Optimization of cranial nerve stimulation to treat seizure disorders during sleep

• US 9,700,723 B2
• Filed: 05/13/2015
• Issued: 07/11/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Sabesan, Shivkumar
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/711,190
• Publication Number:
  US 20150238761A1
• Time in Patent Office: 790 Days
• Field of Search: 607 45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A method includes determining sleep cycle information related to a sleep cycle of a patient based on body parameter data. The method also includes adjusting a cranial nerve stimulation parameter based on the sleep cycle information.

Claims

1. A method comprising:

receiving, at a computing device, body parameter data of a patient;

determining that the patient is in a lighter sleep cycle stage based on the body parameter data;

detecting, while the patient is in the lighter sleep cycle stage, a presence of an epileptic event by analyzing the body parameter data using a first set of seizure detection parameters based on the lighter sleep cycle stage;

initiating application of a first cranial nerve stimulation to the patient based on a first value of a cranial nerve stimulation parameter to drive the patient from the lighter sleep cycle stage to a deeper sleep cycle stage in response to detecting the presence of the epileptic event;

after initiating application of the first cranial nerve stimulation to the patient, determining whether the patient has progressed to the deeper sleep cycle stage or remains in the lighter sleep cycle stage;

in response to determining the patient remains in the lighter sleep cycle stage, initiating application of a second cranial nerve stimulation to the patient based on a second value of the cranial nerve stimulation parameter to drive the patient from the lighter sleep cycle stage to the deeper sleep cycle stage;

in response to detecting the patient is in the deeper sleep cycle stage, modifying the first set of seizure detection parameters to a second set of seizure detection parameters based on the deeper sleep cycle stage and detecting whether the epileptic event is present using the second set of seizure detection parameters.

2. The method of claim 1, wherein determining that the patient is in the lighter sleep cycle stage is further based on at least one of:

detection of a sleep stage transition;

a first amount of time the patient spends in one or more stages during the lighter sleep cycle stage;

or a second amount of time the patient spends in one or more stages during a sleep period that includes multiple sleep cycles.

3. The method of claim 1, wherein the body parameter data is received from a sensor that is attached to the patient.

4. The method of claim 1, further comprising adjusting the first value to the second value based on a first transition from a light sleep stage to an awake state;

a second transition from stage 1 sleep to stage 2 sleep;

the patient being in the light sleep stage;

the patient being in the light sleep stage for a particular amount of time;

or a combination thereof.

5. The method of claim 1, wherein the event indicates a transition from stage two sleep toward wakefulness.

6. The method of claim 1, wherein the event indicates time in a REM sleep stage that is less than a threshold and the next sleep cycle stage corresponds to the REM sleep stage.

7. The method of claim 1, wherein the body parameter data comprises electroencephalography (EEG) data, electrooculography (EOG) data, electromyography (EMG) data, electrocardiography (ECG) data, accelerometer data, or a combination thereof.

8. The method of claim 1, wherein the body parameter data is received from a sensor that is attached to the patient.

9. The method of claim 1, further comprising applying stimulation signals to a vagus nerve or a trigeminal nerve of the patient via a therapy delivery unit based on the second value of the cranial nerve stimulation parameter.

10. The method of claim 1, wherein the cranial nerve stimulation parameter indicates a pulse width, an output current, a cranial nerve stimulation frequency, a cranial nerve stimulation duty cycle, a particular nerve or nerves stimulated, a cranial nerve stimulation frequency sweep, a cranial nerve stimulation ontime, a cranial nerve stimulation off-time, or a combination thereof.

11. The method of claim 1 wherein application of the first cranial nerve stimulation comprises applying a first electrical signal to a cranial nerve of the patient to treat a medical condition, and wherein the first electrical signal is based on the first value, the first value comprising at least one of a current amplitude, a pulse width, a frequency, a cranial nerve stimulation ON time, or a cranial nerve stimulation OFF time.

12. The method of claim 11, further comprising adjusting the first value to the second value, wherein the second cranial nerve stimulation to the patient comprises a second electrical signal, and wherein the second electrical signal is based on the second value.

13. The method of claim 1, wherein the lighter sleep cycle stage is a light sleep stage, and wherein the second value is selected to drive the patient from the light sleep stage to a deep sleep stage.

14. The method of claim 1, wherein the lighter sleep cycle stage is selected from stage one sleep, stage 2 sleep, and stage 3 sleep.

15. The method of claim 1, wherein the second value is selected based at least in part on the lighter sleep cycle stage.