Blood gas analyzer fluid treatment device and blood gas analyzer fluid treatment method

By using the sample introduction mechanism and tubing module to alternately deliver cleaning fluid and gas in the blood gas analyzer, the problems of poor cleaning effect and large sample volume are solved, thereby reducing sample volume and improving cleaning efficiency, reducing the burden on the instrument and patient discomfort.

CN120820731APending Publication Date: 2025-10-21NANJING EAGLENOS CO LTD
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Patent Information

Application Number
CN202410445265.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-04-15
Publication Date
2025-10-21

AI Technical Summary

Technical Problem

Existing blood gas analyzers have poor cleaning performance when cleaning tubing, requiring large amounts of cleaning solution, resulting in large reagent packs and kits, increasing the burden on the instrument, and the large sample volume requirement puts a burden on critically ill patients.

Method used

The blood gas analyzer fluid processing device is used to input gas after the sample or reagent enters the pipeline module through the sampling mechanism, reducing the amount of sample or reagent used, and alternately delivering cleaning liquid and gas during cleaning to improve cleaning efficiency.

Benefits of technology

The amount of sample or reagent used is reduced, the cleaning efficiency is improved, the amount of cleaning fluid used is reduced, the accuracy of the test results is enhanced, and the size of the instrument and the burden on patients are reduced.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides a fluid treatment device of a blood gas analyzer, and relates to the technical field of in-vitro medical detection.The fluid treatment device is characterized in that a sample, a reagent and gas are input from a storage container through a sample introduction mechanism; the test card is used for performing electrochemical detection on a sample or a reagent entering the test card, and the cuvette is used for performing optical detection on the sample or the reagent entering the cuvette; and circulation of samples, reagents and gas is realized through the pipeline module. During detection, the sample introduction mechanism firstly inputs a sample or a reagent, and when the sample or the reagent enters the pipeline module and reaches a set amount, gas is input into the pipeline module, so that residual liquid which cannot be detected in a pipeline is reduced, and the use amount of the sample or the reagent is reduced; when cleaning is needed, the sample injection mechanism alternately conveys cleaning liquid and gas into the pipeline module, so that the cleaning liquid is conveyed at intervals, the liquid column is alternately washed in the pipeline, and a more effective cleaning effect can be achieved.
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Description

Technical Field

[0001] The present invention relates to the technical field of in vitro medical detection, and further to a fluid processing device and a fluid processing method for a blood gas analyzer. Background Art

[0002] The determination of gaseous components in blood is crucial in various scientific research and practical applications. Blood gas analysis is the primary method for monitoring the acid-base balance in the human body, primarily used to monitor the internal environment of critically ill hospitalized patients.

[0003] Blood gas analyzers can directly measure pH, oxygen partial pressure and carbon dioxide partial pressure, as well as standard bicarbonate, base excess and buffer base, and calculate related indicators (such as SO2, actual bicarbonate, etc.), and can detect various electrolytes and various metabolite levels, including glucose, lactate, blood urea nitrogen (BUN) and creatinine.

[0004] To ensure sufficient blood flow into the measurement chamber and to prevent gases from affecting measurement accuracy, the sample must be directly drawn into the measurement chamber. This leaves a significant amount of sample unused in the pipeline, resulting in a relatively large sample volume required each time. Patients in intensive care units require multiple blood gas analyses daily, and the large sample volume required for each test by the blood gas analyzer can be a significant burden for critically ill patients.

[0005] When cleaning the pipelines of existing blood gas analyzers, residual samples, dirt or bubbles in the pipelines are directly flushed out with cleaning fluid. However, this cleaning method is not effective. To achieve a certain cleaning effect, a large amount of cleaning fluid must be used, which leads to waste of cleaning fluid, resulting in larger reagent packs and test kits, and increasing the size of the instrument. Summary of the Invention

[0006] The core of the present invention is to provide a fluid processing device for a blood gas analyzer, which can reduce the amount of sample or reagent used when transporting samples and can achieve alternating flushing of cleaning fluid and gas during cleaning to improve cleaning efficiency. The specific solution is as follows:

[0007] A fluid processing device for a blood gas analyzer, comprising:

[0008] A sample introduction mechanism, connected to the storage container, for introducing samples, reagents, and gases from the storage container;

[0009] A test card for electrochemically detecting a sample or reagent introduced therein;

[0010] Cuvette, used for optical detection of samples or reagents entering it;

[0011] A pipeline module, comprising a plurality of pipelines and control valves and a drive pump provided thereon, for controlling the on-off of the pipelines and driving the fluid, so that the fluid flows from the injection mechanism to the test card and the cuvette;

[0012] The sample injection mechanism can inject gas into the pipeline module after the sample or reagent enters the pipeline module to reduce the amount of sample or reagent used;

[0013] The sample injection mechanism can alternately deliver cleaning liquid and gas to the pipeline module during cleaning.

[0014] Optionally, the test card includes a test matrix on which a liquid flow channel is arranged, the liquid flow channel includes a main channel and a branch channel, a reference electrode is arranged in the branch channel, and a liquid level judgment electrode and an electrochemical detection electrode are arranged in the main channel; the injection mechanism is used to deliver samples or reagents into the main channel, and the branch channel is connected to a reference container to provide a reference liquid.

[0015] Optionally, the cuvette includes a cuvette base and an optical cell disposed thereon.

