WO2022038596A1

WO2022038596A1 - Emotion and stress regulative assistance device, method, and system

Info

Publication number: WO2022038596A1
Application number: PCT/IL2021/050991
Authority: WO
Inventors: Yechiel SAYAG; Edo CEDER
Original assignee: Anicca Wellness Ltd.
Priority date: 2020-08-16
Filing date: 2021-08-15
Publication date: 2022-02-24

Abstract

There is provided an emotional regulative assistance device, including: a respiration sensing unit configured to be placed in direct or indirect contact with a user's body, the respiration sensing unit including: at least one sensor configured to detect the breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a tactile stimulation unit, separated from the respiration sensing unit, configured to directly or indirectly contact a body surface of the user, the tactile stimulation unit including: an actuator configured to generate a tactile stimulation based at least on the determined user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness by affecting the parasympathetic tone in the autonomic nervous system.

Description

EMOTION AND STRESS REGULATIVE ASSISTANCE DEVICE, METHOD, AND SYSTEM

TECHNICAL FIELD OF THE INVENTION

The present disclosure generally relates to the field of emotional regulative assistance device, method and system.

BACKGROUND OF THE INVENTION

The use of technology to promote well-being in general, and emotion regulation in particular, has been a growing trend in the past years. Yet, successfully hacking the human experience, or in other words, finding robust solutions to emotional distress, has been a task going back throughout human history, and probably prehistory. Nevertheless, some techniques and practices have been shown to work, and many of them involve the connection to our breath and body. Today, the common technology relating to emotion regulation through breathing offers alert systems or guides to correct breathing. However, these solutions both require the user to direct their attention away from what they are engaged with, and they force a specific breathing pattern that may not suit their physiological or emotional state. There is thus a need in the art for improved emotion regulation solutions.

SUMMARY

According to some embodiments, the present disclosure provides an emotional regulative assistance device. The device and/or system echoes a user's own breathing pattern by using a gentle tactile stimulation to their body as sensory feedback, thus allowing them to naturally /organically adapt their breathing pace without explicitly imposing any specific breathing pattern, and allowing them to stay engaged in whatever it is they are doing. Furthermore, the applied tactile stimulation is designed to increase the parasympathetic tone in the autonomic nervous system. Jointly, these two features contribute more to a calm/relaxed state than each of them separately. Advantageously, unlike existing solutions, the user is not required to direct their attention away from what they are engaged with at that moment, and is not forced into a specific breathing pattern that does not suit their physiological or emotional state. The device and/or system promotes one’s emotional as well as behavioral adaptiveness to challenging situations, regulating their stress levels to fit the situation.

According to some embodiments, there is provided herein an emotional regulative assistance device, including: a respiration sensing unit configured to be placed in direct (e.g., under the clothes) or indirect (e.g., over the clothes) contact with a user's body, the respiration sensing unit including: at least one sensor configured to detect breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a tactile stimulation unit, separated from the respiration sensing unit, configured to directly or indirectly contact a body surface of the user, the tactile stimulation unit including: an actuator configured to generate a tactile stimulation based at least on the determined user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness. Calmness may be induced by affecting the parasympathetic tone of the autonomic nervous system. According to some embodiments, affecting is increasing.

According to some embodiments, the tactile stimulation includes vibration, pressure application or both. According to some embodiments, the tactile stimulation pattern mirrors the detected breathing pattern. According to some embodiments, the tactile stimulation pattern amplifies the detected breathing pattern. According to some embodiments, the processor is configured to automatically command an activation of the actuator in response to a specified received signal.

According to some embodiments, the specified received signal is associated with a change of the breathing pattern of the subject relating to increasing stress or to loss of concentration of the user. According to some embodiments, the tactile stimulation unit is configured to provide the tactile stimulation during at least a portion of an inspiration phase of a cycle of the user's breath. According to some embodiments, the tactile stimulation unit is configured to provide the tactile stimulation during at least a portion of an expiration phase of a cycle of the user's breath.

According to some embodiments, the tactile stimulation unit is configured to provide the tactile stimulation following a full cycle of the user's breath. According to some embodiments, the calming response induced by the tactile stimulation pattern includes reduction of negative stress and/or increased concentration (focus) of the subject. According to some embodiments, the tactile stimulation unit includes an inflating unit (such as a balloon) configured to inflate and/or deflate to apply pressure to the body in a pattern correlating to the detected breathing pattern.

According to some embodiments, the length of each vibration or inflation/deflation is adjustable. According to some embodiments, the intensity of the tactile stimulation is adjustable. According to some embodiments, the level of inflation/deflation is adjustable.

According to some embodiments, the device/system disclosed herein includes a user interface module being in communication with the processor.

According to some embodiments, any one of an intensity of the tactile stimulation, a length of the tactile stimulation, a timing of the tactile stimulation in relation to the breathing cycle of the user, and an operation mode of the tactile stimulation device is controllable through the user interface module.

According to some embodiments, the tactile stimulation unit further includes a communication module (e.g., transceiver) configured to wirelessly receive instructions from the respiration sensing unit.

