APPARATUS FOR REAL-TIME WIRELESS TRANSMISSION OF VITAL PARAMETERS AND METHOD OF MANUFACTURING THE SAME

Abstract

ABSTRACT APPARATUS FOR REAL-TIME WIRELESS TRANSMISSION OF VITAL PARAMETERS AND METHOD OF MANUFACTURING THE SAME The present invention describes an apparatus (100) having a flexible band (101), and a flexible circuit board. The flexible circuit board is coupled with the flexible band. The flexible circuit board includes flexible electrodes (102, 108, 110, 112, 114), sensing modules (104, 106), and a control module. The flexible electrodes are adapted to position on the subject, and configured to detect raw bio-signals from the subject. The sensing modules (104, 106) are coupled to the flexible electrodes and configured to acquire bio-signals from the raw bio-signals detected by the flexible electrodes. The sensing modules correspond to the flexible electrodes, and the bio-signals correspond to the vial physiological parameters of the subject. The control module is coupled to the sensing modules and configured for processing and wirelessly transmitting the processed bio-signals to a destination computing device. A method of manufacturing the apparatus is also described. (Fig. 1)

Specification

Description:[001] FIELD OF THE INVENTION
[002] The present invention relates to the health monitoring of patients, and particularly, to an apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject and a method of manufacturing the same.

[003] BACKGROUND OF THE INVENTION
[004] Background description includes information that may be useful in understanding the present invention
[005] In the context of medical emergencies such as road traffic accidents or cardiac arrests, the timely initiation of an emergency response is crucial. Emergency calls from the emergency site is initiated and approximately 90% of emergency calls are successfully connected, only 78% of ambulances successfully reach the incident site. This is partly due to issues such as server overload or busy lines, which account for about 5% of call failures. As per research study, on an average, emergency services in India receive between 4,000 to 6,000 calls daily.
[006] Ambulances are categorized into Basic Life Support (BLS) and Advanced Life Support (ALS) units. BLS ambulances, about 16,859, are equipped with basic medical equipment such as oxygen cylinders, stretchers, and first aid kits. In contrast, ALS ambulances, of which there are only 1,856, are equipped with advanced medical devices including defibrillators, cardiac monitors, and patient monitoring systems (PMS), and are staffed with trained paramedics. However, as per research study, only 3% of all ambulances in India have paramedics on board, highlighting a significant gap in emergency medical services.
[007] The concept of the "golden hour" is critical in this context. As per research studies, the golden hour refers to the 60-minute period following trauma, during which prompt medical intervention is vital to improving survival outcomes. This period starts from when the emergency call is made, to the ambulance arriving at the scene, and the patient being transported to the hospital. However, in practice, it takes approximately 5 minutes for the emergency call to be initiated and connected, and an additional 25 to 40 minutes for the ambulance to reach the site of the accident. Vehicle extrication at the site takes about 5 minutes, followed by 15 to 25 minutes for the patient to be transferred to the hospital. As per research study, once at the hospital, another 5 to 10 minutes are needed to prepare for emergency procedures. Altogether, this process takes approximately 75 minutes, exceeding the critical golden hour. According to the Ministry of Road Transport and Highways (MoRTH) 2023 report, this delay contributes to approximately 1,68,491 patients dying en-route to the hospital.
[008] According to the World Health Organization, road traffic accidents and falls account for most injuries. As per WHO, each year, 1.35 million and 646,000 people lose their lives due to road traffic accidents and unintentional falls, respectively. Accidents cause a burden on victims and public health systems. Moreover, the situation is especially severe in low- or middle-income countries. For instance, 93% of all road traffic deaths and 80% of all deadly falls occur in these countries. A total number of 4,61,312 road accidents have been reported during 2022, claiming 1,68,491 lives and causing injuries to 4,43,366 persons in India. The risk of suffering from an accident depends on age: 73% of all road traffic deaths occur among young males, and death rates because of falls are highest among adults older than 60 years. According to the report published in 2023 - World Health Organization (WHO), approximately 1.19 million people die per year due to road crashes. According to the Rural health statistics 2021-22 by the Ministry of health and family welfare: the total number of ambulances in India is around 78,000.
[009] Cardiac monitors in ambulances for advanced life support to monitor heart activities in real-time, and quickly identify life-threatening conditions, but the monitors require stable connectivity, huge investments, and proper training for the paramedics to work with. The poor cellular coverage, limited budgets, and improper trained staff can reduce the results. There are concerns regarding comfort due to the wired system and gel-based electrode during prolonged use, which could cause discomfort to the patient from wearing the device consistently. The Kode blue is one of the startups, but it requires significant manual interventions to accomplish the purpose. The Oura Ring is a circular titanium-based health monitor that tracks heart rate, temperature, breathing, and sleep tracker. But it is not medically certified and cannot be used as a substitute for professional advice. The Withings ScanWatch is a hybrid smartwatch for healthcare applications, providing medical-grade monitoring of heart rate, ECG for atrial fibrillation detection, and SpO2 for blood oxygen levels. It focuses on patients with chronic conditions to track their health remotely, improving communication with doctors through the Withings Health Mate app.
