OPTIMIZATION OF CRANIAL NERVE STIMULATION TO TREAT SEIZURE DISORDERS DURING SLEEP

• US 20140277255A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: SABESAN, Shivkumar
• Granted Patent: US 9,056,195 B2
• Time in Patent Office: Days
• US Class Current: 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:

determining, at a computing device, sleep cycle information related to a sleep cycle of a patient based on body parameter data; and

adjusting, at the computing device, a cranial nerve stimulation parameter based on the sleep cycle information.

2. 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.

3. The method of claim 1, further comprising evaluating the sleep cycle information to determine a particular sleep stage of the patient, a sleep stage transition, an amount of time the patient spends in one or more sleep stages during a particular sleep cycle, an amount of time the patient spends in one or more sleep stages during a sleep period that includes multiple sleep cycles, or a combination thereof.

4. The method of claim 1, further comprising:

collecting the body parameter data from a sensor that is attached to the patient; and

determining cranial nerve stimulation parameter adjustment data based on the sleep cycle information, wherein adjusting the cranial nerve stimulation parameter based on the sleep cycle information includes adjusting the cranial nerve stimulation parameter based on the cranial nerve stimulation parameter adjustment data.

5. The method of claim 1, wherein the cranial nerve stimulation parameter is adjusted when the sleep cycle information indicates:

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 is in the light sleep stage;

the patient has been in the light sleep stage for a predetermined amount of time;

or a combination thereof.

6. The method of claim 5, further comprising stimulating a cranial nerve with the adjusted cranial nerve stimulation parameter to drive the patient toward a deep sleep stage.

7. The method of claim 1, wherein, when the sleep cycle information indicates a transition from stage two sleep toward wakefulness, the cranial nerve stimulation parameter is adjusted to increase synchrony of a brain of the patient.

8. The method of claim 1, wherein, when the sleep cycle information indicates time in REM stage sleep during a sleep period that includes multiple sleep cycles is less than a threshold, the cranial nerve stimulation parameter is adjusted to apply stimulation that drives the patient toward the REM stage sleep.

9. The method of claim 1, wherein, when the sleep cycle information indicates time in stage three sleep during a sleep period that includes multiple sleep cycles is less than a threshold, the cranial nerve stimulation parameter is adjusted to apply stimulation that drives the patient toward the stage three sleep.

10. 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 adjusted cranial nerve stimulation parameter such that synchrony of a brain of the patient substantially conforms to a synchrony profile.

11. The method of claim 1, wherein the cranial nerve stimulation parameter includes 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 on-time, a cranial nerve stimulation off-time, or a combination thereof.

12. A device comprising:

a processor configured to;

determine sleep cycle information related to a sleep cycle of a patient based on body parameter data; and

adjust a cranial nerve stimulation parameter based on the sleep cycle information;

a memory coupled to the processor; and

a therapy delivery unit configured to apply cranial nerve stimulation based on the sleep cycle information.

13. The device of claim 12, wherein the processor is further configured to:

determine cranial nerve stimulation parameter adjustment data based on the sleep cycle information; and

adjust the cranial nerve stimulation parameter further based on the cranial nerve stimulation parameter adjustment data.

14. The device of claim 12, wherein the processor is further configured to evaluate the sleep cycle information to determine a particular sleep stage of the patient, a sleep stage transition, an amount of time the patient spends in one or more sleep stages during a particular sleep cycle, an amount of time the patient spends in one or more sleep stages during a sleep period that includes multiple sleep cycles, or a combination thereof.

15. The device of claim 12, wherein the processor is further configured to:

determine information regarding efficacy of a cranial nerve stimulation therapy based on a comparison of the sleep cycle information to sleep cycle information of the patient prior to receiving the cranial nerve stimulation therapy; and

communicate the information regarding the efficacy of the cranial nerve stimulation therapy to a health care provider, the patient, or a combination thereof.

16. The device of claim 15, wherein the processor is further configured to adjust the cranial nerve stimulation parameter further based on the information regarding the efficacy of the cranial nerve stimulation therapy.

17. The device of claim 12, further comprising a sensor data gathering unit configured to receive the body parameter data from a sensor that is attached to the patient.

18. The device of claim 12, wherein, when the sleep cycle information indicates time in stage three sleep during a sleep period that included multiple sleep cycles is less than a threshold, the cranial nerve stimulation parameter is adjusted to apply stimulation that drives the patient toward the stage three sleep.

19. The device of claim 12, wherein the therapy delivery unit is further configured to apply the cranial nerve stimulation such that synchrony of a brain of the patient substantially conforms to a synchrony profile.

20. A non-transitory computer-readable medium comprising instructions executable by a processor to:

determine sleep cycle information related to a sleep cycle of a patient based on body parameter data; and

adjust a cranial nerve stimulation parameter based on the sleep cycle information.