RU2783787C1 - Pocket blood analyzer adapter - Google Patents

Abstract

FIELD: medicine and biology.

SUBSTANCE: invention relates to the field of medicine and biology, namely a mobile portable electronic-mechanical device for sampling and testing blood, and can be used to determine the quantitative content of the analyte in a physiological fluid. The pocket blood analyzer adapter includes a body, on the inner walls of which there are guide recesses opposite each other, which are necessary in order to set the trajectory of movement for a number of test cassettes. Opposite the guide recesses there is a partition, behind which is placed a winding mechanism, consisting of a compression spring, a locking plate, two cams and a plate for fixing the test cassettes. On the inner wall behind the winding mechanism there is a winding motor for stretching the spring of the winding mechanism. Above the winding mechanism there is a working area of ​​the analyzer, which is an empty space with two holes. One hole, located at the bottom, is designed to shoot the lancet into the finger, and the second, on the side wall of the working area, is for blood sampling. In addition, the side wall is a partition, behind which there is an immunochromatographic strip attached to the test cassette. The case contains an indicator sensor for taking readings from an immunochromatographic strip, a backlight system, a side cover for replacing used test cassettes with new ones, and a removable module in which the battery is located. Above the removable module there is a control board for receiving and transmitting data and for outputting the result of taking readings from the immunochromatographic strip through the backlight system to the user, for controlling the indicator sensor and winding motor, and for monitoring the battery status.

EFFECT: achieved is the combination in one miniature device of a blood sampling system, a system for collecting, processing and subsequent data analysis in special software, and a system for the constant supply of new, pre-filled test cassettes of the required type.

1 cl, 17 dwg

Description

SUBSTANCE: invention relates to medicine and biology, namely to a mobile portable electronic-mechanical device for taking and testing blood, and can be used to determine the quantitative content of an analyte in a physiological fluid.

Known adapters designed for a wide range of studies, for example, RU 126137 and RU 2509297, produced by the Research and Production Enterprise "TECHNOMEDICA" and PD-303S, manufactured by Apel Co., Ltd, Japan. These models are part of spectrophotometers and are used as test containers in the form of test tubes, semi-micro cuvettes or optical disposable capillary micro cuvettes.

The disadvantages of the known devices are the complexity of use, since they consist of several collapsible parts, and most importantly, they themselves perform their functions only within the framework of spectrophotometers, which have rather large dimensions.

Of the portable devices for measuring the concentrations of substances in the blood, which are similar in their tasks to the claimed invention, the invention RU 2745294, AFON TECHNOLOGY LTD (GB) is close. This is a device for non-invasive determination of the concentration of a target substance (such as blood sugar, blood alcohol, cholesterol, etc.) in the patient's blood. The device includes applying an RF output signal to the patient's skin via an antenna and measuring the amplitude and phase of the response signal, which is a function of the RF output signal modified by interaction with the patient's blood.

The disadvantages of the known device and method are the need for certain qualifications and knowledge to use the device, the presence of additional non-built-in modules, such as an antenna, and most importantly, a limited range of substances under study, due to the features of the radio frequency method and its non-invasive application.

The closest device in terms of its functionality is the analyzers of Iglu LLC (access mode: https://iglootest.ru/ Date of access: 04/07/2022).

The disadvantages of the prototype include the need to use separate non-built-in devices, such as a lancet, a test cassette and an adapter, and the need to assemble them before each test, which takes time. The dimensions of the analyzer are not convenient for individual use, in comparison with the claimed device, which can easily fit in the user's pockets.

The technical result achieved when using the claimed invention is to combine in one miniature device a blood sampling system, a system for collecting, processing and subsequent analysis of data from immunochromatographic test strips in special software and a system for the constant supply of new, pre-filled test cassettes of the required type. .

The essence of the invention lies in the fact that the pocket adapter-blood analyzer is a set of interconnected electromechanical systems. On the inner walls of the case, opposite each other, there are guide recesses that are necessary in order to set the trajectory of movement for a number of test cassettes, opposite the guide recesses there is a partition behind which the winding mechanism is placed, above the winding mechanism there is an analyzer working area, which is an empty space with two holes, one hole, located at the bottom, is intended for shooting the lancet into the finger, and the second, on the side wall of the working area, for blood sampling, in addition, the side wall is a partition, behind which there is an immunochromatographic strip attached to the test cassette, also the case has a side cover for replacing used test cassettes with new ones and a removable module in which the battery is located.