According to some embodiments, at least one sensor includes a force resistance sensor. According to some embodiments, at least one sensor includes an accelerometer. According to additional or alternative embodiments, the respiration sensing unit may measure the breath through means, such as an accelerometer and/or utilize the accelerometer to distinguish between breathing and movement of the user. According to some embodiments, the processor is configured to differentiate between movement of the user and a breathing pattern of the user. According to some embodiments, the device includes a memory unit configured to store data associated with respiration, activity and/or data from other sensors of the user, the memory unit being in communication with the processor, and wherein the processor is configured to retrieve data associated with previous specified breathing patterns of the user and, optionally, any additional data.

According to some embodiments, the processor commands an actuation of the actuator of the tactile stimulation unit based, at least in part, on the retrieved data associated with previous specified breathing patterns of the user. According to some embodiments, the processor is configured to receive data associated with the time during the day, and the processor is configured to command and activate the actuator based, at least in part, on the time.

According to some embodiments, the device includes a location tracker in communication with the processor, wherein the processor is configured to command an actuation of the actuator based, at least in part, on a location tracked by the location tracker. According to some embodiments, the tactile stimulation unit is wearable.

According to some embodiments, the tactile stimulation unit may include a strap configured to facilitate wearing the tactile stimulation unit over the neck of the subject and in close proximity to the subject's chest or abdomen.

According to some embodiments, the respiration sensing unit may include a clip for attaching the respiration sensing unit to a clothing item of the subject.

According to some embodiments, the respiration sensing unit may be in a U shape for attaching to a clothing item of the subject. It is noted that according to additional or alternative embodiments, the respiration sensing unit may have additional or alternative shape and/or attachment means, such as a clip, belt, strap or Velcro, to facilitate placing it in direct contact with the body or in indirect contact with the body (e.g., via a clothing item).

According to some embodiments, the respiration sensing unit is wirelessly coupled to the tactile stimulation device. According to some embodiments, the respiration sensing unit further includes a communication module (e.g., a transceiver or a transmitter) configured to wirelessly transmit instructions to the tactile stimulation unit. According to some embodiments, the respiration sensing unit further includes a circuit configured to wirelessly communicate with a smart device. According to some embodiments, the respiration sensing unit further includes a circuit configured to wirelessly communicate with a remote service.

According to some embodiments, there is provided a method for emotional regulative assistance, the method including: providing an emotional regulative assistance device/system, as disclosed herein, detecting a breathing pattern of a user in real time, providing tactile stimulation to the user (for example, either by contacting a body surface or by being placed in proximity to the body surface, e.g., be worn over a shirt, a jacket, placed in a pocket, in a pouch, in a hat, etc.) so as to echo to the user their breathing pattern, wherein the provided tactile stimulation is configured to induce calmness.

According to some embodiments, there is provided a method for emotional regulative assistance, the method including: providing an emotional regulative assistance device/system, as disclosed herein, detecting a breathing pattern of a user in real time, providing tactile stimulation to the user (for example, either by contacting a body surface or by being placed in proximity to the body surface, e.g., be worn over a shirt, a jacket, placed in a pocket, in a pouch, in a hat, etc.) so as to echo to the user their breathing pattern, wherein the provided tactile stimulation is configured to induce calmness, for example, by affecting/increasing the parasympathetic tone in the autonomic nervous system.

According to some embodiments, there is provided an emotional regulative assistance system, including: a respiration sensing device disclosed herein in accordance with some embodiments, and a smart device.

According to some embodiments, there is provided an emotional regulative assistance device including: a respiration sensing unit configured to be placed in direct or indirect contact with a user's body, the respiration sensing unit including: at least one sensor configured to detect the breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a communication module (e.g., a transceiver or a transmitter) configured to transmit instructions containing data relating to the user's breathing pattern to a stimulation device, the stimulation device is configured to generate a tactile stimulation based at least on the user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness.

According to some embodiments, there is provided an emotional regulative assistance device including: a respiration sensing unit configured to be placed in direct or indirect contact with a user's body, the respiration sensing unit including: at least one sensor configured to detect the breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a communication module (e.g., a transceiver or a transmitter) configured to transmit instructions containing data relating to the user's breathing pattern to a stimulation device, the stimulation device is configured to generate a tactile stimulation based at least on the user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness by affecting/increasing the parasympathetic tone in the autonomic nervous system.

According to some embodiments, the stimulation device is a smart phone or a smart watch. The stimulation device may be any third-party device such as a phone app, a smart watch, or any other programmable third party device.

According to some embodiments, the specified received signal is associated with a change of the breathing pattern of the subject relating to increasing stress or to loss of concentration of the user. According to some embodiments, the respiration sensing device is wirelessly coupled to the tactile stimulation device. According to some embodiments, the length of each vibration is adjustable. According to some embodiments, an intensity of the tactile stimulation is adjustable. According to some embodiments, the system includes a user interface module, the user interface module being in communication with the processor.

According to some embodiments, the system includes a memory unit configured to store data associated with respiration data of the user, the memory unit being in communication with the processor, and wherein the processor is configured to retrieve data associated with previous specified breathing patterns of the user. According to some embodiments, the processor commands the tactile stimulation based, at least in part, on the retrieved data associated with previous specified breathing patterns of the user. According to some embodiments, the processor is configured to receive data associated with the time during the day, and the processor is configured to command the tactile stimulation based, at least in part, on the time.

According to some embodiments, the system includes a location tracker in communication with the processor, wherein the processor is configured to command the tactile stimulation based, at least in part, on a location tracked by the location tracker.

