Analyser for automatic determination of hemostatic profile

FIELD: physics.

SUBSTANCE: analyser has a revolving cuvette with a sample in which there is a control ferromagnetic ball, a magnet which can interact with said ball, a coagulation sensor which transmits signals from the ball and having a Hall sensor and a magnet, a signal processing device in form of a power supply unit, a Hall sensor, a microprocessor and a display device included in a common measuring circuit. The analyser is multi-channelled by fitting at least one additional revolving cuvette to form several channels. All cuvettes lie in a temperature-controlled unit included in the common measuring circuit. The longitudinal axis of each cuvette is inclined at an acute angle to the vertical. In the coagulation sensor, the magnet lies opposite the Hall sensor on the opposite side of the cuvette. The magnet is in form of a flat cylinder mounted with possibility of displacement along the cuvette. The analyser is also fitted with a unit for controlling rotation of the cuvettes and, included in the common measuring a circuit, a measurement parameter adjustment unit having rewritable read-only memory, and a timer configured to automatically switch on when a reactant is fed into the cuvette.

EFFECT: use of the invention increases reliability and broadens functional capabilities of the analyser owing to use of a multichannel measuring circuit, and simplifies the measuring procedure by automating the process.

4 cl, 2 dwg

 

The invention relates to medical devices, and in particular to structures analyzers hemostasis (coagulometer) and allows to improve the reliability of recording the time of coagulation in the analysis of the blood coagulation system, in particular when determining the basic tests of coagulation based on the registration process fibrinopeptide. Due to the multi-channel significantly increases the performance.

Known ball coagulometer in German patent DE 3523906, CL G01N 11/10, publ. 04.07.1955. Coagulometer contains a rotating cuvette with the sample, which is a controlling ferromagnetic ball sensor that transmits signals from the ball, and device processing of this signal. The ball is attracted and fixed by the magnet located on the side of the cuvette. The coagulation of the ball is captured breakdown is rotationally driven, resulting in a magnetic sensor, located between the ball and the magnet generates a signal processed by the signal processing unit.

The disadvantages of this solution should include low reliability due to low noise immunity due to the fact that:

distance from the ball to the magnet is adjusted so that the force of gravity had set value. As the sensor is mechanically connected with the magnet, and signals the sensor decreases sharply with increasing distance from the sensor to the ball, at large distances, magnet ball, the sensor signal may be very weak, which reduces the accuracy and objectivity of clinical diagnostic tests.

- this device is usually surrounded by other devices and elements that generate magnetic fields of low frequency and large ferromagnetic masses affecting the magnetic sensor. Temperature changes also affect its sensitivity, and this inevitably affects the accuracy of diagnosis (all measurement of blood parameters should be carried out strictly at 37°C). At other temperature proteins are inadequate, therefore, the specified temperature shall be maintained with appropriate technical solutions.

The closest functionality to the proposed analyzer is coagulometer ball containing a rotating cuvette with the sample, which is a controlling ferromagnetic ball, the sensor bulb and the signal processing unit, characterized in that the sensor bulb contains located at the minimum from the cell distance stationary Hall sensor and having a longitudinal movement regulating the force of gravity ball magnet, and a circuit for signal processing includes sequentially located the source of current, a Hall sensor, a voltage amplifier, the filter h is some frequency, filter low frequency, the comparator, the microprocessor, the device starts and the display device, with the device launching connected with the microprocessor and power source. (Patent RU 2133955, CL G01N 11/10, publ. 27.07.1999). This solution is taken as the nearest equivalent.

The disadvantage of this solution is:

- the location in the immediate vicinity of the magnet and the sensor, which leads to a considerable influence of the field magnet on the sensor. In addition, due to the oblong (elongated) shape of the magnet is formed a field that "covers" all the basic elements: the ball, the sensor and the magnet. To address this impact similar used extremely complex circuit and anti-jamming;

- the absence of a system for pre-heating (temperature) to the desired temperature (about 37°C) will not allow the device to function normally, as fibrin threads exactly when this temperature is capable of capturing the ball;

- limited functionality due to odnogolosy, i.e. the impossibility of the simultaneous study of several samples, as well as the lack of output on the external device (computer, printing device) and the possibility of using automatic pipedoctor;

- no additional stabilization system the position of the ball in a ditch for the region is Genia calibration channels and improve the noise immunity will inevitably reduce the reliability of the device.

The technical problem to be solved using the claimed device is increased reliability and enhanced functionality through the creation of multi-channel Electromechanical coagulopathies analyzer with advanced quality and quantity measurements, automation, maximum simplification and ease of use to staff, opportunities to adjust and introduction of new methods of measurement.

The technical result, that is, the invention lies in the realization of multichannel measurement scheme, simplifying the measurement procedure for automating the process, reducing subjective factors measurements, as well as improving the reliability and accuracy of measurements of appropriate technical solutions.

