Nerve stimulator system

• US 9,205,258 B2
• Filed: 11/04/2013
• Issued: 12/08/2015
• Est. Priority Date: 11/04/2013
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Mendez, Steven
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/071,577
• Publication Number:
  US 20150127068A1
• Time in Patent Office: 764 Days
• Field of Search: 607/60
• US Class Current: 1/1
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Devices, systems and methods for applying electrical impulse(s) to one or more selected nerves are described. An electrical stimulator is introduced through a to a target location within, adjacent to, or in close proximity with, the carotid sheath. The stimulator has an antenna that allows it to be powered solely by far-field or approximately plane wave electromagnetic radiation, having frequencies in the range of 0.3 to 10 GHz. Electrical impulses are applied through the stimulator to a vagus nerve to stimulate, block or otherwise modulate activity of the nerve and treat the patient'"'"'s condition. The stimulator uses an adjustable number of fixed voltage (or fixed current) pulses with fixed duration to elicit desired changes in nerve response, the timing of which are controlled by an external power transmitter and controller.

Claims

1. A method for treating a condition or a symptom of a patient, the method comprising:

receiving an input signal wirelessly from a controller at a stimulation device positioned at a target site adjacent to or near a nerve within a neck of the patient, wherein the input signal contains electrical energy, wherein the stimulation device comprises an antenna, a storage device coupled to the antenna, and an electrode, wherein the antenna receives the input signal, wherein the storage device stores the electrical energy;

generating an electrical impulse within the stimulation device with the electrical energy from the storage device, wherein the electrical impulse comprises a fixed amplitude;

varying a duration of the electrical impulse via the stimulation device; and

applying the electrical impulse to the nerve via the electrode, wherein the electrical impulse is sufficient to modulate the nerve and treat the condition or the symptom.

2. The method of claim 1, wherein the controller is located remotely from the stimulation device and the receiving is through electrical radiative coupling.

3. The method of claim 2, wherein the controller is located external to the patient.

4. The method of claim 1, wherein the electrical impulse comprises one or more pulses, wherein each of the one or more pulses comprises a fixed amplitude and a fixed duration, and wherein the electrical impulse comprises a duration equal to a combined duration of the fixed duration of each of the one or more pulses.

5. The method of claim 4, wherein the varying is by varying a number of the one or more pulses within the electrical impulse.

6. The method of claim 1, further comprising:

storing the electrical energy from the input signal within the stimulation device via the storage device; and

releasing the electrical energy from the storage device to a pulse generator within the stimulation device to generate the electrical impulse, wherein the pulse generator is coupled to the electrode.

7. The method of claim 6, wherein the electrical energy is stored within a capacitor in the stimulation device, wherein the storage device comprises the capacitor.

8. The method of claim 7, wherein the electrical energy is stored during a period of time between a generation of electrical impulses.

9. The method of claim 1, wherein the electrical impulse comprises a fixed voltage.

10. The method of claim 1, wherein the electrical impulse comprises a fixed current.

11. The method of claim 4, wherein the fixed amplitude of each of the one or more pulses is from about 1 V to about 20 V.

12. The method of claim 4, wherein the fixed amplitude of each of the one or more pulses is about 10 V.

13. The method of claim 4, wherein the fixed duration of each of the one or more pulses is from about 100 uS to about 400 uS.

14. The method of claim 4, wherein the fixed duration of each of the one or more pulses is about 200 uS.

15. The method of claim 4, wherein the duration of the electrical impulse is from about 200 uS to about 1000 uS.

16. The method of claim 4 wherein the duration of the electrical impulse occurs during a stimulation and rising phase of the nerve.

17. The method of claim 2, wherein the input signal is received via a carrier signal comprising a frequency from about 300 MHz to about 6 GHz.

18. The method of claim 17, wherein the carrier signal comprises a frequency from about 800 MHz to about 1.2 GHz.

19. The method of claim 1, wherein the electrical impulse comprises a frequency from about 1 Hz to about 50 Hz.

20. The method of claim 1 wherein the electrical impulse generates an electric field at a 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.

21. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator, wherein the electrical impulse comprises one or more pulses, wherein each of the one or more pulses comprises a fixed amplitude and a fixed duration, wherein the electrical impulse comprises a duration equal to a combined duration of the fixed duration of each of the one or more pulses, wherein the fixed amplitude of each of the one or more pulses is from about 1 V to about 20 V; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve.

22. The stimulation device of claim 21, wherein the antenna is housed within the enclosure.

23. The stimulation device of claim 21, wherein the pulse generator is configured to vary a number of the one or more pulses within the electrical impulse to vary the duration of the electrical impulse.

24. The stimulation device of claim 21, wherein the storage device is a capacitor configured to store the electrical energy during a period of time between a generation of electrical impulses via the pulse generator.

25. The stimulation device of claim 21, wherein the fixed amplitude of each of the one or more pulses is about 10 V.

26. The stimulation device of claim 21, wherein the input signal is received from the power source through electrical radiative coupling on a carrier signal comprising a frequency from about 300 MHz to about 6 GHz.

27. The stimulation device of claim 21, wherein the electrical impulse comprises a frequency from about 1 Hz to about 50 Hz.

28. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve, wherein the electrical impulse comprises a fixed voltage.

30. The stimulation device of claim 28, wherein the fixed amplitude of each of the one or more pulses is from about 1 V to about 20 V.

29. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve, wherein the electrical impulse comprises a fixed current.

31. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve, wherein the electrical impulse comprises one or more pulses, wherein each of the one or more pulses comprises a fixed amplitude and a fixed duration, wherein the electrical impulse comprises a duration equal to a combined duration of the fixed duration of each of the one or more pulses, wherein the fixed duration of each of the one or more pulses is from about 100 uS to about 400 uS.

32. The stimulation device of claim 31, wherein the fixed duration of each of the one or more pulses is about 200 uS.

33. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve, wherein the electrical impulse comprises one or more pulses, wherein each of the one or more pulses comprises a fixed amplitude and a fixed duration, wherein the electrical impulse comprises a duration equal to a combined duration of the fixed duration of each of the one or more pulses, wherein the duration of the electrical impulse is from about 200 uS to about 1000 uS.

34. A stimulation device for treating a condition of a patient, the stimulation device comprising:

an enclosure configured for positioning adjacent to or near a nerve within a neck of the patient;

an antenna configured to receive an input signal from a power source located remotely from the enclosure, wherein the input signal comprises electrical energy, wherein the enclosure comprises the antenna;

a storage device coupled to the antenna, wherein the storage device is configured to store the electrical energy, wherein the enclosure comprises the storage device;

a pulse generator coupled to the storage device, wherein the pulse generator is configured to generate an electrical impulse based on the electrical energy stored in the storage device, wherein the electrical impulse comprises a fixed amplitude and a variable duration, wherein the enclosure comprises the pulse generator; and

one or more electrodes housed within the enclosure and coupled to the pulse generator, wherein the one or more electrodes is configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve, wherein the electrical impulse comprises one or more pulses, wherein each of the one or more pulses comprises a fixed amplitude and a fixed duration, wherein the electrical impulse comprises a duration equal to a combined duration of the fixed duration of each of the one or more pulses, wherein the duration of the electrical impulse occurs during a stimulation and rising phase of the nerve.

35. A method for facilitating a treatment of at least one of a condition or a symptom of a patient, the method comprising:

sending an input signal wirelessly from a controller to a stimulation device positioned at a target site adjacent to or near a nerve within a neck of the patient, wherein the input signal contains electrical energy, wherein the stimulation device comprises an antenna, a storage device coupled to the antenna, and an electrode, wherein the antenna is configured to receive the input signal, wherein the storage device is configured to store the electrical energy, wherein the stimulation device is configured to generate an electrical impulse within the stimulation device with the electrical energy from the storage device, wherein the electrical impulse is configured to comprise a fixed amplitude, wherein the stimulation device is configured to vary a duration of the electrical impulse, wherein the electrode is configured to apply the electrical impulse to the nerve, wherein the electrical impulse is configured to be sufficient to modulate the nerve and treat at least one of the condition or the symptom.