FIELD OF INVENTION [01] 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

BACKGROUND OF THE INVENTION [02] According to reports by the World Health Organization (WHO), there were approximately

2.6 million stillbirths globally in the year 2015, with more than 7178 stillbirths in a day. It was further determined that about 50% of the stillbirths occur in the intra-partum period, i.e., between the period from the onset of labor to the delivery of the child. Some of the main causes of stillbirth are related to physiological wellbeing of fetus and expectant mother. However, majority of stillbirths are preventable by proper monitoring of the fetus.

[03] 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.

[04] Several techniques are available for monitoring of the fetus and wellbeing of the expectant mother. 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. A lot of high risk pregnancies, such as IUGR and Ectopic can be easily detected by monitoring the simple heart rate patterns. [05] The heart rate of the fetus is typically monitored by FHR monitor, which uses Doppler

Effect to measure the heart rate of the fetus by continuously emitting and receiving ultrasound waves. Any shift or change in frequency of the ultrasound waves received from the emitted ultrasound waves is further converted into audible fetal heart beats. The audible fetal heart beats may be heard by a doctor or mother through an ear piece. Similarly, 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.

[06] Although there are several the techniques known in the art, the techniques does not provide monitoring of fetus in real-time during active pregnancy. Further the techniques involve constant clinical supervision.

[07] In addition, other 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. However, 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.

[08] For example, currently the position of the fetus is identified using Ultrasound. The ultrasound is performed on a given day in intervals and nor regularly. However, the position of the baby changes any time during pregnancy as baby keeps moving in the amniotic fluid in the uterus. For instant if the position of the baby in 24 ^th week was Cephalic then it could be Breech position during 38 ^th week or delivery time. Often, midwives tend to identify the position of the fetus using palpation technique, which is very subjective and differs from nurse to nurse. Further, the expectant mother never understands the criticality of the position as she is not the clinical practitioner. [09] Other methods, such as physical examination by palpation and auscultation of fetal heart noise are also known in the art. However, all these methods do not provide real-time information and have to be performed under clinical supervision.

[010] Therefore there is a need of a method to monitor and analysis the health of fetus in real- time so as to maintain the healthy development of the fetus.

[Oil] 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.

[012] Another PCT application WO 2007/095457 discloses a method for obtaining fetal heart activity. Particularly, 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.

[013] 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.

[014] Studies shows that apart from the mentioned fetal conditions, wellbeing of the fetus is also dependent and directly proportional to the physiological wellbeing of the expectant mother and father i.e. the wellbeing of parents in totality (Impact of Maternal Stress, Depression & Anxiety on Fetal Neurobehavioral Development; Michael, et.al; Clinical Obstetrics and Gynecology. 52(3):425-440, SEP 2009 and Psychological and psychophysiological considerations regarding the maternal-fetal relationship; Janet; Wiley Online Library; Jan 18 2010). Monitoring the physiological wellbeing of the parents includes confirmation of pregnancy, monitoring sleeping position and quality, and weight changes in the mother, and monitoring prenatal mental stress (such as BP, maternal heart rate and pulse, mood, and emotion score). So far, none of the prior- arts disclose monitoring of physiological conditions of fetus along with maternal and paternal wellbeing. More specially, the prior-arts have not focused on monitoring maternal and paternal mental stress at all.

[015] Further, current method to confirm pregnancy is through a Urine test where a certain line pattern predicts the pregnancy. Often this experience is not hygienic and not even accurate everytime. In some cases a woman needs to do it multiple times and it gives a different result which doesn’t confirm anything. Another method to confirm the pregnancy is blood test, which requires mandatory supervision of nurses, doctors, or clinics.

[016] Therefore, there is a need for a system that would monitor the fetal, maternal, and paternal wellbeing right from the start i.e. confirmation of pregnancy to the birth of the fetus. Further, there is also a need for a system that would monitor physiological wellbeing of fetus i.e. fetal conditions in real-time, as well as monitor the physiological, which includes mental wellbeing of the parents, as well. The techniques disclosed in the prior art for monitoring the fetus are generally used in hospitals or clinics under the supervision of doctors, nurses or midwives. However, 98% of the stillbirths occur in developing and under-developed countries where women do not have access to proper hospitals or maternity clinics. Further, 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.

[017] In addition, the prior-arts disclose separate and multiple systems to monitor health conditions of the fetus and the expectant mother. Therefore, there exists a need to develop an integrated system that would monitor both fetus and expectant mother in order to aid the healthy development of the fetus. SUMMARY OF THE INVENTION

[018] This summary is provided to introduce a selection of concepts in a simple manner that is further described in the detailed description of the disclosure. This summary is not intended to identify key or essential inventive concepts of the subject matter nor is it intended for determining the scope of the disclosure.

