibration output
parameters are stored in memory and linked with a unique electronic
identifier.
260. The system of claim 256, wherein the calibration routine is
performed on a periodic basis.
261. The system of claim 256, wherein the calibration routine
selects a subset of the multicellular signals received from the
sensor to be processed by the processing unit.
262. The system of claim 256, wherein the calibration routine
utilizes one or more calibration input parameters to determine the
calibration output parameters.
263. The system of claim 262, wherein the calibration input
parameters comprise system performance criteria or controlled
device performance criteria.
264. The system of claim 262, wherein the calibration input
parameters are stored in memory and linked with a unique electronic
identifier.
265. The system of claim 262, 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.
266. The system of claim 262, 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.
267. The system of claim 168, further comprising an information
transfer cable between the first controlled device and the second
controlled device.
268. The system of claim 168, further comprising a library of
system specific values that are linked to the first or second
controlled device.
269. The system of claim 268, wherein the library of system
specific values is stored in a component other than the sensor, the
processing unit, and the first and second controlled devices.
270. The system of claim 269, wherein the library of system
specific values are stored in a computer network based
platform.
271. The system of claim 270, wherein the computer network based
platform comprises one or more of: a local area network, a wide
area network, and the Internet.
272. The system of claim 268, wherein the library of system
specific values is stored in one or more of: the sensor, the
processing unit, and the first and second controlled devices.
273. The system of claim 268, wherein the library of system
specific values includes a list of controlled devices compatible
with the system.
274. The system of claim 168, further comprising an alarm
transducer.
275. The system of claim 274, wherein the alarm transducer
comprises one or more of: an audio transducer, a visual transducer,
an olfactory transducer, and a tactile transducer.
276. The system of claim 274, wherein the system comprises multiple
discrete components, and the alarm transducer is activated when a
unique electronic identifier contained in the one of the discrete
components is not compatible with a unique electronic identifier
contained in the other of the discrete components.
277. The system of claim 168, further comprising a memory storage
module for storing information about the first or second controlled
device.
278. The system of claim 277, further comprising an additional
memory storage module for storing controlled device
information.
279. The system of claim 277, wherein system information is stored
in the memory storage module and linked with the first or second
controlled device.
280. A method of controlling multiple devices, comprising:
providing the system of claim 168; and controlling the first and
second controlled devices with the processed signals.
281. The method of claim 280, wherein the system includes a unique
electronic identifier, and the identifier is transmitted with the
processed signals.
282. The method of claim 280, wherein the first controlled device
and the second controlled device are controlled independently.
283. The method of claim 282, wherein the first controlled device
and the second controlled device are configured to receive the
processed signals simultaneously.
284. The method of claim 280, wherein the first controlled device
and the second controlled device are controlled simultaneously.
285. The method of claim 280, wherein the first controlled device
is a medical device.
286. The method of claim 285, wherein the first controlled device
is under voluntary control of the patient.
287. The method of claim 286, wherein the second controlled device
is a medical device.
288. The method of claim 287, wherein the second controlled device
is not under voluntary control of the patient.
289. The method of claim 280, wherein the sensor comprises two or
more discrete components, and each of the discrete components
comprises one or more electrodes.
290. The method of claim 289, wherein at least one discrete
component of the sensor comprises at least one electrode disposed
in or on the patient's brain.
291. The method of claim 290, wherein at least one discrete
component of the sensor comprises at least one electrode not
disposed in or on the patient's brain.
292. A system comprising: a first sensor comprising a plurality of
electrodes for detecting first multicellular signals from a first
patient; a second sensor comprising a plurality of electrodes for
detecting second multicellular signals from a second patient; a
processing unit configured to receive the first multicellular
signals from the first sensor and the second multicellular signals
from the second sensor and process the first multicellular signals
of the first patient and the second multicellular signals of the
second patient to produce processed signals derived from the first
and second multicellular signals, the processing unit being
configured to transmit the processed signals to a controlled
device; and the controlled device for receiving the processed
signals.
293. The system of claim 292, further comprising a first
calibration routine for calibrating the system with the first
patient and a second calibration routine for calibrating the system
with the second patient.
294. The system of claim 292, further comprising a unique
electronic identifier which is embedded in one or more
transmissions of electronic information between two or more of: the
first sensor, the second sensor, the processing unit, and the
controlled device.
295. The system of claim 292, wherein the processing unit includes
a first portion communicating with the first sensor and a second
portion communicating with the second sensor.
296. The system of claim 295, wherein the processing unit includes
a third portion which communicates with both the first portion and
the second portion.
297. The system of claim 295, wherein the controlled device
communicates with both the first portion and the second
portion.
298. The system of claim 292, wherein the processing unit conducts
adaptive processing of the multicellular signals so that the system
responds to changes in the first and second multicellular signals.
Description
DESCRIPTION OF THE INVENTION
[0001] This application claims the benefit of priority under 35
U.S.C. .sctn. 119(e) of U.S. provisional application No.
60/524,969, filed Nov. 25, 2003.
FIELD OF THE INVENTION
[0002] The present invention relates to neural interface systems
with unique embedded identifiers, and, more particularly, to
systems and methods whereby a neural interface system utilizes the
unique embedded electronic signature or identifier to assure
compatibility of a multiple component system.
DESCRIPTION OF RELATED ART
[0003] Neural interface devices are currently under development for
numerous applications including restoration of lost function due to
traumatic injury or neurological disease. Sensors, such as
electrode arrays, implanted in the higher brain regions that
control voluntary movement can be activated voluntarily to generate
electrical signals that can be processed by a neural interface
device to create a thought invoked control signal. Such control
signals can be used to control numerous devices including computers
and communication devices, external prostheses, such as an
artificial arm or functional electrical stimulation of paralyzed
muscles, as well as robots and other remote control devices.
Patient's afflicted with amyotrophic lateral sclerosis (Lou
Gehrig's Disease), particularly those in advanced stages of the
disease, would also be applicable to receiving a neural interface
device, even if just to improve communication to the external world
and thus improve their quality of life.
[0004] Early attempts to utilize signals directly from neurons to
control an external prosthesis encountered a number of technical
difficulties. The ability to identify and obtain stable electrical
signals of adequate amplitude was a major issue. Another problem
that has been encountered is caused by the changes that occur to
the neural signals that occur over time, resulting in a degradation
of system performance. Neural interface systems that utilize other
neural information, such as electrocorticogram (ECOG) signals,
local field potentials (LFPs) and electroencephalogram (EEG)
signals have similar issues to those associated with individual
neuron signals. Since all of these signals result from the
activation of large groups of neurons, the specificity and
resolution of the control signal that can be obtained is limited.
However, if these lower resolution signals could be properly
identified and the system adapt to their changes over time, simple
control signals could be generated to control rudimentary devices
or work in conjunction with the higher power control signals
processed directly from individual neurons.
[0005] Commercialization of these neural interfaces has been
extremely limited, with the majority of advances made by
universities in a preclinical research setting. As the technologies
advance and mature, the natural progression will be to
sophisticated human applications, such as those types of devices
regulated by various governmental regulatory agencies including the
Food and Drug Administration in the United States. When
sophisticated neural interface systems are commercially available
for prescription by an appropriate clinician, it will become very
important for these devices to include numerous safety features
required in the hospital and home health care settings. Systems
which perform component compatibility, software compatibility and
other checks of safe and effective performance may be
necessary.
[0006] There is therefore a need for an improved neural interface
system which incorporates hardware and/or software embodiments
which may confirm safe and effective performance of the system.
Performance of these safety checks at specific events and repeated
periodically throughout the life of the system would ensure a
sophisticated and effective control signal for the long term
control of an external device.
SUMMARY OF THE INVENTION
[0007] According to a first aspect of the invention, a neural
interface system is disclosed. The neural interface system collects
multicellular signals emanating from the central nervous system of
a patient and transmits processed signals to a controlled device.
The system comprises a sensor for detecting multicellular signals.
