WO2018013835A4 - Wearable devices, systems, and methods for balancing and maintaining autonomic nervous system health - Google Patents
Wearable devices, systems, and methods for balancing and maintaining autonomic nervous system health Download PDFInfo
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- WO2018013835A4 WO2018013835A4 PCT/US2017/041972 US2017041972W WO2018013835A4 WO 2018013835 A4 WO2018013835 A4 WO 2018013835A4 US 2017041972 W US2017041972 W US 2017041972W WO 2018013835 A4 WO2018013835 A4 WO 2018013835A4
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- electrical stimulation
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- nervous system
- stimulation device
- autonomic nervous
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0484—Garment electrodes worn by the patient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/375—Electroencephalography [EEG] using biofeedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
- A61B5/4035—Evaluating the autonomic nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6802—Sensor mounted on worn items
- A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Radiology & Medical Imaging (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Psychology (AREA)
- Psychiatry (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
- Neurosurgery (AREA)
- Physiology (AREA)
- Child & Adolescent Psychology (AREA)
- Developmental Disabilities (AREA)
- Hospice & Palliative Care (AREA)
- Social Psychology (AREA)
- Radiation-Therapy Devices (AREA)
Abstract
The inventive subject matter provides a wearable device for application of methods for balancing and maintaining the health of the human autonomic nervous system, including a wearable frame; cranio-electrical stimulation (CES) circuitry and electrodes positioned on the wearable frame; and optionally including audio entrainment with binaural beats circuitry and audio outputs, and an attachable visual mask containing light-blocking material and frequency-following response visual stimulation circuitry and lights. The device may also include sensors to monitor various physiologic indicators. The system communicates the physiologic data with other devices (such as smart phones or tablets) that have algorithms to interpret the data to determine whether additional therapy is required. Based on this feedback, the smart phone communicates with the therapy elements, e.g., CES, to continue or discontinue therapy.
Claims
1. An electrical stimulation device for modulating an autonomic nervous system of a user comprising:
a frame having at least one temple tip and at least one nose support that supports a
weight of the device on a head of the user;
an electrode configured to deliver an electric stimulus to the skin of the user that
entrains the user's brain waves with a binaural beat;
a power source mechanically coupled to the frame and electrically coupled to the
electrode;
a sensor configured to detect an autonomic nervous system metric; and
a controller configured to control at least one of a power and a duration of the electric stimulus based on the autonomic nervous system metric,
2. The electrical stimulation device of claim 1, wherein the frame is configured to be worn across a human user's forehead and behind the human's ears,
3. The electrical stimulation device of claim 1 or 2, wherein the frame further comprises an eye mask coupled to the frame.
4. The electrical stimulation device of claim 3, wherein the eye mask is removably coupled to the frame via a coupler.
5. The electrical stimulation device of claim 4, wherein the coupler comprises a magnet,
6. The electrical stimulation device of claim 3, wherein at least one of the frame and the eye mask comprises a light-emitting diode (LED).
7. The electrical stimulation device of any of the preceding claims, wherein the sensor comprises an electroencephalogram (EEG) electrode, and the autonomic nervous system metric comprises an EEG of the user's brain activity.
8. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a temperature sensor, and the autonomic nervous system metric comprises a temperature of the user.
9. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a skin conductivity electrode, and the autonomic nervous system metric comprises a conductance of the user's skin.
10. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a pulse sensor, and the autonomic nervous system metric comprises a heart rate of the user.
1 1. The electrical stimulation device of claim 9, wherein the pulse sensor comprises a blood volume pulse sensor.
12. The electrical stimulation device of any one of claims 1 -6, wherein the sensor comprises a Laser Doppler Velocimeter (LDV), and the autonomic nervous system metric comprises at least one of a blood flow rate, a blood volume amplitude, and a pulse transit time of the user.
13. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises an electrocardiogram (ECG) electrode, and the autonomic nervous system metric comprises an electrocardiogram.
14. The electrical stimulation device of any one of claims 1-6, wherein the sensor comprises a respiration rate sensor, and the autonomic nervous system metric comprises a respiration rate.
15. A system for modulating the autonomic nervous system comprising:
an electrical stimulation device according to any one of claims 1-14; and
an audio system configured to entrain the user's brain waves with a binaural beat.
