WO2020194350A1 - Dispositif portable pour mesurer la santé d'un fœtus - Google Patents

Dispositif portable pour mesurer la santé d'un fœtus Download PDF

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Publication number
WO2020194350A1
WO2020194350A1 PCT/IN2020/050284 IN2020050284W WO2020194350A1 WO 2020194350 A1 WO2020194350 A1 WO 2020194350A1 IN 2020050284 W IN2020050284 W IN 2020050284W WO 2020194350 A1 WO2020194350 A1 WO 2020194350A1
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Prior art keywords
fetus
wearable device
subject
sensors
monitoring
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PCT/IN2020/050284
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English (en)
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Shivi KAPIL
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Empathy Design Labs Private Limited
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Publication of WO2020194350A1 publication Critical patent/WO2020194350A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02411—Detecting, measuring or recording pulse rate or heart rate of foetuses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4362—Assessing foetal parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
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    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
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    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
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    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
    • A61B5/1114—Tracking parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1116—Determining posture transitions
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    • A61B5/16—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state
    • A61B5/165—Evaluating the state of mind, e.g. depression, anxiety
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    • 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
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/344—Foetal cardiography
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    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064—Evaluating the brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4094—Diagnosing or monitoring seizure diseases, e.g. epilepsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4356—Assessing uterine contractions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4815—Sleep quality

Definitions

  • the present disclosure relates to a field of objective monitoring a fetus, and more particularly relates to a wearable device for a gestating subject for monitoring fetus health
  • Some of the fetal conditions include Reduced Fetal Movements (RFM), fetal growth restrictions (such as reduced heart-beat, brain disorder), and low birth weight.
  • Some of the maternal physiological conditions include maternal disorders (such as obesity, diabetes and hypertension), pregnancy risks, maternal stress, sleeping position and quality of the expectant mother, and prenatal mental stress of parents.
  • the wellbeing of the fetus can be monitored by several methods including monitoring heart rate, ECG patterns, fetal movements, fetal heart rates patterns (such as amplitude change, signal frequency and unique events occurrence), hiccups, birth weight, and position of the fetus.
  • monitoring heart rate ECG patterns
  • fetal movements fetal movements
  • fetal heart rates patterns (such as amplitude change, signal frequency and unique events occurrence)
  • hiccups birth weight
  • a lot of high risk pregnancies, such as IUGR and Ectopic can be easily detected by monitoring the simple heart rate patterns.
  • the heart rate of the fetus is typically monitored by FHR monitor, which uses Doppler
  • ECG patterns of the fetus can be monitored by conventionally monitored by collecting fetal ECG signals using a wire electrode onto the fetal scalp during labor. It is known that by monitoring ECG pattern of the fetus, several brain disorders (such as fetal seizures, epilepsy, mental retardness, downs syndrome, and brain development growth) can be monitored and take care of at the very early onset. Therefore, monitoring of ECG patterns at initial 26 weeks is extremely necessary during active pregnancy. Further, the irregular heartbeat patterns of the fetus and fetal movements are also early indicators of several conditions, such as low birth weights and high risk pregnancies.
  • fetal conditions such as fetal movements, fetal heart rates patterns (such as amplitude change, signal frequency and unique events occurrence), hiccups, birth weight, and position of the fetus can be conventionally monitored using either Doppler Effect ultrasound technique.
  • the ultrasound technique is expensive and not available easily. Further, the ultrasound technique needs a skilled operator to interpret the ultrasound images which comes only through experience and training. Furthermore, the ultrasound technique may need constant supervision from clinic, nurse, doctor, or a medical practitioner. This means that the expectant mother or parents are consistently dependent on someone else to understand and monitor the wellbeing of their fetus. Often the ultrasound tests are performed after a long duration, which may result in major complications and high risk.
  • a PCT patent application WO 2013/130979 relates to fetus monitoring and, more particularly, to an electronic external fetus monitoring system that includes a self-adhering single use dermal patch including embedded sensors that can be attached to the skin of an expectant maternal patient and is configured to record FHR, uterine activity, and uterine integrity.
  • WO 2007/095457 discloses a method for obtaining fetal heart activity.
  • WO 2007/095457 relates to an integrated patch for the non-invasive monitoring of a laboring woman.
