Non-invasive vagal nerve stimulation to treat disorders

• US 8,983,629 B2
• Filed: 09/05/2012
• Issued: 03/17/2015
• 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:
  US13/603,810
• Publication Number:
  US 20130245712A1
• Time in Patent Office: 923 Days
• Field of Search: 607/142, 607/68, 607/69, 607/70, 607/71
• US Class Current: 607/142
• 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 1/3601 of respiratory organs
• 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 bronchial constriction related to asthma, anaphylaxis, chronic obstructive pulmonary disease (COPD), exercise-induced bronchospasm and post-operative bronchospasm. The treatment comprises transmitting impulses of energy non-invasively to selected nerve fibers that activate neural pathways to reduce the release of acetycholine from airway-related vagal preganglionic neurons within the brain of the patient. The transmitted energy impulses, comprising magnetic and/or electrical energy, stimulate the selected nerve fibers to produce the bronchodilation.

Claims

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

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

generating a single signal comprising one or more electrical impulses with said device; and

transmitting the one or more electrical impulses to a vagus nerve in the patient, wherein the one or more electrical impulses comprise 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, and wherein the one or more electrical impulses is sufficient to activate neural pathways that reduce a release of acetycholine from airway-related vagal preganglionic neurons within a brain of the patient.

2. The method of claim 1 further comprising generating an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating said neural pathways that reduce the release of acetycholine from the airway-related vagal preganglionic neurons.

3. The method of claim 2 wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

4. The method of claim 2 wherein the electric field is below the threshold for generating action potentials within fibers of the vagus nerve responsible for increasing or decreasing heart rate or blood pressure.

5. The method of claim 1 wherein the one or more electrical impulses are sufficient to activate neural pathways that reduce mucous production in mucous glands in air passages in the patient.

6. The method of claim 2 wherein the fibers of the vagus nerve are A and B fibers.

7. The method of claim 3 wherein the fibers of the vagus nerve responsible for bronchoconstriction are C fibers.

8. The method of claim 2 wherein the electric field at the vagus nerve is above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating said neural pathways that cause a release of inhibitory neurotransmitters within the brain of the patient.

9. The method of claim 8 wherein at least one of the inhibitory neurotransmitters is at least one of serotonin, GAMA and norepinephrine.

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

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

an energy source positioned within the housing and configured to transmit a shaped electric current through the outer skin surface of the patient to a vagus nerve within the patient, wherein the electric current is sufficient to generate a single signal comprising one or more electrical impulses 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 microsecond to about 1000 microseconds, and wherein the electrical impulses are sufficient to activate neural pathways that reduce a release of acetylcholine from airway-related vagal preganglionic neurons within a brain of the patient.

11. The device of claim 10 wherein the energy source is configured to generate an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating said neural pathways that reduce the release of acetylcholine from the airway-related vagal preganglionic neurons.

12. The device of claim 11 wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

13. The device of claim 11 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.

14. The device of claim 10 wherein the electric current is sufficient to activate neural pathways that reduce mucous production in mucous glands in air passages in the patient.

15. The device of claim 11 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.

16. The device of claim 11 wherein the electric field is from about 10 V/m to about 600 V/m.

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

18. The device of claim 11 wherein the electric field is less than about 100 V/m.

19. The device of claim 10 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

20. The device of claim 19 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

21. The device of claim 10 wherein the energy source comprises a battery.

22. The device of claim 10 wherein the housing is a handheld device configured for contacting a surface of the skin of a patient.