The invention is illustrated by the following drawings:

fig. 1 - internal device of the blood analyzer adapter,

fig. 2 - operation of the device when the button is pressed,

fig. 3 - appearance and internal shape of the case,

fig. 4 - electrical system of the device,

in fig. 5 - appearance of the test cassette with a lancet (needle) and a test strip,

fig. 6 - working space of the analyzer,

fig. 7 - indicator sensor for the test strip,

fig. 8 - control board,

fig. 9 - backlight,

fig. 10 - visual indicator of results,

fig. 11 - winding motor,

fig. 12 - case without back cover,

fig. 13 - back cover,

fig. 14 - store mechanism,

fig. 15 - test cassettes,

fig. 16 - battery.

fig. 17 - charging module

The claimed device consists of the following components (Fig. 1):

1. Button.

2. Backlight system.

3. Cassette winding mechanism.

4. Test cassette.

5. Indicator sensor.

6. Clockwork motor.

7. System wiring.

8. Shoulder pusher store.

9. Magazine spring.

10. Control board.

11. Battery.

Externally, the case has a laconic design that looks like a cylinder with rounded ends, a small hole at the top and a visual indicator of the results (the device's illumination system, located under the working area and necessary to display test results to the user), in the form of a translucent ring. The inner part of the case has a special design due to the operation of the mechanism. On the inner walls of the case, opposite each other, there are guide recesses resembling rails. These recesses are necessary to set the trajectory of movement for a number of test cassettes 4 (a device that performs the function of a lancet and an adapter for test strips). Opposite the guide recesses there is a partition, behind which the cassette winder 3 is placed. The cassette winder 3 is a mechanical device necessary for shooting the test cassette 4 with a lancet into the hole of button 1 when it is pressed. It consists of a compression spring, a locking plate, two cams and a plate for fixing test cassettes 4. Above the winding mechanism 3 is the working area of the analyzer, which is an empty space with two small holes. One hole, located at the bottom, is designed for shooting the lancet into the finger, and the second, on the side wall of the working area, for blood sampling. In turn, this side wall is a partition, behind which lies an immunochromatographic strip attached to the test cassette 4. Also in the case there is a side cover for replacing used test cassettes 4 with new ones and a removable module containing the battery 11. Battery 11 is a power source for the electronic elements of the device and is located in the removable part of the case (charging module), which is located under the control board 10.

The analyzer device is a system consisting of elements partially dependent on each other. The mechanism of the store, which through the shoulder-pusher 8 continuously raises a number of test cassettes 4 along the guides in the recesses in the body. At the end of the guide grooves, the last test cassette 4 is mounted on the plate of the winding mechanism 3, which consists of an extended “compression” spring, two cams and a stopper. When button 1 is pressed in the working area of the analyzer, special plates-pushers attached to the button rotate cams fixed by a locking mechanism. This provokes a sharp compression of the spring and shoots the cartridge with the lancet into the finger through the hole located in the button 1. Following this action, a small electric motor located under the winding mechanism 3 restarts it. After the test substance is delivered to the side opening of the working space and the immunochromatographic strip is developed, indicator sensor 5 (a device designed to take readings from the immunochromatographic strip), consisting of one LED that acts as a light source, and several photodiodes for reading data, takes readings from the test -strips. The data is transmitted to the control board 10, which, through the backlight system 2, will display the test result to the user, or send the data to a third-party device. The control board 10 y is designed to receive, transmit data, output the result through the backlight system 2 to the user, control the indicator sensor 5 and the winding motor 6 and monitor the battery 11. Next, the user needs to remove the used test cassette 4 from the analyzer, and the testing cycle can be repeated .

By pressing the button 1 (Fig. 2), the cams begin to rotate in the winding mechanism 3 of the cassette 4. This provokes a sharp compression of the pre-stretched spring and the raising (shooting) of the test cassette 4 with a needle into the hole of the button 1.

After a finger puncture, it is necessary either directly from the finger or using a special pipette (Panchenkov's capillary) to deliver blood into the hole in the side wall of the working space (Fig. 6).

After waiting for some time, indicator lines will appear on the test strip, which indicate a negative or positive result. The indicator lines will be read by the indicator sensor 5 (Fig. 7) consisting of two photodiodes, one LED and a mirror located at an angle (30°) above the diodes.

The LED serves as a light source for the photodiode. The lower photodiode reads the development reaction or its absence on the indicator line, which informs about the performance of the test strip. And the top one is about the presence of a positive or negative test result.

Photodiodes are also able to determine the degree of development (brightness) of the indicator line of the immunochromatographic test strip, thereby taking values in the form of an orpediated gradient, converting this into numerical values.

Next, the data is transmitted to the control board 10 (Fig. 8), which, depending on the readings of the photodiodes, will output a certain signal to the backlight system 2 (Fig. 9), consisting of a number of LEDs. And also give the numerical values of testing to a special program, in which, depending on the type of analysis, they will be converted into the necessary units of measurement for further medical research.

