Nerve stimulation methods for averting imminent onset or episode of a disease

• US 10,252,074 B2
• Filed: 01/24/2012
• Issued: 04/09/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce, Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US13/357,010
• Publication Number:
  US 20120185020A1
• Time in Patent Office: 2,632 Days
• Field of Search: 607 45, 607 46, 607 48, 607149, 607150
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

Abstract

Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of averting imminent medical attacks using energy that is delivered noninvasively by the devices. The attacks comprise asthma attack, epileptic seizure, attacks of migraine headache, transient ischemic attack or stroke, onset of atrial fibrillation, myocardial infarction, onset of ventricular fibrillation or tachycardia, panic attack, and attacks of acute depression. The imminence of an attack is forecasted using grey-box or black-box models as used in control theory. A vagus nerve in the neck of a patient can be stimulated noninvasively to avert the attack.

Claims

1. A method of averting an onset of an acute medical event in a patient, the method comprising:

detecting a signal via a sensor, wherein the signal is at least one of physiological or environmental, wherein the signal is at least one of within, on, or about the patient, wherein the signal includes a value;

forecasting the onset of the acute medical event based at least in part on the value;

positioning a contact surface of a housing against an outer skin surface of a neck of the patient, wherein an electrical impulse generator is positioned within the housing and wherein the contact surface is integral with the housing;

generating an electrical impulse with the electrical impulse generator; and

transmitting, via the electrical impulse generator, based at least in part on the forecasting, the electrical impulse non-invasively and transcutaneously through the outer skin surface of the neck of the patient to a selected nerve fiber in the patient to treat the acute medical event, wherein the electrical impulse is sufficient to avert the acute medical event, wherein the acute medical event is selected from a group of events comprising an asthma attack, an epileptic seizure, an attack of migraine headache, a transient ischemic attack, an onset of atrial fibrillation, a myocardial infarction, an onset of ventricular fibrillation or tachycardia, a panic attack, and an attack of acute depression.

2. The method of claim 1, further comprising:

generating a shaped electrical impulse within the housing; and

wherein the transmitting comprises transmitting the shaped electrical impulse to the patient through a conducting medium positioned within the housing.

3. The method of claim 2, wherein the transmitting includes transcutaneously passing an electrical current through the outer skin surface of the neck of patient to a target region within the patient.

4. The method of claim 3, further comprising generating an electrical field at or near the contact surface and shaping the electrical field such that the electrical field is sufficient to modulate a nerve 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 4, wherein the electric field is not sufficient to produce movement of a skeletal muscle of the patient.

6. The method of claim 2, wherein the transmitting includes generating a magnetic field exterior to the patient sufficient to induce an electrical impulse at or near the selected nerve fiber within the patient.

7. The method of claim 1, wherein the electrical impulse is generated at or near the selected nerve fiber.

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

10. The method of claim 1, wherein the electrical impulse comprises bursts of pulses with a frequency from about 5 bursts to about 100 bursts per second (Hz).

11. The method of claim 10, wherein each of the bursts contains from about 1 pulse 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 of the pulses is from about 50 microseconds to about 1000 microseconds in duration.

14. A system for averting an acute medical event in a patient, the system comprising:

a sensor configured to sense a physiological or environmental signal, wherein the physiological or environmental signal is at least one of within, on, or about the patient, wherein the physiological or environmental signal comprises a value;

a controller coupled to the sensor, wherein the controller is configured to forecast an onset of the acute medical event based at least in part on the value;

a housing coupled to the controller and including an electrically permeable or conducting contact surface configured to contact an outer skin surface of the patient, wherein the contact surface is integral to the housing;

an energy source housed within the housing, wherein the energy source is configured to generate an electric field sufficient to transmit an electric current transcutaneously and non-invasively via the electrically permeable or conducting contact surface through the outer skin surface of the patient to a nerve at a target region within the patient; and

wherein the electric current is sufficient to avert or at least partially ameliorate an acute medical event, wherein the acute medical event is selected from a group of medical events comprising an asthma attack, an epileptic seizure, an attack of migraine headache, a transient ischemic attack or a stroke, an onset of atrial fibrillation, a myocardial infarction, an onset of ventricular fibrillation or a tachycardia, a panic attack, and an attack of acute depression.

15. The system of claim 14, wherein the energy source comprises a signal generator and an electrode coupled to the signal generator within the housing.

16. The system of claim 15, further comprising:

a conducting medium positioned within the housing between the electrode and the electrically permeable or conducting contact surface.

17. The system of claim 15, wherein the signal generator is configured to generate an electric field comprising bursts of pulses with a frequency from about 5 bursts to about 100 bursts per second.

18. The system of claim 15, wherein the electric field comprises bursts from about 1 pulse to about 20 pulses with each of the pulses from about 50 microseconds to about 1000 microseconds in duration.

19. The system of claim 14, wherein the energy source comprises a battery.

20. The system of claim 14, wherein the energy source comprises a toroid positioned within the housing, wherein the toroid is configured to generate a magnetic field sufficient to induce the electric field.

21. The system of claim 20, further comprising:

a conduction medium positioned within the housing between the toroid and the electrically permeable or conducting contact surface.

22. The system of claim 14, wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

23. The system of claim 14, wherein the housing is a handheld device configured to contact the outer skin surface of the patient.

24. The system of claim 14, wherein the outer skin surface of the patient lies over a vagus nerve.

25. A method comprising:

averting an onset of an acute medical event in a patient, via at least;

forecasting the onset of the acute medical event based at least in part on a value of a signal obtained from a sensor, wherein the signal is indicative of at least one physiological or environmental condition or event, and wherein the condition or event is detected within, on, or about the patient;

positioning a contact surface of a housing against an outer skin surface of a neck of the patient, wherein the electrical impulse generator is positioned within the housing and wherein the contact surface is integral with the housing;

generating an electrical impulse with the electrical impulse generator; and

transmitting, based at least in part on the forecasting, the electrical impulse non-invasively, via the neck of the patient, to a nerve fiber in the patient to at least partially treat the acute medical event, wherein the electrical impulse is sufficient to avert the acute medical event, wherein the acute medical event is selected from a group of events comprising an asthma attack, an epileptic seizure, an attack of migraine headache, a transient ischemic attack, an onset of atrial fibrillation, a myocardial infarction, an onset of ventricular fibrillation or tachycardia, a panic attack, and an attack of acute depression.