[0016] Optionally, it further comprises a bubble and blood coagulation detection unit for detecting the sample delivered from the sampling mechanism to determine whether there is blood coagulation or bubbles in the sample;

[0017] The pipeline module includes a main pipeline and a bypass pipeline, and the bubble coagulation detection unit, the test card and the cuvette are arranged in the main pipeline;

[0018] The bypass line is connected to the outlet end of the bubble coagulation detection unit and the waste liquid bag, and is used to discharge the fluid that fails the detection by the bubble coagulation detection unit directly into the waste liquid bag.

[0019] Optionally, the test card and the cuvette are sequentially arranged in the main line, so as to allow the fluid to flow through the test card and the cuvette in that order.

[0020] Optionally, the driving pump is provided on the main line, and the bypass line is connected before the driving pump, so that the bypass line and the main line share the driving pump.

[0021] Optionally, the main line includes a first branch and a second branch connected in parallel with each other, the test card is arranged in the first branch, and the cuvette is arranged in the second branch.

[0022] Optionally, the first branch and the second branch are each independently provided with the driving pump.

[0023] Optionally, the injection mechanism includes an injection needle, an injection bracket and a sealing body, and the injection needle is movably inserted into the sealing body;

[0024] The two ends of the injection needle are closed and the side wall is provided with an injection hole. Each storage container is connected to an inlet tube, and one end of the inlet tube is inserted into the sealing body.

[0025] The injection needle can move axially relative to the sealing body, and the injection hole not sealed by the sealing body is used for injection.

[0026] Optionally, the injection mechanism includes an injection needle, an injection bracket and a sealing body, and the injection needle is fixedly inserted into the sealing body;

[0027] The side wall of the injection needle is provided with a plurality of injection holes, each of the storage containers is correspondingly connected to an inlet tube, each of the inlet tubes is correspondingly connected to one of the injection holes, and each of the inlet tubes is correspondingly provided with a cut-off valve.

[0028] The present invention also provides a blood gas analyzer fluid processing method, comprising:

[0029] When testing samples:

[0030] The driving pump generates driving force, and the sample and gas are supplied by the sample injection mechanism; after the sample enters the pipeline module by a set amount, gas is input into the pipeline module to reduce the amount of sample;

[0031] The bubble coagulation detection unit is used to detect the sample provided by the sampling mechanism to determine whether there is coagulation or bubbles; if so, it is directly drained to the waste liquid bag through the bypass line; if not, it is drained to the test card and cuvette through the main line for separate testing.

[0032] Optionally, it also includes: calibration and quality control, and cleaning.

[0033] The present invention provides a fluid processing device for a blood gas analyzer, which utilizes an injection mechanism to input samples, reagents, and gases from a storage container; a test card is used to perform electrochemical detection on the sample or reagent entering the device, and a cuvette is used to perform optical detection on the sample or reagent entering the device; and a pipeline module is used to achieve the circulation of the sample, reagent, and gas. During detection, the injection mechanism first inputs the sample or reagent. When the sample or reagent has entered the pipeline module to a set amount, gas is then input into the pipeline module to reduce the amount of liquid that cannot be detected in the pipeline, thereby reducing the amount of sample or reagent used. When cleaning is required, the injection mechanism alternately delivers cleaning liquid and gas into the pipeline module, so that the cleaning liquid is delivered at intervals, and the liquid columns alternately flush the pipeline, thereby achieving a more effective cleaning effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0035] Figure 1 A schematic diagram of a first series embodiment of a fluid processing device for a blood gas analyzer provided by the present invention;

[0036] Figure 2 A schematic diagram of a second parallel embodiment of the fluid processing device for a blood gas analyzer provided by the present invention;

[0037] Figure 3 A schematic diagram of a specific embodiment of a sample injection mechanism;

[0038] Figure 4 A schematic diagram showing that liquid is input first and gas is input later;

[0039] Figure 5 Schematic diagram showing the alternation of liquid and gas sections during the cleaning process.

[0040] The diagram includes:

[0041] Injection mechanism 100, injection needle 101, injection bracket 102, sealing body 103, inlet tube 104, shut-off valve 105, injection hole 106;

[0042] Bubble coagulation detection unit 200;

[0043] Test card 300, test substrate 301, liquid flow channel 302, main flow channel 3021, branch flow channel 3022, reference electrode 303, liquid level determination electrode 304;

[0044] Cuvette 400, cuvette base 401, optical cell 402;

[0045] Pipeline module 500 , main line 501 , first branch 5011 , second branch 5012 , bypass line 502 , control valve 503 , drive pump 504 , storage container 505 , reference container 506 , and waste liquid bag 507 . DETAILED DESCRIPTION

[0046] In order to enable those skilled in the art to better understand the technical solution of the present invention, the blood gas analyzer fluid processing device of the present invention will be described in detail below with reference to the accompanying drawings and specific implementation methods.

[0047] The present invention provides a fluid processing device for a blood gas analyzer, comprising a sample injection mechanism 100, a test card 300, a cuvette 400, a pipeline module 500, and other structures. The pipeline module 500 is used to connect the other structures, allowing liquid and gas to flow in the pipeline and guiding the liquid and gas to move along the pipeline.

[0048] The sample injection mechanism 100 is connected to a storage container 505. Multiple storage containers 505 are provided. Each storage container 505 can independently store a reagent or gas. Different storage containers 505 can store different reagents or gases, or some storage containers 505 can store the same reagent or gas. The storage container 505 can be a flexible bag or other type of container such as a syringe. These specific forms are all acceptable.

[0049] The sample injection mechanism 100 is connected to each storage container 505 and can input samples, reagents, and gases from the storage containers 505. The sample is the liquid to be tested, the reagent is the liquid that assists the detection process, and the gas can be air or other gases that do not interfere with the sample and reagent. The sample injection mechanism 100 can extract the corresponding sample, reagent, or gas from a storage container 505 at a time and can switch between different storage containers 505 to input the required sample, reagent, or gas.