[0010] Research based on vital monitoring with compact bands and patches has made some significant progress. A patent application US 2021/0113132 A1 titled "DISPOSABLE HEALTH AND VITAL SIGNS MONITORING PATCH AND MAKING OF SAME" discloses a disposable patch made of hydrogel-based conductive adhesive and printed silver-silver chloride electrodes to enable better contact and provide better vital monitoring. However, the reliance on hydrogel-based materials may lead to issues with skin irritation or allergic reactions in some users, potentially limiting its widespread use.
[0011] Thus, there is a desired need for a flexible, and compact integrated apparatus for real-time monitoring of vital parameters in ambulance patients, which is user-friendly with a minimum discomfort for individuals without medical training.

[0012] OBJECTS OF THE INVENTION:
[0013] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are listed herein below.
[0014] The primary objective of the present invention is to develop a flexible, wireless band designed for real-time monitoring of vital signs in patients being transported in ambulances.
[0015] Another objective of the present invention is to implement the single lead single arm ECG for patient comfort.
[0016] Another objective of the present invention is to develop flexible and adhesive electrodes that conform and adhere to the skin surface and conducts stable and undistorted bio signals.
[0017] Another objective of the present invention is to design and develop a flexible Printed circuit board (PCB) consisting of different sensor ICs to acquire ECG, PPG, temperature and EDA signals.
[0018] Another objective of the present invention is to integrate the developed electrode and PCB into the flexible band forming a single compact device for real time vital monitoring.
[0019] Another objective of the present invention is to address the challenge of the limited availability of trained paramedics in emergency medical services using this user-friendly band, that allows any individual, including the ambulance driver, to easily attach it to the patient's body.
[0020] These and other objects and advantages will become more apparent when reference is made to the following description and accompanying drawings.

[0021] SUMMARY OF THE INVENTION
[0022] This summary is provided to introduce concepts related to real-time wireless transmission of a plurality of vital physiological parameters of a subject. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
[0023] In an aspect of the present invention, an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject is described. The apparatus includes a flexible band and a flexible circuit board. The flexible circuit board is coupled with the flexible band. The flexible circuit board includes a plurality of flexible electrodes, a plurality of sensing modules, and a control module. The plurality of flexible electrodes are adapted to position on the subject, and configured to detect a plurality of raw bio-signals from the subject. The plurality of sensing modules are coupled to the plurality of flexible electrodes and configured to acquire a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes. The plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject. The control module is coupled to the plurality of sensing modules and configured for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
[0024] In an embodiment of the present invention, the plurality of vital physiological parameters comprise Electrocardiogram, ECG, Photoplethysmography, PPG, temperature, electrodermal activity, EDA, and blood oxygen saturation, SpO2.
[0025] In another embodiment of the present invention, the ECG bio-signals are acquired with a single lead on a single arm of the subject.
[0026] In another embodiment of the present invention, the plurality of flexible electrodes are dry and self-adhesive.
[0027] In another embodiment of the present invention, the plurality of flexible electrodes comprise a plurality of ECG electrodes, a PPG electrode, a plurality of GSR electrodes, and a temperature electrode.
[0028] In another embodiment of the present invention, the plurality of flexible electrodes are of a slightly concave shape, to conform easily on a body surface of the subject.
[0029] In another embodiment of the present invention, the flexible circuit board is printed on a flexible base material of the flexible band.
[0030] In another embodiment of the present invention, the flexible band is made of a flexible polymer.
[0031] In another embodiment of the present invention, the flexible band includes a zipper lock to ensure a tight and secure fit around a wrist of the subject.
[0032] In another embodiment of the present invention, the apparatus includes a power source for providing power and a USB correcting module for connecting an external device.
[0033] In another embodiment of the present invention, the plurality of sensing modules communicate with the control module based on an Inter-Integrated Circuit, I2C, protocol.
[0034] In another aspect of the present invention, a method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject is described. The method includes the step of providing a flexible band. The method further includes the step of coupling a flexible circuit board with the flexible band. The step of coupling the flexible circuit board includes the sub-step of providing a plurality of flexible electrodes to be positioned on the subject, for detecting a plurality of raw bio-signals from the subject. The step of coupling the flexible circuit board further includes the sub-step of providing a plurality of sensing modules coupled to the plurality of flexible electrodes, for acquiring a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes. The plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject. The step of coupling the flexible circuit board further includes the sub-step of providing a control module coupled to the plurality of sensing modules, for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
[0035] 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.

