Non-invasive vagal nerve stimulation to treat disorders

• US 9,415,219 B2
• Filed: 03/17/2015
• Issued: 08/16/2016
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/660,136
• Publication Number:
  US 20150190636A1
• Time in Patent Office: 518 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, depression, anxiety, epilepsy, fibromyalgia, and the like. The invention involves the use of an energy source comprising magnetic and/or electrical energy that is transmitted non-invasively to, or in close proximity to, a selected nerve to temporarily stimulate, block and/or modulate the signals in the selected nerve such that neural pathways are activated to release inhibitory neurotransmitters in the patient'"'"'s brain.

Claims

1. A method of treating a disorder in a patient, the method comprising:

positioning a device adjacent to a skin surface of the patient;

generating, via the device, a signal comprising one or more electrical impulses; and

transmitting, via the device, the one or more electrical impulses to a nerve in the patient, wherein the one or more electrical impulses comprises bursts of pulses with a silent inter-burst interval between each of the bursts, wherein each of the bursts and the silent inter-burst interval repeats from about 3 Hz to about 100 Hz, wherein each of the pulses has a duration from about 50 microseconds to about 1000 microseconds, wherein each of the bursts comprises from about 2 pulses to about 20 pulses.

2. The method of claim 1, wherein the one or more electrical impulses generates an electric field at a vagus nerve of the patient above a threshold for generating action potentials within A and B fibers of the vagus nerve and below a threshold for generating action potentials within C fibers of the vagus nerve.

3. The method of claim 2, wherein the electric field is between about 10 to 600 V/m.

4. The method of claim 1, wherein the one or more electrical impulses is sufficient to generate an electric field gradient at a vagus nerve of the patient, wherein the electric field gradient is greater than about 2 V/m/mm.

5. The method of claim 4, wherein the electric field is less than 100 V/m.

6. The method of claim 4, wherein the electric field is above a threshold for generating action potentials within A fibers of the vagus nerve and below a threshold for generating action potentials within B fibers of the vagus nerve.

7. The method of claim 4, wherein the electric field is below a threshold for generating action potentials within A-delta fibers of the vagus nerve.

8. The method of claim 4, wherein the electric field is not sufficient to produce a movement of a skeletal muscle of the patient.

9. The method of claim 1, wherein the one or more electrical impulses is constrained from modulating one or more nerves in a region between the skin surface and a vagus nerve of the patient.

10. The method of claim 1, wherein the pulses are full sinusoidal waves.

11. A device for treating a disorder in a patient, the device comprising:

a housing comprising a contact surface configured to contact an outer skin surface of the patient; and

an energy source coupled to the housing, wherein the energy source is configured to transmit an electric current through the outer skin surface of the patient to a nerve within the patient, wherein the electric current comprises a signal comprising bursts of pulses with a silent inter-burst interval between each of the bursts, wherein each of the bursts and the silent inter-burst interval repeats from about 3 Hz to about 100 Hz, wherein each of the pulses has a duration from about 50 microseconds to about 1000 microseconds, wherein each of the bursts comprises from about 2 pulses to about 20 pulses.

12. The device of claim 11, wherein the electric current is sufficient to generate an electric field at a vagus nerve of the patient above a threshold for generating action potentials within A and B fibers of the vagus nerve and below a threshold for generating action potentials within C fibers of the vagus nerve.

13. The device of claim 11, wherein the energy source is enclosed within the housing.

14. The device of claim 12, wherein the electric field is between about 10 to 600 V/m.

15. The device of claim 11, wherein the electric current is sufficient to generate an electric field gradient at a vagus nerve of the patient, wherein the electric field gradient is greater than about 2 V/m/mm.

16. The device of claim 15, wherein the electric field is less than 100 V/m.

17. The device of claim 11, wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

18. The device of claim 17, further comprising:

a conducting medium positioned within the housing between the one or more electrodes and the contact surface.

19. The device of claim 11, wherein the energy source comprises a battery.

20. The device of claim 11, wherein the housing is a handheld device configured to contact the outer skin surface of the patient.