[0050] The test card 300 is used to perform electrochemical detection on the sample or reagent entering it, mainly for blood gas (pO2, pCO2, pH), electrolyte (K + , Ca ++ 、Na + Mg ++ 、Cl - ), detection of hematocrit Hct, glucose Glu, lactate Lac, creatinine Creat and other indicators.

[0051] In a specific embodiment, the test card 300 includes a test substrate 301, on which a liquid flow channel 302 is provided. The liquid flow channel 302 is used for allowing liquid and gas to pass through. The liquid flow channel 302 is connected to the pipeline, and the liquid or gas input from the injection mechanism 100 can flow into the liquid flow channel 302.

[0052] Combine Figure 1 、 Figure 2As shown, the liquid flow channel 302 includes a main channel 3021 and a branch channel 3022, and the two ends of the main channel 3021 are respectively connected to the pipeline, one end of the branch channel 3022 is connected to the pipeline, and the other end is connected to the main channel 3021. A reference electrode 303 is set in the branch channel 3022, and a liquid level judgment electrode 304 and an electrochemical detection electrode are set in the main channel 3021 (the electrochemical detection electrode is not shown in the accompanying drawings). The liquid level judgment electrode 304 is used to determine whether the sample is in place, and the electrochemical detection electrode is used to perform electrochemical detection on the liquid. The injection mechanism 100 delivers the sample or reagent into the main channel 3021 through the pipeline, and the branch channel 3022 is connected to the reference container 506 through the pipeline to provide a reference solution, so that the reference solution can enter the test card 300. The reference solution is also called a blank solution, which is used for comparison during measurement. It does not contain the substance to be measured, but its matrix is ​​as similar as possible to the sample solution. Generally, the curve scanned with the reference solution should be a flat straight line. Sometimes, although the matrix does not contain the substance to be measured, it may contain other substances. In this case, it is necessary to ensure that these substances do not affect the test. It is also common to encounter blank reagents that contain the substance to be measured. In this case, purification must be performed to remove these substances, otherwise the test results will be affected.

[0053] Cuvette 400 is used to perform optical detection on samples or reagents placed within it. In a specific embodiment, cuvette 400 includes a cuvette base 401 and an optical cell 402 disposed thereon. During detection, liquid flows into optical cell 402. Cuvette 400 is an instrument used for spectral analysis, primarily a quartz cuvette made of quartz powder, and is used for spectral analysis of liquids.

[0054] The pipeline module 500 is composed of several pipelines. Pipelines are provided between two devices that need to flow liquids or gases, and the pipelines guide the flow of liquids and gases. The pipeline module 500 includes several pipelines, control valves 503, and drive pumps 504. The control valves 503 and drive pumps 504 are provided on the corresponding pipelines to control the on-off of the pipelines and fluid drive. The control valves 503 are used to control the on-off of the pipelines in which they are located, and the drive pumps 504 are used to provide driving force for the liquid or gas in the pipelines, causing the liquid, gas, or a mixture of the two to move in the pipelines. Under the power of the drive pumps 504, the fluid enters the pipeline module 500 from the sample injection mechanism 100 and flows to the test card 300 and the cuvette 400 under the guidance of the pipelines and the drive of the drive pumps 504. The drive pumps 504 can be peristaltic pumps, and the control valves 503 can be solenoid valves. The states of the control valves 503 and drive pumps 504 are achieved through the logic control module.

[0055] The blood gas analyzer fluid processing device provided by the present invention can achieve the following process:

[0056] After a set amount of sample or reagent enters the pipeline module 500, the injection mechanism 100 injects gas into the pipeline module 500 to reduce the amount of sample or reagent used. Since the injection mechanism 100 can inject gas into the pipeline, when performing a test, the control valve 503 and the drive pump 504 are operated to allow liquid to enter the pipeline module 500 first. After a certain amount of liquid has entered (the specific amount of liquid entering needs to be pre-set), the pipeline module 500 is no longer injected with liquid, but instead switches to injecting gas. The gas is located behind the previously injected liquid, and the gas input maintains air pressure balance. The amount of liquid injected first needs to be greater than the test amount of the test card 300 and the cuvette 400. When the liquid enters the test card 300 or the cuvette 400 for testing, it can meet the test amount. The gas that subsequently enters the pipeline is only located in the pipeline during testing, and does not enter the test card 300 or the cuvette 400, that is, it does not enter the test card 300 during testing, and does not enter the cuvette 400 during testing. Compared with the traditional liquid supply method, the subsequent amount of liquid entering is reduced, that is, after the testing amount of the test card 300 and the cuvette 400 is met, no more liquid is supplied, and gas enters instead, and the gas is used to fill the space in the pipeline to keep the air pressure in the pipeline balanced. The part filled with gas replaces the liquid in the traditional sampling process, reducing the amount of this part of the liquid, and can save the total amount of liquid used in the entire testing process. Combined with Figure 4 As shown, the solid line L represents liquid and the dotted line A represents gas. The test card 300 is filled with liquid for testing, while the area between the test card 300 and the injection mechanism 100 is gas. In the traditional process of aspirating liquid, the area at the dotted line A is filled with liquid. With the device of the present invention, the area at the dotted line A does not require liquid, thereby reducing the amount of liquid used.

