RU2729430C1 - Hardware-software system for life indicators monitoring - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to medical equipment, namely to a hardware-software system for vital signs monitoring. Complex represents a T-shirt fastened to the chest with a strong component in the area of the solar plexus and shoulder straps and a sensor attachment line under the breast. T-Shirt is made from elastic fabric material with system of flexible polymer wiring for power distribution from central data aggregator. Aggregator comprises battery hot-swap subsystem and wireless communication and charging controller for connection of micro-power sensors, on which in the form of an additional board there is an accumulator and warning system of its low charge. Plug-in connections of controller data interfaces are designed to connect high-current sensors. Modular-based sensory network of the complex includes a non-invasive biochemical native sensor of lactate and glucose content of a flow type based on bioelectrochemical analysis of sweat composition (BNS), non-invasive skin semiconductor skin temperature and moisture sensor, non-invasive native electrocardiograph on 4–6 leads, multispectral pulse oximetry parameters measurement (PPS) sensor, a sensor for measuring frequency and volume of respiration on the basis of tensometry (TD) data, an arterial pressure measurement sensor (PMS) and a system of sensors for measuring motor activity as a center of mass of body, and individual parts thereof, joints and extremities with fixation of kinematic motion vectors in dynamics (MVD).EFFECT: vital signs are monitored with effective early detection of organ pathology, improved quality of life of the patients with the acquired disease, reduced risk of sudden death or loss of health and disability.5 cl, 6 dwg, 1 tbl, 1 ex

Description

TECHNICAL FIELD OF THE INVENTION

The invention relates to medicine, and more specifically to the field of non-invasive and implantable sensors for monitoring health. The method for determining the physiological index of the subject is carried out using a device on which the wearable sensors are placed to determine the physiological index of the subject.

BACKGROUND OF THE INVENTION

Scientists from different countries, incl. from the USA, Japan, Finland are developing in the field of implantable sensors for monitoring health. The question is in the creation of autonomous / long-playing power supplies for such sensors and materials that are well tolerated by the body.

At the moment there is a huge variety of devices and systems for remote monitoring, different in functions, purposes and prices.

Most of the solutions existing on the foreign market that provide monitoring of vital signs are based on the use of data from one or two sensors, for example, ECG or pulse oximetry. In addition, the systems for remote monitoring of a person's condition, which are currently used, provide for a large number of wired connections from sensors to a data processing device. This does not allow the patient to be served properly, and does not provide data on his condition, even when the patient moves around the medical facility. The ability to collect personal medical information, remotely interact with medical personnel regardless of the location of the patient and the doctor, connect to new sources of medical information is especially relevant for patients with high risk of death diseases. As a rule, such patients, due to the large number of examinations and their frequent periodicity, have a large volume of their own clinical data, the analysis of which by traditional manual methods is practically impossible for the average patient, and this is not the task of the doctor.

The most promising developments are research in the field of using biochemical sensors to determine the level of lactate and / or glucose in sweat or saliva. At the moment, similar developments in the field of non-invasive and implantable health monitoring sensors are being carried out in different countries of the USA, Canada, Korea, Japan, Israel, Finland, the Netherlands, etc.

Apple's iWatch line is steadily developing [https://www.apple.com/ru/apple-watch-series-4/]. In the latest 4th generation of the product, there is a single-lead electrocardiograph (ECG) and a health monitor that monitors the permissible heart rate ranges, makes it possible to send cardio data to the doctor. The implementation of a sleep monitor and cloud support for proactive diagnostics in the 5th generation of the product is provided, which indicates the relevance of the trend in the development of personal health management systems. There are many options for the iWatch ecosystem that significantly expand the capabilities of health monitoring, in particular, a continuous type blood sugar monitor has appeared, albeit with an invasive probe.