  • the patch incorporates biopotential electrodes for sensing fetal ECG and EMG indicative of myometrial activity.
  • the patch also incorporates a processor for extracting labor activity and fetus heart activity after filtering out maternal ECG from the composite biopotential signal present on the abdomen of the pregnant woman.
  • CIS patent 8306610B2 relates to a non-invasive method to determine psychiatric and physical condition of a human being. However, the patent does not disclose the implementation of the method on the expectant mother and further its results in wellbeing of the fetus.
  • the methods or techniques disclosed in the patent applications above do not provide a means for continuous monitoring of the fetus without disrupting the mother’s daily activities. Furthermore, the use of invasive and active sensors and electrodes for measuring of fetal parameters may cause inconvenience to the mother.
  • a wearable device for monitoring fetus health is disclosed. Particularly, a wearable device for a gestating subject for monitoring a fetus of the subject is disclosed.
  • the wearable device comprises a plurality of sensors for sensing at least one physiological parameter each of the fetus and the subject, and a controller in communication with the plurality of sensors and a memory unit storing instructions for execution by the controller.
  • the controller is configured for, deriving a value associated with each of the physiological parameters, comparing the derived value with one or more of a corresponding historical values and corresponding one or more predefined values, and performing one or more actions based on results of the comparisons, wherein the one or more actions include providing a stimulus for stimulating the fetus, predicting a fetal health condition, and communicating, through at least one communication means, one or more alerts to one or more pre-designated devices.
  • a method for monitoring a fetus of a gestating subject comprises the steps of, receiving the plurality of sensor data indicative of at least one physiological parameter each of the fetus and the subject, deriving a value associated with each of the physiological parameters, comparing the derived value with one or more of a corresponding historical values and corresponding one or more predefined values, and performing one or more actions based on results of the comparisons, wherein the one or more actions include providing a stimulus for stimulating the fetus, predicting a fetal health condition, and communicating, through at least one communication means, one or more alerts to one or more pre-designated devices.
  • FIG. 1A is a block diagram of an exemplary wearable device 100 for a gestating subject, for monitoring a fetus heath of the subject is disclosed.
  • FIG. IB illustrates an arrangement of combination of sensors within the wearable device, in accordance with one exemplary embodiment of the present disclosure
  • FIG. 2 illustrates an environment of a wearable device for monitoring fetal health, in accordance with another embodiment of the present disclosure
  • FIGS. 3A, 3B and 3C illustrate front, side and back views respectively, of a wearable device attached to a mother in the form of a maternity belt or patch, in accordance with one exemplary embodiment of the present disclosure
  • relational terms such as first and second, and the like, may be used to distinguish one entity from the other, without necessarily implying any actual relationship or order between such entities.
  • the present disclosure attempts to overcome the problems of the existing art by providing a system and method for objective monitoring of physiological health of fetus and expectant mother (gestating subject).
  • a wearable device for monitoring the fetus health that is, fetus movements, irregular heartbeats patterns, ECG patterns, Ectopic/normal pregnancy, position, and birth weight of the fetus, which acts as early indicators of fetus distress and developments.
  • the present disclosure also relates to objective monitoring of pregnancy confirmation, maternal stress, maternal health conditions (such as BP), sleeping position and quality of the expectant mother and prenatal mental stress of parents which are also reasons and indicators of the fetal distress and development.
  • the mother may wear the wearable device around the abdomen for objective monitoring of the fetus movements, irregular heartbeats patterns, ECG patterns, Ectopic/normal pregnancy, position, and birth weight of the fetus, pregnancy confirmation, maternal stress, maternal health conditions (such as BP), sleeping position and quality of the expectant mother, and prenatal mental stress of parents without any assistance from a doctor, nurse or midwife.
  • the wearable device comprises a plurality of sensors. The various embodiments of the proposed disclosure are explained using FIGS. 1A - 3.
  • FIG. 1A is a block diagram of an exemplary wearable device 100 for a gestating subject, for monitoring a fetus heath of the subject is disclosed.
  • the gestating subject hereafter referred to as mother
  • the wearable device 100 may wear the wearable device 100 around the abdomen for objective monitoring of the fetus health and movements.
