CN210376377U

CN210376377U - Platelet function detection device

Info

Publication number: CN210376377U
Application number: CN201921073328.0U
Authority: CN
Inventors: 徐新
Original assignee: Jiangsu Clindiag Medical Technology Co ltd
Current assignee: Sinnowa Medical Science & Technology Co.,Ltd.
Priority date: 2019-07-10
Filing date: 2019-07-10
Publication date: 2020-04-21
Anticipated expiration: 2029-07-10

Abstract

The utility model discloses a platelet function detection device, which comprises a detector and a detection card; the detector comprises a separation-detection disc, a driving motor and a detection unit; the separation-detection disc is provided with more than one detection screens, is driven by a driving motor to rotate, and uniformly mixes, separates and detects the samples and the reagents on the detection screens; the detection card is arranged on the detection clamping position, the detection card is internally divided into more than two inner cavity pools, the inner cavity pools are respectively connected by narrow channels with the cross section area being less than 60% of the maximum cross section area of the inner cavity of each pool, and all the inner cavity pools are sequentially communicated in a single-channel series connection mode. The utility model discloses a detector and the detection card cooperation of supporting design specially under, accomplish whole blood sample and reagent mixing reaction, separation and detection overall process.

Description

Platelet function detection device

Technical Field

The utility model relates to a platelet detects the technique, concretely relates to platelet function detection device.

Background

Thrombotic diseases are the diseases which are the most serious harm to human health and life globally at present. Controlling platelet function is currently the most common and commonly used method of thrombus control. However, the current approach to "standardizing" the application of antiplatelet drugs to all patients presents significant problems clinically due to individual differences among patients and differences in response to drugs: or the thrombus disease cannot be effectively prevented and treated, or the patient suffers from bleeding damage due to the excessive amount. And the research in more than 10 years confirms that the individual difference of the antiplatelet drugs is ubiquitous. Therefore, the platelet function detection in the thrombus prevention and treatment is very important and is an important measure for realizing accurate thrombus prevention and treatment and improving the thrombus prevention and treatment level.

Although platelet function tests have been in history for more than fifty years, the existing platelet function test methods have obvious defects: poor accuracy, slow speed and incapability of high-speed mass detection. For example, the optical method is a platelet function detection method with the longest history, and the method needs repeated centrifugation for sample detection, and manual operation for separating platelet-rich plasma and platelet-poor plasma, so the operation is very complicated, and the excessive operation links before sample detection often lead to activation of platelets before detection. In contrast, in recent years, platelet function meters which directly detect changes in platelet aggregation in whole blood have appeared on the market, but since the number of red blood cells is much larger than that of platelets in a general clinical blood sample and the volume of red blood cells is much larger than that of platelets, the detection signal for platelet function is weak. Most of the clinical trials published at home and abroad in recent years using these methods have failed.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a platelet function testing device.

Realize the utility model discloses the technical solution of purpose does: a platelet function detection device comprises a detector and a detection card;

the detector comprises a separation-detection disc, a driving motor and a detection unit; the separation-detection disc is provided with more than one detection clamping position and is driven by a driving motor to do reciprocating and unidirectional rotation motion, and samples in the detection card are uniformly mixed, separated and detected; the detection unit comprises a light source transmitter and a receiver;

the detection clamping position is used for loading a detection card and a comparison card, the structures of the detection card and the comparison card are the same, the inside of the card is divided into more than two inner cavity pools by narrow connecting channels, the inner cavity pools are respectively connected by narrow channels with the cross section area of less than 60 percent of the cross section area of the maximum position of each inner cavity pool, and all the inner cavity pools are sequentially communicated in a single-channel series connection mode.

