CA2961228A1 - Wearable device to faciliate mindfulness practices with brain activity analyzer and brain stimulator, and methods thereof - Google Patents

Wearable device to faciliate mindfulness practices with brain activity analyzer and brain stimulator, and methods thereof Download PDF

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CA2961228A1
CA2961228A1 CA2961228A CA2961228A CA2961228A1 CA 2961228 A1 CA2961228 A1 CA 2961228A1 CA 2961228 A CA2961228 A CA 2961228A CA 2961228 A CA2961228 A CA 2961228A CA 2961228 A1 CA2961228 A1 CA 2961228A1
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user
brain
org
mindfulness
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French (fr)
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Sidney Goiame
Jean-Baptiste Turpin
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Turpin Jean Baptiste
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Turpin Jean Baptiste
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • 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]
    • 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
    • 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
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • 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
    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/70—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0055—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with electric or electro-magnetic fields
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0072—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with application of electrical currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Description

PROVISIONAL PATENT APPLICATION
Sidney GOIAME
jean-Baptiste TUENN
March 20th, 2017 Wearable device to facilitate mindfulness practices with brain activity analyzer and brain stimulator, and methods thereof ABSTRACT
Aweaxable device to facilitate mindfulness practices with brain activity analyzer and brain stimulator: the kind of portable device described here is designed as a comfortable and lightweight headband, to capture and analyze the user' s brain activity, and to deliver a. non-invasive brain stimulation along with a, mindfulness audio guide, in order to facilitate the practice of mindfulness meditation.
Also described herein are the methods to heighten attention, mental focus, and eventually facilitate mindfulness by combining the use of non-invasive brain stimulation, cognitive assessment, pre-recorded or live mindfulness audio instructions, and real-time monitoring of the user' s brain activity through wireless communication.
The technical specifications of an example of such portable device and methods are presented hereby.
REFERENCES
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https://doi.org/10. 1007/s12671-016-0591-zWhat is claimed is:
Any and all features of novelty disclosed or suggested herein, including without limitation the following:
1. A system comprising: one brain activity analyzer, one brain stimulator, one audio guiding system, one user interface, one user terminal, one remote server.
2. The system of claim 1 wherein the user is directly interacting visually and through touch with the user interface, transmitting signals to the brain activity analyzer and receiving signals from the brain stimulator and the audio guiding system.
3. The system of claim 2 wherein the brain activity analyzer, the brain stimulator, the audio guiding system, and the user interface are all connected to the user terminal.
4. The system of claim 3 wherein the user terminal is able to connect to a remote server and exchange data anonymously.
5. The system of claim 4 wherein the remote server can handle data, anonymously from one 'master' user terminal, and several 'slave' user terminals.
6. The system of claim 5 wherein the brain activity analyzer is able to identify the current state of mind of the user, transcribe it into an electrical signal, classify it according to a number of cri teria., and transmit the data to the user terminal.
7. The system of claim 6 wherein the brain activity analyzer could consist.
in a number of dry electrodes applied on one or several locations on the user' s scalp, identifying the current state of mind of the user by elec troencephalogra.phy.
8. The system of claim 7 wherein the brain activity analyzer could record the user' s alpha., gamma and theta brain waves, as well as any event-related potential.
9. The system of claim 6 wherein the brain activity analyzer could consist.
in a number of near-infrared sensors identifying the current state of mind of the user by functional near¨infrared spectroscopy.
10. The system of claim 6 wherein the brain stimulator is able to non¨invasively influence the connectivity and/or function and/or the plasticity of the user' s brain to facilitate the practice of mindfulness meditation, based on the data received from the user terminal_
11. The system of claim 10 wherein the brain stimulator could consist in a, number of dry electrodes on one or several locations on the user' s scalp emitting a. low amplitude transcranial direct electrical_ current, for the purpose of heightening attention, mental focus, equanimity, and eventually facilitating mindfulness.
12. The system of claim 10 wherein the brain stimulator could consist in a number of low¨power lasers or light¨emitting diodes on one or several locations on the user' s scalp emitting a. specified set of wavelengths of laser, for the purpose of heightening attention, mental focus, -equanimity, and eventually facilitating mindfulness.
