WO2019014942A1

WO2019014942A1 - Sample analyzer and sample monitoring method

Info

Publication number: WO2019014942A1
Application number: PCT/CN2017/093927
Authority: WO
Inventors: 冯祥; 申涛; 滕锦; 郑文波
Original assignee: 深圳迈瑞生物医疗电子股份有限公司
Priority date: 2017-07-21
Filing date: 2017-07-21
Publication date: 2019-01-24
Also published as: CN110892245A

Abstract

A sample analyzer and a sample monitoring method therefor, wherein a sample-acquisition unit (100) of the sample analyzer comprises a sample-sucking needle (10), a tubing (20) and a pressure sensor (40) . The sample-sucking needle (10) extracts a sample; the tubing (20) is in communication with the sample-sucking needle (10); and the pressure sensor (40) is in communication with the tubing (20) and is used to monitor the pressure of the tubing (20) during the sample-acquisition process. Thus, the pressure of the tubing (20) is monitored during the sampling process by means of the pressure sensor (40) so as to determine whether an abnormality occurs during the sample-acquisition process.

Description

Sample analyzer and sampling monitoring method

Technical field

The invention relates to the field of medical instruments, in particular to a sample analyzer and a sample monitoring method.

Background technique

A sample analyzer such as a blood cell analyzer or the like is widely known which has a sampling device for taking a blood sample from a test tube container and has an analysis device for analyzing the extracted blood sample. Typically, the sampling device also has the function of monitoring whether the blood sample is normally extracted.

An existing sampling device is provided with a first liquid sensor and a second liquid sensor respectively on both sides of the sampling and sampling valve of the quantitative pipette. After the pipette is sampled, whether the sample is detected by the sensor is used to monitor whether the sample is Normal sampling. However, the sampling device must quantify the sample with a sample separation valve. The sampling and sampling valve is suitable for dividing the sample into several equal parts at the same time, which is expensive, and there is a flow path from the pipette to the sampling and sampling valve. The sample (self-consumption) not used for analysis is more wasteful. .

In another sampling device, a light transmitting portion and a light blocking portion are alternately provided at regular intervals along the longitudinal direction of the pipette for confirming the amount of liquid. The liquid amount confirmation pipette is made of a transparent material such as quartz glass or hard transparent glass, and the surface thereof is sprayed with aluminum foil or the like at regular intervals in the longitudinal direction, and the light-receiving device receives light emitted from the light-emitting device transmitted through the pipette. Confirm the amount of liquid. However, materials such as quartz glass and hard transparent glass are difficult to perform precision machining, and it is difficult to meet the requirements of pipette processing precision.

Summary of the invention

Based on this, it is necessary to provide a sample analyzer and a sample monitoring method with lower cost, high precision and high reliability in view of the above-mentioned deficiencies in the prior art.

A sample analyzer includes a sampling unit, and the sampling unit includes:

Aspirating needle having a needle and a needle tail, the needle being inserted into a sealed container to draw a sample; and a tubing connected to the needle end of the aspirating needle;

The pressure sensor is connected to the pipeline to monitor the pressure of the pipeline during the sampling process.

In one embodiment, a power source is further included in communication with the conduit and providing the suction needle with power to draw a sample.

In one of the embodiments, the pressure sensor is located at a power source.

In one of the embodiments, the pressure sensor is located at the aspiration needle.

In one embodiment, further comprising a first switching member and a second switching member, the pipeline comprising a first conduit and a second conduit, the first conduit being connected to the needle tail of the suction needle The second conduit is connected between the first switching member and the second switching member, and the first switching member is configured to communicate or cut the first tube And a second conduit connected to the source of negative pressure or the atmosphere by the second switching member.

In one embodiment, the second switching component includes a first interface, a second interface, and a third interface, the first interface is connected to the second pipeline, and the second interface is connected to the negative pressure source The third interface is connected to the atmosphere, and the second switching component can communicate with the first interface and the second interface or communicate with the first interface and the third interface.

In one embodiment, the second switching component comprises:

a first sub-switching member, the two ends are respectively connected to the second pipeline and the negative pressure source, and the first sub-switching member is configured to connect or cut the second pipeline and the negative pressure source; and

The second sub-switching member is respectively connected to the second pipeline and the atmosphere at two ends, and the second sub-switching member is configured to connect or cut the second pipeline and the atmosphere.

In one embodiment, the suction needle is provided with a deflation passage for communicating the sealed container with the atmosphere.

In one embodiment, the deflation channel is a venting channel disposed on an outer sidewall of the aspiration needle. In one embodiment, further comprising a sample preparation unit, a detection unit and a control unit, the sampling unit suction sample is provided to the sample preparation unit, the sample preparation unit reacts the sample with the reagent to generate a sample, and the detection unit measures the sample. And obtaining the detection result, and the control unit controls the sampling unit, the sample preparation unit and the detection unit.

In one embodiment, the control unit includes a storage module, a comparison module, and an execution module, the storage module stores a threshold pressure range of the pipeline during sampling, and the comparison module compares the sampling process provided by the pressure sensor The pressure in the pipeline monitored in the pipeline is within a threshold pressure range, and the execution module controls the sampling unit, the sample preparation unit, and the detection unit according to the comparison result of the comparison module.

In one embodiment, the control unit controls the suction needle to puncture the closed container to deflate the closed container, and if the pressure of the pipeline after the puncturing is within a threshold pressure range, the control The unit controls the sampling unit to perform sampling, control the sample preparation unit to perform sample preparation, and control the detection unit to perform measurement and output detection results.

