Sampling assembly, sample analyzer, and sampling method

Abstract

A sampling assembly comprises a sampling needle (1), a first pipeline (2), a second pipeline (3), a driving member (4), a first switching member (5) and a second switching member (6), the first pipeline (2) is connected between the sampling needle (1) and the first switching member (5), the second pipeline (3) is connected between the first switching member (5) and the driving member (4), the first switching member (5) is used for connecting or cutting off the first pipeline (2) and the second pipeline (3), and the second pipeline (3) can be connected to a negative pressure source (7) through the second switching member (6). The sampling time of the sampling assembly is shorter. The application further discloses a sample analyzer and a sampling method.

Description

[0001] Case Analysis

[0002] This application is a divisional application of Chinese patent application No. 201880038783.9, entitled "Sampling Component, Sample Analyzer and Sampling Method", which entered the Chinese national phase of PCT international patent application PCT / CN2018 / 093453, filed on June 28, 2018. Technical Field

[0003] This invention relates to the field of medical device technology, and in particular to a sampling component, a sample analyzer, and a sampling method. Background Technology

[0004] Blood cell analyzers require the extraction of biological samples from sealed test tubes for analysis. Since there is usually pressure inside the sealed test tubes, the pressure can adversely affect the accuracy of sampling. Therefore, how to accurately extract samples from sealed test tubes is a common problem faced in the industry.

[0005] Current methods typically involve two punctures. The first puncture is a pretreatment to release pressure within the test tube, followed by cleaning of the needle. Then, a second puncture is performed to aspirate the biological sample. Because the sampling needle needs to be punctured twice, and cleaning is required between the two punctures, this directly limits the sampling speed of the hematology analyzer, resulting in a slow measurement speed. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a sampling component, a sample analyzer, and a sampling method with a shorter sampling time.

[0007] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions:

[0008] On one hand, a sampling component is provided, including a sampling needle, a first conduit, a second conduit, a driving component, a first switching component, and a second switching component. The first conduit is connected between the sampling needle and the first switching component, and the second conduit is connected between the first switching component and the driving component. The first switching component is used to connect or disconnect the first conduit and the second conduit, and the second conduit can be connected to a negative pressure source through the second switching component.

[0009] The second pipeline can also be connected to the atmosphere via the second switching element. In other words, the second pipeline can be connected to a negative pressure source and the atmosphere via the second switching element.

[0010] The second switching component includes a first interface and a second interface. The first interface is connected to the second pipeline, and the second interface is connected to the negative pressure source. The second switching component can connect the first interface and the second interface.

[0011] The second switching component includes a first interface, a second interface, and a third interface. The first interface is connected to the second pipeline, the second interface is connected to the negative pressure source, and the third interface is connected to the atmosphere. The second switching component can connect the first interface and the second interface or connect the first interface and the third interface.

[0012] The second switching component includes:

[0013] A first sub-switching component, with its two ends respectively connected to the second pipeline and the negative pressure source, is used to connect or disconnect the second pipeline from the negative pressure source; and

[0014] The second sub-switching unit has two ends connected to the second pipeline and the atmosphere, respectively. The second sub-switching unit is used to connect or disconnect the second pipeline from the atmosphere.

[0015] The negative pressure source includes a gas storage tank, which forms a negative pressure. The gas storage tank is connected to the second pipeline so that the second pipeline is in a negative pressure state.

[0016] The negative pressure value inside the gas storage tank is less than or equal to -30 kPa.

[0017] The sampling needle includes a needle body and a needle tip arranged along a length axis. The needle body and the needle tip have a connected fluid passage extending along the length axis, with one end open on the needle tip. The needle body has a closed outer surface. The needle tip includes a pointed portion, which includes a first end, a second end, and a smooth side surface extending between the first end and the second end. The first end of the pointed portion is located on the side away from the needle body, and the second end is located on the side close to the needle body. The pointed portion is a blunt end.

[0018] The first end of the tip is connected to the side surface through a first transition arc surface, the radius of which is less than or equal to 0.1 mm.

[0019] Wherein, the extension direction of the side surface of the tip forms a first angle with respect to the length axis, the first angle being greater than or equal to 20° and less than or equal to 40°.

[0020] Wherein, the radial dimension of the second end of the tip is greater than or equal to one-half the radial dimension of the needle body.

[0021] The needle further includes a first transition portion, which is located between the needle body and the tip portion and connects the needle body and the tip portion; one end of the first transition portion connected to the tip portion has a first radial dimension, and the other end of the first transition portion connected to the needle body has a second radial dimension, wherein the first radial dimension is smaller than the second radial dimension.

[0022] The first transition portion includes an outer surface extending between its two ends, the extension direction of the outer surface forming a second included angle with respect to the length axis, the second included angle being less than or equal to 10°.

[0023] The first transition portion is a truncated cone structure with a smooth outer surface. The first radial dimension is smaller than the radial dimension of the needle body, and the second radial dimension is equal to the radial dimension of the needle body.

[0024] The needle further includes a second transition portion, which is located between the first transition portion and the tip portion and connects the first transition portion and the tip portion; the second transition portion is connected to the second end of the tip portion through a second transition arc surface, the radius of which is 0.1mm to 1mm.

[0025] The fluid passage has an opening at one end on the second transition section, and the direction of the opening forms an angle greater than 0° and less than or equal to 90° with the direction of the length axis.

[0026] The second transition portion is a cylindrical structure with a constant radial dimension, the radial dimension of which is smaller than the radial dimension of the needle body and equal to the radial dimension of the second end of the tip portion.

[0027] The fluid passage has an opening at one end located on the side surface of the tip.

[0028] Wherein, the outer contour of any cross section of the needle body in the direction perpendicular to the length axis is circular or elliptical, and the tip is a conical or truncated conical structure that decreases in size from its second end to its first end.

[0029] The driving component includes a syringe.

