Non-invasive vagus nerve stimulation

Patent metadata

Field	Value
Publication number	US-11298535-B2
Application number	US-202117220805-A
Country	US
Kind code	B2
Filing date	Apr 1, 2021
Priority date	Mar 20, 2009
Publication date	Apr 12, 2022
Grant date	Apr 12, 2022

Abstract

Devices, systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache, by electrical noninvasive stimulation of a vagus nerve. The system comprises a stimulator that applies an electrical impulse transcutaneously through an outer skin surface of the patient. The electrical impulse includes pulses having a frequency of about 1 kHz to about 20 kHz. The device housing may transmit data to or from a patient interface device, such as a mobile phone or computer, relating to the stimulation parameters. The interface device in turn may communicate with a database contained within other computers, via a network or the internet.

First claim

The invention claimed is:

1. A method for treating a medical condition in a patient, the method comprising:
positioning a device adjacent to, or in contact with, an outer skin surface of the patient, wherein the outer skin surface is adjacent to an auricular branch of the vagus nerve;
generating an electrical impulse sufficient to modulate a vagus nerve within the patient;
transmitting the electrical impulse transcutaneously through the outer skin surface to the vagus nerve such that the vagus nerve is modulated and thereby the medical condition is treated, wherein the electrical impulse comprises pulses having a frequency of about 2.5 kHz to about 7.5 kHz.

2. The method of claim 1 , wherein the pulses have a frequency of about 5 kHz.

3. The method of claim 1 , further comprising transmitting an electric current from the device through the outer skin surface to the vagus nerve.

4. The method of claim 1 , wherein the electrical impulse is an electric field.

5. The method of claim 1 , wherein the pulses have a pulse width of about 1 microsecond to about 1,000 microseconds.

6. The method of claim 4 further comprising varying the electric field to create burst periods and constant periods, wherein the charge of the electric field emitted during the burst periods alternates between positive and negative, wherein the frequency of the burst periods is about 1 to about 100 Hz.

7. The method of claim 1 further comprising positioning one or more electrodes near the outer skin surface and applying a voltage to the electrode(s) to generate the electric field.

8. The method of claim 6 , wherein the charge of the electric field alternates between positive and negative 2 and 20 times per burst.

9. The method of claim 1 , further comprising communicating data for one or more stimulation parameters wirelessly to the device.

10. The method of claim 9 , further comprising communicating data from a remote source to a mobile device and wirelessly coupling the mobile device to the device in order to transmit the data to the device.

11. The method of claim 10 , further comprising communicating authorization to the device in order to enable the device to operate.

12. A device for treating a medical condition in a patient, the device comprising:
a housing having a contact surface for contacting an outer skin surface of a patient adjacent to an auricular branch of the vagus nerve; and
an energy source coupled to the housing, the energy source being configured to generate an electrical impulse sufficient to modulate a vagus nerve within the patient and to transmit the electrical impulse transcutaneously through the outer skin surface to the vagus nerve such that the vagus nerve is modulated and thereby the medical condition is treated, wherein the electrical impulse comprises pulses having a frequency of about 2.5 kHz to about 7.5 kHz.

13. The device of claim 12 further comprising one or more electrodes coupled to the energy source, wherein the energy source applies a voltage to the electrode(s) to generate the electrical impulse.

14. The device of claim 12 , wherein the energy source transmits an electric current through the outer skin surface to the vagus nerve.

15. The device of claim 12 , wherein the pulses have a frequency of about 5 kHz.

16. The device of claim 12 , wherein the electrical impulse is an electric field.

17. The device of claim 12 , wherein the pulses have a pulse width of about 1 microsecond to about 1,000 microseconds.

18. The device of claim 16 , wherein the energy source is configured to vary the electric field to create burst periods and constant periods, wherein the charge of the electric field emitted during the burst periods alternates between positive and negative, wherein the frequency of the burst periods is about 1 to about 100 Hz.

19. The device of claim 18 , wherein the charge of the electric field alternates between positive and negative 2 and 20 times per burst.

20. The device of claim 12 , wherein the energy source is housed within the housing.

21. The device of claim 12 , further comprising a mobile device that receives data from a remote source, wherein the mobile device couples to the housing and transmits the data to the housing, wherein the data includes one or more stimulation parameters for treating a medical condition in the patient.

22. The device of claim 21 , wherein the one or more stimulation parameters includes an amplitude of the electrical impulse.

23. The device of claim 12 , wherein the energy source includes a signal generator within the housing.

Assignees

• Electrocore Inc

Inventors

• Simon Bruce J
• Errico Joseph P
• Raffle John T

Classifications

• A61B2560/0456

  Apparatus provided with a docking unit · CPC title

• A61N1/40

  Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals} · CPC title

• A61N2/02

  using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence) · CPC title

• A61N1/36034

  specified by the stimulation parameters · CPC title

• G16H40/20

  for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms · CPC title