In one embodiment, if the pressure of the pipeline after the puncture is not within the threshold pressure range, the control unit controls the suction needle to puncture the closed container to perform secondary deflation on the closed container. ;

If the pressure of the pipeline after the second puncture is within a threshold pressure range, the control unit controls the sampling unit to perform sampling, control the sample preparation unit to perform sample preparation, and control the detection unit to perform measurement and output detection. result;

If the pressure of the pipeline after the second puncture is not within the threshold pressure range, the control unit controls the sampling unit, the sample preparation unit and the detecting unit not to perform sampling, sample preparation, measurement operations, or sample and sample preparation The measurement results are measured and output, but the alarm indicates that the pressure is abnormal.

In one embodiment, if the pressure of the pipeline is not within the threshold pressure range during sampling, the control unit controls the sampling unit to perform needle washing and secondary sampling;

If the pressure of the pipeline during the subsampling is within a threshold pressure range, the control unit controls the sample preparation unit to perform sample preparation and control the detection unit to perform measurement and output detection results;

If the pressure of the pipeline is not within the threshold pressure range during the subsampling process, the control unit controls the sample preparation unit and the detection unit not to perform sample preparation, measurement operations, or perform sample preparation, measurement, and output detection. The result, but the alarm indicates that the pressure is abnormal.

In one embodiment, the alarm indicating pressure anomaly includes any one of a sampling needle abnormality, an under-sampling abnormality, a sampling impurity abnormality, and an unsampled abnormality.

In one embodiment, the control unit records the pressure of the pipeline during the sampling process to form a pressure characteristic curve, and identifies the sampling plug abnormality, the under-sampling abnormality according to the pressure characteristic curve in the sampling process, Sampling impurity is abnormal or unsampled abnormal.

In one embodiment, the sampling unit divides the sample into the process of preparing the sample unit, the control unit controls the pressure sensor to record the pressure of the pipeline, and if the pipeline pressure is not within the threshold pressure range, the control unit controls The detection unit outputs an alarm indicating that the pressure is abnormal.

A sampling monitoring method includes the following steps:

Providing a sample analyzer, the sample analyzer comprising a sampling unit, a sample preparation unit, a detection unit and a control unit, the sampling unit is provided from the closed container to the sample preparation unit, and the sample preparation unit reacts the sample with the reagent to generate a test The detecting unit measures the sample and obtains the detection result, and the control unit controls the sampling unit, the sample preparing unit and the detecting unit; the sampling unit includes a sampling needle, a pipeline connected with the sampling needle, and a pressure sensor connected to the pipeline;

The sampling unit monitors the pressure of the pipeline during the sampling process, and determines whether the sampling process is abnormal according to the obtained pressure.

In one embodiment, the suction needle is provided with a deflation channel, and the suction needle pierces the closed container to deflate the closed container, and if the pressure of the pipeline is at a threshold pressure after puncturing Within the range, sampling, sample preparation, measurement, and output test results are performed.

In one embodiment, if the pressure of the pipeline after the puncture is not within the threshold pressure range, the suction needle twice punctures the closed container to perform secondary deflation on the closed container;

If the pressure of the pipeline after the second puncture is within the threshold pressure range, sampling, sample preparation, measurement, and output detection results are performed;

If the pressure of the pipeline after the second puncture is not within the threshold pressure range, the sampling, sample preparation, measurement operation, or the sampling, sample preparation, measurement, and output detection results are not performed, but the alarm indicates that the pressure is abnormal. In one embodiment, if the pressure of the pipeline during the sampling process is not within the threshold pressure range, the needle washing and the secondary sampling are performed;

If the pressure of the pipeline during the subsampling is within the threshold pressure range, the sample preparation, measurement and output test results are performed;

If the pressure of the pipeline is not within the threshold pressure range during the subsampling process, the sample preparation and measurement actions are not performed; or the sample preparation and measurement actions are performed, the alarm indicates that the pressure is abnormal; or after the sample preparation and measurement operations are performed, the output is output. The result is detected and the result is abnormal.

In one embodiment, the method further comprises: forming a pressure characteristic curve of the pipeline obtained by monitoring during the sampling process, and identifying, according to the pressure characteristic curve, the alarm prompt pressure abnormality as sampling plug abnormality, under sampling abnormality, sampling Abnormal impurities, no sampling abnormalities.

In one embodiment, the aspirating needle samples the aspirated sample into the sample preparation unit, and the pressure sensor monitors the pressure of the pipeline in real time. If the pipeline pressure is not within the threshold pressure range, an alarm prompts The pressure is abnormal.

Compared with the prior art, the above sample analyzer and sampling monitoring method have the following advantages: Firstly, a venting monitoring method for the sealed container is provided, which can effectively monitor the deflation effect of the sealed container, and the deflation of the sealed container cannot meet the requirement. It can alarm prompts and mask the results to effectively avoid clinical risks. Second, it uses pressure monitoring sampling and sampling process, without adding any unnecessary sample volume and reagent volume, saving compared to other monitoring methods. Samples and reagents; thirdly, pressure monitoring can compare the range of pressure values according to different abnormal patterns, thus providing the possibility to distinguish a variety of abnormal modes including puncture abnormality, sampling plugging, insufficient sampling, sampling impurities, and unabsorbed. The sample and sample abnormalities, etc., have greatly improved the reliability of sampling and sample monitoring, and have largely avoided the risk of clinical testing.

DRAWINGS

1 is a schematic structural diagram of a sample analyzer according to an embodiment of the present invention;

2 is a schematic structural view of a sampling unit in the sample analyzer shown in FIG. 1;

3 is another schematic structural view of a sampling unit in the sample analyzer shown in FIG. 1;

4 is a schematic structural view of another sampling unit in the sample analyzer shown in FIG. 1;

FIG. 5 is a flowchart of a sample sampling and sample monitoring method of a sample analyzer according to an embodiment of the present invention; FIG.