Known technical solution Astroskin, company and Hexsokin, which even provides a REST API for http interaction with their Vital Signs T-shirts, which contains a 3-lead ECG, systolic pressure, pulse oximetry sensor (photoplethysmography) and temperature sensor [https: // www. hexoskin.com/pages/astroskin-vital-signs-monitoring-platform-for-advanced-research]. However, the following has not been implemented: electrochemical analysis of biological secrets, functional registration of changes in temperature and humidity of the skin, and functional registration of BCG signals (ballistocardiography). A scheme with three ECG sensors connected in a V-shape in the heart area is used.The system provides a high-quality selection of the moment of depolarization of the ventricles of the heart (reaching the peak of the ECG signal), the frequency of the cardiac cycle is recorded with a frequency of 4 ms. The sampling and reading frequency of 1 Hz is fixed. The system is made in the form of a T-shirt and an elastic headband. The oxygen saturation sensor is located on the head, which makes it difficult to use, the ECG sensors are connected in a V-shape, and the functionality of the system does not include the ability to adjust the size to ensure the correct position of the ECG sensors. The system is used by NASA to monitor apparently healthy test subjects who are able to take off and put the T-shirt over their heads on their own. The material contains elastane - a synthetic fabric that can irritate the skin. The T-shirt is available in seven standard sizes 2XS-2XL. Lack of lower pressure measurements prevents hypertension from being diagnosed. it is impossible to reliably measure both the motor activity of a person, since there are no sensors on the limbs, and it is impossible to determine the vectors of movements, which is very important when considering human movements in the form of a biomechanical vector model, which is very important, for example, for use in the field of medical rehabilitation. Compatible exclusively with the family of devices operating on the iOS operating system (desktop computers and laptops of the Mac series, iPhone phones, tablet computers iPad), the Aggregator is not able to provide the result according to the patterns of diseases preloaded into memory, the 4 GB device memory serves only for storing the results measurements. Powered by two AA batteries, without the ability to recharge the batteries without shutting down the complex.

The closest is Samsung's announced wearable health monitoring device Simband and the SAMI cloud storage platform [https://www.simband.io/documentation/simband-documentation/]. The device is a bracelet that includes such parameters as: hydration, ECG measurements, body temperature, pulse, oximetry, bioimpedance, calorie activity, API, variability of the set of sensors. The device monitors a person's well-being around the clock, and is charged at night from a docked battery. the prototype design includes a 28nm processor with two ARM Cortex-A7 cores and an operating frequency of 1 GHz, plus support for Wi-Fi and Bluetooth wireless standards for interacting with smartphones and other gadgets. Simband measures 14 × 34 mm. All collected information about human health Simband sends to Samsung Architecture for Multimodal Interactions (SAMI) - a cloud platform that collects information from various devices, processes and presents it to the user in the form of a "medical diary".

Unfortunately, this device itself does not include monitoring sensors, but an open API (application programming interface, application programming interface) platform for integrating various medical sensors, thus the proposed solution is not a final product, but a platform for developers linked to a cloud service by Samsung.

Not implemented: electrochemical analysis of biological secrets; Respiratory activity function and BCG signal registration functionality. As in all implementations of the bracelet-type sensor system, the Simband uses a single sensor and requires user action to record ECG readings. Body temperature and electrical activity of the skin are influenced by external environmental factors due to the periphery of the measurement, the errors exceed 15-20% of the measurement scale. The bracelet is made of silicone, which can cause an allergic reaction. A tight fit of the bracelet to the skin can cause anemia of the hand, a loose fit - incorrect sensor readings. In Simband, a moisture and skin temperature sensor is present, but is located on the back of the forearm, and placement in this area does not allow temperature measurements to be made with sufficient accuracy. Measurement of systolic upper pressure depends on the position of the hand relative to the heart, is estimated by measuring the delay in the propagation of the pulse wave, and the error may exceed 40-50% of the scale. It is impossible to reliably measure both the human motor activity, since there are no sensors on the limbs, and it is impossible to determine the motion vectors, which is very important when considering human movements in the form of a biomechanical vector model, which is very important, for example, for use in the field of medical rehabilitation. The bracelet design does not allow increasing the number of sensors. The system does not have its own software, the manufacturer only provides software libraries for implementing data reception from the bracelet. The time of continuous operation of the bracelet is not specified by the manufacturer, simultaneous charging of the internal battery and the use of the bracelet is not possible.

Table 1 shows a comparison of the functionality of the claimed invention with analogues. The comparison criteria were selected based on the application of the ideology of non-invasive polymetry (at least different vital signs, the presence of a cloud environment for the accumulation and analysis of big data and a wearable subsystem of aggregation and express diagnostics).

