RU220408U1 - Portable telemedicine cardiorecorder - Google Patents

Abstract

The utility model relates to medical equipment, in particular to devices for express control and long-term monitoring of the state of the human cardiovascular system. A portable telemedicine cardiac recorder contains a housing and a power supply unit, an electronic unit, a signal adder, a programmable microprocessor and a Bluetooth radio module located inside it, to which are connected electrodes placed on the housing and a plate clamp-clamp that performs the function of an indifferent electrode, a display, and a connector for connecting the electrode cable . At the same time, a graphic color display is used as a display, made with overall dimensions and resolution providing visualization of the ECG in the format of clinical electrocardiography, with a scale range of 5, 10, 20 mm/mV and with a signal sweep range of 5, 25, 50 mm/s . And the microprocessor that controls the operation of the display is designed to set the required version of the ECG visualization format. The technical result is to increase the efficiency and versatility, expand the information content and operational capabilities of the portable telemedicine cardiac recorder. 3 salary f-ly, 7 ill.

Description

The utility model relates to medical equipment, in particular to devices for express control and long-term monitoring of the state of the human cardiovascular system.

The design of the portable telemedicine cardiac recorder allows it to be used both autonomously and as part of various remote health monitoring systems, for example, clinical telemedicine systems, functional monitoring systems for athletes, production operators, expedition participants, etc. The telecommunication tool in most cases is a smartphone or computer with appropriate software.

A portable telemedicine cardiac recorder is known, used for recording and analyzing ECGs [1, Application ITPI 20130096, IPC A61B 5/0404, A61B 5/0408, A61B 5/0404, priority 12/03/2013, published 06/04/2015]. It contains a housing with an electronic unit, a power supply, and a speaker placed inside it, which are interconnected and also connected to flat electrodes located on the housing, elements for indicating measurement results, control elements, connectors for connecting the electrode cable and recharging the power supply. The electronic unit of this device contains a Bluetooth radio module, which allows you to transmit an ECG to a communication device, and through it to a consultation center. A remote monitoring system can be built on the basis of similar cardiac recorders.

However, the disadvantage of the analogue cardiac recorder [1] is its low efficiency of use. In particular, its design solutions exclude the possibility of attaching ECG chest leads to the body of the subject, as well as removing the ECG leads with built-in electrodes. To do this, the user is forced to use external electrodes connected via an electrode cable. This is not always convenient and increases the duration of the examination. For example, under conditions of physical activity of the subject (clinical bicycle ergometry, athlete training, industrial work), taking an ECG from the hands is either impossible or gives low-reliability results due to muscle tremors, deep breathing, galvanic skin response, etc. Therefore, the analysis It is better to conduct an ECG in the chest leads, where the signal amplitude and signal-to-noise ratio are higher. But even short-term use of an electrode cable in addition to such a device creates inconvenience and interferes with the actions of the subject. In athletes, for example, the body is able to recover within a minute, so the assessment of the achieved pulse and the time spent in a given pulse zone becomes inaccurate.

In addition, the disadvantages of the analogue device [1] is the lack of graphical display of the ECG, which allows for visual monitoring of signal quality and its diagnostic interpretation. It is believed that these tasks are solved by specialists on the advisory portal.

The listed factors prevent the widespread use of an analogue device [1] in the areas of healthcare, education, physical culture and sports, and occupational safety, where mass health monitoring is increasingly being organized, stress tests are performed, and remote monitoring technologies are being developed.

These shortcomings are partially eliminated in the portable telemedicine cardiac recorder adopted as a prototype of the utility model [2, Patent BY 11668 U, IPC A61B 5/00, 5/04, 5/16, priority 11/10/2017, published 04/30/2018].

This device also contains a housing with built-in electrodes and a connected electrode cable (in the description of the specified patent [2] they are shown in Fig. 2, 3, 7). Moreover, in such a cardiac recorder, an end electrode is specially provided for removing chest leads, which makes it possible to do without wires in the tasks of express pulse control.

As in the analogue device [1], the prototype cardiac recorder [2] contains an electronic unit, a device for indicating measurement results, a power supply, a Bluetooth radio module, controls, a speaker, connectors for connecting the electrode cable and charging the device.