[0057] When the sample injection mechanism 100 is cleaning, it alternately delivers cleaning liquid and gas to the pipeline module 500. The cleaning liquid can moisten and dissolve the clotted pollutants attached to the inner wall, and at the same time flush the pipeline by impact force. The impact force of the gas is greater than that of the liquid, and can better flush the clotted pollutants attached to the inner wall, especially for smaller clotted pollutants or curved corners. By alternating gas and liquid flushing, the flushing effect can be effectively improved and the accuracy of the test results can be improved. Combined with Figure 5 As shown, the dotted line represents a mixed fluid of liquid and gas, wherein the black part represents liquid, and the blank area between the two black sections is gas. The columnar liquid and the columnar gas alternately advance along the pipeline, and the gas and liquid alternately achieve flushing.

[0058] On the basis of the above scheme, combined with Figure 1 、 Figure 2As shown, the fluid processing device for a blood gas analyzer provided by the present invention also includes a bubble coagulation detection unit 200, which is used to detect the sample delivered from the sample injection mechanism 100 and determine whether there is coagulation or bubbles in the sample. The pipeline module 500 includes a main pipeline 501 and a bypass pipeline 502. The bubble coagulation detection unit 200, the test card 300, and the cuvette 400 are disposed in the main pipeline 501. The main pipeline 501 is used during normal testing and allows samples or reagents to flow into the main pipeline 501.

[0059] The bypass line 502 is connected between the outlet of the bubble coagulation detection unit 200 and the waste liquid bag 507. It is used to discharge fluid that fails the bubble coagulation detection unit 200 directly into the waste liquid bag 507. The bypass line 502 is used during abnormal conditions to discharge samples or reagents containing coagulation or bubbles directly into the waste liquid bag 507. It should be noted that the liquid that flows into the main line 501 and passes through the test card 300 and cuvette 400 to complete the test is also discharged into the waste liquid bag 507.

[0060] The bubble and coagulation detection unit 200 can utilize optical or electrical signal detection. When the bubble and coagulation detection unit 200 detects bubbles or clots in the sample, the sample does not enter the test card 300 or cuvette 400, but is instead discharged directly into the waste liquid bag 507 via the bypass line 502. Before the liquid enters the main line 501 or the bypass line 502, the present invention first determines whether the liquid itself meets the requirements for normal detection. If normal, the liquid enters the main line 501; otherwise, it enters the bypass line 502. This prevents samples containing clots or bubbles from entering the test card 300 and cuvette 400, thereby preventing blockage or invalid detection.

[0061] The present invention provides the following two (1, 2) specific configurations:

[0062] 1) The test card 300 and the cuvette 400 are sequentially arranged in the main line 501, so that the fluid flows through the test card 300 and the cuvette 400 in sequence. In this embodiment, the test card 300 and the cuvette 400 are arranged in series in the main line 501. Figure 1 As shown, the test card 300 and the cuvette 400 are connected in series. In this embodiment, the test card 300 is located before the cuvette 400, that is, the liquid first flows through the test card 300 for detection and then flows through the cuvette 400 for detection. The liquid undergoes two detection processes in succession.

[0063] In addition to the configurations shown in the drawings, the order of the test card 300 and the cuvette 400 can be reversed, that is, the flow passes through the cuvette 400 first and then the test card 300, which can also meet the detection process. Therefore, these configurations should also be included in the scope of protection of the present invention.

[0064] Combine Figure 1 As shown, a driving pump 504 is provided on the main line 501, and the bypass line 502 is connected before the driving pump 504. The connection point of the bypass line 502 is located in the area between the cuvette 400 and the driving pump 504. The bypass line 502 and the main line 501 share the driving pump 504, that is, the liquid is driven to flow in the bypass line 502 and the main line 501 at the same time through the same driving pump 504. When the control valve 503 of the main line 501 is closed and the control valve 503 of the bypass line 502 is opened, the driving pump 504 drives the liquid to flow from the bypass line 502; when the control valve 503 of the main line 501 is opened and the control valve 503 of the bypass line 502 is closed, the driving pump 504 drives the liquid to flow from the main line 501. It should be noted that at least one control valve 503 is respectively provided on the main line 501 and the bypass line 502, in combination with Figure 1 As shown, a control valve 503 is also provided in the pipeline between the reference container 506 and the test card 300. Control valves can also be provided at other positions, which are not shown in the drawings.

[0065] 2) The main line 501 includes a first branch 5011 and a second branch 5012 connected in parallel. The test card 300 is set in the first branch 5011, and the cuvette 400 is set in the second branch 5012. Figure 2 As shown in FIG, the test card 300 and the cuvette 400 are connected in parallel. The first branch 5011 and the second branch 5012 are independently provided with a driving pump 504. Figure 2 In the embodiment, the first branch 5011 and the second branch 5012 are each provided with a driving pump 504, wherein the pipeline connecting the reference container 506 to the test card 300 and the first branch 5011 share the same driving pump 504. Figure 2 As shown, the second branch 5012 and the bypass line 502 both share the same drive pump 504 .

[0066] The present invention provides the following two (A, B) specific configurations of the sample injection mechanism 100:

[0067] A) Combination Figure 1 、 Figure 2 As shown, both devices utilize the same injection mechanism 100. The injection mechanism 100 comprises an injection needle 101, an injection support 102, and a sealing body 103. The injection needle 101 is movably mounted within the sealing body 103, which is mounted within the injection support 102. The sealing body 103 ensures a sealed connection between the injection needle 101 and each inlet tube 104. The sealing body 103 can be made of materials such as rubber and silicone.

[0068] In this embodiment, both ends of the injection needle 101 are closed and the side wall is provided with an injection hole 106. Figure 2 In the embodiment, the left end of the injection needle 101 is closed but connected to the pipeline to discharge liquid or gas, and the right end of the injection needle 101 remains closed, and the injection is completed by relying on the injection hole 106 set on the side wall of the injection needle 101.