[0030] On the other hand, a sample analyzer is also provided, including the aforementioned sampling components.

[0031] Furthermore, a sampling method is also provided, wherein the sampling method uses a sampling component for sampling. The sampling component includes a sampling needle, a first tube, a second tube, a driving component, a first switching component, and a second switching component. The first tube is connected between the sampling needle and the first switching component, and the second tube is connected between the first switching component and the driving component. The first switching component is used to connect or disconnect the first tube and the second tube, and the second tube is connected to a negative pressure source through the second switching component.

[0032] The sampling method includes:

[0033] After the first switching component disconnects the first pipeline from the second pipeline, the sampling needle pierces the test tube cap and extends into the test tube;

[0034] The second switching element connects the second pipeline to the negative pressure source;

[0035] After the second switching element disconnects the second pipeline from the negative pressure source, the first switching element connects the first pipeline to the second pipeline;

[0036] The driving component draws the biological sample from the test tube into the sampling needle; and

[0037] After the first switching element disconnects the first pipeline from the second pipeline again, the sampling needle leaves the test tube.

[0038] The second switching component includes a first interface and a second interface. The first interface is connected to the second pipeline, and the second interface is connected to the negative pressure source. The second switching component can connect the first interface and the second interface.

[0039] After the step "the first switching element disconnects the first pipeline from the second pipeline again", the sampling method further includes:

[0040] The second switching element reconnects the second pipeline to the negative pressure source; and

[0041] After the second switching component disconnects the second pipeline from the negative pressure source again, the first switching component reconnects the first pipeline to the second pipeline.

[0042] When the first switching component reconnects the first pipeline and the second pipeline, the end of the sampling needle away from the first pipeline forms a front-end air column;

[0043] After step "the first switching element reconnects the first pipeline and the second pipeline", the sampling method further includes:

[0044] The driving component pushes the front air column out of the sampling needle.

[0045] The steps “the sampling needle leaves the test tube” and “the second switching element reconnects the second pipeline to the negative pressure source” are performed simultaneously.

[0046] The second pipeline can also be connected to the atmosphere through the second switching element;

[0047] After the step "the first switching element disconnects the first pipeline from the second pipeline again", the sampling method further includes:

[0048] The second switching element connects the second pipeline to the atmosphere; and

[0049] After the second switching component disconnects the second pipeline from the atmosphere, the first switching component reconnects the first pipeline to the second pipeline.

[0050] The steps “the sampling needle leaves the test tube” and “the second switching element connects the second pipeline to the atmosphere” are performed simultaneously.

[0051] The second switching component includes a first interface, a second interface, and a third interface. The first interface is connected to the second pipeline, the second interface is connected to the negative pressure source, and the third interface is connected to the atmosphere. The second switching component can connect the first interface and the second interface or connect the first interface and the third interface.

[0052] The second switching component includes:

[0053] A first sub-switching component, with its two ends respectively connected to the second pipeline and the negative pressure source, is used to connect or disconnect the second pipeline from the negative pressure source; and

[0054] The second sub-switching unit has two ends connected to the second pipeline and the atmosphere, respectively. The second sub-switching unit is used to connect or disconnect the second pipeline from the atmosphere.

[0055] The steps “the sampling needle pierces the test tube cap and extends into the test tube” and “the second switching component connects the second pipeline to the negative pressure source” are performed simultaneously.

[0056] The step "the sampling needle pierces the test tube cap and extends into the test tube" includes:

[0057] The sampling needle pierces the test tube cap and extends into the test tube, remaining inside for a predetermined time; and

[0058] The sampling needle continues to extend into the test tube so that the tip of the sampling needle is immersed in the biological sample.

[0059] Compared with the prior art, the present invention has the following beneficial effects:

[0060] The sampling assembly can control the pressure environment of the first pipeline through the actions of the first and second switching components, thereby eliminating the adverse effects of pressure within the sealed test tube on sampling accuracy. Therefore, when using the sampling assembly, sampling can be completed with only one puncture of the sampling needle, eliminating the need for puncture pretreatment and subsequent needle cleaning, thus shortening sampling time and increasing sampling speed. Since the sampling process is the critical path measured by the sample analyzer, using the sampling assembly shortens the measurement time of the sample analyzer and increases its measurement speed. Simultaneously, requiring only one puncture for sampling also reduces wear on the sampling needle, extending its service life. Attached Figure Description

[0061] To more clearly illustrate the technical solution of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0062] Figure 1 This is a schematic diagram of one embodiment of the sampling component provided in this invention.

[0063] Figure 2 This is a schematic diagram of another implementation of the sampling component provided in this embodiment of the invention.

[0064] Figure 3 yes Figure 1 A schematic diagram of one embodiment of the sampling needle of the sampling component shown.

[0065] Figure 4 yes Figure 3 Enlarged view of the structure at point A in the middle.

[0066] Figure 5 yes Figure 1 A schematic diagram of another embodiment of the sampling needle of the sampling component shown.

[0067] Figure 6 This is a flowchart of a sampling method provided in an embodiment of the present invention;

[0068] Figure 7 This is a schematic diagram of another embodiment of the sampling component provided in this invention;

[0069] Figure 8This is a flowchart of another sampling method provided in an embodiment of the present invention. Detailed Implementation

[0070] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0071] This invention provides a sample analyzer. The sample analyzer can be used for biological sample analysis, such as blood and urine. The sample analyzer includes a sampling component for collecting and dispensing biological samples. The sample analyzer also includes a driving component, a reaction component, a detection component, a waste liquid treatment component, and a controller. The driving component drives various flow paths (including gas and liquid paths) within the sample analyzer. The reaction component processes the biological sample to form a test solution. The detection component detects the test solution to generate detection information. The waste liquid treatment component collects and discharges waste liquid from the sample analyzer. The controller controls the workflow of the sample analyzer and processes the detection information to generate analytical results.

