Device for facilitating non-invasive, continuous monitoring of maternal and fetal health and method thereof

A lightweight, wearable device with biopotential sensors and ultrasound capabilities addresses the limitations of existing cardiotocograph machines by enabling continuous, accurate monitoring of maternal and fetal health, with data transfer to digital platforms for analysis.

WO2025052340A1PCT designated stage expired Publication Date: 2025-03-13FOUNDATION FOR CENT FOR HEALTHCARE ENTREPRENEURSHIP
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Patent Information

Application Number
PCT/IB2024/058749
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-08
Filing Date
2024-09-09
Publication Date
2025-03-13

AI Technical Summary

Technical Problem

Existing cardiotocograph machines are bulky, require multiple wired connections, and lack a continuous monitoring mechanism, making them ineffective for monitoring maternal and fetal health during labor, delivery, and post-pregnancy. Additionally, they fail to calibrate themselves, reducing accuracy and reliability.

Method used

A lightweight device comprising a wearable belt with biopotential electrode sensors, an amplifier, an analog-to-digital converter module, and a computing unit that detects and processes biopotential signals to provide continuous monitoring of maternal and fetal health. The device includes ultrasound sensors for fetal heart rate monitoring and can transfer data to digital platforms for storage and analysis.

Benefits of technology

The device enables non-invasive, continuous, and accurate monitoring of maternal and fetal health, improving monitoring during labor, delivery, and post-pregnancy. It provides reliable data transfer to digital platforms for comprehensive analysis.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure relates to a device (300) for for facilitating non-invasive, continuous monitoring of maternal and fetal health. A wearable belt (306) placed around an abdomen a user (204). At least one biopotential electrode sensor (104) coupled to the wearable belt (306), and configured to detect and generate a first set of analogue biopotential signals 5 corresponding to the maternal and fetal health of the user (204). The device (300) receives the first set of digital signals from the ADC module (108) and process the received first set of digital signals to generate a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the device (300) during one or more phases of the user (204). The generated 0 second set of digital signals processed by computing unit (110) to represent on mobile computing device (202).
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Description

DEVICE FOR FACILITATING NON-INVASIVE, CONTINUOUS MONITORINGOF MATERNAL AND FETAL HEALTH AND METHOD THEREOFTECHNICAL FIELD

[0001] The present disclosure relates to the field of fetal health monitoring. More particularly, the present disclosure relates to a device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof.BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] In general, a device for maternal and fetal health refers to a technological tool or apparatus specifically designed and utilized to monitor, assess, and support the well-being and health of both the pregnant woman (maternal health) and the developing fetus (fetal health) during pregnancy. Cardiotocography (CTG) is used to monitor a baby's heart rate and a mother's contractions during pregnancy. Cardiotocography is used to monitor a baby's heart rate and a mother's contractions during pregnancy. Cardiotocography is usually called a 'CTG' by doctors and midwives, which generally uses a doppler ultrasound to detect fetal heart rate and strain gauge pressure transducers for uterine contractions. Other devices may use biopotential signals or acoustic signals for fetal heart rate and electromyograph for uterine contractions but can only be used in the 9thmonth of pregnancy.

[0004] Currently, in the market, the existing cardiotocograph machines are bulky, includes multiple wired connections and require a separate display to present the results to the users. The existing cardiotocograph machines do not stay in a fixed place around the abdomen and may require adjustment from time to time. Also, the existing cardiotocograph machines do not provide continuous monitoring mechanism and home monitoring from second trimester. Other devices can generally be used only in the 9thmonth of pregnancy. Thus, the existing cardiotocograph machines are not effective for monitoring during labor, delivery and post pregnancy. In addition, the existing cardiotocograph machines available in the market fail to calibrate themselves, which significantly reduces the accuracy and reliability of such devices.

[0005] There is therefore need in the art to develop a light weight, accurate, cost effective and single device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof, and provide transfer of the measured data to various digital platforms for storage and analysis.OBJECTS OF THE PRESENT DISCLOSURE

[0006] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0007] It is an object of the present disclosure to provide a device for facilitating non- invasive, continuous monitoring of maternal and fetal health, and a method thereof.

[0008] It is an object of the present disclosure to provide a device for facilitating non- invasive, continuous monitoring of maternal and fetal health, and a method thereof, which is light weight, accurate and reliable.

