Devices and methods for nerve stimulation

Patent metadata

Field	Value
Publication number	US-11147961-B2
Application number	US-202016837812-A
Country	US
Kind code	B2
Filing date	Apr 1, 2020
Priority date	Aug 19, 2010
Publication date	Oct 19, 2021
Grant date	Oct 19, 2021

Abstract

Methods and devices for stimulating a nerve in a patient include emitting an electrical signal near a target nerve within the patient. The electrical signal comprises bursts with a frequency of 1 to 100 Hz. Each of the bursts has 2 to 20 pulses with a duration of about 50 microseconds to about 1000 microseconds.

First claim

The invention claimed is:

1. A method comprising:
generating an electrical signal within a housing having a lead extending therefrom;
positioning the lead near, or in operational proximity to, a spinal nerve;
emitting the electrical signal near, or in operational proximity to, the spinal nerve such that the patient experiences at least some pain relief;
wherein the electrical signal generated within the housing comprises bursts of pulses, wherein each burst of pulses comprises a burst period and a constant period, wherein each burst period and constant period together have a combined frequency of about 15 Hz to about 50 Hz, wherein each of the burst periods comprises 2 pulses to 20 pulses; and
wherein each of the pulses has a duration of about 50 microseconds to about 1000 microseconds.

2. The method of claim 1 , wherein at least one of the pulses has a duration of about 100 microseconds to about 400 microseconds.

3. The method of claim 1 , wherein at least one of the pulses has a duration of about 200 microseconds.

4. The method of claim 1 , wherein each of the burst periods comprises 4 to 10 pulses.

5. The method of claim 1 , wherein each of the burst periods comprises 5 pulses.

6. The method of claim 1 , wherein the lead includes an electrode, wherein emitting the electrical signal comprises positioning the electrodes near, or in operational proximity to, the spinal nerve.

7. The method of claim 1 , wherein the patient has a lower back, wherein the spinal nerve is located in the lower back.

8. The method of claim 1 , wherein the electrical signal induces an electric field at, or near, the spinal nerve, wherein the electric field has a magnitude of about 10 to about 600 V/m.

9. The method of claim 1 , wherein the electrical signal induces an electric field gradient at, or near, the nerve, wherein the electric field gradient has a magnitude of at least about 2 V/m/mm.

10. The method of claim 1 , wherein the electrical signal comprises a current having an amplitude of greater than 0 mA and less than about 40 mA.

11. The method of claim 1 , wherein each of the burst periods has a duration of less than about 20,000 microseconds.

12. The method of claim 1 , wherein each of the burst periods has a duration of less than about 10,000 microseconds.

13. The method of claim 1 , wherein each of the burst periods has a duration of less than about 5,000 microseconds.

14. The method of claim 1 , wherein each of the burst periods has a duration of less than about 2,000 microseconds.

15. The method of claim 1 , wherein each of the burst periods has a duration of less than about 1,000 microseconds.

16. The method of claim 1 , wherein each of the constant periods have a longer duration than each of the burst periods.

17. The method of claim 16 further comprising varying a voltage such that a charge of an electric field emitted during each of the burst periods alternates between positive and negative.

18. The method of claim 17 , wherein the electric field emitted during the constant periods has a magnitude of zero.

19. A device comprising:
a housing;
a lead extending from the housing, wherein the lead is configured to be positioned near, or in operational proximity to, a spinal nerve within a patient;
a source of energy positioned within the housing and operably coupled to the lead; and
a signal generator configured for generating an electrical signal via the lead towards the spinal nerve such that the patient experiences at least some pain relief, wherein the electrical signal comprises bursts of pulses, wherein each burst of pulses comprises a burst period and a constant period, wherein the burst period and the constant period together have a combined frequency of about 15 Hz to about 50 Hz, wherein each of the burst periods comprises 2 pulses to 20 pulses, wherein each of the pulses has a duration of about 50 microseconds to about 1,000 microseconds.

20. The device of claim 19 , wherein at least one of the pulses has a duration of about 100 microseconds to about 400 microseconds.

21. The device of claim 19 , wherein each of the burst periods comprises 4 to 10 pulses.

22. The device of claim 19 , wherein the source of energy comprises a power supply and a signal generator, wherein the power supply is operably coupled to the signal generator, wherein the signal generator is operably coupled to the lead.

23. The device of claim 22 , wherein the signal generator generates the electrical signal at a duty cycle, wherein the duty cycle comprises an ON time of about 30 seconds to about 5 minutes and an OFF time of about 30 seconds to about 5 minutes.

24. The device of claim 19 wherein each of the constant periods have a longer duration than each of the burst periods and wherein the source of energy varies a voltage such that a charge of an electric field emitted during each of the burst periods alternates between positive and negative.

25. The device of claim 24 , wherein the electric field emitted during the constant periods has a magnitude of zero.

26. The device of claim 19 , wherein at least one of the pulses has a duration of about 200 microseconds.

27. The device of claim 19 , wherein each of the burst periods comprises 5 pulses.

Assignees

• Electrocore Inc

Inventors

• Simon Bruce J
• Errico Joseph P
• Raffle John T

Classifications

• A61N1/40

  Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals} · CPC title

• A61N1/36053

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title

• A61N2/006

  for magnetic stimulation of nerve tissue · CPC title

• A61N1/36034

  specified by the stimulation parameters · CPC title

• A61N1/0456 Primary

  Specially adapted for transcutaneous electrical nerve stimulation [TENS] · CPC title