SUMMARY OF THE INVENTION

The objective of the claimed invention is the development of an automated complex for everyday wear for the purpose of monitoring vital signs, as well as improving the quality of control of parameters of vital signs.

The technical result, which is aimed at the hardware and software complex for monitoring vital signs, is to more effectively identify pathology in the work of organs at an early stage, improve the quality of life of patients with an acquired disease, reduce the risks of sudden death or loss of health and disability.

The technical result of the invention is achieved due to the fact that the hardware and software complex is a T-shirt fixed on the chest, having a strong component in the solar plexus region, shoulder straps and on the line of attachment of sensors under the chest, made of elastic fabric material with a flexible polymer wiring system, providing power distribution from a central data aggregator containing a hot-swappable battery subsystem and a wireless communication and recharging controller for connecting micropower sensors, located in the projection of the human solar plexus, on which a battery and a low-charge notification system are installed as an additional board, which also contains data interfaces , which also has detachable connections made with the possibility of connecting high-current sensors, on which, according to a modular principle, a sensor network is located, including:

- non-invasive body biochemical sensor for lactate and glucose content of flow-through type based on bioelectrochemical analysis of sweat composition (DLG), including a sweat collector that collects secretions of the patient's sweat glands, installed on the skin surface in the axillary region by means of straps fixed to the mounting holes and held by a holder and controller located in the housing and representing a printed circuit board in which the following components are provided: control unit, data transmission module, display and control panel, power supply with battery, electrode block, potentiostat, accelerometer, amplifier, converter, quartz resonator, external power connectors and connecting electrodes, designed to collect, analyze and send readings to a central data aggregator, to which a thermal sensor is additionally connected, to measure the temperature of the skin;

- non-invasive body-worn semiconductor skin temperature and humidity sensor, made on the basis of semiconductor sensors on surface effects, containing a plastic case with an indication and control panel for data collection and processing, a functional cell in the form of a printed circuit board, on which a semiconductor temperature and humidity sensor are located , with built-in batteries and a Bluetooth interface for communication with the controller through which measurements are made, a transmission module made with the ability to transmit data to a central data aggregator, which is fixed in the axillary region on the strap, to the left of the last ECG sensor, between the middle and far axillary lines.

- non-invasive wearable electrocardiograph for 4-6 leads, made in a plastic case, in which the sensors are located in accordance with the vector form of the ECG current movement, two or more electrical leads are connected through the connector to the control and data processing unit, and the power is connected through the connector.

- a multispectral sensor for measuring pulse oximetry parameters (DPP), which is a plastic case containing a battery and a functional cell made in the form of a printed circuit board, the collection and processing of data from which is carried out in the control unit, and sending to the central data aggregator through the data transmission module, located on the forearm on the cuffs at the attachment points that allow the sensor to be rigidly fixed;

- a sensor for measuring the frequency and volume of respiration based on tensometric data (DT), containing a battery and representing an EMFi-plate made of a ferroelectric material in the form of a latch with a size of 100 × 15 mm, with the possibility of measuring tension in two directions, consisting of three plastic parts: a pusher , a pusher holder and a belt holder, which is located in the cut of the elastic belt on the right shoulder strap along the ribs, so that there is no contact with the skin, while the signal from the sensor is processed in the control unit, the data is transmitted to the central data aggregator via the data transmission module.

- a blood pressure measurement sensor (DBP), which is a combined ECG and BCG measurement sensor, one part of which consists of a piezoelectric material to generate a signal when it is deformed by the skin surface, to which it adheres tightly, and the other part records ECG indicators, while for determination of ECG and BCG parameters on the sensor there are 4 electrodes for removing electrophysiological signals and two electrodes for determining the mechanical deformations of the film caused by cardiac activity, while the functional cell is a flexible printed circuit board on which the processing and control unit and the data transfer module to the central a data aggregator located along the direction of propagation of the ECG signal between the EPIC sensors. For this, a fastening cuff was sewn onto the strap of the fabric frame, the sensor electrodes are connected by flexible polymer wiring inside the fabric frame to the aggregating part of the sensor;

- a system of sensors for measuring motor activity, both the center of mass of the body and its individual parts, joints and limbs with fixation of the kinematic vectors of movements in dynamics (DDA), which is a printed circuit board on which there are: an accelerometer and a gyroscope in mems-version, an altimeter , as well as a connector for a battery and a connector for communication with the central data collection and processing unit, located on the forearm at the attachment points, which allow rigidly fixing each sensor.