6 is a flowchart of a sample sampling and sample monitoring method of a sample analyzer according to another embodiment of the present invention;

Figure 7 shows the pressure characteristic curve of a normal sample;

Figure 8 shows the pressure characteristic curve of the abnormal mode as the aspiration needle;

Figure 9 shows a pressure characteristic curve in which the abnormal mode is insufficient for aspiration;

Figure 10 shows a pressure characteristic curve in which the abnormal mode is a sample-like impurity;

Fig. 11 shows a pressure characteristic curve in which the abnormal mode is unabsorbed.

Detailed ways

As shown in FIG. 1 , a sample analyzer provided by an embodiment of the present invention may be a blood cell analyzer or a blood coagulation instrument. The sample analyzer includes a sampling unit 100, a sample preparation unit 101, a detection unit 102, and a control unit 103. The sampling unit 100 draws a blood sample to be detected from a sealed container (for example, a closed tube type vessel) to the sample preparation unit 101. The sample preparation unit 101 reacts the reagent with the sample supplied from the sampling unit 100 to generate a sample required for the detection. The detecting unit 102 measures the sample supplied from the sample preparing unit 101 and obtains the detection result. The control unit 103 is in communication connection with the sampling unit 100, the sample preparation unit 101, and the detection unit 102, and controls the sampling unit 100, the sample preparation unit 101, and the detection unit 102 to make the sampling unit 100, the sample preparation unit 101, and The detecting unit 102 performs corresponding sampling, sample preparation, detection, and the like.

Referring to FIG. 2, in a possible embodiment of the present invention, the sampling unit 100 includes a sampling needle 10, a pipeline 20, a power source 30, and a pressure sensor 40.

The aspiration needle 10 includes a needle and a needle tail. The needle of the aspirating needle 10 is for insertion into a sealed container (not shown) to take a sample. The wicking needle 10 is provided with a deflation channel 11. The venting passage 11 is for communicating the sealed container with the atmosphere. In one embodiment, the deflation passage 11 is a venting groove provided on the outer side wall of the suction needle 10. In another embodiment, the squirting needle 10 may be combined with a deflation tube, and the deflation channel 11 is formed in the deflation tube.

The line 20 is in communication with the needle tail of the suction needle 10. The power source 30 is in communication with the conduit 20 and provides the suction needle 10 with power to draw a sample. The power source 30 can be an automatic syringe that is automatically controlled by a power mechanism. The power source 30 is communicatively coupled to the control unit 103 and controlled by the control unit 103.

After the sampling needle 10 sucks the sample, depending on the amount of suction, the sample may partially enter the pipeline 20, but the sample should be prevented from entering the power source 30 so as not to affect the normal operation of the power source 30.

Pressure sensor 40 is mounted in line 20 in communication with line 20 for monitoring the pressure of line 20 during sampling and recording the measured pressure value in real time. The pressure sensor 40 can be remote from the needle 10, such as at the power source 30. Since the pressure sensor 40 is disposed at the power source 30 without being contaminated by the sample, the biocompatibility of the sampling unit 100 can be improved, and different types of samples can be taken without frequent replacement or cleaning of the pressure sensor 40. In view of the proximity of the aspiration needle 10, the detected pressure can more realistically reflect the pressure of the line 20 during sampling, and the pressure sensor 40 can also be placed at the suction needle 10 to increase the pressure sensitivity of the pressure sensor 40. .

By setting the pressure sensor 40 to monitor in real time whether the pressure of the pipeline 20 is within the threshold range during the sampling process, it can be judged whether the sampling process is in a normal state or an abnormal state, and thus the abnormal detection result is screened to avoid clinical risk. Further, the pressure sensor 40 can also monitor whether the sampling unit 100 samples the sample into the sample preparation unit 101, and whether the pressure of the pipeline 20 is within a threshold range, thereby judging whether the sampling process is normal, to further avoid clinical risks.

The sampling process mentioned above refers to the period of time after the aspiration needle 10 is punctured into the sealed container until the sampling needle 10 sucks the sample and exits the sealed container; the above-mentioned sampling process refers to the sampling needle 10 exiting the sealed container. This is a period of time until the sample is discharged to the reaction cell of the sample preparation unit 101. The pressure sensor 40 can record the pressure of the line 20 in any unit time of the sampling process and the sampling process described above in real time.

In this embodiment, the process of further puncturing the aspiration needle 10 into the sealed container until the sample needle 10 contacts the sample in the sealed container is defined as a puncture process. Before the aspirating needle 10 pierces the sealed container, the pressure in the sealed container may be either a positive pressure or a negative pressure with respect to the external environment. Experiments have shown that the pressure inside the sealed container will affect the accuracy of the sampling and test results, so through the sampling process Monitoring the pressure in the sealed container and eliminating the test results corresponding to the sampling in the sealed container under abnormal conditions can reduce the clinical risk. When the suction needle 10 is inserted into the sealed container, the deflation passage 11 communicates with the sealed container and the external environment, and the pressure inside the sealed container can be released. When the aspiration needle 10 is inserted into the sealed container, the sealed container communicates with the line 20, so that the pressure sensor 40 monitors the pressure in the line 20, that is, monitors the pressure in the sealed container, thereby venting the sealed container. Monitor.

Specifically, according to the pressure value of each unit time monitored by the pressure sensor 40 in real time, the average pressure in the sealed container during the puncture process is calculated, and compared with the threshold pressure range, whether the deflation effect during the puncture process is abnormal is determined. . If it is abnormal, other treatments such as secondary puncture and deflation may be performed on the sealed container, which will be further described below when the sampling monitoring method is introduced. The threshold pressure range of the puncture process can be determined by statistically analyzing the value of the pressure anomaly that occurs during the puncture, or by using a boundary test experiment to obtain the threshold pressure range. Further, the pressure obtained can be monitored every unit time during the puncture to form a pressure characteristic curve. It is determined whether the deflation effect during the puncturing process is abnormal by determining whether each point in the pressure characteristic curve of the puncturing process is within the threshold pressure range of the corresponding point.