[0009] It is an object of the present disclosure to provide a device for facilitating non- invasive, continuous monitoring of maternal and fetal health, and a method thereof, which is multiple ultrasound sensors to pick up fetal heart rate.

[0010] It is an object of the present disclosure to provide a device for facilitating non- invasive, continuous monitoring of maternal and fetal health, and a method thereof, which provides at least single lead ECG of maternal heart rate can be detected throughout the pregnancy, especially during 9thmonth of pregnancy.

[0011] It is an object of the present disclosure to provide a device for facilitating non- invasive, continuous monitoring of maternal and fetal health, and a method thereof, which provides multiple data parameter collection.

[0012] It is an object of the present disclosure to provide a device for detecting uterine contractions of a user, and a method thereof, which can transfer the measured data to various digital platforms for storage and analysis purpose.SUMMARY

[0013] The present disclosure relates to the field of fetal health monitoring. More particularly, the present disclosure relates to a device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof.

[0014] An aspect of the present disclosure pertains to a device for facilitating non- invasive, continuous monitoring of maternal and fetal health. The device comprising a a wearable belt, at least one biopotential electrode sensor, an amplifier, an analog to digitalconverter (ADC) module, and a computing unit. The wearable belt adapted to be placed around an abdomen a user. The at least one biopotential electrode sensor coupled to the wearable belt, the at least one biopotential electrode sensor is configured to detect and generate a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user. The amplifier can be operatively coupled to the at least one biopotential electrode sensor, the amplifier configured to amplify an amplitude of the first set of electrical signals to a predefined amplitude. The analog to digital converter (ADC) module can be operatively coupled to the amplifier, the ADC module configured to receive the amplified first set of electrical signals and convert it into a first set of digital signals. The computing unit can be operatively coupled to the ADC module, the computing unit comprising one or more processors coupled with a memory. The memory storing instructions executable by the one or more processors to receive the first set of digital signals from the ADC module and process the received first set of digital signals to generate a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the housing of the device during one or more phases of the user. The generated second set of digital signals is processed by the computing unit so as to be represented on at least one mobile computing device.

[0015] In an aspect, the first set of analogue biopotential signals include at least one of a maternal electrocardiogram (mECG), a fetal electrocardiogram (fECG) and an uterine contractions electromyogram (uEMG).

[0016] In an aspect, one or more phases pertains to an antepartum phase, an intrapartum phase, and a postpartum phase.

[0017] In an aspect, device includes at least one ultrasound transmitter and at least one ultrasound receiver. The at least one ultrasound transmitter is configured to receive a set of digital signals which is converted to an ultrasound waves in the MHz range. The at least one ultrasound receiver can be configured to receives a reflected ultrasound waves, and amplified and processed using a doppler effect to calculate changes in a heart rate of the fetus, and other physiological and pathological changes.

[0018] In an aspect, the device includes at least one temperature sensor configured to monitor a baseline abdominal skin temperature.

[0019] In an aspect, the device comprises a communication module operatively which is coupled to the computing unit. The communication module is configured to communicatively couple the device to the at least one mobile computing device and transmit the second set ofdigital signals corresponding to the continuous monitoring and detection of maternal and fetal health of the user to the at least one mobile computing devices of the users

[0020] In an aspect, the computing unit is any or a combination of a microcontroller, and a microprocessor.

[0021] An aspect of the present disclosure pertains to a method for for facilitating non- invasive, continuous monitoring of maternal and fetal health. The method comprises the step of detecting and generating, by a device, a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user. The method comprises the step of amplifying, by the device, an amplitude of the first set of electrical signals to a predefined amplitude. The method comprises the step of receiving and processing, by the device, the first set of digital signals for generating a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated. The generated second set of digital signals is processed by the computing unit so as to be represented on at least one mobile computing device.

[0022] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

[0023] Within the scope of this application it is expressly envisaged that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and / or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.BRIEF DESCRIPTION OF DRAWINGS

[0024] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.

[0025] FIG. 1 illustrates functional modules of the proposed device for facilitating non- invasive, continuous monitoring of maternal and fetal health, in accordance with an exemplary embodiment of the present disclosure, to elaborate upon its working.