Compared with the prior art, the utility model, it is showing the advantage and is: (1) the detection is convenient: the whole blood is directly used, and the platelet is detected after red blood cells and white blood cells are automatically separated in the detection process, so that the interference of other cells is avoided; (2) can detect any platelet receptor function and fully meet the clinical requirement; (3) the rapid detection can be suitable for the bedside detection of a small amount of samples and the batch rapid detection of a large amount of samples; (4) differences caused by the detection card and the sample are effectively eliminated in the detection process, so that the quality of the detection result can be better ensured; the method only needs no manual participation instrument to automatically complete the mixing reaction of the blood sample and the reagent, separate plasma, accurately detect the content of the platelet in the sample and the activation of the platelet caused by the stimulation of the aggregation inducing agent, and directly reflect the function of the platelet. And the detection error possibly caused by the difference of red blood cells and the detection card in the blood sample is eliminated; (5) the detection method can also effectively monitor the quality of the sample, and can eliminate detection result errors caused by activation and aggregation of platelet functions in the sample before detection; (6) the reagent consumption is low, and the waste is low; (7) the instrument has simple structure and small volume.

Drawings

FIG. 1 is a schematic diagram of the apparatus. In the figure: 1. a control unit; 2. a display; 3. a drive motor; 4. a separation-detection tray; 5. a detection unit; 6. a printer; 7. a light source of the detection unit; 8. a signal detector of the detection unit; 9. a test card loaded on the separation-test tray.

FIG. 2-1 is a schematic top view of an instrument separation-detection tray in a horizontal tray configuration.

FIG. 2-2 is a schematic view of the position of the separation-detection plate and the detection card of the instrument. FIG. 10 shows an adjustable fixing device for a test card; 11. the card is fixed for detection.

FIG. 3-1 is a schematic top view of a test card having three inner chamber wells.

FIG. 3-2 is a longitudinal cross-sectional view of a test card having three inner cavity wells.

Fig. 3-3 are top perspective views of a probe card with three internal cavities, in which E is a connecting cell C exhaust plenum and its opening F is located in cell a.

FIG. 4 is a top view of a triple card.

FIG. 5-1 is a longitudinal cross-sectional view of an open-topped test card.

Fig. 5-2 is a side perspective view of fig. 5-1.

FIG. 6-1 is a schematic view of a horizontal separation test tray structure and a test card assembly for performing the transmitted light test.

Fig. 6-2 is a schematic view of a horizontally split detection tray configuration for performing scatter detection.

Fig. 6-3 are schematic views of an angled split detection disk performing transmission detection.

Fig. 6-4 are schematic diagrams of an angled split detection tray performing scatter detection.

Detailed Description

Platelet function has many functions, playing an important role in maintaining the health of the body and the pathological process of various diseases. The existing platelet function detection method has defects, so that the clinical application of the platelet function detection is limited. Therefore, a simple, convenient, rapid, small-sample-consumption and automatic detection method and an instrument are designed. Under the cooperation of the instrument and a detection card specially designed in a matching way, the whole process of mixing reaction, separation and detection of a whole blood sample and a reagent can be automatically completed, and the instrument is also designed with various quality control measures to ensure high precision of a detection result.

A platelet function detection device comprises a detector and a detection card;

the detector comprises a separation-detection disc, a driving motor and a detection unit; the separation-detection disc is provided with more than one detection screens, the separation-detection disc is driven by a driving motor to do reciprocating and unidirectional rotation motion, and samples in the detection cards on the detection screens are uniformly mixed, separated and detected; the detection unit comprises a light source transmitter and a receiver;

the detection clamping position is used for loading a detection card and a comparison card, the structures of the detection card and the comparison card are the same, the inside of the card is divided into more than two inner cavity pools by narrow connecting channels, the inner cavity pools are respectively connected by narrow channels with the cross section area of less than 60 percent of the cross section area of the maximum position of each inner cavity pool, and all the inner cavity pools are sequentially communicated in a single-channel series connection mode. The detection card and the comparison card are of a closed structure from the whole body to the tail part except for the inlet opening.