Unless specifically stated or obvious from context, as used herein, the term "about" is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. "About" can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.

Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages. BRIEF DESCRIPTION OF THE FIGURES

Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the disclosure may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show details of an embodiment in more detail than is necessary for a fundamental understanding of the teachings of the disclosure.

FIG. 1 is a schematic illustration of a two-unit emotional regulative assistance device, in accordance with some embodiments;

FIG. 2 is a schematic illustration of a respiration sensing system, in accordance with some embodiments;

FIG. 3 is a schematic illustration of a two-unit emotional regulative assistance system, in accordance with some embodiments; and

FIG. 4 is a schematic illustration of a user wearing a two-unit emotional regulative assistance device, in accordance with some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

According to some embodiments, there is provided a device and system configured to help users regulate their emotions and/or stress levels in everyday life situations so they can remain in their useful stress levels with enough motivation and energy to perform, but without excess stress which is known to inhibit well-being and performance. The device and system are meant to be used before, during, or after stressful events. For example, before a stressful situation a user may wear the device and/or system to calm their feelings and mind so they can have a level of stress optimal for preparing for the situation. During the stressful situation, and while still wearing the device and/or system, the user can use the device to stay within the levels of stress optimal for the situation. After the stressful situation, the user can use the device and/or system to process the occurrences of the stressful situation, with less emotional stress, possibly have a better understanding from it for future interactions, with less chances of incurring negative trauma.

The present disclosure provides a solution for maladaptive affect in daily situations, difficulty remaining within an optimal level of stress, difficulty regaining emotional balance when over-stress occurs, and failure to respond calmly and creatively to situations, which creates more stress in itself.

The present disclosure provides, in accordance with some embodiments, a device and/or system configured to amplify the sensation of breathing such that the user can experience it while being engaged in an activity, thus maintaining calm without disruption to their ability to remain engaged in the activity, and even enhance it.

The present disclosure provides, in accordance with some embodiments, a device and/or system configured to provide tactile stimulation (for example, vibrate or inflate/deflate) while abutting the skin of the user (or being close to the skin, but still able to deliver the tactile stimulation to the body), wherein the vibration correlated to a user's breathing rhythm, enabling them to have an idiosyncratic experience rather than a generic one. According to some embodiments, the device and/or system disclosed herein provides a combination of syncing with the breath of the user and applying a calming vibration to the user’s body, either directly by contacting the body surface, or indirectly by being placed in proximity to the body surface (for example, but not limited to, over a shirt, a jacket, placed in a pocket, in a pouch, in a hat, etc.).

According to some embodiments, the device and/or system can be used passively or actively. A potential advantage of a passive operation of the device and/or system is in that the user may continue with daily tasks without stopping to give full attention to the device and/or system.

According to some embodiments, the device and/or system includes a unique vibro-tactile experience.

According to some embodiments, the device and/or system is configured to be worn by a user. According to some embodiments, the device and/or system includes a string configured to hang around a neck of a user. According to some embodiments, the device and/or system includes a strap configured to couple the device and/or system to the body of the user. According to some embodiments, the device and/or system may be positioned at any point along the body of the user. For example, a user may choose to position the device and/or system at their wrist or waist.

According to some embodiments, the device and/or system are configured to vibrate, wherein the vibration is used as a feedback and/or a regulative agent.

According to some embodiments, the device and/or system includes a wearable portion configured to be worn by the user throughout the day and help them stay calm and manage their emotions when needed. According to some embodiments, a first portion of the device and/or system detects respiration rhythm and possibly other biometrics (for example, heart rate variability (HRV) and/or galvanic skin response (GSR), activity sensor). According to some embodiments, a second portion of the device and/or system creates vibration on the body. According to some embodiments, the pattern of the vibration is configured to induce calmness to the user. According to some embodiments, the pattern of the vibration is specific and correlated with a respiration rhythm and/or pattern of the user.

According to some embodiments, the term "respiration pattern" as used herein may refer to breathing rate, tidal volume, inhalation time, exhalation time, time between inhalation and exhalation, time between exhalation and inhalation, and/or any combination of and/or ratio therebetween. A stimulation pattern (e.g., vibration pattern) correlated to the actual breathing pattern of the subject may refer to a pattern identical to any of the above properties or any combination thereof.

For example, if the breathing rate of the subject is 10 breaths per minute, the pattern of the stimulation (for example, the vibration pattern) will also be at 10 stimulations per minute, each stimulation having a length of about 0.5-2.5 seconds, e.g., 1.5 seconds. For example, the stimulation may be provided at the beginning of each inhalation, each stimulation having a length of about 0.5-2.5 seconds, e.g., 1.5 seconds. The stimulation may have a modulated strength in the form of a wave. For example, the stimulation may be provided at the beginning of each exhalation, each stimulation having a length of about 0.5-2.5 seconds, e.g., 1.5 seconds. For example, a modulating wave of vibration may start upon the beginning of inhalation and stop at the end of exhalation. For example, pulses of vibrations may be generated with each inhalation, exhalation, or both.

Vibration frequency may be about 30-80 Hz, for example 40-50 Hz. Vibration intensity may be constant or vary.

The stimulations provided may be the same or different from each other. Each possibility is a separate embodiment.