However, a significant drawback of the prototype cardiac recorder [2] is the implementation of the display device in the form of a monochrome liquid crystal character-digital display. Such a display is not informative enough for specialists and is obsolete for a wide range of users. It does not give an idea of the shape and magnitude of the recorded signal, and the number of numerical indicators displayed on it is limited by the design of the indicator. Strictly specified positions and sizes of symbols, inscriptions and numbers exclude the possibility of focusing the user’s attention on a particularly important indicator, and changing their color and format in this case is impossible. This negatively affects the functionality of the product and reduces its consumer properties.

To accurately diagnose the condition of the heart, it is necessary to visualize the ECG form, compare the parameters of its elements, calculate additional diagnostic rhythm indicators, etc. For these purposes, as a rule, an application for a smartphone or computer is used, and this narrows the circle of potential users of the device and limits the conditions for its use.

The disadvantages of the prototype device [2] also include the low reliability of fixation of the electrode cable under conditions of physical activity of the subject. Even with a relatively small force (elementary tension of the electrode cable), the cable clamp of the design used does not reliably hold the connector of such a cable. The plastic hooks easily come out of the cut in the metal plate of the clamp-bracket, and the cable connector falls out of the housing. This leads to the loss of physiologically significant information, which is sometimes difficult to restore, for example, during a maximum stress test.

In addition, the prototype product [2] is not clearly associated with a medical diagnostic device, primarily due to the lack of information placed on it (there are no explanatory inscriptions, designations and symbols characteristic of this product). This also narrows the circle of people who can become interested in the device and use it.

Therefore, the objective of the utility model is to increase the efficiency and versatility of a portable telemedicine cardiac recorder through new constructive approaches to its implementation, while simultaneously expanding the information content and operational capabilities of the device.

The problem is solved by the fact that (Fig. 1-7) in a portable telemedicine cardiac recorder (1), containing a housing (2) and a power supply unit (3), an electronic unit (4), a signal adder (11), and a programmable microprocessor located inside it (10) and a Bluetooth radio module (14), to which are connected the electrodes (8,12) located on the body (2) and a plate clamp (13), a display (5), and a connector (7) for connecting the electrode cable (23), there are distinctive features: a graphic color display is used as a display (5).

The use of a graphic color display allows the user of a portable telemedicine cardiac recorder (hereinafter abbreviated as KRPTM) to receive information in a significantly larger volume and better quality, and in some cases, completely eliminate the need for the use of other ECG visualization devices.

Such a display (5) provides a more expressive and contrasting display of physiological data and device settings, while scaling the signal and generating dynamic images is possible. Moreover, voice messages from the built-in speaker and test results can be accompanied by animation that is intuitive to the user (for example, in the form of emoji, gif images, etc.).

It is important to note that the display (5) used in this useful model has the necessary dimensions and resolution, allowing them to display the ECG in a manner familiar to a cardiologist (standard for a clinical

electrocardiography) format, that is, set in the settings the required scale range (5, 10, 20 mm/mV) and the signal time base range (5, 25, 50 mm/s). This gives the specialist the basis for quickly forming a diagnostic conclusion based on existing experience and knowledge.

Thus, the use of a graphic color display as a display (5) helps to improve the holistic perception of the new product, increases its functionality and consumer qualities.

Additional distinctive features of the utility model that enhance the efficiency and ease of use of the KRPTM:

the housing (2) is equipped with a removable clamp (25) of the electrode cable (23), made in the form of an L-shaped figure with a transversely located rotary axis and an adjacent narrow groove (26), on one side, and a C-shaped grip of the end part ( 24) electrode cable (23), on the other; in this case, the rotary axis of the clamp (25) in the working position is located between the end part of the housing (2) and the plate clamp (13).

For reference: to record an ECG during the physical activity of the subject, a removable clamp (25) is put on the plate clamp (13) through the mentioned groove, so that its rotary axis is between the end part of the body (2) and the plate clamp (13) (Fig. 7). After this, the C-shaped clamp of the clamp (25) is lowered onto the end part (24) of the electrode cable (23) and ensures its secure retention in the connector (7).