13. The system of claim 10 wherein the audio guiding system is able to deliver pre¨recorded digital mindfulness instructions, or live digital instructions from a. remote mindfulness teacher.
14. The system of claim 13 wherein the audio guiding system is delivering pre¨recorded digital mindfulness instructions, based on the chlta received from the user terminal.
15. The system of claim 14 wherein the audio guiding system is able to deliver pre¨recorded digital cognitive assessment instructions.
16. The system of claim 15 wherein the user interface is available on the user' ssmartphone, tab let, smartwatch, or electronic device allowing for visual and touch command with wireless connection functionalities.
17. The system of claim 16 wherein the user interface is able to offer control to the user over its usage of and interaction with the system, and display consolidated and graphic live information about the current.
state of mind of the user.
18. The system of claim 17 wherein the user interface is able to send wirelessly the electronic signal corresponding to the user' s command to the user terminal, and to receive updated data about the current usage of the system frdm the user terminal.
19. The system of claim 18 wherein the user terminal is able to identify any unique user by an individual account through the user interface.
20. The system of claim 19 wherein the user interface is able to receive and collect data from the brain activity analyzer, run an algorithm able to modulate the data, to be sent to the brain stimulator and audio guiding system, as well as to update the information provided to the user through the user interface.
21. The system of claim 20 wherein the user interface is able to send the user's collectedand synthesized brain data anonymously to aremote server, and to receive updates of algorithm, firmware and software front a, remote server.
22. The system of claim 21 wherein the remote server is able to receive the collected and synthesized anonymous brain data from any user, to establish and update reference brain data, and store it safely.
23. The system of claim 22 wherein the remote server is able to allow a, restricted number of administrators and superusers able to access the collected and synthesized anonymous brain data.
24. The system of claim 23 wherein the remote server is able to connect the user terminal from one mindfulness teacher with a number or user terminals from mindfulness meditation practitioners.
25. The system of claim 24 wherein the remote server is able to handle the connections between the master user terminal of one mindfulness teacher and a number of slave user terminals of mindfulness meditation practitioners.
26. The system of claim 25 wherein the remote server is able to use the collected and synthesized anonymous brain data from a. user and to suggest to that user the connection to the class offered by an available mindfulness teacher through their respective user terminals.
27. The methods pertaining to the system of claim 26 comprising signal processing, pattern classification, and contingency handler, for the purpose of ensuring an appropriate and safe neuromodulation throughout each session.
28. The methods of claim 27 wherein signal processing in the user terminal allows for collecting electrical signals front the brain activity analyzer including the source of each, filtering them to eliminate all unwanted noise, and identifying each component relevant for the analysis of the current state of mind of the user.
29. The methods of claim 28 wherein signal processing in the user terminal could resort to collecting electrical signals from the brain activity analyzer such as that of claim 8 including the electrodes fmilwhich each stems, filtering them to eliminate all unwanted noise and frequencies related to brain activity not relevant to the methods, and accordingly identifying the frequency bands and event-related potentials relevant for the analysis of the current state of mind of the user.
30. The methods of claim 28 wherein signal processing in the user terminal allows for collecting the data of the user cognitive tasks from the user interface to improve the assessment of the current state of mind of the user.
31. The methods of claim 30 wherein signal processing in the user terminal could resort to collecting data of visual and working memory tasks from the user interface to improve the assessment of the current state of mind of the user.
32. The methods of claim 30 wherein pattern classification in the user terminal allows for handling the classification of the components provided by the signal processing of' claim 28, according to a number of categories and rules, to the time course of the each component, to the history of the user, and to reference brain data, obtained from a, remote server.
33. The methods of claim 32 wherein pattern classification in the user terminal could resort to handling the classification of the frequency bands and event-related potentials of claim 29, and of the data of visual and working memory tasks of claim 31, according to a number of categories and rules, to the time course of the each component, to the history of these frequency bands, event-related potentials, and data of visual and working memory tasks collected from previous sessions of' the same user, and to reference brain data, obtained from a. remote server.
34. The methods of claim 32 wherein pattern classification in the user terminal allows for providing to the audio guiding system and the brain stimulator the appropriate neuromodulation commands, according to the classification of the current state of mind of the user.
