Medical self-treatment using non-invasive vagus nerve stimulation

• US 9,248,286 B2
• Filed: 04/08/2013
• Issued: 02/02/2016
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US13/858,114
• Publication Number:
  US 20140142654A1
• Time in Patent Office: 1,030 Days
• Field of Search: 607/59, 607/60, 607/118
• US Class Current: 1/1
• 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 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• 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 40/67 for remote operation

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, as well as a docking station that is used to charge a rechargeable battery within the stimulator. The docking station and stimulator housing transmit data to one another regarding the status of a stimulation session, as well as to a computer program in a patient interface device such as a mobile phone or computer. The interface device in turn communicates with medical record and billing databases contained within other computers, via 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 system comprising:

a stimulator comprising a housing and an energy source, wherein the housing comprises a contact surface configured to contact an outer skin surface of a patient, wherein the energy source is housed within the housing and is configured to generate an electric field sufficient to transmit an electric current non-invasively through the outer skin surface of the patient via the contact surface, wherein the electric current is sufficient to modulate a nerve at a target region within the patient; and

a docking station configured to couple to the stimulator, wherein the docking station comprises a first communication interface and a second communication interface, wherein the docking station is configured to communicate with a first computer that is independent of the stimulator, via the first communication interface, wherein the docking station is configured to communicate with a second computer that is independent of the stimulator, via the second communication interface, wherein the docking station is configured to perform a first function involving the first computer, wherein the first function comprises receiving data from the first computer and transmitting the data to the stimulator, wherein the electric field is based at least in part on the data, wherein the docking station is configured to perform a second function involving the second computer, wherein the first communication interface is distinct from the second communication interface, wherein the first function is distinct from the second function, wherein the first computer is distinct from the second computer.

2. The system of claim 1 wherein the stimulator is configured to permit the patient to modulate an amplitude of the electric field.

3. The system of claim 1 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

4. The system of claim 3 further comprising a conducting medium within the housing between the electrodes and the contact surface.

5. The system of claim 1 wherein the energy source comprises a rechargeable battery.

6. The system of claim 1 wherein the electric field comprises bursts of pulses with a frequency of about 1 to about 100 bursts per second.

7. The system of claim 6 wherein the electric field comprises bursts of about 1 to about 50 pulses per burst, with each pulse being about 50 to 1000 microseconds in duration.

8. The system of claim 1 wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

9. The system of claim 1, wherein the housing is a handheld device configured to contact the outer skin surface of the patient.

10. The system of claim 1, wherein the electric current is configured to generate an electric field at a vagus nerve of the patient 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.

11. The system of claim 1, wherein the docking station is configured to at least one of transfer information distinct from the data to the stimulator or receive information from the stimulator.

12. The system of claim 1, further comprising:

a third computer connected to a network, wherein the docking station is configured to wirelessly receive the data from the third computer.

13. The system of claim 1, wherein the docking station is configured to directly connect to a network.

14. The system of claim 1, further comprising:

a computer connected to a network, wherein the computer contains a database comprising at least one of a medical record for the patient or a billing account for the patient, wherein the database at least partially relates to an operation of at least one of the stimulator or the docking station.

15. The system of claim 14, wherein the medical record comprises information representative of an amount of energy to transfer from the docking station to the stimulator housing, 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.

16. The system of claim 1, wherein the data comprises a therapy regimen to treat a medical condition in the patient.

17. A method comprising:

performing, via a stimulator, a first function involving a first computer that is independent of the stimulator, wherein the stimulator comprises a first communication interface to communicate with the first computer, wherein the first function comprises the stimulator receiving electrical stimulation therapy data from the first computer via a docking station, wherein the stimulator comprises a housing and an energy source positioned within the housing;

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

generating, via the stimulator, based at least in part on the electrical stimulation therapy data, an electric field sufficient to transmit an electric current non-invasively through the outer skin surface of the patient, wherein the electric current is sufficient to modulate a nerve at a target region within the patient; and

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

18. The method of claim 17, wherein the receiving is based at least in part on a receipt of the electrical stimulation therapy data from a remote source over a network via a docking station, a coupling of the docking station to the stimulator, and a transmission of the electrical stimulation therapy data to the stimulator.

19. The method of claim 18 further comprising transferring energy from the docking station to the stimulator.

20. The method of claim 17, wherein the receiving comprises a receipt of an authorization to the stimulator, wherein the authorization enables the stimulator to operate.

21. The method of claim 17, wherein the receiving comprises a receipt of dosing information via the stimulator.

22. The method of claim 21 wherein the dosing information comprises a duration of time in which the stimulator generates the electric field.

23. The method of claim 17, wherein the receiving comprises a receipt of information regarding the electric field to the stimulator.

24. The method of claim 23 wherein the information comprises an amplitude of the electric current.

25. The method of claim 17 wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

26. The method of claim 17 wherein the electric current is configured to generate the electric field at a vagus nerve of the patient 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.

27. The method of claim 17 further comprising:

sending information over a network from the stimulator to a computer, wherein the information relates at least in part to the generating.

28. A method comprising:

enabling a performance of a first function involving a nerve stimulation device and a first computer that is independent of the nerve stimulation device, wherein the nerve stimulation device comprises a first communication interface to communicate with the first computer, wherein the first function comprises the first computer sending an electronic authorization for a medical therapy to the nerve stimulation device such that the nerve stimulation device is able to receive via the base station the electronic authorization using the first communication interface and to transmit an electric current non-invasively through an outer skin surface of a patient, wherein the nerve stimulation device comprises a housing and an energy source positioned within the housing, wherein the electric current is sufficient to stimulate a nerve within the patient to treat a medical condition of the patient, and wherein the therapy is for the medical condition; and

enabling a performance of a second function involving the nerve stimulation device and a second computer that is independent of the nerve stimulation device, wherein the first function is distinct from the second function, wherein the first computer is distinct from the second computer, wherein the nerve stimulation device comprises a second communication interface to communicate with the second computer, wherein the second communication interface is distinct from the first communication interface.

29. The method of claim 28, wherein the sending further comprises transmitting data related to a treatment regimen to the nerve stimulation device, wherein the therapy is based at least in part on the regimen.

30. The method of claim 29, wherein the data comprises a duration of time in which the nerve stimulation device generates the electric current in a treatment.

31. The method of claim 30 wherein the data further comprises a number of treatments authorized for the nerve stimulation device.

32. The method of claim 31 wherein the data further comprises an amount of time between treatments.

33. The method of claim 29 wherein the data comprises a range of amplitudes of the electric current.

34. The method of claim 28, further comprising:

receiving information from the nerve stimulation device over a network.

35. The method of claim 34 wherein the information comprises data related to a time in which the nerve stimulation device was activated by the patient.

36. The method of claim 34 wherein the information comprises data related a duration in which the nerve stimulation device was activated by the patient.

37. The method of claim 34 wherein the information comprises data related to an amplitude generated by the nerve stimulation device.