  • the term fetus health as described herein refers to one or more physiological parameters including but not limited to the fetus movements, heartbeats patterns, ECG patterns, Ectopic/normal pregnancy, position, and birth weight of the fetus, , maternal stress, maternal health conditions (such as BP), sleeping position and quality of the expectant mother, and prenatal mental stress of parents. Since the fetus health is also dependent on the mother health, the physiological parameters also include physiological parameters of the mother such as sleeping position and quality of the expectant mother, and prenatal mental stress of parents, etc.
  • the wearable device 100 comprises a plurality of sensors 105-1, 105-2...105-n (collectively referred as sensors 105), at least one low- pass filter 110, at least one Analog to Digital Converter (ADC) 115, at least one microcontroller 120, a memory 130 and an I/O interface 135.
  • the wearable device 100 may further comprise a rechargeable power source 122 to supply power to the active components in the low-pass filter 110, the ADC 115 and the microcontroller 120.
  • the wearable device 100 may further comprise one or more functional blocks such as network interface modules, Bluetooth modules, etc. for wirelessly communicating with other devices and servers as well known in the art.
  • the at least one microcontroller 120 may be implemented as one or more microprocessors, microcomputers, central processing units, logic circuitries, and/or any devices that manipulate signals based on operational instructions. Among other capabilities, the at least one microcontroller 120 is configured to fetch and execute computer-readable instructions stored as codes in the memory 130.
  • the I/O interface 135 may include a variety of software and hardware interfaces, for example, a graphical user interface, a display and the like.
  • the I/O interface 135 may allow the mother to configure the wearable device 100 and/or the at least one microcontroller. Further, the mother may use the I/O interface 135 to communicate with electronic device (not shown). Further, the I/O interface 135 enables the mother to input various physiological parameters such as weight, height, age, blood pressure, etc.
  • the wearable device 100 with the sensors 105, the low-pass filter 110, the ADC 115, the at least one microcontroller 120, the memory 130 and the I/O interface 135 may be implemented in the form of small insulated chip on a maternity belt. In another embodiment, the wearable device 100 may be implemented in the form of a dermal patch.
  • the sensors 105 may include but not limited to pressure sensors, a motion sensors, a strain sensors, a piezoelectric sensors, ultrasonic sensors, Electrocardiography (ECG), electrode, Electromyography (EMG) electrode, Doppler sensor, accelerometers, gyroscope, heart rate sensor, temperature sensors, and so on.
  • the pressure sensors include strain gauge sensors arranged to form a Wheatstone bridge for detecting the fetus movement.
  • the motion sensors are configured for monitoring the number of fetal movements
  • the blood pressure sensors are configured for measuring blood pressure of the expectant mother
  • the piezoelectric sensor monitors are configured for measuring mechanical stress.
  • the ECG and EMG monitors not limited to, EEG patterns of the fetus and the expectant mother.
  • the Doppler sensor are used for monitoring heart rate patterns and movements of the fetus.
  • the accelerometers and gyroscope monitor are used sleeping position patterns of the expectant mother.
  • the heart rate sensor monitors, but not limited to, fetal heart rate, maternal heart rate, heart rate patterns including amplitude change, signal frequency and unique events occurred with respect to time and pregnancy week.
  • the system comprises of markers, such as like BP, MHR, Pulse, Mood, and Emotion score to determine the mental health status of mother and Mood and Emotion score of Father.
  • the system comprises of markers to determine blood pressure pregnancy value and sleeping quality of the expectant mother.
  • the wearable device 100 comprises of the Doppler sensor and stethoscope mechanism, which picks up fetus heartbeats and enhances for a person to hear the same.
  • the system depicts the fetus heartbeats and patterns in the form of audio and/or visual pattern.
  • the fetus heartbeats and patterns are displayed on phone or other similar devices in the form of audio and/or visual pattern.
  • the wearable device 100 comprises of motion sensor to identify fetal movements.
  • the motion sensor present in the wearable device 100 identifies the sleeping pattern of the fetus based on the movements.
  • an external stimulus is given to the mother’s belly to wake up the fetus. This stimulus is often given by tapping the belly or in the form of music or some noise played near the belly so as enable a reaction and movement of the fetus.
  • the wearable device 100 automatically identifies the situation where the fetus’s movements are less or nil i.e. the pregnancy test is non-reactive and suggests for musical stimulus to stimulate the fetus.
