IP Library Granted Patent US 11,197,998
Granted Patent B2
US 11,197,998 · App. 16/535,624 · Granted Dec 14, 2021

Medical self-treatment using non-invasive vagus nerve stimulation

Inventors: Bruce J. Simon (Mountain Lakes, NJ); Joseph P. Errico (Warren, NJ); John T. Raffle (Austin, TX)
Assignee: ELECTROCORE, INC.
A61N1/36021A61N1/36034G06Q10/10G16H20/30G16H20/40G16H40/20A61B5/4836A61B2560/0456A61N1/0456A61N1/37235A61N1/40A61N2/006A61N2/008A61N2/02
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Quick Facts
Patent No.
US 11,197,998
App. No.
16/535,624
Granted
Dec 14, 2021
Kind
B2
Abstract

Devices, systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache, by electrical noninvasive stimulation of a vagus nerve. The system comprises a stimulator that is applied to the surface of the patient's neck. The device housing transmits data to a patient interface device such as a mobile phone or computer relating to the status of a stimulation session. The interface device in turn may communicate with a database contained within other computers, via a network or the internet. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.

Claims (35)

1. A system comprising:

a stimulator including a housing with an interior, an interface configured to contact an outer skin surface of a neck of a patient, and an energy source positioned within the housing and coupled to the interface, wherein the energy source transmits an electrical impulse through the interface transcutaneously through an outer skin surface of the neck of the patient to a vagus nerve of the patient such that the vagus nerve is modulated; and

a mobile device that receives data from a remote source, wherein the mobile device couples to the stimulator and transmits the data to the stimulator, wherein the data includes a therapy regimen that treats a primary headache in the patient.

2. The system of claim 1 , wherein the mobile device permits the patient to modulate an amplitude of the electrical impulse.

3. The system of claim 1 , wherein the energy source includes a signal generator within the housing.

4. The system of claim 1 , further comprising:

an electrode positioned within the housing and coupled to the energy source and the interface.

5. The system of claim 4 , further comprising:

an electrically conductive medium positioned within the housing between the electrode and the interface.

6. The system of claim 1 , wherein the energy source includes a rechargeable battery.

7. The system of claim 1 , wherein the electrical impulse includes bursts of pulses with a frequency of about 1 burst per second to about 100 bursts per second.

8. The system of claim 7 , wherein the electrical impulse includes bursts of between about 2 pulses per burst and about 50 pulses per burst, with each of the pulses being about 50 microseconds in duration to 1000 microseconds in duration.

9. The system of claim 1 , wherein the mobile device wirelessly transfers the data at least one of to or from the stimulator.

10. The system of claim 1 , further comprising:

a computer, connected to Internet, and containing a database including at least one of medical records for the patient or billing account information for the patient.

11. The system of claim 10 , wherein the medical records include data representing at least one of an amount of energy to transfer from the mobile device to the handheld device, a number of pulses per burst, a duration of a pulse, an amplitude of an electric field, a wait-time between stimulation sessions, a movement distance, a left-side versus right-side indicator, or a headache level.

12. A method for treating a primary headache in a patient comprising:

communicating data for an electrical stimulation therapy wirelessly to a stimulator;

positioning an interface of the stimulator against an outer skin surface of a neck of a patient;

generating an electrical impulse within the stimulator;

transmitting the electrical impulse through the interface and transcutaneously through the outer skin surface of the neck to a vagus nerve at a target region within the patient such that the vagus nerve is modulated and thereby the primary headache medical condition is treated.

13. The method of claim 12 , further comprising:

communicating data from a remote source over Internet to a mobile device and wirelessly coupling the mobile device to the stimulator in order to transmit the data to the stimulator.

14. The method of claim 13 further comprising:

transferring energy from the mobile device to the stimulator.

15. The method of claim 12 , further comprising:

communicating authorization to the stimulator in order to enable the stimulator to operate.

16. The method of claim 12 , further comprising:

transmitting dosing information to the stimulator.

17. The method of claim 16 , wherein the dosing information includes a duration of time in which the stimulator generates an electric field.

18. The method of claim 12 , further comprising:

transmitting information regarding the electrical impulse to the stimulator.

19. The method of claim 18 , wherein the information includes an amplitude of the electric current.

20. The method of claim 13 , further comprising:

transmitting data from the mobile device over Internet to a computer.

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 8, 2019
From: SIMON, BRUCE J.; ERRICO, JOSEPH P.; RAFFLE, JOHN T.
To: ELECTROCORE, INC.
Reel/Frame 050002/0193 →
Continuity (21)
Continuation 15012689 · Feb 1, 2016
Continuation 13858114 · Apr 8, 2013
Continuation In Part 13603799 · Sep 5, 2012
Continuation In Part 13279437 · Oct 24, 2011
Continuation In Part 13222087 · Aug 31, 2011
Continuation In Part 13183765 · Jul 15, 2011
Continuation In Part 13183721 · 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
Continuation In Part 12612177 · Nov 4, 2009
Continuation In Part 12408131 · Mar 20, 2009
Provisional Application 61752895 · Jan 15, 2013
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 20190358452A1 · Nov 28, 2019