35. The methods of claim 34 wherein pattern classification in the user terminal could resort to providing to the audio guiding system and the brain stimulator the appropriate mindfulness and low amplitude transcranial direct electrical current instructions respectively, according to the classification of the current state of mind of the user.
36. The methods of claim 34 wherein contingency handler in the user terminal allows for identifying, based on the brain data collected, on the personal data, and on the feedback provided through the user interface, any situation that deviate from the expected course of the session or that could disserve the user in any way, and accordingly for limiting the functionalities of the device or terminating the session.
37. The methods of claim 36 wherein contingency handler in the user terminal could resort to identifying, based on the frequency bands and event-related potentials of claim 29 , on the data of visual and working memory tasks of claim 31, on the personal data provided at the time of the creation of the user profile and verified to some extent before each session, and on the feedback requested after the termination of a session provided through the user interface, any abnormality of the system, any contraindicated condition of the user, and any unsuitable evolution of the stale of mind of the user, and accordingly to disable the brain stimulation functionality or terminate the session.
DESCRIPTION
Field of the invention This invention consists in a, wearable brain wellness device to facilitate the practice of mindfulness meditation as well as the methods to benefit from its wholesome effects, in order to to promote personal wellbeing and social intelligence.
Background of the invention / Description of the related art Since they were first introduced to the Western world 40 years ago, mindfulness practices have proved to yield benefits for the body and the mind, to prevent physical and mental illness in healthy individuals, to aid clinical patients with their psychological conditions, to relieve hospitalized patients from their physical condition, and even to pacify relationships in prisons by giving purpose to the inmates.
However, despite their proven benefits for the body and the mind, mindfulness practices are still facing a number of obstacles: I. the belief that they are a religious practice; 2. the distrust of their concrete effects; 3. the difficulty to find time or a, place to practice;
4. the difficulty to reach the necessary level of concentration.
Our device and methods are addressing these issues, not by replacing existing mindfulness practices, but by popularizing them and increasing awareness about their holistic benefits: 1. for those who believe that meditation is a, religious practice, resorting toanelectronic device will dissipate any prejudice; 2. for those who believe that meditation is just a. trend and does not yield any benefit, relying on scientific proofs, partnerships and certifications will grant credibility as for the concrete effects; 3. for those who do not have time or do not know a. place to practice: our device will allow anyone to practice according to their schedule and in the comfort of their how; 4. for those who give up because it is too difficult, we are introducing brain stimulation to facilitate the practice and emphasize on the reward.
There are today 3 kinds of devices and services related to our invention:
brain analyzing devices resorting to EEG (Electro Encephalo Graphy) technology to decode the user's mood and behavior (Muse, Neurosky, FMOT1V

Epoc+ & Insight, etc.), brain stimulating devices resorting to tDCS
technology to target specific brain regions and drive plastic or functional changes (Foc.us, Halo, Thync, etc.), and mindfulness related electronic services assisting users in their practice owing to advice from experienced professionals (lIeadspace,Smiling Mind, Buddhify, The Mindfulness app, Spire, etc.).
Our device and methods are following the trend of wearable brain wellness device, but to the authors' knowledge, they are the first to offer -a, brain activity analyzer and a, brain stimulator along with a, user-friendly interactive graphic interface for the purpose of facilitating mindfulness practices.
Summary This present invention consists in a. portable device designed as a.
comfortable and lightweight headband, to capture and analyze the user' s brain activity, and to deliver a, non-invasive brain stimulation along with a. mindfulness audio guide, in order to facilitate the practice of mindfulness meditation.
The device could for example comprise: a number of dry electrodes applied on one or several locations on the user' s scalp, identifying the current state of mind of the user by electroencephalography; a number or dry electrodes on one or several_ locations on the user' s scalp emitting a low amplitude transoranial direct electrical current; an audio guiding system able to deliver pre-recorded or live digital mindfulness instructions, and pre-recorded digital cognitive assessment instructions.
This present invention also consists in the methods to heighten attention, mental focus, equanimity, and eventually to facilitate mindfulness, by combining signal processing, pattern classification, and contingency handler, for the purpose of ensuring an appropriate and safe neuromodulation throughout each session.