[0026] FIG. 2A illustrates the architecture of the proposed device for facilitating non- invasive, continuous monitoring of maternal and fetal health, in accordance with an exemplary embodiment of the present disclosure, to elaborate upon its working.

[0027] FIG. 2B illustrates exemplary network architecture in which or with which proposed device and mobile computing devices can be implemented, in accordance with an embodiment of the present disclosure.

[0028] FIG. 3A-3D illustrates exemplary architecture of the proposed device, in accordance with an embodiment of the present disclosure.

[0029] FIG. 4 illustrates flowchart of the proposed method for facilitating non-invasive, continuous monitoring of maternal and fetal health, in accordance with an exemplary embodiment of the present disclosure, to elaborate upon its working.DETAILED DESCRIPTION

[0030] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0031] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details.

[0032] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0033] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0034] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”,and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another

[0035] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0036] Embodiments of the present invention may be provided as a computer program product, which may include a machine-readable storage medium tangibly embodying thereon instructions, which may be used to program a computer (or other electronic devices) to perform a process. The machine-readable medium may include, but is not limited to, fixed (hard) drives, magnetic tape, floppy diskettes, optical disks, compact disc read-only memories (CD-ROMs), and magneto-optical disks, semiconductor memories, such as ROMs, PROMs, random access memories (RAMs), programmable read-only memories (PROMs), erasable PROMs (EPROMs), electrically erasable PROMs (EEPROMs), flash memory, magnetic or optical cards, or other type of media / machine-readable medium suitable for storing electronic instructions (e.g., computer programming code, such as software or firmware).

[0037] Exemplary embodiments will now be described more frilly hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure).

[0038] The present disclosure relates to the field of fetal health monitoring. More particularly, the present disclosure relates to a device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof.

[0039] An aspect of the present disclosure pertains to a device for facilitating non- invasive, continuous monitoring of maternal and fetal health. The device comprising a a wearable belt, at least one biopotential electrode sensor, an amplifier, an analog to digital converter (ADC) module, and a computing unit. The a wearable belt adapted to be placed around an abdomen a user. The at least one biopotential electrode sensor coupled to the wearable belt, the at least one biopotential electrode sensor is configured to detect and generate a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user. The amplifier can be operatively coupled to the at least one biopotential electrode sensor, the amplifier configured to amplify an amplitude of the first set of electrical signals to a predefined amplitude. The analog to digital converter (ADC) module can be operatively coupled to the amplifier, the ADC module configured to receive the amplified first set of electrical signals and convert it into a first set of digital signals. The computing unit can be operatively coupled to the ADC module, the computing unit comprising one or more processors coupled with a memory. The memory storing instructions executable by the one or more processors to receive the first set of digital signals from the ADC module and process the received first set of digital signals to generate a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the housing of the device during one or more phases of the user. The generated second set of digital signals is processed by the computing unit so as to be represented on at least one mobile computing device.

[0040] In an aspect, the first set of analogue biopotential signals include at least one of a maternal electrocardiogram (mECG), a fetal electrocardiogram (fECG) and an uterine contractions electromyogram (uEMG).

[0041] In an aspect, one or more phases pertains to an antepartum phase, an intrapartum phase, and a postpartum phase.

[0042] In an aspect, device includes at least one ultrasound transmitter and at least one ultrasound receiver. The at least one ultrasound transmitter is configured to receive a set of digital signals which is converted to an ultrasound waves in the MHz range. The at least one ultrasound receiver can be configured to receives a reflected ultrasound waves, and amplified and processed using a doppler effect to calculate changes in a heart rate of the fetus, and other physiological and pathological changes.

[0043] In an aspect, the device includes at least one temperature sensor configured to monitor a baseline abdominal skin temperature.

[0044] In an aspect, the device comprises a communication module operatively which is coupled to the computing unit. The communication module is configured to communicatively couple the device to the at least one mobile computing device and transmit the second set of digital signals corresponding to the continuous monitoring and detection of maternal and fetal health of the user to the at least one mobile computing devices of the users

[0045] In an aspect, the computing unit is any or a combination of a Microcontroller, and a Microprocessor.

[0046] An aspect of the present disclosure pertains to a method for for facilitating non- invasive, continuous monitoring of maternal and fetal health. The method comprises the step of detecting and generating, by a device, a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user. The method comprises the step of amplifying, by the device, an amplitude of the first set of electrical signals to a predefined amplitude. The method comprises the step of receiving and processing, by the device, the first set of digital signals for generating a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated. The generated second set of digital signals is processed by the computing unit so as to be represented on at least one mobile computing device.

