Devices and methods for monitoring non-invasive vagus nerve stimulation

• US 10,335,593 B2
• Filed: 02/08/2016
• Issued: 07/02/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Hulbert, Amanda K
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US15/018,805
• Publication Number:
  US 20160151628A1
• Time in Patent Office: 1,240 Days
• Field of Search: 607 45
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/394 specially adapted for electroglottography or electropalatography
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4803 Speech analysis specially adapted for diagnostic purposes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/687 Oesophagus
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• 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: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

Devices and methods are disclosed that treat a medical condition, such as migraine headache, by electrically stimulating a nerve noninvasively, which may be a vagus nerve situated within a patient'"'"'s neck. Preferred embodiments allow a patient to self-treat his or her condition. Disclosed methods assure that the device is being positioned correctly on the neck and that the amplitude and other parameters of the stimulation actually stimulate the vagus nerve with a therapeutic waveform. Those methods comprise measuring properties of the patient'"'"'s larynx, pupil diameters, blood flow within an eye, electrodermal activity and/or heart rate variability.

Claims

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

contacting an outer skin surface of the patient with a contact surface of a housing;

generating an electrical impulse within the housing;

transmitting, as the contact surface contacts the outer skin surface, the electrical impulse from the housing, non-invasively, through the outer skin surface, to a nerve at a target region within the patient such that the electrical impulse modulates the nerve;

measuring a physiological response of the patient, wherein the physiological response is directly associated with modulation of the nerve based on the transmitting; and

detecting, based on the physiological response, whether the electrical impulse was transmitted to the nerve.

2. The method of claim 1, wherein the measuring is carried out by measuring a property of a voice of the patient, wherein the nerve is a vagus nerve.

3. The method of claim 1, wherein the measuring is carried out by measuring a laryngeal electromyographic signal of the patient.

4. The method of claim 1, wherein the measuring is carried out by measuring an electroglottographic signal of the patient.

5. The method of claim 1, wherein the measuring is carried out by measuring at least one of a pupil diameter or a blood flow within an eye of the patient.

6. The method of claim 1, wherein the measuring is carried out by measuring at least one of electrodermal activity or heart rate variability.

7. The method of claim 1, wherein the measuring is carried out by measuring a property of an autonomic nervous system of the patient.

8. The method of claim 1, wherein the measuring is carried out by measuring a vagal artery blood flow of the patient.

9. The method of claim 1, wherein the measuring is carried out by measuring a cerebral blood flow of the patient.

10. The method of claim 1, wherein the measuring is carried out by measuring at least one of an evoked potential or an electroencephalogram of the patient.

11. The method of claim 1, wherein the measuring is carried out by measuring at least one of a pain threshold, a sway, or a chemical within blood of the patient.

12. The method of claim 1, wherein the measuring step is carried out by detecting fluorescent material that has been applied onto or under a skin of the patient.

13. The method of claim 1, wherein the measuring step is carried out with at least one of an accelerometer or a gyroscope.

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

15. The method of claim 14, wherein the pulses have a duration of about 50 to about 1000 microseconds.

16. The method of claim 1, wherein the contacting is carried out by contacting an outer skin surface of a neck of the patient.

17. A method of testing a nerve stimulator, the method comprising:

generating an electrical impulse within a housing;

transmitting, as the housing is in contact with an outer skin surface of a patient, the electrical impulse from the housing, non-invasively, through the outer skin surface to a nerve at a target region within the patient;

measuring a physiological response of the patient, wherein the physiological response is directly associated with the transmitting; and

detecting, based on the physiological response, whether the electrical impulse modulates the nerve, wherein the nerve is a vagus nerve.