The methods could for example comprise: signal processing by collecting the electrical signals from the electrodes of thelyminactivity analyzer, filtering them to eliminate all unwanted noise and frequencies related to brain activity not relevant to the methods, accordingly identifying the relevant frequency bands and event-related potentials, and collecting data, of visual and working memory cognitive tasks; pattern classification by handling the classification of the components provided by signal processing, according to a number of categories and rules, to the time course of the each component, to the history of the user, and to reference brain data obtained from a, remote server; contingency handler by identifying, based on the brain data, collected, on the personal data, and on the feedback provided through the user interface, any abnormality of the system, any contraindicated condition of the user, and any unsuitable evolution of the state of mind of the user, and accordingly to disable the brain stimulation functionality or terminate the session.
Brief description of the drawings The attached 11 figures offer a. tentative representation of the specifications of the present device and methods.
Figure 1: describes the 6 components of the device, along with information on their number, nature, function, and position.
Figure 2: presents the connection between these 6 components, as well as the kind of information typically exchanged. A green arrow stands for a unilateral communication, and red for bilateral.
Figure 3: describes in a chronological order the typical list of actions from each of the 6 components during the course of an individual and normal session.
Figure 4: illustrates the bask algorithnirun by the system over the course of a. normal session.
Figure 5 and 6: links the types of stimulators and sensors available, the component to which they belong, their incoming and outgoing signals, their individual. and concomitant effects and processing means respectively.
Figure 7: provides a list of tDCS exclusion criteria, according to those available solely through asking the user and those also identifiable through the brain activity analyzer.
Figure 8: summarizes the main clinical traits of the OCS exclusion criteria, identifiable through the brain activity analyzer.
Figure 9: provides a list of the main identified Low Level Laser Therapy contraindications and precautions.
Figure 10: provides an additional list of specific functionalities and warning messages for each of the 6 components of the device.
Figure 11: shoAs two visuals of a, practical device including all the features of the present invention.
Detailed description 10. This invention consists in a. wearable brain wellness device to facilitate the practice of mindfulness meditation as well as the methods to benefit from its wholesome effects, in order to to promote personal wellbeing and social intelligence.
12. Mindfulness practices have existed for millennia. They stem from several Buddhist meditation traditions, mostly the Theravada, or Mahayana.
Buddhist styles of meditation more focused on relaxation, and the Vajrayana, tradition (also referred to as Tantric Buddhism) more focused on arousal.
14. Among the first category, Shamatha and Vipassana are among the most popular, whereas Visualization of self-generation-as-Deity and Rig-pa, are for the second.
16. In 1979, a, 35-year-old Buddhist meditation student and MIT-trained molecular biologist named Jon Kabat-Zinn creates the Mindfulness-Based Stress Reduction (ABSR) program. It is possibly the landmark identifying the inception of the word 'mindfulness' and its practice in the Western world.
18. In 1990, there are 12 published papers about mindfulness in medical treatment. In 2015, more than 3400 research articles had been published on mindfulness, about 1,000 during 2013-2015 alone. And the numbers are showing exponential growth.
20. The reason for this sustained and increase interest are simple:
mindfulness practices have scientifically proved to yield benefits fer the body and the mind, to prevent physical and mental illness in healthy individuals, to aid clinical patients with thei r psychological conditions, to relieve hospitalized patients from their physical condition, and even to pacify relationships in prisons by giving purpose to the inmates.
22. In short, mindfulness practices seem to illustrate the possibility for almost anyone to getbettercontrol of themselves, to live a healthier, more fulfilling life, free of cravings born out of situations and circumstances one has no power on -a motto all too common in Western societies.
24. What' s more, the practices seem to find an unlimited variety of applications, and everyday there seems to be a, new way to yield the physical and mental benefits of mindfulness.
26. The rationale behind this new trend is certainly its efficacy and versatility, but also the positive reception from most strata or the population and thus the economic potential of its applications.

28. The National Health Interview Survey accounted for 18 million U. S.
adults using some form of meditation in 2012, that' s about 8% of the population. The corresponding industry. is valued at more than 1 hi liion dollars.
30. Among the hundreds of apps available for smartphones and tablets, the top app Headspace recently raised $30 million and has been downloaded more than 6 million times, whereas the pioneer headband company Muse generates $8 million per year.