The sensor may comprise a plurality of electrodes. The electrodes
are designed to allow chronic detection of multicellular signals. A
processing unit is designed to receive the multicellular signals
from the sensor and process the multicellular signals to produce
processed signals. The processed signals are transmitted from the
processing unit to a controlled device. The system comprises two or
more discrete components and a first discrete component transmits
data or other electronic information to a second discrete
component. A unique electronic identifier is embedded in one or
more transmissions of the electronic information.
[0008] The two or more discrete components can be implanted in the
patient or external to the patient's body. Physical cables and/or
wireless communication means are utilized to transfer the
electronic information from one discrete component to another. In a
preferred embodiment, the unique electronic identifier is embedded
in one or more discrete components of the system. In another
preferred embodiment, the unique electronic identifier is embedded
in all discrete components that are detachable from the system or
utilize wireless transmission of electronic information.
[0009] In another preferred embodiment, the neural interface system
includes a calibration module. The calibration module may include
calibration routines for multiple patients, with each patient
corresponding to a different unique electronic identifier.
[0010] In another preferred embodiment, the multicellular signals
detected by the sensor of the system comprise one or more of neuron
spikes, electrocorticogram signals, local field potential signals
and electroencephalogram signals.
[0011] In another preferred embodiment, the sensor comprises one or
more multi-electrode arrays with surface penetrating electrodes.
The arrays are placed in one or more locations within the body of
the patient, such as the motor cortex of the patient's brain. In
another preferred embodiment, non-penetrating electrodes are
utilized, such as in combination with penetrating electrodes, to
detect multicellular signals from the brain or at extracranial
locations such as the patient's scalp.
[0012] In another preferred embodiment, the discrete component
includes, in whole, in part, or in combination, 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.
[0013] In another preferred embodiment, the discrete components
include operator information, such as imprinted text, color codes,
bar codes, brail or other tactile patterns, or other identifiers
that correlate to the unique electronic identifier to predetermine
compatibility of the system. Corresponding operator information can
be included on the connecting end of one or more physical cables or
on multiple discrete components that transfer electronic
information between each other.
[0014] In another preferred embodiment, the unique electronic
identifier is programmable and can be reprogrammed or updated
multiple times. In an alternative embodiment, the unique electronic
identifier is programmable one time only. In another preferred
embodiment, the unique electronic identifier is hardwired in one or
more discrete components of the system, such as a transcutaneous
connector connected to an implanted sensor with a multi-conductor
cable.
[0015] In another preferred embodiment, a neural signature for a
specific patient is created based on an analysis of a set of
multicellular signals detected by a sensor comprising of one or
more groups of electrodes. The neural signature can be compared to
one or more previous neural signatures for purposes of patient
identification or system compatibility confirmation. The comparison
can be performed using one or more different pattern recognition
algorithms including a linear filter, maximum likelihood estimator,
and a neural network.
[0016] In another preferred embodiment, the neural interface system
performs a discrete component compatibility check which results in
the system entering an alarm state if an incompatibility is
detected. The alarm state can activate an alarm transducer such as
an audible alarm, visual alarm, or tactile alarm. In another
preferred embodiment, when an incompatibility is identified,
control of the controlled device is modified or suspended. The
system compatibility check routine confirms the same unique
electronic identifier is embedded in multiple discrete components.
The compatibility check routine is implemented on an active basis,
such as when a physical cable is attached between discrete
components or a wireless transmission is initiated, or a passive
basis such as on a cyclic, routine, or periodic schedule.
[0017] In another preferred embodiment, the neural interface system
includes a library of system specific values that are linked to the
unique electronic identifier. The values can be stored on a
computer network based platform, such as a local area network
(LAN), a wide area network (WAN), or the internet.
[0018] In another preferred embodiment, the neural interface system
further comprises an information recall unit for retrieving the
unique electronic identifier from one or more discrete components.
The information recall unit can be integrated into a discrete
component of the system or be a stand alone device, such as a
modified personal data assistant (PDA) device.
[0019] According to another aspect of the invention, a method is
disclosed for confirming discrete component compatibility of a
system for collecting multicellular signals from a patient and
transmitting processed signals to a controlled device. The system
comprises a sensor, and the sensor may comprise a plurality of
electrodes to detect the multicellular signals. The system also
comprises a processing unit for receiving the multicellular signals
from the sensor, for processing the multicellular signals to
produce processed signals, and for transmitting the processed
signals to a controlled device. The system further comprises a
controlled device for receiving the processed signals. The sensor,
processing unit, and controlled device are contained in two or more
discrete components, and a first discrete component transmits
electronic information to a second discrete component. The system
further comprises a unique electronic identifier which is embedded
in two or more of the discrete components. The unique electronic
identifier may be used to perform a confirmation of discrete
component compatibility.
[0020] According to another aspect of the invention, a system for
collecting multicellular signals from a central nervous system of a
patient and for transmitting processed signals to a controlled
device is disclosed. The system comprises a sensor for detecting
the multicellular signals, the sensor comprising of a plurality of
electrodes for detection of the multicellular signals. The system
also comprises a processing unit for receiving the multicellular
signals, for processing the multicellular signals to produce
processed signals, and for transmitting the processed signals to
the controlled device. The system further comprises a controlled
device for receiving the processed signals. The processing unit
creates a neural signature for the patient, representing a
reproducible derivative of one or more multicellular signals
detected. In a preferred embodiment, the neural signature is
created while the patient is presented with a visual stimulus.
[0021] According to another aspect of the invention, a system for
collecting multicellular signals from a patient and for
transmitting processed signals to a controlled device is disclosed.
The system comprises a sensor for detecting the multicellular
signals. The sensor may comprise a plurality of electrodes to
detect the multicellular signals. The system further comprises a
processing unit for receiving the multicellular signals from the
sensor, for processing the multicellular signals to produce
processed signals, and for transmitting the processed signals to
the controlled device. The system further comprises a first
controlled device for receiving the processed signals and a second
controlled device for receiving the processed signals. In a
preferred embodiment, the system includes a unique electronic
identifier embedded in one or more discrete components of the
system.
[0022] According to another aspect of the invention, a system for
collecting multicellular signals from a first patient and for
collecting multicellular signals from a second patient and for
transmitting processed signals to a controlled device is disclosed.
The system comprises a first sensor for detecting the multicellular
signals from a first patient. The first sensor comprises a
plurality of electrodes to detect the multicellular signals. The
system comprises a second sensor for detecting the multicellular
signals from a second patient. The second sensor comprises a
plurality of electrodes to detect the multicellular signals. The
system further comprises a processing unit for receiving the
multicellular signals from the first sensor and the second sensor,
for processing the multicellular signals to produce processed
signals, and for transmitting the processed signals to the
controlled device. The system further comprises a controlled device
for receiving the processed signals. In a preferred embodiment, the
system included a unique electronic identifier embedded in one or
more discrete components of the system.
[0023] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0024] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate various
embodiments of the present invention, and, together with the
description, serve to explain the principles of the invention.
[0026] FIG. 1 illustrates a neural interface system consistent with
the present invention.
[0027] FIG. 2 illustrates an exemplary embodiment of a brain
implant system consistent with the present invention.
[0028] FIG. 3 illustrates another exemplary embodiment of a neural
interface system consistent with the present invention wherein a
single patient controls multiple devices.
[0029] FIG. 4 illustrates another exemplary embodiment of a neural
interface system consistent with the present invention wherein
multiple patients control a single device.
DESCRIPTION OF THE EMBODIMENTS
[0030] Reference will now be made in detail to the present
embodiments of the invention, examples of which are illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0031] Systems and methods consistent with the invention detect
neural signals generated within a patient's body and implement
various signal processing techniques to generate processed signals
for transmission to a device to be controlled. In one exemplary
embodiment, a neural interface system includes multiple discrete
components which can each transmit electronic information to a
separate component through the use of a physical cable, including
one or more of electrically conductive wires or optical fibers.
Alternatively or additionally, transmission of data or other
electronic information between discrete components can be
accomplished wirelessly, by one or more discrete components
including a transceiver that may transmit and receive data such as
through the use of "Bluetooth" technology or according to any other
type of wireless communication means, method, protocol or standard,
including, for example, code division multiple access (CDMA),
wireless application protocol (WAP), infrared or other optical
telemetry, radiofrequency or other electromagnetic telemetry,
ultrasonic telemetry, or other telemetric technology.