  • the wearable device 100 also detects sleeping patterns of the fetus and therefore, suggest as and when musical stimulus is required.
  • the wearable device 100 is configured of differentiating pregnant and non-pregnant data to detect and confirm pregnancy.
  • the wearable device 100 is capable of detecting and generating alerts in case of risk and/or high risk to pregnancies.
  • the physiological parameters such as blood pressure plays an important role to screen the risk level of the pregnancy.
  • the wearable device 100 is configured to pick up the first and the second trimester parameters, such as Stress and transits to advanced grade when pregnancy advances to third trimester.
  • the wearable device 100 comprises of blood pressure sensor to detect blood pressure of the expectant mother.
  • the wearable device 100 comprises of motion sensors to detect maternal and fetus activity.
  • the sensors are combined with markers to detect the blood pressure of pregnancy value and further define levels of risk of pregnancy and generate corresponding alerts.
  • the wearable device 100 is configured for determining the risk of pregnancy by sensing fetal ECG and EMG pattern at 26 weeks when a brain is developed enough and starts generating the waves which can give a unique pattern to identify certain disorders. Such patterns show the change in frequency and alpha, beta, theta and delta waves. Therefore, the present invention combines the patterns to confirm the complications and disorders in the fetus’s brain.
  • the wearable device 100 determines disorders ranging from fetal seizures, epilepsy, mental retardness, downs syndrome, brain development growth and other possible brain disorders related to the fetus.
  • the wearable device 100 identifies congenital anomaly of central nervous system at 26 Weeks of pregnancy.
  • IUGR Intrauterine growth restriction
  • the system utilizes motion sensors and heart rate pattern sensor to identify high risk pregnancies, not limited to, ectopic and IUGR at least six weeks of pregnancy by monitoring fetal movements, fetal heart rates pattern and hiccups.
  • the wearable device 100 monitors the parameters related to the growth of fetus, the expectant mother’s weight gain and increase in diet patterns by utilizing heart rate sensor and motion sensor.
  • the heart rate sensor senses the fetal heart rate and the motion sensor senses the fetal movement and Ectopic and/or normal pregnancy. On an average a mother puts a total of 25% of the non-pregnancy weight.
  • the wearable device 100 predicts and identifies low birth weight at an early stage so as to enable delivery of the fetus, accordingly.
  • the wearable device 100 identifies the position of the baby by the means of motion sensor and heart rate sensor.
  • the wearable device 100 divides the mother’s belly in four quadrants sensors placed in each quadrant. The motion sensors pick the signal in each quadrant and depending on signal intensity in frequency and amplitude, the wearable device 100 identifies the spine, limbs and head of the baby. Further, the system predicts and identifies the spine of the baby to locate the heartbeat. The heart rate sensor would then sense the heartbeat of the fetus. Using said sensors, the wearable device 100 updates the position of the fetus in real-time by updating the moving zones of the fetus using coordinates.
  • the wearable device 100 is configured for monitoring the heart rate of the expectant mother i.e. the maternal heart rate at a certain time of day using heart rate sensor.
  • the wearable device 100 combines a pattern generated by the heart rate of the expectant mother with mood score and blood pressure of the mother and generates a score for stress (one of a physiological parameter) of the mother.
  • the wearable device 100 is configured for detecting duration and anxious points, based on the change in maternal heart rate when the subject is asleep.
  • the wearable device 100 is configured to pick the markers (change in maternal heart rate) to determine a pattern with respect to duration of sleep cycle and duration of certain events to define sleep quality pattern. Sleep quality is as important as sleep position. If mother is not sleeping properly then it can generate hypertensive situations to mother which can push her to high risk pregnancy. Hence the wearable device 100 is configured for predicting hypertensive situations based on the sleep quality determined using the sensor data.
  • the wearable device 100 picks the pattern for every sleep cycle ranging from 1 hour - 10 hour or daily or weekly or monthly. This in-turn helps parents to focus on being less anxious and finding environment for better sleep for healthy pregnancy.
  • the wearable device 100 incorporates markers, such as blood pressure, maximum heart rate, pulse, mood, and emotion score to determine the mental health status of the expectant mother and mood and emotion score of Father. This mental health score of pregnancy in qualitative format identifies early signs of fetal distress.
