RU219353U1 - Plaster electrophysiological telemedicine - Google Patents

Abstract

The utility model relates to medical equipment, in particular to devices for continuous monitoring of electrophysiological parameters of the body, placed directly on the human body and used as part of remote monitoring systems. The task is to increase the efficiency and versatility of using the electrophysiological telemedicine patch. The electrophysiological telemedicine patch (1) is formed (Fig. 1) by two flexible plates (2, 3) aligned with each other, forming its front and back sides. At the same time, an electronic board and its power source are placed between the flexible plates (2, 3), and on the back side of the electrophysiological telemedicine patch (1), on the flexible plate (3), there are two electrodes connected to the electronic board. On the flexible cover (3), on the rear side of the electrophysiological telemedicine patch (1), there is also an additional electrode, and on the other flexible cover (2), on the front side of the electrophysiological telemedicine patch (1), there is a connector (8) for charging the power source, which is a battery. A temperature sensor connected to the electronic board can be built into the additional electrode, and reusable capacitive electrodes or metal sockets for fixing disposable electrodes in them can be used as electrodes. A block diagram of the device of the electrophysiological telemedical patch (1), the materials used and the designations on its front side are also given.

Description

The utility model relates to medical equipment, in particular to devices for continuous monitoring of electrophysiological parameters of the body, placed directly on the human body and used as part of remote monitoring systems.

The device is called "electrophysiological telemedicine patch" by analogy with other similar devices, which are referred to by the authors as "cardio patch", "electronic patch", "electrode patch", "biosensor", etc., which emphasizes the possibility of placing the device directly on the skin of the subject. In essence, this device is an electronic device, as it contains electronic components, their power source and various sensors. This utility model is designed to capture such electrophysiological signals as electrocardiogram (ECG), body temperature (TT), bioimpedance signals (BIS) of respiration and pulse blood flow, electromyogram (EMG), accelerometer (CA) signals indicating the position of the body and the level of motor activity of the subject, etc.

Such an electrophysiological telemedicine patch (hereinafter referred to as PET) contains a Bluetooth radio module and is used as an attachment to a smartphone, tablet or computer provided with the same Bluetooth communication channel and an application that allows visualizing the above signals, processing them according to specified algorithms and transmitting them to a remote server, for example, a server of a medical advisory center.

PET-type devices are becoming an important part of household and professional telemedicine health monitoring systems today. We are talking not only about outpatients or clinical patients, but also athletes, pensioners, students, specialists working in responsible production, etc. For example, a doctor of a sports team and its coach after the end of the training camp can continue to monitor the functional state of athletes by connecting their smartphones or computers to a remote server that broadcasts PET signals installed on these athletes.

Known "electrode patch" [1, Patent US 10531813 (B2), IPC A61B 5/00, priority 01/12/2015, publication 01/14/2020], made of a flexible material with the possibility of attachment to the skin of the human body and containing protruding edge parts, on which electrodes for ECG recording are installed, connected to the connector. At the same time, such a patch contains a narrowed central part connecting its upper and lower pairs of protruding parts, and also contains, in continuation of the lower pair, another protruding part, on which a common connector is installed, designed to connect an ECG analyzer to it, containing an electronic board and its power source.

The disadvantage of such an "electrode patch" [1] is the presence of a large number of parts connected to each other, causing the complexity and low reliability of its design, and creating inconvenience in their regular use, especially when a person is free to move. A separate ECG analyzer connection is also required. The efficiency of using such a device is low and it is not very suitable for solving problems of group functional monitoring.

Simpler in design and more convenient to use is the patch, adopted by us as a prototype utility model, referred to by the manufacturer as a “biosensor” [2, Philips biosensor for monitoring the condition of patients with COVID-19. Electronic resource: https://evercare.ru/news/biosensor-philips-dlya-monitoringa-sostoyaniya-pacientov-s-covid-19. Access date 09/28/2022].