32. Mindfulness has found a very keen audience in the office space as proved by a survey anticipating 45% of US employers in 2017 to offer some kind of mindfulness training priced between $500 and $10, 000. The example of Aetna is notable: after introducing a mindfulness curriculum to their employees, they noticed that paid medical claims dropped by 7.3% amounting to about $9 million in savings.
34. Mindfulness has also been an effective component of rehabilitation therapies and has shown for example to be twice as good as gold standard therapy at helping people quit smoking. Considering the costs of substance abuse related to crime, lost work productivity and healthcare exceeds $700 billion annually, it is sensible to promote the use of mindfulness based therapies.
36. Very notably, a number of mindfulness based programs offered in prisons have yielded fantastic results, both during incarceration by pacifying the relations between the inmates and the personnel and giving purpose to the former, but also after by significantly reducing the rate of recidivism.
38. Indeed, according to the conclusions of a, 2005 report by the Bureau of Justice Statistics stating that out of 405' 000 prisoners released in 30 states, 77% were arrested for a new crime within 5 years. While out of the 182 graduates of the Guiding Rage into Power Program at San Quentin State Prison, in 5 years 53 have been released by a. parole board and none have conic back to prison, saving more than $3 million every year.
40. The economic justifications of this invention are therefore very real, but the social aspect is even more important.
42. As such, this invention aims at popularizing the existing mindfulness practices and at increasing awareness about their holistic benefi ts. This invention does not aim at replacing the existing practices.

44. indeed, despite their proven benefits for the body and the mind, mindfulness practices are still facing a. number of obstacles that are hindering their even wider spread: 1. the belief that they are a religious practice; 2. the distrust of their concrete effects; 3. the difficulty to find time or a place to practice; 4. the difficulty to reach the necessary level of concentration.
46. This invention plans on addressing these issues and lowering the entry barriers to allow the greater number to benefit from the advantages of the practices.
48. Considering that this invention consist in an electronic device, the prejudice that meditation is a religious practice will be ruled out.
50. Considering that this invention relies on scientific proofs, and later on partnerships and certifications, the concrete effects of mindfulness meditation will be substantiated.
52. Considering that this invention offers the flexibility for the users to practice according to their schedule and in the comfort of their home, the difficulty to find time or a. place to practice will be greatly reduced.
54. Considering that this invention allows to heighten attention, mental focus, equanimity, and eventually to facilitate mindfulness, the challenge to reach and maintain the necessary level of concentration will he made easier, and the benefits of the practice made more accessible.
56. Today there are mostly 3 kinds of commercial devices and services that claim to either help users enhance the control of their own mind, or help in the practice of some form of meditation.
58. There are brain analyzing devices resorting for the most part to EEG
(Electro Encephalo Graphy) technology to decode the user's mood and behavior: Muse, Neurosky, EMOTiV Epoc+ & insight, and a. few other offer headbands and apps or softwares to identify arid understand the functioning of the user' s brain. However these do not include any form of active stimulation.
60. There are brain stimulating devices resorting for the most part to tDCS (transeranial Direct Current Stimulation) technology to target specific brain regions and drive plastic or functional changes: Foe. us, Halo, Thync, offer wearable apparatuses to modulate the functioning of the user' s brain. However these do not include any form of monitoring of the user' s stale ofmnindbefore, during or after the stimulation. Moreover, only to a, very limited extent are they offered for a. purpose related to some form of meditation.
62. There are mindfulness related electronic services assisting users in their practice owing to advice from experienced professionals, mostly apps offered form smartphones and tablets: Headspace, Smiting Mind, Buddhify, The Mindfulness app, Spire, to name a. few are focused on mindfulness or some form of meditation, but do not include any aspect of brain analysis or stimulation.
64. Considering the state of the art, this invention is to the knowledge of its creators the fist of its kind to include all 3 components: brain analysis, brain stimulation, for the purpose of mindfulness practices.
66. This present invention consists in: a device including a, brain analysis component, a, brain stimulation component, for the purpose of mindfulness practices; methods to use this device itia variety of contexts, to properly identify the user' s current state of mind, to help the user make progress in the practice of mindfulness meditation, while ensuring the user' s safety by preventing any adverse effect.