In addition, this distinctive feature allows the plate clamp (13) to be made in one piece, without its axial cut in the end part, which improves the springy properties of such a plate, necessary for firmly securing the device to the clothes of the subject, and at the same time simplifies the manufacture of this part (13) and the body itself (2), where in its end part (Fig. 7, prototype [2]) there was a prismatic recess for inserting plastic hooks.

The used display (5) is made with overall dimensions and resolution that provide visualization of the ECG in the format of clinical electrocardiography, with a scale range of 5, 10, 20 mm/mV and with a signal sweep range of 5, 25, 50 mm/s, while the microprocessor ( 10), which controls the operation of the display (5), is made with the ability to set the required version of the ECG visualization format, as well as the ability to display a calibration or test signal on the display (5), specifying their color.

For reference: the formation of a calibration signal in the device, for example, a meander with a swing of 1 mV and a frequency of 2.5 Hz, allows you to check the correct marking of the scale of the device screen and the computer screen of the expert doctor. Submission of a test ECG signal, in the form corresponding to that specified in GOST 50.2.009-2011, makes it possible to evaluate the resolution of the display (5) and its suitability for formulating diagnostic conclusions.

the microprocessor (10) that controls the operation of the display (5) is configured to set the viewing mode of the ECG stored in the memory of this microprocessor (10), and the mode of overlaying selected or averaged cardiac cycles of the current and previously saved ECG, as well as the ability to select their color.

The essence of the utility model is illustrated by illustrations (Fig. 1-7), where

in fig. 1 shows a general view of the cardiac recorder;

in fig. 2 - its block diagram;

figure 3 is a similar general view to figure 1, but from a different angle;

in fig. 4 - rear view of FIG. 1;

in fig. 5 - side view of FIG. 1;

in fig. 6 is an enlarged top view of FIG. 1;

in fig. 7 - enlarged fragment of the upper part of the device according to FIG. 1 with plug-in electrode cable.

The utility model device shown in Fig. 1-7, has the following elements with serial position numbers listed in the table below:

Portable telemedicine cardiac recorder (KRPTM) (1), (Fig. 1-7), contains a housing (2) with an electronic unit (4), a programmable microprocessor (10), a signal adder (11) located inside it (Fig. 2), Bluetooth radio module (14), speaker (15) and power supply (3), which are interconnected by functional connections.

Also connected to the electronic unit (4) are electrodes (8, 12) located on the surface of the housing (2) and a plate clamp-clamp (13) that functions as an indifferent electrode, as well as a connector (7) for connecting the electrode cable (23). On one of the side surfaces of the case (2) there is a connector (9) for recharging the power supply (3). Control elements (6) of the microprocessor (10), also located on the surface of the housing (2), determine the operating modes of the device and the state of the display (5).

Using the control elements (c) and setting symbols (16) in the microprocessor (10), the individual parameters of the subject (gender and age) and the measurement conditions (rest/load) necessary for the correct interpretation of the measurement results are set. Other device settings are also set: duration of ECG recording, alarm thresholds, transition to test signals, etc.

The front electrodes (8) and the end electrode (12) are made as capacitive electrodes - dry, non-polarizing, and do not require skin treatment or the use of electrode gels. This increases the efficiency of the examination and the quality of the signal. The frontal electrodes (8) are placed in recesses (19), which protect them from abrasion of the dielectric coating, and next to the recesses (19) there are arc-shaped tides (20) covering them, which improves the tactile search of the electrodes (8), for example, in the dark.

The electronic unit (4) provides reception, amplification and digital conversion of the ECG, and its processing and output to the display (5) is carried out by a programmable microprocessor (10). The signal adder (11), connected to the built-in electrodes (8, 12) and to the connector contacts (7), provides the ability to remove any of the 12 ECG leads adopted in classical electrocardiography (I, II, III, avR, avL, avF , V1, V2,… V6). Moreover, some of them (I, II, III, R-V5, etc.) can be removed wirelessly, through built-in electrodes (8, 12), and the other part - wired, that is, using an electrode cable (23) and external electrodes , for example - disposable. For this purpose, the end electrode (12) is connected to one of the connector contacts (7) and the left front electrode (8), which is connected to the first input of the electronic unit (4), and the output of the signal adder (11) is connected to the right electrode (8) frontal, which is connected to the second input of the electronic unit (4). In this case, the three inputs of the signal adder (11) are connected to the other three contacts of the connector (7) for connecting the electrode cable (23). The procedure for removing ECG leads is determined by the methodological instructions that are given in the instructions for the CRPTM and mentioned in the description of the prototype [2].