According to some embodiments, the device and/or system may have a few effects - firstly they amplify the sensation of the breath and the body, thus increasing the calming and focusing effects of being in the here and now through feeling one’s physical self. Second, they generate a pleasant affect in the body: for example, vibrations are known to “hijack” pain signal bandwidth in the nervous system, and thus tell the brain that things are better than they seem to be, reducing the level of pain-fear alarm. In addition, the vibration on the body has an additional calming effect, telling the brain things are “ok”, similar to the intervention of a physical companion’s touch. According to some embodiments, the device includes a single unit which measures the biometrics and creates the vibration at the same area.

According to some embodiments, the system includes two separate units and/or devices. The devices of the system are worn separately so as breathing can be detected in the best place for it on the body, and the vibration can be used anywhere on the body that the user feels and/or experts advise that it gives greatest benefit.

According to some embodiments, the device and/or system is configured to combine vibrations and breath awareness to induce calm. According to some embodiments, the device and/or system includes a wearable device that can help users stay within their useful level of stress as they go about their day.

Reference is made to FIG. 1, which is a schematic illustration of an emotional regulative assistance device 100, in accordance with some embodiments of the present invention. Device 100 includes two separated, functionally associated, units: a respiration sensing unit 150 configured to sense a respiratory pattern of the user and a tactile stimulation unit 110 configured to apply tactile stimulation (such as vibrations) to the body of the user. Respiration sensing unit 150 includes one or more sensors (not shown, such as but not limited to, a force sensor) configured to measure the user's breathing pattern.

Respiration sensing unit 150 further includes a processor (not shown) configured to receive a signal associated with the detected breathing pattern from the one or more sensors, to determine a calming tactile stimulation pattern based at least on the signal obtained from the sensor and to provide respective instructions (via a transducer, not shown) to tactile stimulation unit 110.

Respiration sensing unit 150 is shown in Fig. 1 as having a U shape, forming a narrow gap 152 allowing attaching and securing tactile stimulation unit 150 between a piece of clothing or accessory and the body. This can be around the waist area or around the chest area. It is noted that according to additional or alternative embodiments, respiration sensing unit 150 may have additional or alternative shapes and/or attachment means, such as a clip, belt, strap or Velcro, to facilitate placing it in direct contact with the body or in indirect contact with the body (e.g., via a clothing item). It is noted that according to additional or alternative embodiments, respiration sensing unit 150 may measure the breath through other means, such as an accelerometer and/or utilize the accelerometer to distinguish between breathing and movement of the user.

Respiration sensing unit 150 may also include a charging/communication socket 154.

Tactile stimulation unit 110 includes an actuator (not shown), such as a vibration motor or a balloon configured to inflate and deflate, configured to generate the tactile stimulation based on signal (instructions) received from the processor of respiration sensing unit 150 (via the communication module (e.g., a transceiver or a transmitter) of respiration sensing unit 150 and a receiver (not shown) of the tactile stimulation unit 110. The tactile stimulation pattern provided by the tactile stimulation unit thus echoes/mirrors/reflects to the user their breathing pattern, and the tactile stimulation itself has characteristics (such as, frequency, intensity, modulation etc.) that are inducive of calmness.

Tactile stimulation unit 110 is shown in Fig. 1 to include a strap 114 to allow wearing over the neck and comfortably carrying it in contact or in proximity to the chest or abdomen during everyday activity. It is noted that according to additional or alternative embodiments, tactile stimulation unit 110 may have additional or alternative wearable means, such as a belt, a clip, a pouch, a hat, or Velcro to facilitate wearing it on any body part. Tactile stimulation unit 110 may also include a charging/communication socket 116.

Reference is made to FIG. 2, which is a schematic illustration of a respiration sensing system 200, in accordance with some embodiments of the present invention.

Respiration sensing system 200 includes respiration sensing unit 202, which includes a sensor 204 (such as, but not limited to, a force sensor) configured to measure the user's breathing and, optionally, an accelerometer 206 configured to sense the user's movements.

Respiration sensing unit 202 may also include or may be associated with a memory unit 208 configured to store data associated with respiration of the user.

Respiration sensing unit 200 further includes a processor (not shown) configured to receive the detected signal from sensor 204, to determine the user's breathing pattern, and to provide instructions containing the user's breathing pattern, via communication means 210 (e.g., via a radio-frequency using, for example, Bluetooth or WiFi protocol), to another device such as a tactile stimulation generating device or a smart phone.

According to additional or alternative embodiments, respiration sensing unit 202 may also be in communication via communication 212 (e.g., via a radio-frequency using, for example, Bluetooth protocol) with another device, such as a smartphone 214, which can be in communication with a remote server/cloud 216.

Reference is made to FIG. 3, which is a schematic illustration of an emotional regulative assistance system 500, according to some embodiments. Emotional regulative assistance system 500 includes a respiration sensing system 200 (first unit), associated with a tactile stimulation system 300 (second unit), in accordance with some embodiments of the present invention.

Fig. 3 illustrates the physical and logical components of the of emotional regulative assistance system 500. Respiration sensing system 200 measures the respiration pattern, and can, for example, whenever it determines a breath had been taken, send an instruction to the second unit (tactile stimulation system 300) to create a corresponding tactile sensation, for example, through vibration or alternating pressure on the body.

