WO2018093288A1

WO2018093288A1 - Cardioqvark cardiac monitoring system with integral two-channel photoplethysmograph

Info

Publication number: WO2018093288A1
Application number: PCT/RU2016/000824
Authority: WO
Inventors: Александр Викторович Ежков; Владислав Хэнрыкович БУТКЕВИЧ; Владимир Александрович УСАНОВ
Original assignee: Александр Викторович Ежков
Priority date: 2016-11-15
Filing date: 2016-11-28
Publication date: 2018-05-24
Also published as: RU2016144656A3; RU2016144656A

Abstract

The invention relates to the field of medicine and is directed toward increasing the existing range of technical means and functional capabilities by enabling on-the-spot recording of cardiac function dynamics and parameters from uncovered regions of the upper limbs using a non-invasive, autonomous, compact and ergonomic device without the need for preliminary preparations and adjustments, said device having at least two channels for recording blood circulatory system dynamics and parameters and blood values and making it possible to synchronize data from different sources on the fly and to overcome other disadvantages of existing technical solutions, thus leading to an overall improvement in the performance of such systems. This technical result is achieved in a system for the combined recording of a high-definition ECG and at least two independent PPG signals from identical regions of the upper limbs using external devices with a digital or analog interface, said system comprising: at least two PPG sensors connected by standard digital buses to a controller; at least two ECG sensing electrodes which transmit a signal from a first stage of a differential amplifier with a common-mode noise filter, which is connected to a second stage of the differential amplifier with a common-mode noise filter, which is connected via a driver to an ADC with a common-mode noise filter; and a trigger for controlling the receipt of data from the ADC to a controller that is connected to a direct current power supply with noise suppression filters, a cryptoprocessor, an external interface switching unit connected to the direct current power supply and to a unit for providing surge protection for the interfaces, said controller receiving signals from a power monitor connected to a logic block for switching data buses and control.

Description

CARDIOMONITORING COMPLEX COMBINED WITH TWO CHANNEL PHOTOPLETISMOGRAPHY CARDIOQVARK photoplethysmograms (PPG) using external devices having a digital or analog interface.

As the closest analogue of the claimed invention, it is possible to take a complex containing a sensor, configured and configured, together with a user physiological data transmission scheme, to obtain, in a location near or directly on the lower part of the body (or lower limb) of the user, time-related data that provide an idea about the speed or transit time of the propagating pressure wave along the wave along the artery and further down to the user's leg; and a circuit configured and tuned to compare information related to or obtained from time-synchronized data with information about the cardiovascular system in the upper and lower parts of the body, information about the cardiovascular system in the upper and lower parts of the body, related or received based on the hemodynamic parameters of the user using another sensor located directly or near the location of the upper limb or lower limb of the user (WO 2016/049202, 03/31/2016).

The disadvantage of this circuit design solution is the need to distribute the sensors to the most remote distance within the human body - installation in both its upper and lower parts or, in one implementation, the installation of one of the sensors on the upper limb, and the other on the lower limb. In addition, a prerequisite for recording physiological parameters is a preliminary synchronization procedure between themselves before the exchange of data between spatially and physically separated components of the measuring system, which, together with the need to install sensors on body parts that are usually hidden by clothes and shoes, reduces the speed of data acquisition and ease of use in clinical and outpatient practice.

The technical problem to which the proposed invention is directed is to create a cardiomonitoring complex, which combined with a two-channel photoplethysmograph and parameters, the characteristics of which provide an improvement in technology due to the on-line recording of dynamics and parameters of cardiac activity and having at least two channels for recording dynamics and parameters of the circulatory system and blood parameters, which would realize the possibility of synchronizing data from various sources on the fly and would eliminate the other disadvantages mentioned above.

The technical result achieved by the implementation of this invention is to expand the arsenal of technical means and functionality by providing rapid registration of dynamics and parameters of cardiac activity and having at least two channels for recording dynamics and parameters of the circulatory system and blood parameters, which would realize the possibility of synchronizing data from of various sources on the fly and would eliminate the other disadvantages indicated above, which generally leads to increased operation The characteristics of this series of complexes / systems.