Unlike the prototype [2], where a qualitative assessment of the indicators measured by the device (HR, HRV, SI, IR) is made by color illumination of a monochrome display (green, yellow, orange, red and purple colors symbolize, respectively, excellent, good, satisfactory, poor and very poor condition), in KRPTM (1), thanks to the use of a color graphic display (5), it is possible to display each calculated parameter in a separate color, with an emphasis (for example, red) on an indicator that is of particular importance for assessing health. In this case, the screen background can remain neutral or switch from one color to another.

The key advantage of KRPTM (1) is the graphic color display of the ECG recorded or reproduced from the memory of the microprocessor (10), as well as the ability to combine on the display (5) several cardiac cycles from different records at once, and in different colors, for their visual comparison (for example, up to and after physical activity, taking pharmacological drugs, surgical interventions, etc.).

Therefore, it is often enough for an experienced cardiologist to look at the ECG, in his usual format, to immediately make a diagnostic conclusion and move on to recommendations.

Voice messages displayed on the speaker (15) using a programmable microprocessor (10) and its built-in algorithms facilitate the interpretation of an ECG recorded by a less-trained user. This allows you to reduce the number of unfounded requests to the advisory portal, or, conversely, direct the user to urgently see a doctor.

Changes in the design of the KRPTM (1) and the clamp (25) of the electrode cable (23) expand the possibilities of using the KRPTM (1) in conditions of physical activity of the subject and increase the reliability of ECG registration. This is in demand at the stage of rehabilitation of cardiac patients, during stress testing of athletes, in solving occupational safety problems, etc. A new type of retainer (25) prevents the end part (24) of the electrode cable (23) from falling out of the body (2) when it is tensioned.

Another additional difference from the prototype [2] is the placement on the back side of the housing (2) (Fig. 4) of a marking label (29) with the output data of the product. In addition to the name, the model, serial number, website and logo of the manufacturer, operational symbols) and the placement of the enlarged size emblem (28) of the manufacturer KRPTM (1) on the plate clamp (13) are indicated here.

Also changed, in relation to the prototype [2], is the brand name (17) of the device, indicated on its front side. It (Delfihealth) is made taking into account the name of the applicant of the utility model - the manufacturer of the KRPTM (1). The professional use of the device is indicated by the symbols (22) - Cardio Assistant (translated as “Cardiologist Assistant”). Such information improves the overall composition of the product and gives a clearer idea of its purpose. In addition, the output data of the device plays an important role in organizing metrological control of devices used for remote diagnostics (additional explanations are given in the final part of the description).

This and other information placed on the marking label (29), in particular - the manufacturer’s logo, the device model (as shown “Cardio Assistant PRO”), its serial number, a link to the manufacturer’s website, symbols reflecting the rules for using KRPTM (1 ) etc., placement on the bracket-clamp (13) (Fig. 4) of the enlarged emblem (28) of the manufacturer increases the integrity of the perception of KRPTM (1) as a product of medical equipment.

Indication of the manufacturer, model and serial number of the KRPTM (1), their duplication in the data transfer protocol to the Bluetooth radio module (14) allows you to compare the results of metrological verification of the device with the requirements of the technical specifications of production and determine its suitability for use as part of telemedicine systems used for remote, including automated diagnostics.

For reference: KRPTM (1) according to the utility model is a measuring instrument and its technical characteristics correspond, in particular, to GOST R 50.2.009-2011. When using appropriate verification tools and a mobile application created by the applicant on a smartphone, a virtual verification protocol is automatically generated and sent to a remote server. The server software provides the ability to view the verification history of each KRPTM (1) included in the telemedicine complex. Such metrological control creates the basis for the preparation of reliable diagnostic conclusions on ECG by automatic programs or experts, under whose remote control the patient independently takes an ECG.

Thus, the claimed utility model makes it possible to increase the efficiency of using CRPTM (1) in routine medical practice and in the provision of mass telemedicine services.

Thanks to the use of a color graphic display (5) and the use of other design and software modifications of the KRPTM (1), the possibilities of its autonomous use and use as part of software and hardware systems have been expanded. The Bluetooth radio module (14) ensures communication between the CRPTM (1) and devices that allow for in-depth analysis of the ECG (smartphone, tablet, computer, remote server). The use of an electrode cable (23) with external electrodes allows, if necessary, to free the subject’s hands from holding the CRPTM (1) and to carry out continuous monitoring of heart function with alarm signals. The modes of the stress test provided for in the CRPTM (1) and the display of the ECG on a color graphic display (5) with different signal colors at rest and under load, the overlay on the screen of averaged or selected ECG cardiac cycles taken at different times provide the basis for identifying hidden cardiovascular failure. Providing an ECG calibration mode and test signal supply (not present in the prototype [2]) increases the professional significance of the CRPTM (1), allowing you to check the correct operation of the software and telecommunications hardware used

This CRPTM (1) can be used by specialists who prefer to rely on their personal experience and knowledge, without spending time downloading and using software applications. It can also be used by poorly trained persons using voice, text and animation support of the KRPTM (1). The role of the device in systems for remote interaction between a doctor and a patient is increasing: the doctor, by accessing the server database, can check the availability of the current metrological verification protocol KRPTM (1) used by the client, request that he submit a calibration or test signal to ensure the proper technical condition of the device , and only after that begin online monitoring of this client’s ECG. It should be noted that many well-known models of wearable cardiac recorders, made in the form of smart watches, fitness bracelets, chest sensors, etc., do not provide such an opportunity, and therefore, as a rule, are not used in centers for the provision of telemedicine services.

The created useful model KRPTM (1) is applicable in the developed systems of individual-group functional health monitoring of students and athletes, working and single pensioners, tourists and participants in long-distance expeditions.

In the context of the ongoing pandemic of coronavirus infections and seasonal pulmonary diseases, this useful model is indispensable for home and corporate health monitoring and self-monitoring, testing physical fitness, identifying stress factors, early signs of heart failure, risks of sudden cardiac death, etc.

Information sources:

1. Application ITPI 20130096, IPC A61B 5/0404, A61B 5/0408, A61B 5/0404, priority 12/03/2013, published 06/04/2015.

2. Patent BY 11668 U, IPC A61B 5/00, 5/04, 5/16, priority 11/10/2017, published 04/30/2018 /prototype/.

Claims (4)

1. Portable telemedicine cardiac recorder (1), containing a housing (2) and a power supply unit (3), an electronic unit (4), a signal adder (11), a programmable microprocessor (10) and a Bluetooth radio module (14) located inside it, to which the electrodes (8, 12) located on the body (2) and the plate clamp-clamp (13), the display (5), as well as the connector (7) for connecting the electrode cable (23), which performs the function of an indifferent electrode, are connected, characterized in that As a display (5), a graphic color display is used, made with overall dimensions and resolution providing visualization of the ECG in the format of clinical electrocardiography, with a scale range of 5, 10, 20 mm/mV and with a signal sweep range of 5, 25, 50 mm/s , while the microprocessor (10) controlling the operation of the display (5) is configured to set the required version of the ECG visualization format. 2. Cardiac recorder according to claim 1, characterized in that the body (2) is equipped with a removable retainer (25) of the electrode cable (23), made in the form of an L-shaped figure with a transversely located rotary axis and a narrow groove adjacent to it (26), on the one hand, and a C-shaped grip of the end part (24) of the electrode cable (23), on the other; in this case, the rotary axis of the clamp (25) in the working position is located between the end part of the housing (2) and the plate clamp (13). 3. Cardiac recorder according to claims. 1, 2, characterized in that the microprocessor (10) that controls the operation of the display (5) is configured to display a calibration or test signal on the display (5), specifying their color. 4. Cardiac recorder according to paragraphs. 1-3, characterized in that the microprocessor (10) that controls the operation of the display (5) is configured to set the viewing mode of the ECG stored in the memory of this microprocessor (10), and the mode of overlaying selected or averaged cardiac cycles of the current and previously saved ECG, and also with the ability to choose their color.