SYSTEMS AND METHODS FOR VAGAL NERVE STIMULATION

• US 20130310909A1
• Filed: 07/29/2013
• Published: 11/21/2013
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Granted Patent: US 10,441,780 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• 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, comprising:

applying one or more electrical impulses to a vagus nerve of the patient according to a treatment paradigm; and

wherein the treatment paradigm comprises continuously applying the electrical impulses for a time period of about 30 seconds to about 5 minutes as a single dose and wherein the treatment paradigm further comprises applying one or more doses on a daily basis.

2. The method of claim 1 wherein a single dose comprises applying the electrical impulses for a time period of about 60 seconds to about three minutes.

3. The method of claim 1 wherein a single dose comprises applying the electrical impulses for a time period of about 90 seconds to about 150 seconds.

4. The method of claim 1 wherein electrical impulses are not applied to the vagus nerve between each single dose.

5. The method of claim 1 wherein the treatment paradigm comprises applying a single dose two to five times per day.

6. The method of claim 1 wherein the treatment paradigm comprises applying one or more treatment sessions per day, wherein each treatment session comprises applying a single dose 2 to 4 times within an hour time period.

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

8. The method of claim 7 wherein each single dose is applied within 5 minutes of each other.

9. The method of claim 1 further comprising:

positioning a device adjacent to a skin surface of the patient;

generating the electrical impulses with said device; and

transmitting the electrical impulses through the skin surface to the vagus nerve in the patient, wherein the electrical impulses are sufficient to modify selected fibers within the vagus nerve such that the disorder in the patient is treated or prevented.

10. The method of claim 9 wherein the transmitting step comprises transmitting the electrical impulses from one or more electrodes through a conducting medium within the device.

11. The method of claim 1 wherein the electrical impulses have a frequency of about 1 to about 20 KHz.

12. The method of claim 1 wherein the electrical impulses have a frequency of about 2.5 to about 10 KHz.

13. The method of claim 1 wherein the electrical impulses have a frequency of about 5 KHz.

14. The method of claim 1 wherein the electrical impulses comprise bursts of pulses with a frequency of about 1 to about 100 bursts per second.

15. The method of claim 14 wherein each burst contains from 1 to 20 pulses.

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

18. The method of claim 14 wherein each pulse is about 100 to about 1000 microseconds in duration.

19. The method of claim 14 wherein the duration of a pulse within a burst is about 200 microseconds, wherein the number of pulses per burst is from 4 to 6, and wherein the number of bursts per second is from 20 to 30.

20. 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 A and B fibers of the vagus nerve and below a threshold for generating action potentials within C fibers of the vagus nerve.

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 release of inhibitory neurotransmitters within a brain of the patient.