RU30545U1 - Device for determining the patient's infection rate with Helicobacter pylori bacterium and a sample delivery system to it - Google Patents

Description

Device for determining the patient's infection rate with Helicobacter pylori bacterium and a sample delivery system to it

Utility models relate to the field of medical measuring equipment, more specifically to laboratory diagnostics and can be used to determine the patient's infection rate with Helicobacter pylori.

Currently, there are methods 1-6 that allow both a qualitative determination of infection with Helicobacter pylori bacterium and a quantitative assessment of the degree of infection of the patient, but for the most part they are based on invasive techniques.

A device is known for determining the patient's infection rate with the Helicobacter pylori bacterium (FIG. 1) 7, comprising an electron-optical unit 1, an analog processing and amplification unit 7, an electronic analytical unit 8, an information display unit 9. The electron-optical unit 1 contains a sampling capillary 2, a sample supply system 3, a radiation source unit 4, a capillary output 5, and an optical radiation receiver unit 6. A sample of air exhaled by the patient through the sampling capillary 2 enters the sample supply system 3, in which it is exposed to radiation from the radiation source unit 4. The studied sample is removed through the sample capillary 5 from the sample supply system. Radiation from the components of the studied air falls on the block 6 of the receiver of optical radiation. The signals from the output of block 6 are fed to the input of block 7 of analog processing and amplification. The output of block 7 is connected to the input of the electronic-analytical block 8. The output of block 8 is connected to the input of the information display block 9. In this device for determining the patient’s infection rate,

closest to the offer, an expensive and bulky electron-optical unit is used, which is an obstacle to using it as a wearable device.

In the same device, a sampling system closest to the one used is used. This sample supply system (FIG. 2) contains a sample supply capillary 10, for supplying samples of exhaled air 11, a measuring chamber 12 and a sample output capillary 13. In the measuring nozzle 12, radiation 14 7 acts on the test sample.

When using this sampling system, difficulties arise because the air exhaled by the patient has significant humidity, and in some cases (stomach ulcer, gastritis), there is significant salivation, further enhanced by the fact that examinations are carried out on an empty stomach. Since the exhaled air of the patient is pumped through the capillary system and the sample supply system, condensation necessarily appears on the walls of the latter. For these reasons, when using optical and the vast majority of other research methods, significant interference occurs, often leading to disruption of the examination process or distortion of experimental data.

The objective of the claimed utility models is to create a device for determining the patient's infection rate with Helicobacter pylori bacterium, which allows to achieve a technical result, which consists in increasing the accuracy and noise immunity when making an appropriate diagnosis and monitoring the course of treatment, by using a simpler sensor and an appropriate sampling system in the device, expanding the ability to examine patients with high salivation.

2 The task is achieved due to the fact that in the device for determining

the level of infection of the patient containing the electron-optical unit, the output of which is connected to the input of analog processing and amplification, the output of which is connected to the input of the electronic-analytical unit, the output of the latter being connected to the input of the information display unit, while the electron-optical unit is replaced by a measuring transducer, which is used as an electrochemical cell.

A sample supply system containing a sample supply capillary, a measuring chamber and a sample delivery capillary is supplemented by a connecting capillary, while a collector is introduced between the last and sample delivery capillaries to collect moisture from the patient’s exhaled air and saliva.

The inventive utility model allows to obtain an indicator of infection of the patient Helicobacter pylori non-invasive method and is a breathing test. When determining the Helicobacter pylori patient's infection rate based on determining the concentration of ammonia in exhaled air, the accuracy of the diagnosis depends on the initial (basal) gas concentration. The latter depends on factors such as smoking, alcohol consumption, age, gender and some others. In the data processing algorithm of the claimed utility model, basal concentration values specific for each individual patient are taken into account, which significantly increases the probability of an objective diagnosis. The accuracy of the results obtained by some methods also depends on the humidity of the exhaled air and saliva entering the measuring device (measuring nozzle, sensor), which sometimes leads to the inapplicability of some methods. The sample supply system used in the proposed utility model is made whiter resistant to such influences, allowing the problem to be solved.

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The inventive utility models are illustrated by the following figures: Figure 1 - block diagram of an infrared spectrophotometer (prototype); Figure 2 is a sectional view of the design of a sample supply system of an infrared spectrophotometer (prototype);

Figure 3 is a block diagram of the inventive utility model of a gas analyzer for determining the patient's infection rate with Helicobacter pylori bacterium; Figure 4 is a sectional view of the design of the inventive utility model of a gas analyzer sample supply system for determining a patient's infection rate with Helicobacter pylori bacterium;

Figure 5 - comparison of data obtained using various diagnostic tools.

A device for determining the patient's infection rate with Helicobacter pylori bacterium (Fig. 3), contains an electrochemical cell 15, a sampling capillary 16, a sampling system 17, the output capillary 18, an analog processing and amplification unit 19, an electronic analytical unit 20 and an information display unit 21.

The sample supply system (Fig. 4) contains a sample supply capillary 22, a collector 23 for collecting moisture exhaled by the patient's air and saliva, a connecting capillary 24, a measuring chamber 25 and a sample collection capillary 26.