[0036] BRIEF DESCRIPTION OF DRAWINGS:
[0037] The illustrated embodiments of the subject matter will be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. The following description is intended only by way of example and simply illustrates certain selected embodiments of devices, apparatus, systems, and methods that are consistent with the subject matter as claimed herein, wherein:
[0038] FIG. 1 illustrates an integrated flexible apparatus made of a flexible material with various electrodes including ECG, PPG, body temperature, and GSR, strategically positioned on the surface of the flexible band for optimal contact with the user's skin, in accordance with an exemplary embodiment of the present disclosure;
[0039] FIG. 2a illustrates a 3D top view of a flexible circuit board having (1) LiPo battery connector, (2) Microcontroller unit, (3) USB Connector, and (4) GSR Sensor IC, in accordance with an exemplary embodiment of the present disclosure;
[0040] FIG. 2b illustrates a 3D bottom view of flexible circuit board having (1) ECG Electrode (negative), (2) ECG Electrode (positive), (3) ECG Electrode (ground), (4) Body temperature sensor, (5) PPG and ECG sensor IC, (6) GSR electrode - 1, and (7) GSR electrode - 2, in accordance with an exemplary embodiment of the present disclosure;
[0041] FIG. 3 illustrates the properties of a plurality of flexible electrodes, in accordance with an exemplary embodiment of the present disclosure;
[0042] FIG. 4 illustrates (a) top view and (b) a bottom view of flexible circuit board embedded in the flexible band, in accordance with an exemplary embodiment of the present disclosure;
[0043] FIG. 5 illustrates a schematic (a) bottom view (b) side view, and (c) top view of flexible electrode, in accordance with an exemplary embodiment of the present disclosure;
[0044] FIG. 6 illustrates a schematic block diagram depicting a method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure;
[0045] FIG. 7 illustrates a schematic block diagram depicting a method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure; and
[0046] FIG. 8 illustrates a tabular experimental results of the single-arm single-lead ECG in sitting position using the apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure.
[0047] The figures depict embodiments of the present subject matter for the purposes of illustration only. A person skilled in the art will easily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the disclosure described herein.

[0048] DESCRIPTION OF THE INVENTION:
[0049] 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.
[0050] While the embodiments of the disclosure are subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the figures and will be described below. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.
[0051] The terms "comprises", "comprising", or any other variations thereof used in the disclosure, are intended to cover a non-exclusive inclusion, such that a device, system, or assembly that comprises a list of components does not include only those components but may include other components not expressly listed or inherent to such system, or assembly, or device. In other words, one or more elements in a system or device proceeded by "comprises… a" does not, without more constraints, preclude the existence of other elements or additional elements in the system or device.
[0052] The present invention relates to an apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject and a method of manufacturing the same.
This apparatus is a novel, wireless, flexible band for real-time vital physiological parameters monitoring designed for use in ambulances. The apparatus includes a flexible band integrated with flexible dry electrodes, and circuit board (ICs) printed on a flexible base material of the band to acquire raw bio signals. The signals are obtained through electrocardiography (ECG), photoplethysmography (PPG), temperature and electrodermal activity (EDA). These signals are processed and wirelessly transmitted by the control module for real-time vital monitoring.
[0053] The flexible conductive electrodes are used to detect signals from the body. These electrodes are integrated as a part of the band and by connecting them to sensing module of a flexible circuit board, raw bio signals are acquired. The present invention ensures that the vital parameters, such as ECG, heart rate and oxygen saturation, are constantly monitored to enable timely interventions and better preparations are already done upon arrival at the hospital. Combining the flexible electrodes, the sending module and a control module of the flexible circuit board into a single flexible band creates a compact and fully integrated solution which significantly enhances the effectiveness and accuracy of patient monitoring in ambulatory environments, thereby minimizing the delays and risks associated with traditional and some modern methods. This improvement is essential for emergency medical treatment, because the longer it takes to monitor and assess a patient's condition can increase their chances of survival.
[0054] In emergency medical situations such as road traffic accidents, poisoning, burns, shortness of breath, cardiac arrests, and pregnancy-related emergencies, the time taken to transfer a patient from an ambulance to the emergency room can cause critical delays, especially within the golden hour which is an extremely crucial period where timely medical intervention significantly improves the outcomes for patients. The golden hour concept, according to some research, suggests that if treatment for extreme injury is not provided within a 60-minute window from the event time, the survival chance is reduced. Traditional methodologies for the measurement of vital physiological parameters often require direct physical measurements that are to be performed by emergency medical technicians (EMT) using standard medical devices, which can be time-consuming and susceptible to human error. Modern methods use electronic devices for monitoring many parameters automatically, but traditional systems usually require separate units, which might not be ideal in the fast-moving environment of an ambulance.
[0055] By implementing the present invention, it is possible to update physical parameters before the patient arrives at the hospital. This diminishes the necessity for human intervention in the ambulance, as the apparatus only requires being secured to the patient's body.
[0056] For better understanding, one or more embodiments of the present invention shall be described with respect to the earlier-mentioned drawings.