The specified technical result in a complex for joint registration of a high resolution electrocardiogram (ECG) and at least two independent photoplethysmogram signals (PPG) from the same parts of the upper extremities using external devices having a digital or analog interface is achieved by the fact that it contains at least at least two PPG sensors connected through a standard digital bus with a controller, at least two ECG sensor electrodes transmitting a signal to the first stage of a differential amplifier with a filter phase interference associated with the second stage of the differential amplifier with a common-mode filter, connected through a driver to an analog-to-digital converter (ADC) with a common-mode filter, a trigger for controlling the reception of data from the ADC to a controller connected to a DC power source with noise-suppressing filters, a crypto processor , a switching unit for external interfaces connected to a DC power source and an interface surge protection unit, and receiving signals from a power monitor, connected of the logical unit switching the data bus and control.

The ECG sensor electrode is a plate of conductive material with a pre-treated surface to ensure reliable recording of the bioelectric potentials of the heart from the surface of the body without the use of gels and conductive compounds. The FPG sensor is an integrated module containing two or more emitters of different spectral ranges, and a photodetector, a data preprocessing unit, and an interface for exchange via a standard digital bus that are matched to them by the passband.

The differential amplifier is designed according to a multistage circuit, it contains feedback from the equalizing DC bias signal, common-mode interference filters and an ADC driver for matching the signal level.

As an ADC, a stereo audio codec-decoder is used, containing a microphone input and digital interface buses.

The DC power source is program-controlled, with the function of stabilizing and converting the unipolar supply voltage to a series of voltages to power the functional units, including the formation of bipolar voltage, and with the possibility of partial disconnection of consumers in low power mode.

The interface contains a switching unit having a splitter with an automatic switch to one of several external devices and serving to supply an external supply voltage to the complex.

Cryptoprocessor ensures the correct operation of the device with products

Apple

A cardiogram is obtained according to standard cardiological lead I.

ECG and independent FPG signals are recorded from the fingers of two hands or from the wrists of two hands, or from other accessible areas of the same name of the upper limbs.

The ECG sensor electrode and the FPG sensor are structurally combined and fixed in the complex housing.

The ECG sensor electrode and the FPG sensor are structurally combined and have a common individual power source and a data exchange channel that allows using them at a distance from the complex building, while the power source may not be connected to the device.

The ECG sensor electrode and the FPG sensor have individual power sources and data exchange channels that allow using them at a distance from the complex building, while the power sources may not be connected with the device and with each other. A digital or analog interface is implemented at the physical level either in the form of a loop or in the form of a wireless channel, including, but not limited to, radio frequency, light, and acoustic.

As a reference signal for end-to-end synchronization of all sensors is the signal of one of the sensors and, in particular, its sections with controlled amplitude-phase characteristics.

The sensors are configured to extract amplitude-phase characteristics from their signals — signatures of biophysical and biochemical parameters.

The complex has software control.

The driver is configured to transmit parallel signals to the first and second inputs of a two-channel ADC with a common-mode interference filter.

Thus, the complex realizes the possibility of simultaneous recording together with a high-resolution cardiogram by standard cardiological abduction I of two photoplethysmogram signals from the same parts of two upper limbs and transferring them to an external device via a digital or analog interface, while significantly correlating the data significantly the reliability of the information obtained on cardiac activity, the state of blood vessels, and localization of foci increases erdechno-vascular diseases, and also it is possible to observe the cardiology, pacemaker signal and the pulse wave shape is directly displayed on an external device.

The main elements of the complex are assembled into a single module and are limited by a common external shell.

Structurally, the complex has the form, including, but not limited to, a cover for a mobile phone, game pad, remote control, steering wheel (steering wheel) or levers for controlling vehicles and other mechanisms and devices, a handrail, handle, tide of the hull or other structurally distinguishable element of another device, object, with physically distinguishable locations of the sensors, allowing you to touch or hold it simultaneously with two hands.