Respiration sensing system 200 and the components/functions thereof are similar to those described in Fig. 2. Tactile stimulation system 300 includes tactile stimulation unit 302, which includes a stimulator (actuator) 304 and a communication means 306 (e.g., a radio-frequency receiver/transceiver using, for example, Bluetooth protocol) configured to receive signal(s) from communication means 210 of respiration sensing unit 202 containing tactile stimulation instructions. Stimulator (actuator) 304 is configured to provide stimulation based on the instructions received. Tactile stimulation unit 302 may also include a processor.

Reference is made to FIG. 4, which is a schematic illustration of a user with a two-unit emotional regulative assistance device, in accordance with some embodiments. The two-unit emotional regulative assistance device includes two separated, functionally associated, units: a respiration sensing unit 450 (which may be similar to respiration sensing unit 150 of Fig. 1) attached to the user's waistline and configured to sense a respiratory pattern of the user; and a tactile stimulation unit 410 (which may be similar to stimulation unit 110 of Fig. 1) worn around the user's neck and configured to apply tactile stimulation (such as vibrations) to the body of the user. The tactile stimulation unit can be worn under or over the clothes.

According to some embodiments, the tactile unit is activated upon user's request or upon an instruction from the respiration sensing unit to activate the tactile unit. The tactile unit, once activated, induces a tactile stimulation, e.g., a vibration or an inflation/deflation motion, with a particular rhythm and frequency to induce the calming effect. According to some embodiments, in the two-units device, the tactile unit can be placed anywhere on the body the user feels tension.

A smart device (e.g., a smart phone) app may be used, in accordance with some embodiments, to change operation modalities, and to be a conduit of respiration data to the server/database. The app may also give the user information about their breathing rates, their stress onset and reliefe data, insights and other relevant information in the different situations they go through, and it could also be used to communicate with the user.

The respiration sensing unit, which can be considered as a 1 ^st unit, is configured to measure the user's respiration. According to some embodiments, when the respiration sensing unit determines respiration signifying a non-optimal stress level, or when the user chooses to, it activates the tactile unit, which can be considered as a 2^nd unit, to create a tactile experience to the user. According to some embodiments, the user can (for example, at the end of the day) look at these breathing patterns and receive insights about their stressors (and other stress related data) through a phone app, which can be considered as a 3^rd unit.

According to some embodiments, the user may wear the respiration sensing unit all day. When they determine that they want assistance, or the respiration sensing unit determines that they need it, the respiration sensing unit will start sending signals to the tactile unit to provide stimulation (for example to vibrate) stimulate vibrate according to the rhythm of the respiration.

According to some embodiments, the device and/or system combines breathing awareness and calming stimulation together. Additionally, it operates in a way that the user doesn't have to stop what they are doing but can stay involved in the situation that they are in, keeping them involved in life rather than avoid it.

According to some embodiments, one way to measure respiration is to use a force sensor resistor to measure expansion of torso as breath comes in, and deflation as breath goes out. According to some embodiments, embedded software (processor) analyses the data and determines when a breath is taken, and then sends a signal to a stimulator, such as a vibration motor, with instructions to work. According to some embodiments, the system provides instructions to provide tactile stimulation (e.g., to vibrate) over wireless communication.

According to some embodiments, the device and/or system are wearable, which assist a person to stay connected to themselves through amplifying the sensation of their real-time breathing and their body using a pleasant vibration, thus helping them to keep calm, centered, and focused in the here and now.

According to some embodiments, the device and/or system are made of two parts which act together - a sensing unit which senses the person’s real-time breathing, and a vibration unit which vibrates at the rate of the person’s breathing. The two units can either form a single device, or, preferably, two separate devices.

According to some embodiments, in the single-device mode, the user can place the device either between the pants/belt and the lower abdomen, or between the bra and the chest.

According to some embodiments, in the two-device mode, the user has to place the respiration sensing unit at the waistline or chest line, but the tactile stimulation unit can be placed anywhere the user feels they want it. According to some embodiments, the devices are designed to be small enough so they can easily be carried and used, but large enough so the sensing unit can be accurate, and the tactile stimulation unit can have the effect on the user’s mind and nervous system.

According to some embodiments, the devices are designed to be worn all day without obstructing the user’s normal functioning.

According to some embodiments, the device may also include a mobile-based software which gathers usage information, allows the user to choose operation modes, allows the user to program the device to start at specific times of the day or at specific locations, displays the user’s breathing patterns and help them discover their specific stressors so they can work with them, and in the future include a robust coaching platform that will assist the user to achieve their well-being goals.

According to some embodiments, the device and/or system aims to create a solution which will assist the person not only in feeling better, but actually get to know themselves and promote inner peace through integrating their inner world.

According to some embodiments, the device and/or system can be used to regulate emotions as they appear, as well as help the person process situations after they occur, or get ready for stressful situations before-hand.

Advantageously, according to some embodiments, the device and/or system are unique in that they operate discreetly on the body, without requiring the user to change anything in their activity or behavior, thus allowing them to remain present in whatever activity they are taking part in.

According to some embodiments, the device and/or system may include a wearable device/unit designed to be worn seamlessly throughout the day, that combine gentle tactile stimulation (such as vibration) with personal breathing rate feedback to provide real-time emotional regulative assistance during challenging situations.