[0032] The system of the disclosed invention includes a sensor for
detecting multicellular systems from the central nervous system of
a patient. The sensor may include a plurality of electrodes that
allow continual or chronic detection of the multicellular signals.
A processing unit receives these multicellular signals from the
sensor and utilizes various signal processing, electronic,
mathematic, neural net and other techniques and processes to
produce a processed signal used to control a device such as a
prosthetic limb, ambulation vehicle, communication device, robot,
computer or other controllable device. The system includes two or
more discrete components, such as those defined by a housing or
other enclosing or partially enclosing structure, or those defined
as being detached or detachable from another discrete component.
The discrete components of the system in their entirety include the
sensor, the processing unit and the controlled device. Any one of
the sensor, the processing unit and the controlled device may be
only partially included in a single discrete component, and a
portion of one may be included with a portion or the entirety of
another in a single discrete component.
[0033] Any and all discrete components may be internal to the body
of the patient, external to the body of the patient, as well as
implanted in the patient but protruding through the skin such as to
be accessible for connection to a physical cable. Discrete
components can include, in whole or in part, numerous functions
and/or components of system 100 or components to be used in
combination with system 100. These discrete components include but
are not limited to: a multicellular sensor, a processing unit, a
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. In the instance where a discrete component
includes a configuration module, the configuration module may
include configuration programs, settings, and patient or system
specific data for multiple patients and/or systems. In those
instances, all data for a specific single system is associated, or
electronically linked, with that system's unique electronic
identifier. The configuration module uses the embedded unique
electronic identifier during the configuration process to assure
the proper data is utilized.
[0034] Electronic information or data is transmitted between one or
more discrete components using one or more physical cables and/or
wireless communication means. A unique electronic identifier, such
as a unique alphanumeric code or serial number associated with the
system, is included in one or more transmissions of electronic
information between discrete components or between any discrete
component and a separate device outside the system. Any and all
communications that include the unique electronic identifier can be
used to confirm that each discrete component is from the same or at
least a compatible system. In wireless communication, the unique
electronic identifier can be included in various handshaking
protocols used in one or more information transmissions, such as
handshaking protocols well known to those of skill in the art of
wireless communication. This safety feature may be important
especially as it relates to critical patient care devices such as a
neural interface systems disclosed herein. For example, if a
discrete component that had been calibrated or otherwise configured
for use with another system or patient were accidentally attached
to a discrete component of a different or otherwise incompatible
system, undesired and potentially hazardous effects could occur.
Thus, some exemplary embodiments of the invention may include
multiple embodiments that can detect such an incompatibility to
prevent undesired device control and alert the patient or other
involved party of the issue.
[0035] Referring now to FIG. 1, a neural interface system 100 is
shown comprising of implanted components and components external to
the body of a patient 500. A sensor for detecting multicellular
signals (not shown), such as a two dimensional array of multiple
protruding electrodes, may be implanted in the brain of patient 500
in an area such as the motor cortex. In a preferred embodiment, the
sensor is placed in an area to record multicellular signals that
are under voluntary control of the patient. Alternatively or
additionally, the sensor may include one or more wires or wire
bundles which include a plurality of electrodes. Patient 500 of
FIG. 1 is shown as a human being, but other mammals and life forms
which produce recordable multicellular signals would also be
applicable. Patient 500 may be a patient with a spinal cord injury
or afflicted with a neurological disease that has resulted in a
loss of voluntary control of various muscles within the patient's
body. Alternatively or additionally, patient 500 may have lost a
limb, and system 100 will include a prosthetic limb as its
controlled device.
[0036] The various electrodes of the sensor detect multicellular
signals, such as neuron spikes which emanate from the individual
neurons of the brain. The sensor can be placed at one or more
various locations within the body of patient 500, such as at an
extracranial site, and preferably in a location to collect
multi-cellular signals directly from the central nervous system.
The electrodes can take on various shapes and forms, including the
penetrating electrodes described hereabove, as well as atraumatic
or blunt shapes such as those included in subdural grid electrodes
or scalp electrodes. The sensor can be placed on the surface of the
brain without penetrating, such as to detect local field potential
(LFP) signals, or on the scalp to detect electroencephalogram (EEG)
signals.
[0037] The sensor electrodes of system 100 can be used to detect
various multicellular signals including neuron spikes,
electrocorticogram signals (ECoG), local field potential (LFP)
signals, electroencelphalogram (EEG) signals and other
multicellular signals. The electrodes can detect multicellular
signals from clusters of neurons and provide signals midway between
single neuron and electroencephalogram recordings. Each electrode
is capable of recording a combination of signals, including a
plurality of neuron spikes.
[0038] A processing unit, shown in FIG. 1, comprises processing
unit first portion 130a and processing unit second portion 130b.
The processing unit receives the multicellular signals from the
sensor and performs various signal processing functions including
but not limited to amplification, filtering, sorting, conditioning,
translating, interpreting, encoding, decoding, combining,
extracting, mathematically transforming and/or otherwise processing
those signals to generate a control signal for transmission to a
controlled device. The processing unit may process signals that are
mathematically combined, such as the combining neuron spikes that
are first separated using spike discrimination methods known to
those of skill in the art. The processing unit may include multiple
components, as shown in FIG. 1, or a single component. Each of the
processing unit components can be fully implanted in patient 500,
be external to the body, or be implanted with a portion of the
component exiting through the skin.
[0039] In FIG. 1, controlled device 300 is a computer system
including a computer display with cursor control, and patient 500
may be controlling one or more of a mouse, keyboard, cursor,
joystick, other computer input device, or any combinations and/or
multiples of these devices. Numerous other controlled devices can
be included in system 100, individually or in combination,
including but not limited to prosthetic limbs, functional
electrical stimulation (FES) devices and systems, robots and
robotic components, teleoperated devices, computer controlled
devices, communication devices, environmental control devices,
vehicles such as wheelchairs, remote control devices, medical
therapeutic and diagnostic equipment such as drug delivery
apparatus and other controllable devices applicable to patients
with some form of paralysis or diminished function as well as any
device that may be better utilized under direct brain or thought
control.
[0040] The sensor is connected via a multi-conductor cable, not
shown, to processing unit first portion 130a which includes a
transcutaneous pedestal which is mounted to the patient's skull and
includes multiple conductive pads for connecting to a physical
cable. The multi-conductor cable includes a separate conductor for
each electrode, as well as additional conductors to serve other
purposes. Various descriptions of the sensor and multi-conductor
cable are described in detail in relation to subsequent figures
included herebelow.
[0041] Processing unit first portion 130a may include various
signal conditioning elements such as amplifiers, filters, and
signal multiplexing circuitry. Processing unit first portion 130a
includes a unique electronic identifier, such as a unique serial
number or any alphanumeric or other retrievable, identifiable code
associated uniquely with the system 100 of patient 500. The unique
electronic identifier may take many different forms in processing
unit first portion 130a, such as a piece of electronic information
stored in a memory module; a semiconductor element or chip that can
be read electronically via serial, parallel or telemetric
communication; pins or other conductive parts that can be shorted
or otherwise connected to each other or to a controlled impedance,
voltage or ground, to create a unique code; pins or other parts
that can be masked to create a binary or serial code; combinations
of different impedances used to create a serial code that can be
read off contacts, features that can be optically scanned and read
by patterns and/or colors; mechanical patterns that can be read by
mechanical or electrical detection means or by mechanical fit,
radio frequency ID or other frequency spectral codes sensed by
radiofrequency or electromagnetic fields, pads or other marking
features that may be masked to be included or excluded to represent
a serial code, or any other digital or analog codes that can be
retrieved from the discrete component.
[0042] The discrete component may require power, provided
internally or externally, to allow the unique electronic identifier
to be retrievable, or no power may be required. Power can be
supplied with numerous different forms of energy including but not
limited to one or more of: acoustic energy, light energy,
electromagnetic energy, electrical energy, mechanical energy and
chemical energy. The unique electronic identifier can be
transmitted with many different types of signals including but not
limited to: acoustic signals, infrared signals, radiofrequency
signals, microwave signals, optical signals and electrical
signals.