The invention can also form a pressure characteristic curve of the pressure of the pipeline 20 in each unit time monitored by the suction needle 10 after contacting the sample and completing the suction of the sample to the sealed container, and the pressure curve is formed according to the above monitoring pressure. The pressure characteristic curve is compared with a preset pressure characteristic curve in a normal state, and it is judged whether the pressure difference in each unit time is within a threshold pressure range, thereby judging whether the sampling process is abnormal. Further, pressure characteristic curves in a plurality of abnormal modes may be preset, and the pressure characteristic curves in the abnormal modes include sampling plug abnormalities, under-sampling abnormalities, sampling impurity abnormalities, and unsampled abnormalities. When it is judged that the aspirating process is abnormal, the specific result can be identified according to the comparison result between the pressure characteristic curve formed by the above monitoring pressure and the pressure characteristic curve in the abnormal mode. Abnormal mode. For example, when the pressure characteristic curve formed according to the above-mentioned monitoring pressure coincides with the pressure characteristic curve in the sampling impurity abnormal mode therein, it can be judged that an abnormality of the sampling impurity is generated in the aspirating process. The threshold pressure range of the sampling process can be determined by statistically analyzing the value of the pressure anomaly occurring during the sampling process, or by the boundary test experiment to obtain the threshold pressure range. The pressure characteristic curve in each abnormal mode during sampling can also be obtained by statistical or boundary test.

The invention can also form the pressure characteristic curve of the pipeline 20 pressure in each unit time monitored during the sampling process, and compare with the preset pressure characteristic curve in the normal state to determine the pressure difference in each unit time. Whether it is in the threshold pressure range, thereby judging whether the sampling process is abnormal. The threshold pressure range of the sampling process can be determined by statistically indicating the value of pressure anomalies occurring during the sampling process, or by using a boundary test experiment to obtain a threshold pressure range.

As shown in FIG. 3, in another possible embodiment of the present invention, the sampling unit 100 includes a sampling needle 21, a pipeline 22, a power source 23, a pressure sensor 24, a first switching member 25, and a second switching member. 26. The line 22 includes a first line 221 and a second line 222. The first line 221 is connected between the sample needle 21 and the first switching member 25. The second conduit 222 is connected between the first switching member 25 and the second switching member 26. The first switching member 25 is configured to connect or disconnect the first conduit 221 and the second conduit 222. The second line 222 is connected to the negative pressure source 7 and the atmosphere through the second switching member 26. It can be understood that the second conduit 222 is also connected between the first switching member 25 and the power source 23.

Pressure sensor 24 is used to monitor the pressure of line 22 during the sampling process and to record the measured pressure value in real time. The pressure monitoring process in the sampling process in this embodiment is slightly different from the above embodiment, and the sampling process and the sample preparation process are substantially the same as those in the previous embodiment. Specifically, in the embodiment, the pressure sensor 24 can record in real time that the first switching member 25 connects the first conduit 221 and the second conduit 222 (ie, the suction needle 21 is connected to the power source 23 for aspirating); Exit the sealed container to the suction needle 21 (ie, finish The suction value of the paired sample, the first switching member 25 cuts off the communication between the first line 221 and the second line 222). In the present embodiment, the process from the insertion of the suction needle 21 into the hermetic container to the suction needle 21 to take out the sealed container is defined as a sampling process. It can be understood that the pressure sensor 24 can also monitor the pressure of the whole process of sampling in real time, and select the pressure change of the above aspirating process for analysis.

Specifically, the pressure sensor 24 can be remote from the aspiration needle 21, such as at the power source 23. Since the pressure sensor 24 is disposed at the power source 23 and is not contaminated by the sample, the biocompatibility of the sampling unit 100 can be improved, and different types of samples can be taken without frequent replacement or cleaning of the pressure sensor 24. Considering the proximity of the suction needle 21, the detected pressure can more realistically reflect the pressure of the line 22 during the sampling process, and the pressure sensor 24 can also be placed at the suction needle 21 to increase the pressure sensitivity of the pressure sensor 40. .

In this embodiment, the sampling unit 100 can control the pressure environment of the first conduit 221 by the actions of the first switching member 25 and the second switching member 26 to eliminate the closed test tube. The pressure has an adverse effect on the sampling accuracy. Therefore, when the sampling unit 100 is used for sampling, the sampling needle 21 only needs to perform a puncture to complete the sampling, and the puncture pretreatment is no longer needed. The process of cleaning the sample needle 21 after the puncture pretreatment is usually performed in a few seconds or more, and the sampling time is shortened and the sampling speed is increased. Since the sampling process is a critical path measured by the sample analyzer, sampling by the sampling unit 100 shortens the measurement time of the sample analyzer and improves the measurement speed of the sample analyzer. At the same time, the sampling by the sampling unit 100 requires only one puncture, and the wear of the aspirating needle 21 can be reduced, and the service life of the aspirating needle 21 is prolonged.

In one embodiment, as shown in FIG. 3, the second switching member 26 includes a first interface 261, a second interface 262, and a third interface 263. The first interface 261 is connected to the second conduit 222. The second interface 262 is connected to the negative pressure source 7, the third interface 263 is connected to the atmosphere, and the second switching member 26 can communicate with the first interface 261 and the second interface 262 or communicate with the first The interface 261 is connected to the third interface 263. The second switching member 26 can be a valve, such as a two-position three-way solenoid valve or the like.

