IP Library Granted Patent US 11,376,430
Granted Patent B2
US 11,376,430 · App. 17/066,404 · Granted Jul 5, 2022

Auricular nerve stimulation to address patient disorders, and associated systems and methods

Inventors: Vivek K. Sharma (San Ramon, CA); Konstantinos Alataris (Menlo Park, CA); Gary Heit (Redwood City, CA); Jason Sutor (Pacific Grove, CA); Pankaj Sunkeri (Belmont, CA)
Assignee: Nesos Corp.
A61N1/36034A61N1/0456A61N1/36021A61N1/36025A61N1/36036
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Quick Facts
Patent No.
US 11,376,430
App. No.
17/066,404
Granted
Jul 5, 2022
Kind
B2
Abstract

Auricular nerve stimulation techniques for addressing patient disorders, and associated systems and methods. A representative system includes a signal generator having instructions to generate an electrical therapy signal, at least a portion of the electrical therapy signal having a frequency at or above the patient's auditory frequency limit, an amplitude in an amplitude range from about 0.1 mA to about 10 mA, and a pulse width in a pulse width range from 5 microseconds to 30 microseconds. The system further includes at least one earpiece having a contoured outer surface shaped to fit against the skin of the patient's external ear, external ear canal, or both, the at least one earpiece carrying at least two transcutaneous electrodes positioned to be in electrical communication with the auricular innervation of the patient, e.g., the auricular vagal nerve.

Claims (47)

1. A system for delivering electrical signals to a person having a headache disorder, comprising:

a signal generator having instructions to generate an electrical signal to address the person's headache disorder, at least a portion of the electrical signal having:

an average frequency in a frequency range of about 15 kHz to about 50 kHz;

an amplitude in an amplitude range from about 0.1 mA to about 10 mA;

a pulse width in a pulse width range from about 5 microseconds to about 30 microseconds;

an interpulse period in an interpulse period range from about 1 microsecond to about 15 microseconds; and

an interphase period in an interphase period range from about 1 microsecond to about 10 microseconds; and

two earpieces, each shaped to fit against skin of the person's external ear, external ear canal, or both, each earpiece carrying at least two transcutaneous electrodes coupled to the signal generator and positioned to be in electrical communication with at least one auricular nerve of the person, wherein the electrical signal includes a first electrical signal directed to the person's right ear, and a second electrical signal directed to the person's left ear, the first electrical signal differing from the second electrical signal with respect to one or more of the average frequency or the amplitude.

2. The system of claim 1 wherein the electrical signal is a non-paresthesia-generating electrical signal or a non-sensory response electrical signal.

3. The system of claim 1 wherein the average frequency is customized to the person.

4. The system of claim 3 wherein the average frequency is selected to be at or above the person's auditory frequency limit.

5. The system of claim 1 wherein each earpiece is shaped to position its corresponding at least two transcutaneous electrodes at a cymba concha of the person's ear.

6. A system for delivering electrical signals to a person having a headache disorder, comprising:

a signal generator having instructions to generate an electrical signal to address the person's headache disorder, at least a portion of the electrical signal having:

a frequency in a frequency range from about 15 kHz to about 50 kHz;

an amplitude in an amplitude range from about 0.1 mA to about 10 mA; and

a pulse width in a pulse width range from about 5 microseconds to about 30 microseconds; and

two earpieces, each shaped to fit against skin of the person's external ear, external ear canal, or both, each earpiece carrying at least two transcutaneous electrodes coupled to the signal generator and positioned to be in electrical communication with at least one auricular nerve of the person, wherein the electrical signal includes a first electrical signal directed to the person's right ear, and a second electrical signal directed to the person's left ear, the first electrical signal differing from the second electrical signal with respect to one or more of the frequency or the amplitude.

7. The system of claim 6 wherein the electrical signal is a non-paresthesia-generating electrical signal.

8. The system of claim 6 wherein the electrical signal is a non-sensory response electrical signal.

9. The system of claim 6 wherein the frequency is customized to be at or above the person's auditory threshold.

10. The system of claim 6 wherein the portion of the electrical signal includes an interpulse period in an interpulse period range from about 1 microsecond to about 15 microseconds.