[0043] In an alternative, preferred embodiment, the unique
electronic identifier is a representation of one or more system
parameters related to patient 500 such as the electrode impedances
and/or multicellular signal shapes or amplitudes that exist after
the sensor is in place, such as after having been implanted in the
brain of patient 500, and potentially when the patient is presented
with a particular stimulus or asked to imagine a particular event.
This type of neural information, herein termed as a neural
signature, is described in greater detail herebelow.
[0044] A neural signature can be used as a distinctive biometric
patient identification means. Various algorithms can be used to
identify a patient's identification from his brain activity
including but not limited to: defining sets of electrodes that have
neuron spike activity, autocorrelation shapes characterized on each
electrode, firing rates on each electrode, correlation patterns
between electrodes and other multicellular signal characteristics.
A system could be developed to recognize a set of characteristic
patterns of a patient using one or more recognition means including
but not limited to: a linear filter, maximum likelihood estimator,
neural network or other pattern recognition algorithm. In some
exemplary embodiments, recognition of the patient's neural
signature can be an active or passive part of the system 100. The
recognition process could begin as soon as the patient 500 is
connected via a physical cable, or a wireless transmission has been
sent. The recognition process could also begin in response to
another change in state. In order to create and/or check the neural
signature, a stimulus, such as the flashing of a bright light,
display of a picture or movie, a patient imagined movement or other
imagined state or event can be used to stimulate particular
multicellular signals to be generated. The specific stimulus would
be repeated each time a comparative recognition process is desired,
each time creating a derivative of the multicellular signals
detected. The neural signature would apply to neuron spikes, LFPs,
EEGs, ECoGs and other bio-electric signals.
[0045] Storage of neural signatures can be accomplished within
system 100 via storage in one or more memory modules.
Alternatively, separate computer systems may maintain database-like
structure of neural signatures. Such databases may be maintained by
service companies, supporting the neural interface systems, at
hospitals and other healthcare settings, and/or at government
institutions. The information can be transferred and accessed via
phone lines, the internet, wireless technologies and other
information transfer means. Such databases of information, whether
integrated into system 100 or available at outside sources, can
link neural signature information to various pieces of information,
such as particular information relevant to system 100. Such
information includes but is not limited to: patient calibration
parameters, historic system performance, configuration and
diagnostic information, controlled device calibration and other
configuration settings, other patient diagnostic information
gathered by system 100, and patient permissions within system 100
such as a list of useable control devices, and functional access
permissions for those devices. In a preferred embodiment, these
databases are under control of a caregiver, such as the clinician,
which has secure control over the modification of the
information.
[0046] Referring back to FIG. 1, alternatively or in addition to
embedding the unique electronic identifier in processing unit first
portion 130a, the unique electronic identifier can be embedded in
the sensor and/or the multi-conductor cable connecting the sensor
and processing unit first portion 130a. Under certain
circumstances, the transcutaneous pedestal with multiple conductive
pads, such as that shown embedded in processing unit first portion
130a of FIG. 1, may need to be replaced. Under these circumstances,
a system compatibility check between a new pedestal and the
remaining implanted system, the implanted sensor and/or
multi-conductor cable, can be confirmed at the time of the repair
or replacement surgery through the use of the embedded unique
electronic identifier.
[0047] The unique electronic identifier can be embedded in one or
more of the discrete components at the time of manufacture, or at a
later date such as at the time of any clinical procedure involving
the system, such as a surgery to implant the sensor electrodes into
the brain of patient 500. Alternatively, the unique electronic
identifier may be embedded in one or more of the discrete
components at an even later date such as during system
configuration or calibration.
[0048] Referring again to FIG. 1, processing unit first portion
130a is electrically attached to processing unit second portion
130b via intra-processing unit cable 140. Intra-processing unit
cable 140, as well as other physical cables incorporated into
system 100, may include electrical wires, optical fibers, other
means of transmitting data and/or power and any combination of
those. The number of individual conductors of intra-processing unit
cable 140 can be greatly reduced from the number of conductors
included in the multi-conductor cable between the implanted sensor
and processing unit first portion 130a through signal combination
circuitry included in processing unit first portion 130a.
Intra-processing unit cable 140, as well as all other physical
cables incorporated into system 100, may include shielding elements
to prevent or otherwise reduce the amount of electromagnetic noise
added to the various neural signals, processed neural signals and
other signals carried by those cables. In an alternative preferred
embodiment, intra-processing unit cable 140 is replaced with a
wireless connection for transmission between processing unit first
portion 130a and processing unit second portion 130b. Wireless
communication means, well known to those of skill in the art and
described in more detail, can be utilized to transmit information
between any of the components of system 100.
[0049] A qualified individual, operator 110, performs a calibration
of system 100 at some time during the use of system 100, preferably
soon after implantation of the sensor. As depicted in FIG. 1,
operator 110 utilizes configuration apparatus 115 which includes
two monitors, first configuration monitor 120a and second
configuration monitor 120b, along with configuration keyboard 116
to perform the calibration routine and other configuration tasks
such as patient training, algorithm and algorithm parameter
selection, and output device setup. The software programs and
hardware required to perform the calibration can be included in the
processing unit, such as processing unit second portion 130b, or in
a central processing unit incorporated into configuration apparatus
115. Configuration apparatus 115 can include additional input
devices, such as a mouse or joystick, not shown. Configuration
apparatus 115 can include various elements, functions and data
including but not limited to: memory storage for future recall of
calibration activities, operator qualification routines, standard
human data, standard synthesized data, neuron spike discrimination
software, operator security and access control, controlled device
data, wireless communication means, remote (such as via the
internet) calibration communication means and other elements,
functions and data used to provide an effective and efficient
calibration on a broad base of applicable patients and a broad base
of applicable controlled devices. The unique electronic identifier
can be embedded in one or more of the discrete components at the
time of system configuration, including the act of identifying a
code that was embedded into a particular discrete component at its
time of manufacture, and embedding that code in a different
discrete component.
[0050] Operator 110 may be a clinician, technician, caregiver or
even the patient themselves in some circumstances. Multiple
operators may be needed to perform a calibration, and each operator
may be limited by system 100, via passwords and other control
configurations, to only perform specific functions. For example,
only the clinician may be able to change specific critical
parameters, or set upper and lower limits on other parameters,
while a caregiver, or the patient, may not be able to access those
portions of the calibration procedure. The calibration procedure
includes the setting of numerous parameters needed by the system
100 to properly control controlled device 300. The parameters
include but are not limited to various signal conditioning
parameters as well as selection and de-selection of specific
multicellular signals for processing to generate the device control
creating a subset of signals received from the sensor to be
processed. The various signal conditioning parameters include, but
are not limited to, threshold levels for amplitude sorting and
filtering levels and techniques.
[0051] The operator 110 may be required by system 100 to perform
certain tasks, not part of the actual calibration, to be qualified
and thus allowed to perform the calibration routine. The tasks may
include analysis of pre-loaded multicellular signals, either of
synthetic or human data, and may include previous data captured
from patient 500. The mock analysis can be tested for accuracy,
requiring a minimum performance for the calibration routine to
continue.
[0052] The calibration routine will result in the setting of
various calibration output parameters. Calibration output
parameters may include but are not limited to: 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. In a preferred embodiment,
the calibration output parameters are stored in memory in one or
more discrete components, and the parameters are linked to the
system unique electronic identifier.
[0053] Calibration routines may be performed on a periodic basis,
and may include the selection and deselection of specific neural
signals over time. The initial calibration routine may include
initial values, or starting points, for one or more of the
calibration output parameters. Subsequent calibration routines may
involve utilizing previous calibration output parameters which have
been stored in a memory storage element of system 100. Subsequent
calibration routines may be shorter in duration than an initial
calibration and may require less patient involvement. Subsequent
calibration routine results may be compared to previous calibration
results, and system 100 may require a repeat of calibration if
certain comparative performance is not achieved.