[019] 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. In one embodiment, 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.

[020] Further, a method for monitoring a fetus of a gestating subject is disclosed. The method 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.

[021] Further to clarify advantages and features of the present disclosure, a more particular description of the disclosure will be rendered by reference to specific embodiments thereof, which is illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. The disclosure will be described and explained with additional specificity and detail with the accompanying figures.

BRIEF DESCRIPTION OF FIGURES

[022] The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:

[023] 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;

[024] FIG. 2 illustrates an environment of a wearable device for monitoring fetal health, in accordance with another embodiment of the present disclosure;

[025] 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;

[026] Further, persons skilled in the art to which this disclosure belongs will appreciate that elements in the figures are illustrated for simplicity and may not have been necessarily drawn to scale. Furthermore, in terms of the construction of the joining ring and one or more components of the bearing assembly may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.

DETAILED DESCRIPTION

[027] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications to the disclosure, and such further applications of the principles of the disclosure as described herein being contemplated as would normally occur to one skilled in the art to which the disclosure relates are deemed to be a part of this disclosure.

[028] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the disclosure and are not intended to be restrictive thereof.

[029] In 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.

[030] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or a method. Similarly, one or more elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other elements, other structures, other components, additional devices, additional elements, additional structures, or additional components. Appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The components, methods, and examples provided herein are illustrative only and not intended to be limiting.

[032] 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). In the present disclosure, 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, is disclosed. In addition, 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.

[033] While aspects of proposed disclosure may be implemented in any number of different computing systems, environments, and/or configurations, the embodiments are described in the context of the following exemplary environment.

[034] 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. As described, the gestating subject (hereafter referred to as mother) 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.

[035] 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.

[036] 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.

[037] 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.

[038] In one embodiment, 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.

[039] 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. In one embodiment of the present disclosure, the pressure sensors include strain gauge sensors arranged to form a Wheatstone bridge for detecting the fetus movement.In a feature of the present invention, 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, and 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.

[040] In another feature of the present invention, 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. In yet another feature of the present invention, the system comprises of markers to determine blood pressure pregnancy value and sleeping quality of the expectant mother.

[041] In an embodiment of the present invention, 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. In a feature of the present invention, the system depicts the fetus heartbeats and patterns in the form of audio and/or visual pattern. In another feature of the present invention, the fetus heartbeats and patterns are displayed on phone or other similar devices in the form of audio and/or visual pattern.

[042] In another embodiment of the present invention, the wearable device 100 comprises of motion sensor to identify fetal movements. In a feature of the present invention, the motion sensor present in the wearable device 100 identifies the sleeping pattern of the fetus based on the movements. When the fetus is asleep and does not move during non-sleeping periods, as a clinical practice 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. Therefore, whenever the movements of the fetus are nil, such pregnancy test is considered non-reactive, an external stimulus is given to wake the fetus up. In another feature of the present invention, 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. In yet another feature of the present invention, the wearable device 100 also detects sleeping patterns of the fetus and therefore, suggest as and when musical stimulus is required.

[043] In another embodiment of the present invention, the wearable device 100 is configured of differentiating pregnant and non-pregnant data to detect and confirm pregnancy.

[044] In an embodiment of the present invention, 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. In a feature of the present invention, 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.

[045] In another feature of the present invention, the wearable device 100 comprises of blood pressure sensor to detect blood pressure of the expectant mother.

[046] In yet another feature of the present invention, 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.

[047] In another embodiment of the present invention, 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. In a feature of the present invention, 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.

[048] High risk pregnancy, such as ectopic pregnancies are the pregnancy when the egg gets fertilized outside Uterus and embryo gets attached to wall of the uterus outside. It is complicated pregnancy as fetus is unable to get all the nutrition which it gets normally when in uterus. Such pregnancies are prone to heavy vaginal bleeding as well. Intrauterine growth restriction (IUGR) is another high risk pregnancy, which refers to poor growth of a fetus while in the mother's womb during pregnancy, mainly due to inadequate oxygen supply to the fetus.

[049] In an embodiment of the present invention, 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.

[050] In another embodiment of the present invention, 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. In a feature of the present invention, the wearable device 100 predicts and identifies low birth weight at an early stage so as to enable delivery of the fetus, accordingly.

[051] In yet another embodiment of the present invention, the wearable device 100 identifies the position of the baby by the means of motion sensor and heart rate sensor. In a feature of the present invention, 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. [052] In a preferred embodiment of the present invention, 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. In a feature of the present invention, 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.

[053] In another embodiment of the present invention, 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. In a feature of the present invention, 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.

[054] Therefore, in a feature of the present invention, 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.

[055] In yet another embodiment of the present invention, 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.

