Pulse generator for cranial nerve stimulation

• US 10,016,601 B2
• Filed: 05/20/2016
• Issued: 07/10/2018
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: NeuroSigma, Inc., Regents of the University of California (University of California)
• Inventors: Cook, Ian A., DeGiorgio, Christopher M., Ekchian, Leon, Miller, Patrick, Kealey, Colin
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US15/160,480
• Publication Number:
  US 20160339242A1
• Time in Patent Office: 781 Days
• Field of Search: 607 45, 607 59, 607 60
• 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 pulse generator, which includes a user control configured to receive a user adjustment and a microcontroller configured to receive electric stimulation parameters and operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session. A method for nerve stimulation includes receiving, by a pulse generator, electric stimulation parameters, and producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session. The electric stimulation parameters include at least one user-set parameter, which includes a current amplitude that is responsive to the user adjustment of the user control, and at least one physician-set parameter, which includes an upper bound and a lower bound for the current amplitude.

Claims

1. A system for nerve stimulation, comprising:

a pulse generator comprising;

a user control configured to receive a user adjustment; and

a 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; and

operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session.

2. The system of claim 1, further comprising an electrode assembly communicatively coupled to the pulse generator.

3. The system of claim 2, wherein the electrode assembly is coupled to the pulse generator by a connector or a lead wire, or wirelessly coupled to the pulse generator.

4. The system of claim 2, wherein the electrode assembly comprises two contacts.

5. The system of claim 2, wherein the microcontroller is further configured to detect a model of the electrode assembly.

6. The system of claim 2, wherein the microcontroller is further configured to set a used bit on the electrode assembly at the end of the treatment session.

7. The system of claim 1, wherein the microcontroller is further configured to record a log of use for monitoring a patient'"'"'s adherence to a treatment plan, wherein the log includes a duration of the treatment session, a start time for the treatment session, an end time for the treatment session, a setting for the at least one user-set parameter for the treatment session, and/or an impedance for the treatment session.

8. The system of claim 1, wherein the electric stimulation parameters comprise a current amplitude between 0.3 and 30 mA, a frequency between 1 and 300 Hz, a pulse duration between 50 and 500 microseconds, and a duty cycle between 1 and 100%.

9. The system of claim 1, further comprising a power source.

10. The system of claim 9, wherein the power source comprises a battery electrically coupled to the pulse generator.

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

12. A method for nerve stimulation, comprising:

receiving, by a pulse generator, 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; and

producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session.

13. The method of claim 12, further comprising applying, by an electrode assembly communicatively coupled to the pulse generator, the electrical pulses to at least one branch of a patient'"'"'s trigeminal nerve.

14. The method of claim 13, wherein the applying is performed using a connector or a lead wire coupling the electrode assembly and the pulse generator, or using a wireless connection coupling the electrode assembly and the pulse generator.

15. The method of claim 13, wherein the applying is performed via two contacts provided by the electrode assembly.

16. The method of claim 13, further comprising detecting a model of the electrode assembly.

17. The method of claim 13, further comprising setting a used bit on the electrode assembly at the end of the treatment session.

18. The method of claim 12, further comprising recording, by the pulse generator, a log of use of for monitoring a patient'"'"'s adherence to a treatment plan, wherein the log includes a duration of the treatment session, a start time for the treatment session, an end time for the treatment session, a setting for the at least one user-set parameter for the treatment session, and/or an impedance for the treatment session.

19. The method of claim 12, wherein the electric pulses have a current amplitude between 0.3 and 30 mA, a frequency between 1 and 300 Hz, a pulse duration between 50 and 500 microseconds, and a duty cycle between 1 and 100%.

20. The method of claim 12, further comprising supplying, by a power source electrically coupled to the pulse generator, power to the pulse generator.