Systems and methods for vagal nerve stimulation

• US 10,441,780 B2
• Filed: 07/29/2013
• Issued: 10/15/2019
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US13/952,916
• Publication Number:
  US 20130310909A1
• Time in Patent Office: 2,269 Days
• Field of Search: 607 42, 607 45, 607115-118
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• 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
• 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 electrical stimulation of the vagus nerve to treat or prevent disorders in a patient. The methods comprise transmitting impulses of energy to the vagus nerve according to a treatment paradigm that includes single doses of 30 seconds to 5 minutes of continuous stimulation. The treatment paradigm further comprises one or more daily treatment sessions that each include one or more doses for prophylactic or acute treatment of the patient'"'"'s condition. Vagus nerve stimulation is used to modulate the release of inhibitory neurotransmitters in the brain, such as GABA, norepinephrine, and/or serotonin.

Claims

1. A method of treating or preventing a disorder in a patient, the method comprising:

positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient, wherein the device comprises a housing and an energy source, wherein the energy source is located within the housing, wherein the contact surface is coupled to the energy source, and wherein the housing comprises an outer surface that includes the contact surface; and

applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, one or more electrical impulses transcutaneously and non-invasively via the contact surface through the outer skin surface of the neck of the patient to a vagus nerve of the patient according to a treatment paradigm, wherein the energy source generates the one or more electrical impulses; and

wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose from two times to five times during the day.

2. The method of claim 1, wherein the single dose is from about 60 seconds to about three minutes.

3. The method of claim 1, wherein the single dose is from about 90 seconds to about 150 seconds.

4. The method of claim 1, wherein the electrical impulse is not applied to the vagus nerve via the device between each single dose during the day.

5. The method of claim 1, wherein the treatment paradigm comprises applying a treatment session during the day, wherein the treatment session comprises applying the single dose from 2 to 4 times within an hour time period.

6. The method of claim 5, wherein the treatment session comprises applying the single dose twice within a 15 minute time period within the hour time period.

7. The method of claim 6, wherein each single dose is applied within 5 minutes of each other during the day.

8. The method of claim 1, wherein the applying comprises transmitting the electrical impulse from an electrode through a conducting medium positioned within the housing, wherein the housing comprises the electrode.

9. The method of claim 1, wherein the electrical impulse has a frequency from about 1 KHz to about 20 KHz.

10. The method of claim 1, wherein the electrical impulse has a frequency from about 2.5 KHz to about 10 KHz.

11. The method of claim 1, wherein the electrical impulse has a frequency of about 5 KHz.

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

13. The method of claim 12, wherein each of the bursts contains from 1 pulse to 20 pulses.

14. The method of claim 12, wherein the pulses are full sinusoidal waves.

15. The method of claim 12, wherein each of the pulses is from about 100 microseconds to about 1000 microseconds in duration.

16. The method of claim 12, wherein a duration of a pulse of the pulses within a burst of the bursts is about 200 microseconds, wherein a number of the pulses per burst of the bursts is from 4 to 6, and wherein a number of the bursts per second is from 20 to 30.

17. The method of claim 1, wherein the electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within an A fiber or a B fiber of the vagus nerve and below a threshold for generating an action potential within a C fiber of the vagus nerve.

18. The method of claim 1, wherein the electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within a fiber of the vagus nerve responsible for activating a neural pathway causing a release of an inhibitory neurotransmitter within a brain of the patient.

19. The method of claim 1, wherein the energy source is a single energy source.

20. The method of claim 1, wherein the contact surface is movable along the outer skin surface of the neck of the patient during the applying.

21. The method of claim 1, wherein the contact surface is movable along the outer skin surface of the neck of the patient.

22. A method of treating or preventing a disorder in a patient, the method comprising:

positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient, wherein the device comprises a housing and an energy source, wherein the energy source is located within the housing, wherein the contact surface is coupled to the energy source, and wherein the housing comprises an outer surface that includes the contact surface; and

applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, an electrical impulse transcutaneously and non-invasively via the contact surface through the outer skin surface of the neck of the patient to a vagus nerve of the patient according to a treatment paradigm, wherein the energy source generates the electrical impulse; and

wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose every 4 to 5 hours during the day.