[0047] FIG. 1A-1B illustrates functional modules of the proposed device for facilitating non- invasive, continuous monitoring of maternal and fetal health, in accordance with an exemplary embodiment of the present disclosure, to elaborate upon its working.

[0048] As illustrated, in an embodiment, the proposed device 300 for facilitating non- invasive, continuous monitoring of maternal and fetal health of a user 204. The device 300 can include a housing 102, at least one biopotential electrode sensor 104 (also known as the sensors 104, herein). Further, the sensors 104 can be configured to detect and generate a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user 204. The amplifier 106 can be operatively coupled to the sensors 104, the amplifier 106 configured to amplify an amplitude of the first set of electrical signals to a predefined amplitude.

[0049] In an embodiment, the device 200 can include an analog to digital converter (ADC) module (also referred to as ADC module 108, herein) operatively coupled to the amplifier 106. The ADC module 108 can be configured to receive the amplified first set of electrical signals from the amplifier 106 and convert into a first set of digital signals.

[0050] In an embodiment, the ADC module 108 can be a HX711 ADC module, but not limited to the likes. In a non-limiting embodiment, the HX711 ADC module can include aninput multiplexer, which can select either Channel A or B differential input to the low-noise programmable gain amplifier 106 (PGA). Channel A can be programmed with a gain of 128 or 64, corresponding to a full-scale differential input voltage of ±20mV or ±40mV respectively, when a 5V supply is connected to a VDD analog power supply pin. Channel B has a fixed gain of 32. The HX711 ADC module can include an on-chip power supply regulator, which can eliminate the need for an external supply regulator to provide analog power for the ADC. The clock input of the HX711 ADC module can be flexible and can be from an external clock source, a crystal, or the on-chip oscillator that does not require any external component.

[0051] In an embodiment, the device 300 can include a computing unit 110 operatively coupled to the ADC module 108. The computing unit 110 can include one or more processors coupled with a memory, the memory storing instructions executable by the one or more processors to receive the first set of digital signals from the ADC module 108 and process the received first set of digital signals to generate a second set of digital signals. The second set of digital signals can corresponds to the continuous monitoring and detection of maternal and fetal health generated by the device 300 during one or more phases of the user 204. The generated second set of digital signals is processed by the computing unit 110 so as to be represented on at least one mobile computing device 202.

[0052] In an exemplary embodiment, the computing unit 110 can selected from any or a combination of a Microcontroller, Microprocessor, Arduino chipset, but not limited to the likes.

[0053] In an embodiment, the computing unit 110 can be configured to self-calibrate the device 200 upon turning ON the device and / or whenever the device 200 is used. The self or automatic calibration performed by the device can be based on either continuous or periodic calibration of the amplifier 106, ADC module 108, computing unit 110 and / or load cell 104 against two stable references. Before any measurement is done, or when the device 200 is receiving the stimulus from the user, the computing unit 110 can provide a low reference electrical signal, followed by a high reference electrical signal to the amplifier 106 to finally measure the output value by the computing unit 110. Now the deviations of the device 200 can be known, and the reading of the actual measurement by the device 200 can be corrected for improved accuracy and reliability.

[0054] In an embodiment, the device 300 can include a communication module 112 operatively coupled to the computing unit 110. The communication module 112 can be configured to communicatively couple the device 300 to mobile computing devices 202, andtransmit the second set of digital signals corresponding to the measured strength of the surface stimulus generated by the housing of the device 300 on the housing 102 to the mobile computing devices 202.

[0055] In an exemplary embodiment, the communication module 112 can be any or a combination of a Bluetooth module, a WIFI module, an IR module, but not limited to the likes.

[0056] In an embodiment, the device 300 can include a display module 114 operatively coupled to the computing unit 110 to provide instructions to the user and / or display readings of the measured handgrip force. In an exemplary embodiment, the display module 114 can be or a combination of LED, LCD, PicoLED, AMOLED, but not limited to the likes.

[0057] In an embodiment, the computing unit 110 can be configured to process the generated set of second signals corresponding to the force applied on the housing 102 of the device 300, and convert it into a format being displayable on the mobile computing devices and the display module 114 of the device 300.