[0054] The calibration routine may include the steps of (a) setting
a preliminary set of calibration output parameters; (b) generating
processed signals to control the controlled device; (c) measuring
the performance of the controlled device control; and (d) modifying
the calibration output parameters. The calibration routine may
further include the steps of repeating steps (b) through (d).
[0055] In the performance of the calibration routine, the operator
110 may involve the patient 500 or perform steps that do not
involve the patient. The operator 100 may have patient 500 think of
an imagined movement, imagined state, or other imagined event, such
as a memory, an emotion, the thought of being hot or cold, or other
imagined event not necessarily associated with movement. The
patient participation may include the use of one or more cues such
as audio cues, visual cues, olfactory cues, and tactile cues. The
patient 500 may be asked to imagine multiple movements, and the
output parameters selected during each movement may be compared to
determine an optimal set of output parameters. The imagined
movements may include the movement of a part of the body, such as a
limb, arm, wrist, finger, shoulder, neck, leg, ankle, and toe, and
imagining moving to a location, moving at a velocity, or moving at
an acceleration.
[0056] The calibration routine will utilize one or more calibration
input parameters to determine the calibration output parameters. In
addition to the multicellular signals themselves, system or
controlled device performance criteria can be utilized. In order to
optimize the system, an iterative analysis of modifying the
performance criteria, based on the number of multicellular signals
that meet the criteria versus the optimal number of multicellular
signals to be included in the signal processing for the particular
controlled device, can be performed. Criteria can be increased or
decreased in the signal selection process during the calibration
procedure.
[0057] Other calibration input parameters may include various
properties associated with the multicellular signals, including one
or more of: 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
as well as a mathematical analysis of any signal property including
modulation of any signal property. Additional calibration input
parameters include but are not limited to: 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,
and event-based (such as a patient imagined movement event)
variations in signal properties including neuron firing rate
activity. In a preferred embodiment, one or more calibration input
parameters are stored in memory and linked to the embedded,
specific, unique electronic identifier.
[0058] The calibration routine may classify one or more
multicellular signals into three or more classifications for
subsequent selection for further processing into the processed
signal for transmission to the controlled device. The multiple
classifications can be completed in the initial portion of the
calibration routine, resulting in a count of each class of
available signal. Based on various requirements including the
requirements of the control device and applicable mathematical
transfer functions, signals can be selected from the most
appropriate classification, or a different number of classification
states can be chosen and the signals can be reclassified in order
to select the most appropriate signals for optimal device
control
[0059] It may be desirous for the calibration routine to exclude
one or more multicellular signals based on a desire to avoid
signals that respond to certain patient active functions, such as
non-paralyzed functions, or even certain imagined states. The
calibration routine may include having the patient imagine a
particular movement or state, and based on sufficient signal
activity such as firing rate or modulation of firing rate, exclude
that signal from the signal processing based on that particular
undesired imagined movement or imagined state. Alternatively real
movement accomplished by the patient may also be utilized to
exclude certain multicellular signals emanating from specific
electrodes of the sensor.
[0060] FIG. 2 generally illustrates a brain implant system
consistent with an embodiment of the present invention. As shown in
FIG. 2, the system includes an electrode array 210 inserted into a
patient's cerebral cortex 101 through an opening in the skull 222.
Array 210 may include a plurality of electrodes 212 for detecting
electrical brain signals or impulses. While FIG. 2 shows array 210
inserted into cerebral cortex 101, array 210 may be placed in any
location of a patient's brain allowing for array 210 to detect
electrical brain signals or impulses. Other locations for array
210, such as those outside of the cranium, can record multicellular
signals as well. Non-penetrating electrode configurations, such as
subdural grids, cuff electrodes and scalp electrodes are applicable
both inside the cranium such as to record LFPs, in, on or near
peripheral nerves, and on the surface of the scalp such as to
record EEGs. Though FIG. 2 depicts the sensor as a single discrete
component, in alternative embodiments, the sensor may comprise
multiple discrete components. Multiple sensor components can be
implanted in the brain, at an extracranial location, or any
combination of locations for the multiple discrete components
making up the sensor. Each discrete component can have as few as a
single electrode, with the cumulative sensor containing a plurality
of electrodes. Each electrode is capable of recording a plurality
of neurons or other electrical activity.
[0061] Electrode array 210 serves as the sensor for the brain
implant system. While FIG. 2 shows electrode array 210 as eight
electrodes 212, array 210 may include one or more electrodes having
a variety of sizes, lengths, shapes, forms, and arrangements.
Moreover, array 210 may be a linear array (e.g., a row of
electrodes) or a two-dimensional array (e.g., a matrix of rows and
columns of electrodes). Each electrode 212 extends into brain 101
to detect one or more electrical neural signals generated from the
neurons located in proximity to the electrode's placement within
the brain. Neurons may generate such signals when, for example, the
brain instructs a particular limb to move in a particular way.
[0062] In the embodiment shown in FIG. 2, each electrode 212 may be
connected to a processing unit 130 via wiring 216. Processing unit
130 may be secured to skull 222 by, for example, the use of an
adhesive or screws, and may even be placed inside the skull if
desired. A protective plate 230 may then be secured to skull 222
underneath the surface of the patient's skin 224. In exemplary
embodiments, plate 230 may be made of titanium and screwed to skull
222 using screws 232, or may comprise a section of skull 222
previously removed and attached to skull 222 using bridging straps
and screws (both not shown). However, the invention may use any of
a number of known protective plates, such as a biological material,
and methods for attaching the same to a patients skull. Further,
processing unit 130 and other surgically implanted components may
be placed within a hermetically sealed housing to protect the
components from biological materials. Alternative embodiments also
include processing unit 130 being located external to the patient's
body.
[0063] Electrodes 212 transfer the detected neural signals to
processing unit 130 over wiring 216. Each projection of electrode
array 210 may include a single electrode, such as an electrode at
the tip of the projection, or multiple electrodes along the length
of each projection. As shown in FIG. 2, wiring 216 may pass out of
the opening in skull 222 beneath protective plate 230. Wiring 216,
such as, for example, a multi-conductor cable connecting each
electrode to processing unit 130, may then run underneath the
patient's skin 224 to connect to processing unit 130. Persons
skilled in the art, however, will appreciate that arrangements
other than the one shown in FIG. 2 may be used to connect array 210
to processing unit 130 via wiring 216.
[0064] Processing unit 130 may preprocess the received neural
signals (e.g., impedance matching, noise filtering, or amplifying),
digitize them, and further process the neural signals to extract
neural information that it may then transmit to an external device
(not shown), such as a further processing device and/or any device
to be controlled by the processed multicellular signals. For
example, the external device may decode the received neural
information into control signals for controlling a prosthetic limb
or limb assist device, for controlling a computer cursor, or the
external device may analyze the neural information for a variety of
other purposes.
[0065] Processing unit 130 may also conduct adaptive processing of
the received neural signals by changing one or more parameters of
the system to achieve or improve performance. Examples of adaptive
processing include, but are not limited to, changing a parameter
during a system calibration, changing a method of encoding neural
information, changing the type, subset, or amount of neural
information that is processed, or changing a method of decoding
neural information. Changing an encoding method may include
changing neuron spike sorting methodology, calculations,
thresholds, or pattern recognition. Changing a decoding methodology
may include changing variables, coefficients, algorithms, and/or
filter selections. Other examples of adaptive processing may
include changing over time the type or combination of types of
signals processed, such as EEG, LFP, neural spikes, or other signal
types.
[0066] Referring now to FIG. 3, a neural interface system 100'
comprises implanted components and components external to the body
of a patient 500. System 100' includes multiple controlled devices,
controlled computer 3000, first controlled device 300a, and second
controlled device 300b. While three controlled devices are
depicted, this particular preferred embodiment includes any
configuration of two or more controlled devices for a single
patient. First controlled device 300a and second controlled device
can be various types of devices such as prosthetic limbs or limb
assist devices, robots or robotic devices, communication devices,
computers and other controllable devices as have been described in
more detail hereabove. The multiple controlled devices can include
two or more joysticks, two or more computers, a robot and another
controlled device, and many other combinations and multiples of
devices. Each controlled device is one or more discrete components
or a portion of a discrete component.