This technical result is achieved due to the fact that the multichannel analyzer for the automatic determination of hemostasis contains a rotating cuvette with the sample, which is a controlling ferromagnetic ball is located with the opportunity to interact with the magnet, the sensor coagulation, transmitting signals from the bulb and including a Hall sensor and a magnet, the signal processing unit in the form included in the total measuring circuit power supply, Hall sensor, high performance embedded the quarrel and display unit, moreover, the multichannel analyzer is built through supply of at least one additional rotating cuvette with the formation of multiple channels, all of the cell are controlled unit included in the measuring circuit, the longitudinal axis of each cell is inclined at an acute angle to the vertical, and the sensor coagulation magnet is opposite to the Hall sensor on the opposite side of the cuvette, and the magnet is made in the form of a flat cylinder mounted for movement along the cell, while the analyzer is equipped with a control unit of rotation of the cuvettes, and is included in the measuring circuit block correction measurement parameters containing writable persistent storage device, and the timer is configured to automatically turn on when adding reagent in the cuvette.

thermostating unit contains devices of light and sound display temperature control.

The analyzer can be equipped with devices for interfacing with external devices - automatic pipestone, a print device and a keyboard.

The analyzer can also be performed with interface connection to a host computer.

The inventive device is illustrated by drawings,

where 1 is a structural block diagram of the device

Figure 2 - General view of the measuring channel of the cuvette and the sensor.

Multi-channel semi-automatic analyzer contains the unit cuvette 1 with samples. Figure 1 shows a variant of the device with four measuring cells, each of which is control of ferromagnetic ball 2 held by the permanent magnet 3 and is associated with the magnetic field sensor (Hall sensor) 4.

The cell with the help of the motor and the control circuit 5 are rotated at a constant speed. The longitudinal axis of each of the cell 1 is inclined at an acute angle to the vertical for operator comfort and improved ergonomics of the analyzer.

In the sensor coagulation magnet 3 is located opposite to the Hall sensor 4 on the opposite side of the cell 1, which increases the stability of the system and eliminates the chance of false positives.

The magnet 3 is made in the form of a flat cylinder mounted for movement along the cell and having axial symmetry of the magnetic field, which simplifies and makes more reliable the site settings of the measuring channels.

Maintaining a constant temperature in the measured cells and cells of the sample preparation is provided by thermostat 6, with length 7 and the audio 8 zone temperature control.

Select the cell in which the measurement is manual 9. Each cell has its own the public display of his condition 10.

The signals from the sensors are received in the controller 11, where for certain programs is the processing of the results. The measurement results are displayed on the display 12.

The management process is carried out using the built-in keyboard 13.

The presence of block correction measurement parameters 14 containing writable persistent storage device, permits (if necessary) to introduce new or modify existing measurement techniques.

Built-in clock 15 maintain medical standards of accountability, in which you want to specify the exact time of the measurement, and also perform the timer function.

The presence of industry-standard interface 16 with galvanic separation 17 allows you to connect external devices (computer, printer).

Automatic pipestone connect using sockets 18. Connect the keyboard is also implemented through the slot 19. The device is powered with built-in power supply unit 20.

The device is a microprocessor-based device to determine a baseline koagulogicheskie tests based on the reception time of the formation of a clot after incubation of the sample with reagents, activating and carrying out the coagulation process up to the formation of a clot.

the Device is a semi-automated system for measuring the time of formation of a clot (mechanical method), used to determine prothrombinase time (PT) sec, prothrombinase time for Quick, %, prothrombinase relations (ON), international normalized ratio (MPE), activated partial thromboplastin time (APTT), sec, thrombosed time, in seconds, fibrinogen according to Klaus, the activity of coagulation factors II, V, VII, VII, IX, X, XI.

The proposed analyzer can be measured by any test, based on the determination of the time of formation of the fibrin clot. For any test is determined only coagulation time. The calculation is performed only if the device is an appropriate methodology. The measurement result can be both quantitative and qualitative.

When using the appropriate reagents as samples you can use plasma or whole blood. Coagulometer applies to "open" systems, i.e. can work with both domestic and imported reagents.

Add samples and reagents is performed manually. Automatically includes the time of the formation of a clot.

The analyzer is a device power failure and is designed to perform the tests required in the inpatient and outpatient environment: in clinical diagnostic laboratories, quality control departments, blood banks, and with utilityowned productions for fractionation of donor blood plasma and other institutions of the blood Service, as well as in research institutes.

The functioning of the inventive device is as follows.

The analyzer uses a special cuvette 1 with ferromagnetic steel (stainless steel) ball 2 (Figure 2). The sample is added into a cuvette and after a suitable time warming up in a special cell of thermostat is transferred to the measuring channel of the analyzer, which rotates slowly (50 rpm) around its longitudinal axis.