68. The device is designed as a, comfortable and lightweight wearable headband, to capture and analyze the user.' s brain activity, and to deliver a, non¨invasive brain stimulation along with a, mindfulness audio guide, in order to facilitate the practice of inindfulness meditation. The device would also bear several buttons and light indicators for the comfort and information of the user.
70. Initially, the device would comprise a, number of dry electrodes between 3 and 9 to perform the brain analysis, depending on the target audience and specific outcome expected.
72. Dry electrodes enable most if not all users to benefit from the EEG
technology, irrelevantly of their hair density, and without the hassle of applying conductive gel, while maintaining an impedance within the acceptable range to ensure the proper flow of current.
74. The locations chosen on the user' s scalp are chosen among this list according to the international 10-20 EEG system positioning: Fz, Cz, Pz, F3, F4, C3, C4, P3, P4.
76. These locations have proven to be the most appropriate to assess the brain activity by measuring the Alpha, Gamma. and Theta waves, as well as ERPs (Event Related Potentials).

78. Indeed, studies have established a, number of reliable indicators of the state of mindfulness: a, state-related slowing of the alpha. rhythm (8 -12Hz) in combination with an increase in the frontal alpha power, theta band (3 - 81Iz) activity and amplitude found to increase, largest imnplitude and synchronization increases of gamma band activity (around 40 Hz) reported in highly advanced meditators, and larger P300 amplitudes after mindfulness training.
80. The device would therefore initially resort to LEG technology to measure the brain waxes and event related potentials in order to assess the current state of mind of the user, and over time the evolution in the practice of mindfulness meditation.
82. In later evolutions, it is not excluded that the device would resort to other technologies as well, such as fNIRS (functional_ Near Infra Red Spectroscopy), to provide an ever more reliable analysis of the user' s brain.
84. Initially, the device would comprise a. number of dry electrodes between 1 and 4 to perform the brain stimulation, depending on the target audience and specific outcome expected.
86. Dry electrodes enable most if not all users to benefit from the tDCS
technology, irrelevantly of their hair density, and without the hassle of applying conductive gel, while maintaining an impedance within the acceptable range to ensure the proper flow of current.
88. The locations chosen on the user' s scalp are chosen among this list according to the international 10-20 LEG system positioning: anode over F8/F10, cathode over the left mastoid, clavicular, or ear region, F3, F4.
90. These locations have proven to be the most appropriate to stimulate the brain activity by increasing attentional control, enhancing working -memory, increasing self-awareness and reducing cravings.
92. Indeed, studies have established a body of observations from users stimulated on these locations while receiving mindfulness and cognitive instructions: frontal alpha power increase during meditation, alpha.
frequency decrease during meditation, posterior alpha power increase during arousal, posterior alpha power decrease during target response, frontal P300 amplitude increase duringmeditation, frontal P300 amplitude decrease after rest, frontal theta power increase during and after meditation, posterior theta power increase after meditation, frontal theta, power decrease after meditation, bilateral gamma power increase during meditation, bilateral gamma synchronicity increase during meditation.
94. The device would therefore initially resort to OCS technology to stimulate the user' s brain and foster a stale of mind similar to that.
of mindfulness meditation. The device would provide the user an external button to immediately interrupt the brain stimulation, for example on the right earphone.
96. In later evolutions, it is not excluded that the device would resort to other technologies as well, such as LLLT (Low Level Laser Therapy), to provide an ever more reliable stimulation of the user' s brain.
98. To yield its wholesome mindfulness outcome, the brain stimulation has to be accompanied by an appropriate set of mindfulness and cognitive instructions. Together, they allow for heightening attention, mental focus, equanimity, and eventually facilitating mindfulness.
100. For this reason, the device also includes an audio guiding system.
It consists in a couple of earphones allowing to deliver the mindfulness and cognitive instructions in an audio format. These earphones have independent volume control buttons available to the user, for example on the left earphone.
102. The mindfulness instructions are available by two means: the user can listen to a set of pre¨recorded digital mindfulness instructions, delivered according to the appropriate mindfulness program suggested based on the user' s current stale of mind and progress, and eventually chosen by the user.
104. All mindfulness instructions will be provided by certified mindfulness instructors, and the programs created to match with the purpose and objectives of this invention.