This "biosensor" [2] is also made of a flexible material that can be attached to human skin and contains edge parts on which electrodes for ECG recording are installed.

Structurally, the "biosensor" [2] is made in the form of a flat figure formed by two plates of flexible material combined with each other with a curvilinear contour, forming three edge parts (kind of petals) and a central part, where an electronic board and a disposable battery feeding it are located between the plates.

A significant drawback of the prototype [2] is the one-time nature of its use, which is confirmed by the lack of a connector for recharging the built-in power source and the manufacturer's textual recommendation (in the datasheet) to replace such a biosensor when the supply battery is depleted. Moreover, two gel electrodes built into the lining are also, in fact, disposable. This causes a short service life of the device (usually several days) and leads to an increase in the costs of medical institutions that carry out constant cardiac monitoring of patients, and the costs of the patients themselves, who need home ECG monitoring.

According to the datasheet of the biosensor [2], before taking an ECG using the mentioned gel electrodes, preliminary skin preparation is required, and this negatively affects the ease of use of the product and the pace of monitoring. In addition, it is known that the drift of the polarization potentials of the "electrode-skin" contact in galvanic (gel) electrodes is a source of interference and the cause of artifacts during patient movements.

In addition, in this type of biosensor [2], there is an uncertainty in its positioning on the patient's body due to the lack of clear landmarks on its surface. That is, it is not clear which of its three marginal lobes should be directed upwards or away from the sternum, which - towards the top of the heart, etc. And this is of decisive importance for obtaining a high-amplitude ECG. In this case, the device performs a single-channel ECG recording, which eliminates the possibility of compensating for noise and artifacts due to another of the same channel.

The number of indicators recorded by this biosensor [2] is also small. According to the datasheet [2], the device measures the pulse rate, respiratory rate, and indicators of the patient's physical activity. There is no information about the measurement of body temperature or pulse flow signals. This reduces the practical significance of the product, positioned as a device for monitoring the condition of covid patients.

The combination of the above drawbacks hinders the effective use of the prototype product [2] in the tasks of remote health monitoring, reduces its consumer properties.

Therefore, the task of the utility model is to increase the efficiency and versatility of the application of the electrophysiological telemedicine (PET) patch due to other constructive approaches to its implementation, eliminating the above disadvantages of the prototype [2].

The problem is solved by the fact that (Fig. 1-4) in the electrophysiological telemedical patch (1), formed by two flexible plates (2, 3) combined with each other, forming its front and back sides, and at the same time between the flexible plates (2, 3) there is an electronic board (4) and its power source (5), and on the back side of the electrophysiological telemedical patch (1), on a flexible th plate (3), there are two electrodes (6) connected to the electronic board (4), there are distinctive features: on the flexible plate (3), on the back side of the electrophysiological telemedicine patch (1), there is also an additional electrode (7), and on the other flexible plate (2), on the front side of the electrophysiological telemedicine patch (1), there is a connector (8) for charging the power source (5), while this power source (5) is a battery.

The location of the additional electrode (7) on the flexible cover (3), on the back side of the electrophysiological telemedical patch (1), is aimed at expanding the functionality of such a product, since additional ECG signals can be taken through the additional electrode (7) (only from three electrodes, in their combinations of “two”, three leads can be taken), as well as additional electrophysiological signals, moreover, in their different combinations, for example, to record ECG and lung impedance signals (moreover, by the tetrapolar method), which it is important to accurately diagnose the condition of covid patients, or to take an ECG in two or three channels to increase the noise immunity of ECG monitoring, or to take an ECG and an EMG at the same time, which is of interest to athletes, etc. In essence, the functionality of such a product is determined by the circuitry placed on the electronic board (4). Taking into account the tasks of introducing a product, their model range can be produced, or a universal device can be designed.

This expands the functionality and improves the consumer properties of the patch electrophysiological telemedicine (PET) (1).

