Non-invasive vagal nerve stimulation to treat disorders

• US 8,918,178 B2
• Filed: 09/05/2012
• Issued: 12/23/2014
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• 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:
  US13/603,799
• Publication Number:
  US 20130238049A1
• Time in Patent Office: 839 Days
• Field of Search: 607/46, 607/48, 607/118, 607/142, 607/134
• US Class Current: 607/46
• 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 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 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 an electric field between about 10 to 600 V/m 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.

2. The device of claim 1 wherein the inhibitory neurotransmitters comprise GABA, serotonin and/or norepinephrine.

3. The device of claim 1 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.

4. The device of claim 1 wherein a sufficient level of inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain.

5. The device of claim 1 wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

6. The device of claim 1 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.

7. The device of claim 1 wherein the electric current is sufficient to generate an electrical field gradient at the vagus nerve greater than 2 V/m/mm.

8. The device of claim 1 wherein the electric field is less than 100 V/m.

9. The device of claim 1 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

10. The device of claim 9 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

11. The device of claim 1 wherein the energy source comprises a battery.

12. The device of claim 1 wherein the electric current comprises bursts of pulses with a frequency of about 3 to about 100 bursts per second.

13. The device of claim 12 wherein the electric current comprises bursts of between 1 and 20 pulses per burst, with each pulse being about 50 to 1000 microseconds in duration.

14. The device of claim 1 wherein the housing is a handheld device configured for contacting a surface of the skin of a patient.

15. 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 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 an electrical field gradient at the vagus nerve greater than 2 V/m/mm 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.

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

17. The device of claim 15 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.

18. The device of claim 15 wherein a sufficient level of inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain.

19. The device of claim 15 wherein the electric field is below a threshold for generating action potentials within fibers of the vagus nerve responsible for bronchoconstriction.

20. The device of claim 15 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.

21. The device of claim 15 wherein wherein the electric field is between about 10 to 600 V/m.

22. The device of claim 21 wherein the electric field is less than 100 V/m.

23. The device of claim 15 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

24. The device of claim 23 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

25. The device of claim 15 wherein the energy source comprises a battery.

26. The device of claim 15 wherein the electric current comprises bursts of pulses with a frequency of about 3 to about 100 bursts per second.

27. The device of claim 26 wherein the electric current comprises bursts of between 1 and 20 pulses per burst, with each pulse being about 50 to 1000 microseconds in duration.

28. The device of claim 15 wherein the housing is a handheld device configured for contacting a surface of the skin of a patient.