If there is no detected lower indicator line on the test strip, the control board 10 sends a signal (Fig. 10) to the backlight system 2 that it is necessary to turn on the yellow color, which will prompt the user about the inoperability of this test strip. If there is only a lower colored line, the red color lights up, informing about a negative test. And in the presence of both lines, that is, with a positive test result, green lights up.

When displaying the test result to the user, the control board 10 sends a signal to the winding motor 6. The winding motor 6 (Fig. 11) is a miniature electric motor with a limited angle of rotation, designed to stretch the spring of the winding mechanism using carbon fiber fishing line (diameter 0.5 mm) . Clockwork motor 6 is located on the inner wall behind the clockwork mechanism 3.

After testing, to prepare the analyzer for subsequent use, you need to remove the used test cassette 4 from the device. This can be done by opening the cover on the back of the case and carefully pulling it out (Fig. 12, 13).

Following the removal of the used test cassette 4, the magazine mechanism raises a row of cassettes 4 through the shoulder-pusher 8 (Fig. 14).

Test cassettes 4 move along a predetermined trajectory due to the guide recesses in the inner part of the case, and thanks to them, the first cassette 4 from above is mounted on the plate of the winding mechanism 3, and the testing cycle is repeated (Fig. 15).

The power source for the electrical elements of the analyzer is the battery 11, located in the removable part of the housing (charging module), which is located under the control board 10 (Fig. 16).

The charging module is charged by the auxiliary charger.

The test cassette 4 has a special shape due to the design features. Low-melting thermoplastic polymers should be chosen as the material for cassettes 4. Silicone on a platinum catalyst is suitable for this, as it has good chemical neutrality and sufficient mechanical hardness.

It is more convenient to manufacture a test cassette by casting into a mold (Fig. 5).

The shape of the test cassette 4 is determined by the features of operation and the design of the device. In the upper front part of the cassette 4 is placed and directed upwards a steel lancet for piercing the finger. In the upper rear part there is an angled rectangular hole for fixing the immunochromatographic test strip. On the sides there is an axis necessary for movement along the guide recesses of the body. At the front end of the cassette 4 there is a special hole, into which the winding mechanism plate 3 enters for subsequent firing, and which also allows you to freely remove the used test cassette 4 from the device. Test cassette 4 is a disposable consumable for the analyzer.

The test cassette 4 utilizes third party immunochromatographic test strips, thereby providing the user with a very wide range of test cassettes 4 with a variety of test strips.

The recommended way to produce the body is to print on a 3D printer. Based on the required mechanical properties, the following materials are available to choose from: ABS plastic (long service life, heat resistant, industrial use) and nylon (strong, durable and resistant to friction). It can also be done by injection molding. But in the case of casting, it is necessary either to use molds with a rather complex design, or to make a body from several components.

The lighting system protection ring is an integrated part of the housing and is designed to transmit light and protect the lighting system. Represents a transparent ring, rigidly soldered from two ends into the case. For a ring, a material such as cast monolithic polycarbonate is well suited (high-strength transparent material with increased impact resistance (often used in the production of bulletproof structures), resistance to natural and chemical environments, simple processing)

Thus, the claimed invention is an adapter with a built-in function for determining the quantitative content of the analyte, by removing and processing information from the immunochromatographic test strips used in the analyzer. The claimed technical solution allows, without prior adjustment, to carry out a large number of test cycles with a wide range of analyzes of commercially available immunochromatographic test strips. The device is easy to use for a person without special training, and is conceived as a device for individual use. The claimed invention is quite portable, has a cylindrical shape like a marker, small dimensions and can easily fit in a pocket. Designed for repeated (from 5 or more times) use of pre-inserted cassettes with the necessary types of immunochromatographic test strips.

Claims (1)

A pocket adapter-blood analyzer, including a housing, on the inner walls of which there are guide recesses opposite each other, which are necessary in order to set the trajectory of movement for a number of test cassettes, opposite the guide recesses there is a partition, behind which is placed a winding mechanism consisting of a spring compression, a locking plate, two cams and a plate for fixing test cassettes, a winding motor for stretching the spring of the winding mechanism is located on the inner wall behind the winding mechanism, the working area of the analyzer is located above the winding mechanism, which is an empty space with two holes, one hole located below , is intended for firing a lancet into the finger, and the second, on the side wall of the working area, for taking blood, in addition, the side wall is a partition, behind which there is an immunochromatographic strip attached to the test cassette, an indicator sensor is placed in the housing for taking readings with him immunochromatographic strip, backlight system, side cover for replacing used test cassettes with new ones and a removable module in which the battery is located, a control board is placed above the removable module for receiving and transmitting data and for displaying the result of taking readings from the immunochromatographic strip through the backlight system to the user, to control the indicator sensor and the clockwork motor and to monitor the condition of the battery.

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