Non-invasive vagal nerve stimulation to treat disorders

• US 9,399,134 B2
• Filed: 09/23/2014
• Issued: 07/26/2016
• Est. Priority Date: 03/10/2011
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/494,505
• Publication Number:
  US 20150032178A1
• Time in Patent Office: 672 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• 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 2/02 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 technology 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 handheld device comprising a housing comprising;

an electrically permeable or electrically conducting contact surface for contacting an outer skin surface of the patient, an energy source housed within the housing, an electrode directly coupled to the power source, and an electrically conductive gel, adjacent to a skin surface of the patient;

wherein the electrically conductive gel fills a gap between the electrode and the electrically conducting contact surface and couples the electrode to the electrically conducting contact surface,

generating one or more electrical impulses with said device; and

transmitting the electrical impulses to a vagus nerve in the patient, wherein the electrical impulses having a frequency from about 1 Hz to about 100 Hz and a duty cycle from about 1% to about 10%.

2. The method of claim 1 wherein the frequency is from about 10 Hz to about 35 Hz.

3. The method of claim 1 wherein the electrical impulses comprise bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 1 Hz to about 100 Hz.

4. The method of claim 3 wherein the pulses have a frequency from about 1,000 Hz to about 10,000 Hz.

5. The method of claim 3 wherein the pulses have a frequency from about 4,000 Hz to about 6,000 Hz.

6. The method of claim 3 wherein the pulses have a frequency of about 5,000 Hz.

7. The method of claim 1 wherein the duty cycle is from about 2% to about 5%.

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

9. The method of claim 4 wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.

10. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve above a first threshold for generating action potentials within A and B fibers of the vagus nerve and below a second threshold for generating action potentials within C fibers of the vagus nerve.

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

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

13. The method of claim 1 wherein the disorder is a primary headache and the electrical impulses are sufficient to treat symptoms of the primary headache.

14. The method of claim 12 wherein the disorder is a migraine.

15. The method of claim 12 wherein the disorder is a cluster headache.

16. The method of claim 1 wherein the disorder is an anxiety and the electrical impulses are sufficient to treat symptoms of the anxiety.

17. The method of claim 1 wherein the disorder is a depression and the electrical impulses are sufficient to treat symptoms of the depression.

18. The method of claim 1 wherein the disorder is an epilepsy and the electrical impulses are sufficient to reduce at least one of a number of seizures in the patient and a severity of seizures in the patient.

19. The method of claim 1 wherein the disorder is a fibromyalgia and the electrical impulses are sufficient to treat symptoms of the fibromyalgia.

20. The method of claim 1 wherein the disorder is a bronchoconstriction and the electrical impulses are sufficient to treat symptoms of the bronchoconstriction.

21. 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 a release of inhibitory neurotransmitters within a brain of the patient.

22. The method of claim 21 wherein the inhibitory neurotransmitters comprise at least one of GABA, serotonin and norepinephrine.

23. The method of claim 21 wherein the inhibitory neurotransmitters are released onto airway-related vagal preganglionic neurons to reduce a release of acetycholine from the airway-related vagal preganglionic neurons.

24. The method of claim 21 wherein a sufficient level of the inhibitory neurotransmitters are released in the brain of the patient to reduce a level of glutamate in the brain of the patient.

25. The method of claim 21 wherein the electric field is below the threshold for generating action potentials within fibers of the vagus nerve responsible for modulating at least one of a heart rate and a blood pressure.

26. The method of claim 21 wherein the inhibitory neurotransmitters inhibit mucous production in mucous glands in airways of the patient.

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

a housing comprising;

an electrically permeable or electrically conducting contact surface for contacting an outer skin surface of the patient, an energy source housed within the housing, an electrode directly coupled to the power source, and an electrically conductive gel,

wherein the electrically conductive gel fills a gap between the electrode and the electrically conducting contact surface and couples the electrode to the electrically conducting contact surface,

the energy source 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 from about 1 Hz to about 100 Hz and a duty cycle from about 1% to about 10%.

28. The device of claim 27 wherein the frequency is from about 10 Hz to about 35 Hz.

29. The device of claim 27 wherein the electrical impulses comprise bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 1000 Hz to about 10,000 Hz.

30. The device of claim 29 wherein the burst frequency is from about 4,000 Hz to about 6,000 Hz.

31. The device of claim 29 wherein the burst frequency is about 5,000 Hz.

32. The device of claim 27 wherein the duty cycle is from about 2% to about 5%.

33. The device of claim 27 wherein the duty cycle is about 2.5%.

34. The device of claim 29 wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.

35. The device of claim 27 wherein the burst frequency is from about 10 Hz to about 35 Hz.

36. The device of claim 27 wherein the electrical impulses generate an electric field at the vagus nerve above a first threshold for generating action potentials within A and B fibers of the vagus nerve and below a second threshold for generating action potentials within C fibers of the vagus nerve.

37. The device of claim 36 wherein the electric field is from about 10 V/m to about 600 V/m.

38. The device of claim 36 wherein the electric impulses are sufficient to generate an electrical field gradient at the vagus nerve greater than about 2 V/m/mm.

39. The device of claim 36 wherein the electric field is less than about 100 V/m.

40. The device of claim 27 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

41. The device of claim 27 wherein the energy source comprises a battery.

42. The device of claim 27 wherein the disorder is a primary headache and the electrical impulses are sufficient to treat symptoms of the primary headache.

43. The device of claim 42 wherein the disorder is a migraine.

44. The device of claim 42 wherein the disorder is a cluster headache.

45. The device of claim 27 wherein the disorder is an anxiety and the electrical impulses are sufficient to treat symptoms of the anxiety.

46. The device of claim 27 wherein the disorder is a depression and the electrical impulses are sufficient to treat symptoms of the depression.

47. The device of claim 27 wherein the disorder is an epilepsy and the electrical impulses are sufficient to reduce at least one of a number of seizures in the patient and a severity of seizures in the patient.

48. The device of claim 27 wherein the disorder is a fibromyalgia and the electrical impulses are sufficient to treat symptoms of the fibromyalgia.

49. The device of claim 27 wherein the disorder is a bronchoconstriction and the electrical impulses are sufficient to treat symptoms of the bronchoconstriction.