VAGAL NERVE STIMULATION TO AVERT OR TREAT STROKE OR TRANSIENT ISCHEMIC ATTACK

• US 20130317580A1
• Filed: 07/29/2013
• Published: 11/28/2013
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Granted Patent: US 10,537,728 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• 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 treating or preventing a stroke and/or a transient ischemic attack in a patient, comprising:

positioning a device adjacent to a skin surface of the patient;

generating one or more electrical impulses with said device; and

transmitting the electrical impulses to selected nerve fibers in the patient, wherein the electrical impulses are sufficient to modify the nerve fibers, such that the stroke and/or transient ischemic attack in the patient is treated or prevented.

2. The method of claim 1 wherein the transmitting step comprises transmitting the electrical impulses from one or more electrodes through a conducting medium within the device.

3. The method of claim 1 wherein the electrical impulses are transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers.

4. The method of claim 3 further comprising generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve fiber at the target region, and wherein the electric field is not sufficient to substantially modulate a nerve or muscle between the outer skin surface and the target region.

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

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

7. The method of claim 6 wherein the electric field is less than about 100 V/m.

8. The method of claim 4 wherein the nerve fiber at the target region is at least about 0.5 cm to about 2 cm below an outer skin-surface of the patient.

9. The method of claim 1 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

10. The method of claim 1 wherein the electrical impulses comprise bursts of pulses with a frequency of about 1 to about 100 bursts per second.

11. The method of claim 10 wherein each burst contains about 1 to about 20 pulses.

12. The method of claim 10 wherein the pulses are full sinusoidal waves.

13. The method of claim 10 wherein each pulse is about 100 to about 1000 microseconds in duration.

14. The method of claim 13 wherein the duration of a pulse within a burst is about 200 microseconds, wherein the number of pulses per burst is from 4 to 6, and wherein the number of bursts per second is from 20 to 30.

15. The method of claim 1 wherein the selected nerve fibers control or modulate the release of GABA, norepinephrine, or serotonin.

16. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve 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.

17. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

18. The method of claim 1 wherein norepinephrine is released into a resting state neural network of the patient.

19. The method of claim 18 wherein the resting state network comprises a default mode network, an attentional network, a salience network, a part of an anterior insula and/or an anterior cingulate cortex, or a sensory-motor network.

20. The method of claim 1 wherein the treatment is for spatial neglect or for recovery of motor skills.

21. A device for treating or preventing a stroke or a transient ischemic attack in a patient, comprising:

a housing having an electrically permeable contact surface for contacting an outer skin surface of the patient;

an energy source within the housing configured to generate an electric field sufficient to transmit a shaped electric current through the outer skin surface of the patient to a nerve at a target region within the patient;

wherein the electric current is sufficient to treat or prevent the stroke or the transient ischemic attack in the patient.

22. The device of claim 21 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

23. The device of claim 22 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

24. The device of claim 21 wherein the energy source comprises a battery.

25. The device of claim 21 wherein the electric field comprises bursts of pulses with a frequency of about 1 to about 100 bursts per second.

26. The device of claim 25 wherein the electric field comprises bursts of about 1 to about 50 pulses per burst, with each pulse being about 50 to about 1000 microseconds in duration.

27. The device of claim 21 wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

28. The device of claim 21 wherein the housing is a handheld device configured for contacting a surface of the skin of a patient.

29. The device of claim 21 wherein the electrical current generates an electric field at the vagus nerve 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.

30. The device of claim 21 wherein the electrical current generates an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

31. The device of claim 30 wherein the inhibitory neurotransmitters comprise GABA, norepinephrine, or serotonin.

32. The device of claim 31 wherein norepinephrine is released into a resting state neural network of the patient.

33. The device of claim 32 wherein the resting state network comprises a default mode network, an attentional network, a salience network, a part of an anterior insula and/or an anterior cingulate cortex, or a sensory-motor network.

34. The device of claim 21 wherein the treatment is for spatial neglect or for the recovery of motor skills.