Surgery – Diagnostic testing – Detecting brain electric signal
Reexamination Certificate
1999-08-13
2001-05-08
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Detecting brain electric signal
Reexamination Certificate
active
06230049
ABSTRACT:
FIELD OF USE
This invention is in the field of devices for the treatment of neurological disorders in human subjects, particularly those disorders that originate in the brain.
BACKGROUND OF THE INVENTION
It is well known that, in certain patients, epileptic seizures consistently originate from a single location within the brain. When a primary epileptogenic region or seizure focus is suspected some form of monitoring by implanted electrodes may be performed during which time the electrodes are connected to recording instruments such as an electroencephalograph (EEG) machine. Additionally, in some patients, intracranial electrical stimulation using implanted electrodes is performed to map regional brain function as a precursor to surgical removal of the epileptogenic region. Current apparatus for performing such a mapping procedure requires the patient be connected to both an EEG monitoring system and a separate electrical stimulator. In addition, these systems are connected to the patient via a cumbersome multi-wire cable. Current systems also require manual connection of the electrical stimulation systems to specific electrodes (i.e. clip leads are moved on a connector box by the operator).
Having separate monitoring and stimulation systems, requires two sets of controls and complicates operation as compared to an integrated monitoring and stimulation system with a single control console.
Multi-wire cables are a source of unwanted electrical noise and place constraints on patient movement. It is highly desirable to have the EEG monitoring and stimulation system be remotely controllable from the EEG monitoring system console without direct wire connection to the patient.
SUMMARY OF THE INVENTION
The disclosed invention is an integrated system for EEG monitoring and electrical stimulation from a multiplicity of scalp or intracranial implanted electrodes. The system integrates EEG monitoring and brain stimulation, supports remote electrode selection for stimulation and provides a wireless connection between the patient's brain electrodes and the EEG analysis workstation used to collect EEG data, analyze EEG signals and control system functionality.
The EEG monitoring and electrical stimulation system comprises the EEG analysis workstation, a patient electronics module wired to a multiplicity of electrodes, and a wireless data link between the EEG analysis workstation and the patient electronics module. The patient electronics module includes multi-channel low noise amplifiers, analog-to-digital (A to D) converters and a programmable electrical stimulator with selectable output electrodes.
The EEG analysis workstation has the capability to process, store, retrieve and display patient EEG data. The EEG analysis workstation also has the capability to program and control the electrical stimulator in the patient electronics module. It is also envisioned that high, low and band pass filters are part of the amplifier system in the patient electronics module and that they are programmable from commands sent by the EEG analysis workstation via the wireless data link to the patient electronics module.
To use the integrated EEG analysis and stimulation system for a standard EEG monitoring and brain mapping procedure, a neurosurgeon would first implant a multiplicity of brain electrodes under the patient's scalp. Brain electrodes can include an array of surface electrodes placed above the surface of the patient's brain and/or a multiplicity of depth electrodes implanted deep into the patient's brain. Intracerebral depth electrodes, which are often line arrays of electrodes, are useful for recording from or stimulating deep cerebral structures such as the amygdala, hippocampus, cingulate and orbital-frontal regions which deep cerebral structures are characteristically involved in many medically refractory partial epilepsies. Brain electrodes can also include electrodes placed elsewhere under the patient's scalp near or within the brain.
The patient electronics module is then attached to the brain electrodes and turned on. The EEG analysis workstation is then activated and the system's wireless link is checked. If all is working, the system is ready to collect EEG data from the patient's brain electrodes. After collecting and displaying the EEG data using the EEG analysis workstation, the physician can then map the function of the brain tissue near each of the brain electrodes by electrical stimulation of a specific subset of electrodes; the specific subset of electrodes being selectable from the EEG analysis workstation.
In another application, the integrated EEG analysis and stimulation system can be used to test the efficacy of responsive stimulation for the control of epileptogenic activity (i.e., to abort an epileptic seizure). In this case, there is an additional step of activating the stimulator in the patient electronics module when a seizure or seizure-like discharges are detected by the EEG analysis system. For this purpose, programmable detection algorithms for detecting specific types of epileptiform activity would be an essential part of the EEG analysis workstation software. The integrated EEG monitoring and electrical stimulation system would be programmed to determine specific therapeutic stimulation parameters during an evaluation procedure prior to the implantation of an electrical stimulation therapy device (a neuropacemaker). Such an evaluation procedure would be especially useful for determining the seizure detection and stimulation parameters for a closed-loop neuropacemaker that is responsive to the onset of epileptic seizures. A neuropacemaker such as this is described in U.S. patent application Ser. No. 8/957,869 by Fischell et al.
Thus it is an object of the present invention to have an integrated EEG monitoring and electrical stimulation system that has a wireless link between a patient electronics module and an EEG analysis workstation.
Another object of the present invention is to have an integrated EEG monitoring and electrical stimulation system that allows choice of electrodes for stimulation from the EEG monitoring system console.
Still another object of the present invention is to have an integrated patient electronics module, which contains both multi-channel EEG amplification means and electrical stimulation means.
Yet another object of the present invention is to have an EEG analysis workstation capable of automated detection of epileptiform activity using EEG signals received from a patient electronics module by means of a wireless data link.
Yet another object of the present invention is to have an EEG monitoring system with a wireless link to a patient electronics module attached to brain electrodes.
Yet another object of the present invention is to have an EEG analysis workstation capable of (1) automated detection of epileptiform activity, and (2) responsive stimulation to attempt to control or abort the epileptiform activity; the epileptiform signals being received and the stimulation being applied from a remote patient electronics module using a wireless link.
These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading of the detailed description of this invention including the associated drawings as presented herein.
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Fischell David R.
Fischell Robert E.
Nasser Robert L.
Neuro Pace, Inc.
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