IP Library Granted Patent US 10,376,696
Granted Patent B2
US 10,376,696 · App. 15/012,689 · Granted Aug 13, 2019

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.
A61N1/36021A61N1/36014G06F19/328G06F19/3481A61B5/4836A61B2560/0456A61N1/0456A61N1/37235A61N1/40A61N2/006A61N2/008A61N2/02
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Quick Facts
Patent No.
US 10,376,696
App. No.
15/012,689
Granted
Aug 13, 2019
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 (36)

1. A device for treating a medical condition in a patient comprising:

a housing comprising a contact surface configured to contact an outer skin surface of the patient;

an energy source positioned within the housing, wherein the energy source generates and transmits an electrical impulse through the contact surface and the outer skin surface of the patient to a nerve at a target region within the patient, non-invasively, wherein the electrical impulse is sufficient to modulate the nerve;

a microprocessor coupled to the energy source;

a first communication interface that enables communication between the microprocessor and a first computer, wherein the energy source performs a first function under control of the microprocessor based on a first communication from the first computer; and

a second communication interface distinct from the first communication interface, wherein the second communication interface enables communication between the microprocessor and a second computer, wherein the energy source performs a second function under control of the microprocessor based on a second communication from the second computer, wherein the first function is distinct from the second function and the first computer is distinct from the second computer.

2. The device of claim 1 , wherein the energy source, the first communication interface and the second communication interface are enclosed within the housing.

3. The device of claim 1 , wherein the electrical impulse is based at least in part on the first communication.

4. The device of claim 1 , further comprising a docking station separate from the housing, wherein the first communication interface and the second communication interface are enclosed within the docking station.

5. The device of claim 1 , wherein the first communication comprises instructions for an amplitude of the electrical impulse, and wherein the first function involves modifying the amplitude.

6. The device of claim 1 , wherein the first communication comprises instructions for a duration of the electrical impulse, and wherein the first function involves modifying the duration.

7. The device of claim 1 , wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator, wherein the one or more electrodes is positioned within the housing.

8. The device of claim 1 , wherein the electrical impulse comprises bursts of pulses with a frequency of about 1 to about 100 bursts per second.

9. The device of claim 8 , wherein the pulses have a duration of about 50 to about 1000 microseconds.

10. The device of claim 1 , wherein the electrical impulse modulates a vagus nerve in the patient.

11. The device of claim 1 , wherein the housing is a handheld device that contacts an outer skin surface of a neck of the patient.

12. The device of claim 1 , wherein at least one of the first communication interface or the second communication interface is configured to transmit information from the microprocessor to at least one of the first computer or the second computer.

13. The device of claim 1 , wherein the first communication interface is configured to wirelessly receive the at least one of the first communication or the second communication over a network.

14. The device of claim 1 , further comprising a database coupled to the first communication interface, the database comprising a record for the patient or relating to an operation of the energy source.

15. The device of claim 14 , wherein the record comprises a medical record for the patient or a billing account for the patient.

16. The device of claim 15 , wherein the medical record comprises information representative of an amount of energy to transfer from the energy source to the patient, a number of pulses per burst for the electrical impulse, a duration of each pulse, an amplitude of the electrical impulse, a wait-time between stimulation sessions, a movement distance, a left-side versus right side indicator, or a headache level.

17. A method for treating a medical condition of a patient, comprising:

performing, via a stimulator, a first function involving a first computer, wherein the stimulator comprises a microprocessor and a first communication interface to communicate with the first computer, wherein the first function comprises the stimulator receiving data from the first computer;

positioning the stimulator against an outer skin surface of the patient;

transmitting, via the stimulator, while the stimulator is positioned against the outer skin surface of the patient, based at least in part on the data, an electrical impulse through the outer skin surface of the patient to a nerve at a target region within the patient, non-invasively, wherein the electrical impulse is sufficient to modulate the nerve; and

performing, via the stimulator, a second function involving a second computer, wherein the first function is distinct from the second function and the first computer is distinct from the second computer and the stimulator.

18. The method of claim 17 , wherein the stimulator comprises a second communication interface to communicate with the second computer, wherein the second communication interface is distinct from the first communication interface.

19. The method of claim 17 , further comprising transferring energy from the first computer to the stimulator through the first communication interface.

20. The method of claim 17 , further comprising transmitting an electrical stimulation therapy data from a remote source over a network, through the first computer to the stimulator.

21. The method of claim 20 , further comprising a docking station housing the first computer.

22. The method of claim 17 , further comprising transmitting an authorization to the stimulator from a remote location, wherein the authorization enables the stimulator to operate.

23. The method of claim 17 , further comprising transmitting dosing information to the stimulator from a remote location, wherein the dosing information comprises a duration of time during which the stimulator transmits the electrical impulse to the patient.

24. The method of claim 17 , further comprising transferring data related to an amplitude of the electrical impulse to the stimulator.

25. The method of claim 17 , wherein the electrical impulse modulates a vagus nerve of the patient.

26. The method of claim 17 , further comprising transmitting information from the stimulator to the first computer, wherein the information relates at least in part to the electrical impulse transmitted to the patient.

27. The method of claim 17 , wherein the housing is a handheld device that contacts an outer skin surface of a neck of the patient.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 1, 2016
From: SIMON, BRUCE J.; ERRICO, JOSEPH P.; RAFFLE, JOHN T.
To: ELECTROCORE, LLC
Reel/Frame 037637/0391 →
Continuity (20)
Continuation In Part 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 20160144175A1 · May 26, 2016