[0069] Combine Figure 1 and Figure 2 As shown, there are multiple storage containers 505, which can be made of soft and deformable materials or hard containers. Each storage container 505 is connected to an inlet tube 104. One end of the inlet tube 104 is connected to the storage container 505, and the other end of the inlet tube 104 is inserted into the sealing body 103 and docked with the side wall of the injection needle 101. The injection needle 101 can move axially relative to the sealing body 103, and the injection hole 106 that is not sealed by the sealing body 103 is used for injection. Figure 1 As shown, when the injection hole 106 is directly opposite a particular inlet tube 104, the storage container 505 corresponding to the inlet tube 104 can be used to input liquid or gas. It should be noted that one end of the inlet tube 104 for gas intake is inserted into the sealing body 103, and the other end can be connected to the storage container 505 for gas storage, or directly connected to the outside atmosphere. Inlet tubes 104 that are not directly opposite the injection hole 106 will contact the wall of the injection needle 101, making sample injection impossible. The number of injection holes 106 can be set according to the needs of use and is not specifically limited in this invention.

[0070] Combine Figure 1 As shown, the tube wall on the right side of the injection needle 101 is provided with an injection hole 106 that can extend outward to the outside of the sealing body 103. When the injection hole 106 extends to the outside, it can be connected to an external sampling device for storing samples, such as a syringe.

[0071] B) Combination Figure 3 As shown, a structural example of another injection mechanism 100 is separately shown. The injection mechanism 100 includes an injection needle 101, an injection bracket 102 and a sealing body 103. The injection needle 101 is fixedly inserted into the sealing body 103. Unlike the above-mentioned embodiment A), the injection needle 101 in this embodiment remains fixed. The side wall of the injection needle 101 is provided with a plurality of injection holes 106. Each storage container 505 is connected to a corresponding inlet pipe 104. There is no need to switch back and forth through a certain injection hole 106. Each inlet pipe 104 is connected to a corresponding injection hole 106. Each inlet pipe 104 is provided with a shut-off valve 105. The supply of contents in each storage container 505 is achieved by cutting off and opening the shut-off valve 105. Similarly, a shut-off valve 105 is also provided in the pipeline corresponding to the intake inlet pipe 104, which can be directly connected to the outside atmosphere.

[0072] Combine Figure 2In this structure, the right end of the injection needle 101 is a through non-enclosed structure, and the external sample can enter the injection needle 101 from the right end.

[0073] The present invention also provides a blood gas analyzer fluid processing method, when performing sample detection, according to the following steps:

[0074] S1. Generate driving force by driving pump 504 and use sample injection mechanism 100 to supply sample and gas. After a set amount of sample enters pipeline module 500, input gas into pipeline module 500 to reduce the amount of sample.

[0075] S2. Use the bubble coagulation detection unit 200 to detect the sample provided by the sample injection mechanism 100 to determine whether there is coagulation or bubbles; if so, drain it directly to the waste liquid bag 507 through the bypass line 502; if not, drain it through the main line 501 to the test card 300 and the cuvette 400 for separate testing.

[0076] The blood gas analyzer fluid processing method of the present invention also includes: calibration and quality control, cleaning and other processing processes.

[0077] Calibration: Before the blood sample enters the detection channel, the standard reagent enters the detection channel to obtain the electrochemical signal, and the electrochemical signal is used as the standard to test the blood sample.

[0078] Quality control: Reagents with standard concentrations are used during maintenance, inspection, or analysis to determine whether the analyzer is working properly and whether the test results are accurate.

[0079] The following targets Figure 1 The series structure shown and Figure 2 The parallel structure shown is used to introduce and explain the processing methods respectively.

[0080] ①About Figure 1 The displayed tandem structure:

[0081] Calibration:

[0082] The control valve 503 between the test card 300 and the cuvette 400 is open, the control valve 503 between the reference container 506 and the test card 300 is closed, and the control valve 503 on the bypass line 502 is closed. The injection needle 101 and the injection holder 102 move relative to each other. One injection hole 106 on the injection needle 101 is connected to a calibration solution through the inlet tube 104, while the remaining injection holes 106 are sealed by the sealing body 103. The drive pump 504 rotates clockwise, and the calibration solution is drawn into the liquid flow channel 302 and optical cell 402 through the pipeline, and the drive pump 504 stops. The injection needle 101 and injection holder 102 move relative to each other, sealing the sealing member 103 and sealing all injection holes 106. The control valve 503 between the reference container 506 and the test card 300 opens, and the drive pump 504 rotates clockwise, drawing the reference solution from the reference container 506 into the flow channel 302. The drive pump 504 stops, and the control valve 503 between the reference container 506 and the test card 300 closes. Electrochemical and optical signal detection is performed on the test card 300 and the cuvette 400, and the system is calibrated based on the collected signals.

[0083] Sample testing:

[0084] The control valve 503 between the test card 300 and the cuvette 400 is opened, the control valve 503 between the reference container 506 and the test card 300 is closed, and the control valve 503 on the bypass line 502 is closed. The injection needle 101 and the injection holder 102 move relative to each other, and the injection hole 106 on the right side of the injection needle 101 extends into the external sampling device. The remaining injection holes 106 are sealed by the sealing body 103. The pump 504 is driven to rotate clockwise, and the sample is drawn into the injection needle 101 and enters the bubble and coagulation detection unit 200 through the pipeline for bubble and coagulation detection.