[0072] In the first embodiment:

[0073] Please refer to the following: Figure 1 and Figure 2 In this embodiment, the sampling component 100 includes a sampling needle 1, a first conduit 2, a second conduit 3, a driving element 4, a first switching element 5, and a second switching element 6. The first conduit 2 connects the sampling needle 1 and the first switching element 5. The second conduit 3 connects the first switching element 5 and the driving element 4. The first switching element 5 connects or disconnects the first conduit 2 and the second conduit 3. The second conduit 3 can be connected to a negative pressure source 7 and the atmosphere via the second switching element 6.

[0074] In this embodiment, the sampling component 100 can control the pressure environment of the first pipeline 2 through the actions of the first switching element 5 and the second switching element 6, thereby eliminating the adverse effects of pressure inside the sealed test tube on sampling accuracy. Therefore, when using the sampling component 100 for sampling, only one puncture of the sampling needle 1 is required to complete the sampling, eliminating the need for puncture pretreatment (which typically takes several seconds) and subsequent cleaning of the sampling needle 1, thus shortening the sampling time and increasing the sampling speed. Since the sampling process is the critical path measured by the sample analyzer, using the sampling component 100 shortens the measurement time of the sample analyzer and increases its measurement speed. Simultaneously, requiring only one puncture for sampling using the sampling component 100 also reduces wear on the sampling needle 1, extending its service life.

[0075] In one implementation, such as Figure 1 As shown, the second switching component 6 includes a first interface 61, a second interface 62, and a third interface 63. The first interface 61 is connected to the second pipeline 3, the second interface 62 is connected to the negative pressure source 7, and the third interface 63 is connected to the atmosphere. The second switching component 6 can connect the first interface 61 and the second interface 62 or connect the first interface 61 and the third interface 63. The second switching component 6 can be a valve, such as a two-position three-way solenoid valve.

[0076] In another implementation, such as Figure 2 As shown, the second switching component 6 includes a first sub-switching component 64 and a second sub-switching component 65. The two ends of the first sub-switching component 64 are respectively connected to the second pipeline 3 and the negative pressure source 7, and the first sub-switching component 64 is used to connect or disconnect the second pipeline 3 from the negative pressure source 7. The first sub-switching component 64 can be a valve, such as a shut-off valve. The two ends of the second sub-switching component 65 are respectively connected to the second pipeline 3 and the atmosphere, and the second sub-switching component 65 is used to connect or disconnect the second pipeline 3 from the atmosphere. The second sub-switching component 65 can be a valve, such as a shut-off valve.

[0077] Optionally, the negative pressure source 7 includes a gas storage tank 71, within which a negative pressure is formed, and the gas storage tank 71 is connected to the second pipeline 3 to place the second pipeline 3 in a negative pressure state. The negative pressure source 7 may also include an air pump 72, which is used to connect to the gas storage tank 71 to establish the negative pressure within the gas storage tank 71.

[0078] The negative pressure value inside the gas storage tank 71 is less than or equal to -30 kPa. When the second pipeline 3 is connected to the gas storage tank 71, the pressure in the second pipeline 3 is the same as that in the gas storage tank 71, thereby making the pressure in the second pipeline 3 lower than the negative pressure inside the test tube.

[0079] Optionally, the drive unit 4 includes a syringe for drawing a quantitative amount of biological sample from the sampling needle 1. In other embodiments, the drive unit 4 may also include a metering pump or other device capable of drawing a quantitative amount of liquid.

[0080] Please refer to the following: Figures 1 to 5 As an optional embodiment, the sampling needle 1 includes a needle body 12 and a needle tip 13 disposed along a length axis 11. A communicating fluid passage 14 is provided within the needle body 12 and the needle tip 13. The fluid passage 14 extends along the length axis 11, and one end of it has an opening 141 disposed on the needle tip 13. The opening 141 is used for aspirating and discharging biological samples. The needle body 12 has a closed outer surface. The needle tip 13 includes a tip portion 131, which includes a first end 1311, a second end 1312, and a smooth side surface 1313 extending between the first end 1311 and the second end 1312. The first end 1311 of the tip portion 131 is disposed on the side away from the needle body 12, and the second end 1312 is disposed on the side closer to the needle body 12 and is a blunt end. The second end 1312 is located between the first end 1311 and the needle body 12. The blunt end includes, but is not limited to, a planar end or a curved end.

[0081] In this application, since the first end 1311 of the tip 131 of the needle 13 is set as a blunt end, and the side surface 1313 connecting the first end 1311 and the second end 1312 is a smooth surface, the sampling needle 1 can avoid cutting the test tube cap due to the needle tip 13 being too sharp, resulting in less debris when the sampling needle 1 is punctured. Since the needle body 12 has a closed outer surface and no venting groove is provided on the needle body 12, the processing technology of the sampling needle 1 is simplified, and thus debris can also be avoided due to the venting groove cutting the test tube cap.

[0082] Optionally, the fluid passage 14 extends from the needle tip 13 to the needle body 12 along the direction of the length axis 11. The fluid passage 14 penetrates the needle body 12. The fluid passage 14 draws in and discharges biological samples through the opening 141 provided in the needle tip 13.

[0083] Optional, such as Figure 5 As shown, one end opening 141 of the fluid passage 14 is disposed on the side surface 1313 of the tip portion 131.

[0084] Optionally, the shape of any cross-section of the needle body 12 in the direction perpendicular to the length axis 11 is circular or elliptical. The needle body 12 is generally a hollow cylinder or elliptical cylinder.

[0085] Optionally, the tip 131 is a conical or truncated cone structure that tapers from its second end 1312 to its first end 1311. In this case, the cross-sectional shape of the side surface 1313 perpendicular to the length axis 11 is circular, and the side surface 1313 is a smooth surface that can avoid cutting the test tube cap.