In addition, an option is provided when the non-invasive body-worn semiconductor sensor of temperature and humidity of the skin is attached to the wrist by means of a cotton wristband on the inner side of the wrist with the sensitive element downward, since the sensor must be in close contact with the skin.

Also, the design of the hardware and software complex for monitoring vital signs allows the use of a differential method for measuring blood pressure and a computational method for measuring its measurement by analyzing the results of measuring the pulse at various points. The difference in pulsation in different parts of the body is estimated from the data of both the ECG / BCG module and the pulse oximetry sensor, allowing the data from the sensors to be correlated in motion.

In addition, the control of motor activity has both the main purpose of recording body movements in six axes (3-linear and 3 angular accelerations) and determination of relative coordinates using ultrasonic motion sensors to correct the functions of the user's musculoskeletal system.

An additional difference is that the measurement of respiratory activity determines the frequency and change in the volume of ventilation of the lungs on a secondary basis - a change in the circumference of the ribs during inhalation and exhalation.

BRIEF DESCRIPTION OF DRAWINGS

The invention is illustrated by the following figures: FIG. 1 - Body sensors placement system: 1 - body semiconductor skin temperature and humidity sensor; 2 - multispectral sensor for measuring pulse oximetry parameters (DPP); 3 - elastic sleeve; 4 - lead wires of high-impedance EPIC sensors; 5 - high impedance EPIC sensors; 6 - the holder of the blood pressure sensor; 7 - a sensor for measuring blood pressure (DBP); 8 - non-invasive wearable electrocardiograph for 4-6 leads; 9 - a sensor for measuring the frequency and volume of respiration based on strain gauge data (DT); 10 - cardiograph holder; 11 - data aggregator control buttons; 12 - display panel of the data aggregator; 13 - data aggregator.

FIG. 2 - Location of body sensors: 14 - lactate sensor, 15 - lactate sensor holder.

FIG. 3 - Body sensor placement system.

FIG. 4 - Average indicators of ECG sensors in different modes of activity.

FIG. 5 - Results of measurements of parameters of respiratory activity.

FIG. 6 - Results of measurements of temperature and humidity of the skin surface.

DESCRIPTION OF THE INVENTION

The invention is a chest-mounted bracket made of dense hypoallergenic fabric having a strong component in the region of the solar plexus and straps on the shoulders and on the line of attachment of ECG sensors. Left and right on the chest line there are locks, articulated with short elastic inserts.

The hardware and software complex for monitoring vital signs includes (Fig. 1-3): a body-worn semiconductor sensor for temperature and humidity of the skin (1), a multispectral sensor for measuring pulse oximetry parameters (DPP) (2), an elastic sleeve (3), high-impedance lead wires EPIC sensors (4), high-impedance EPIC sensors (5), a blood pressure sensor holder (6), a blood pressure (DBP) sensor (7), a non-invasive body-worn 4-6-lead electrocardiograph (8), a frequency sensor and respiratory volume based on tensometric data (DT) (9), cardiograph holder (10), data aggregator control buttons (11), data aggregator display panel (12), data aggregator (13); lactate sensor (14), lactate sensor holder (15).

Elastic fabric frame with a flexible polymer wiring system providing power wiring and data interfaces in two main formats, PoE, USB2.0. The wiring is done from the central data aggregator, the power system of the hardware and software complex for monitoring vital signs. The aggregator provides at least 3 × USB and 2 × FE with a load of at least 2.5 W per consumer, contains a hot-swap battery subsystem and a wireless communication and charging controller for connecting micro-power sensors.

