Non-invasive vagal nerve stimulation to treat disorders

• US 8,843,210 B2
• Filed: 09/05/2012
• Issued: 09/23/2014
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce, Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US13/603,852
• Publication Number:
  US 20130238050A1
• Time in Patent Office: 748 Days
• Field of Search: 607/46, 607/72, 607/142
• US Class Current: 607/72
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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, comprising:

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

generating one or more electrical impulses with said device; and

transmitting the electrical impulses to a vagus nerve in the patient, the electrical impulses having a frequency of between 1000 Hz and 10,000 Hz and a duty cycle between 1% and 10%.

2. The method of claim 1 wherein the frequency is between 4000 Hz and 6000 Hz.

3. The method of claim 1 wherein the frequency is about 5000 Hz.

4. The method of claim 1 wherein the duty cycle is between 2% and 5%.

5. The method of claim 1 wherein the duty cycle is 2.5%.

6. The method of claim 1 wherein the electrical impulses include bursts of pulses having a burst duration of between 0.1 and 10 milliseconds and a burst frequency of between 10-50 Hz.

7. The method of claim 4 wherein the burst duration is between 2 and 6 milliseconds.

8. The method of claim 4 wherein the burst frequency is between 10 and 35 Hz.

9. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve 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.

10. The method of claim 9 wherein the electric field is between about 10 to 600 V/m.

11. The method of claim 1 wherein the electric impulses are sufficient to generate an electrical field gradient at the vagus nerve greater than 2 V/m/mm.

12. The method of claim 1 wherein the electric impulses are not sufficient to substantially produce movement of a skeletal muscle of the patient.

13. The method of claim 1 wherein the electrical impulses are substantially constrained from modulating one or more nerves in a region between the outer skin surface and the vagus nerve.

14. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

15. The method of claim 14 wherein the inhibitory neurotransmitters comprise GABA, serotonin and/or norepinephrine.

16. The method of claim 14 wherein the inhibitory neurotransmitters are released onto airway-related vagal preganglionic neurons to reduce the release of acetycholine from the airway-related vagal preganglionic neurons.

17. The method of claim 14 wherein a sufficient level of inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain.

18. The method of claim 14 wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

19. The method of claim 14 wherein the electric field is below the threshold for generating action potentials within fibers of the vagus nerve responsible for modulating heart rate or blood pressure.

20. The method of claim 14 wherein the inhibitory neurotransmitters inhibit mucous production in mucous glands in airways of the patient.

21. A device for treating a disorder in a patient comprising:

a housing having an electrically permeable or conducting contact surface for contacting an outer skin surface of the patient; and

an energy source within the housing configured to transmit electrical impulses through the outer skin surface of the patient to a vagus nerve within the patient, wherein the electric impulses have a frequency of between 1000 Hz and 10,000 Hz and a duty cycle between 1% and 10%.

22. The device of claim 21 wherein the frequency is between 4000 Hz and 6000 Hz.

23. The device of claim 21 wherein the frequency is about 5000 Hz.

24. The device of claim 21 wherein the duty cycle is between 2% and 5%.

25. The device of claim 21 wherein the duty cycle is 2.5%.

26. The device of claim 21 wherein the electrical impulses include bursts of pulses having a burst duration of between 0.1 and 10 milliseconds and a burst frequency of between 10-50 Hz.

27. The device of claim 26 wherein the burst duration is between 2 and 6 milliseconds.

28. The device of claim 26 wherein the burst frequency is between 10 and 35 Hz.

29. The device of claim 21 wherein the electrical impulses generate an electric field at the vagus nerve 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.

30. The device of claim 29 wherein the electric field is between about 10 to 600 V/m.

31. The device of claim 21 wherein the electric impulses are sufficient to generate an electrical field gradient at the vagus nerve greater than 2 V/m/mm.

32. The device of claim 29 wherein the electric field is less than 100 V/m.

33. The device of claim 21 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

34. The device of claim 33 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

35. The device of claim 21 wherein the energy source comprises a battery.