[0085] When the sample passes the test, the sample continues to enter the liquid flow channel 302 through the pipeline. When the liquid level judgment electrode 304 detects that a sample has entered, the drive pump 504 stops moving, the injection needle 101 and the injection bracket 102 move relative to each other, and the injection hole 106 is connected to the gas supply through an inlet tube 104, and the other injection holes 106 are sealed by the sealing body 103. The drive pump 504 rotates clockwise, and the gas is sucked into the injection needle 101, pushing the sample into the test card 300 and the cuvette 400. Here, it is necessary to control the amount of inhaled gas to prevent the sample from not entering and filling the cuvette 400, or the sample from being pushed out of the test card 300. It is necessary to ensure that both the test card 300 and the cuvette 400 are full of sample. The drive pump 504 stops, the injection needle 101 and the injection holder 102 move relative to each other, the seal 103 seals all injection holes 106, and the control valve 503 between the reference container 506 and the test card 300 opens. The drive pump 504 rotates clockwise, drawing the reference solution from the reference container 506 into the liquid flow channel 302. The drive pump 504 stops, and the control valve 503 between the reference container 506 and the test card 300 closes. The amount of reference solution drawn in must be controlled to prevent it from entering the cuvette 400.

[0086] Electrochemical and optical signal detection is performed on the test card 300 and the cuvette 400. The amount of each indicator in the sample is calculated based on the collected signals to achieve sample detection. After the sample detection is completed, the injection needle 101 and the injection bracket 102 move relative to each other. One injection hole 106 on the injection needle 101 is connected to the cleaning liquid through the inlet tube 104, and the remaining injection holes 106 are sealed by the sealing body 103. The pump 504 is driven to rotate clockwise, and the sample in the flow channel is pushed into the waste liquid bag 507. The cleaning liquid is sucked into the test card 300 and the cuvette 400 through the pipeline. Through the cleaning process, the main pipeline 501, the test card 300 and the cuvette 400 are cleaned.

[0087] When a sample fails the test, the control valve 503 between the test card 300 and the cuvette 400 closes, and the control valve 503 on the bypass line 502 opens. The injection needle 101 and the injection holder 102 move relative to each other, connecting one injection hole 106 on the injection needle 101 to the cleaning solution via the inlet tube 104. The remaining injection holes 106 are sealed by the sealing body 103. The abnormal sample that did not pass through the main line 501 is driven by the drive pump 504 through the bypass line 502 and into the waste liquid bag 507. Then, the control valve 503 between the test card 300 and the cuvette 400 opens, and the control valve 503 on the bypass line 502 closes. The sample that has passed through the interface between the main line 501 and the bypass line 502 and reached the main line 501 is driven by the drive pump 504 through the test card 300 and the cuvette 400 and discharged into the waste liquid bag 507. Then, the main line 501 and the bypass line 502 are cleaned separately using a cleaning process.

[0088] Quality Control:

[0089] For internal quality control, the process is the same as calibration, and only the calibration solution needs to be switched to the quality control solution.

[0090] For external quality control, the process is the same as sample testing, and the sample is quality control fluid.

[0091] Cleaning:

[0092] The pipelines must be cleaned after sample testing is completed, sample testing is abnormal, calibration fails, or quality control fails. This is divided into cleaning of the main pipeline 501 and cleaning of the bypass pipeline 502.

[0093] During cleaning of the main line, the control valve 503 between the test card 300 and the cuvette 400 is opened, the control valve 503 between the reference container 506 and the test card 300 is closed, and the control valve 503 on the bypass line 502 is closed. The injection needle 101 and the injection support 102 move relative to each other, connecting one injection hole 106 on the injection needle 101 to the cleaning fluid via the inlet tube 104. The remaining injection holes 106 are sealed by the sealing body 103. The pump 504 is driven to rotate clockwise, allowing the cleaning fluid to enter the injection needle 101 for a short distance. The injection needle 101 then moves relative to the injection support 102, connecting one injection hole 106 on the injection needle 101 via the air inlet tube 105, and a portion of gas is drawn into the injection needle 101. This process is repeated to form a cleaning liquid with a gas-liquid interval (a section of cleaning liquid and a section of gas alternating) in the pipeline, which is used to flush the pipeline, the test card 300 and the cuvette 400, thereby improving the cleaning efficiency and reducing the amount of cleaning liquid. The cleaning liquid is finally discharged into the waste liquid bag 507.

[0094] When cleaning the bypass line, the control valve 503 between the test card 300 and the cuvette 400 is closed, the control valve 503 between the reference container 506 and the test card 300 is closed, and the control valve 503 set on the bypass line 502 is opened. The remaining actions are the same as those for cleaning the main line.

[0095] ②About Figure 2 The parallel structure shown:

[0096] The parallel solution refers to the parallel connection of the electrochemical detection module and the optical detection module.

[0097] The parallel liquid circuit diagram of the blood gas analyzer is as follows Figure 2 As shown, it mainly includes a sample injection mechanism 100, a bubble coagulation detection unit 200, a test card 300, a cuvette 400, and a pipeline module 500. Among them, the sample injection mechanism 100, the bubble coagulation detection unit 200, the test card 300, and the cuvette 400 are consistent with those in the series liquid circuit and are not described here.