[0086] Optionally, the first end 1311 of the tip 131 is connected to the side surface 1313 via a first transition arc surface 132, the radius of which is less than or equal to 0.1 mm. The first transition arc surface 132 makes the outer surface 1331 of the tip 131 smoother, further reducing the risk of cutting the test tube cap.

[0087] Optionally, the extension direction of the side surface 1313 of the tip 131 forms a first included angle A with respect to the length axis 11, the first included angle A being greater than or equal to 20° and less than or equal to 40°. The first included angle A can be 30°. In this case, the cross-sectional area of ​​the tip 131 perpendicular to the length axis 11 gradually increases from the first end 1311 to the second end 1312, thereby enabling the tip 131 to pass smoothly through the test tube cap and reducing the difficulty of puncturing the sampling needle 1.

[0088] Optionally, the radial dimension of the second end 1312 of the tip 131 is greater than or equal to half the radial dimension of the needle body 12. In this case, the tip 131 creates a larger through hole in the test tube cap, the radial dimension of which is greater than or equal to half the radial dimension of the needle body 12, allowing the needle body 12 to pass through the through hole smoothly with a smaller force, thus reducing the difficulty of puncturing the sampling needle 1.

[0089] Please refer to the following: Figure 3 and Figure 4 As an optional embodiment, the needle 13 further includes a first transition portion 133, which is located between the needle body 12 and the tip portion 131, and connects the needle body 12 and the tip portion 131. The end of the first transition portion 133 connected to the tip portion 131 has a first radial dimension, and the end of the first transition portion 133 connected to the needle body 12 has a second radial dimension, the first radial dimension being smaller than the second radial dimension. When the sampling needle 1 is used for puncture, the first transition portion 133 can further enlarge the radial dimension of the through hole on the test tube cap pierced by the sampling needle 1, thereby further reducing the difficulty of puncture by the sampling needle 1.

[0090] Optionally, the first transition portion 133 includes an outer surface 1331 extending between its two ends, the extension direction of the outer surface 1331 forming a second included angle B with respect to the length axis 11, the second included angle B being less than or equal to 10°. The second included angle B can be 5°. In this case, the area of ​​the cross-section of the first transition portion 133 perpendicular to the length axis 11 gradually increases from the end connected to the tip portion 131 to the end connected to the needle body 12, thereby reducing the difficulty of puncturing the sampling needle 1.

[0091] Optionally, the first transition portion 133 is a truncated cone structure with a smooth outer surface 1331. The first radial dimension is smaller than the radial dimension of the needle body 12, and the second radial dimension is equal to the radial dimension of the needle body 12. In this case, the needle tip 13, through the tip portion 131 and the first transition portion 133, makes the radial dimension of the through hole on the test tube cap through which the sampling needle 1 passes equal to the radial dimension of the needle body 12, thereby further reducing the difficulty of puncturing the sampling needle 1.

[0092] In the direction of the length axis 11, the size of the tip 131 is smaller than the size of the first transition portion 133, so that the sampling needle 1 can quickly pierce a through hole in the test tube cap and then slowly enlarge the through hole.

[0093] Please refer to the following: Figure 3 and Figure 4 As an optional embodiment, the needle 13 further includes a second transition portion 134, which is located between the first transition portion 133 and the tip portion 131, and connects the first transition portion 133 and the tip portion 131. The second transition portion 134 is connected to the second end 1312 of the tip portion 131 via a second transition arc surface 135. The radius of the second transition arc surface 135 is 0.1 mm to 1 mm, for example, 0.5 mm. The second transition arc surface 135 makes the outer surface 1331 of the needle 13 smoother, which can further reduce the risk of cutting the test tube cap.

[0094] Optional, such as Figure 4 As shown, one end opening 141 of the fluid passage 14 is disposed on the second transition portion 134, and the direction of the opening 141 forms an angle greater than 0° and less than or equal to 90° with the direction of the length axis 11. For example, the direction of the opening 141 is approximately perpendicular to the direction of the length axis 11.

[0095] Optionally, the second transition portion 134 is a cylindrical structure with a constant radial dimension, the radial dimension of which is smaller than the radial dimension of the needle body 12 and equal to the radial dimension of the second end 1312 of the tip portion 131. In this case, since the second transition portion 134 is a cylindrical structure, it experiences almost no puncture resistance during the puncture of the sampling needle 1. The opening 141 on the second transition portion 134 will not cut the test tube cap, meaning that the sampling needle 1 will not generate debris, and the debris will not enter the fluid channel inside the sampling needle 1.

[0096] Optionally, the surface roughness of the outer wall of the sampling needle 1 is 0.1 μm to 3.2 μm, for example, 0.2 μm. In this case, the sampling needle 1 has a smooth outer wall, which can reduce puncture resistance. The surface roughness of the outer wall can be achieved by an electroplating process.

[0097] In the second embodiment:

[0098] Please see Figure 7 The difference between the sampling component 100 in this embodiment and the sampling component 100 in the first embodiment is that:

[0099] The second switching element 6 includes a first interface 61 and a second interface 62. The first interface 61 is connected to the second pipeline 3. The second interface 62 is connected to the negative pressure source 7. The second switching element 6 can connect the first interface 61 and the second interface 62. In other words, the second pipeline 3 can be connected to the negative pressure source 7 through the second switching element 6.

[0100] In this embodiment, the sampling component 100 can control the pressure environment of the first pipeline 2 through the actions of the first switching element 5 and the second switching element 6, thereby eliminating the adverse effects of pressure inside the sealed test tube on sampling accuracy. Therefore, when using the sampling component 100 for sampling, only one puncture of the sampling needle 1 is required to complete the sampling, eliminating the need for puncture pretreatment (which typically takes several seconds) and subsequent cleaning of the sampling needle 1, thus shortening the sampling time and increasing the sampling speed. Since the sampling process is the critical path measured by the sample analyzer, using the sampling component 100 shortens the measurement time of the sample analyzer and increases its measurement speed. Simultaneously, requiring only one puncture for sampling using the sampling component 100 also reduces wear on the sampling needle 1, extending its service life.