In another embodiment, as shown in FIG. 4, the second switching member 26 includes a first sub-switching member 264 and a second sub-switching member 265. The two ends of the first sub-switching member 264 are respectively connected to the second conduit 222 and the negative pressure source 7, and the first sub-switching member 264 is configured to connect or disconnect the second conduit 222 and the The negative pressure source 7 is described. The first sub-switching member 264 can be a valve, such as a shut-off valve or the like. Two ends of the second sub-switching member 265 are respectively connected to the second conduit 222 and the atmosphere, and the second sub-switching member 265 is used to connect or cut the second conduit 222 to the atmosphere. The second sub-switching member 265 can be a valve, such as a shut-off valve or the like.

Optionally, the negative pressure source 7 includes a gas storage tank 71, a negative pressure is formed in the gas storage tank 71, and the gas storage tank 71 communicates with the second pipeline 222 to make the second pipeline 222 negative. Pressure state. The negative pressure source 7 may further include an air pump 72 for communicating the gas storage tank 71 to establish the negative pressure within the gas storage tank 71.

The pressure value of the negative pressure in the gas storage tank 71 is -30 kPa or less. When the second conduit 222 communicates with the gas storage tank 71, the pressure of the second conduit 222 is the same as that of the gas storage tank 71, so that the pressure of the second conduit 222 is lower than the test tube Negative pressure inside.

In an embodiment, the control unit 103 includes a storage module 104, a comparison module 105, and an execution module 106.

The storage module 104 stores a threshold pressure range of the pipeline 20 during sampling. The storage module 104 can also store a threshold pressure range of the conduit 20 during the puncture. The storage module 104 can also store a threshold pressure range of the conduit 20 during the dispensing process. Further, the storage module 104 can also store the pressure characteristic curve of the pipeline 20 in the normal state under the puncture process, the sampling process, the sampling process, and the typical pressure characteristic curve of the storage pipeline 20 in various abnormal modes during the sampling process, such as sampling plugging. Needle pressure characteristic curve, undersampling pressure characteristic curve, sampling impurity pressure characteristic curve, unsampled pressure characteristic curve.

The comparison module 105 is configured to determine whether the pressure of the pipeline 20 in the puncture, sampling, and sampling process is monitored within a threshold pressure range in real time. The comparison module 105 can also be used to determine whether the pressure difference in each unit time in the pressure characteristic curve formed by the monitoring pressure and the corresponding unit time curve in the corresponding pressure characteristic curve are within the threshold pressure range. Further, the comparison module 105 is further configured to determine whether the pressure characteristic curve formed by the recognition monitoring pressure matches the pre-existing pressure characteristic curve in each abnormal mode, and further identify a specific abnormal mode.

The execution module 106 is in communication with the sampling unit 100, the sample preparation unit 101, and the detection unit 102, and controls the sampling unit 100, the sample preparation unit 101, and the detection unit 102 according to the determination result of the comparison module 105 to perform corresponding puncture. , sampling, sample preparation, testing and other actions.

The two sampling monitoring methods provided by the present invention will be described below with reference to FIGS. 5 and 6. Both methods include: providing a sample analyzer, the sample analyzer comprising a sampling unit, a sample preparation unit, a detection unit, and a control unit, the sampling unit is provided from the closed container to the sample preparation unit, and the sample preparation unit The sample reacts with the reagent to generate a sample, the detecting unit measures the sample and obtains the detection result, and the control unit controls the sampling unit, the sample preparing unit and the detecting unit; the sampling unit includes a sampling needle and a sampling needle a connected pipeline and a pressure sensor connected to the pipeline; the sampling unit monitors the pressure of the pipeline in real time during the sampling process, and determines whether the sampling process is abnormal according to the obtained pressure.

Specifically, as shown in FIG. 5, in a mid-sampling method of the present invention, step S1 is a puncture step, that is, a process before the aspiration needle is inserted into the sealed container until it contacts the sample in the sealed container. Wherein said The suction needle is provided with a deflation channel, and the suction needle deflates the closed container after piercing the closed container. The puncture step can be accomplished by the control unit controlling the aspiration needle in the drive sampling unit.

Step S2 is a step of determining the deflation effect, that is, determining whether the pressure in the pipeline after the puncturing step S1 is within the threshold pressure range. Since the puncture needle enters the sealed container after the puncture step S1, the pressure sensor communicates with the sealed container through the pipeline, and the pressure in the pipeline is monitored, that is, the pressure in the sealed container is monitored, so that it can be used to judge whether the pressure in the sealed container is at a threshold pressure. range. If it is judged that the pressure in the sealed container is within the threshold pressure range, the subsequent sampling step S3, the sample preparation step S5, and the measurement are performed and the normal result step S7 is output. Since the pressure inside the sealed container will affect the accuracy of the sampling and detection results, the pressure in the sealed container can be monitored during the sampling process, and the detection result corresponding to the sampling in the abnormal state in the sealed container can be eliminated. Clinical risk.

If it is determined in step S2 that the pressure in the sealed container is not within the threshold pressure range, the second puncture step S21 is performed, and the sealed container is again deflated. After the second puncture step S21, the step S22 of determining the secondary deflation effect is performed, that is, whether the pressure in the pipe after the puncture step S21 is within the threshold pressure range is determined. If it is judged that the pressure in the sealed container is within the threshold pressure range, the subsequent sampling step S3, the sample preparation step S5, and the measurement are performed and the normal result step S7 is output.