The aggregator provides automatic reassembly of the hardware and software complex for monitoring vital signs when replacing or moving sensors, or damage to individual connections. Aggregator design. The mode selection button is available for pressing with a force of up to 500 g. The size and shape of the button are selected for ease of use. The surface of the button does not extend beyond the dimensions of the case, which reduces the likelihood of accidental pressing during operation. LED indicators for battery status and charge level are located opposite the transparent inserts in the housing. The use of transparent inserts for indicators, rather than holes, is due to the desire to reduce the likelihood of damage to the blood pressure elements during incorrect operation. The wireless charging coil is located on the opposite side of the case from the one on which the mode selection button and indicators are located. This solution allows you to assess the charge level of the blood pressure accumulator without removing it from the charger panel. The operation of the data aggregator with wireless communication channels was tested using 20 simulators of sensors, which were used as the DDA exchange boards of the extremities. For communication of the aggregator with the stationary part of the CCT, the Bluetooth 5.0 protocol with low energy consumption (BLE) was used. An Android tablet PC was used as a stationary part. In addition to organizing a piconet of sensors, the wireless controller provides interaction as a single complex with a public network infrastructure or an authorized private network; in each case, different information security policies are used.

Detachable connections provide connection of high-current sensors such as intelligent data analysis (IAD), electrochemical lacate / glucose sensors with microfluidics subsystem, multichannel ECG, spectrophotometric devices.

The sensor network is built on a modular basis and is configured in accordance with the personal requirements of the organization of monitoring and the characteristics of the physiology and state of health of the user. The hardware and software complex for monitoring vital signs includes:

1. Non-invasive body-worn biochemical sensor of lactate and glucose content of flow-through type based on bioelectrochemical analysis of sweat composition (DLG). The flow-through wearable lactate sensor works by collecting secretions from the patient's sweat glands with a sweat collector. A sweat collector is required to increase the working area and provide sufficient sweat for the lactate sensor to function. Implementation of a non-invasive glucose / lactate sensor to obtain detailed information about the state of the patient's functional systems - the level of glucose and lactate - one of the most important metabolites in the human body.

2) Non-invasive body-worn semiconductor skin temperature and humidity sensor based on semiconductor surface-effect sensors (DTV).

The skin temperature and humidity sensor is a functional cell in the form of a printed circuit board and a plastic case with a display and control panel. A semiconductor temperature and humidity sensor is located on the printed circuit board, through which measurements are made. The collection and processing of data is carried out in the control unit, and sending to the data aggregator by means of the data transmission module. The device is powered by a battery. The combined sensor of humidity and temperature of the skin, allows you to track the difference in perspiration in different modes of physical activity.

3) Non-invasive body-worn electrocardiograph for 4-6 leads using high-impedance EPIC sensors (ECG)

The electrocardiograph is made in a plastic case with a standard fastening for tightening a bolt. The mount is compatible with standard latches used on a variety of body straps and holders. Two or more electrical leads are connected via a connector to the control and data processing unit. Power is connected through the connector.

4) Multispectral sensor for measuring pulse oximetry parameters (DPP)

The sensor for measuring pulse oximetry parameters is a functional cell in the form of a printed circuit board and a plastic case. The main function of the device is performed by means of a blood saturation analyzer. The collection and processing of data is carried out in the control unit. Sending to the aggregator is carried out in the data transfer module. Powered by a lithium battery.

5) Sensor for measuring the frequency and volume of respiration based on strain gauge data (DT)

The respiratory rate and volume sensor is a plastic clip made by injection molding of plastic. The sensor consists of three plastic parts - a pusher, a pusher holder and a belt holder. The sensor is positioned in the cut of the elastic strap that is worn over the patient's chest The latch makes it easy to remove and put on the device. When breathing, a change in the volume of the chest leads to an increase in pressure on the strain gauge, the signal from which is processed in the control unit. The data is transferred to the aggregator by means of the data transmission module. Powered by a lithium battery. The measurement of respiratory activity determines the frequency and change in the volume of ventilation of the lungs on a secondary basis - a change in the circumference of the ribs during inhalation and exhalation.

6) Blood pressure measurement sensor (DBP)

The blood pressure sensor works by simultaneously processing ECG and BCG readings. ECG electrodes are screen printed with silver-based conductive ink. The BCG part works by removing and amplifying the signal from the electroactive EMFit film, on the surface of which an electric charge appears when bent or squeezed. The functional cell is a flexible printed circuit board on which the processing and control unit and the module for transmitting data to the aggregator are located. Application of a combined ECG / BKG sensor, which allows to analyze the relationship of electrical and biomechanical activity of the heart, the level of fatigue and maximum permissible loads. It also allows you to evaluate systolic and mean arterial pressure. The system of ECG sensors is connected in a vector form on the solar plexus and along the fourth rib and consists of 6 sensitive elements, and having a high internal resistance of the sensor itself, dry electrodes that do not require contact with the skin surface and wetting it with a conductive gel, provide registration of a signal in motion.

