IP Library Granted Patent US 11,389,646
Granted Patent B2
US 11,389,646 · App. 17/402,690 · Granted Jul 19, 2022

Systems and methods for treating headache with vagal nerve stimulation

Inventors: Bruce J. Simon (Mountain Lakes, NJ); Joseph P. Errico (Palm Beach Gardens, FL)
Assignee: ELECTROCORE, INC
A61N1/0551A61N1/0456A61N1/36021A61N1/36025A61N2/006A61B5/369A61B5/4836A61N1/0408A61N1/36053A61N2/008A61N2/02
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Quick Facts
Patent No.
US 11,389,646
App. No.
17/402,690
Granted
Jul 19, 2022
Kind
B2
Abstract

Devices, systems and methods are disclosed for electrical stimulation of the vagus nerve to treat or prevent symptoms of headache in a patient. The headache may include primary headache, such as migraine and cluster headache, or secondary headache resulting from an underlying medical condition, such as post-concussion headache. The methods comprise transmitting impulses of energy to the vagus nerve according to a treatment paradigm that includes single doses of between about 30 seconds to about 5 minutes. The electrical impulses may have a frequency of about 1 kHz to about 20 kHz.

Claims (33)

1. A method of treating a symptom of a headache in a patient, the method comprising:

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

applying, via the device, when the contact surface is in contact with the outer skin surface of the patient, an electrical impulse transcutaneously, via the contact surface, through the outer skin surface of the patient to a vagus nerve of the patient according to a treatment paradigm; and

wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose from about 30 seconds to about 5 minutes and wherein the electrical impulse is sufficient to at least partially alleviate the symptom of the headache and wherein the treatment paradigm comprises 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.

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 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, wherein the energy source generates the electrical impulse.

5. The method of claim 1 , wherein the treatment session comprises applying the single dose twice within a 15 minute time period within the hour time period.

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

7. The method of claim 1 , wherein the device comprises one or more electrodes.

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

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

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

11. The method of claim 10 , wherein each of the bursts contains from 2 to 20 pulses and each of the pulses is from about 100 microseconds to about 1000 microseconds in duration.

12. The method of claim 1 , wherein the headache is a secondary headache.

13. The method of claim 12 , wherein the secondary headache is post-concussion headache.

14. The method of claim 1 , wherein the symptom is pain.

15. A method of treating a symptom of a headache in a patient, the method comprising:

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

applying, via the device, when the contact surface is in contact with the outer skin surface of the patient, an electrical impulse transcutaneously, via the contact surface, through the outer skin surface of the patient to a vagus nerve of the patient; and

wherein the electrical impulse has a frequency of about 5 Hz and is sufficient to at least partially alleviate the symptom of the headache.

16. The method of claim 15 , wherein the electrical impulse is applied according to a treatment paradigm, wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose from about 30 seconds to about 5 minutes.

17. The method of claim 16 , wherein the single dose is from about 60 seconds to about three minutes.

18. The method of claim 16 , wherein the single dose is from about 90 seconds to about 150 seconds.

19. The method of claim 15 , 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, wherein the energy source generates the electrical impulse.

20. The method of claim 16 , wherein the treatment paradigm comprises 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.

21. The method of claim 20 , wherein the treatment session comprises applying the single dose twice within a 15 minute time period within the hour time period.

22. The method of claim 20 , wherein each single dose is applied within 5 minutes of each other during the day.

23. The method of claim 15 , wherein the device comprises one or more electrodes.

24. The method of claim 15 , wherein the electrical impulse comprises bursts of pulses, wherein the bursts each have a frequency from about 1 burst per second to about 100 bursts per second.

25. The method of claim 24 , wherein each of the bursts contains from 2 to 20 pulses and each of the pulses is from about 100 microseconds to about 1000 microseconds in duration.

26. The method of claim 15 , wherein the headache is a secondary headache.

27. The method of claim 26 , wherein the secondary headache is post-concussion headache.

Assignments (2)
SECURITY INTEREST Recorded Aug 12, 2025
From: ELECTROCORE, INC.
To: AVENUE VENTURE OPPORTUNITIES FUND II, L.P.
Reel/Frame 072452/0559 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2021
From: SIMON, BRUCE J.; ERRICO, JOSEPH P.
To: ELECTROCORE, INC.
Reel/Frame 057184/0453 →
Continuity (17)
Continuation 16542818 · Aug 16, 2019
Continuation 13952916 · Jul 29, 2013
Continuation In Part 13603781 · Sep 5, 2012
Continuation In Part 13222087 · Aug 31, 2011
Continuation In Part 13183721 · Jul 15, 2011
Continuation In Part 13183765 · Jul 15, 2011
Continuation In Part 13109250 · May 17, 2011
Continuation In Part 13075746 · Mar 30, 2011
Continuation In Part 13005005 · Jan 12, 2011
Continuation In Part 12964050 · Dec 9, 2010
Continuation In Part 12859568 · Aug 19, 2010
Provisional Application 61488208 · May 20, 2011
Provisional Application 61487439 · May 18, 2011
Provisional Application 61471405 · Apr 4, 2011
Provisional Application 61451259 · Mar 10, 2011
Provisional Application 61415469 · Nov 19, 2010
Related Publication 20220023619A1 · Jan 27, 2022
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