The intended users of the system and/or device may be people from all walks of life who realize they can have a better quality of life, improved health, and more efficacy in their personal and professional lives through regulating their emotional reactions to daily situations. According to some embodiments, the system and/or device are configured to technologically support emotional well-being. Instead of guiding the user to regulate their stress levels through outside controlled breathing, the device and/or system turns their attention to their own breathing using a gentle tactile (e.g., vibrotactile) stimulation as sensory feedback, thus allowing them to naturally adapt their breathing pace without explicitly imposing any specific breathing pattern. The device and/or system promotes one’s emotional as well as behavioral adaptiveness to challenging situations, and that their stress level fits the situation. For example, if they need to save themselves from an oncoming car, they can bolt; but if they are in a social engagement - such as a romantic date - they can be calm enough to enjoy and be creative, or be clearer headed and focused on an important exam.

According to some embodiments, the use of the device and/or system can promote emotional adaptation, well-being, and cognitive coherence through a combination of several mechanisms: real time soothing via tactile (e.g., vibrotactile) stimulation, real time soothing via increased awareness of the breath leading to breathing pace adaptation, calming of the mind by focusing on a pleasant sensation, and short and long-term strengthening of interoceptive awareness.

According to some embodiments, the device and/or system apply localized vibration stimulation (for example, on chest, back, limb, or belly) at the pace of one's natural breath during a stressful situation, which will moderate objective and subjective levels of stress.

According to some embodiments, usage of the device and/or system leads to reduction in reported stress levels, especially negative stress, slower respiration and increase in parasympathetic (PNS) tone as measured using heart rate variability, improved cognitive performance under the same external conditions/situation, and/or a shorter recovery time after the outside stressor is removed.

According to some embodiments, the use of the device and/or system can promote falling asleep faster, staying asleep longer, and having a better sleep quality.

According to some embodiments, the user places the respiration rate sensing unit at the waistline or chest line, and the vibrating unit can be placed anywhere the user feels they need it. The system and/or device is designed to be small enough so it can easily be carried and used, but large enough to have an effect on the user’s mind and nervous system. According to some embodiments, the system and/or device is designed to be worn all day without obstructing the user’s normal functioning or put in a purse or bag and used upon need.

According to some embodiments, the system and/or device may be couplable to a mobile - based software, which gathers usage information, allows the user to choose operation modes, and program the device to start at specific times of the day or at specific locations, displays the user’s breathing patterns and help them discover their specific stressors so they can work with them, and in the future include a robust person/computer coaching platform.

According to some embodiments, the term "smart device" as used herein, may refer to any electronic device, connectable to other devices or networks via wireless protocols, such as, but not limited to, Bluetooth, Zigbee, NFC, Wi-Fi, LiFi, 5G, etc.

According to some embodiments, the terms "communication", "communication means" or "communicate" as used herein, may refer to any type of communication, via wires or wireless, e.g., by Bluetooth, Zigbee, NFC, Wi-Fi, LiFi, 5G protocols or any other protocol.

According to some embodiments, the terms "breathing" or "breathing pattern" may refer to any breathing related parameter or any combination of parameters, such as breathing rate tidal volume, inhalation time, exhalation time, time between inhalation and exhalation, time between exhalation and inhalation, or any combination thereof, and/or a ratio therebetween.

According to some embodiments, the term "in direct or indirect contact with a user's body" may refer to a direct body surface contact or to an indirect contact via a clothing item, such as a shirt, skirt, pants, etc.

According to some embodiments, the terms "stimulator" and "actuator" may be used interchangeably.

According to some embodiments, the term "echo" may refer to mean to reflect or to mirror.

The following examples are presented in order to more fully illustrate some embodiments of the invention. They should in no way be construed, however, as limiting the broad scope of the invention. One skilled in the art can readily devise many variations and modifications of the principles disclosed herein without departing from the scope of the invention.

While certain embodiments of the invention have been illustrated and described, it will be clear that the invention is not limited to the embodiments described herein. Numerous modifications, changes, variations, substitutions and equivalents will be apparent to those skilled in the art without departing from the spirit and scope of the present invention as described by the claims, which follow.

EXAMPLE 1

According to some preferred embodiments, the device and/or system is made of two parts which act together - a sensing unit that follows the person’s real-time breathing, and a separate tactile stimulation unit that vibrates accordingly. There are three types of stimulation- vibration upon inspiration, vibration upon expiration, or vibration following the whole cycle of the breath.

The respiration unit is placed between the pants or bra and the body, and the vibrating unit anywhere the user wants to use it on the body.

A lab experiment is conducted to test the effects of the device. We expect that the device will have the following effects on the user:

1) Lead to reduction in reported stress levels, especially negative stress

2) Lead to slower respiration and increase in PNS tone as measured using heart rate variability

3) Lead to improved cognitive performance under the same external conditions/situation

4) Lead to a shorter recovery time after the outside stressor is removed

The experiment is conducted on 60 healthy adult volunteers between the age of 20-60 that are not under psychiatric treatment. Subjects are randomly assigned into three groups: group 1 - in which subjects receive a real device and are told that the device vibrates at the pace of their breath; group 2 - where subjects receive a real device and are only told that the device helps reduce stress, and group 3 - where subjects receive a sham device and are told that the device helps reduce stress. Stress of the subjects is induced in the lab using an anticipation of public speaking manipulation which has been shown to successfully induce anxiety and stress in subjects.