16. A method of modulating the autonomic nervous system comprising:
providing an electrical stimulation device according to any one of claims 1-14; and providing software that when installed on a phone or tablet of the user is configured to play binaural audio that entrains the user's brain waves,
17. The method of claim 16, further comprising providing an anxiolytic agent to the user.
18. The method of claim 17, wherein the anxiolytic agent comprises a topical anxiolytic agent.
19. The method of claim 18, wherein the topical anxiolytic agent comprises a bio-frequency chip.
20, The method of claim 16, wherein the anxiolytic agent comprises an oral anxiolytic agent,
21. A system for balancing and maintaining the health of the human autonomic nervous system, the system comprising:
a wearable frame having at least one temple tip and at least one nose support that supports a weight of the device on a head of the user;
cranio-electrical stimulation (CES) circuitry and electrodes positioned on the
wearable frame;
audio entrainment with binaural beats circuitry and audio outputs that entrains the user's brain waves with a binaural beat selected as a function of signals detected by the CES circuitry; and
a visual mask attachable to the wearable frame, the visual mask comprising light- blocking material and frequency-following response visual stimulation circuitry and lights,
REMARKS
D1: US 2012-0149973 A1 (Hollowav. G. B.) 14 June 2012
D2: USE 2012-0271377 A1 (Hagedorn, D. W. et al.) 25 October 2012
The Office considers claims 1 -6 and 21 to lack novelty and an inventive step over Holloway Hagedorn. The amended claims clarify that the frame has a temple tip and an nose support so that the frame is supported by the ear and nose of the wearer, and that the electrodes or audio outputs provide binaural beats that entrain the user's brain waves.
All of the rejections have been overcome. Those features are not present in any of the cited references, and there is no teaching, suggestion or motivation in the cited art to include them.
Conclusion
Claims 1-21 are pending in this application. The Applicants request allowance of all pending claims.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662361905P | 2016-07-13 | 2016-07-13 | |
| US62/361,905 | 2016-07-13 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2018013835A1 WO2018013835A1 (en) | 2018-01-18 |
| WO2018013835A4 true WO2018013835A4 (en) | 2018-03-01 |
Family
ID=60953345
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2017/041972 WO2018013835A1 (en) | 2016-07-13 | 2017-07-13 | Wearable devices, systems, and methods for balancing and maintaining autonomic nervous system health |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2018013835A1 (en) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3092689A1 (en) | 2017-10-23 | 2019-05-02 | Patent Holding Company 001, Llc | Communication devices, methods, and systems |
| AU2019352954B2 (en) | 2018-10-01 | 2022-03-10 | Biovisics Medical, Inc. | System and methods for controlled electrical modulation for vision therapy |
| WO2020112980A2 (en) | 2018-11-30 | 2020-06-04 | Biovisics Medical, Llc | Head worn apparatuses for vision therapy |
| EP3952979A1 (en) | 2019-04-10 | 2022-02-16 | Biovisics Medical, Inc. | Systems and interfaces for ocular therapy |
| US11511112B2 (en) | 2019-06-14 | 2022-11-29 | Biovisics Medical, Inc. | Wearable medical device |
| WO2021011255A1 (en) | 2019-07-12 | 2021-01-21 | Biovisics Medical, Inc. | Ocular therapy modes and systems |
| JP6900432B2 (en) * | 2019-08-08 | 2021-07-07 | 京セラ株式会社 | Electronics, control methods, and control programs |
| US20210128058A1 (en) * | 2019-11-04 | 2021-05-06 | Umay Care Holdings Inc. | Methods and apparatuses for sensing and relieving stress |
| US11934583B2 (en) | 2020-10-30 | 2024-03-19 | Datafeel Inc. | Wearable data communication apparatus, kits, methods, and systems |
| US11819625B1 (en) | 2022-04-27 | 2023-11-21 | Therabody, Inc. | Facial wearable device and methods for providing external stimuli using the same |
| US12017009B2 (en) | 2022-06-14 | 2024-06-25 | Therabody, Inc. | System and method for altering user mind-body states through external stimuli |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997043954A1 (en) * | 1996-05-24 | 1997-11-27 | Brux Care L.L.C. | Bruxism biofeedback apparatus and method |
| US9079030B2 (en) * | 2004-12-22 | 2015-07-14 | G. Blake Holloway | Systems and methods for balancing and maintaining the health of the human autonomic nervous system |
| US8239030B1 (en) * | 2010-01-06 | 2012-08-07 | DJ Technologies | Transcranial stimulation device and method based on electrophysiological testing |
| US9440070B2 (en) * | 2012-11-26 | 2016-09-13 | Thyne Global, Inc. | Wearable transdermal electrical stimulation devices and methods of using them |
| US9955907B2 (en) * | 2014-04-23 | 2018-05-01 | Case Western Reserve University | Low frequency non-invasive sensorial stimulation for seizure control |
-
2017
- 2017-07-13 WO PCT/US2017/041972 patent/WO2018013835A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| WO2018013835A1 (en) | 2018-01-18 |
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