106. If the user is connected to the internet and the device connected to one of the remote servers, the user can also choose to listen to one or the live mindfulness courses offered by a. certified mitulfulness instructor. The user will be suggested a, list of courses compatible with its current state of mind and progress.
108. The cognitive instructions aim at assessing the visual attention and working memory of the user by measuring the brain activity, responses and reaction times.

110. Programs including these cognitive instructions will be proposed before or after the mindfulness instructions in order to establish-a, baseline and quantify the progress and transfer effects of the user.
112. All cognitive instructions will he provided by appropriate instructors, and the programs created to match with the purpose and objectives of this invention.
114. The instructions are provided through the audio guiding system, and also through the user interface. Indeed, at this time the user will be requested to use a. visual interface and answer to the instructions, possibly through a touch screen.
116. The user interface is provided for the user to interact with the system, through a, wireless connection with the user terminal.
118. The user interface allows mostly for controlling the session, answering the cognitive assessments, and display current status of the user.
120. The user interface receives commands and inputs from the user and transmits them to the user terminal for the purpose of updating and modulating the user' s session. In turn, the user interface receives a.
feedback from the user terminal in order to update the current status of the user and the cognitive assessments.
122. The user interface is offered through an app on smartphones, tablets, smartwatches, and through a, computer software.
124. The user terminal holds a, central part in the device as it: receives the user' s commands and inputs from the user interface for the purpose of updating and modulating the user' s session, and sends hack updates of the current status of the user and the cognitive assessments; receives the electrical signals collected by the brain activity analyzer; sends commands to the audio guiding systems to update the mindfulness and cognitive instructions; sends commands to the brain stimulator to initiate and handle the appropriate stimulalion; sends classified and anonymous user statistics to a remote server and receives updates of the algorithms supporting the methods and of the software and firmware.
126. The user terminal is likely to be directly integrated in the device, and to communicate with the remote server wirelessly, possibly through the user' s smartphone or tablet or smartwatch or computer; it is also likely to be easily removable from the device.

128. The user terminal is the commander in chief of the operations happening during a session, and executes the methods.
130. The remote server holds all users' classified and anonymous user statistics, and also generates baselines to establish global user profiles. These serve statistical purposes and can be accessed by a.
limited number of server administrators. These administrators can in turn create access for some privileged user to some of the user information, in particular for scientific or healthcare purposes.
132. The remote server sends back to user terminals updates of the algorithms supporting the methods and of the software and firmware.
134. The remote server is also used to cotutectanoster user terminal owned by a, user identified as a certified mindfulness instructor, and a. number of slave user terminals owned by regular users seeking for live mindfulness courses.
136. The connection is offered based on the user' s current and historical brain data, as well as on the kind of instructions offered by the mindfulness instructor.
138. Along with the aforementioned device, this invention also consists in the methods to heighten attention, mental focus, equanimity, and eventually to facilitate mindfulness, by combining signal processing, pattern classification, and contingency handler, for the purpose of ensuringan appropriate and safe neuromodulation throughout each session.
140. The signal processing could rely on: collecting electrical signals from the brain activity analyzer including the electrodes from which each stems, filtering them to eliminate all unwanted noise and frequencies related to brain activity not relevant to the methods, accordingly identifying the relevant frequency hands and event-related potentials, and collecting data of visual and working memory tasks for the analysis of the current state of mind of the user.
142. The user is naturally going to generate brain waves, whether with or without the brain stimulation enabled. Based on the status of the user (at rest, meditating, stimulated or not) the data, from the user' s brain activity is being collected by the brain activity analyzer.
144. The signal processing is responsible for making sense out of the electrical signals collected from the brain activity analyzer by filtering them, and identifying the indicators of mindfulness.

146. These indicators are established based on the scientific observations of mindfulness meditation prantitioners and of individuals stimulated on these locations while receiving mindfulness and cognitive instructions.
148. The pattern classification could rely on: handling the classification of the frequency bands and event-related potentials, and of the data of visual and working memory tasks, according to a, number of categories and rules, to the time course or the each component, to the history of these frequency bands, event-related potentials, and data, of visual and working memory tasks collected from previous sessions of the same user, and to reference brain data, obtained from a. remote server.