In the sample supply system (prototype), the studied samples of air exhaled by the patient are pumped without separation of moisture and saliva. In the proposed utility model, the moisture and saliva sample from the patient’s exhaled air 27 is separated by using an appropriate collector. According to the sample-leading capillary 22, the studied samples of exhaled air by the patient are supplied to the inlet of the collector 23 to collect moisture exhaled by the patient's air and saliva. On the connecting capillary 24, air samples are pumped towards the measuring chamber 25 mounted on the electrochemical cell 15, from

which are displayed on the sample capillary 26.

A device for determining the patient's infection rate with Helicobacter pylori bacterium works as follows.

Samples of air 27 exhaled by the patient through the sampling capillary 16 enter the sample supply system 17. Gaseous ammonia enters the electrochemical cell 15 of the diffusion type. The signals from the output of the electrochemical cell 15 are fed to the input of the block 19 of analog processing and amplification. The signals from the output of the analog processing and amplification unit 19 are fed to the input of the electronic-analytical unit 20, the output of which is fed to the input of the information display unit 21. Samples of air 27 exhaled by the patient through the outlet capillary 18 are removed from the sample supply system.

The principle of operation of the device for determining the patient's infection rate with Helicobacter pylori and

measurement conditions

The operation of the device for determining the patient's infection rate with Helicobacter pylori bacterium is based on determining the amplitude of the pulses proportional to the concentration of ammonia in the air exhaled by the patient.

Based on the studies, it can be concluded that the result of the work will be a device that allows you to determine the presence of Helicobacter pylori infection in the subject in no more than 10 minutes. The study time compared with the fastest of currently used methods ("breath tests) is reduced by 50%, while the reliability of the diagnosis increases. The last statement is based on testing the device’s layout on 54 patients aged 4 to 18 years and 15 adults (age 20 to 47 years). At

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the study takes into account factors affecting the basal (initial) level of ammonia concentration in the exhaled air, such as smoking, drinking alcohol, and pregnancy. Also, using the appropriate sampling system, the effect on the examination of moisture and saliva in the expired air and oral cavity is minimized. Processing of the data obtained during the study is carried out in real time. The program implemented in the microcomputer of the developed system has a convenient interface. During the examination, the necessary actions of the doctor appear in the form of prompts on the liquid crystal screen (LCD) of the device. The device is equipped with a sound and visual indication of the sequence of operations with the sample and the patient.

The test sample of air exhaled by the patient is pumped by the compressor through a sequentially placed sampling capillary, a supply and connecting capillary between which there is a collector for collecting moisture and saliva, as well as a measuring nozzle on the sensor, to the output of which an output capillary is connected. A pump located at the end of the sampling path creates a pressure difference and draws in the test air. Through a sample-leading capillary, air samples enter a collector to collect saliva and moisture, from which they enter a measuring nozzle to a sensor through a connecting capillary, from which they are removed through a sample-leading capillary. A chemical reaction occurs in the sensor (diffusion type electrochemical cell).

When air enters into an electrochemical sensor that contains ammonia, a chemical reaction occurs, resulting in an electric current whose strength is proportional to the concentration of ammonia. The chemical reaction takes place according to the following formula: From the output of the sensor, electric current is supplied to the input of the analog block

processing and gain. The analog processing and amplification unit consists of a filtering system and a precision low-noise amplifier (OP727). From the output of the analog processing and amplification unit, the signals are fed to the input of the electron-analytical unit.

The electronic analytical unit consists of a microcontroller (PIC16F73). The microcontroller works according to a program that processes the pulses arriving at its input, outputs the necessary operations with the patient to the input of the information display unit in the sequence required to comply with the examination methodology, as well as the result of the examination itself.

The information display unit is based on a liquid crystal display (WH1202 AC).

The power supply unit is implemented using a DC power source.

The OR727 chip is a dual operational amplifier with zero drift and powered by a unipolar source, with a signal from the output to the input equal to the supply voltage. The power of this chip is +5 V. The main parameters of the chip are given in table. 1.

The PIC16F73 chip is a RISC microcontroller and operates at frequencies up to 20 MHz. This chip has three channels with a bit depth of 8 bits each. Operating frequencies up to 20 MHz satisfy the speed of data generation by the analog processing and amplification unit. The power of this chip is + 5V. The main parameters are given in table. 2.

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Dual operational amplifier

8 tab. 1 OR727

Claims (2)

1. A device for determining the patient's infection rate with Helicobacter pylori bacterium containing a sample supply system, to the input of which a sample is supplied, an analog signal processing and amplification unit, the output of which is connected to the input of the electronic-analytical unit, the output of the latter being connected to the input of the information display unit, characterized in that an electrochemical measuring cell is additionally introduced into it, the output of which is connected to the input of the analog processing and signal amplification unit. 2. A sample supply system containing a sample supply capillary, a measuring chamber and a sample output capillary, characterized in that a connecting capillary is additionally introduced into it, while a collector is installed between the last and sample supply capillary.