Nerve stimulator system

• US 10,363,419 B2
• Filed: 05/19/2017
• Issued: 07/30/2019
• Est. Priority Date: 11/04/2013
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Mendez, Steven
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/599,680
• Publication Number:
  US 20170259061A1
• Time in Patent Office: 802 Days
• Field of Search: 607 2, 607 60
• 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 treating at least one of a condition or a symptom of a patient by positioning a stimulation device at a target site adjacent to or near a nerve within a patient. The stimulation device comprising an antenna and one or more electrodes. Transmitting electrical energy to the antenna and generating electrical impulses within the stimulation device with the electrical energy and applying the series of electrical impulses to the nerve via the electrode. The electrical impulses sufficient to modulate the nerve and treat the condition or symptom of the patient; and which have on periods where the electrical impulses are generated and applied to the nerve and off periods between the electrical impulses, where the electrical energy is transmitted to the antenna.

Claims

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

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

storing the electrical energy from the input signal within the stimulation device via the storage device, wherein the electrical energy is delivered to the storage device only during a period of time at least one of when an electrical impulse is not being applied to the nerve, during a refractory period of the nerve, or between electrical impulses;

releasing the electrical energy from the storage device to the pulse generator;

generating the electrical impulse with the pulse generator with the electrical energy from the storage 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 symptom of the patient.

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 externally to the patient.

4. The method of claim 1, wherein the electrical impulse comprises a fixed amplitude, the method further comprising varying a duration of the electrical impulse via the stimulation device.

5. The method of claim 4, 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.

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

7. The method of claim 5, wherein the fixed amplitude of each of the one or more pulses is from about 1 Volt to about 20 Volt.

8. The method of claim 5, wherein the fixed amplitude of each of the one or more pulses is about 10 Volt.

9. The method of claim 5, wherein the fixed duration of each of the one or more pulses is from about 100 uS to about 400 uS.

10. The method of claim 5, wherein the fixed duration of each of the one or more pulses is about 200 uS.

11. The method of claim 5, wherein the duration of the electrical impulse is from about 200 uS to about 1000 uS.

12. The method of claim 5, wherein the duration of the electrical impulse occurs during a stimulation and rising phase of the nerve.

13. The method of claim 1, wherein the electrical energy is stored within a capacitor in the stimulating device.

14. The method of claim 13, wherein the carrier signal comprises a frequency from about 800 MHz to about 1.2 GHz.

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

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

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

19. The method of claim 1, wherein the stimulation device is positioned adjacent the vagus nerve.

20. A stimulation device for treating a condition or symptom of a patient, the stimulation device comprising:

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

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

a storage device coupled to the antenna and configured to store the electrical energy, wherein the electrical energy is delivered to the storage device only during a period of time at least one of when an electrical impulse is not being applied to the nerve, during a refractory period of the nerve, or between electrical impulses;

a pulse generator coupled to the storage device and configured to generate the electrical impulse upon release of the electrical energy from the storage device; and

an electrodes coupled to the pulse generator and configured to conduct the electrical impulse to the nerve sufficient to modulate the nerve.

21. The stimulation device of claim 20, wherein the antenna, storage device and pulse generator are housed within the enclosure.

22. The stimulation device of claim 20, wherein the antenna is configured to receive the input signal through electrical radiative coupling.

23. The stimulation device of claim 20, wherein the power source is located external to the patient.

24. The stimulation device of claim 20, wherein the electrical impulse comprises a fixed amplitude and a variable duration.

25. The stimulation device of claim 24, wherein the electrical impulse comprises one or more pulses each comprising 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.

26. The stimulation device of claim 25, wherein the fixed amplitude of each of the one or more pulses is from about 1 Volt to about 20 Volts.

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

28. The stimulation device of claim 25, wherein the fixed duration of each of the one or more pulses is from about 100 uS to about 400 uS.

29. The stimulation device of claim 25, wherein the fixed duration of each of the one or more pulses is about 200 uS.

30. The stimulation device of claim 24, wherein the variable duration of the electrical impulse occurs during a stimulation and rising phase of the nerve.

31. The stimulation device of claim 20, wherein the storage device is a capacitor.

32. The stimulation device of claim 20, wherein the input signal is received via a carrier signal comprising a frequency from about 300 MHz to about 6 GHz.

33. The stimulation device of claim 32, wherein the frequency is from about 800 MHz to about 1.2 GHz.

34. The stimulation device of claim 20, wherein the stimulation device is positioned adjacent the vagus nerve.