Devices and methods for treating medical disorders with evoked potentials and vagus nerve stimulation

• US 10,350,411 B2
• Filed: 08/09/2016
• Issued: 07/16/2019
• Est. Priority Date: 04/28/2013
• 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:
  US15/232,158
• Publication Number:
  US 20160346542A1
• Time in Patent Office: 1,071 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 5/7264 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 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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, systems and methods for treating medical disorders, such as migraine or other primary headaches, or fibromyalgia, by noninvasive electrical stimulation of a vagus nerve, used in conjunction with the measurement of evoked potentials (EPs). The system comprises a stimulator that is applied to the surface of the patient'"'"'s neck to apply electrical impulses sufficient to stimulate a cervical vagus nerve, scalp electrodes that are used to measure EPs that are evoked by that stimulation, feedback or biofeedback circuits to vary the stimulation based upon EP characteristics, and other sensory stimulation modalities that produce EPs. The system is preferably used to optimize the placement of the stimulator, to test whether a patient is a suitable candidate for treatment using vagus nerve stimulation, and to select the stimulation parameters that optimized acute or chronic treatment, e.g., by correcting an EP habituation deficit.

Claims

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

applying a first sensory stimulus to the patient;

measuring a first baseline evoked potential from the patient, wherein the first baseline potential is evoked by the first sensory stimulus;

applying an electrical impulse transcutaneously through an outer skin surface of the patient to a vagus nerve of the patient;

measuring a second evoked potential from the patient subsequent to the applying, wherein the second evoked potential relates to a response of the patient to the medical condition as a function of a characteristic of the electrical impulse;

comparing a characteristic of the first baseline evoked potential with a characteristic of the second evoked potential; and

determining, based on the comparing, whether the electrical impulse has triggered an action potential in the vagus nerve.

2. The method of claim 1, further comprising:

varying an amplitude of the electrical impulse based on the comparing.

3. The method of claim 1, further comprising:

varying a frequency of the electrical impulse based on the comparing.

4. The method of claim 1, wherein the applying comprises positioning an electrode in contact with the outer skin surface.

5. The method of claim 4, further comprising:

varying a position of the electrode on the outer skin surface based on the comparing.

6. The method of claim 4, further comprising:

varying an orientation of the electrode on the outer skin surface based on the comparing.

7. The method of claim 1, wherein the measuring comprises positioning an electrode on a scalp of the patient and measuring a voltage fluctuation arising from an ionic current within a brain of the patient.

8. The method of claim 1, further comprising:

measuring an acute response of the patient to the medical condition as a function of a characteristic of the electrical impulse; and

comparing the acute response with the first baseline evoked potential and the second evoked potential.

9. The method of claim 8, wherein the acute response comprises a reduction in pain.

10. The method of claim 1, wherein the sensory stimulus comprises at least one of a visual stimulus, an auditory stimulus, a somatosensory stimulus, a painful stimulus, an olfactory stimulus, a gustatory stimulus, a vestibular stimulus, or an interoceptive stimulus.

11. The method of claim 1, wherein the action potential in the vagus nerve is associated with an increase in a habituation of the second evoked potential compared to a habituation of the first baseline evoked potential.

12. The method of claim 1, wherein the action potential in the vagus nerve is associated with a deficit in a habituation of the second evoked potential compared to a habituation of the first baseline evoked potential.

13. The method of claim 1, wherein the medical condition comprises a primary headache.

14. A method for treating a medical condition in a patient, the method comprising:

applying a first sensory stimulus to the patient;

measuring a first baseline electrical potential from the patient, wherein the first baseline electrical potential is evoked by the first sensory stimulus;

applying an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient;

measuring an acute response of the patient to the medical condition as a function of a characteristic of the electrical impulse; and

comparing the acute response with the first baseline electrical potential.

15. The method of claim 14, further comprising varying an amplitude of the electrical impulse based on the comparing.

16. The method of claim 14 further comprising varying a frequency of the electrical impulse based on the comparing.

17. The method of claim 14 wherein the applying comprises positioning an electrode in contact with the outer skin surface.

18. The method of claim 17 further comprising varying a position of the electrode on the outer skin surface based on the comparing.

19. The method of claim 17 further comprising varying an orientation of the electrode on the outer skin surface based on the comparing.

20. The method of claim 14 wherein the first sensory stimulus comprises at least one of a visual stimulus, an auditory stimulus, a somatosensory stimulus, a painful stimulus, an olfactory stimulus, a gustatory stimulus, a vestibular stimulus, or an interoceptive stimulus.

21. The method of claim 14 further comprising determining, based on the comparing, whether the electrical impulse has triggered an action potential in the vagus nerve.

22. The method of claim 21 wherein the action potential in the vagus nerve is associated with an increase in a habituation of the acute response compared to a habituation of the first baseline electrical potential.

23. The method of claim 21 wherein the action potential in the vagus nerve is associated with a deficit in a habituation of the acute response compared to a habituation of the first baseline electrical potential.

24. The method of claim 14 wherein the medical condition comprises a primary headache.

25. The method of claim 24 wherein the acute response is a reduction in pain.

26. A method comprising:

measuring a first evoked potential from a patient having an outer skin surface and a vagus nerve, wherein the first evoked potential has a first characteristic and was evoked via a first sensory stimulus applied to the patient;

applying an electrical impulse transcutaneously through the outer skin surface to the vagus nerve after the first evoked potential has been measured;

measuring a second evoked potential from the patient responsive to the electrical impulse being applied, wherein the second evoked potential has a second characteristic, performing a comparison between the first characteristic and the second characteristic; and

taking an action based on the comparison being informative of the electrical impulse causing a response in the patient.

27. The method of claim 26, wherein the electrical impulse causes an action potential in the vagus nerve.