After the first separation is completed, the driving motor drives the separation-detection disc to rotate at a low speed to drive the detection cards to the detection unit one by one to detect the detection cards one by one. The detection unit can rotate to a position away from the separation-detection disc when the instrument works in high-speed centrifugal separation, and the detection unit moves to a position close to the separation-detection disc when the detection card needs to be detected, so that the detection of the detection card is facilitated. It is also possible that only the light source part of the detection unit, or the detector part, is moved to change position.

Furthermore, the detection card is provided with only one opening which is axially vertical to the card, the opening is close to the central position of the separation-detection disc, and the bottom edge of the narrow channel between each inner cavity pool is higher than the top of the adjacent inner cavity pool when the detection card is horizontally placed.

Furthermore, the separation-detection plate is arranged in the instrument working chamber, the heating constant temperature work is provided in the instrument working chamber, and the centrifugal separation and the detection of the sample are completed in the instrument working chamber.

Further, the detection card uses an angle turn or a horizontal turn.

The separation detection disc of the instrument can be of a horizontal disc-shaped structure, and a detection card is horizontally placed and fixed on the horizontal separation-detection disc when detection is executed, and is also horizontally placed.

Or the detection card is placed and fixed on the angle separation-detection plate at an angle of 5-45 degrees.

The axis of a detection light source of the detection unit is vertical to the detection card; the receiver is arranged at a position corresponding to the light source and is used for detecting the transmitted light; or the receiver forms a certain included angle with the detection light to detect the scattered light.

The position of the detection device is automatically adjusted according to the requirement, or the position of the light source emitter and the receiver is automatically adjusted.

Furthermore, the opening of the detection card is the same as the axial direction of the pipe, is positioned at the upper top end of the pipe and is matched with the angle turning head for use.

Furthermore, the narrow channel of the detection card internally connected with each inner cavity pool is positioned at the center of the tube, and the shape of the tube forms a sugarcoated haws string structure according to the inner cavity and the narrow channel, or the appearance of the tube is a straight tube or a strip structure.

Furthermore, the detection card is a fan-shaped multi-connected cup structure formed by compounding a plurality of single detection cards with the same structure, and the multi-connected cup structure is formed by 2-10 single detection cups.

Furthermore, three inner cavity pools which are mutually connected in series and communicated are arranged in the detection card, namely a pool A, a pool B and a pool C in sequence, wherein the pool A is a reaction pool, the pool B is a detection pool, and the pool C is a sedimentation pool; the A pool is provided with an upward opening which is axially vertical to the detection card and is used for adding a sample and a reagent, and the sample and the reagent are mixed and react in the A pool; the pool B is connected with the pool A, C through a narrow channel, the cross section area of the narrow channel is less than 60% of the maximum cross section area of the inner cavity of each pool, and the pool B is not directly opened to the outside; the C pool is provided with a fine exhaust channel which is independently communicated with the C pool and is communicated to the vicinity of the A pool area to be opened outwards, but the fine exhaust channel is not connected with any other inner cavity pool; the channel and the opening are used for exhausting original air in the B, C pool during centrifugal separation; the detection card assembly is loaded on a horizontal separation-detection plate for use.

Further, the volume of the A pool is equal to or more than B, C pool volume sum, and the difference of the B, C pool volume is not more than 30%.

Or, two inner cavity pools which are communicated with each other are arranged in the detection card, the reaction pool and the detection pool share one inner cavity pool, and the other inner cavity pool is used as a sedimentation pool.

The detection method based on the platelet function detection device comprises the following steps:

step 1, adding a sample and a polymerization inducing agent into a reaction tank of a detection card A, and then placing the detection card on a detection clamping position on an instrument separation-detection turntable for fixing; synchronously adding the same blood sample into a control detection card A pool with the same structure in an equivalent manner, and adding an equivalent isotonic diluent or anticoagulant into the control detection card A pool; placing the sample detection card and the comparison detection card on a separation-detection tray;

step 2, starting the instrument, repeatedly rotating the separation-detection turntable for multiple times, uniformly mixing the blood sample and the aggregation inducing agent in the detection card A pool along with shaking and reacting for more than 3 minutes, keeping the working chamber of the instrument at a constant temperature, and taking the instrument at 28-38 ℃;