The following data is extracted for each subject: self-reported stress at three time points, HRV data at three time points, performance in the task (number of errors), average breathing pace during task, baseline breathing pace. The data is analyzed using a parametric or non-parametric statistical testing of group differences (depending on the variable). Cognitive performance evaluation: the well-established n-back task is used to evaluate cognitive performance and is administered twice. Once 5 min after stress induction, and again 30 min after stress subsided.

Intervention: A real or sham device and/or system are placed and properly attached on the subject’s torso. The exact position of the device is determined based on the subject’s preference. Self-report measures: Subjects are asked to rate their affective states on validated self-reporting scales before the task, immediately after the task and 20 minutes later.

Physiological stress measures: Heart rate and respiration pace are recorded using a respiration and heart rate strap. Heart rate is used to extract the high frequency component of heart rate variability, which is a known indicator of stress reduction and emotion regulation. Respiration testing is used to validate the accuracy of the device and/or system.

EXAMPLE 2

The target users were people with daily excessive stress levels, difficulty concentrating, or difficulty falling asleep. Reasons could be internal such as high sensitivity, or external objective stressors such as economic concerns, illness of a loved one, etc.

Purpose: to affirm that a wearable device which emits vibrations synchronized with a user's breathing has a calming effect on the user.

Participants:

People who suffer from excessive stress on a daily basis, therapists, and people who were curious about the relationship between breathing and well-being.

No. of participants: 29

Frame: 2 - 4 weeks of use at home or on-the-go

Process:

Applicants filled out a full questionnaire which included demographic and medical details, as well as a PSS (Perceived Stress Scale) & QoLQ (Quality of Life Questionnaire) questionnaires.

All questionnaires were reviewed and those with major clinical disorders were filtered out. Users were sent a device by courier, and upon arrival received a 45-minute onboarding session on how to operate the device. Users were asked to wear the device all day and activate it upon need. Users were told the device helps with stress by connecting them with their real breathing rhythm. Users did not receive any breath practice instructions.

Users were sent daily usage reports in which they filled out details on how they used the device and marked how much the device was effective for them.

Users were contacted once in the middle of the period and once at the end.

At the end of the experiment Users filled out a usage summary questionnaire.

Users could select the strength, length, and mode of the vibration (with inhale, exhale, or full breath).

Results:

62% of users marked “Yes” to the question “Looking at the full length of the period of using the device, did using the device help you?”

48% of users marked “Yes” to the question “Would you recommend the device to a friend / family member?”

31% of users marked “Maybe” to the question “Would you recommend the device to a friend / family member?”

250 usage reports were submitted altogether.

76% of the usage reports specified the device was effective in the situation - a mark of 3+ on a 0-6 scale on the question “How much the device and its effect were generally meaningful in the situation?”

The device was used 46% in resting situations (relaxation, meditation, falling asleep), 28% in task-oriented situations (work, study, driving), 26% in social situations.

The device was effective 76%, 65%, 68% in those situations respectively.

72% of users who were helped by the device were with PSS (Perceived Stress Scale) above the average of the whole study population.

Conclusions: 62% of users found the device effective on their well-being.

The device was marked effective in 76% of the situations reported by users.

79% of users consider recommending it to others

EXAMPLE 3

An academic study is performed in an ecological experimental setting.

Purpose 1: to affirm that a wearable device which emits vibrations synchronized with a user's breathing has a calming effect on the user.

Purpose 2: to affirm that specific respiration patterns correlate to certain emotional states such as stress or anxiety.

90 participants are enlisted from various online groups.

The invitation is extended to people who experience over-stress on a daily basis and wish to do something about it. People with physical or psychiatric ailments are excluded.

Participants are invited to the lab, given instructions of use, and are sent home with the device, the app, and an activity bracelet, to be used for 14 days. They are instructed to wear the respiration unit all day and start/stop the tactile stimulation unit according to how they feel.

When the user activates the tactile stimulation unit they are asked to give feedback on how they feel at that moment. The same feedback is prompted for when they stop the stimulation.

To collect respiration patterns data, the device collects respiration data at three points - start of inhalation, start of exhalation, end of exhalation.

At the end of the experiment the emotional feedback data is compared with the respiration data to determine whether emotional states correlated with specific breathing patterns, and whether the user’s breathing patterns changed as a result of using the device. Activity data is analyzed to eliminate changes in breathing patterns that correlated with activity.

Claims

CLAIMS What we claim is:

1. An emotional regulative assistance device, comprising: a respiration sensing unit configured to be placed in direct or indirect contact with a user's body, said respiration sensing unit comprising: at least one sensor configured to detect breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a tactile stimulation unit, separated from said respiration sensing unit, configured to directly or indirectly contact a body surface of the user, said tactile stimulation unit comprising: an actuator configured to generate a tactile stimulation based at least on the determined user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness by affecting the parasympathetic tone of the autonomic nervous system.

2. The device according to claim 1, wherein said actuator comprises a vibration motor.

3. The device according to any one of claims 1-2, wherein said tactile stimulation pattern mirrors a detected breathing pattern.