[0067] A sensor 200 for detecting multicellular signals, such as a
two dimensional array of multiple protruding electrodes, may be
implanted in the brain of patient 500, in an area such as the motor
cortex. In a preferred embodiment, the sensor is placed in an area
to record multicellular signals that are under voluntary control of
the patient. Alternatively or additionally, the sensor may include
one or more wires or wire bundles which include a plurality of
electrodes, subdural grids, cuff electrodes, scalp electrodes, or
other electrodes. Sensor 200 is attached to transcutaneous
connector 165 via wiring 216, such as a multi-conductor cable
including a separate conductor for each electrode of sensor 200.
Transcutaneous connector 165 includes a pedestal which is screwed
into the scalp of the patient, preferably in the surgical procedure
in which sensor 200 is implanted in the brain of patient 500. A
detachable cable, such as transcutaneous connector cable 141,
attaches to transcutaneous connector 165 via transcutaneous mating
plug 142. In a preferred embodiment, mating plug 142 includes
amplifier circuitry, electrostatic discharge protection circuitry
and/or single multiplexing circuitry such that connecting cable 141
has a reduced number of conductors as compared to wiring 216.
Connector cable 141, a physical cable, is attached to processing
unit first portion 130a, depicted as a permanent attachment but, in
an alternative embodiment, the attachment point to processing unit
first portion 130a is detachable. All of the physical cables of
FIG. 3, as well as all the other figures of this disclosure, can be
in a permanently attached, or detachable form. In addition, all of
the physical cables included in system 100' of FIG. 3, as well as
the systems of the other figures, such as transcutaneous connector
cable 141, can be eliminated with the inclusion of wireless
transceiver means incorporated into the applicable, communicating
discrete components.
[0068] Processing unit first portion 130a, which may be a discrete
component as defined in this disclosure, includes various signal
processing functions as has been described in detail in relation to
separate figures hereabove. Processing unit first portion 130a
preferably includes a unique electronic identifier of the system,
the makeup and applicability of which are described in detail
hereabove. Processing unit first portion 130a electrically connects
to processing unit second portion 130b via intra-processing unit
cable 140. Cable 140 is detachable from processing unit second
portion 130b via female plug 153 which attached to processing unit
second portion 130b at its input port, male receptacle 152.
[0069] Processing unit second portion 130b includes further signal
processing capability which, in combination with the signal
processing of processing unit first portion 130a, produces
processed signals, such as to control multiple controlled devices.
As depicted in FIG. 3, controlled computer 3000, first controlled
device 300a, and second controlled device 300b are controlled by
the processed signals produced by processing unit first portion
130a and processing unit second portion 130b. Similar to processing
unit first portion 130a, processing unit first portion 130b
preferably includes the system unique electronic identifier, which
can be embedded in processing unit second portion 130b at the time
of manufacture, during installation procedures, during calibration
or other configuration procedures, or at a later date.
[0070] The three controlled devices are shown permanently attached
to physical cables, with each physical cable including a removable
connection at the other end. Controlled computer 3000 is attached
to controlled computer cable 3001 which has female plug 155 at its
end. First controlled device 300a is attached to first controlled
device cable 301a which has female plug 159 at its end. Second
controlled device 300b is attached to second controlled device
cable 301b which has female plug 157 at its end. Each physical
cable can be attached and detached from processing unit second
portion 130b. Female plug 159 attaches to male receptacle 158;
female plug 157 attaches to male receptacle 156; and female plug
155 attaches to male receptacle 154.
[0071] Each of controlled computer 3000, first controlled device
300a, and second controlled device 300b preferably has embedded in
it the unique electronic identifier of the system. When any of the
physical cables are first attached, such as controlled computer
cable 3001 being attached via female plug 157 to male receptacle
156, a compatibility check is performed by the system to assure
that the unique electronic identifier embedded in controlled
computer 3000 is identical or otherwise compatible with a unique
electronic identifier embedded in any and all other discrete
components of the system such as the unique electronic identifier
embedded in processing unit second portion 130b. Similar system
compatibility checks can be performed with the attachment of first
controlled device 300a or second controlled device 300b. If
improper compatibility is determined by the system, various actions
can be taken including but not limited to: entering an alarm state,
displaying incompatibility information, transmitting
incompatibility information, deactivation of controlled device
control, limiting controlled device control and other actions.
[0072] Also depicted in FIG. 3 is information recall unit 400 which
can be used to recall and/or display the unique electronic
identifier, or a surrogate, such as a more user friendly
representation of the information, to an operator or other user of
system 100'. The information recall unit 400 of FIG. 3 communicates
with one or more discrete components of system 100' to recall the
unique electronic identifier via wireless communication. In an
alternative, also preferred embodiment, a physical cable attaches
information recall unit 400 to one or more discrete components to
recall and/or display the unique electronic identifier of that
discrete component. Information recall unit 400 may include system
access passwords to prevent unauthorized use, and may also include
a function to set or change the unique electronic identifier of one
or more discrete components of system 100'. Information recall unit
400 may have other integrated functions such as a calculator,
cellular telephone, pager or personal data assistant (PDA)
functions. Information recall unit 400 may be a PDA that has been
modified to access system 100' to recall the unique electronic
identifier of one or more components.
[0073] The information recall unit 400 of FIG. 3 includes an
integrated monitor for displaying the unique electronic identifier,
however in an alternative embodiment, the information recall unit
can cause the unique electronic identifier to be displayed on a
visualization apparatus such as the monitor of controlled computer
3000. Alternatively or additionally, the function of the
information recall unit can be integrated into one or more discrete
components of system 100'.
[0074] Numerous configurations and types of controlled devices can
be used with system 100' of FIG. 3. Numerous types of controlled
devices have been described in detail in relation to system 100 of
FIG. 1 and are applicable to system 100' of FIG. 3 as well. System
100' includes a single patient 500 which can control multiple
controlled devices such as controlled computer 3000, first
controlled device 300a, and second controlled device 300b. While
each controlled device is connected to the same discrete component,
processing unit second portion 130b, in an alternative embodiment,
the multiple controlled components can be connected to multiple
processing unit discrete components. Also, while patient 500 may be
implanted with a sensor 200 comprising a single discrete component,
sensor 200 may comprise multiple discrete components, not shown,
such as multiple electrode arrays, implanted in different parts of
the brain, or in other various locations to detect multicellular
signals. Multicellular signals from the individual sensor discrete
components may be sent to individual processing units, or may be
segregated in a single processing unit. Separate processed signals
can be created from each individual discrete component of the
sensor, and those particular signals tied to a specific controlled
device. Thus, each controlled device can be controlled by processed
signals from a different sensor discrete assembly, such as discrete
components at different locations in the brain or other parts of
the body. It should be appreciated that any combination of discrete
component multicellular signals can be used in any combination of
multiple controlled devices. Alternatively, whether the sensor is
in a single discrete component or multiple discrete components, the
processed control signals for individual controlled devices may be
based on specific multicellular signals or from specific
electrodes, such that individual device control is driven by
specific multicellular signals. Any combination of specifically
assigned signals and shared signals assigned to a controlled device
are to be considered within the scope of this application.
[0075] The system 100' of FIG. 3 may include two or more separate
calibration routines, such as a separate calibration routine for
each controlled device. Any and all discrete components of system
100' may have a unique electronic identifier embedded in it. The
processing unit of system 100' comprises processing unit first
portion 130a and processing unit second portion 130b. The
processing unit 100' may conduct adaptive processing as has been
described in relation to the system of FIG. 2. Information transfer
cables, such as the physical cables of system 100' comprising of
controlled computer cable 3001, first controlled device cable 301a,
second controlled device cable 301b, intra-processing unit cable
140, and transcutaneous connector cable 141 may include information
such as color coded information, text information, pattern
information, or other forms of visual indicators which is made
available to a user connecting one or more of the physical cables
in setting up the system, such that a pre-confirmation of system
compatibility can be performed prior to an internal system check of
compatible unique electronic identifier's being present in all
applicable discrete components. The visual or other information
included on the physical cables can be the unique electronic
identifier or a surrogate to properly match the various discrete
components of system 100'. In an alternative embodiment, one or
more physical cables are replaced with a wireless transceiver
included in the one or more discrete components. In this preferred
embodiment, compatibility information, such as text codes, bar
codes, color codes and other codes can be made available to a user
setting up the system. The compatibility information can be placed
or otherwise made viewable on or retrievable from the discrete
components which are proximally placed to support the wireless
communication.