step 3, after the blood sample and the reagent are uniformly mixed, the separation-detection turntable rotates at a high speed in a single direction at a first speed, so that the samples in the A pools of the detection cards and the comparison card flow to the B-C pools under the driving of centrifugal force, and in the centrifugal process, the blood sample is separated due to different specific gravities of different components in the blood sample: red blood cells and white blood cells with higher specific gravity enter the C pool, and the aggregated platelet complex also enters the C pool; the B pool is plasma and monomer platelets distributed in the plasma, or small platelet aggregates with low aggregation degree are also contained;

step 4, detecting the absorbance of the B cell for the first time by the instrument, wherein the detected absorbance (turbidity) is related to the content of the platelets in the plasma; the instrumental detection may be at a single wavelength, at multiple wavelengths, or by the addition of dyes to the sample to aid in the identification of specific cell types.

And 5, after the first detection is finished, continuing to rotate the separation-detection turntable at a high speed at a second speed, so that original platelet monomers and platelet aggregates aggregated to a low degree in the B pool are precipitated into the C pool under the action of centrifugal force due to high-speed centrifugation, and then detecting the B pools of the detection cards and the comparison detection card again by the instrument to obtain blank values of the B pools of the detection cards.

Step 6, calculating the platelet content and aggregation rate results of the blood samples of each detection card

The content of the platelets in the plasma after the blood sample is separated is related to the detected absorbance (O.D value). The instrument calculates and obtains more accurate platelet content of each sample by detecting the O.D value obtained by the first detection of the B pool and deducting the blank value of the B pool obtained by subsequent detection, and the platelet content/concentration is represented by net absorbance O.D. The calculation method is as follows:

and (3) comparing the clean platelet content value in the detection card B pool with the absorbance value obtained by the first detection of the control detection card B pool, namely the blank absorbance value of the detection card B pool. The absorbance values are all represented using o.d. values.

The net platelet content of the sample detection card is equal to the absorbance value obtained by the first detection of the sample detection card B pool, namely, the blank absorbance value (the absorbance O.D. value detected after the second centrifugation) of the sample detection card B pool;

the platelet aggregation rate was calculated from the above results as follows:

further, the first speed in step 3 is 2000-4000 rpm, and the rotation time is 5-8 minutes; the second speed in the step 5 is more than 5000 r/min, and the time is more than 5 min; during detection, the rotating speed is lower than 100 revolutions per minute.

The same separation conditions were used for each test card and control card of the same blood sample.

When the absorbance of the detection contrast detection card B pool is too low and is lower than the absorbance of platelet-rich plasma freshly separated from a normal blood sample, the instrument automatically prompts the quality problem of the sample or the high-degree aggregation of the platelets in the sample before detection, and the reliability of the platelet function detection result obtained under the condition is low. Detection errors due to sample quality can be avoided.

The instrument has the function of automatically analyzing the separation condition of the blood sample on line. The instrument analyzes the erythrocyte sedimentation condition in the sample by using multi-wavelength (400-700nm range), and when the RBC in the detection area is fully sedimentated and separated and enters the C pool, the instrument starts turbidimetric scanning on each card detection area of the same group of samples; the sample which is separated early is early in the result, and the sample which is separated late is separated for a long time to ensure that the detection is carried out after the separation is finished.

The acridine dye can be used for the instrument to judge whether the blood sample is separated from the PLT or not, because the specific gravity of the instrument is larger relative to platelets RBC and WBC, and the WBC contains rich DNA and can be stained by the acridine dye, the 'acridine dye' in the separated plasma prompts the existence of WRC or is detected by hemoglobin specific absorption wavelength, and the RBC is absorbed too much, which indicates that the RBC is not well separated from the platelets.

The detector has the functions of determining the height of the upper and lower interfaces of the supernatant after the sample in the detection card is separated and scanning in the whole process.

