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

• US 10,220,207 B2
• Filed: 10/19/2012
• Issued: 03/05/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US13/655,716
• Publication Number:
  US 20130066395A1
• Time in Patent Office: 2,328 Days
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3603 Control systems
• 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 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• 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 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Systems, devices and methods for averting imminent medical attacks comprise transcutaneous electrical and magnetic nerve stimulation devices using energy that is delivered non-invasively to the patient. One or more sensors detect physiological and/or environmental signals within a patient and the values of these signals are used to forecast an acute medical event, which can be treated via non-invasive nerve stimulation. The acute medical events may comprise, among others, bronchoconstriction, epileptic seizures, primary headache, such as migraine or cluster headaches, transient ischemic attack or stroke, onset of atrial fibrillation, myocardial infarction, and acute depression or anxiety.

Claims

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

sensing a signal by 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 comprises a value;

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

positioning a portion of a housing in contact with a skin surface of a neck of the patient, wherein the portion of the housing comprises a contact surface and the housing comprises an electrical impulse generator;

generating an electrical impulse within the housing; and

transmitting, based at least in part on the forecasting, the electrical impulse from the housing via the contact surface transcutaneously and non-invasively through the skin surface of the neck of the patient to a vagus nerve in the patient to treat the acute medical event.

2. The method of claim 1, wherein the housing contains a conducting medium, wherein the transmitting is through the conducting medium.

3. The method of claim 1, wherein the electrical impulse is sufficient to avert the acute event selected from a group of events comprising an asthma attack, an epileptic seizure, an attack of a migraine headache, a transient ischemic attack or a stroke, an onset of an atrial fibrillation, a myocardial infarction, an onset of a ventricular fibrillation or a tachycardia, a panic attack, and an attack of acute depression.

4. 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 at the target region; and

wherein the electric field is not sufficient to substantially modulate a nerve or muscle between the skin surface and the target region.

5. The method of claim 1, wherein the transmitting comprises generating a magnetic field exterior to the patient sufficient to induce an electrical impulse at or near the vagus nerve.

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

7. The method of claim 6, wherein each of the bursts contains from about 1 pulse to about 20 pulses.

8. The method of claim 6 wherein the pulses are full sinusoidal waves.

9. The method of claim 6, wherein each of the pulses is from about 50 microseconds to about 1000 microseconds in duration.

10. The method of claim 1 wherein the physiological signal monitors one or more of:

a heart rate or a heart rate variability, an ECG or an arrhythmia, an EEG or a sleep state, a brain function, a respiration, a component of breath, a core temperature, an hydration, a volume, a blood pressure, a blood flow, a blood oxygenation, an EMG, a patient motion, a posture, a gait, a skin conductance or a skin temperature.

11. The method of claim 1 wherein the environmental signal monitors one or more of:

a formaldehyde, a carbon monoxide, a carbon dioxide, an ozone, a nitrogen oxide, a sulfur oxide, a total volatile organic compounds, an ammonia, an airborne particles or a dust, a pollen, a mold, an animal dander, a dust mites, a smoke particulates, an ambient temperature, an ambient humidity, an ambient light, or an ambient sound.

12. The method of claim 1, wherein the forecasting is based at least in part on a model selected from:

an autoregressive model, a principal component model, a Kalman filter, a wavelet transform model, a hidden Markov model, an artificial neural network, or a support vector machine.

13. The method of claim 1, wherein the forecasting is based at least in part on a black-box model or a gray-box model.

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

a sensor configured to sense a physiological signal, wherein the physiological signal is at least one of within, on, or about the patient, wherein the physiological 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 comprising an electrically permeable or conducting contact surface configured to contact an outer skin surface of a neck of the patient, wherein the electrically permeable or conducting contact surface is integral with 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 via the electrically permeable or conducting contact surface transcutaneously and non-invasively through the outer skin surface of the neck of the patient to a vagus nerve at a target region within the patient; and

wherein the electric current is sufficient to avert or at least partially ameliorate the acute medical event selected from a group of medical events comprising an asthma attack, an epileptic seizure, an attack of a migraine headache, a transient ischemic attack or a stroke, an onset of an atrial fibrillation, a myocardial infarction, an onset of a 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 housed within the housing between the electrode and the electrically permeable 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 per second to about 100 bursts per second.

18. The system of claim 17, 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 housed 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 housed within the housing between the toroid and the electrically permeable contact surface.

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

23. A method comprising:

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

forecasting 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; and

transcutaneously and non-invasively transmitting, based at least in part on the forecasting, one or more electrical impulses to a vagus nerve in a neck of the patient to treat the acute medical event, wherein the transmitting is via a contact surface of a housing, wherein the housing containing an energy source configured to generate the one or more electrical impulses, wherein the housing is in contact with the neck during the transmitting, and wherein the housing is integral with the contact surface.