IP Library Granted Patent US 12,053,631
Granted Patent B2
US 12,053,631 · App. 17/318,824 · Granted Aug 6, 2024

Devices and methods for determining the effectiveness of electrical stimulation

Inventors: Bruce J. Simon (Mountain Lakes, NJ); Joseph P. Errico (Warren, NJ)
Assignee: ELECTROCORE, INC
A61N1/36021A61B5/394A61B5/4035A61B5/4041A61B5/4803A61B5/4836A61B5/7264A61B5/7267A61N1/0456A61N1/36031A61N1/36034A61B5/02405A61B2090/3941A61N1/40
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Quick Facts
Patent No.
US 12,053,631
App. No.
17/318,824
Granted
Aug 6, 2024
Kind
B2
Abstract

Methods for treating medical disorders, such as migraine or other primary headaches, or fibromyalgia, by electrical stimulation of a nerve. The method comprises applying a first stimulus to a patient having a medical condition and measuring a first baseline physiological response from the patient. An electrical impulse is applied to a nerve within the patient and second stimulus is applied to the patient. A second physiological response evoked by the second stimulus is measured and compared to the first baseline physiological response. The methods may be used to optimize the placement of a stimulator, to test whether a patient is a suitable candidate for treatment using nerve stimulation, and/or to select the stimulation parameters that optimize acute or chronic treatment.

Claims (29)

1. A method comprising:

applying a first stimulus to a patient having a medical condition;

measuring a first baseline physiological response from the patient;

applying an electrical impulse to a nerve within the patient;

applying a second stimulus to the patient;

measuring a response of the patient to the second stimulus, wherein the response comprises a second physiological response evoked by the second stimulus, wherein the second baseline physiological response comprises a reduction in pain of the patient; and

comparing the second physiological response to the first baseline physiological response.

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

3. The method of claim 1 , wherein the nerve is a vagus nerve.

4. The method of claim 1 , wherein the treatment comprises applying an electrical impulse transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient.

5. The method of claim 4 , further comprising varying a plurality of different parameters of the electrical impulse based on comparing the response to the first baseline physiological response to determine whether the patient is a responder to the different parameters.

6. The method of claim 5 , wherein the different parameters comprise at least one of an amplitude or a frequency of the electrical impulse.

7. The method of claim 5 , wherein the different parameters comprise applying the electrical impulse to a different location on the patient.

8. The method of claim 5 , wherein the different parameters comprise applying the electrical impulse via a different orientation on the patient.

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

10. The method of claim 1 , further comprising determining whether the nerve has fired an action potential based on the electrical impulse.

11. The method of claim 1 , further comprising determining whether the patient is a responder to the electrical impulse based on the first and second physiological responses.

12. A method comprising:

applying a stimulus to a patient having a medical condition;

measuring a first baseline physiological response from the patient;

applying an electrical impulse to a nerve within the patient in multiple doses per day for a period of time greater than 1 day and less than 3 months;

measuring a second baseline physiological response from the patient, wherein the second baseline physiological response is measured after the electrical impulse has been applied for multiple doses per day for a period greater than one day; and

comparing the second baseline physiological response to the first baseline physiological response.

13. The method of claim 12 , wherein the stimulus comprises at least one of a visual, auditory, somatosensory, painful, olfactory, gustatory, vestibular, or interoceptive stimulus.

14. The method of claim 12 , wherein the medical condition comprises a primary headache.

15. The method of claim 12 , wherein the second baseline physiological response comprises a reduction in pain of the patient.

16. The method of claim 12 , wherein the second baseline physiological response comprises a reduction in a number of headache days of the patient.

17. The method of claim 12 , wherein the electrical impulse increases a habituation of the second physiological response.

18. The method of claim 12 , wherein the electrical impulse is applied transcutaneously through an outer skin surface of a neck of the patient to a vagus nerve of the patient.

Assignments (2)
SECURITY INTEREST Recorded Aug 12, 2025
From: ELECTROCORE, INC.
To: AVENUE VENTURE OPPORTUNITIES FUND II, L.P.
Reel/Frame 072452/0559 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2021
From: ELECTROCORE, LLC
To: ELECTROCORE, INC
Reel/Frame 056220/0715 →
Continuity (5)
Continuation 16511953 · Jul 15, 2019
Continuation 15232158 · Aug 9, 2016
Division 14212992 · Mar 14, 2014
Continuation In Part 13872116 · Apr 28, 2013
Related Publication 20210330972A1 · Oct 28, 2021