  • the present invention provides a single wearable device 100 to senses, detect, analyze, and transfer signal and data relating to various physiological parameters of the fetus and the subject, including but not limited to fetal heartbeat, fetus movement, risk to pregnancy based on at least one marker, brain disorders, low birth weight, and position of the fetus, maternal stress, sleep position and quality of the expectant mother, and prenatal stress of the parents.
  • the sensors 105-1, to 105-N are arranged in a predefined order on the wearable device 100 e.g., a maternity belt.
  • the pressure sensors 105-3, 105-4, 105-5 and 105-6 are positioned around the navel of the mother, in a rhombus arrangement.
  • Each of the sensors 105-3, 105-4, 105-5 and 105-6 in the rhombus arrangement are placed at a specific distance from the mother’s navel.
  • the sensors 105-3, 105-4, 105-5 and 105-6 may be strain gauges.
  • the strain gauges i.e., sensors 105-3, 105-4, 105-5 and 105-6 may be arranged to form a Wheatstone bridge.
  • the Wheatstone bridge arrangement helps in maximizing sensitivity of the sensors 105-3, 105-4, 105-5 and 105-6 in detecting the fetal movements.
  • the placement of sensors 105-3, 105-4, 105-5 and 105-6 around the navel helps in detecting strains due to fetal movement along both the horizontal and vertical axes.
  • the other sensors 105 are associated with detection of parameters including, but not limited to, fetal heart rate, maternal heart rate, respiratory rate of the fetus, respiratory rate of the mother, uterine contraction, amniotic fluid levels, ECG and EMG patterns of the fetus, blood pressure of the mother.
  • the plurality of sensors 105 are configured for sensing at least one physiological parameter each of the fetus and the subject, wherein the physiological parameters may include but not limited to heart rate of the fetus and the subject, respiratory rate of the fetus and the subject, uterine contraction of the subject, amniotic fluid levels of the subject, ECG and EMG patterns of the fetus, the blood pressure of the fetus and the subject, and temperature of the fetus and the subject
  • the output of the sensors 105 is filtered using the low-pass filter 110.
  • the low-pass filter 110 helps in reducing motion artifacts that distort the output of the sensors 105.
  • the motion artifacts may include distortions in the outputs of the sensor 105 due to fluids in the amniotic sac, inadequate surface contact between the sensor 105 and the skin of the mother and so on.
  • the low pass filter 110 filters out high frequency noise signals from the output of the sensors 105.
  • the Analog to Digital Converter (ADC) 115 converts the analog output of the low pass filter 110 into a digital signal.
  • the digital signal from the ADC 115 is given as input to the at least one microcontroller 120.
  • the at least one microcontroller 120 manipulates the digital signals received from the ADC 115 using an algorithm stored in the memory 130.
  • the controller 120 is configured for deriving a value associated with each of the physiological parameters, comparing the derived value with one or more of a corresponding historical values and corresponding one or more predefined values, and performing one or more actions based on results of the comparisons, wherein the one or more actions include providing a stimulus for stimulating the fetus, predicting a fetal health condition, and communicating, through at least one communication means, one or more alerts to one or more pre-designated devices.
  • the controller 120 derives the value associated with each of the physiological parameters from the sensed signals, compares the derived value with one of the historical value of the corresponding physiological parameter or with the one or more pre-defined values or both. Then based on the results of comparison, the controller 120 performs the one or more actions.
  • the controller 120 performs the one or more actions.
  • the wearable device 100 monitors the movement of the fetus.
  • the microcontroller 120 processes the digital signals received from the motion sensors or pressure sensors (105-3, 105-4, 105-5 and 105-6) to calculate a total number of fetus movements within a period.
  • the microcontroller 120 may calculate a total number of fetus movements in one hour. It is to be noted that the movement count is the value associated with the physiological parameter fetus movement, in this example.
  • the microcontroller 120 determines whether the number of fetus movements in an hour is less than a pre-defined threshold value.
  • the pre-defined threshold value may be considered as 3 movements per hour when the fetus is awake.
  • the microcontroller 120 detects a Reduced Fetal Movement (RFM) condition.
