WO2020263125A1 - Device for diagnosing helicobacter pylori bacteria infection - Google Patents

Abstract

The utility model relates to the field of medicine, and more particularly to systems for diagnosing diseases caused by infection with Helicobacter pylori bacteria. A diagnostic device is equipped with a replaceable measuring module mounted in a seat of the device and containing a measuring transducer, a signal processing and amplifying unit, and a memory unit. A sample supply system is configured in the form of a nozzle mounted around the outer diameter of the seat. The device comprises a control and data processing unit connected to the measuring module, to a display and input unit, and to a data transfer unit. The control and data processing unit is connected via an auxiliary controller unit to a power unit, a built-in storage battery, a storage battery recharging unit and a micropump. The micropump is mounted at the outlet of a through-opening configured in the seat of the device. The technical result is to provide increased ease of use, autonomous operation of the device and the possibility of exchanging medical information within the field of telemedicine using computer and telecommunications technology.

Description

DEVICE FOR DIAGNOSTIC BACTERIA INFECTION

Helicobacter pylori

FIELD OF TECHNOLOGY

The useful model relates to the field of medicine, in particular, to systems for diagnosing diseases caused by infection with the Helicobacter pylori bacterium by exhaled air.

Currently, there are technical means that make it possible to diagnose Helicobacterpylori infection by air extracted from the oral cavity.

PRIOR ART

A device is known according to the patent RU 2263468, 2003, (patent holder LLC "Association of Medicine and Analytics") "Method for non-invasive diagnosis of Helicobacter pylori infection in vivo and a device for its implementation", containing a sampling device connected by a capillary to a sensor, the latter is connected by an aspiration capillary device (compressor). The disadvantage of this device is that the compressor works continuously and is connected directly to the 220 V 50 Hz network.

The closest to the claimed one is a diagnostic system for analyzing the gas composition of exhaled air according to patent RU 2373850, 2007, (patent holder LLC "Scientific and Technical Enterprise" TKA "), including a measuring transducer, a sampling capillary, a sample supply system, a capillary, an analog processing unit and amplification, electronic analytical unit and display unit with an electronic key to control the operation of the flow rate generator. The disadvantages of this device, selected as a prototype, include:

- lack of internal memory for storing data (to save data requires a connection to a personal computer). It is not possible to save patient data necessary for personalizing test results (creating a patient card. The data is not saved and subsequently cannot be identified by the "patient-result" attribute. In field diagnostics, the results can only be recorded from the screen.

- replacement of the measuring module requires partial disassembly of the device, disconnection and connection of electrical connectors. Replacing the converter requires the involvement of a technician or contact a service center. After replacing the transducer, a software update of the device with new transducer calibration parameters is required.

- there is no possibility of charging the battery on the device selected as a power source (there is no battery charging unit). After the battery has been discharged, it must be charged with another device or the batteries must be replaced.

- there is no possibility of remote transmission of medical data directly from the device.

DISCLOSURE OF THE INVENTION

The technical problem is to improve the usability, ensure the autonomous operation of the device and the possibility of exchanging medical information in the framework of the direction of "Telemedicine" using computer and telecommunication technologies.

The technical problem posed is solved due to the fact that in the known device for diagnosing infection with the Helicobacter pylori bacterium, which includes a sample supply system, a converter and a processing and amplification unit, the input of which is connected to the output of the converter, according to the stated solution, the device is equipped with a replaceable measuring module installed in the landing place of the device and containing a measuring transducer, a signal processing and amplification unit and a memory unit, and the sample supply system is made in the form of a nozzle installed along the outer diameter of the seat, the measuring module is connected to the control and data processing unit, and the control and data processing unit is connected to the unit display and input and with a data transmission unit, as well as, through an auxiliary controller unit, with a power supply, a built-in rechargeable battery, a battery charging unit and a micropump installed at the outlet of the through hole made in the landing location of the device. And also due to the fact that the nozzle is installed above the replaceable measuring module with the formation of a flow chamber for studying the exhaled air, and the measuring module is connected to the control and data processing unit through spring-loaded contacts, on the board of the replaceable measuring module, ring electrical contact platforms, while the display and input unit is made in the form of a touch screen.