[0098] The pipeline module 500 includes a main pipeline 501 and a bypass pipeline 502. The main pipeline 501 further includes a first branch 5011 and a second branch 5012 arranged in parallel. The first branch 5011 mainly connects the bubble coagulation detection unit 200, the test card 300, the control valve 503, the drive pump 504, the reference container 506, and the waste liquid bag 507 through pipelines. The second branch 5012 mainly connects the main pipeline 501, the control valve 503, the cuvette 400, the drive pump 504, the one-way valve, and the waste liquid bag 507 through pipelines. The bypass pipeline 502 mainly connects the main pipeline 501, the control valve 503, the drive pump 504, the one-way valve, and the waste liquid bag 507 through pipelines. The first branch 5011 and the second branch 5012 of the main pipeline 501 intersect at a three-way valve, and the main pipeline 501 and the bypass pipeline 502 intersect at the three-way valve.

[0099] In the calibration, sample testing, quality control, and cleaning processes, the sample aspiration process and the bubble coagulation detection process are consistent with those described in the serial fluid circuit.

[0100] Calibration:

[0101] The control valve 503 of the second branch 5012 is closed, and the control valve 503 and drive pump 504 of the bypass line 502 are closed. The drive pump 504 of the first branch 5011 rotates counterclockwise, and the sample introduction mechanism 100 draws the calibration solution, which passes through the bubble coagulation detection unit 200 and enters the test card 300. In the parallel fluid circuit diagram, the reference solution line and the first branch 5011 of the main line 501 share a common drive pump 504. When the drive pump 504 rotates, the reference solution also enters the test card 300 simultaneously. When the calibration solution and reference solution fill the test card 300, the drive pump 504 is closed, and the control valve 503 and drive pump 504 of the second branch 5012 are opened. The calibration solution enters the cuvette 400 through the three-way valve, and the drive pump 504 of the second branch 5012 stops. Electrochemical and optical signal acquisition is then performed, completing the calibration process.

[0102] Sample testing:

[0103] The control valve 503 of the second branch 5012 is closed, and the control valve 503 and the driving pump 504 of the bypass line 502 are closed. The driving pump 504 of the first branch 5011 rotates counterclockwise, and the reference solution enters the test card 300. The synchronous system completes the sample absorption through the sampling mechanism 100. After the sample is detected by the bubble coagulation detection unit 200, it enters the test card 300. When the liquid level judgment electrode 304 detects a signal, the driving pump 504 is closed, and the control valve 503 of the second branch 5012 is opened. The driving pump 504 of the second branch 5012 is opened, and the sample between the three-way valve and the injection needle 101 enters the cuvette 400 and fills the cuvette 400; the driving pump 504 and the control valve 503 of the second branch 5012 are closed; the driving pump 504 of the first branch 5011 is opened, and the sample between the three-way valve and the liquid level judgment electrode 304 is sucked into the test card 300. When the sample fills the test card 300, the driving pump 504 is closed, and then electrochemical and optical signal acquisition is performed to complete the sample detection. Then, a cleaning process is used to clean the first branch 5011 and the second branch 5012 respectively.

[0104] If a sample is determined to be unqualified after being tested by the bubble coagulation detection unit 200, the drive pump 504 of the first branch 5011 is closed, the control valve 503 of the second branch 5012 is closed, the control valve 503 and drive pump 504 of the bypass line 502 are opened, and the sample on the right side of the three-way valve is discharged into the waste liquid bag 507 through the bypass line 502. The control valve 503 and drive pump 504 of the bypass line 502 are closed, the drive pump 504 of the first branch 5011 is opened, and the sample from the three-way valve to the test card 300 is discharged into the waste liquid bag 507 through the first branch 5011 of the main line 501. The drive pump 504 of the first branch 5011 is closed, the control valve 503 and drive pump 504 of the second branch 5012 are opened, and the sample from the three-way valve to the cuvette 400 is discharged into the waste liquid bag 507 through the second branch 5012. Afterwards, a cleaning process is used to clean the first branch 5011 , the second branch 5012 and the bypass line 502 of the main line 501 .

[0105] Quality Control:

[0106] For internal quality control, the process is the same as calibration, and only the calibration solution needs to be switched to the quality control solution.

[0107] For external quality control, the process is the same as sample testing, and the sample is quality control fluid.

[0108] Cleaning:

[0109] The pipeline needs to be cleaned when sample testing is completed, sample testing is abnormal, calibration fails, quality control fails, etc. This is divided into cleaning the first branch 5011 of the main pipeline 501, cleaning the second branch 5012 of the main pipeline 501, and cleaning the bypass pipeline 502.

[0110] The cleaning liquid absorption process is the same as that of the series liquid circuit.

[0111] When cleaning the first branch 5011 of the main pipeline 501, the control valves 503 and the drive pump 504 of other pipelines are closed, and the control valve 503 and the drive pump 504 of the first branch 5011 are opened. The cleaning liquid is sucked through the sampling mechanism 100, and the cleaning liquid in the gas-liquid interval passes through the test card 300 and is discharged into the waste liquid bag 507.

[0112] When cleaning the second branch 5012 of the main line 501, the control valves 503 and the drive pump 504 of other lines are closed, and the control valve 503 and the drive pump 504 of the second branch 5012 are opened. The cleaning liquid is sucked through the sampling mechanism 100, and the cleaning liquid in the gas-liquid interval passes through the cuvette 400 and is discharged into the waste liquid bag 507.

[0113] When cleaning the bypass line 502, the control valves 503 and the drive pump 504 of other lines are closed, and the control valve 503 and the drive pump 504 of the bypass line 502 are opened. The cleaning liquid is sucked through the sampling mechanism 100, and the cleaning liquid in the gas-liquid interval passes through the bypass line 603 and is discharged into the waste liquid bag 507.

[0114] The blood gas analyzer fluid processing device provided by the present invention adopts a series scheme with simple fluid circuits, clear logic, and short pipelines. The series scheme only requires one peristaltic pump as a power source, and the series scheme can achieve a smaller volume and lower cost. The parallel scheme has relatively complex fluid circuits and logic control, requires two peristaltic pumps as power sources, and has slightly higher cost and volume than the series scheme. The parallel scheme has relatively independent electrochemical detection and optical detection, and can perform only electrochemical detection, only optical detection, or both simultaneously. In the parallel scheme, if one of the test card 300 or the cuvette 400 is blocked or otherwise malfunctions, the faulty circuit can be blocked, while the other circuit can still be used normally.

[0115] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A fluid processing device for a blood gas analyzer, characterized in that: include: The sample introduction mechanism (100) is connected to the storage container (505) and is used to introduce samples, reagents, and gases from the storage container (505); A test card (300) for performing electrochemical detection on a sample or reagent entering the test card; a cuvette (400) for optically detecting a sample or reagent entering the cuvette; A pipeline module (500), comprising a plurality of pipelines and control valves (503) and a drive pump (504) arranged thereon, for controlling the on-off of the pipelines and fluid drive, so that the fluid flows from the injection mechanism (100) to the test card (300) and the cuvette (400); The sample injection mechanism (100) can inject gas into the pipeline module (500) to reduce the amount of sample or reagent after a set amount of sample or reagent enters the pipeline module (500); The sample injection mechanism (100) can alternately deliver cleaning liquid and gas to the pipeline module (500) during cleaning.

2. The fluid processing device for a blood gas analyzer according to claim 1, characterized in that: The test card (300) comprises a test base (301) on which a liquid flow channel (302) is arranged. The liquid flow channel (302) comprises a main flow channel (3021) and a branch flow channel (3022). A reference electrode (303) is arranged in the branch flow channel (3022), and a liquid level judgment electrode (304) and an electrochemical detection electrode are arranged in the main flow channel (3021). The sample injection mechanism (100) is used to send a sample or a reagent into the main flow channel (3021), and the branch flow channel (3022) is connected to a reference container (506) to provide a reference solution.

3. The fluid processing device of the blood gas analyzer according to claim 2, characterized in that: The cuvette (400) comprises a cuvette base (401) and an optical cell (402) arranged thereon.

4. The fluid processing device for a blood gas analyzer according to claim 3, characterized in that: It also includes a bubble and blood coagulation detection unit (200) for detecting the sample delivered from the sample injection mechanism (100) and determining whether blood coagulation or bubbles exist in the sample; The pipeline module (500) includes a main pipeline (501) and a bypass pipeline (502), and the bubble coagulation detection unit (200), the test card (300) and the cuvette (400) are arranged on the main pipeline (501); The bypass line (502) is connected to the outlet end of the bubble coagulation detection unit (200) and the waste liquid bag (507), and is used to discharge the fluid that fails the detection by the bubble coagulation detection unit (200) directly into the waste liquid bag (507).

5. The fluid processing device for a blood gas analyzer according to claim 4, characterized in that: The test card (300) and the cuvette (400) are sequentially arranged on the main pipeline (501) to allow the fluid to flow through the test card (300) and the cuvette (400) in sequence.

6. The fluid processing device for a blood gas analyzer according to claim 5, characterized in that: The driving pump (504) is provided on the main line (501), and the bypass line (502) is connected before the driving pump (504), so that the bypass line (502) and the main line (501) share the driving pump (504).

7. The fluid processing device for a blood gas analyzer according to claim 4, characterized in that: The main line (501) comprises a first branch (5011) and a second branch (5012) which are arranged in parallel with each other, the test card (300) is arranged in the first branch (5011), and the cuvette (400) is arranged in the second branch (5012).

8. The fluid processing device for a blood gas analyzer according to claim 7, characterized in that: The first branch (5011) and the second branch (5012) are each independently provided with the driving pump (504).

9. The fluid processing device for a blood gas analyzer according to claim 5 or 7, characterized in that: The injection mechanism (100) comprises an injection needle (101), an injection support (102) and a sealing body (103), wherein the injection needle (101) is movably inserted into the sealing body (103); Both ends of the injection needle (101) are closed and an injection hole (106) is provided on the side wall. Each storage container (505) is connected to a corresponding inlet tube (104), and one end of the inlet tube (104) is inserted into the sealing body (103); The injection needle (101) is capable of moving axially relative to the sealing body (103), and the injection hole (106) not sealed by the sealing body (103) is used for injection.

10. The fluid processing device for a blood gas analyzer according to claim 5 or 7, characterized in that: The injection mechanism (100) comprises an injection needle (101), an injection support (102) and a sealing body (103), wherein the injection needle (101) is fixedly inserted into the sealing body (103); The side wall of the injection needle (101) is provided with a plurality of injection holes (106), each storage container (505) is connected to a corresponding inlet tube (104), each inlet tube (104) is connected to a corresponding injection hole (106), and each inlet tube (104) is provided with a corresponding shut-off valve (105).

11. A blood gas analyzer fluid processing method, characterized in that: include: When testing samples: A driving pump (504) is driven to generate driving force, and a sample and gas are supplied by a sample feeding mechanism (100); after a set amount of sample enters the pipeline module (500), gas is fed into the pipeline module (500) to reduce the amount of sample used; The bubble coagulation detection unit (200) is used to detect the sample provided by the sample injection mechanism (100) to determine whether coagulation or bubbles exist; if so, the sample is directly drained to the waste liquid bag (507) through the bypass line (502); if not, the sample is drained to the test card (300) and the cuvette (400) through the main line (501) for detection.

12. The blood gas analyzer fluid processing method according to claim 11, characterized in that: Also includes: Calibration, quality control and cleaning.