The complex has two versions: one-piece, when the sensors are fixedly mounted in the device and modular, when the sensors are located at some distance from the main unit in order to increase the convenience of fixing on the user's hands, while there is no rigid connection between the sensors and the main unit, and interaction is carried out via a cable or wireless channel, in the latter case, the sensors are self-powered.

The invention is illustrated in the drawing, which shows a block diagram of a complex of simultaneous registration of an ECG and two independent signals of FIG.

The complex for joint registration of high-resolution ECG and at least two independent FPG signals from the same parts of the upper extremities using external devices having a digital or analog interface contains two or more ECG 1 sensor electrodes, two or more FPG 2 sensors each with a standard digital bus, the first stage 3 of the differential amplifier with the common mode filter, the second stage 4 of the differential amplifier with the common mode filter and the ADC driver, two-channel ADC 5 with the common mode filter, three ger 6 control the reception of data from the ADC to the controller, software-controlled power supply 7 with noise suppressing filters, controller 8 with control and data buses, cryptoprocessor 9, logical unit 10 for switching data and control buses, power monitor 11, block 13 for switching external interfaces, block 12 surge protection switching unit external interfaces 13.

Structurally, the complex for simultaneous registration of ECG and two independent FPG signals is in one implementation a plastic case worn on the back of an external device - a mobile phone or smartphone. Inside the case of the plastic case there is a printed circuit board with electronic components and two structurally isolated sensor blocks, each block consisting of an ECG sensor electrode and an integrated FIG sensor. Access to the sensors for the fingers of two hands is provided by cutouts on the outside of the case. There are power and data connectors on the inside and outside of the case.

The external device is a mobile phone with pre-installed software that serves to send commands to the device controller to receive an ECG and two PPG signals, display diagnostic information, measurement results in text and graphic form and exchange with remote databases via wireless communication channels. An external device can also be a tablet, personal computer, another device connected via a digital or analog interface. A device for receiving an ECG and two PPG signals works as follows.

Initial activation of the complex occurs sequentially in several stages.

When connecting an external device to one of the inputs of the external interface switching unit 13, the voltage of the external device +5 V from the third output of the unit 13 is supplied to the logical unit 10 and activates its built-in trigger, which, in turn, gives a command to the two-channel analog switch included in it to connect an external device data bus to the internal bus of the device. At the same time, from the third output of block 13, a +5 V supply voltage from an external device is supplied to the second input of a software-controlled power supply 7, which forms a series of stabilized voltages + 1.8 V on the corresponding output power bus; + 3, ST; + 4.25V supplying the digital part of the device

After that, at the output of the power monitor 11, an initialization signal is generated, which is fed to the third signal input of the controller 8 and sets its software and ports to the initial configuration, the same signal is fed to the input of the logical unit 10 and fixes the selected configuration of the external interface switching unit 13.

Following the power supply + 1.8V; + 3, ST; + 4.25V, the crypto processor 9 is also activated, from the output of which the data necessary for information exchange via the data bus of the external device with the Apple device is transmitted to the first input of controller 8.

At the end of the initial activation procedure, the controller 8, following the algorithm embedded in its non-volatile memory and using the data of the cryptoprocessor 9, establishes information exchange with an external device and is waiting for external commands.

In the absence of external commands, the controller 8 after a specified period of time goes into low power mode and stays in it until the activation signal arrives from an external device, or until the power is turned off through the external interface switching unit from the external device, or until the external device is physically disconnected from the connector unit 13 switching external interfaces of the cardiomonitor. If there is a request from an external device for registration of ECG and FIG, controller 8 activates the corresponding firmware block and starts a sequence of commands that allow you to register a cardiological signal and two independent FPG signals, process, convert, decode them and transmit via external interface switching unit 13 to the external device for storing, displaying, analyzing and further manipulations.

Before the registration of the cardiogram, the controller 8 gives the command to turn on the analog part of the device, which is designed so that it requires a bipolar power supply of +3.3 V / -3.3 V. A program-controlled power supply unit 7, which generates a voltage of negative polarity in addition to being turned on during initial activation by the line voltage forming unit + 1.8V; + 3, ST; + 4.25V, is triggered by a signal supplied to the first input of power supply 7 from the fourth signal output of controller 8. As a result, a stabilized voltage of -3.3 V appears on the corresponding output bus of power supply 7 and the analog part of the device is turned on, namely: differential amplifier and ADC 5.