[0057] FIG. 1 illustrates an integrated flexible apparatus (100) made of a flexible material with various electrodes including ECG, PPG, body temperature, and GSR, strategically positioned on the surface of the flexible band for optimal contact with the user's skin, in accordance with an exemplary embodiment of the present disclosure. FIG. 2a illustrates a 3D top view of a flexible circuit board (404) having (1) power source, (2) control module, (3) USB Connector, and (4) GSR sensing module, in accordance with an exemplary embodiment of the present disclosure. FIG. 2b illustrates a 3D bottom view of flexible circuit board (404) having (1) ECG Electrode (negative), (2) ECG Electrode (positive), (3) ECG Electrode (ground), (4) Body temperature sensor, (5) PPG and ECG sensor IC, (6) GSR electrode - 1, and (7) GSR electrode - 2, in accordance with an exemplary embodiment of the present disclosure. FIG. 3 illustrates the properties of a plurality of flexible electrodes (302), in accordance with an exemplary embodiment of the present disclosure. FIG. 4 illustrates (a) top view and (b) a bottom view of flexible circuit board (404) embedded in the flexible band (406), in accordance with an exemplary embodiment of the present disclosure.
[0058] As illustrated, the integrated flexible apparatus (100) includes a flexible band (101, 406), and a flexible circuit board (404). The flexible circuit board (404) is coupled with the flexible band. The flexible circuit board includes a plurality of flexible electrodes (102, 108, 110, 112, 114, 302, 500), a plurality of sensing modules (104, 106, 208, 210, 212, 214, 216, 218, 220, 222), and a control module (204). The plurality of flexible electrodes (102, 108, 110, 112, 114, 302, 500) are adapted to position on the subject, and configured to detect a plurality of raw bio-signals from the subject. The plurality of sensing modules (104, 106, 208, 210, 212, 214, 216, 218, 220, 222) are coupled to the plurality of flexible electrodes and configured to acquire a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes. The plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject. The control module (204) is coupled to the plurality of sensing modules and configured for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
[0059] In an embodiment of the present invention, the plurality of vital physiological parameters comprise Electrocardiogram, ECG, Photoplethysmography, PPG, temperature, electrodermal activity, EDA, and blood oxygen saturation, SpO2.
[0060] In another embodiment of the present invention, the ECG bio-signals are acquired with a single lead on a single arm of the subject.
[0061] In another embodiment of the present invention, the plurality of flexible electrodes are dry and self-adhesive.
[0062] In another embodiment of the present invention, the plurality of flexible electrodes comprise a plurality of ECG electrodes, a PPG electrode, a plurality of GSR electrodes, and a temperature electrode.
[0063] In another embodiment of the present invention, the plurality of flexible electrodes are of a slightly concave shape, to conform easily on a body surface of the subject.
[0064] The flexible dry electrodes provide comfort, improved signal quality and easily conform to various skin contours. In addition, the self-adhesive property allows quick and easy attachment to the skin, eliminate the need for conductive gels and provides uniform contact over the entire surface. These electrodes are also stretchable (as shown in Fig. 3(1)) making them more resilient to stress and enhancing the overall durability. Conducting stable and continuous signals, with reduced motion artifacts and decreased skin irritation are the key advantages of the electrodes. FIG. 5 illustrates a schematic (a) bottom view (b) side view, and (c) top view of flexible electrode, in accordance with an exemplary embodiment of the present disclosure.
[0065] In another embodiment of the present invention, the flexible circuit board is printed on a flexible base material of the flexible band.
[0066] In another embodiment of the present invention, the flexible band is made of a flexible polymer for comfortable wear. In an example, the flexible band is 35 cm long and 4 cm wide.
[0067] In another embodiment of the present invention, the flexible band includes a zipper lock (402) to ensure a tight and secure fit around a wrist of the subject.
[0068] The unique zipper lock ensures for quick and secure attachment of the band around the patient's upper arm, provides a reliable and consistent fit and making it easy to wear for various emergency situations. The zipper lock is placed on the flexible band so that it does not interfere with the placement of the flexible electrodes or the flexible circuit board. The band is designed to be user-friendly, which allows EMTs or even untrained people to attach the band around the patient's arm without the need for complex adjustments. The overall design of the flexible band is conformable to different body types.
[0069] In another embodiment of the present invention, the apparatus include a power source (202) for providing power and a USB correcting module (206) for connecting an external device.
[0070] For power source, a lithium polymer (LiPo) battery is employed, providing a reliable and efficient energy source for the entire system. The LiPo battery is chosen for its lightweight and compact characteristics, making it suitable for comfort of wearing. The schematic also includes power management components to ensure that the sensors and microcontroller operate within their specified voltage ranges, optimizing performance and extending battery life.
[0071] In another embodiment of the present invention, the plurality of sensing modules communicate with the control module based on an Inter-Integrated Circuit, I2C, protocol.
[0072] The internal structure of the flexible apparatus consists of a flexible circuit board that houses the integrated sensor ICs (i.e. sensing modules) and the microcontroller unit (MCU) (i.e. the control module), allowing for seamless data collection and processing. The compact and unobtrusive design of the apparatus, comparable in size to a standard wristwatch, ensures comfortable wear throughout the day, while the Wi-Fi connectivity enables real-time data transmission to a smartphone app or cloud-based platform for comprehensive health monitoring and analysis.
