Vagal nerve stimulation to avert or treat stroke or transient ischemic attack

• US 10,537,728 B2
• Filed: 07/29/2013
• Issued: 01/21/2020
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): Bays, Pamela M.
• Application Number:
  US13/952,859
• Publication Number:
  US 20130317580A1
• Time in Patent Office: 2,367 Days
• Field of Search: 607 41, 607 42, 607115, 607116, 607117, 607118
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• 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

Abstract

Devices, systems and methods are disclosed for treating or preventing a stroke and/or a transient ischemic attack in a patient. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve. Vagus nerve stimulation is used to modulate the release of GABA, norepinephrine, and/or serotonin, thereby providing neuroprotection to the patient; to modulate the activity of resting state neuronal networks, particularly the sensory-motor network or resting state networks containing the insula; and to avert a stroke or transient ischemic attack that has been forecasted.

Claims

1. A method of at least one of treating or preventing at least one of a stroke or a transient ischemic attack in a patient, the method comprising:

contacting a contact surface of a housing against an outer skin surface of a neck of the patient, wherein the housing includes a power source coupled to the contact surface;

generating, with the power source, at least one or more electrical impulse; and

transmitting the at least one electrical impulse transcutaneously and non-invasively from the contact surface through the outer skin surface of the neck to a selected nerve fiber in the patient during the contacting, wherein the at least one electrical impulse comprises bursts of pulses with each burst having a frequency of about 1 to about 100 bursts per second and each pulse having a duration of about 100 to about 1000 microseconds in duration, and wherein the at least one electrical impulse is sufficient to modify the nerve fiber, such that at least one of the stroke or the transient ischemic attack in the patient is at least one of treated or prevented.

2. The method of claim 1, wherein the transmitting comprises transmitting the at least one electrical impulse through a conducting medium stored within the housing.

3. The method of claim 1, further comprising:

generating an electric field at or near the housing; and

shaping the electric field such that the electric field is sufficient to modulate a nerve fiber at a target region, and wherein the electric field is insufficient to substantially modulate at least one of a nerve or a muscle between the outer skin surface and the target region.

4. The method of claim 3 wherein the electric field at the nerve fiber at the target region is from about 10 V/m to about 600 V/m.

5. The method of claim 4 wherein the electric field is less than about 100 V/m.

6. The method of claim 3, wherein the at least one electrical impulse generated by the power source comprises a sufficient amplitude to pass through the outer skin surface to the nerve fiber at the target region that is at least from about 0.5 cm to about 2 cm below the outer skin surface.

7. The method of claim 1, wherein the power source comprises a signal generator, and one or more electrodes coupled to the signal generator.

8. The method of claim 1, wherein the selected nerve fiber is associated with a vagus nerve of the patient.

9. The method of claim 8, wherein the at least one electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within at least one of an A fiber or a B fiber of the vagus nerve and below a threshold for generating an action potential within a C fiber of the vagus nerve.

10. The method of claim 8, wherein the at least one electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within a fiber of the vagus nerve responsible for activating a neural pathway causing a release of an inhibitory neurotransmitter within a brain of the patient.

11. The method of claim 10, wherein the inhibitory neurotransmitter includes at least one of GABA, norepinephrine, or serotonin.

12. The method of claim 1, wherein each of the bursts contains from about 2 pulses to about 20 pulses.

13. The method of claim 1 wherein the pulses are full sinusoidal waves.

14. The method of claim 1, wherein the duration of a pulse of the pulses within a burst of the bursts is about 200 microseconds, wherein a number of the pulses per burst of the bursts is from about 4 to about 6, and wherein the number of the bursts per second is from about 20 to about 30.

15. The method of claim 1, wherein at least one of the stroke or the transient ischemic attack in the patient is treated via a treatment for at least one of a spatial neglect or for a recovery of a motor skill.

16. The method of claim 1, wherein the power source comprises an electrical impulse generator coupled to the contact surface, wherein the generating comprises the electrical impulse generator generating the one or more electrical impulses.

17. The method of claim 1, wherein the contacting is below a skull of the patient.

18. The method of claim 1, wherein the contacting is between a collar bone of the patient and a jaw bone of the patient.

19. A method of at least one of treating or preventing at least one of a stroke or a transient ischemic attack in a patient, the method comprising:

contacting a contact surface of a housing against an outer skin surface of a neck of the patient, wherein the housing comprises a generator coupled to the contact surface and an energy source coupled to the generator;

generating an electrical impulse via the generator; and

transmitting the electrical impulse transcutaneously and non-invasively from the contact surface through the outer skin surface of the neck of the patient to a nerve fiber in the patient during the contacting, wherein the electrical impulse comprises bursts of about 2 to 20 pulses with each of the bursts having a frequency from about 1 burst per second to about 100 bursts per second and with each of the pulses having a duration from about 100 microseconds to about 1000 microseconds, and wherein the electrical impulse is sufficient to modify the nerve fiber such that at least one of the stroke or the transient ischemic attack is at least one of treated or prevented.