When the analog part is turned on, the biological potentials of the selected cardiological lead are recorded by ECG electrodes 1, after which the signals are transmitted respectively to the first and second inputs of the first stage 3 of the differential amplifier with an in-phase noise filter, and the same inputs from the midpoint of the second stage 4 of the differential amplifier are fed DC equalizing bias signal. The signal from the first output of the first stage 3 of the differential amplifier is fed to the first input, and the signal from the second output of the first stage 3 of the differential amplifier is synchronously fed to the second input of the second stage 4 of a two-channel precision differential amplifier with an in-phase noise filter and an ADC driver, where the signals are normalized by level, and then simultaneously fed to the first and second inputs of the two-channel ADC 5 with a common mode filter, respectively. Due to the similarity of the parameters of speech and cardiac signals, a stereo audio codec with standard digital buses for data exchange with controller 8 is used as an ADC 5, while the outputs of one of the available microphone inputs are used as the first and second inputs. The digitized and pre-processed data are transmitted from the ADC 5 via the command and data bus, connecting the first output of the ADC 5 and the second input of the controller 8, while the data transfer permission signal is generated by the data reception control trigger 6 connected between the first signal output of the controller 8 and the third ADC input 5. The logic of the trigger 6 involves the prohibition of data transmission from the ADC 5 when lack of a command to turn on the analog part of the complex.

The FPG 2 sensors switch from the energy saving mode to the operating mode when the supply voltage is + 4.25V and the command 8 receives commands from the controller via the standard digital bus of commands and data, after which their emitters, receivers, data preprocessing units, and interfaces for standard digital communication the bus starts working according to previously saved settings or according to newly transmitted commands and uploads data on the bus to controller 8. The command to turn on and off the converter, which forms the supply voltage + 4.25V output It is programmed in accordance with the algorithm, regardless of other supply voltage levels.

The data received by the controller 8 from the ADC 5 and from the FIG 2 sensors are processed in accordance with the embedded algorithm and transmitted from the second output of the controller 8 via an internal digital bus to the first input of block 13, and from the output of block 13 are redirected to the input of the connected external device. Control signals are transmitted on the same channel.

Depending on the software settings, the controller 8 can transmit both processed data and raw data, accompanied by time stamps.

The length of time for recording a cardiogram and two FPG signals is set programmatically and controlled by controller 8. Upon receipt of a sufficient amount of data for analysis or after an expired time period, controller 8 stops receiving data from ADC 5 and FIG 2 sensors, removes synchronization signals from the corresponding bus , and if there is a command from the external device to end the session, the controller 8 programmatically disconnects the supply voltage + 4.25V and the analog part, removing the corresponding enable signal from the power source 7, after which it goes into standby mode of external commands as after the initial initialization.

To protect the circuit elements of the ECG recording device and two PPG signals from discharges of static electricity and other types of impulse noise of various power and duration, the input circuits of block 13 are installed distributed components of the protection unit 12, which are combinations of semiconductor surge arresters.

Thus, the claimed invention implements a programmable control circuit and design of a compact ergonomic personal device designed primarily to hold both hands of a user simultaneously with two hands or otherwise in contact with open skin, including, but not limited to, fingers and wrists, with the purpose of recording together with a high-resolution cardiogram of two PPG signals and transmitting data to an external device through any of the available analogues or digital interfaces.

A high-resolution cardiogram and, in particular, its characteristic sections, serve as a reference signal for end-to-end synchronization of all sensors in the device, as well as for resynchronization, if necessary, in the registration process without interrupting the recording. The circuitry solution provides the selection of specific amplitude-phase characteristics from the sensor signals — signatures of biophysical and biochemical parameters, a comprehensive program analysis of which can significantly increase the reliability of the information received on cardiac activity, the state of blood vessels, biochemical and physical blood parameters, and improve the quality of localization of cardiac and vascular pathologies , and also makes it possible to observe the cardiac signal, the signal of the pacemaker and pulse wave directly on the screen of an external device.

