IP Library Granted Patent US 11,654,082
Granted Patent B2
US 11,654,082 · App. 17/363,620 · Granted May 23, 2023

Auricular peripheral nerve field stimulator and method of operating same

Inventors: Christopher R. Brown (Greensburg, IN); Gary M. Peterson (Versailles, IN)
Assignee: Neuraxis, Inc.
A61H39/002A61H39/02A61N1/0551A61N1/36135A61H2201/5005A61H2201/5007A61H2201/5023A61H2201/5033A61H2201/5038A61H2201/5058A61H2205/027A61H2230/105A61H2230/405A61H2230/505A61H2230/605
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Quick Facts
Patent No.
US 11,654,082
App. No.
17/363,620
Granted
May 23, 2023
Kind
B2
Abstract

An auricular peripheral nerve field stimulator includes at least one therapy electrode configured for percutaneous insertion into an auricle of a human ear near at least one neurovascular bundle, and an electrical stimulation device electrically coupled to the at least one therapy electrode, the electrical stimulation device programmed to generate and deliver electrical stimulation signals, with defined stimulation parameters, to the percutaneously inserted at least one therapy electrode to stimulate at least one auricular peripheral nerve field within the auricle, the defined stimulation parameters including a defined signal amplitude, a defined pulse frequency, a defined pulse width, a defined duty cycle and a defined stimulation signal duration.

Claims (29)

1. An auricular peripheral nerve field stimulator, comprising:

at least one therapy electrode configured for percutaneous insertion into an auricle of a human ear near at least one neurovascular bundle located therein, and

an electrical stimulation device electrically coupled to the electrical stimulation device, the electrical stimulation device programmed to generate and deliver electrical stimulation signals, with defined stimulation parameters, to the percutaneously inserted at least one therapy electrode to stimulate at least one auricular peripheral nerve field within the auricle, the defined stimulation parameters including a defined signal amplitude, a defined pulse frequency, a defined pulse width, a defined duty cycle and a defined stimulation signal duration.

2. The auricular peripheral nerve field stimulator of claim 1 , wherein the defined stimulation parameters include a defined signal repetition frequency.

3. The auricular peripheral nerve field stimulator of claim 1 , further comprising means for attaching the housing to or adjacent to the human ear.

4. The auricular peripheral nerve field stimulator system of claim 1 , further comprising one of a battery and an accumulator electrically coupled to the electrical stimulation device to supply the electrical stimulation device with electrical energy.

5. The auricular peripheral nerve field stimulator of claim 1 , further comprising a remote control device,

wherein operation of the electrical stimulator device is controllable via the remote control device.

6. The auricular nerve field stimulation device of claim 1 , wherein the defined signal amplitude is a constant current amplitude.

7. The auricular nerve field stimulation device of claim 1 , further comprising a reference electrode electrically coupled to the electrical stimulation device and configured for percutaneous insertion into a skin surface of or near the human ear, the reference electrode providing a reference for the electrical stimulation signals.

8. The auricular nerve field stimulation device of claim 2 , wherein the defined stimulation parameters include a total therapy duration during which the electrical stimulation signals are generated and delivered by the electrical stimulation device.

9. The auricular nerve field stimulation device of claim 1 , wherein the at least one therapy electrode includes at least one needle for percutaneous insertion into the auricle.

10. The auricular nerve field stimulation device of claim 1 , wherein the at least one therapy electrode comprises a plurality of therapy electrodes each electrically coupled to the electrical stimulation device and each including at least one needle for percutaneous insertion into the auricle.

11. A method for auricular peripheral nerve field stimulation, the method comprising:

locating at least one auricular neurovascular bundle within an auricle of a human ear,

percutaneously inserting at least one needle, carried by at least one therapy electrode, into the auricle near the at least one located auricular neurovascular bundle,

electrically coupling an electrical stimulation device to the at least needle of the at least one therapy electrode, and

controlling the electrical stimulation device to generate and deliver electrical stimulation signals, with defined stimulation parameters, to the percutaneously inserted at least one therapy electrode to stimulate at least one auricular peripheral nerve field within the auricle, the defined stimulation parameters including a defined signal amplitude, a defined pulse frequency, a defined pulse width, a defined duty cycle and a defined stimulation signal duration.

12. The method of claim 11 , wherein the defined stimulation parameters include a defined signal repetition frequency.

13. The method of claim 11 , wherein percutaneously inserting the at least one needle carried by the at least one therapy electrode into the auricle comprises percutaneously inserting the at least one needle into a ventral or dorsal aspect of the auricle within about 2 mm of the located neurovascular bundle.

14. The method of claim 11 , further comprising controlling operation of the electrical stimulation device with a remote control device.

15. The method of claim 11 , wherein the defined signal amplitude is a constant current amplitude.

16. The method of claim 11 , further comprising providing a reference for the electrical stimulation signals with a reference electrode electrically coupled to the electrical stimulation device and configured for percutaneous insertion into a skin surface on or near the human ear.

17. The method of claim 12 , wherein the defined stimulation parameters include a total therapy duration during which the electrical stimulation signals are generated and delivered by the electrical stimulation device.

18. The method of claim 11 , wherein controlling the electrical stimulation device comprises controlling the electrical stimulation device to generate and deliver the electrical stimulation signals in the form of a pulse train having a repetition frequency of at least one of +1 Hz, −1 Hz, +10 Hz and −10 Hz.

19. The method of claim 11 , wherein controlling the electrical stimulation device comprises controlling the electrical stimulation device to generate and deliver the electrical stimulation signals in the form of a pulse train having a repetition frequency of between about 0.5 Hz to 100 Hz.

20. The method of claim 11 , wherein percutaneously inserting at least one needle comprises inserting at least one needle of each of a plurality of therapy electrodes into the auricle near one or more located auricular neurovascular bundles within the auricle,

wherein electrically coupling an electrical stimulation device to the at least needle comprises electrically coupling the electrical stimulation device to the at least one needle of each of the plurality of therapy electrodes,

and wherein controlling the electrical stimulation device to generate and deliver electrical stimulation signals to the percutaneously inserted at least one needle comprises controlling the electrical stimulation device to generate and deliver electrical stimulation signals to the percutaneously inserted at least one needle of each of the plurality of therapy electrodes.

Assignments (1)
CHANGE OF NAME Recorded Jun 10, 2022
From: INNOVATIVE HEALTH SOLUTIONS, INC.
To: NEURAXIS, INC.
Reel/Frame 060335/0195 →
Continuity (7)
Continuation 16408004 · May 9, 2019
Continuation 16014169 · Jun 21, 2018
Continuation 15811278 · Nov 13, 2017
Continuation 15595185 · May 15, 2017
Continuation 14277158 · May 14, 2014
Provisional Application 61894270 · Oct 22, 2013
Related Publication 20210322268A1 · Oct 21, 2021
Cited By (1)
US 12,377,272