During the actual sampling process, there is a possibility that the pressure in the sealed container after the second puncture still does not meet the requirements. Therefore, when it is judged that the pressure in the pipeline is still not within the threshold pressure range after the puncture step S21, the sampling step S23, the sample preparation step S24, the measurement and the output detection result step S8 can be performed. Among them, the alarm may be abnormal when the detection result is output, and the measurement result may be inaccurate. Further, the alarm prompt pressure abnormality can be embodied as an abnormal puncture pressure. The alarm mode can be a way of marking the output detection result. In the above step S8, the output detection result may be that the detection result is normally displayed, but a reminder mark that is not referred to may be made, or the detection result may be shielded by a character or a pattern having no readable meaning. Or, the detection result is only an output report The police indicated that the pressure was abnormal.

When it is judged that the pressure in the pipeline is not within the threshold pressure range after the puncture step S21, the subsequent sampling, sample preparation, and measurement operations may not be performed, and the sampling process is directly terminated, and a sampling abnormal alarm prompt is given.

In an embodiment, after the sampling step S3, the determining step S4 of whether the sampling is normal is performed. Wherein, the pressure characteristic curve of each pipeline time monitored in the process after the suction needle is contacted with the sample and the sample is sucked out to the sealed container is formed, and the pressure characteristic formed according to the above monitoring pressure is formed. The curve is compared with the pre-stored pressure characteristic curve in the normal state, and it is judged whether the pressure difference in each unit time is within the threshold pressure range, thereby judging whether the sampling is abnormal. If the determination in step S4 is normal, the subsequent sample preparation step S5 and the measurement are performed and the normal result step S7 is output. If the determination in step S4 is abnormal, the needle washing is performed and the sampling step S41 is subsampled. After the subsampling step S41, it is judged whether or not the sampling is normal, step S42. The judging process in step S42 may be the same as the judging process in step S4, and the pressure of the pipeline pressure in each unit time monitored during the process after the sample needle is contacted with the sample and the sample is sucked out to the sealed container can be formed. The characteristic curve is compared with the pre-existing pressure characteristic curve in the normal state according to the pressure characteristic curve formed by the above-mentioned monitoring pressure, and it is judged whether the pressure difference in each unit time is within the threshold pressure range, thereby judging whether the sampling is abnormal. If the determination in step S42 is normal, the subsequent sample preparation step S5 and measurement are performed and the normal result step S7 is output. If the determination in step S42 is abnormal, the subsequent sample preparation step S43, measurement and output detection result step S8 are performed.

In the above step S8, the output detection result may be that the detection result is normally displayed, but a reminder mark that is not referred to may be made, or the detection result may be shielded by a character or a pattern having no readable meaning. Further, the present invention can also preset pressure characteristic curves in a plurality of abnormal modes, and the pressure characteristic curves in the abnormal modes include sampling plug abnormalities, under-sampling abnormalities, sampling impurity abnormalities, and not taken. Abnormal. When it is determined that the abnormality is determined in step S42, the pressure characteristic curve formed by the monitoring pressure and the pressure characteristic curve in the abnormal mode may be compared to identify a specific abnormal mode, and in step S8, the alarm prompt pressure abnormality is embodied. Abnormal for a specific sampling pressure. For example, when the pressure characteristic curve formed by comparing the above-mentioned monitoring pressure coincides with the sampling impurity abnormal pressure characteristic curve, the alarm may be prompted to sample the impurity abnormality mode.

FIG. 6 illustrates a second sampling monitoring method provided by the present invention. Step S11 is a sampling step, that is, a process from the insertion of the suction needle into the sealed container to the suction of the suction container to define the sampling process. The sampling step can be accomplished by the control unit controlling the aspiration needle in the drive sampling unit. Specifically, after the first switching member cuts off the first pipeline and the second pipeline, the sampling needle pierces the test tube cap and extends into the test tube, so as to shield the deformation of the second pipeline. The effect on the isolated gas column within the first conduit. Then, the second switching member communicates with the second pipeline and the negative pressure source. The source of negative pressure causes the second conduit to be in a negative pressure state, thereby offsetting the effect of negative pressure on the isolated gas column in the test tube. Then, after the second switching member opens the second pipeline and the negative pressure source, the first switching member communicates with the first pipeline and the second pipeline. Next, the power source draws the in-vitro biological sample into the aspiration needle. Finally, after the first switching member cuts off the first conduit and the second conduit again, the aspirating needle leaves the test tube. Complete the sampling process. The pressure sensor can record the pressure change of the pipeline in each unit time during the sampling process, and form a pressure characteristic curve.

Step S12 is a step of judging the sampling process. Specifically, according to the pressure characteristic curve formed by the monitoring pressure and the pre-existing pressure characteristic curve in the normal state, it is determined whether the pressure difference in each unit time is within a threshold pressure range, thereby determining whether the sampling is abnormal.

If the determination in step S12 is normal, the subsequent sample preparation step S13 and measurement are performed and the normal result step S15 is output.

If the determination in step S12 is abnormal, the needle washing is performed and the sampling step S121 is sub-sampled. After the subsampling step S121, it is judged whether or not the sampling is normal, step S122. The judging process in step S122 may be the same as the judging process in step S12, and the pressure of the pipeline pressure in each unit time detected in the process after the sampling needle is contacted with the sample and the sample is sucked out to the sealed container can be formed. The characteristic curve is compared with the pre-existing pressure characteristic curve in the normal state according to the pressure characteristic curve formed by the above-mentioned monitoring pressure, and it is judged whether the pressure difference in each unit time is within the threshold pressure range, thereby judging whether the sampling is abnormal. If the determination in step S122 is normal, the subsequent sample preparation step S13 and measurement are performed and the normal result step S15 is output. If the determination in step S122 is abnormal, the subsequent sample preparation step S123, measurement and output detection result step S124 are performed.

In the above step S124, the output detection result may be that the detection result is normally displayed, but a reminder mark that is not referred to is made (that is, the prompt result is abnormal), or the detection result may be shielded by a character or a pattern having no readable meaning.