  • the RFM condition may indicate a fetal distress, which if left unattended may lead to intra-partum fetal death or stillbirth.
  • the microcontroller 120 Upon detecting the RFM, the microcontroller 120 generates an alert and communicates the alert message to one or more pre designated devices.
  • the pre-designated device may be devices associated with the family members, care takers, clinics, and doctors. It is to be noted that a minimum threshold value may be set for the movement distance. For example, movement below 10mm may not be the actual movement of the fetus and such movements may be discarded while counting the number of movements.
  • the microcontroller 120 on detecting RFM conditions in the given period generates an alert to provide an external stimulus to the fetus.
  • the stimulus may be one of a vibration, or music or some noise played near the belly so as enable a reaction and movement of the fetus.
  • the wearable device 100 measures the response to monitor the further movement.
  • the wearable device 100 is configured for determining the risk of pregnancy by sensing fetal ECG and EMG pattern when a brain is developed enough and starts generating the waves which can give a unique pattern to identify certain disorders. Such patterns show the change in frequency and alpha, beta, theta and delta waves.
  • the ECG and EMG sensors’ output is processed to derive the ECG and EMG signals. The derived signals are compared with one or more reference signals for identifying the disorders in the fetus’s brain. The reference signals as described herein define the one or more thresholds.
  • the wearable device 100 determines disorders ranging from fetal seizures, epilepsy, mental retardness, downs syndrome, brain development growth and other possible brain disorders related to the fetus. In another feature of the present invention, the wearable device 100 identifies congenital anomaly of central nervous system at 26 Weeks of pregnancy.
  • the microcontroller 120 processes the digital signals received from the ADC 115 using an algorithm stored in the memory 130.
  • the microcontroller 120 processes the digital signals to calculate a total number of fetal heart beats and ECG pattern of the fetus along with fetal movements within a period.
  • the controller 120 is configured for predicting the health condition of the fetus, such as any form of brain disorders.
  • the controller 120 is for predicting the fetus health condition based on one or more predefined rules.
  • an AI model may be trained using data from a plurality of wearable devices, clinical reports, subject experts, etc.
  • the wearable device 100 is configured for monitoring heartbeat of the fetus. That is, the microcontroller 120 processes the signals received from the ultrasound sensors of the wearable device 100 and counts the number of fetal heartbeat within a pre-defined time period, for example two minutes. Then the controller 120 compares the measured value with the historical value or with the pre-defined thresholds and generates an alert to indicate high risk pregnancy in case of any variations.
  • the at least one microcontroller 120 manipulates the digital signals received from each quadrant of the abdomen of the mother to calculate a total number of fetus movements in each quadrant within a period to identify the spine, limbs and head of the fetus. Further, the microcontroller 120 predicts and identifies the spine of the fetus to locate the heart and hence the position of the fetus. Furthermore, the microcontroller 120 is configured for continuously monitoring the moving zones of the fetus using the coordinates of the abdomen of the mother, and such movements and position are recorded and updated periodically or in real-time
  • the wearable device 100 is configured for receiving inputs from the subject or the user through the I/O interface 135 or through a device paired with the wearable device 100.
  • the inputs may include but not limited to subject’s height, weight, age, blood group, blood pressure, etc.
  • such inputs are used, along with the measured physiological parameters of fetus and the subject, for predicting the fetus health condition.
  • the heart rate of the fetus along with the subject’s height, weight and blood pressure value are used for predicting pregnancy risk.
  • the wearable device 100 is configured for detecting the sleeping position of the subject.
  • the microcontroller 120 may be configured for providing progressive alerts for a predefined period, e.g. 24 hours.
  • the alert may be visual, textual or an audio message.
  • the alert may be an audio tone.
  • the alert may involve display of a warning message, e.g. blinking of light on the I/O interface 135.
  • the mother may seek immediate medical help for further diagnosis to confirm the RFM, fetal brain disorders, high risk pregnancies, and mental stress and to avert the risk of stillbirth and/or fetal development.
  • an environment of a wearable device 205 for monitoring fetus movements, and fetus health including but not limited to irregular heartbeats patterns, ECG patterns, Ectopic/normal pregnancy, position, and birth weight of the fetus, etc. and the subject health conditions including but not limited to maternal mental stress, maternal health conditions (such as BP), sleeping position and quality of the expectant mother and prenatal mental stress of parents is shown, in accordance with another embodiment of the present disclosure.