[0101] The second switching component 6 can be a valve, such as a shut-off valve.

[0102] This invention also provides a sampling method applied to the sample analyzer described above. The sampling method can utilize the sampling component 100 described in the above embodiments for sampling.

[0103] In one embodiment:

[0104] The sampling method may employ the sampling component 100 described in the first embodiment above (see [reference]). Figures 1 to 5 Sampling is performed. The sampling assembly 100 includes a sampling needle 1, a first conduit 2, a second conduit 3, a drive unit 4, a first switching unit 5, and a second switching unit 6. The first conduit 2 is connected between the sampling needle 1 and the first switching unit 5. The second conduit 3 is connected between the first switching unit 5 and the drive unit 4. The first switching unit 5 is used to connect or disconnect the first conduit 2 and the second conduit 3. The second conduit 3 can be connected to the negative pressure source 7 and the atmosphere through the second switching unit 6.

[0105] Please see Figure 6 The sampling method includes:

[0106] 001: After the first switching component 5 disconnects the first pipeline 2 and the second pipeline 3, the sampling needle 1 pierces the test tube cap and extends into the test tube.

[0107] 002: The second switching component 6 connects the second pipeline 3 to the negative pressure source 7.

[0108] 003: After the second switching component 6 disconnects the second pipeline 3 from the negative pressure source 7, the first switching component 5 connects the first pipeline 2 to the second pipeline 3.

[0109] 004: The driving component 4 extracts the biological sample from the test tube into the sampling needle 1.

[0110] 005: After the first switching component 5 disconnects the first pipeline 2 and the second pipeline 3 again, the sampling needle 1 leaves the test tube.

[0111] 0061: The second switching component 6 connects the second pipeline 3 to the atmosphere.

[0112] 0071: After the second switching component 6 disconnects the second pipeline 3 from the atmosphere, the first switching component 5 reconnects the first pipeline 2 and the second pipeline 3.

[0113] In step 001, an isolation air column is formed at the end of the sampling needle 1 furthest from the second conduit 3. This isolation air column isolates the liquid in the first conduit 2 from the subsequently drawn biological sample, preventing inaccurate results from the sample analyzer due to contamination of the biological sample by the liquid in the first conduit 2. Firstly, the first conduit 2 and the second conduit 3 are disconnected via the first switching element 5 before the sampling needle 1 is inserted into the test tube. This shields the isolation air column in the first conduit 2 from the influence of deformation of the second conduit 3. If the sampling needle 1 is inserted into the test tube while the first conduit 2 is connected to the second conduit 3, a pressure difference between the pressure inside the test tube and the pressure in the second conduit 3 can easily cause deformation of the second conduit 3, resulting in a significant shortening or disappearance of the isolation air column. This would contaminate the subsequently drawn biological sample with the liquid in the first conduit 2, leading to inaccurate analysis results from the sample analyzer.

[0114] In step 002, the negative pressure source 7 causes the second pipeline 3 to be in a negative pressure state, thereby offsetting the effect of the negative pressure in the test tube on the isolation column.

[0115] In step 003, after the first conduit 2 is connected to the second conduit 3, the pressure in the first conduit 2 is the same as the pressure in the second conduit 3, and the pressure in the first conduit 2 is slightly less than or equal to the pressure in the test tube. When the pressure in the first conduit 2 is slightly less than the pressure in the test tube, a small amount of biological sample (pre-sample) in the test tube enters the sampling needle 1 under the action of pressure difference, and the isolation air column separates the biological sample from the liquid in the first conduit 2.

[0116] In step 004, a relatively large amount of biological sample (the latter part of the sample) in the test tube enters the sampling needle 1 under the suction force of the drive element 4.

[0117] In step 005, the first tube 2 and the second tube 3 are first disconnected by the first switching element 5, and then the sampling needle 1 is removed from the test tube. This shields the impact of deformation of the second tube 3 on the isolation air column, the front sample, and the rear sample. At this time, a very short air column is formed at the end of the sampling needle 1 furthest from the second tube 3. Inside the sampling needle 1, the isolation air column, the front sample, the rear sample, and the air column are arranged sequentially.

[0118] In this embodiment, biological samples can be accurately collected into the sampling needle 1 through steps 001 to 005. The sampling method eliminates the adverse effects of pressure within the sealed test tube on sampling accuracy by controlling the pressure environment of the first tubing 2. This method requires only one puncture of the sampling needle 1 to complete the sampling, eliminating the need for puncture pretreatment (which typically takes several seconds) and subsequent cleaning of the sampling needle 1, thus shortening the sampling time and increasing the sampling speed. Since the sampling process is the critical path for the sample analyzer, this method shortens the measurement time and increases the measurement speed of the sample analyzer. Furthermore, requiring only one puncture also reduces wear on the sampling needle 1, extending its service life.

[0119] Understandably, the present invention controls the pressure environment in the first pipeline 2 and the second pipeline 3 through the first switching element 5 and the second switching element 6. The switching action of the first switching element 5 and the second switching element 6 is simple and efficient, which is conducive to the accurate and efficient implementation of the sampling method.

[0120] Experiments have shown that, after sampling using the described sampling method, the biological sample offset within the sampling needle 1 can be controlled to within ±0.3 μL. The portion of the latter part of the sample serves as the measurement blood segment, and isolation blood segments (such as the former sample segment) are reserved before and after this measurement blood segment, thereby eliminating the influence of biological sample offset. Therefore, the sampling method has high accuracy and helps ensure the detection accuracy of the sample analyzer. This sampling method can be applied to low-cost puncture needle sampling and blood separation platforms using impedance technology.