7) A system of sensors for measuring motor activity, both the center of mass of the body and its individual parts, joints and limbs with fixation of the kinematic vectors of movements in dynamics (DDA)

The movement activity sensor located on the forearm at the attachment points that allow each sensor to be rigidly fixed is a printed circuit board on which all the components of the device are located. The mems accelerometer and gyroscope are used to convert the accelerations and rotations of the device into digital signals processed by the control unit. The motor activity detection system is provided with the placement of sensors with a three-axis electronic gyroscope and an accelerometer at 17 points of the human body. Also located on the forearm: an altimeter, which measures the absolute and relative height of the device indirectly - through pressure measurements. And also a connector for a battery and a connector for communication with the central unit of data collection and processing. The subsystem for monitoring motor activity has both the main purpose of registering body movements in six axes (3-linear and 3 angular accelerations) and determining relative coordinates using ultrasonic motion sensors to correct the functions of the user's musculoskeletal system.

The controller is located in the case and is a printed circuit board with all the necessary components to collect, analyze and send readings to the data aggregator. An additional thermal sensor is connected to the controller to measure the temperature of the skin.

The controller, which is part of the data aggregator and controls the collection of data from wired (ECG, BCG and respiratory activity sensors) and wireless (temperature and humidity sensor, lactate sensor) sensors, was installed on a bracket located in the projection of the human solar plexus.

In addition to the controller itself, and the data transmission and storage module in the form of an additional board installed on the controller, a battery and a notification system about its low charge are installed in a single case. The following parameters are displayed:

- indication of the charge level of the internal battery in the form of four LEDs arranged in a row: 100% charge - 4 LEDs on simultaneously, 75% - 3, 50% - 2, 25% - one LED, the battery charge is accompanied by the "filling" of a strip of LEDs with sequential flashing, when the battery is fully charged, flashing stops;

- indication of the receipt of a signal from the sensors in the form of a separately switched on LED with the correct operation of each of the sensors (a total of 11 permanent sensors and one additional LED), whose indication is triggered only when the lactate sensor is connected;

- indication of the operation of the Bluetooth module in the form of a blue LED located under the corresponding transparent icon on the body.

The controller is controlled via a micro-USB cable connected to a stationary computer, or via an application on a portable device. The controller's battery is charged both via a micro-USB cable and via a radial female connector.

The hardware and software complex for monitoring vital signs implements a mechanism for controlling the sampling rate and generating ECG readings, which provides a better resolution of ECG signals, which is especially important at a high heart rate (more than 100 beats per minute). The modular design of the invention allows the use of a differential method for measuring blood pressure and a computational method for measuring its measurement by analyzing the results of measuring the pulse at various points. The difference in pulsation in different parts of the body is estimated according to the data of both the ECG / BCG module and the pulse oximetry sensor, allowing the data from the sensors to be correlated in motion.

The subsystem for collecting statistics and diagnostic forecasting is implemented through long-term accumulation of data in various modes of the body's functioning, the formation of typical state models. Deviations in the data of personalized models are revealed that can indicate the appearance of pathologies.

Wide compatibility, open API, developed applications for stationary platforms on Windows and Linux operating systems and for mobile iOS and Android.

The difference between the developed complex is the ability to combine sensors and process information received from them. The complex includes not just an aggregator and cloud data storage, but also a diagnostic component, with the possibility of forming an individual database of standards (permissible limits of vital signs, "norm" for each individual patient), on the basis of which the system analyzes the current readings and compares them with standards, issues recommendations and / or warns of impending critical conditions.

EXAMPLE OF CARRYING OUT THE INVENTION

Attaching the system to the human body did not imply putting it on a naked body, this is due to the fact that there is no need for direct contact of ECG sensors in the amount of 6 pieces with the skin surface, and in the area of attachment of such components as, for example, an EMFi-plate, tightly to the skin due to its flexibility and covering a significant area of the skin, it is necessary to provide an air gap to ensure the natural thermoregulation of the body in order to avoid irritation on the skin in its absence, in addition, high humidity has a negative effect on the parameters recorded by the sensors.