Adding the appropriate reagent using pipemaster 18 is automatically activated the timer 15. The device has a connection of two pipedoctor - one for the start of incubation (warm-up) with the corresponding start the timer incubation, the second to start the measurement.

In the unit cell 1 are in the rotation, so that the ball 2 is not spinning randomly in the cell before adding the analyzed samples and reagents, it is by tilting the cell at an acute angle to the vertical and hold the magnet 3 is always lower point that allows easier and more accurate to adjust the system, when this ball performs the function of a mixer. Shifting the ball only under the influence of the emerging strands of fibrin (zagustevanii blood or blood plasma), resulting in displacement of the ball and commit time to this point by the device.

In the process of coagul the logical reaction is the formation of filaments of fibrin, that should stop the ball, which initiates the signal from the sensor coagulation e-stop timer. With the help of thermostat 6 provide the desired temperature in the working cells and in cells for pre-heating the samples.

External keyboard 19 provides adjustment if necessary, the existing methods of measurement (in the "care" parameter) or the introduction of new techniques, for this purpose, the device has a writable persistent storage device.

The pulse from the Hall sensor 4 is fed to a controller which stops the countdown and transmits the value to the display 12 and a printing device connected via the RS232 interface 16. The analyzer provides the ability to store previous measurements.

In comparison with the known analogues of the proposed device is advanced adjustments and the introduction of new measuring techniques, a new set of essential features to ensure declare the above technical result of the measurement, automatic calibration of measurement channels before beginning work on reference reagents (standards), which is implemented by means of software.

This, in turn, increases the objectivity and efficiency measurement, empowerment, reduction of time and the measurements when running tests necessary inpatient and outpatient conditions: in clinical diagnostic laboratories, quality control departments, blood banks and specialized production for fractionation of donor plasma and other institutions of the blood Service, as well as in research institutes.

The use of the analyzer allows to considerably simplify the procedure and process reliability mode register the coagulation time in the analysis of the blood coagulation system in accordance with the nomenclature of tests for coagulation, installed and accepted standards of treatment.

The advantages of the described parser included extending the functionality by including in the measurement circuit of thermostat 6, the interface 16 (allows you to connect a portable printing device), data calibration and measurement data in the computer), EPROM 14 (writable persistent storage device) and a controller 11 corrects if necessary, the so-called "care" parameter during operation of the device, as well as introduce additional measurement techniques, if such a need arises, which significantly extends the capabilities of the device.

In addition, when connecting a computer provided is a current archive data (storing the results of previous measurements).

Implemented as a light and sound display temperature control and measurement, because thermostating unit contains devices light 7 and the audio 8 zone temperature control. The presence of two slots for automatic pipedoctor 18 allows their use automatically (when making use of their working in cuvette reagent) to start the measurement process and incubation (implemented programmatically). At the same time saved and manual mode, allowing you to make samples and reagents manually using the normal budget pipedoctor.

The device is easy to use. When it is used to simplify and automate the work of the laboratory.

Multichannel capability. The measurements are carried out simultaneously in several channels. In addition, the device has cooled channels 6 for preheating subsequent samples. Feeds themselves are absolutely identical, but the process of their composition and implementation of schemes (primarily in relation to suppress interference in the interference part) exclude the possibility of failures. The developed device has passed technical and medical tests. Currently training coagulopathies analyzer for serial production.

1. Analyzer for automatic measurement of hemostasis containing urasawa the Xia cuvette with sample for control of ferromagnetic ball is located with the opportunity to interact with the magnet, the sensor coagulation, transmitting signals from the bulb and including a Hall sensor and a magnet, the signal processing unit in the form included in the total measuring circuit power supply, Hall sensor, microprocessor and display unit, characterized in that it is made multichannel due to supply at least one additional rotating cuvette with the formation of multiple channels, all of the cell are controlled unit included in the measuring circuit, the longitudinal axis of each cell is inclined at an acute angle to the vertical, and the sensor coagulation magnet is opposite to the Hall sensor on the opposite side of the cuvette, and the magnet is made in the form of a flat cylinder mounted for movement along the cell, while the analyzer is equipped with a control unit of rotation of the cuvettes, and is included in the measuring circuit block correction measurement parameters containing writable persistent storage device, and the timer is configured to automatically turn on when adding reagent in the cuvette.

2. The analyzer for the automatic determination of hemostasis according to claim 1, characterized in that h is of thermostating unit contains devices of light and sound display temperature control.

3. The analyzer for the automatic determination of hemostasis according to claim 1, characterized in that it is equipped with devices for interfacing with external devices - automatic pipestone, a print device and a keyboard.

4. The analyzer for the automatic determination of hemostasis according to claim 1, characterized in that it is made with interface connection to a host computer.



 

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