150. The pattern classification could also provide the audio guiding system and the brain stimulator the appropriate mindfulness and low amplitude transcranial direct electrical current instructions respectively, according to thedassification of the current stateofmind of the user.
152. The pattern classification is responsible for determining the right course of action based on the data from signal processing, in order to meet with the objectives of the user and the targets of the session.
154. The contingency handler could rely on: identifying, based on the frequency bands and event-related potentials, on the data, of visual and working memory tasks, on the personal data, provided at the time of the creation of the user profile and verified to some extent before each session, and on the feedback requested after the termination of a session provided through the user interface, any abnormality of the system, any contraindicated condition of the user, and any unsuitable evolution of the state of mind of the user, and ancordingly to disable the brain stimulation functionality or terminate the session.
156. An abnormality' of the system is identified by any software or hardware response that would differ from that which is expected, for example:
sudden end of ongoing session, loss of power, of electrical connectivity, of internet connectivity, command from the user to interrupt the brain stimulation, or download of a. critical update.
158. The criteria used by the contingency handler to trigger a, warning signal consist in part or the following list identified tDCS exclusion criteria: brain not fully developed (user under aged), schizophrenic traits, epilepsy, depression, addiction, pregnancy, history of mentat illness, seizures and neurological_ disorders, cognitive, vision, hearing impairment, frequent headaches, cardiovascular condition, onmedication, head injury or skin disorder, presence of inetallic component in the head, first or excessive usage of brain stimulator.
160. Some of these criteria. (brain not fully developed (user under aged), schizophrenic traits, epilepsy, depression, addiction) can be to a. good extent identified directly by the brain activity analyzer; this information will therefore be taken into account in the pattern classification to determine whether and how to enable the brain stimulator.
162. All criteria, are assessed in an initial questionnaire asked to the user on the creation ofapersonal account. By default, any criteria. picked up by the brain activity analyzer or provided by the user in the initial questionnaire will result in a. deactivation of the brain stimulator, unless authorized by a valid clinical authority. All other functionalities would remain available.
164. The sequence of events of a typical session can be described as follows:
1. the user starts by turning on the system, in case of a status of low battery detected by either the wearable device or the app or software supporting the user interface, it will not be possible to start the system unless all components hold a. sufficient. level of battery.
2. if the user is new, it will be necessary to create a new and unique user account_ During the creation, it will be requested to fill in a. basic questionnaire for the system to be aware of any noteworthy information (such as a. contraindication) that would influence the proceedings of a.
mindfulness program. The user will also be asked to choose if the brain data collected can be shared and uploaded to a, remote server for scientific or healthcare purposes.
If the user is not new, a log in page on the user interface will allow to access the functional ities of the device.
3. once the user has logged in, the device runs a. test to check the status of all sensors (for example, the electrodes of the brain activity analyzer and brain stimulator). It is possible that the user has to change or clean a sensor, or to check that they are all correctly connected and possibly fix them if loose.
4. if all sensors are online and fine, the user interface prompts the user to put on the device, which then starts collecting user information from the brain activity analyzer. According to the history of the user, its current state of niitlik and the connectivity to the internet, the user interface will offer a list of programs. Each program will likely start with a. cognitive assessment and includea.pre-recordedor live mindfulness course. The brain stimulator is not enabled in case the user meets with any of the criteria requiring the deactivation of the brain stimulator;

also the very first session will not enable the brain stimulator.
5. the program is ending by evaluating its effect, and the current status of the user with regards to the personal objectives set and those of the program.
6. the user can then go on with another program, or conclude the current session. At the end of the session, the data collected is saved on the user terminal as it will be taken into account to adjust the pattern classification of subsequent sessions. If allowed by the user and if the device is connected to the internet, the data collected is also uploaded to the remote server.
7. eventually, the user is asked to provide a. personal feedback informing of the perceived effects of the session, as well as of any issue or trouble encountered. That data is uploaded to the remote server if the device is connected to the internet.
8. the user is asked to confirm the shut down of the device, which will turn itself off upon confirmation.
CA2961228A 2017-03-20 2017-03-20 Wearable device to faciliate mindfulness practices with brain activity analyzer and brain stimulator, and methods thereof Abandoned CA2961228A1 (en)

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