4. The device according to any one of claims 1-3, wherein said tactile stimulation pattern amplifies a detected breathing pattern.

5. The device according to any one of claims 1-4, wherein said processor is configured to automatically command and activate said actuator in response to a specified signal received from said sensor.

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6. The device according to claim 5, wherein said specified received signal is associated with a change of a breathing pattern of the subject relating to increasing stress or to loss of concentration of the user.

7. The device according to any one of claims 1-6, wherein said tactile stimulation unit is configured to provide said tactile stimulation during at least a portion of an inspiration phase of a cycle of the user's breath.

8. The device according to any one of claims 1-7, wherein said tactile stimulation unit is configured to provide said tactile stimulation during at least a portion of an expiration phase of a cycle of the user's breath.

9. The device according to any one of claims 1-8, wherein said tactile stimulation unit is configured to provide said tactile stimulation following a full cycle of the user's breath.

10. The device according to any one of claims 1-9, wherein the calming response induced by the tactile stimulation pattern comprises reduction of negative stress of the subject.

11. The device according to any one of claims 1-10, wherein said actuator comprises an inflating unit configured to inflate and/or deflate at a pattern correlating to a detected breathing pattern.

12. The device according to any one of claims 1-11, wherein said at least one sensor comprises a force resistance sensor.

13. The device according to any one of claims 1-12, wherein said at least one sensor comprises an accelerometer.

14. The device according to any one of claims 1-13, wherein said processor is configured to differentiate between movement of the user and a breathing pattern of the user.

15. The device according to any one of claims 1-14, comprising a memory unit configured to store data associated with respiration, activity and/or data from other sensors of the user, said memory unit being in communication with said processor, and wherein said processor is configured to retrieve data associated with previous specified breathing patterns of the user and, optionally, any additional data.

16. The device according to claim 15, wherein said processor is configured to command an actuation of said actuator based, at least in part, on said retrieved data associated with previous specified breathing patterns and, optionally, additional data of the user.

17. The device according to any one of claims 1-16, wherein said processor is configured to receive data associated with the time during the day, and said processor is configured to command and activate said actuator based, at least in part, on the time.

18. The device according to any one of claims 1-17, further comprising a location tracker in communication with said processor, wherein said processor is configured to command and activate said actuator based, at least in part, on a location tracked by said location tracker.

19. The device according to any one of claims 1-18, wherein said tactile stimulation unit is wearable.

20. The device according to any one of claims 1-19, wherein said tactile stimulation unit comprises a strap configured to facilitate wearing said tactile stimulation unit over the neck of the subject and in close proximity to the subject's chest or abdomen.

21. The device according to any one of claims 1-20, wherein said respiration sensing unit comprises a clip for attaching said respiration sensing unit to a clothing item of the subject.

22. The device according to any one of claims 1-21, wherein said respiration sensing unit is in a U shape for attaching to a clothing item of the subject.

23. The device according to any one of claims 1-22, wherein said respiration sensing unit is wirelessly coupled to said tactile stimulation device.

24. The device according to any one of claims 2-23, wherein a length of each vibration is adjustable.

25. The device according to any one of claims 1-24, wherein an intensity of the tactile stimulation is adjustable.

26. The device according to any one of claims 1-25, comprising a user interface module, said user interface module being in communication with said processor.

27. The device according to claim 26, wherein any one of an intensity of the tactile stimulation, a length of the tactile stimulation, a timing of the tactile stimulation in relation to the breathing cycle of the user, and an operation mode of the tactile stimulation device is controllable through said user interface module.

28. The device according to any one of claims 1-27, wherein said respiration sensing unit further comprises a communication module configured to wirelessly transmit instructions to said tactile stimulation unit.

29. The device according to any one of claims 1-28, wherein said tactile stimulation unit further comprises a receiver configured to wirelessly receive instructions from said respiration sensing unit.

30. The device according to any one of claims 1-29, wherein said respiration sensing unit further comprises a circuit configured to wirelessly communicate with a smart device.

31. The device according to any one of claims 1-29, wherein said respiration sensing unit further comprises a circuit configured to wirelessly communicate with a remote service.

32. A method for emotional regulative assistance, the method comprising: providing a device according to claim 1 ; detecting a breathing pattern of a user in real time; providing tactile stimulation so as to echo to the user their breathing pattern, wherein the provided tactile stimulation is further configured to induce calmness by affecting a parasympathetic tone of the autonomic nervous system.

33. An emotional regulative assistance system, comprising: an emotional regulative assistance device according to any one of claims 1-32; and a smart device.

34. An emotional regulative assistance device, comprising: a respiration sensing unit configured to be placed in direct or indirect contact with a user's body, said respiration sensing unit comprising: at least one sensor configured to detect the breathing pattern of a user and to provide, in real time, a signal indicative of the user's breathing; and

28 a processor configured to receive the detected signal and to determine the user's breathing pattern based at least on the signal obtained from the sensor; and a communication module configured to transmit instructions containing data relating to the user's breathing pattern to a stimulation device, the stimulation device is configured to generate a tactile stimulation based at least on the user's breathing pattern so as to echo to the user their breathing pattern, wherein the tactile stimulation is further configured to induce calmness by affecting the parasympathetic tone in the autonomic nervous system.

35. The device according to claim 34, wherein the stimulation device is a smart phone or a smart watch.

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