Further, the present invention can also preset pressure characteristic curves in a plurality of abnormal modes, and the pressure characteristic curves in the abnormal modes include sampling plug abnormalities, under-sampling abnormalities, sampling impurity abnormalities, and unsampled abnormalities. When it is determined that the abnormality is determined in step S122, the pressure characteristic curve formed by the monitoring pressure and the pressure characteristic curve in the abnormal mode may be compared to identify a specific abnormal mode, and in step S124, the alarm prompt pressure abnormality is embodied. Abnormal for a specific sampling pressure. For example, when the pressure characteristic curve formed by comparing the above-mentioned monitoring pressure coincides with the sampling impurity abnormal pressure characteristic curve, the alarm may be prompted to sample the impurity abnormality mode.

In the method, the clinical risk can be reduced by monitoring the pressure in the sealed container during the sampling process and eliminating the detection result corresponding to the sampling in the abnormal state in the sealed container.

Figure 7 shows the pressure profile of a typical normal aspirate. Figure 8 shows the pressure characteristic curve of a typical aspiration needle; Figure 9 shows a typical pressure profile of the sample aspiration; Figure 10 shows the code Pressure characteristic curve of a type of aspirate impurity; Figure 11 shows a typical unabsorbed pressure characteristic curve. As an example, when the pressure value corresponding to each unit time formed on a certain pressure characteristic curve formed by monitoring the pipeline pressure during sampling is different from the pressure value corresponding to the unit characteristic time on the pressure characteristic curve of the normal suction sample shown in FIG. Outside the threshold pressure range, it can be determined that the certain pressure characteristic curve does not coincide with the pressure characteristic curve of the normal aspirating sample, thereby judging that the sampling process is abnormal.

As an example, the pressure value corresponding to each unit time on a certain pressure characteristic curve formed by monitoring the pipeline pressure during sampling and the corresponding unit time on the pressure characteristic curve in the specific abnormal mode shown in FIGS. 8 to 11 If the pressure value difference is within the threshold pressure range, it can be determined that the certain pressure characteristic curve coincides with the pressure characteristic curve of the specific abnormal mode, thereby determining that the specific abnormality exists in the sampling process.

As a further embodiment of the present invention, the determination step S6/S14 of whether or not the sample is normal is also performed after the sample preparation step S5/S13. The suction needle samples the sample to be sampled into the sample preparation unit. The pressure sensor monitors the pressure of the pipeline in real time. If the pipeline pressure is within the threshold pressure range, the measurement is performed and the normal result is output. Step S7/S15 If the line pressure is not within the threshold pressure range during this process, the measurement and output detection result steps S8/S124 are performed. Among them, in step S8/124, an alarm can be issued to indicate that the pressure is abnormal. Further, the alarm prompt pressure abnormality can be embodied as a sample pressure abnormality. The alarm mode can be a way of marking the output detection result. In the above step S8/124, the output detection result may be a normal display of the detection result, but a reminder mark which is not referred to may be used, or the detection result may be shielded by a character or a pattern having no readable meaning.

The sample determination step S6/S14 is used as the secondary verification of the sampling determination step, which can further improve the sampling reliability and reduce the risk of clinical detection.

Compared with the prior art, the above sample analyzer and sampling monitoring method have the following advantages: First, a sealed container venting monitoring mode is provided, which can effectively monitor the venting effect of the sealed container, and is placed on the sealed container. If the gas does not meet the requirements, the alarm can be prompted and the shielding result can be processed to effectively avoid the risk of clinical testing. Second, the pressure monitoring sampling and sampling process can be used without adding any unnecessary samples and reagents. Compared with other monitoring methods, the reagents and samples are saved. Thirdly, the pressure monitoring can compare the pressure value range according to different abnormal modes, thereby providing the possibility to distinguish a plurality of abnormal modes including puncture abnormality, sampling plugging, sampling. Insufficient, sampling impurities, non-absorbed samples and abnormal sampling, etc., have greatly improved the reliability of sampling and sampling monitoring, and have largely avoided the risk of clinical testing.

The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.

The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

A sample analyzer includes a sampling unit, wherein the sampling unit comprises:

Aspirating needle having a needle and a needle tail, the needle being inserted into a sealed container to draw a sample; and a tubing connected to the needle end of the aspirating needle;

The pressure sensor is connected to the pipeline to monitor the pressure of the pipeline during the sampling process.
The sample analyzer of claim 1 further comprising a power source in communication with said conduit and providing the suction needle with power to draw a sample.
The sample analyzer of claim 2 wherein said pressure sensor is located at a power source.
The sample analyzer of claim 1 wherein said pressure sensor is located at the aspiration needle.
A sample analyzer according to claim 1, further comprising a first switching member and a second switching member, said conduit comprising a first conduit and a second conduit, said first conduit being connected Between the needle tail of the suction needle and the first switching member, the second pipeline is connected between the first switching member and the second switching member, and the first switching member is used for The first conduit and the second conduit are connected or disconnected, and the second conduit is connected to a source of negative pressure or the atmosphere through the second switching member.
The sample analyzer according to claim 5, wherein the second switching member comprises a first interface, a second interface, and a third interface, the first interface connecting the second conduit, the first The second interface is connected to the negative pressure source, the third interface is connected to the atmosphere, and the second switching component can communicate with the first interface and the second interface or communicate with the first interface and the third interface.
The sampling assembly of claim 5 wherein said second switching member comprises:

a first sub-switching member, the two ends are respectively connected to the second pipeline and the negative pressure source, and the first sub-switching member is configured to connect or cut the second pipeline and the negative pressure source; and

