Non-invasive vagal nerve stimulation to treat disorders

• US 10,384,059 B2
• Filed: 06/02/2016
• Issued: 08/20/2019
• Est. Priority Date: 03/10/2011
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US15/171,684
• Publication Number:
  US 20160279410A1
• Time in Patent Office: 1,174 Days
• 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 method for treating a disorder in a patient, the method comprising:

positioning a device in contact with an outer skin surface of the patient;

generating, via the device, an electric current externally to the patient; and

transmitting, via the device, the electric current transcutaneously through the outer skin surface to a vagus nerve within the patient, wherein the electric current alone is sufficient to generate an electric field from about 10 V/m to about 600 V/m at the vagus nerve above a threshold for generating an action potential within a fiber of the vagus nerve responsible for activating a neural pathways causing a modulation of a neurotransmitter within a brain of the patient.

2. The method of claim 1, wherein the electric field is sufficient to cause a release of an inhibitory neurotransmitter in the brain.

3. The method of claim 1, wherein the electric field is sufficient to cause a suppression of an excitatory neurotransmitter in the patient.

4. The method of claim 3, wherein the excitatory neurotransmitter comprises at least one of a catecholamine or an acetylcholine.

5. The method of claim 1, wherein the transmitting facilitates a sufficient level of an inhibitory neurotransmitter to be released in the brain to reduce a level of a glutamate in the brain.

6. The method of claim 2, wherein the inhibitory neurotransmitter comprises at least one of GABA, serotonin, or norepinephrine.

7. The method of claim 1, wherein the electric field is below a threshold for generating an action potential within a fiber of the vagus nerve responsible for a bronchoconstriction.

8. The method of claim 1, wherein the electric field is below a threshold for generating an action potential within a fiber of the vagus nerve responsible for modulating at least one of a heart rate or a blood pressure.

9. The method of claim 1, wherein the electric current is sufficient to generate an electric field gradient at the vagus nerve equal to or greater than about 2 V/m/mm.

10. The method of claim 1, wherein the electric field is equal to or less than about 100 V/m.

11. The method of claim 1, wherein the electric field is equal to or greater than about 100 V/m but equal to or less than about 600 V/m.

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

13. The method of claim 12, wherein the electric current comprises bursts from about 2 pulses per burst to about 20 pulses per burst, with each of the pulses being from about 50 microseconds in duration to about 1000 microseconds in duration.

14. A method for treating a disorder in a patient, the method comprising:

positioning a device in contact with an outer skin surface of the patient;

generating, via the device, an electric current externally to the patient; and

transmitting, via the device, the electric current transcutaneously through the outer skin surface to a vagus nerve within the patient, wherein the electric current alone is sufficient to generate an electric field gradient at the vagus nerve greater than about 2 V/m/mm above a threshold for generating an action potentials within a fiber of the vagus nerve responsible for activating a neural pathway causing a modulation of a neurotransmitter within a brain of the patient, and the electric current is not sufficient to modulate the nerves between the outer skin surface of the patient and the vagus nerve.

15. The method of claim 14, wherein the electric field is sufficient to cause a release of an inhibitory neurotransmitter in the brain.

16. The method of claim 14, wherein the electric field is sufficient to cause a suppression of an excitatory neurotransmitter in the brain.

17. The method of claim 16, wherein the excitatory neurotransmitter comprises at least one of a catecholamine or an acetylcholine.

18. The method of claim 15, wherein the transmitting facilitates a sufficient level of an inhibitory neurotransmitter to be released in the brain to reduce a level of a glutamate in the brain.

19. The method of claim 15, wherein the inhibitory neurotransmitter comprises at least one of GABA, serotonin, or norepinephrine.

20. The method of claim 14, wherein the electric current is sufficient to generate an electric field from about 10 V/m to about 600 V/m at the vagus nerve.

21. The method of claim 14, wherein the electric current comprises bursts of pulses with a frequency from about 3 bursts per second to about 100 bursts per second.

22. The method of claim 21, wherein the electric current comprises bursts from about 2 pulses per burst to about 20 pulses per burst, with each of the pulses being from about 50 microseconds in duration to about 1000 microseconds in duration.

23. A method for treating a disorder in a patient, the method comprising:

positioning a housing in contact with an outer skin surface of the patient;

generating an electric current within the housing; and

transmitting the electric current transcutaneously from the housing through the outer skin surface to a vagus nerve within the patient, wherein the electric current alone is sufficient to generate an electric field from about 10 V/m to about 600 V/m at the vagus nerve above a threshold for generating an action potential within a fiber of the vagus nerve responsible for activating a neural pathways causing a modulation of a neurotransmitter within a brain of the patient.