[0121] In step 0061, the second conduit 3 is connected to the atmosphere to release pressure, and the pressure environment of the second conduit 3 is consistent with the pressure environment of the end of the sampling needle 1 away from the second conduit 3.

[0122] In step 0071, since the pressure environment of the second conduit 3 is consistent with the pressure environment of the end of the sampling needle 1 furthest from the second conduit 3, the biological sample in the sampling needle 1 hardly shifts or fluctuates. This is beneficial to the accuracy of the subsequent biological sample dispensing action of the sample analyzer, thus improving the analytical accuracy of the sample analyzer. After step 0071, the driving component 4 can push the biological sample in the sampling needle 1 outward to perform biological sample dispensing.

[0123] In this embodiment, by using steps 0061 and 0071, the biological sample in the sampling needle 1 can be kept within the sampling needle 1 without being displaced or fluctuating within the sampling needle 1, thereby improving the accuracy of the subsequent biological sample dispensing action of the sample analyzer.

[0124] Optionally, the steps "the sampling needle 1 pierces the test tube cap and extends into the test tube" and "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously. Since the first switching element 5 isolates the first pipeline 2 from the second pipeline 3, they no longer interfere with each other. Therefore, the steps "the sampling needle 1 pierces the test tube cap and extends into the test tube" and "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously, thereby further shortening the sampling time of the sampling method. Of course, the step "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can also be performed after the step "the sampling needle 1 pierces the test tube cap and extends into the test tube" is completed.

[0125] Optionally, the steps "the sampling needle 1 leaves the test tube" and "the second switching element 6 connects the second pipeline 3 to the atmosphere" are performed simultaneously. Since the first switching element 5 isolates the first pipeline 2 from the second pipeline 3, they no longer interfere with each other. Therefore, the steps "the sampling needle 1 leaves the test tube" and "the second switching element 6 connects the second pipeline 3 to the atmosphere" can be performed simultaneously, thereby further shortening the sampling time of the sampling method. Of course, the step "the second switching element 6 connects the second pipeline 3 to the atmosphere" can also be performed after the step "the sampling needle 1 leaves the test tube" is completed.

[0126] Optionally, the step "the sampling needle 1 pierces the test tube cap and extends into the test tube" includes:

[0127] 0011: The sampling needle 1 pierces the test tube cap and extends into the test tube, remaining inside for a predetermined time.

[0128] 0012: The sampling needle 1 continues to extend into the test tube so that the tip 13 of the sampling needle 1 is immersed in the biological sample.

[0129] The predetermined time can be used to balance the pressure in the first pipeline 2 with the pressure in the test tube.

[0130] Of course, in other embodiments, the sampling needle 1 can pierce the test tube cap at a uniform speed and immerse the needle tip 13 of the sampling needle 1 into the biological sample.

[0131] In another embodiment:

[0132] The sampling method may employ the sampling component described in the second embodiment above (see...). Figure 7Sampling is performed. The sampling assembly 100 includes a sampling needle 1, a first conduit 2, a second conduit 3, a drive unit 4, a first switching unit 5, and a second switching unit 6. The first conduit 2 is connected between the sampling needle 1 and the first switching unit 5. The second conduit 3 is connected between the first switching unit 5 and the drive unit 4. The first switching unit 5 is used to connect or disconnect the first conduit 2 and the second conduit 3. The second conduit 3 can be connected to a negative pressure source 7 through the second switching unit 6.

[0133] The sampling method includes:

[0134] 001: After the first switching component 5 disconnects the first pipeline 2 and the second pipeline 3, the sampling needle 1 pierces the test tube cap and extends into the test tube.

[0135] 002: The second switching component 6 connects the second pipeline 3 to the negative pressure source 7.

[0136] 003: After the second switching component 6 disconnects the second pipeline 3 from the negative pressure source 7, the first switching component 5 connects the first pipeline 2 to the second pipeline 3.

[0137] 004: The driving component 4 extracts the biological sample from the test tube into the sampling needle 1.

[0138] 005: After the first switching component 5 disconnects the first pipeline 2 and the second pipeline 3 again, the sampling needle 1 leaves the test tube.

[0139] 0062: The second switching component 6 reconnects the second pipeline 3 to the negative pressure source 7.

[0140] 0072: After the second switching component 6 disconnects the second pipeline 3 from the negative pressure source 7 again, the first switching component 5 reconnects the first pipeline 2 to the second pipeline 3.

[0141] In step 001, an isolation air column is formed at the end of the sampling needle 1 furthest from the second conduit 3. This isolation air column isolates the liquid in the first conduit 2 from the subsequently drawn biological sample, preventing inaccurate results from the sample analyzer due to contamination of the biological sample by the liquid in the first conduit 2. Firstly, the first conduit 2 and the second conduit 3 are disconnected via the first switching element 5 before the sampling needle 1 is inserted into the test tube. This shields the isolation air column in the first conduit 2 from the influence of deformation of the second conduit 3. If the sampling needle 1 is inserted into the test tube while the first conduit 2 is connected to the second conduit 3, a pressure difference between the pressure inside the test tube and the pressure in the second conduit 3 can easily cause deformation of the second conduit 3, resulting in a significant shortening or disappearance of the isolation air column. This would contaminate the subsequently drawn biological sample with the liquid in the first conduit 2, leading to inaccurate analysis results from the sample analyzer.

[0142] In step 002, the negative pressure source 7 causes the second pipeline 3 to be in a negative pressure state, thereby offsetting the effect of the negative pressure in the test tube on the isolation column.

[0143] In step 003, after the first conduit 2 is connected to the second conduit 3, the pressure in the first conduit 2 is the same as the pressure in the second conduit 3, and the pressure in the first conduit 2 is slightly less than or equal to the pressure in the test tube. When the pressure in the first conduit 2 is slightly less than the pressure in the test tube, a small amount of biological sample (pre-sample) in the test tube enters the sampling needle 1 under the action of pressure difference, and the isolation air column separates the biological sample from the liquid in the first conduit 2.