The use of a battery as a power source (5), as well as the installation on a flexible cover (2) of an electrophysiological telemedical patch (1), on its front side, a connector (8) for charging this battery is also of great practical importance for improving the performance properties of the product. In particular, this is one of the conditions for ensuring its reusable and continuous use. (We note in this regard that some well-known analogues (not considered here) use a battery, but the connector for charging it is located on the inside of the product, which excludes the possibility of recharging the device during its operation. In addition, the contacts of this connector will be subject to oxidation and corrosion due to sweat).

Additional distinctive features of the utility model that enhance the efficiency and ease of use of PET (1):

- a temperature sensor (9) connected to the electronic board (4) is built into the additional electrode (7) (this increases the accuracy of diagnosing the patient's condition and the efficiency of the doctor's conclusions, since the temperature sensor is as close as possible to the patient's skin);

- capacitive electrodes are used as electrodes (6) and additional electrode (7) (for reference: capacitive electrodes are metal electrodes with a special dielectric coating that eliminates the polarization of the electrode-skin contact, this reduces the sensitivity of the product to movement artifacts and does not require skin preparation, increases the comfort and efficiency of the examination). In addition, capacitive electrodes also provide a reusable nature of the use of the product);

- the additional electrode (7) is made of a chemically inert, heat-conducting material, and the electrodes (6) are made in the form of metal sockets for fixing disposable electrodes in them (this embodiment of the product also makes it possible to use it multiple times, by recharging the device and replacing disposable electrodes, which is less expensive for the operation of infectious diseases departments than regular replacement (and disposal) of PET (1) with capacitive electrodes);

- the electronic board (4) is made on a flexible basis, with a contour covering the positions of the electrodes (6) and the additional electrode (7), while the electrodes (6) and the additional electrode (7) are installed on this electronic board (4) from the side of the flexible cover (3) in such a way that their working surface is located on the same level with the surface of the back side of the electrophysiological telemedicine patch (1), (a single basis of the electronic board (4), electrodes (6) and additional electrode (7) excludes the possibility of their independent displacement and asynchronous oscillations of the connecting wires (17, Fig. 3) during the movements of the subject; for reference: the basis of flexible printed circuit boards is a heat-resistant film, for example, from polyimide);

- flexible covers (2, 3) are made of foamiran, and the flexible cover (3), which forms the back side of the electrophysiological telemedical patch (1), is made with the possibility of fixing it on human skin (foamiran is an environmentally friendly and plastic material with properties such as flexibility, water resistance, hypoallergenicity, due to which it is allowed for use in everyday life, including in children's creativity; foamiran provides reliable protection electronic board (4) from moisture and sweat, allows you to use the product repeatedly, and due to the wide palette of colors produced, it is possible to use skin-colored foamiran, which increases the aesthetic and consumer properties of such a product as PET (1).

The above features increase the efficiency and versatility of the application of the electrophysiological telemedicine patch (1). This applies both to the clinical implementation area and to a number of scientific studies related to continuous monitoring of the heart.

The essence of the utility model is illustrated by illustrations (Fig. 1-4), where in Fig. 1, 2 shows a general view of the electrophysiological telemedicine patch (1), from its front and back sides (an image of an industrial design is shown); in fig. 3 - view of the electronic board of the product with the flexible plates of the product disconnected (a breadboard model is shown); in fig. 4 is a general block diagram of the device.

The electrophysiological telemedicine patch (1) (Fig. 1-4) is formed by two flexible plates (2, 3) combined with each other, forming its front and back sides, while between these flexible plates (2, 3) there is (Fig. 3) an electronic board (4) and its power source (5).

On the back side of the electrophysiological telemedicine patch (1), on its flexible cover (3), there are (Fig. 2) two electrodes (6) connected to the electronic board (4), as well as an additional electrode (7), which is placed in the center of the figure formed by the covers (2, 3)

Capacitive-type electrodes are installed as electrodes (6) and additional electrode (7) (these are metal electrodes with a special dielectric coating that eliminates the polarization of the electrode-skin contact and reduces the sensitivity of the product to motion artifacts). These electrodes have an almost unlimited resource of use, that is, they are used repeatedly.