The technical result is achieved due to the fact that the claimed device is equipped with a replaceable measuring module, which is a single structure and is installed in the device seat. The design of the replaceable measuring module is implemented for the possibility of self-replacement by the user. Replacement of the module is maximally simplified for the user and is carried out using a special key that comes with the device. Neither the connection of connectors is required (electrical connection is realized using spring-loaded pins and precision positioning of the module relative to the control board of the device), nor additional tools. The software of the device automatically reads the data of the installed measuring module (calibration, serial number of the module, information on the date of the next replacement). The possibility of self-replacement of the sensor by the user, eliminates the economic costs caused by sending the device to service centers, as well as the absence of the device during this period. The solution to the problem of autonomous operation of the device for diagnosing infection with the bacterium Helicobacter pylori is realized due to the low-voltage power supply of all units of the device and the built-in rechargeable battery, as well as by equipping with modules for receiving and transmitting data. Equipped with a display and input unit in the form of a touch screen allows the input of patient identification data, and, if necessary, store them on the device, thereby personalizing each study. Information with the examination results can be sent to the e-mail of the attending physician or patient directly from the device, via Ethernet, Wi-Fi or Bluetooth data transmission and reception channels. In turn, depending on the results of the Helicobacter pylori test and the patient's anamnesis data, the doctor can prescribe or adjust the treatment within the teleconsultation.

BRIEF DESCRIPTION OF THE FIGURES DRAWINGS

The stated solution is illustrated by graphic materials.

Figure 1 is a block diagram of a device for diagnosing infection with the Helicobacterpylori bacterium.

Figure 2 shows a replaceable measuring module assembled with a seat

The graphic materials show:

Means of sampling 1 - mouthpiece;

Sampling capillary 2 - polyvinyl chloride tube;

Sample supply system 3 - fluoroplastic nozzle;

Seat 4 of the measuring module - cylindrical sleeve

Replaceable measuring module 5, includes a single design for self-replacement by the user and consists of a converter 6, a signal processing and amplification unit 7, and a memory unit 8.

Converter 6 - electrochemical ammonia sensor

Signal processing and amplification unit 7 Module 8 memory block

Control and data processing unit 9

Built-in micropump 10

Sub controller unit 11

Display and input unit 12

Data transmission unit 13 -implemented via modules for transmitting and receiving data Ethernet, wireless network (Wi-Fi) and Bluetooth

Sound notification block 14

PC communication unit 15 - implemented via USB I / O port

Battery charging unit 16

Device power supply 17

Built-in rechargeable battery 18

Real time clock block 19

Flow chamber 20 - volume between seat 4, with installed measuring module 5, and sample supply system 3.

Through hole 21 - hole for aspiration of exhaled air

Micropump attachment point 22 - implemented through the fitting for the tube

Spring loaded contacts 23

Fastening the seat to the body of the device 24 - implemented through the screw holes

Sample inlet system connection 25 - for connection with sampling capillary 2 The sampling device 1 is connected by the sampling capillary 2 to the sample supply system 3 (nozzle). The sample supply system 3 is connected to the seat 4 of the device, with the installed replaceable measuring module 5, forming a flow chamber 20 for examining the exhaled air. The seat 4 is equipped with a through hole 21, at the outlet of which a micropump 10 is installed.

The replaceable measuring module 5 is a unified structure and includes a converter 6, a signal processing and amplification unit 7, a memory unit 8. The memory unit 8 stores the calibration and identification data of the module, which are automatically read and stored in the memory of the control and data processing unit 9 implemented on a single board computer with a memory slot. On the board of the replaceable measuring module 5, ring electrical contact pads (not shown) are applied, which, when the module is fixed by twisting in its seat on the device, form an electrical contact due to the spring-loaded contacts 23 on the device board. This implementation allows the user to replace the measuring module 5 independently, using only a key for unscrewing and twisting the replaceable measuring module 5. The sampling is carried out by the built-in micropump 10, which is controlled by the commands of the auxiliary controller unit 11 through the installed program with the parameters of turning the pump on and off, adjusting and control of the set performance in the control and data processing unit 9. Preparation for the test with a device for diagnosing infection with the bacterium Helicobacter pylori consists in the fact that the sampling device is connected by a sampling capillary to the propellant system. Then the sample supply system 3 is tightly connected to the seat 4 of the device.

During the test, the patient is given an oral sample collection device (mouthpiece) connected to the supply system 3. The built-in micropump 10 is used to aspirate the exhaled air.

