Medical self-treatment using non-invasive vagus nerve stimulation

• US 10,376,696 B2
• Filed: 02/01/2016
• Issued: 08/13/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Voorhees, Catherine M
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US15/012,689
• Publication Number:
  US 20160144175A1
• Time in Patent Office: 1,289 Days
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• 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 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• 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
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

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

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.