[0058] In an embodiment, the device 200 can include a battery module 116 to provide electrical power to any or a combination of the amplifier 106, ADC module 108, computing unit 110, communication module 112 and display module 114 of the device 300. The battery module 116 can include a set of batteries such as but not limited to rechargeable Li-ion battery, and a battery-charging unit to facilitate charging of the set of batteries. The battery module 116 can further include a power management and safety unit which can be configured to manage transfer of electrical power to any or a combination of the amplifier 106, ADC module 108, computing unit 110, communication module 112 and display module 114 of the device 200, and prevent any mishaps such as but not limited to short circuiting, overcharge, dead charge etc.

[0059] FIG. 2B illustrates exemplary network architecture in which or with which proposed device and mobile computing devices can be implemented, in accordance with an embodiment of the present disclosure.

[0060] As illustrated, in an embodiment, the device 300 can be adapted to be placed on the user 204 by wrapping the belt around the user 204. Further, the device 300 can be configured to generate a second set of digital signal corresponding to corresponds to the continuous monitoring and detection of maternal and fetal health generated by the housing of the device 300 during one or more phases of the user. The device 300 can include a communication module 112 to connect the device 300 to the mobile computing devices 202 such as a smart phone 202-1, a computer / laptop 202-2 and a cloud based server 202-3. The device 300 can beconfigured to process the second set of digital signal corresponds to the continuous monitoring and detection of maternal and fetal health generated by the device 300 during one or more phases of the user 204 and transmit it to the mobile computing devices 202 through a network 206.

[0061] In an embodiment, the device 300 can be accessed using the mobile computing devices 202 connected to the device 300. The device 300 can be calibrated and configured using the applications installed on the mobile computing devices.

[0062] The network architecture 206 in which or with which proposed device 300 and mobile computing devices 202 can be implemented is described demonstrating a single user and a single device. It is to be appreciated that the present disclosure is not limited to single user or a single device being connected to the mobile computing devices. However, a plurality of users and their devices can be communicatively coupled to the mobile computing devices, and the mobile computing devices can configured to display the readings and report associated with the force being measured by the proposed device.

[0063] The user 204 can interact with the mobile computing devices 202 through the network 206 using an application, a web browser, a proprietary program, or any other program executed and operated by the access device. In some embodiments, the access device can communicate directly with the network devices (e.g., communication signal). For example, the access device can communicate directly with network devices using ZigBee™ signals, Bluetooth™ signals, Wi-Fi™ signals, infrared (IR) signals, UWB signals, Wi-Fi- Direct signals, BLE signals, sound frequency signals, or the like. In some embodiments, the access device can communicate with the network devices via the gateways and / or a cloud network.

[0064] The local area network can include a wireless network, a wired network, or a combination of a wired and wireless network. A wireless network can include any wireless interface or combination of wireless interfaces (e.g., ZigBee™, Bluetooth™, Wi-Fi™, IR, UWB, Wi-Fi-Direct, BLE, cellular, Long-Term Evolution (LTE), WiMAX™, or the like). A wired network can include any wired interface (e.g., fiber, Ethernet, powerline, Ethernet over coaxial cable, digital signal line (DSL), or the like). The wired and / or wireless networks can be implemented using various routers, access points, bridges, gateways, or the like, to connect devices in the local area network. For example, the local area network can include gateway and gateway. Gateway can provide communication capabilities to network devices and / or access device via radio signals in order to provide communication, location, and / or other services to the devices. The gateway is directly connected to the external network andcan provide other gateways and devices in the local area network with access to the external network. The gateway can be designated as a primary gateway.

[0065] The network access provided by gateway can be of any type of network familiar to those skilled in the art that can support data communications using any of a variety of commercially-available protocols. For example, gateways can provide wireless communication capabilities for the local area network using particular communications protocols, such as Wi-Fi™ (e.g., IEEE 802.11 family standards, or other wireless communication technologies, or any combination thereof). Using the communications protocol(s), the gateways can provide radio frequencies on which wireless enabled devices in the local area network can communicate. A gateway can also be referred to as a base station, an access point, Node B, Evolved Node B (eNodeB), access point base station, a Femtocell, home base station, home Node B, home eNodeB, or the like.