  • the alert generated by the wearable device 100 is further sent to pre- designated electronic devices 210 carried by a mother or a doctor or any designated person.
  • the alert may be sent as a Short Messaging System (SMS), a call, an audio alert, a visual alert, or a notification on an I/O interface of the wearable device 205.
  • the electronic device 210 may include a mobile phone, a computer, a laptop, a personal digital assistant (PDA), a smart watch, a digital display and so on.
  • the electronic device 210 may be associated with the mother, a family member, an auxiliary nurse midwife (ANM), a Community Health Center (CHC), a Primary Health Centre (PHC) and so on.
  • the electronic device 210 may comprise a dedicated client application for communicating with the wearable device 205 and for processing the alerts received.
  • the wearable device 205 may use communication protocols such as Bluetooth, Infrared or Internet-of-Things (IOT) for communicating with the electronic device 210.
  • IOT Internet-of-Things
  • the wearable device 205 may use passive data transfer using Bluetooth transfer to transfer data such as outputs from sensors and alerts to the electronic device 210.
  • Bluetooth transfer helps in avoiding harmful radiation (e.g., as in case of radio-frequency (RF) communication) from the wearable device 205 that may harm the fetus.
  • RF radio-frequency
  • the wearable device 205 may communicate with the electronic device 210 over a network 215 as shown in FIG. 2.
  • the network 215 may be a wireless network, a wired network or a combination thereof.
  • the network 215 can be implemented as one of the different types of networks, such as intranet, the internet and the like.
  • the wearable device 205 calculates the number of fetus movements per hour using outputs from sensors attached to the abdomen of the mother. In one embodiment, the wearable device 205 stores the number of fetal movements per hour in a memory (similar to memory 130 of FIG. 1A) associated with the wearable device 205. When the number of fetus movements per hour is less than a pre-defined threshold value, the wearable device 205 generates an alert or progressive alerts for a predefined period, e.g. 24 hours.
  • the wearable device 205 stores the fetal and maternal heart rate pattern, fetal ECG pattern, and generate alerts when the value of the parameters is outside a predefined range or when there is an irregularity in the pattern.
  • the wearable device 205 stores the parameters based on as maternal blood pressure and pulse and emotional score of the mother and the father and generates alerts when the value of the parameters is outside a predefined range or when there is an irregularity in the pattern.
  • the wearable device 205 may comprise sensors for measuring other parameters associated with fetal heart rate, maternal heart rate, respiratory rate of mother, blood pressure, respiratory rate of fetus, and amniotic fluid levels. Further, the wearable device 205 may be configured to generate alerts when value of the parameter is outside a predefined range (one or more threshold values). [076] In the present embodiment, the wearable device 205 further transmits the alert to the electronic device 210. Upon receiving the alert, the electronic device 210 generates a notification. The notification may be in the form of visual, textual or audio messages or a combination of two or more media.
  • the wearable device 205 may digitally transmit data comprising the outputs from the sensors to the electronic device 210.
  • the electronic device 210 may further process the data to generate various and/or stepwise and/or progressive notifications on detecting any form or irregularity in the data or when any value from the data is outside a predefined range.
  • the wearable device 100 or the electronic device 210 may further transmit the data comprising the outputs from the sensors to a database or server (not shown) located at a remote location over the network 215.
  • the server further analyses the data based on fetal movements, fetal and maternal heart rate, ECG pattern of the fetus, maternal blood pressure, emotional score of the mother and the father to screen any form of irregularity in the data.
  • the server Upon detecting the irregularity, the server sends an alert or progressive alerts to the electronic device 210.
  • the server may send the alerts or progressive alerts to a plurality of other electronic devices (not shown) that may be associated with the mother, a family member, an auxiliary nurse midwife (ANM), a Community Health Center (CHC), a Primary Health Centre (PHC) and so on.
  • a plurality of other electronic devices may be associated with the mother, a family member, an auxiliary nurse midwife (ANM), a Community Health Center (CHC), a Primary Health Centre (PHC) and so on.
  • the wearable device 300 is manufactured in the form of a maternity belt or a patch that may be attached to the abdomen of the mother, as shown.
