Non-invasive vagal nerve stimulation to treat disorders

• US 9,358,381 B2
• Filed: 05/23/2014
• Issued: 06/07/2016
• 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): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/286,218
• Publication Number:
  US 20140257437A1
• Time in Patent Office: 746 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

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 an electric current through the outer skin surface of the patient to a vagus nerve within the patient,

an electrode directly coupled to the energy source and not directly coupled to the electrically permeable contact surface;

a conducting medium within the housing filling a space created between the electrode and the electrically permeable contact surface,

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 suppression of excitatory neurotransmitters within a brain of the patient.

2. The device of claim 1 wherein the excitatory neurotransmitters comprise catecholamines.

3. The device of claim 1 wherein the excitatory neurotransmitters comprise glutamate.

4. The device of claim 1 wherein the excitatory neurotransmitters comprise acetycholine.

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 electric current is sufficient to generate an electric field greater than 100 V/m but less then about 600 V/m at the vagus nerve.

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

11. 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.

12. The device of claim 11 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.

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

14. 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 an electric current through the outer skin surface of the patient to a vagus nerve within the patient,

an electrode directly coupled to the energy source and not directly coupled to the electrically permeable contact surface;

a conducting medium within the housing filling a space created between the electrode and the electrically permeable contact surface

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 suppression of excitatory neurotransmitters within a brain of the patient.

15. The device of claim 14 wherein the excitatory neurotransmitters comprise catecholamines.

16. The device of claim 14 wherein the excitatory neurotransmitters comprise glutamate.

17. The device of claim 14 wherein the excitatory neurotransmitters comprise acetycholine.

18. The device 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 device 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 device of claim 14 wherein the electric field is between about 10 to 600 V/m.

21. The device of claim 14 wherein the electric field is less than 100 V/m.

22. The device of claim 14 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

23. The device of claim 14 wherein the energy source comprises a battery.

24. The device of claim 14 wherein the electric current comprises bursts of pulses with a frequency of about 3 to about 100 bursts per second.

25. The device of claim 24 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.

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