[056] In a preferred embodiment, 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.

[057] Referring to FIG. 1A, the sensors 105-1, to 105-N are arranged in a predefined order on the wearable device 100 e.g., a maternity belt. Referring to FIG. IB, 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. In one implementation, the sensors 105-3, 105-4, 105-5 and 105-6 may be strain gauges. In another implementation, 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. Further, 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. Hence 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

[058] Referring back to FIG. 1A, 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. Further, the low pass filter 110 filters out high frequency noise signals from the output of the sensors 105. [059] Upon filtering, 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.

[060] In an embodiment of the present invention, the at least one microcontroller 120 manipulates the digital signals received from the ADC 115 using an algorithm stored in the memory 130. In one embodiment of the present disclosure, 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. In other words, 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. Various examples considering different physiological parameters are described in detail further below.

[061] In one example, 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. In one example, 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. Then the microcontroller 120 determines whether the number of fetus movements in an hour is less than a pre-defined threshold value. For example, the pre-defined threshold value may be considered as 3 movements per hour when the fetus is awake. If the number of fetal movements count is less than the pre-defined threshold value i.e., 3 movements per hour, 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. 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.

[062] In another embodiment of the present invention, 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. Upon providing the stimulus, the wearable device 100 measures the response to monitor the further movement.

[063] In another example, 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. In one implementation, 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. In a feature of the present invention, 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.

[064] In yet another embodiment of the present invention, 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. Based on such monitoring, the controller 120 is configured for predicting the health condition of the fetus, such as any form of brain disorders. In one implementation, the controller 120 is for predicting the fetus health condition based on one or more predefined rules. In another implementation, an AI model may be trained using data from a plurality of wearable devices, clinical reports, subject experts, etc.

[065] In another example, 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.

[066] In another embodiment of the present invention, 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

[067] In one embodiment of the present disclosure, 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. In one embodiment of the present disclosure, such inputs are used, along with the measured physiological parameters of fetus and the subject, for predicting the fetus health condition. For example, the heart rate of the fetus along with the subject’s height, weight and blood pressure value are used for predicting pregnancy risk. In yet another example, the wearable device 100 is configured for detecting the sleeping position of the subject. Based on the sleeping position and the fetus movement and position, one or more alerts are generated for the subject. [068] In one implementation, 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. In one example, the alert may be an audio tone. In another example, the alert may involve display of a warning message, e.g. blinking of light on the I/O interface 135. On receiving the alert, 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. Further, the alerts may be communicated to the one or more pre designated devices as described. [069] Referring to FIG. 2, 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. In the present embodiment, the alert generated by the wearable device 100 (in particularly by the microcontroller 120) 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. Further, the electronic device 210 may comprise a dedicated client application for communicating with the wearable device 205 and for processing the alerts received.

[070] In one embodiment, the wearable device 205 may use communication protocols such as Bluetooth, Infrared or Internet-of-Things (IOT) for communicating with the electronic device 210. For example, 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. The use of 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.

[071] In another embodiment, the wearable device 205 may communicate with the electronic device 210 over a network 215 as shown in FIG. 2. In one implementation, 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.

[072] Similar to wearable device 100 of FIG. 1, 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.

[073] In another embodiment, 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.

[074] In yet another embodiment, 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.

[075] In one embodiment, 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.

[077] In another embodiment, 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.

[078] In yet another embodiment, 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. Upon detecting the irregularity, the server sends an alert or progressive alerts to the electronic device 210. In addition 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.

[079] Referring to FIGS. 3A, 3B and 3C, the front, side and back views respectively, of a wearable device 300 are shown, in accordance with one exemplary embodiment of the present disclosure. In the present embodiment, 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. In one example, the belt or patch could be manufactured for single use. In a preferred embodiment, the wearable device in the form belt or patch may be manufactured for multiple uses. Further, 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.

[080] In another embodiment, the microcontroller and the battery may form an external device. Further, 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.

[081] In the present embodiment, 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. In other words, 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.

[082] 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. [083] Even though the present discloser discloses a wearable device for monitoring physiological health of fetus and the expectant mother, 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. [084] Further, as the wearable device is configured for monitoring the heartbeat of the subject, the wearable device disclosed in the present disclosure may be used for monitoring mental stress of pregnant and non-pregnant human subjects.

[085] Although embodiments of a wearable device for monitoring physiological health of fetus and the expectant mother has been described in language specific to features and/or methods, it is to be understood that the description is not necessarily limited to the specific features or methods described. Rather, the specific features and methods are disclosed as examples of implementations of a wearable device for monitoring physiological health of fetus and the expectant mother.

[086] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.

[087] The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure, dimension, and use of material, are possible. The scope of embodiments is at least as broad as given by the following claims.