The detector uses a plurality of different wavelengths, and has the function of analyzing the proportion of particles with different sizes in the turbidity of the supernatant after the sample in the detection card is separated through the absorbance difference of the different wavelengths.

The present invention will be described in detail with reference to the accompanying drawings and examples.

Example 1

As shown in fig. 1, a platelet function test device is composed of a test instrument and a test card; the detector comprises a separation-detection plate 4, a driving motor 3 and a detection unit 5; the separation-detection disc is provided with more than 1 detection screens and is driven by a driving motor to rotate so as to separate samples on the detection screens; the detection unit comprises a light source emitter 7 and a receiver 8 and is used for detecting a sample, the control and analysis unit 1 controls the separation detection disc and the driving motor and processes detection data to generate a platelet function detection result report, the display unit 2 displays a detection result and human-computer interaction, and the detection result is printed by the printer 6; the detection instrument automatically completes sample mixing, separation, detection, analysis and structure report at one time.

Referring to fig. 2-1 and 2-2, the separation-detection tray 4 has a horizontal tray structure, and the detection card 9 is fixed to the separation-detection tray by the fixing clip 11 and the adjustable card 10.

Set up detection card 9 on detecting the screens, establish three pond chambeies in the detection card 9: the reaction tank A, the detection tank B and the sedimentation tank C are sequentially arranged. The detection card 9 is horizontally arranged, the pool A is provided with an upward opening, and the pool C is also provided with a channel which is opened outwards in the area of the pool A; the inner cavity pools are respectively connected by channels with the cross-sectional area of less than 60 percent of the maximum cross-sectional area of the inner cavity of each pool, and all the inner cavity pools are sequentially communicated in a single-channel series connection mode.

As shown in fig. 3-1, a, B, C are three lumens, D1, D2 are narrow passages connecting the three lumens, and O is the opening of the test card; the test card has no exhaust passage. As shown in fig. 3-2, the cavity a has an opening that is axially perpendicular to the test card. And the bottom edges of the narrow channels D1 and D2 connecting the A, B, C inner cavities are higher than the top edges of the B, C inner cavities, so that the backflow of the sample after the centrifugation is finished can be avoided.

The platelet function detection method by using the detector comprises the following steps:

① adding the sample and the reagent into the detection joint card A pool respectively;

② starting the instrument, and mixing the reagent and blood sample in the A pool back and forth by the sample carrying chuck;

③ centrifuging at medium speed on the turntable of the instrument to make blood sample flow into B, C from the A pool, make WBC, RBC and platelet complex after aggregation centrifugally enter the C pool, and make single platelet and plasma concentrate in the B pool;

④ detecting absorbance of the B cell by instrument to determine platelet content in plasma after each blood sample and inducer act, and determining platelet concentration of blood sample plasma by reference cell;

⑤ when some sample pools have RBC or WBC, the instrument will continue to centrifuge again and detect the poor centrifuged pool B, and the pools B with the same blood sample are compared;

⑥ centrifuging at high speed to separate the single platelet in the B cell into the C cell or B-C channel, detecting each B cell again with ⑦ instrument to obtain blank value of each B cell;

⑧ Instrument reports the aggregation function or aggregation rate of each blood sample under the action of different inducer.

Example 2

Referring to fig. 3-3, this embodiment differs from embodiment 1 in that the last cavity C of the test card has a fine exhaust channel to the opening near the inlet for exhausting the gas/pressure in the last cavity.

Example 3

As shown in fig. 4, in the present embodiment, the test cards on the separation-test tray are arranged in a fan shape. Each card contains the same cavity and channel. Each clamping opening is an angle opening which is vertical to the axial direction of the cup, and the opening is upward. And each pool C of the combined cup can also be provided with a tiny exhaust channel to the position of the pool A to be opened outwards.

Example 4

As shown in fig. 5-1 and 5-2, the detection card in this embodiment has an opening at the top, and three inner cavities are provided in the detection card, the opening is at the top of the detection card, and the direction is the same as the axial direction of the detection card.