The greatest clarity of the ECG signals from the EPIC sensors was achieved through a single-layer and double-layer knitted T-shirt fabric made of 100% cotton, on top of which was a system for attaching sensors with electrodes. The straps of the fastening system are made of 100% cotton, elastic inserts are sewn in the place of fastening the size adjustment to ensure a constant snug fit to the body.

Direct contact with the skin surface is only necessary for a wireless temperature and humidity sensor, which is located with a sensitive element to the skin surface, and is fixed to the base of a textile fastener from the inner surface of the strap of the fastening system so that the position of the fabric does not affect the values of the measured parameters.

The data aggregation module is located on the front of the bracket to provide mobility and comfortable wearing of the system. Such an arrangement limited the person only to the fact that he was unable to sleep in the prone position, which is a minor limitation. If a person has restrictions that prevent sleeping in the supine position, the system allows you to detach the straps and swap the front panel with a bracket for fixing the unit and the rear strap attachment, thereby placing the data aggregation module on the patient's back. To do this, both of these elements were equipped with textile fasteners in the shape of ECG sensors to quickly change their position. All other sensors are attached to textile fasteners located on the straps, which ensures their fixation and the possibility of replacing the element in case of failure, without resorting to the use of tools.

The system was tested in three modes. FIG. 4 shows a graph of the dependence of ECG indicators from six sensors and EMFi-film in three states. From 12 to 14 seconds, the person was at rest, sitting in a chair, from 26 to 28 - he walked, and from 34 to 36 - he slowly ran on the treadmill. In all modes, ECG indices had slight deviations due to human movement, and had pronounced peak values, which were easily recognized by the ECG graph.

FIG. 5 shows a graph of the respiratory activity of a person in the same testing, at 40 seconds, after a slow run, the tester held his breath for up to 75 seconds, and then returned to a free breathing rhythm.

The choice of these three modes of human activity (rest, walking, slow running) is due to the fact that these modes most adequately characterize different levels of activity and for test use are hypothetically well distinguishable from each other.

The graph (Fig. 6), which shows two parameters: perspiration (blue graph) and skin surface temperature (red graph), an increase in skin surface temperature and perspiration is noticeable with a change in the nature of human physical activity.

In addition to testing ECG sensors, tests were carried out for data transmission via a Bluetooth channel using a router with a Bluetooth channel, which is planned to be used in an inpatient examination of a patient. The increase in the number of devices connected to the same router did not affect the data received through it to the computer used as the workstation of the medical worker.

Using a separate Bluetooth USB device as a collection point had a negative impact on the WiFi network created with the USB device, as both devices were operating at 2.4 GHz, interfering with each other. Using a WiFi USB modem operating at 5 GHz fixed this problem. Thus, we can conclude that data collection in a stationary study should be carried out in the absence of other devices operating at 2.4 GHz, transferring all nearby WiFi devices to a 5 GHz frequency. Electrical appliances, other Bluetooth devices, and electrical wiring in the walls of the hospital room did not significantly affect data transmission.

Claims (12)