[0066] Gateways can include a router, a modem, a range extending device, and / or any other device that provides network access among one or more computing devices and / or external networks. For example, gateway can include a router or access point or a range extending device. Examples of range extending devices can include a wireless range extender, a wireless repeater, or the like.

[0067] A router gateway can include access point and router functionality, and can further include an Ethernet switch and / or a modem. For example, a router gateway can receive and forward data packets among different networks. When a data packet is received, the router gateway can read identification information (e.g., a media access control (MAC) address) in the packet to determine the intended destination for the packet. The router gateway can then access information in a routing table or routing policy, and can direct the packet to the next network or device in the transmission path of the packet. The data packet can be forwarded from one gateway to another through the computer networks until the packet is received at the intended destination.

[0068] FIG. 3A-3D illustrates exemplary architecture of the proposed device 300, in accordance with an embodiment of the present disclosure.

[0069] As illustrated, in an embodiment, the exemplary system architecture 100 of the proposed device and digital platforms can include the proposed device 300 being communicatively coupled to mobile computing device 110 through a communication module 112 of the device 300, to provide various digital platforms using mobile applications, computer software and website, etc.

[0070] In an embodiment, the proposed device 300 can include a circuit board 302, at least one biopotential electrode sensor 104, a portable display 304, a belt strap 306, and the battery 116. The proposed device 300 can be a wearable belt 306 which can be worn around the abdomen of the user 204. The sensor 104, at least one ultrasound transmitter and receiver, at least one temperature sensor and each of them is in contact with the abdomen of the user 204 when the device 300 is worn by the user 204. An ultrasound conductive gel is applied on the abdoment of the user 204 to ensure contact of the sensors 104 to the abdomen.

[0071] In an embodiment, the proposed device 300 can receive the first set of digital signals from the ADC module 108 and process the received first set of digital signals to generate a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the device 300 during one or more phases of the user. Further, the generated second set of digital signals is processed by the computing unit 110 so as to be represented on at least one mobile computing device 202. The first set of analogue biopotential signals includes at least one of a maternal electrocardiogram (mECG), a fetal electrocardiogram (fECG) and an uterine contractions electromyogram (uEMG). The one or more phases pertains to an antepartum phase, an intrapartum phase, and a postpartum phase.

[0072] In an embodiment, the proposed device 300 the device includes at least one ultrasound transmitter and at least one ultrasound receiver. The at least one ultrasound transmitter can be configured to receive a first set of analogue biopotential signals which ca be converted to an ultrasound waves in the MHz range. The at least one ultrasound receiver can be configured to receive a reflected ultrasound waves, and amplified and processed using a doppler effect to calculate changes in a heart rate of the fetus, and other physiological and pathological changes. The device can include at least one temperature sensor configured to monitor a baseline abdominal skin temperature.

[0073] In an embodiment, the device 300 can be configured to extract maternal electrocardiogram (mECG), fetal electrocardiogram (fECG) and uterine contractions electromyogram (uEMG) based on the signals. The raw biopotential signal, after electronic amplification and / or filtering, is digitally filtered and subtracted to get accurate signals from the raw biopotential signal. The ultrasound transmitter is given signals from a processing unit which is converted to ultrasound waves in the MHz range. The ultrasound receiver receives the reflected ultrasound waves, which is then electronically amplified and processed using doppler effect to calculate changes in heart rate of the fetus and other physiological and pathological changes. The processed data from the wearable is then transferred to cloudand / or any external processing devices like computers, mobiles, tablets etc. for further processing, data analysis, artificial intelligence training / machine leaming / deep learning algorithms and storage. The data is stored securely and is accessible to doctors with accounts. There is a web / app-based software which can show relevant details to doctors and basic information to patients.

[0074] In an embodiment, Fig. 3B depicts a side view of the device 300. Fig. 3C depicts a front view of the device 300. Fig. 3D depicts a rear view of the device 300.

[0075] FIG. 4 illustrates flowchart of the proposed method for facilitating non-invasive, continuous monitoring of maternal and fetal health, in accordance with an exemplary embodiment of the present disclosure, to elaborate upon its working.