An electrochemical sensor serves as a measuring transducer, which outputs an electrical signal proportional to the ammonia concentration. The sensor has a high resolution. High selectivity of the sensor eliminates the influence of other gases on the analysis result.

A single board computer controls the entire measurement process and converts the sensor output signals into readings on the display

An electrical signal proportional to the ammonia concentration from the output of the converter 6 enters the signal processing and amplification unit 7, then the amplified and digitized signal enters the control and data processing unit 9.

In accordance with the program installed in the control and data processing unit 9, the data on the examination results are output to the display and input unit 12. The display and input unit 12 allows you to enter data, select on the screen of commands that are executed by the control and data processing unit 9. By means of the data transmission unit 13 associated with the control and data processing unit 9, medical information with the examination results can be transmitted to the e-mail of the attending physician or patient directly from the device, through the receiving channels and data transfer Ethernet, Wi-Fi or Bluetooth. In turn, depending on the results of the Helicobacter pylori test and the patient's anamnesis data, the doctor can prescribe or adjust the treatment within the teleconsultation.

The device is powered from the device power supply 17 through an external power adapter (voltage 5 V, current 2 A) from an external power source or from the built-in rechargeable battery 18. To extend the service life of the built-in rechargeable battery 18 and the duration of the autonomous mode without replacing the rechargeable battery , the power circuit is implemented through the battery charging unit 16. The auxiliary controller unit 11 receives signals from the battery charging unit 16 about the current state of charge and regulates the charging through the transistor in the power unit 17, opening or closing the charging circuit of the built-in battery 18, thereby controlling the process of uniform and periodic charge / discharge. This solution will extend the battery life even if the device is constantly connected to an external source during the work shift. For sound signaling of the completion of the research stages, the control and data processing unit 9 sends a command to the auxiliary controller unit 11, an alert is implemented in the sound notification unit 14. To display the examination results on a stationary personal computer, a connection is provided through the USB input-output port in the communication unit with PC 15.

The real time clock unit 19 is connected to the control and data processing unit 9.

INDUSTRIAL APPLICABILITY

The developed device for diagnosing infection with the bacterium Helicobacter pylori has a compact size and a weight of no more than 1 kg, which allows the device to be used as a mobile device. Depending on the parameters of the built-in rechargeable battery, the device can work in autonomous mode for more than 6 hours without recharging. This performance is especially important for diagnostics in remote areas of the country. The internal memory is capable of storing at least 300 patient cards containing data such as name, date of birth, medical record number, institution, test date and test result. The touch 5-inch capacitive screen allows you to conveniently enter this data without connecting to a personal computer. The "GastroTest" device supports all the necessary channels for receiving and transmitting data: the technology for receiving and transmitting data Ethernet, as well as wireless channels (wireless network and Bluetooth). The method for diagnosing helicobacteriosis using a device for diagnosing infection with the bacterium Helicobacter pylori is accurate, non-invasive, simple in execution, does not require highly qualified personnel, express, safe and comfortable for the patient being examined (urea of normal isotopic composition is used, contact of patients with the device is excluded, infection is excluded following patients), economical and highly cost-effective. The results of the method are comparable to invasive techniques, which makes it a preferable method for the diagnosis of Helicobacter pylori in persons with diseases of the stomach and duodenum, as well as for the control of eradication.

Claims

USEFUL MODEL FORMULA 1. A device for diagnosing infection with the bacterium Helicobacter pylori, including a sample supply system, a converter and a processing and amplification unit, the input of which is connected to the output of the converter, characterized in that the device is equipped with a replaceable measuring module installed in the device seat and containing a measuring transducer, processing unit and signal amplification and a memory unit, and the sample supply system is made in the form of a nozzle installed along the outer diameter of the seat, the measuring module is connected to the control and data processing unit, and the control and data processing unit is connected to the display and input unit and to the data transmission unit, and also, through the auxiliary controller unit, with a power supply, a built-in rechargeable battery, a rechargeable battery charging unit and with a micropump installed at the outlet of the through hole made in the device seat. 2. The device according to claim 1, characterized in that the nozzle is installed above the replaceable measuring module to form a flow chamber for examining the exhaled air. 3. The device according to claim 1, characterized in that the measuring module is connected to the control and data processing unit through spring-loaded contacts. 4. The device according to claim 1, characterized in that annular electrical contact pads are applied on the board of the replaceable measuring module. 5. The device according to claim 1, characterized in that the display and input unit is made in the form of a touch screen.