1. The hardware-software complex for monitoring vital signs is a T-shirt fixed on the chest, which has a strong component in the solar plexus area, shoulder straps and on the line of attachment of sensors under the chest, made of elastic fabric material with a flexible polymer wiring system that provides power distribution from a central data aggregator containing a hot-swappable battery subsystem and a wireless communication and recharging controller for connecting micropower sensors, located in the projection of the solar plexus of a person, on which a battery is installed as an additional board and a low-charge notification system, which also contains data interfaces, which has also detachable connections made with the possibility of providing connection of high-current sensors, on which, according to the modular principle, a sensor network is located, including: - non-invasive body biochemical sensor for lactate and glucose content of flow-through type based on bioelectrochemical analysis of sweat composition (DLG), including a sweat collector that collects the secretions of the patient's sweat glands, installed on the skin surface in the axillary region by means of straps fixed to the mounting holes and held by a holder and a controller located in the housing and representing a printed circuit board in which the following components are provided: a control unit, a data transmission module, an indication and control panel, a power supply unit with a battery, an electrode unit, a potentiostat, an accelerometer, an amplifier, a converter, a quartz resonator, external connectors for power supply and connection of electrodes, designed to collect, analyze and send readings to the central data aggregator, to which a thermal sensor is additionally connected, to measure the temperature of the skin; - non-invasive body-worn semiconductor skin temperature and humidity sensor, made on the basis of semiconductor sensors on surface effects, containing a plastic case with an indication and control panel for data collection and processing, a functional cell in the form of a printed circuit board, on which a semiconductor temperature and humidity sensor are located , with built-in batteries and a Bluetooth interface for communication with the controller, through which measurements are made, a transmission module made with the ability to transmit data to a central data aggregator, which is fixed in the axillary region to the strap, to the left of the last ECG sensor, between the middle and far axillary line; - a non-invasive wearable electrocardiograph for 4-6 leads, made in a plastic case in which the sensors are located in accordance with the vector form of the ECG current movement, two or more electrical leads are connected through a connector to the control and data processing unit, and power is connected through the connector; - a multispectral sensor for measuring pulse oximetry parameters (DPP), which is a plastic case containing a battery and a functional cell made in the form of a printed circuit board, the collection and processing of data from which is carried out in the control unit, and sending to the central data aggregator through the data transmission module, located on the forearm on the cuffs at the attachment points that allow the sensor to be rigidly fixed; - a sensor for measuring the frequency and volume of respiration based on tensometric data (DT), containing a battery and representing an EMFi-plate made of a ferroelectric material in the form of a latch with a size of 100 × 15 mm, with the possibility of measuring tension in two directions, consisting of three plastic parts: a pusher , a pusher holder and a belt holder, which is located in the cut of the elastic belt on the right strap along the ribs so that there is no contact with the skin, while the signal from the sensor is processed in the control unit, the data is transmitted to the central data aggregator by means of the data transmission module; - a blood pressure measurement sensor (DBP), which is a combined ECG and BCG measurement sensor, one part of which consists of a piezoelectric material to generate a signal when it is deformed by the surface of the skin, to which it adheres tightly, and the other part registers ECG indicators, while to determine the parameters of the ECG and BCG on the sensor there are 4 electrodes for removing electrophysiological signals and two electrodes for determining the mechanical deformations of the film caused by cardiac activity, while the functional cell is a flexible printed circuit board on which the processing and control unit and the data transfer module are located central data aggregator located along the direction of propagation of the ECG signal between the EPIC sensors, for this, a fastening cuff was sewn onto the strap of the fabric frame, the sensor electrodes are connected by flexible polymer wiring inside the fabric frame to the aggregating part of the sensor; - a system of sensors for measuring the motor activity of both the center of mass of the body and its individual parts, joints and limbs with fixing the kinematic vectors of movements in dynamics (DDA), which is a printed circuit board on which there are: an accelerometer and a gyroscope in mems-version, an altimeter, as well as a connector for a battery and a connector for communication with the central data acquisition and processing unit, located on the forearm at the attachment points, which allow rigidly fixing each sensor. 2. Hardware and software complex for monitoring vital signs according to claim 1, characterized in that the non-invasive body-worn semiconductor sensor of temperature and humidity of the skin is fixed on the wrist by means of a cotton wristband on the inner side of the wrist with the sensitive element downward, since the sensor must be in close contact with skin. 3. Hardware and software complex for monitoring vital signs according to claim 1, characterized in that it allows the use of a differential method for measuring blood pressure and a computational method for measuring its measurement by analyzing the results of measuring the pulse at different points, while the difference in pulsation in different parts of the body is estimated according to the data of both the ECG / BCG module and the pulse oximetry sensor, allowing the data from the sensors to be correlated in motion. 4. Hardware and software complex for monitoring vital signs according to claim 1, characterized in that the control of motor activity has both the main purpose of recording body movements in six axes (3-linear and 3 angular acceleration), and determination of relative coordinates using ultrasonic motion sensors to correct the functions of the user's musculoskeletal system. 5. Hardware and software complex for monitoring vital signs according to claim 1, characterized in that the measurement of respiratory activity determines the frequency and change in the volume of ventilation of the lungs on a secondary basis - a change in the circumference of the ribs during inhalation and exhalation.

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