[0144] In step 004, a relatively large amount of biological sample (the latter part of the sample) in the test tube enters the sampling needle 1 under the suction force of the drive element 4.

[0145] In step 005, the first tube 2 and the second tube 3 are first disconnected by the first switching element 5, and then the sampling needle 1 is removed from the test tube. This shields the impact of deformation of the second tube 3 on the isolation air column, the front sample, and the rear sample. At this time, a very short front air column is formed at the end of the sampling needle 1 furthest from the first tube 2. Inside the sampling needle 1, the isolation air column, the front sample, the rear sample, and the front air column are arranged sequentially.

[0146] In this embodiment, biological samples can be accurately collected into the sampling needle 1 through steps 001 to 005. The sampling method eliminates the adverse effects of pressure within the sealed test tube on sampling accuracy by controlling the pressure environment of the first tubing 2. This method requires only one puncture of the sampling needle 1 to complete the sampling, eliminating the need for puncture pretreatment (which typically takes several seconds) and subsequent cleaning of the sampling needle 1, thus shortening the sampling time and increasing the sampling speed. Since the sampling process is the critical path for the sample analyzer, this method shortens the measurement time and increases the measurement speed of the sample analyzer. Furthermore, requiring only one puncture also reduces wear on the sampling needle 1, extending its service life.

[0147] Understandably, the present invention controls the pressure environment in the first pipeline 2 and the second pipeline 3 through the first switching element 5 and the second switching element 6. The switching action of the first switching element 5 and the second switching element 6 is simple and efficient, which is conducive to the accurate and efficient implementation of the sampling method.

[0148] Experiments have shown that the proposed sampling method has high accuracy, which helps ensure the detection accuracy of the sample analyzer. This sampling method can be applied to low-cost needle sampling and blood separation platforms using impedance technology.

[0149] In step 0062, the second pipeline 3 is reconnected to the negative pressure source 7, so that the second pipeline 3 is in a negative pressure state.

[0150] In step 0072, because the second conduit 3 is under negative pressure, the biological sample in the sampling needle 1 will move a fixed displacement toward the inside of the sampling needle 1. Since the negative pressure state in the third conduit 3 is fixed and controllable, the value of the fixed displacement of the biological sample can be calculated based on this negative pressure state, and subsequent sample dispensing actions can be set based on this value. This helps improve the accuracy of the subsequent biological sample dispensing actions of the sample analyzer, thereby improving the analytical accuracy of the sample analyzer. After step 0072, the driving component 4 can push the biological sample in the sampling needle 1 outward to perform biological sample dispensing.

[0151] In this embodiment, through steps 0062 and 0072, the biological sample in the sampling needle 1 can be kept from leaving the sampling needle 1 and can move a fixed displacement within the sampling needle 1, thereby improving the accuracy of the subsequent biological sample dispensing action of the sample analyzer.

[0152] Optionally, when the first switching element 5 reconnects the first pipeline 2 and the second pipeline 3, the end of the sampling needle 1 away from the first pipeline 2 forms a front-end air column.

[0153] After step "the first switching element 5 reconnects the first pipeline 2 and the second pipeline 3", the sampling method further includes:

[0154] 0082: The driving component 4 pushes the front air column out of the sampling needle 1.

[0155] In this embodiment, the drive unit 4 pushes the biological sample inside the sampling needle 1 to push out the front air column. Since the front end of the sampling needle 1 (i.e., the end away from the first tube 2) will form the front air column due to the negative pressure in the second tube 3 in step 0072, the front air column can be pushed out of the sampling needle 1 before the biological sample is dispensed to balance the displacement of the biological sample that occurs in step 0072, thereby improving the accuracy of the biological sample dispensing action of the sample analyzer.

[0156] In step 0082, the distance by which the driving component 4 moves the biological sample within the sampling needle 1 is set based on the fixed displacement of the biological sample that occurs in step 0072. In step 0082, the driving component 4 can extend all of the front-end air columns, or, depending on the requirements, only a portion of the front-end air columns.

[0157] Optionally, the steps "the sampling needle 1 pierces the test tube cap and extends into the test tube" and "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously. Since the first switching element 5 isolates the first pipeline 2 from the second pipeline 3, they no longer interfere with each other. Therefore, the steps "the sampling needle 1 pierces the test tube cap and extends into the test tube" and "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously, thereby further shortening the sampling time of the sampling method. Of course, the step "the second switching element 6 connects the second pipeline 3 with the negative pressure source 7" can also be performed after the step "the sampling needle 1 pierces the test tube cap and extends into the test tube" is completed.

[0158] Optionally, the steps "the sampling needle 1 leaves the test tube" and "the second switching element 6 reconnects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously. Since the first switching element 5 isolates the first pipeline 2 from the second pipeline 3, they no longer interfere with each other. Therefore, the steps "the sampling needle 1 leaves the test tube" and "the second switching element 6 reconnects the second pipeline 3 with the negative pressure source 7" can be performed simultaneously, thereby further shortening the sampling time of the sampling method. Of course, the step "the second switching element 6 reconnects the second pipeline 3 with the negative pressure source 7" can also be performed after the step "the sampling needle 1 leaves the test tube" is completed.

[0159] Optionally, the step "the sampling needle 1 pierces the test tube cap and extends into the test tube" includes:

[0160] 0011: The sampling needle 1 pierces the test tube cap and extends into the test tube, remaining inside for a predetermined time.

[0161] 0012: The sampling needle 1 continues to extend into the test tube so that the tip 13 of the sampling needle 1 is immersed in the biological sample.

[0162] The predetermined time can be used to balance the pressure in the first pipeline 2 with the pressure in the test tube.

[0163] Of course, in other embodiments, the sampling needle 1 can pierce the test tube cap at a uniform speed and immerse the needle tip 13 of the sampling needle 1 into the biological sample.