11. The system of claim 6 wherein the portion of the electrical signal includes an interphase period in an interphase period range from about 1 microsecond to about 10 microseconds.

12. The system of claim 6 wherein the signal generator includes a neckpiece positionable to be supported by the person around the person's neck, and wherein the system further comprises an earpiece link coupled between the neckpiece and the two earpieces.

13. The system of claim 6 , further comprising an external controller configured to be in wireless communication with the signal generator, wherein the external controller includes a mobile device having an application for controlling the signal generator.

14. A method for delivering an electrical signal to a person having a headache disorder, comprising:

applying at least one electrical signal to at least one auricular nerve of the person to address the person's headache disorder, wherein the at least one electrical signal is applied via a plurality of transcutaneous electrodes carried by an earpiece positioned against skin of the person's external ear, external ear canal, or both; and

wherein at least a portion of the at least one electrical signal has:

a frequency in a frequency range from about 15 kHz to about 50 kHz;

an amplitude in an amplitude range from about 0.1 mA to about 10 mA; and

a pulse width in a pulse width range from about 5 microseconds to about 30 microseconds; and

wherein the at least one electrical signal includes a first electrical signal applied to one of the patient's ears and a second electrical signal applied to the other of the patient's ears, the first electrical signal differing from the second electrical signal with respect to one or more of the frequency or the amplitude.

15. The method of claim 14 wherein the at least one electrical signal does not generate paresthesia in the person.

16. The method of claim 14 wherein the at least one electrical signal does not generate a person-detectable sensory response.

17. The method of claim 14 , further comprising selecting the frequency for the at least one electrical signal based on an auditory frequency limit of the person.

18. The method of claim 14 wherein applying the at least one electrical signal includes applying the first electrical signal to a cymba concha of the one ear, and applying the second electrical signal to a cymba concha of the other ear.

19. The method of claim 14 wherein applying the at least one electrical signal to address the person's headache disorder includes applying the at least one electrical signal to address one or more of migraines or cluster headaches.

20. The method of claim 14 wherein applying the at least one electrical signal is performed as part of a treatment regimen including a pharmacological treatment of the person.

21. The method of claim 20 wherein the pharmacological treatment includes administering a calcitonin gene-related peptide (CGRP) inhibitor to the person.

22. A method for making a treatment device, comprising:

programming a signal generator to produce at least one electrical signal to treat a headache disorder, at least a portion of the at least one electrical signal having:

a frequency in a frequency range from about 15 kHz to about 50 kHz;

an amplitude in an amplitude range from about 0.1 mA to about 10 mA; and

a pulse width in a pulse width range from about 5 microseconds to about 30 microseconds; and

configuring the signal generator to couple to two earpieces, each shaped to fit against skin of a person's external ear, external ear canal, or both, each earpiece carrying at least two transcutaneous electrodes positioned to be in electrical communication with at least one auricular nerve of the person; and

wherein the at least one electrical signal includes a first electrical signal applied to one of the patient's ears and a second electrical signal applied to the other of the patient's ears, the first electrical signal differing from the second electrical signal with respect to one or more of the frequency or the amplitude.

23. The method of claim 22 wherein programming the signal generator includes customizing the frequency to the person.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2022
From: NESOS CORP.
To: NESOS LLC
Reel/Frame 061226/0120 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2022
From: NESOS LLC
To: NEXTSENSE, INC.
Reel/Frame 061226/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 1, 2020
From: SHARMA, VIVEK K.; ALATARIS, KONSTANTINOS; HEIT, GARY; SUTOR, JASON; SUNKERI, PANKAJ
To: VORSO CORP.
Reel/Frame 054508/0621 →
CHANGE OF NAME Recorded Dec 1, 2020
From: VORSO CORP.
To: NESOS CORP.
Reel/Frame 054559/0950 →
Continuity (5)
Division 16581139 · Sep 24, 2019
Provisional Application 62735492 · Sep 24, 2018
Provisional Application 62785205 · Dec 26, 2018
Provisional Application 62891203 · Aug 23, 2019
Related Publication 20210031036A1 · Feb 4, 2021