# US 6,459,936 B2 · Methods for responsively treating neurological disorders

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- Number: US 6,459,936 B2
- Document ID: US6459936B2
- Status: Granted
- Kind: B2
- Application number: 09/932,175
- Filed: 2001-08-17
- Published: 2001-12-27
- Granted: 2002-10-01
- Earliest claimed: 1997-10-27
- Assignees: NeuroPace, Inc.
- Inventors: Robert E. Fischell; David R. Fischell; Adrian R. M. Upton
- Web page: https://patentgrep.com/patent/US6459936B2

## CPC

- A61N 1/36135: {using physiological parameters}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36064: {Epilepsy}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36075: {Headache or migraine}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Disclosed is a multiple electrode, closed-loop, responsive system for the treatment of certain neurological diseases such as epilepsy, migraine headaches and Parkinson's disease. Brain electrodes would be placed in close proximity to the brain or deep within brain tissue. When a neurological event such as the onset of an epileptic seizure occurs, EEG signals from the electrodes are processed by signal conditioning means in a control module that can be placed beneath the patient's scalp, within the patient's chest, or situated externally on the patient. Neurological event detection means in the control module will then cause a response to be generated for stopping the neurological event. The response could be an electrical signal to brain electrodes or to electrodes located remotely in the patient's body. The response could also be the release of medication or the application of a sensory input such as sound, light or mechanical vibration or electrical stimulation of the skin. The response to the neurological event can originate from devices either internal or external to the patient. The system also has the capability for multi-channel recording of EEG related signals that occur both before and after the detection of a neurological event. Programmability of many different operating parameters of the system by means of external equipment provides adaptability for treating patients who manifest different symptoms and who respond differently to the response generated by the system.

## Claims

### Claim 1

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
detecting a neurological event in the EEG signal; and
initiating an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient and includes applying electrical brain stimulation.

### Claim 2 (depends on 1)

The method for providing responsive therapy of claim 1, further comprising the step of processing the EEG signal with an electronic circuit in the implanted control module.

### Claim 3 (depends on 2)

The method for providing responsive therapy of claim 2, wherein the electronic circuit comprises an event detection subsystem.

### Claim 4 (depends on 1)

The method for providing responsive therapy of claim 1, further comprising the step of converting the EEG signal into a digital data stream.

### Claim 5 (depends on 4)

The method for providing responsive therapy of claim 4, wherein the digital data stream is representative of the EEG signal.

### Claim 6 (depends on 4)

The method for providing responsive therapy of claim 4, further comprising the step of processing the digital data stream.

### Claim 7 (depends on 1)

The method for providing responsive therapy of claim 1, wherein the step of applying electrical brain stimulation comprises delivering an electrical stimulation signal to a location in a brain of the patient.

### Claim 8 (depends on 7)

The method for providing responsive therapy of claim 7, wherein the step of delivering an electrical stimulation signal comprises the steps of:
generating the electrical stimulation signal; and
transmitting the electrical stimulation signal to a stimulation electrode via a lead.

### Claim 9 (depends on 8)

The method for providing responsive therapy of claim 8, wherein the stimulation electrode is implanted in the brain of the patient.

### Claim 10 (depends on 7)

The method for providing responsive therapy of claim 7, wherein the electrical stimulation signal includes a pulse.

### Claim 11

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
converting the EEG signal into a digital data stream;
detecting a neurological event in the digital data stream; and
performing an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient;
wherein the digital data stream is representative of an energy spectrum of the EEG signal.

### Claim 12

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
converting the EEG signal into a digital data stream;
processing the digital data stream;
detecting a neurological event in the digital data stream; and
performing an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient;
wherein the step of processing the digital data stream employs a digital signal processor.

### Claim 13

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
converting the EEG signal into a digital data stream;
detecting a neurological event in the digital data stream; and
performing an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient;
wherein the step of detecting a neurological event comprises performing a detection algorithm on the digital data stream.

### Claim 14 (depends on 13)

The method for providing responsive therapy of claim 13, wherein the step of performing the detection algorithm comprises the steps of:
extracting a characteristic from the digital data stream;
comparing the characteristic of the digital data stream to a threshold; and
if the characteristic exceeds the threshold, indicating that a neurological event has been detected.

### Claim 15 (depends on 14)

The method for providing responsive therapy of claim 14, wherein the characteristic comprises an energy of the EEG signal in a frequency band.

### Claim 16 (depends on 14)

The method for providing responsive therapy of claim 14, wherein the characteristic comprises a signal amplitude.

### Claim 17 (depends on 14)

The method for providing responsive therapy of claim 14, wherein the characteristic comprises a signal event density within a time period.

### Claim 18

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
detecting a neurological event in the EEG signal; and
performing an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient;
wherein the step of performing an action comprises delivering an electrical stimulation signal to a brain of the patient including a pulse; and
wherein the pulse is biphasic.

### Claim 19

A method for providing responsive therapy to a patient with epilepsy, comprising the steps of:
receiving an EEG signal with an implanted control module;
detecting a neurological event in the EEG signal; and
performing an action in response to the detected neurological event; wherein the action provides a therapeutic effect to the patient;
wherein the step of performing an action comprises actuating a buzzer to cause an acoustic signal to be perceived by the patient.