PPG is recorded using multispectral light sources, which increases noise immunity and increases the reliability of the data.

The circuitry and associated design solution provide convenient non-invasive registration of these signals from open areas of the upper limbs on demand - without preliminary preparation and setup.

Claims

Claim

1. A complex for joint recording of a high resolution electrocardiogram (ECG) and at least two independent photoplethysmogram (PPG) signals from the same parts of the upper limbs using external devices having a digital or analog interface, characterized in that it contains at least two sensors PPG connected through a standard digital bus with a controller, at least two ECG sensor electrodes transmitting a signal to the first stage of a differential amplifier with a common mode filter associated with a cascade of a differential amplifier with an in-phase noise filter connected via a driver to an analog-to-digital converter (ADC) with an in-phase noise filter, a trigger for controlling the reception of data from the ADC to a controller connected to a DC power supply with noise-suppressing filters, a cryptoprocessor, a switching unit for external interfaces connected to a DC power supply and an interface surge protector, and receiving signals from a power monitor connected to a switch logical unit tion and management of the data bus.

2. The complex according to claim 1, characterized in that the ECG sensor electrode is a plate of conductive material with a pre-treated surface to ensure reliable recording of the bioelectric potentials of the heart from the body surface without the use of gels and conductive compositions.

3. The complex according to claim 1, characterized in that the PPG sensor is an integrated module containing two or more emitters of different spectral ranges, and a photodetector, a data preprocessing unit and an interface for exchange via a standard digital bus, matched to them by the passband.

4. The complex according to claim 1, characterized in that the differential amplifier is made according to a multistage circuit, contains feedback from the equalizing DC bias signal, common-mode noise filters, and an ADC driver for matching the signal level.

5. The complex according to claim 1, characterized in that a stereo audio codec-decoder is used as the ADC, comprising a microphone input and digital interface buses.

6. The complex according to claim 1, characterized in that the DC power source is software-controlled, with the stabilization and conversion function unipolar supply voltage in a series of voltages to power functional units, including the formation of bipolar voltage, and with the possibility of partial disconnection of consumers in low power mode.

7. The complex according to claim 1, characterized in that the interface comprises a switching unit having a splitter with an automatic switch to one of several external devices and serving to supply an external supply voltage to the complex.

8. The complex according to claim 1, characterized in that the cryptoprocessor ensures the correct operation of the device with Apple products.

9. The complex according to claim 1, characterized in that a cardiogram is obtained according to a standard cardiological lead I.

10. The complex according to claim 1, characterized in that the ECG and independent FPG signals are recorded from the fingers of two hands or from the wrists of two hands, or from other accessible parts of the same named upper limbs.

1 1. The complex according to claim 1, characterized in that the ECG sensor electrode and the PPG sensor are structurally combined and fixed in the complex body.

12. The complex according to claim 1, characterized in that the ECG sensor electrode and the PPG sensor are structurally combined and have a common individual power source and a data exchange channel that allows using them at a distance from the complex building.

13. The complex according to claim 1, characterized in that the ECG sensor electrode and the PPG sensor have individual power sources and data exchange channels that allow using them at a distance from the complex building.

14. The complex according to claim 1, characterized in that the digital or analog interface is implemented at the physical level either in the form of a loop or in the form of a wireless channel, including radio-frequency, light, and acoustic ones.

15. The complex according to claim 1, characterized in that the signal of one of the sensors and, in particular, its sections with controlled amplitude-phase characteristics serves as a reference signal for end-to-end synchronization of all sensors.

16. The complex according to claim 1, characterized in that the sensors are configured to isolate amplitude-phase characteristics from their signals — signatures of biophysical and biochemical parameters.

17. The complex according to claim 1, characterized in that it has software control.

18. The complex according to claim 1, characterized in that the driver is configured to transmit parallel signals to the first and second inputs of a two-channel ADC with a common-mode interference filter.

19. The complex according to claim 1, characterized in that it has an autonomous power source.