On the other flexible lining (2), on the front side of the electrophysiological telemedicine patch (1), a connector (8) is installed (Fig. 1) for charging the built-in power source (5). A battery is used as this power source (5). As shown in the photo (Fig. 3), a micro-powerful lithium-polymer battery is used in the prototype product and it is located on top of the electronic board (4). A magnetic connector is installed on the plate (2) as a connector (8). In the industrial design (Fig. 1) it is round and located on the side of the product, marked with the symbol R. The advantages of the magnetic connector (8) are expressed in its tightness, convenience and efficiency of use. Its placement on the outer side of the PET (1) eliminates the direct effect of sweat and makes it possible to recharge the battery during the operation of the product.

Inside the additional electrode (7), a temperature sensor (9) can be built in, indicated on the block diagram of the product (Fig. 4) and connected to a microprocessor (11) (Fig. 4) placed on the electronic board (4). With the help of a temperature sensor (9), as close as possible to the surface of the patient's skin, stable control of body temperature is ensured. The digital temperature indicator of which enters the microprocessor (11), and then, through the Bluetooth module (13) (Fig. 4), is transmitted to the mobile application.

The additional electrode (7) can be made of a chemically inert, heat-conducting material, and the electrodes (6) are made in the form of metal sockets for fixing disposable electrodes in them. As a chemically inert heat-conducting material, both metals (for example, food steel, noble metals, etc.) and non-metals (for example, glass, plastic, ceramics, etc.) can be used, which also affects the circuitry of the product and its functionality. The possibility of replacing disposable electrodes inserted into metal sockets (taking into account the use of a battery) makes it possible to consider this version of PET (1) as a device for reusable use, which is less expensive to manufacture and potentially cheaper than PET (1) with capacitive electrodes. (In the conditions of operation of infectious diseases departments, where many drugs are disposed of immediately after their single use, this version of PET (1), with the replacement of disposable electrodes, and not the product as a whole, may be less expensive for the work of medical institutions. In other cases (in healthy individuals), PET (1) with capacitive electrodes can be considered as a device for multiple individual use).

The electronic board (4) can be made (shown in Fig. 3) on a flexible basis - for its manufacture, for example, a polyimide film is used. In this case, the electrodes (6), the additional electrode (7), as well as all electronic components, are fixed on this flexible printed circuit board, forming a single structure. The height of said electrodes (6, 7) is set in such a way that their working surface is on the same level with the outer surface of the flexible cover (3) forming the back side of the electrophysiological telemedicine patch (1). In other words, these electrodes (6, 7) protrude through the corresponding holes in the lining (3), taking into account its thickness, and may even protrude somewhat from it, for example, with their convex working surface.

The flexibility and plasticity of the plates (2, 3), as well as the flexibility of the electronic board (4) allow, in their totality, to give the product, PET (1), the necessary rounded shape before applying it to the patient's body. The single base of the electronic board (4), electrodes (6) and additional electrode (7) increases the noise immunity of the use of PET (1), including when the subject moves freely, since it excludes their asynchronous oscillations that can cause interference and artifacts.

The flexible covers (2, 3) are made of foamiran, and the surface of the flexible cover (3), which forms the back side of the electrophysiological telemedicine patch (1), is made with the possibility of fixing it on human skin.

The advantages of foamiran as a material suitable for the manufacture of plates (2, 3) are noted above. As for fixing PET (1) on the human body, there are several solutions. So, in the case of using disposable self-adhesive electrodes in PET (1), especially if they have a large area (for example, electrodes for stress monitoring), they are quite enough to securely hold the product on the patient's skin. When using PET (1) with dry capacitive electrodes, fixation of the product on the skin can be ensured either by pre-coating the entire remaining surface of the back side of PET (1) with a special adhesive composition, with an appropriate protective film removed before using the product. Or so-called electrode rings can be used, made like double-sided adhesive tape. Before using the product, the first protective layer is removed from the ring, which has a hole for the diameter of the electrode, and it is glued onto the lining (3). After installing all three rings, the second protective layer (outer) is removed from them and PET (1) is placed on the skin. Re-fixation of PET (1) is also possible by gluing new rings on top of the old ones. It is also possible to additionally fix the product on the body with a conventional medical plaster, which is advisable to perform with free and long-term movement of the subject. It is also possible to manufacture covers (2, 3) with special grooves for additional fixation of PET (1) using an elastic strap, etc.

