Pulse generator for cranial nerve stimulation

• US 9,364,674 B2
• Filed: 11/30/2011
• Issued: 06/14/2016
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: NeuroSigma, Inc., Regents of the University of California (University of California)
• Original Assignee: Christopher M. Degiorgio
• Inventors: Cook, Ian A., DeGiorgio, Christopher M., Ekchian, Leon, Miller, Patrick, Kealey, Colin
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Carey, Michael
• Application Number:
  US13/990,348
• Publication Number:
  US 20140081353A1
• Time in Patent Office: 1,658 Days
• Field of Search: 607/45, 607/59, 607/60
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing

Abstract

A system for trigeminal nerve stimulation includes a storage medium, a pulse generator in communication with the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.

Claims

1. A system for trigeminal nerve stimulation comprising:

a storage medium;

a pulse generator comprising;

a user control configured to receive a user adjustment; and

a microcontroller coupled to the storage medium and executing instructions from the storage medium, the microcontroller configured to;

receive electric stimulation parameters comprising at least one user-set parameter and at least one physician-set parameter, the at least one user-set parameter comprising a current amplitude responsive to the user adjustment of the user control, and the at least one physician-set parameter comprising an upper bound and a lower bound for the current amplitude;

operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during treatment sessions; and

record a log of use for monitoring a patient'"'"'s adherence to a treatment plan;

a power source; and

an electrode assembly communicatively coupled to the pulse generator.

2. The system of claim 1, further comprising a power supply or charging station.

3. The system of claim 1, wherein the power source is a battery electrically coupled to the pulse generator.

4. The system of claim 1, wherein said electrode assembly is wirelessly coupled to the pulse generator.

5. The system of claim 1 wherein said electrode assembly is coupled to the pulse generator via a connector or lead wire.

6. The system of claim 1, wherein the electrode assembly is a two-contact electrode.

7. The system of claim 1, wherein the electrode assembly is a four-contact electrode.

8. The system of claim 1, wherein the log includes a duration of the treatment sessions, a start time for each of the treatment sessions, an end time for each of the treatment sessions, a setting for the at least one user-set parameter for each of the treatment sessions, and an impedance for each of the treatment sessions.

12. The system of claim 1, wherein the microcontroller is configured to detect a model of the electrode assembly.

13. The system of claim 12, wherein the microcontroller is configured to detect the model of the electrode assembly by downloading a serial number of the electrode assembly.

14. The system of claim 1, wherein the pulse generator is configured to set a used bit on the electrode assembly at the end of each of the treatment sessions.

9. A method for operating a pulse generator having a processing device for stimulating at least one trigeminal nerve branch using the pulse generator, the method comprising:

receiving, by the processing device, electric stimulation parameters comprising at least one user-set parameter and at least one physician-set parameter, the at least one user-set parameter comprising a current amplitude responsive to a user adjusting a user control, and the at least one physician-set parameter comprising an upper bound and a lower bound for the current amplitude;

producing, by the pulse generator, electrical pulses according to electric stimulation parameters during treatment sessions; and

recording, by the processing device, a log of use of for monitoring a patient'"'"'s adherence to a treatment plan.

10. The method of claim 9, wherein the electric stimulation parameters comprise a frequency of 1-300 Hz, pulse duration of 50-500 microseconds, and a duty cycle of 1-100%.

11. The method of claim 9, wherein the log includes a duration of the treatment sessions, a start time for each of the treatment sessions, an end time for each of the treatment sessions, a setting for the at least one user-set parameter for each of the treatment sessions, and an impedance for each of the treatment sessions.

15. The method of claim 9, further comprising detecting a model of an electrode assembly.

16. The method of claim 15, wherein the detecting comprises downloading a serial number of the electrode assembly.

17. The method of claim 9, further comprising setting a used bit on an electrode assembly at the end of each of the treatment sessions.