Example 5

As shown in fig. 6-1, the apparatus performs transmitted light detection on the test card by using a horizontally disposed separation-test tray with a light source 7 and a detector 8 in corresponding positions.

Example 6

As shown in fig. 6-2, on the horizontally disposed separation-detection tray, the light source vertically irradiates the detection card, and the detector forms an angle of 20-45 degrees with the light direction irradiated by the light source; the apparatus may perform scatter detection on the detection card.

Example 7

As shown in fig. 6-3, the separation-detection plate 4 forms an angle of 15-50 degrees with the horizontal plane Z. In the device, the detection light source 7 is vertical to the detection card 9, the detector 8 is vertical to the detection card 9 and is arranged corresponding to the light source, and the device can perform transmission detection.

Example 8

As shown in fig. 6-4, the separation-detection plate 4 is at an angle of 15-50 degrees to the horizontal plane Z. The device can perform scattering detection by irradiating the detection card with the detection light source 7 and the detection card 9 perpendicularly, arranging the detector 8 at the position corresponding to the light source, and arranging the receiving surface and the detection card at an included angle of 15-45 degrees correspondingly.

Claims

1. A platelet function detection device is characterized by comprising a detector and a detection card;

2. A platelet function testing device according to claim 1 wherein the test card has only one opening axially perpendicular to the card near the center of the separation-test plate, and the bottom edge of the channel between each of the inner wells is higher than the top of the adjacent inner well when the test card is horizontally placed.

3. The platelet function testing device according to claim 2, wherein the inside of the test card is provided with three inner cavity pools which are serially connected and communicated with each other, namely a pool A, a pool B and a pool C, wherein the pool A is a reaction pool, the pool B is a test pool and the pool C is a sedimentation pool; the A pool is provided with an upward opening which is axially vertical to the detection card and is used for adding a sample and a reagent, and the sample and the reagent are mixed and react in the A pool; the pool B is connected with the pool A, C through a narrow channel, the cross section area of the narrow channel is less than 60% of the maximum cross section area of the inner cavity of each pool, and the pool B is not directly opened to the outside; the C pool is provided with a fine exhaust channel which is independently communicated with the C pool and is communicated to the vicinity of the A pool area to be opened outwards, but the fine exhaust channel is not connected with any other inner cavity pool; the channel and the opening are used for exhausting original air in the B, C pool during centrifugal separation; the detection card assembly is loaded on a horizontal separation-detection plate for use.

4. A platelet function testing device according to claim 3, wherein the volume of the A cell is equal to or greater than the sum of the volumes of the B, C cells, and the respective volumes of the B, C cells differ by no more than 30%.

5. A platelet function testing device according to claim 2, wherein the inside of the test card is provided with two communicating inner chambers, one inner chamber is shared by the reaction chamber and the test chamber, and the other inner chamber is used as a sedimentation chamber.

6. A platelet function testing device according to claim 1, wherein the opening of the test card is axially aligned with the tube and is located at the upper end of the tube for use with an angle rotator.

7. A platelet function testing device according to claim 1, wherein the testing device is automatically adjusted in position as required, or the light source transmitter and receiver are automatically adjusted in position.

8. A platelet function testing device according to any one of claims 1 to 5, wherein the axis of the test light source of the test unit is perpendicular to the test card; the receiver is arranged at a position corresponding to the light source and is used for detecting the transmitted light; or the receiver forms a certain included angle with the detection light to detect the scattered light.

9. A platelet function testing device according to claim 1, wherein the narrow passage connecting the inner chambers of the test card is located at the center of the tube, and the shape of the tube is a string-like structure of sugarcoated haws on a stick basis or a straight tube or a strip-like structure according to the inner chambers and the narrow passage.

10. The platelet function testing device according to claim 1, wherein the test card is a fan-shaped multi-cup structure composed of a plurality of single test cards with the same structure, and the multi-cup structure is composed of 2-10 single test cups.