When manufacturing PET covers (1), different shapes of the product contour are allowed. For example, in FIG. 1, 2, such a contour in its central part is made in the form of an ellipse, with the transition of its focal sections into rounded petals, the radius of which, for capacitive electrodes, is at least half the length of the minor semiaxis of this ellipse, in order to ensure reliable fastening of the edge parts of the product on the skin. At the same time, when placing metal sockets on the electronic board (4) for fixing disposable self-adhesive electrodes, this radius can be no more than half the length of the said minor semiaxis of this ellipse, since the area of the material around the metal socket is no longer so important - it does not carry a load. It is allowed to make the PET contour (1) with a predominance of rectilinear forms of its central zone (as shown in Fig. 3) and its edge parts. The choice of PET geometry (1) is left to the manufacturer and is shown in industrial samples of the product.

The block diagram of PET (1) is shown in FIG. 4. The electronic board (4) includes an analog block (10), to which electrodes (6) and an additional electrode (7) are connected, and also includes a microcontroller (11), to which a temperature sensor (9), an accelerometer (12) and an analog block (10) are connected. At the same time, the microcontroller (11) contains a built-in Bluetooth radio modem (13), which serves to transfer data to a smartphone. The operation of PET)1) is controlled via a mobile application. The charging controller (14) monitors the charge level of the battery that acts as a power source (5) of the electronic board (4). The power supply of the electronic board (4) is turned on by the button (16) located on this board, but hidden under the flexible cover (2). The location of the button (16) is indicated on the front side of the PET (1) with the corresponding inclusion symbol, as shown in Fig.1. In addition, on the electronic board (4), under a flexible cover (2), which has a slight transparency, there is a colored LED-LED (15) that displays the status of the device: its on/off, battery charge, data transfer via Bluetooth, etc. The location of the colored LED-LED (15) is also indicated on the front side of the PET (1) with the corresponding radiation symbol, as shown in Fig. 1.

On the front side of the electrophysiological telemedicine patch (1), on its lining (2), other text and graphic elements can be applied, for example, as shown in Fig. 1. The symbols R and L are displayed here, making it easier for the user to orient the product when it is applied to the body (this is not in the prototype [2] and other analogues). The company name of the product and the logo of the applicant-developer of this utility model are also reflected.

The product is used according to the utility model by pre-fixing it on the body of the subject in the required area of the body (as a rule, on the sternum or on the left side of the chest, observing the indicated sides R and L). Next, turn on the device by pressing the button (16) and turn on the smartphone on which the corresponding mobile application is installed. The communication of the devices is confirmed by the periodic flashing of a color LED LED (15) on the PET (1) and display the parameters of the product (its name, serial number, the battery charge level, etc. In the mobile application. If the patient has already been registered on a remote server, the name of the subject is selected in the application settings, the data display mode and the registration of electrophysiological signals begins Their transfer to a remote server. Signal analysis can be performed both in the application and on the server, in automatic mode and with the involvement of the expert.

The electrophysiological telemedicine patch (1) can be used for simultaneous recording of a group of physiological signals: electrocardiogram (ECG), body temperature (TT), bioimpedance signals (BIS) of respiration and pulse blood flow, electromyogram (EMG), accelerometer signals (12), indicating the position of the body and motor activity of the subject. If necessary, the device is designed to record an ECG in two or three channels, or record an ECG in conjunction with other signals, in their various combinations.