[0076] The unique electronic identifier is a unique code used to
differentiate one system, such as the system of a single patient,
from another system, as well as differentiate all discrete
components of a system, especially detachable components, from
discrete components of a separate, potentially incompatible system.
The unique electronic identifier may be a random alphanumeric code,
or may include information including but not limited to: patient
name, other patient information, system information, implant
information, number of electrodes implanted, implant location or
locations, software revisions of one or more discrete components,
clinician name, date of implant, date of calibration, calibration
information, manufacturing codes and hospital name. In the
preferred embodiment, the unique electronic identifier is stored in
more than one discrete component such as a sensor discrete
component and a processing unit discrete component. The unique
electronic identifier may be programmable, such as one time
programmable, or allow modifications for multiple time programming,
such programming performed in the manufacturing of the particular
discrete component, or by a user at a later date. The unique
electronic identifier can be configured to be changed over time,
such as after a calibration procedure. The unique electronic
identifier can be permanent or semi-permanent, or hard wired, such
as a hard wired configuration in a transcutaneous connector of the
system. The unique electronic identifier can be used in wireless
communications between discrete components, or in wireless
communications between one or more discrete components and a device
outside of the system.
[0077] The unique electronic identifier can represent or be linked
to system status. System status can include but not be limited to:
output signal characteristics, level of accuracy of output signal,
output signal requirements, level of control needed, patient login
settings, such as customized computer configuration information,
one or more software revisions, one or more hardware revisions,
controlled device compatibility list, patient permissions lists and
calibration status.
[0078] The system 100' may include a library of various system
data, such as data stored in electronic memory, the data being
electronically linked with the unique electronic identifier. The
library data may be stored in memory of one or more discrete
components, such as processing unit second portion 130b.
Alternatively or additionally, the library data may be stored in a
computer based network platform, separate from system 100' such as
a local area network (LAN), a wide area network (WAN) or the
Internet. The library data can contain numerous categories of
information related to the system including but not limited to:
patient information such as patient name and disease state;
discrete component information such as type of sensor and electrode
configuration; system configuration information such as calibration
dates, calibration output parameters, calibration input parameters,
patient training data, signal processing methods, algorithms and
associated variables, controlled device information such as
controlled device use parameters and lists of controlled devices
configured for use with or otherwise compatible with the system;
and other system parameters useful in using, configuring, assuring
safe and efficacious performance of and improving the system.
[0079] Referring now to FIG. 4, a neural interface system 100" is
shown comprising of implanted components and components external to
the bodies of a first patient 500a and a second patient 500b.
System 100" is a system for collecting multicellular signals from
multiple patients to transmit a processed signal to one or more
controlled devices. Sensors, comprising one or more discrete
components, each containing one or more electrodes, detect
multicellular signals from each patient. Signal processing means
having one or more discrete components, are provided for processing
the received multicellular signals from each patient, to produce
processed signals and transmit the processed signals to the
controlled device.
[0080] System 100" includes a single controlled device 300, such as
a computer, a prosthetic limb, a robot, or any electronically
controllable device. Numerous types of controlled devices have been
described in detail in relation to system 100 of FIG. 1 and are
applicable to system 100" as well. Each controlled device may
comprise one or more discrete components. While a single controlled
device is shown, it should be appreciated that multiple patients,
such as first patient 500a and second patient 500b, can jointly
control supplementary devices in addition to controlled device 300.
Thus, in some exemplary embodiments, multiple patients may jointly
control multiple controlled devices.
[0081] First patient 500a may be implanted in his or her brain with
first sensor 200' that includes a plurality of electrodes and
comprises one or more discrete components. Sensor 200' is attached
to processing unit first portion 130a' via a physical cable, such
as first connecting cable 161', which includes individual
conductors for each electrode of sensor 200'. Processing unit first
portion 130a' communicates with processing unit second portion
130b' via wireless communication means, such as first
transcutaneous communication means 160', such that no implanted
component passes through the skin of patient 500a. Processing unit
first portion 130a' and processing unit second portion 130b' are
shown as two individual discrete components, however it should be
appreciated that either a single discrete component or more than
two discrete components could be utilized to perform the functions
of processing unit first portion 130a' and processing unit
130b'.
[0082] Similar to first patient 500a, second patient 500b may be
implanted in his or her brain with second sensor 200" that includes
a plurality of electrodes and comprises of one or more discrete
components. Sensor 200" is attached to processing unit first
portion 130a" via a physical cable, such as first connecting cable
161", which includes individual conductors for each electrode of
sensor 200". Processing unit first portion 130a" communicates with
processing unit second portion 130b" via wireless communication
means, such as first transcutaneous communication means 160", such
that no implanted component passes through the skin of patient
500b. Processing unit first portion 130a" and processing unit
second portion 130b" are shown as two individual discrete
components, however it should be appreciated that either a single
discrete component or more than two discrete components could be
utilized to perform the functions of processing unit first portion
130a" and processing unit 130b".
[0083] It should be noted that the particular design or makeup of
each corresponding component of first patient 500a and second
patient 500b may be exactly the same, similar or quite different.
For example, processing unit first portion 130a' may include
different signal processing algorithms than processing unit first
portion 130a". Also, processing unit second portion 130b' may
include an integrated user interface including display, keyboard
and mouse, while processing unit second portion 130b" may not.
[0084] Controlled device 300 is a computer, prosthetic limb, robot
or other controllable device as have been described throughout this
application, and is connected to both processing unit second
portion 130b' and processing unit second portion 130b" via first
patient controlled device cable 302a and second patient controlled
device cable 302b, respectively. First patient controlled device
cable 302a is shown permanently attached at one end to processing
unit second portion 130b' and includes at its other end a
detachable connector, female plug 307. Female plug 307 attaches to
controlled device 300 at an input port, male receptacle 306.
Similarly, second patient controlled device cable 302b is shown
permanently attached at one end to processing unit second portion
130b" and includes at its other end a detachable connector, female
plug 305. Female plug 305 attaches to controlled device 300 at a
second input port, male receptacle 304.
[0085] System 100" provides two control signals to controlled
device 300. A first signal is created by detection of multicellular
signals from first patient 500a via sensor 200' with signal
processing conducted by processing unit first portion 130a' and
processing unit second portion 130b'. A second control signal is
created by detection of multicellular signals from second patient
500b via sensor 200" with signal processing conducted by processing
unit first portion 130a" and processing unit second portion 130b".
Controlled device 300 is configured to be controlled by two
separate control signals. In an alternative, preferred embodiment,
processing unit second portion 130b' and processing unit second
portion 130b" are combined, such as in a single discrete component,
creating a single control signal which is transmitted to a
controlled device which is controlled with a single control
signal.
[0086] Any and all of the discrete components of system 100" may
have embedded in them a unique electronic identifier. Embedding can
take the form of a hard wired or masked identifier. Alternatively
or additionally, identifiers may be stored in electronic or other
multiple time readable memory. Various system checks can be
performed to determine that each discrete component has the same or
at least a compatible unique electronic identifier. System
compatibility checks can be performed on a routine, predetermined
or cyclic basis, or can be triggered by a specific event such as
the connection of an attachable physical cable.
[0087] Numerous methods are provided in various exemplary
embodiments of the invention. An exemplary method may include a
step 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 system may comprise: a sensor for detecting the
multicellular signals, the sensor comprising a plurality of
electrodes to allow for chronic detection of the multicellular
signals; a processing unit for receiving the multicellular signals
from the sensor, for processing the multicellular signals to
produce processed signals, and for transmitting 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 and a first discrete component transmits electronic
information to a second discrete component. The system may further
comprise a unique electronic identifier which is embedded in two or
more of the discrete components; wherein the unique electronic
identifier in said first discrete component is compared to the
unique electronic identifier in said second discrete component.