  • the maternity belt or patch may be made of a stretchable garment that is manufactured using SpandexTM or LycraTM, for example.
  • the belt or patch could be manufactured for single use.
  • the wearable device in the form belt or patch may be manufactured for multiple uses.
  • the wearable device 300 is provided with a fastening mechanism 310 for securing the wearable device 300 in a fixed position.
  • the fastening mechanism 310 may be one of a buckle, a Velcro strap and so on. Further, the wearable device 300 may be provided with a supporting mechanism 315.
  • the supporting mechanism 315 provides a rigid support for the abdomen. Further, the supporting mechanism 315 along with the fastening mechanism 310 ensures that the sensors embedded in the maternity belt have maximum contact with the abdomen of the mother to pick signals and frequencies accurately.
  • the microcontroller and the battery may form an external device.
  • the external device may be fastened to the maternity belt or patch using the fastening mechanism. After use, the external device may be removed. Upon removal, the battery in the external device may be charged, by connecting to a power source, for further use.
  • the wearable device 300 is further provided with a switch 320.
  • the mother may use the switch 320 to switch ON/OFF the wearable device 300.
  • the mother may turn ON the switch 320 to receive alerts.
  • the alert may be received on an electronic device (not shown) or on an indicator provided on the wearable device 300.
  • the wearable device for monitoring physiological health of fetus and the expectant mother disclosed herein provides a convenient means for continuous monitoring of fetal development and the expectant mother’s mental and physical health along with mental health of father. Further, the mother may easily check for any form of distress or irregularities in the development of the fetus and her health per se without the assistance of a doctor or nurse. Further, when any form of distress or irregularity is detected, the mother may have adequate time to seek medical help. As a result, the possibility of saving the fetus from stillbirth and/or healthy development of the fetus is higher as compared to existing methods for detecting fetal and maternal distress.
  • the wearable device can also be implemented, with minor modifications, for monitoring physiological health animals at different gestational ages.
  • the minor modifications may include threshold values, device size and shape, sensor placement, etc.
  • the wearable device disclosed in the present disclosure may be used for monitoring mental stress of pregnant and non-pregnant human subjects.

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Abstract

L'invention concerne un dispositif portable destiné à une patiente enceinte, servant à surveiller un fœtus de la patiente. Le dispositif portable comprend une pluralité de capteurs détectant au moins un paramètre physiologique du fœtus et de la patiente, et un dispositif de commande en communication avec la pluralité de capteurs. Le dispositif de commande du dispositif portable dérive une valeur associée à chacun des paramètres physiologiques, compare la valeur dérivée avec une ou plusieurs des valeurs historiques correspondantes et une ou plusieurs valeurs prédéfinies correspondantes, et effectue une ou plusieurs actions sur la base des résultats des comparaisons. La ou les actions comprennent la fourniture d'un stimulus pour stimuler le fœtus, la prédiction d'un état de santé fœtale, et la communication, par l'intermédiaire d'au moins un moyen de communication, d'une ou de plusieurs alertes à un ou plusieurs dispositifs prédésignés.
PCT/IN2020/050284 2019-03-26 2020-03-26 Dispositif portable pour mesurer la santé d'un fœtus WO2020194350A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023148650A1 (fr) * 2022-02-04 2023-08-10 Medtronic, Inc. Système de surveillance prénatale

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6790178B1 (en) * 1999-09-24 2004-09-14 Healthetech, Inc. Physiological monitor and associated computation, display and communication unit
US20120232398A1 (en) * 2010-11-05 2012-09-13 Masoud Roham Wireless fetal monitoring system
US20180368753A1 (en) * 2015-12-18 2018-12-27 Koninklijke Philips N.V. Fetal monitoring system and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6790178B1 (en) * 1999-09-24 2004-09-14 Healthetech, Inc. Physiological monitor and associated computation, display and communication unit
US20120232398A1 (en) * 2010-11-05 2012-09-13 Masoud Roham Wireless fetal monitoring system
US20180368753A1 (en) * 2015-12-18 2018-12-27 Koninklijke Philips N.V. Fetal monitoring system and method

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023148650A1 (fr) * 2022-02-04 2023-08-10 Medtronic, Inc. Système de surveillance prénatale

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