[0073] The core of the apparatus is the control module or microcontroller, which is the central processing unit for the apparatus. The ESP32 features built-in Wi-Fi connectivity, facilitating real-time data transmission to a smartphone app or cloud-based platform for further analysis and monitoring. Integrating multiple sensing modules or sensors, the ESP32 MCU, and the Wi-Fi module onto a flexible circuit board is a complex task that requires careful design and optimization. The flexible nature of the circuit board introduces additional constraints compared to traditional rigid circuit boards, making the engineering process both challenging and rewarding.
[0074] The sensing modules i.e. ECG, PPG, body temperature, and GSR sensors or sending modules are all connected to the control module i.e. MCU, allowing for efficient communication and data processing. Each sensor utilizes the I2C protocol for communication, enabling an organized data exchange between the sensors and the microcontroller. It simplifies the wiring and enhances the overall performance of the system by allowing multiple devices to share a common communication bus.
[0075] The ECG sensors (102, 112, 114) and PPG sensors (106) or sending modules are designed to capture vital cardiovascular metrics, while the body temperature sensor (104) provides accurate readings of the user's skin temperature. The GSR sensor (208) measures galvanic skin response, offering insights into the user's stress levels and emotional state. By integrating these sensors into a single schematic, the design ensures that all physiological data can be collected and processed in real time, enabling comprehensive health monitoring.
[0076] The ECG and PPG sensors allow simultaneous measurement of heart rate and blood oxygen saturation (SpO2). The temperature sensor provides accurate measurements of the user's skin temperature. Furthermore, a dedicated GSR sensor integrated into the band, enables the measurement of galvanic skin response, which serves as an indicator of stress and arousal. This combination of sensors provides a comprehensive view of the user's physiological state.
[0077] The multi-sensor apparatus (100) is designed to provide continuous monitoring of various physiological signals, including single lead single arm ECG, PPG, GSR, and body temperature. The flexible circuit board integrates individual sensing modules which eliminates the need for commercial sensor modules and flexible, stretchable and self-adhesive dry electrodes included with each sensing module, conform easily to the skin surface and eliminate the need of gel thereby improving comfort. These electrodes help in acquiring stable signals with minimal noise and have high conductivity. This approach enhances the compactness of the device.
[0078] The apparatus has a set of applications in health monitoring and stress assessment. By continuously monitoring ECG, PPG, GSR, and body temperature, this band offers invaluable insights into the user's overall physiological state and well-being. The data collected can be utilized for the early detection of health issues, stress management, and personalized health recommendations. The apparatus's flexible and comfortable design ensures high user acceptance and compliance, enabling long-term monitoring without discomfort or inconvenience. This integration of multiple sensors into a single wireless apparatus streamlines the monitoring process and offers a more comprehensive view of the user's health status.
[0079] The construction of the band utilizes flexible polymer ensuring a comfortable fit and conformity to the user's wrist or arm. This flexibility allows for easy donning and doffing of the band, making it suitable for continuous wear throughout the day. The dry electrodes that conduct signals from the body are flexible, adhesive and highly conductive. The electrode is designed with a slightly concave shape to conform easily on the body surface. However, in the conventional solutions, the circuit design presents several challenges. Instead of relying on commercially available sensor modules, the present invention integrates individual sensing module directly onto the flexible circuit board. This necessitates careful design and layout to minimize the overall size and weight of the band while ensuring reliable signal transmission. Additionally, the power source is managed by a LiPo battery, powering multiple sensors or sending modules and the control module (i.e. microcontroller unit (MCU)) while maintaining low power consumption is essential for extended battery life and continuous monitoring.
[0080] In one or more embodiments, the apparatus (100) may be part of a larger computer system and/or maybe operatively coupled to a network (e.g., a second network) with the aid of a communication interface to facilitate the transmission of and sharing data and predictive results. The computer network may be a local area network (LAN), an intranet and/or extranet, an intranet and/or extranet that is in communication with the Internet, or the Internet. The network in some cases is a telecommunication and/or a data network, and may include one or more computer servers. In an example, the communication network includes, but not limited to, 2G network, 3G network, 4G network, LTE network, 5G network, 6G network, and so forth. The network, in some cases with the aid of a computer system, may implement a peer-to-peer network, which may enable devices coupled to the computer system to behave as a client or a server. In other examples, the system, the database, and the server may be integrated network node or a single integrated unit.
[0081] The apparatus may communicate with one or more other systems by the interfaces (e.g., network adapters). The memory or memory locations may be, e.g., random-access memory, read-only memory, flash memory. The system may also include at least one electronic storage units (e.g., hard disks), and peripheral devices, such as cache, other memory, data storage, and/or electronic display adapters.
[0082] The apparatus may also include one or more IO Managers as software instructions that may run on the one or more processors and implement various communication protocols such as User Datagram Protocol (UDP), Modbus, MQ Telemetry Transport (MQTT), Open Platform Communications Unified Architecture (OPC UA), Semiconductor's equipment interface protocol for equipment-to-host data communications (SECS/GEM), Profinet, or any other protocol, to access data in real-time from disparate data sources via any communication network, such as Ethernet, Wi-Fi, Universal Serial Bus (USB), Zigbee, Cellular or 5G connectivity, etc., or indirectly through a device's primary controller, through a Programmable Logic Controller (PLC) or through a Data Acquisition System (DAQ), or any other such mechanism.
[0083] Further, the CPU(s) may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, logic circuitries, and/or any devices that manipulate data based on operational instructions. Among other capabilities, the one or more processor(s) are configured to fetch and execute computer-readable instructions stored in the memory of the apparatus.
[0084] Further, the memory may store one or more computer-readable instructions or routines, which may be fetched and executed to create or share data units over a network service. The memory may include any non-transitory storage device including, for example, volatile memory such as RAM, or non-volatile memory such as EPROM, flash memory, and the like.
[0085] Further, the processing devices(s) may be implemented as a combination of hardware and programming device(s) (for example, programmable instructions) to implement one or more functionalities of the processing device(s). In examples described herein, such combinations of hardware and programming may be implemented in several different ways. In one example, the programming for the processing device(s) may be processor executable instructions stored on a non-transitory machine-readable storage medium and the hardware for the processing device(s) may include a processing resource (for example, one or more processors), to execute such instructions. In other examples, the processing devices(s) may be implemented by electronic circuitry.
[0086] FIG. 6 illustrates a schematic block diagram depicting a method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure. FIG. 7 illustrates a schematic block diagram depicting a method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure.
[0087] As illustrated, the method includes the step of providing (602) a flexible band. The method further includes the step of coupling (604) a flexible circuit board with the flexible band.
[0088] The step of coupling the flexible circuit board includes the sub-step of providing (702) a plurality of flexible electrodes to be positioned on the subject, for detecting a plurality of raw bio-signals from the subject. The step of coupling the flexible circuit board further includes the sub-step of providing (704) a plurality of sensing modules coupled to the plurality of flexible electrodes, for acquiring a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes. The plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject. The step of coupling the flexible circuit board includes the sub-step of providing (706) a control module coupled to the plurality of sensing modules, for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
[0089] FIG. 8 illustrates a tabular experimental results of the single-arm single-lead ECG in sitting position using the apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, in accordance with an exemplary embodiment of the present disclosure.
[0090] The present invention enables continuous monitoring of vital parameters such as ECG, heart rate, temperature and oxygen saturation, which is essential for timely medical interventions. The integration of flexible electrodes and sensing module within a compact design allows for accurate data acquisition while ensuring comfort for the patient. The use of a zipper lock mechanism enhances usability, allowing for quick and secure attachment around the upper arm or other part, making it particularly suitable for emergency situations. The dry electrode ensures the elimination of the need for skin preparation, as it can be applied directly to the skin, making the process quicker and more convenient. They also reduce the risk of skin irritation or allergic reactions since no conductive gel is required, thereby producing more comfort which is particularly beneficial for long-term monitoring. The electrode can be reused, conduct continuous and stable signals, as they do not suffer from signal degradation due to gel drying out. Finally, their integration into wearable band makes them ideal for portable and continuous ECG monitoring, enhancing patient mobility and ease of use.
[0091] The present invention operates differently from existing solutions by offering a fully integrated solution that combines multiple monitoring functions into a single flexible apparatus. Traditional monitoring systems often rely on separate, rigid devices that is complex and time-consuming to use, especially in the fast-paced environment of an ambulance. In contrast, the design of the apparatus of the present invention minimizes the need for multiple units, making the monitoring process easy and reducing the risk of human error during critical moments.
[0092] Differentiating Factors of Our Vital Sign Monitoring System from other conventional solutions
• Real-Time Data Transmission to Hospitals: Other solutions require manual intervention or lack seamless integration, while the flexible apparatus updates physical parameters in real-time before the patient arrives at the hospital. This ensures that medical teams are prepared for immediate intervention upon the patient's arrival.
• Minimized Need for Human Intervention: The apparatus is designed to require minimal human intervention. The apparatus only needs to be secured to the patient's body, and the rest of the process is automated, which reduces the errors and decreases the workload on paramedics, allowing them to focus on other critical tasks. It also reduces the need for extensive training, making it easier to deploy across a wide range of EMS providers.
• Comfort and Usability: Traditional ECG monitors use gel-based electrodes and the flexible band prioritizes comfort, which is essential during prolonged use. This is particularly important in emergencies where the patient may be wearing the apparatus for extended periods, which reduces discomfort, which can be crucial in emergency settings.
• Cost-Effectiveness: The apparatus provides advanced monitoring capabilities at a lower cost compared to other solutions which are expensive and wired making it uncomfortable for the patient. It can make the technology more accessible, particularly in low- and middle-income countries, where budget constraints are a significant concern.
• Focus on Emergency Response: The apparatus is for use in emergency medical services (EMS), with a focus on optimizing response times and improving outcomes during the golden hour, unlike general health monitors that may not be optimized for critical, time-sensitive situations.
[0093] Technical effects of invention
• Enhanced skin contact: The ergonomic shape of the apparatus fits comfortably around the patient's body part, depending on the desired monitoring location. The flexible nature of the apparatus ensures a secure fit while allowing for natural movement and minimal interference with the patient's activities. The dry and flexible electrode ensures proper skin contact and hence proper acquisition of ECG signal.
• Single lead single arm ECG: It has simplified operation, which allows for rapid deployment, especially in emergency situations. Its increased portability and compact design make it ideal for use in ambulances, remote locations, or as wearable technology, enabling continuous monitoring without hindering patient mobility. It is cost-effective and the single electrode also reduces the risk of skin irritation, ensuring greater comfort during long-term monitoring
• Low Power Consumption: The apparatus is capable of operating for extended periods without frequent recharging. This is particularly important during long emergency transport times or in remote areas where recharging options may be limited. The extended battery life ensures that the system remains operational when it is most needed.
• Adaptive Connectivity: The apparatus is equipped with adaptive connectivity features that allow it to switch between different communication protocols, such as Wi-Fi or Bluetooth, which ensures continuous data transmission, even in areas with variable or poor network coverage. As a result, the apparatus remains reliable and effective in a wide range of environments, including remote or underserved areas.
[0094] The present invention can be utilized in multiple ways/places. For example:
• Emergency Cardiac Monitoring: In emergency situations, such as during a heart attack or when a patient is experiencing symptoms like chest pain, the single-arm, single-lead ECG can be quickly deployed to monitor the heart's electrical activity. The simplicity of the apparatus allows first responders, such as paramedics or even untrained individuals, to quickly attach the apparatus and obtain vital readings. These readings can provide immediate insights into the presence of arrhythmias, ischemia, or other cardiac abnormalities enabling lifesaving interventions before reaching the hospital.
• Portable and Remote Health Monitoring: The compact design of the single-arm, single-lead ECG makes it highly portable, allowing it to be used in a variety of settings outside traditional healthcare environments. For instance, patients in remote or rural areas with limited access to healthcare facilities can use this apparatus for regular heart monitoring. Healthcare providers can receive the data remotely, enabling them to monitor patient conditions in real-time and provide timely advice or interventions without the need for the patient to travel long distances.
• Pre-Hospital Care: In pre-hospital care, such as in an ambulance, the single-arm, single-lead ECG can be used to assess the patient's cardiac status while en-route to the hospital. The data can be transmitted to the receiving hospital in real-time, allowing the emergency department to prepare in advance for the patient's arrival, thereby reducing the time to treatment and improving the chances of a positive outcome.
• Cost-Effective Cardiac Screening: The simplicity and low cost of a single-arm, single-lead ECG make it an ideal tool for large-scale cardiac screening programs. By providing an affordable means to conduct basic heart health assessments, this apparatus can be deployed in community health initiatives, schools, or workplaces to screen for early signs of heart disease.
• Patient Compliance and Comfort: The design of the flexible apparatus with single-arm, single-lead ECG, requiring only one electrode and minimal setup, enhances patient comfort and ease of use. The apparatus is less intrusive and more comfortable for the patient and increased comfort encourages patients to adhere to long-term monitoring regimens, which is crucial for managing chronic heart conditions.
[0095] A few of the major advantages of the present invention over the conventional solutions:
• Ease of Use: The apparatus design allows it to be easily attached to the patient by anyone, including non-medical personnel, such as an ambulance driver. This simplifies the process of initiating real-time vital sign monitoring, reducing the need for a trained technician and ensuring that monitoring can begin immediately in emergency situations.
• Enhanced Portability and Comfort: With its compact and lightweight design, made possible by the flexible circuit board and integrated sensing module, the apparatus is highly portable and comfortable for the patient. This ensures that it can be worn continuously without causing discomfort, making it suitable for long-term monitoring.
• Real-Time Data Transmission: Powered by the control module, the apparatus enables real-time wireless transmission of vital sign data to healthcare providers via Wi-Fi. This capability allows for immediate remote monitoring and analysis, which is critical in emergency situations where time is of the essence.
• Adherence to Golden Hour Principle: By transmitting real-time data to hospitals while the patient is en-route, the apparatus helps reduce the time needed for preparation at the hospital, thus aligning with the golden hour principle, which emphasizes the importance of prompt medical intervention following trauma.
• Comprehensive Monitoring: The apparatus integrates multiple essential sensors, including ECG, PPG, temperature, and EDA sensors, providing a comprehensive picture of the patient's physiological state. This multi-parameter monitoring is crucial for accurately assessing the patient's condition in dynamic and critical situations.
• High-Quality Signal Acquisition: The use of dry, flexible, conductive, adhesive electrodes ensures high-quality signal acquisition for ECG monitoring, even in challenging environments such as moving vehicles. These electrodes maintain good skin contact, enhancing the reliability and accuracy of the data collected.
• Low Power Consumption: The apparatus is designed with energy efficiency in mind, ensuring that it can operate continuously without frequent recharging. This is particularly important in emergency and remote settings where power resources may be limited.
[0096] Those of skill in the art would appreciate that the various illustrative blocks, modules, elements, components, methods, and algorithms described herein may be implemented as electronic hardware, computer software, or combinations of both. To illustrate this interchangeability of hardware and software, various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application. Various components and blocks may be arranged differently (e.g., arranged in a different order, or partitioned in a different way) all without departing from the scope of the subject technology.
[0097] It is understood that any specific order or hierarchy of blocks in the processes disclosed is an illustration of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks be performed. Any of the blocks may be performed simultaneously. In one or more implementations, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.
[0098] It should be noted that the description and figures merely illustrate the principles of the present subject matter. It should be appreciated by those skilled in the art that conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present subject matter. It should also be appreciated by those skilled in the art by devising various systems that, although not explicitly described or shown herein, embody the principles of the present subject matter and are included within its spirit and scope.
[0099] Furthermore, all examples recited herein are principally intended expressly to be for pedagogical purposes to aid the reader in understanding the principles of the present subject matter and the concepts contributed by the inventor(s) to further the art and are to be construed as being without limitation to such specifically recited examples and conditions. The novel features which are believed to be characteristic of the present subject matter, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures.
[00100] Although embodiments for the present subject matter have been described in language specific to package features, it is to be understood that the present subject matter is not necessarily limited to the specific features described. Rather, the specific features and methods are disclosed as embodiments for the present subject matter. Numerous modifications and adaptations of the system/device of the present invention will be apparent to those skilled in the art, and thus it is intended by the appended claims to cover all such modifications and adaptations which fall within the scope of the present subject matter. 
, Claims:We claim:
1. An integrated flexible apparatus (100) for real-time wireless transmission of a plurality of vital physiological parameters of a subject, the apparatus comprising:
a) a flexible band (101, 406); and
b) a flexible circuit board (404) coupled with the flexible band, the flexible circuit board comprising:
• a plurality of flexible electrodes (102, 108, 110, 112, 114, 302, 500) adapted to position on the subject, and configured to detect a plurality of raw bio-signals from the subject;
• a plurality of sensing modules (104, 106, 208, 210, 212, 214, 216, 218, 220, 222) coupled to the plurality of flexible electrodes and configured to acquire a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes, the plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject; and
• a control module (204) coupled to the plurality of sensing modules and configured for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
2. The apparatus (100) as claimed in claim 1, wherein the plurality of vital physiological parameters comprise Electrocardiogram, ECG, Photoplethysmography, PPG, temperature, electrodermal activity, EDA, and blood oxygen saturation, SpO2.
3. The apparatus (100) as claimed in claim 2, wherein the ECG bio-signals are acquired with a single lead on a single arm of the subject.
4. The apparatus as claimed in claim 1, wherein the plurality of flexible electrodes are dry and self-adhesive.
5. The apparatus as claimed in claim 1, wherein the plurality of flexible electrodes comprise a plurality of ECG electrodes, a PPG electrode, a plurality of GSR electrodes, and a temperature electrode.
6. The apparatus as claimed in claim 1, wherein the plurality of flexible electrodes are of a slightly concave shape, to conform easily on a body surface of the subject.
7. The apparatus as claimed in claim 1, wherein the flexible circuit board is printed on a flexible base material of the flexible band.
8. The apparatus as claimed in claim 1, wherein the flexible band is made of a flexible polymer.
9. The apparatus as claimed in claim 1, wherein the flexible band includes a zipper lock (402) to ensure a tight and secure fit around a wrist of the subject.
10. The apparatus (100) as claimed in claim 1, comprises a power source (202) for providing power and a USB correcting module (206) for connecting an external device.
11. The apparatus (100) as claimed in claim 1, wherein the plurality of sensing modules communicate with the control module based on an Inter-Integrated Circuit, I2C, protocol.
12. A method of manufacturing an integrated flexible apparatus for real-time wireless transmission of a plurality of vital physiological parameters of a subject, the method comprising:
a) providing (602) a flexible band; and
b) coupling (604) a flexible circuit board with the flexible band, wherein coupling the flexible circuit board comprising:
• providing (702) a plurality of flexible electrodes to be positioned on the subject, for detecting a plurality of raw bio-signals from the subject;
• providing (704) a plurality of sensing modules coupled to the plurality of flexible electrodes, for acquiring a plurality of relevant bio-signals from the plurality of raw bio-signals detected by the plurality of flexible electrodes, the plurality of sensing modules correspond to the plurality of flexible electrodes, and the plurality of relevant bio-signals correspond to the plurality of vial physiological parameters of the subject; and
• providing (706) a control module coupled to the plurality of sensing modules, for processing and wirelessly transmitting the processed plurality of relevant bio-signals to a destination computing device.
Dated this 8th day of November, 2024
[SONAL MISHRA]
-DIGITALLY SIGNED-
IN/PA-3929
OF L.S. DAVAR & CO.
ATTORNEY FOR THE APPLICANT(S)

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