[0088] The system 100" of FIG. 4 may include two or more separate
calibration routines, such as a separate calibration routine for
each patient. Any and all discrete components of system 100" may
have a unique electronic identifier embedded in it. In a preferred
embodiment, the processing units of system 100", comprising
processing unit first portion 130a', processing unit second portion
130b', processing unit first portion 130a", processing unit second
portion 130b", collectively or singularly conduct adaptive
processing as has been described in relation to the system of FIG.
2. Information transfer cables, such as the physical cables of
system 100" comprising first patient controlled device cable 302a
and second patient controlled device cable 302b may include
information such as color coded information, text information,
pattern information or other forms of visual or other indicators
which is made available to a user connecting one or more of the
physical cables in setting up the system, such that a
pre-confirmation of system compatibility can be performed prior to
an internal system check of compatible unique electronic
identifier's being present in all applicable discrete components.
The information included on the physical cables can be the unique
electronic identifier or a surrogate to properly match the various
discrete components of system 100". In an alternative embodiment,
one or more physical cables are replaced with a wireless
transceiver included in the one or more discrete components. In
this preferred embodiment, compatibility information, such as text
codes, bar codes, color codes and other codes can be made available
to a user setting up the system. The compatibility information can
be placed or otherwise made viewable on or retrievable from the
discrete components which are proximally placed to support the
wireless communication. In another preferred embodiment, wireless
communication links, such as first transcutaneous communication
means 160' and second transcutaneous communication means 160" are
replaced with physical cables, such as physical cables including
integrated compatibility information as is described hereabove.
[0089] The unique electronic identifier is a unique code used to
differentiate one system, such as a system of a multiple patients,
from another system, as well as to differentiate all discrete
components of a system, especially detachable components, from
discrete components of a separate, potentially incompatible system.
The unique electronic identifier may be a random alphanumeric code,
or may include information including but not limited to: patient
name, other patient information, system information, implant
information, number of electrodes implanted, implant location or
locations, software revisions of one or more discrete components,
clinician name, date of implant, date of calibration, calibration
information, manufacturing codes and hospital name. In the
preferred embodiment, the unique electronic identifier is stored in
more than one discrete component such as a sensor discrete
component and a processing unit discrete component. The unique
electronic identifier may be programmable, such as one time
programmable, or allow modifications for multiple time programming,
such programming performed in the manufacturing of the particular
discrete component, or by a user at a later date. The unique
electronic identifier can be configured to be changed over time,
such as after a calibration procedure. The unique electronic
identifier can be permanent or semi-permanent, or hard wired, such
as a hard wired configuration in a transcutaneous connector of the
system. The unique electronic identifier can be used in wireless
communications between discrete components, or in wireless
communications between one or more discrete components and a device
outside of the system.
[0090] The unique electronic identifier can represent or be linked
to system status. System status can include but not be limited to
output signal characteristics, level of accuracy of output signal,
output signal requirements, level of control needed, patient login
settings, such as customized computer configuration information,
one or more software revisions, one or more hardware revisions,
controlled device compatibility list, patient permissions lists and
calibration status.
[0091] The system of claim 100" may include a library of various
system data, such as data stored in electronic memory, the data
being electronically linked with the unique electronic identifier.
The library data may be stored in memory of one or more discrete
components, such as processing unit second portion 130b' or
processing unit second portion 130b". Alternatively or
additionally, the library data may be stored in a computer based
network platform, separate from system 100" such as a local area
network (LAN), a wide area network (WAN), or the Internet. The
library data can contain numerous categories of information related
to the system including but not limited to: patient information
such as patient name and disease state; discrete component
information such as type of sensor and electrode configuration;
system configuration information such as calibration dates,
calibration output parameters, calibration input parameters,
patient training data, signal processing methods, algorithms and
associated variables, controlled device information such as
controlled device use parameters and lists of controlled devices
configured for use with or otherwise compatible with the system;
and other system parameters useful in using, configuring, assuring
safe and efficacious performance of and improving the system.
[0092] It should be understood that numerous other configurations
of the systems, devices, and methods described herein can be
employed without departing from the spirit or scope of this
application. It should be understood that the system includes
multiple functional components, such as a sensor for detecting
multicellular signals, a processing unit for processing the
multicellular signals, and the controlled device which is
controlled by the processed signals. Different from the logical
components are physical or discrete components, which may include a
portion of a logical component, an entire logical component and
combinations of portions of logical components and entire logical
components. These discrete components may communicate or transfer
information to or from each other, or communicate with devices
outside the system. In each system, physical wires, such as
electrical wires or optical fibers, can be used to transfer
information between discrete components, or wireless communication
means can be utilized. Each physical cable can be permanently
attached to a discrete component, or can include attachment means
to allow attachment and potentially allow, but not necessarily
permit, detachment. Physical cables can be permanently attached at
one end, and include attachment means at the other.
[0093] The sensors of the systems of this application can take
various forms, including multiple discrete component forms, such as
multiple penetrating arrays which can be placed at different
locations within the body of a patient. The processing units of the
systems of this application can also be contained in a single
discrete component or multiple discrete components, such as a
system with one portion of the processing unit implanted in the
patient, and a separate portion of the processing unit external to
the body of the patient. Processing units may include various
signal conditioning elements such as amplifiers, filters and signal
multiplexing circuitry. In a preferred embodiment, an integrated
spike sorting function is included. Processing units perform
various signal processing functions including but not limited to:
amplification, filtering, sorting, conditioning, translating,
interpreting, encoding, decoding, combining, extracting,
mathematically transforming and/or otherwise processing
multicellular signals to generate a control signal for transmission
to a controlled device. Numerous algorithms, mathematical and
software techniques can be utilized by the processing unit to
create the desired control signal. The processing unit may utilize
neural net software routines to map neural signals into desired
device control signals. Individual neural signals may be assigned
to a specific use in the system. The specific use may be determined
by having the patient attempt an imagined movement or other
imagined state. For most applications, it is preferred that that
the neural signals be under the voluntary control of the patient.
The processing unit may mathematically combine various neural
signals to create a processed signal for device control.
[0094] One or more discrete components of the systems of this
application include a unique, readable identifier, termed a unique
electronic identifier. The unique electronic identifier can be
hardwired into the component, such as creating a pattern of
conductors which are shorted or open circuits, a pattern of
measurable impedances or voltages, or other permanent or
semi-permanent, retrievable codes of information that can represent
a serial number or other unique ID. Alternatively, the unique
electronic identifier can be stored in a memory storage device such
as electronic memory such as read only memory (ROM) or random
access memory (RAM). The systems of this application can have
various system checks for discrete component compatibility that can
run routinely, such as on a predetermined cycle, or can be
triggered by an event such as the attachment of a physical cable,
or in the receiving of a wireless transmission. For wireless
communication, the unique electronic identifier can be included in
one or more handshaking protocols, well known to those of skill in
the art, to confirm discrete component compatibility. In a
preferred embodiment of each system, the system can automatically
determine when a physical cable is attached, and a system
compatibility check can be triggered.
[0095] In the event that a compatibility check is completed
successfully, normal function of the system will commence or remain
active. In the event that an incompatibility is determined, or the
compatibility check otherwise fails, numerous actions can take
place including but not limited to: system enters an alarm or
warning state, control of controlled device is blocked, control of
controlled device is partially limited and any combination of the
previous. In another preferred embodiment, the cause of the
incompatibility is made available to a user.
[0096] Each of the systems of this application may include various
display means to display unique electronic identifier information.
Each system may include an integrated alarm, or include means of
activating a separate alarm system. Alarms may include one or more
of audio transducers, visual elements, olfactory elements and
tactile transducers. Each of the systems of this application may
include integrated memory storage elements, in one or more discrete
components, to store the unique electronic identifier as well as
other information. Each of the systems of this application may be
configured to allow remote access, such as for configuration
purposes, including access via wireless means, phone lines and the
internet. In remote access applications, confirmation of specific
system ID, through the use of the unique electronic identifier, may
prevent inadvertent configuration or other changes to a
misidentified system.
[0097] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *