RU132701U1 - HUMAN FUNCTIONAL MONITORING DEVICE - Google Patents

Abstract

1. A device for monitoring the functional state of a person, including five ECG electrodes placed in accordance with the EASI system and connected to the recorder module, configured to register, record and transmit ECG, associated with a non-volatile memory module, a wireless communication module connected to the module registrar, and a battery, characterized in that the device additionally contains four additional electrodes, two high-frequency signal generators and a sound annunciator, moreover, additional electrodes are connected in pairs to high-frequency signal generators that are connected to the registrar module, the registrar module is configured to register ECG, rheogram, respiratory activity and analysis of information for diagnosing exacerbations of diseases, and the sound annunciator is configured to issue an alarm in the event of conditions dangerous to human health. The device according to claim 1, characterized in that the additional electrode is structurally aligned with the ECG electrode and is made in the form of a concentric circle around the ECG electrode or inside it. The device according to claim 1, characterized in that the number of ECG electrodes is determined by the system of ECG leads used.

Description

The proposed technical solution relates to medicine, namely to measurements for diagnostic purposes, and can be used for outpatient or inpatient monitoring of a person’s functional state, diagnosis of exacerbation of diseases, and further data transfer to a medical monitoring center for detailed analysis and diagnosis.

It is known that to assess the functional state of a person, it is necessary to register as many parameters of the vital systems of the body as possible. To identify the condition of a life-threatening person, diagnostics of the parameters of at least the cardiovascular system (CVS) and the respiratory system is required.

Known real-time cardiomonitor [M.W. Soh et al. Cardiac signal real time monitor and method of analysis. / Patent US 4,679,144 IPC G06F 15/42, G06G 7/60, A61B 5/04, publ. 07/07/1987], consisting of an electrocardiogram (ECG) block containing three electrodes, an amplifier and a filter, a mobile computer, a multi-channel monitor, keyboard and signaling device, the computer having software through which the ECG ST segment is continuously extracted and analyzed and analyzed. recommendations for the patient and signals for the medical staff are being developed.

The disadvantages of the device are:

1. The structural complexity and the inability to use as a simple wearable means of monitoring the functional state of human activity and the diagnosis of exacerbation of diseases.

2. A small number of electrodes allows you to register only 1-2 standard ECG leads. This allows you to diagnose only cardiac dysfunctions associated with arrhythmia, and is not enough to make an accurate diagnosis in more complex cases of CVD pathologies.

Known non-invasive method for the diagnosis of acute ischemic disease and a multi-channel electrocardiograph [G.J. Dempsey et al. Non-invasive multi-electrocardiografic apparatus and method of assessing acute ischaemic damage. / Patent US 5,419,337 IPC А61В 5/0452, publ. 05/30/1995.], Containing an ECG removal unit, including an electrode array, amplifiers, a multiplexer, a programmable amplifier, an ADC, a microcontroller, a removable memory card, heart rate analyzers and displays of the ST segment, the operation of which is ensured by the corresponding microcontroller program, and the readout values ST-segments on all channels are continuously displayed on the display screen in a three-dimensional image.

The disadvantages of the device are the structural complexity and the inability to use as a simple wearable means of monitoring the human condition and the diagnosis of exacerbation of diseases.

Known wearable device for monitoring ECG [Volobuev P.Yu. Wearable ECG monitoring device. / Patent RU 2266041 C2 MPK А61В 5/0452, А61В 5/0404, publ. December 20, 2005.], comprising a microprocessor unit, a multi-channel ECG removal unit, a multiplexer, an ADC, a removable memory card, a keyboard and an indication and signaling unit, the indication and signaling unit being configured to simultaneously indicate both current and previous delays for a specified time averaged values of the ECG parameters, and the microprocessor unit software is capable of calculating and storing such values and with the possibility of selectively recording them to a removable memory card in accordance with Wii with a program that can be set from the keyboard.

The disadvantages of the device are the structural complexity and inconvenience of use due to the need to use a patient cable.

A common disadvantage of the known devices is the lack of the ability to remotely transmit information to a monitoring center.

A device for synchronous recording of rheograms from ECG electrodes and monitoring [Klypin D.N., Chernyshev A.K. Device for synchronous recording of rheogram from ECG electrodes and monitoring. / Patent RU 93248 U1 IPC АВВ 5/0432, publ. 04/27/2010.], Containing, in addition to the ECG recording channel, the registration channel of the rheogram of the precardial region (RPO).

The advantages of the device are:

Simultaneous registration of ECG and RPO significantly increases the information content on the functioning of the heart and increases the reliability of the diagnosis of heart diseases [Shershnev V.G. et al. Clinical rheography. / Ed. V.G.Shershneva. - Kiev, Health, 1977. - S.3-7.].

1. The presence of a wireless channel with a doctor’s computer or monitoring center.

The disadvantages of the device are:

1. A small number of recorded ECG leads, which does not allow to make a reliable diagnosis.

2. Lack of analysis tools for recorded data. A common disadvantage of the known devices is the lack of means for recording parameters of the human respiratory system.

The closest in technical essence is a corset device [R. Schmidt et al. Belt device. / Patent application US 2008/0200792 A1, IPC A61B 5/0402, publ. 08/21/2008.] - a prototype. In this device, ECG is recorded and recorded using 3 special ECG leads of the EASI system [Gordon E. Dower. Method and apparatus for sensing and analyzing electrical activity of the human heart. / Patent US 4,850,370 IPC А61В 5/04, publ. 07/25/1989.] Using 5 electrodes, then the data is transmitted wirelessly to the doctor’s computer, where 12 leads of the standard ECG are restored from the received data.

The advantages of this device are:

1. The reduced number of electrodes and measurement channels, which simplifies the circuitry of the device compared to a standard stationary electrocardiograph.

2. Restoring a standard ECG allows analysis

data to any cardiologist, not just a Holter monitoring specialist. The disadvantages of this device are:

1. Registration only ECG signals, and only on the EASI system.

2. Lack of analysis tools for recorded information to identify dangerous conditions for the patient’s health.

3. Lack of means for recording parameters of the respiratory system.

It is known that the registration of human respiratory activity can be carried out by measuring the transthoracic impedance (TTI) by rheography [A comprehensive assessment of the functional state of the circulatory and respiratory systems by the method of integral rheography of the body. // Method, recommendations of the Ministry of Health of the RSFSR. Compiled by: Volkov Yu.N., Bolshov V.M., Singaevsky SB, Zemtsovsky E.V., Huseynov B.A. M., 1989. - 21c.].

The task of creating a new technical solution is to increase the information content and reliability of the diagnostics of the device for monitoring the functional state of a person by supplementing the functions of the device with the function of registering the rheogram of the precardial region of the heart and the function of registering respiratory activity, carried out simultaneously with the registration of the ECG, as well as supplementing the device program with a program for analyzing recorded information diagnosis of exacerbation of human diseases.

This object is achieved in that a device for monitoring the functional state of a person, including five ECG electrodes placed in accordance with the EASI system and connected to a registrar module connected to a non-volatile memory module with an ECG recording, recording and transmission program, a wireless communication module, connected to the recorder module, and the battery, according to the claimed technical solution, the device additionally contains four additional electrodes, two high-frequency signal generators and sound a siren, with additional electrodes connected in pairs to the outputs of the high-frequency signal generators, the recorder module is capable of simultaneously recording ECG, rheogram, respiratory activity and information analysis for the diagnosis of exacerbation of diseases, and a sound siren is connected to the output of the registrar module and serves to issue an alarm when the occurrence of dangerous conditions for human health.

The additional electrode can be structurally combined with the ECG electrode and made in the form of a concentric circle around the ECG electrode or inside it.

The number of ECG electrodes can be any and is determined by the desired system of ECG leads.

The essence of the technical solution is illustrated by the functional diagram of the device for cardiac monitoring, shown in figure 1.

The device contains: active ECG electrodes E, A, S, I and a reference ECG electrode G, a registrar module 1, a non-volatile memory module 2, an audio siren 3, a wireless communication module 4, a battery 5, additional electrodes P1, P2, P3, P4, the first generator 6 and the second generator 7. All nodes of the device are integrated into the corset 8, conventionally shown by a dashed line.

The non-volatile memory module 2 stores the operating program 9 of the registrar 1 module, which includes a program for measuring biopotentials, extracting ECG, RPO, TTI signals, transmitting data over a wireless channel, as well as an information analysis program for diagnosing life-threatening conditions and notifying of the occurrence of such a state person.

The ECG recording channel is formed by active electrodes E, A, S, I connected to the input of the recorder module 1. The reference ECG electrode G serves to eliminate common-mode interference. The ECG signal is extracted from a wide range of pickups, which include the signals of the first generator 6 and the second generator 7, using the band-pass filtering program of the ECG signal performed by recorder 1.

The RPO registration channel is made according to a tetrapolar circuit and includes a first generator 6 connected to additional electrodes P1 and P2, and ECG electrodes S and E connected to the input of the recorder module 1. The output frequency of the first generator 6 can be changed under the control of the registrar module 1 and is set depending on the constitution of man. The low-frequency envelope of the high-frequency signal that carries information about changes in blood flow in the precardial region is extracted using the band-pass filtering and detection program performed by the recorder 1. The central frequency of the selection of the useful signal of the RPO in the program must be equal to the set frequency of the first generator 6.

The TTI registration channel is made according to a tetrapolar circuit and includes a second generator 7 connected to additional electrodes P3 and P4, ECG electrodes I and A connected to the input of the recorder module 1. The output frequency of the second generator 7 can be changed under the control of the registrar module 1 and is set to depending on the constitution of man. The low-frequency envelope of the high-frequency signal that carries information about the change in the volume of the chest is extracted using the band-pass filtering and signal detection program performed by the recorder 1. The central frequency of the selection of the useful TTI signal in the program must be equal to the set frequency of the second generator 7.

The output frequency of the second generator 7 differs from the output frequency of the first generator 6 by at least 1% to exclude beats and ensure simultaneous registration of RPO and TTI.

The non-volatile memory module 2, in addition to storing the functioning program 9 of the recorder 1, serves to store the measurement results. The wireless communication module 4 serves to transmit the measured and accumulated information to the doctor’s computer or to the monitoring console. Battery 5 is used to power all components of the device.

Figure 2 shows the layout of the electrodes on the patient's body. Additional electrodes P1, P2, P3, P4 are structurally combined with ECG electrodes S, E, I, A, respectively. All electrodes are integrated into the corset 8, made of elastic belts 10.

The device operates as follows.

The biopotential that arises on the ECG electrodes E, A, S, I, enters the registrar module 1, where it is converted into a digital form and processed according to the ECG registration program stored in the non-volatile memory module 3. Three channels are recorded and written into the memory - bipolar ECG EASI leads ES, AS and AI.

The high-frequency signal generated by the first generator 6 is supplied to additional electrodes P1 and P2, while a voltage drop is generated on the ECG electrodes E and S, modulated by fluctuations in the blood conduction in the precardial region (located between the electrodes E and S) - the RPO signal. This signal is fed to the registrar module 1, where it is converted to digital form and processed by the RPO registration program stored in the non-volatile memory module 2.

The high-frequency signal generated by the second generator 7 is supplied to additional electrodes RE and P4, while a voltage drop is generated on the ECG electrodes I and A, modulated by fluctuations in the size of the chest during breathing - a TTI signal. This signal is transmitted to the recorder module 1, where it is converted to digital form and processed by the TTI registration program stored in the non-volatile memory module 2.

During the measurement, the recorder module 1, in accordance with the program of functioning 9, extracts the ECG, RPO and TTI signals, writes data to the non-volatile memory module 2, and also analyzes information to diagnose conditions dangerous to human health (exacerbation of heart diseases, arrhythmia, apnea and etc.). When such a condition is detected, a person is notified of this by an audio signal using a sound siren 3, and an alarm is transmitted to the monitoring console using the wireless module 4. When transmitting an alarm, ECG, RPO and TTI data are simultaneously transmitted for detailed analysis and diagnosis.

The recorded data is a file stored in the non-volatile memory module 2. In the absence of alarm conditions, this file is transmitted to the monitoring panel using the wireless module 4 with a predetermined period (for example, once a day). From the ECG data received on the computer of the monitoring console, 12 leads of the standard ECG are restored, which allows further analysis and diagnosis of any cardiologist.

Using the proposed design of the corset, ECG registration is possible both in the EASI system with additional ECG electrodes (for example, with standard chest electrodes V4 - V6, located at the level of electrodes I, E, A), and in other systems, for example, according to Neb, Slopak, Franco, etc., by placing ECG electrodes in appropriate positions on the belts.

The positive effect in the proposed technical solution is based on a combination of constructive, circuitry and software solutions and consists in the following:

1. Using the proposed device for monitoring the functional state of a person, it is possible to register the ECG of different lead systems, followed by data transfer to the monitoring console.

2. When registering an ECG in the EASI system, a standard ECG is restored on the cardiomonitoring console, which allows data analysis and diagnosis to be made to any cardiologist.

3. Simultaneous with ECG registration, additional channels of the human condition are recorded - rheograms of the precardial region and transthoracic impedance, which significantly increases the information content and reliability of the diagnostic device.

4. The analysis of the recorded information is carried out to detect dangerous conditions for health and alerts both the person and the operator of the monitoring console when such a condition occurs, which reduces the risk of disease complications and the number of deaths.

5. It is possible to use the proposed device both on an outpatient basis and in a hospital setting, including during operations on internal organs.

Claims (3)

1. A device for monitoring the functional state of a person, including five ECG electrodes placed in accordance with the EASI system and connected to a registrar module configured to register, record and transmit an ECG associated with a non-volatile memory module, a wireless communication module connected to the module a recorder, and a battery, characterized in that the device additionally contains four additional electrodes, two generators of high-frequency signals and a sound siren, with additional electronic childbirth is connected in pairs to high-frequency signal generators that are connected to the registrar module, the registrar module is configured to record ECG, rheogram, respiratory activity and analyze information to diagnose an exacerbation of diseases, and the sound annunciator is configured to issue an alarm notification in the event of a hazard to human health . 2. The device according to claim 1, characterized in that the additional electrode is structurally combined with the ECG electrode and is made in the form of a concentric circle around the ECG electrode or inside it. 3. The device according to claim 1, characterized in that the number of ECG electrodes is determined by the applied system of ECG leads.

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