The second sub-switching member is respectively connected to the second pipeline and the atmosphere at two ends, and the second sub-switching member is configured to connect or cut the second pipeline and the atmosphere.
The sample analyzer according to claim 1, wherein said suction needle is provided with a deflation passage for communicating said sealed container with the atmosphere.
The sample analyzer according to claim 8, wherein said deflation passage is a venting groove provided on an outer side wall of the absorbing needle.
The sample analyzer according to claim 1, further comprising a sample preparation unit, a detection unit and a control unit, wherein the sampling unit suction sample is supplied to the sample preparation unit, and the sample preparation unit reacts the sample with the reagent to generate a sample. The detecting unit measures the sample and obtains the detection result, and the control unit controls the sampling unit, the sample preparing unit and the detecting unit.
The sample analyzer according to claim 10, wherein the control unit comprises a storage module, a comparison module, and an execution module, wherein the storage module stores a threshold pressure range of the pipeline during sampling, the comparison module Comparing whether the pressure provided by the pressure sensor in the pipeline monitored during the sampling process is within a threshold pressure range, the execution module controls the sampling unit, the sample preparation unit and the detection unit according to the comparison result of the comparison module.
The sample analyzer according to claim 11, wherein said control unit controls said suction needle to puncture said closed container to deflate said closed container, and if said pressure of said line after piercing is at a threshold Within the pressure range, the control unit controls the sampling unit to perform sampling, control the sample preparation unit to perform sample preparation, and control the detection unit to perform measurement and output detection results.
The sample analyzer according to claim 11, wherein if the pressure of the pipeline is not within a threshold pressure range during sampling, the control unit controls the sampling unit to perform needle washing and secondary sampling;

If the pressure of the pipeline during the subsampling is within a threshold pressure range, the control unit controls The sample preparation unit performs sample preparation and controls the detection unit to perform measurement and output detection results;

If the pressure of the pipeline is not within the threshold pressure range during the subsampling process, the control unit controls the sample preparation unit and the detection unit not to perform sample preparation and measurement operations, or performs sample preparation, measurement, and alarm prompt The pressure is abnormal.
The sample analyzer according to claim 13, wherein the alarm indicating pressure abnormality includes any one of a sampling needle abnormality, an under-sampling abnormality, a sampling impurity abnormality, and an unsampled abnormality.
A sample analyzer according to claim 10, wherein said control unit records the pressure of said line during sampling to form a pressure characteristic curve, and identifies a sampling needle in said sampling process based on the pressure characteristic curve Abnormal, under-sampling anomaly, sampling impurity anomaly or unsampled anomaly.
The sample analyzer according to claim 11, wherein the sampling unit divides the sample into the sample preparation unit, and the control unit controls the pressure sensor to record the pressure of the pipeline if the pipeline pressure is not within the threshold pressure range. The control unit controls the detection unit to output an alarm indicating that the pressure is abnormal.
A sampling monitoring method, comprising the steps of:

Providing a sample analyzer, the sample analyzer comprising a sampling unit, a sample preparation unit, a detection unit and a control unit, the sampling unit is provided from the closed container to the sample preparation unit, and the sample preparation unit reacts the sample with the reagent to generate a test The detecting unit measures the sample and obtains the detection result, and the control unit controls the sampling unit, the sample preparing unit and the detecting unit; the sampling unit includes a sampling needle, a pipeline connected with the sampling needle, and a pressure sensor connected to the pipeline;

The sampling unit monitors the pressure of the pipeline during the sampling process, and determines whether the sampling process is abnormal according to the obtained pressure.
The sampling monitoring method according to claim 17, wherein said suction needle is provided An air passage, the suction needle pierces the closed container to deflate the closed container, and if the pressure of the pipeline after the puncturing is within a threshold pressure range, sampling, sample preparation, measurement, and output detection results are performed.
The sampling monitoring method according to claim 18, wherein if the pressure of the pipeline after the puncturing is not within the threshold pressure range, the suction needle twice punctures the closed container to perform the second closed container Secondary deflation;

If the pressure of the pipeline after the second puncture is within the threshold pressure range, sampling, sample preparation, measurement, and output detection results are performed;

If the pressure of the pipeline after the second puncture is not within the threshold pressure range, the sampling, sample preparation and measurement operations are not performed, or the sampling, sample preparation, and measurement are performed, but the alarm indicates that the pressure is abnormal.
The sampling monitoring method according to claim 17, wherein if the pressure of the pipeline during the sampling is not within the threshold pressure range, the needle washing and the secondary sampling are performed;

If the pressure of the pipeline during the subsampling is within the threshold pressure range, the sample preparation, measurement and output test results are performed;

If the pressure of the pipeline is not within the threshold pressure range during the subsampling process, the sample preparation and measurement actions are not performed; or the sample preparation and measurement actions are performed, the alarm indicates that the pressure is abnormal; or after the sample preparation and measurement operations are performed, the output is output. The result is detected and the result is abnormal.
The sampling monitoring method according to claim 20, wherein the alarm indicating pressure abnormality includes any one of a sampling bolt abnormality, an under-sampling abnormality, a sampling impurity abnormality, and an unsampled abnormality.
The sampling monitoring method according to claim 21, further comprising forming a pressure characteristic curve of the pipeline obtained by monitoring during the sampling process, and identifying the alarm indicating that the pressure abnormality is a sampling plug according to the pressure characteristic curve Needle abnormality, abnormal sampling, abnormal sampling impurity, not taken Abnormal.
The sampling monitoring method according to claim 17, wherein the suction needle samples the sample to be sampled into the sample preparation unit, and the pressure sensor monitors the pressure of the pipeline in real time if the pipeline pressure is not within the threshold pressure range. , the alarm indicates that the pressure is abnormal.