It is allowed to use several electrophysiological telemedicine patches at once (1) to increase the volume of physiological information. For example, a pair of such products is used at once, which are placed vertically, along the body, and symmetrically with respect to the sternum or spine, in order to separately record ventilation and pulse blood flow in the right and left lungs, or they are placed in other parts of the body for synchronous recording of two ECG leads, or ECG and EMG, etc., which contributes to in-depth diagnostics.

Also, thanks to the new Bluetooth technology (its version BLE 5.0 and higher), data from several PETs (1) can be collected on one recorder. And vice versa, data from one PET (1) can be simultaneously transmitted to several recorders, for example, to a patient’s smartphone and a doctor’s smartphone, and also transferred from any smartphone to cloud storage, which increases the reliability of storing clinically important information.

A feature of the electrophysiological telemedicine patch (1) according to the utility model (Fig. 1-3) is the reusable nature of its use due to the use of reusable electrodes (6) and an additional capacitive-type electrode (7) (Fig. 2) and the use of a power source (5) charged through the connector (8). These possibilities are supplemented by changing disposable self-adhesive electrodes (6) in case of installing appropriate metal sockets in the product for their fixation instead of capacitive electrodes, which reduces the cost of using PET (1) in infectious diseases departments of a clinical hospital. Placement on the front side of the PET (1) (Fig. 1) of a magnetic connector (8) for charging the built-in battery - power source (5) eliminates its oxidation and corrosion from direct exposure to sweat (especially for athletes) and provides the ability to recharge the device directly during its use (for example, for a human operator). For these purposes, an electrically safe Power Bank type charger can be used, to which a smartphone can be connected at the same time.

Other possibilities of using PET (1) as part of software and hardware systems for individual-group functional control, including in telemedicine complexes, as tools for long-term and continuous monitoring, with real-time visualization of the flow of electrophysiological signals on the computer screens of expert doctors on duty, are determined by software and hardware solutions and resources of the electronic board (4) PET (1), parameters of users' smartphones, mobile application functionality, characteristics and architecture of the remote server, characteristics of the channels used telecommunications, etc.

Information sources:

1. Patent US 10531813 (B2), IPC A61B 5/00, priority 01/12/2015, publication 01/14/2020.

2. Philips biosensor for monitoring the condition of patients with COVID-19. Electronic pecypc - https://evercare.ru/news/biosensor-philips-dlya-monitoringa-sostoyaniya-pacientov-s-covid-19. Access date 11/10/2022 /prototype/.

List of items to the application for patenting a utility model

Claims (2)

1. An electrophysiological telemedicine patch, formed by two flexible plates combined with each other, forming its front and back sides, while an electronic board and its power source are placed between the flexible plates, and on the back side of the patch on the flexible plate there are two electrodes connected to the electronic board, characterized in that an additional electrode is also located on the flexible plate on the back side of the patch, and on the other flexible On the front side of the patch, a round magnetic connector is installed for charging the power source, and a battery located on top of the electronic board is used as a power source, a thermal sensor connected to the electronic board is built into the additional electrode, the additional electrode is made of a chemically inert, heat-conducting material, and the electrodes are made in the form of metal sockets for fixing disposable electrodes in them, the electronic board is made on a flexible base of a polyimide film with a contour covering the positions of the electrodes and the additional electrode, while the electrodes and the additional electrode are installed on this electronic board from the side flexible lining forming the back side of the patch in such a way that their working surface is located on the same level with the surface of the back side of the patch, the flexible linings are made of foamiran, and the flexible lining forming the back side of the patch is made with the possibility of fixing it on human skin, on the electronic board there is a power button hidden under the flexible lining forming the front side of the patch, and under it there is also a colored LED displaying the state of the device , text and graphic elements are applied on the front side of the patch on its lining to facilitate the orientation of the product when it is applied to the body. 2. The electrophysiological telemedicine patch according to claim 1, characterized in that capacitive-type electrodes are installed as electrodes and an additional electrode.