[0076] In an embodiment, the method 400 illustrates a flowchart for facilitating non-invasive, continuous monitoring of maternal and fetal health. The method 400 comprises the step of detecting and generating, by a device, a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user. The method 400 comprises the step of amplifying, by the device, an amplitude of the first set of electrical signals to a predefined amplitude. The method 400 comprises the step of receiving and processing, by the device, the first set of digital signals for generating a second set of digital signals. The second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated. The method 400 comprises the step of processing the generated second set of digital signals by the computing unit so as to be represented on at least one mobile computing device.

[0077] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.ADVANTAGES OF THE INVENTION

[0078] The proposed disclosure provides a device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof.

[0079] The proposed disclosure provides a light weight, accurate and reliable device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof.

[0080] The proposed disclosure provides a device for facilitating non-invasive, continuous monitoring of maternal and fetal health, and a method thereof, which is multiple ultrasound sensors to pick up fetal heart rate.

[0081] The proposed disclosure provides at least single lead ECG of maternal heart rate can be detected.

[0082] The proposed disclosure provides multiple data parameter collection.

[0083] The proposed disclosure transfers the measured data to various digital platforms for storage and analysis purpose.

Claims

We Claim:

1. A device (300) for facilitating non-invasive, continuous monitoring of maternal and fetal health, the device (300) comprises: a wearable belt (306) adapted to be placed around an abdomen a user (204); at least one biopotential electrode sensor (104) coupled to the wearable belt (306), the at least one biopotential electrode sensor (104) is configured to detect and generate a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user (204); an amplifier (106) operatively coupled to the at least one biopotential electrode sensor (104), the amplifier (106) configured to amplify an amplitude of the first set of analogue biopotential signals to a predefined amplitude; an analog to digital converter (ADC) module (108) operatively coupled to the amplifier (106), the ADC module (108) configured to receive the amplified first set of analogue biopotential signals and convert into a second set of digital signals; and a computing unit (110) operatively coupled to the ADC module (108), the computing unit (110) comprising one or more processors coupled with a memory, the memory storing instructions executable by the one or more processors to: receive the first set of digital signals from the ADC module (108) and process the received first set of digital signals to generate a second set of digital signals, wherein the second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the device (300) during one or more phases of the user (204), wherein the generated second set of digital signals is processed by the computing unit (110) so as to be represented on at least one mobile computing device (202).

2. The device (300) as claimed in claim 1, wherein the first set of analogue biopotential signals include at least one of a maternal electrocardiogram (mECG), a fetal electrocardiogram (fECG) and an uterine contractions electromyogram (uEMG).

3. The device (300) as claimed in claim 1, wherein one or more phases pertains to an antepartum phase, an intrapartum phase, and a postpartum phase.

4. The device (300) as claimed in claim 1, wherein the device (300) includes: at least one ultrasound transmitter is configured to receive the first set of digital signals which is converted to an ultrasound waves in the MHz range; and at least one ultrasound receiver is configured to receives a reflected ultrasound waves, and amplified and processed using a doppler effect to calculate changes in a heart rate of the fetus, and other physiological and pathological changes.

5. The device (300) as claimed in claim 1, wherein the device (300) includes at least one temperature sensor configured to monitor a baseline abdominal skin temperature.

6. The device (300) as claimed in claim 1, wherein a communication module (112) operatively coupled to the computing unit (112), and wherein the communication module (112) is configured to communicatively couple the device (300) to the at least one mobile computing device (202), and transmit the second set of digital signals corresponding to the continuous monitoring and detection of maternal and fetal health of the user (204) to the at least one mobile computing device (202) of the user (204).

7. The device (300) as claimed in claim 1, wherein the computing unit (110) is any or a combination of a Microcontroller, and a Microprocessor.

8. A method for facilitating non-invasive, continuous monitoring of maternal and fetal health, the method comprises: detecting and generating, by a device (300), a first set of analogue biopotential signals corresponding to the maternal and fetal health of the user (204); amplifying, by the device (300), an amplitude of the first set of analogue biopotential signals to a predefined amplitude; receiving and processing, by the device (300), the first set of digital signals to generate a second set of digital signals, wherein the second set of digital signals corresponds to the continuous monitoring and detection of maternal and fetal health generated by the housing of the device (300) during one or more phases of the user (204), wherein the generated second set of digital signals is processed by the computing unit (110) so as to be represented on at least one mobile computing device (300).

Citation Information

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