Non-invasive vagal nerve stimulation to treat disorders

• US 9,623,240 B2
• Filed: 03/17/2015
• Issued: 04/18/2017
• 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): Moran, Edward
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/660,377
• Publication Number:
  US 20150190637A1
• Time in Patent Office: 763 Days
• 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 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 handheld device comprising a housing comprising an electrically conductive contacting surface, a power source, an electrode, and a conductive gel, wherein the electrode is coupled to the power source, wherein the housing is adjacent to a skin surface of the patient, wherein the conductive gel couples the electrode to the electrically conductive contacting surface;

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 vagus 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.

2. The method of claim 1, 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.

3. The method of claim 2, further comprising:

generating, via the device, an electric field at the vagus nerve, wherein the electric field is above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating the neural pathways that reduce the release of acetycholine from the airway-related vagal preganglionic neurons.

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

5. The method of claim 3, wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for increasing or decreasing heart rate or blood pressure.

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

7. The method of claim 3, 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 the neural pathways that cause a release of inhibitory neurotransmitters within the brain of the patient.

8. The method of claim 7, wherein at least one of the inhibitory neurotransmitters is at least one of serotonin, GABA, and norepinephrine.

9. The method of claim 1, wherein the power source comprises a signal generator.

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

a housing comprising an electrically conducting contact surface, an energy source, an electrode, and a conductive gel, wherein the electrode is coupled to the energy source, wherein the conductive gel couples the electrode to the electrically conducting contact surface, wherein the electrically conducting contact surface is configured to contact an outer skin surface of the patient, wherein the energy source is configured to transmit an 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 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, and wherein each of the pulses has a duration from about 50 microsecond to about 1000 microseconds.

11. The device of claim 10, wherein the one or more electrical impulses is sufficient to activate neural pathways that reduce a release of acetylcholine from airway-related vagal preganglionic neurons within a brain of the patient.

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

13. The device of claim 10, wherein the electric current is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

14. The device of claim 10, wherein the electric current is below a threshold for generating action potentials within fibers of the vagus nerve responsible for modulating heart rate or blood pressure.

15. 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.

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

17. The device of claim 10, wherein the electric current is sufficient to generate an electric field gradient at the vagus nerve, wherein the electric field gradient is greater than about 2 V/m/mm.

18. The device of claim 10, wherein the electric current 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 10, wherein the energy source comprises a battery.