[0164] The embodiments of the present invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of the present invention. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A sampling component, characterized in that: The device includes a sampling needle, a first tubing, a second tubing, a drive unit, a first switching unit, and a second switching unit. The first tubing is connected between the sampling needle and the first switching unit, and the second tubing is connected between the first switching unit and the drive unit. The first switching unit is used to connect or disconnect the first tubing and the second tubing. The second tubing can be connected to a negative pressure source through the second switching unit. An isolation air column is formed at the end of the sampling needle away from the second tubing. The drive unit is used to enable the sampling needle to draw a quantitative amount of biological sample from a sealed test tube.

2. The sampling component as described in claim 1, characterized in that, The second switching component includes a first interface and a second interface. The first interface is connected to the second pipeline, and the second interface is connected to the negative pressure source. The second switching component can connect the first interface and the second interface.

3. The sampling component as described in claim 1 or 2, characterized in that, The negative pressure source includes a gas storage tank, which forms a negative pressure. The gas storage tank is connected to the second pipeline so that the second pipeline is in a negative pressure state.

4. The sampling component as described in claim 3, characterized in that, The negative pressure value inside the gas storage tank is less than or equal to -30 kPa.

5. The sampling component as described in claim 1, characterized in that, The sampling needle includes a needle body and a needle tip arranged along a length axis. The needle body and the needle tip have a connected fluid passage extending along the length axis, with one end open on the needle tip. The needle body has a closed outer surface. The needle tip includes a pointed portion, which includes a first end, a second end, and a smooth side surface extending between the first end and the second end. The first end of the pointed portion is located on the side away from the needle body, and the second end is located on the side close to the needle body. The pointed portion is a blunt end.

6. The sampling component as described in claim 5, characterized in that, The first end of the tip is connected to the side surface through a first transition arc surface, the radius of which is less than or equal to 0.1 mm.

7. The sampling component as described in claim 5, characterized in that, The extension direction of the side surface of the tip forms a first angle with respect to the length axis, the first angle being greater than or equal to 20° and less than or equal to 40°.

8. The sampling component as described in claim 5, characterized in that, The radial dimension of the second end of the tip is greater than or equal to half the radial dimension of the needle body.

9. The sampling component as described in claim 5, characterized in that, The needle further includes a first transition portion, which is located between the needle body and the tip portion and connects the needle body and the tip portion; one end of the first transition portion connected to the tip portion has a first radial dimension, and the other end of the first transition portion connected to the needle body has a second radial dimension, wherein the first radial dimension is smaller than the second radial dimension.

10. The sampling component as claimed in claim 9, characterized in that, The first transition portion includes an outer surface extending between its two ends, the direction of the extension of the outer surface forming a second included angle with respect to the length axis, the second included angle being less than or equal to 10°.

11. The sampling component as claimed in claim 9, characterized in that, The first transition portion is a truncated cone structure with a smooth outer surface. The first radial dimension is smaller than the radial dimension of the needle body, and the second radial dimension is equal to the radial dimension of the needle body.

12. The sampling component as claimed in claim 9, characterized in that, The needle also includes a second transition portion, which is located between the first transition portion and the tip portion and connects the first transition portion and the tip portion; the second transition portion is connected to the second end of the tip portion through a second transition arc surface, the radius of which is 0.1mm~1mm.

13. The sampling component as claimed in claim 12, characterized in that, One end of the fluid passage is opened on the second transition section, and the direction of the opening forms an angle greater than 0° and less than or equal to 90° with the direction of the length axis.

14. The sampling component as claimed in claim 12, characterized in that, The second transition portion is a cylindrical structure with a constant radial dimension, the radial dimension of which is smaller than the radial dimension of the needle body and equal to the radial dimension of the second end of the tip portion.

15. The sampling component as claimed in claim 5, characterized in that, One end of the fluid passage is opened on the side surface of the tip.

16. The sampling component according to any one of claims 5 to 15, characterized in that, The outer contour of any cross-section of the needle body in the direction perpendicular to the length axis is circular or elliptical, and the tip is a conical or truncated cone structure that decreases in size from the second end to the first end.

17. The sampling component as claimed in claim 1, characterized in that, The driving component includes a syringe.

18. A sample analyzer, characterized in that, Includes the sampling component as described in any one of claims 1 to 17.

19. A sampling method, characterized in that, The sampling method employs a sampling assembly, which includes a sampling needle, a first tubing, a second tubing, a driving component, a first switching component, and a second switching component. The first tubing connects the sampling needle and the first switching component, and the second tubing connects the first switching component and the driving component. The first switching component is used to connect or disconnect the first tubing and the second tubing. The second tubing can be connected to a negative pressure source through the second switching component. An isolation air column is formed at the end of the sampling needle away from the second tubing. The driving component is used to enable the sampling needle to draw a quantitative amount of biological sample from a closed test tube. The sampling method includes: After the first switching component disconnects the first pipeline from the second pipeline, the sampling needle pierces the test tube cap and extends into the test tube; The second switching element connects the second pipeline to the negative pressure source; After the second switching element disconnects the second pipeline from the negative pressure source, the first switching element connects the first pipeline to the second pipeline; The driving component draws the biological sample from the test tube into the sampling needle; and After the first switching element disconnects the first pipeline from the second pipeline again, the sampling needle leaves the test tube.

20. The sampling method as described in claim 19, characterized in that, The second switching component includes a first interface and a second interface. The first interface is connected to the second pipeline, and the second interface is connected to the negative pressure source. The second switching component can connect the first interface and the second interface. After step "the first switching element disconnects the first pipeline from the second pipeline again", the sampling method further includes: The second switching element reconnects the second pipeline to the negative pressure source; as well as After the second switching component disconnects the second pipeline from the negative pressure source again, the first switching component reconnects the first pipeline to the second pipeline.

21. The sampling method as described in claim 20, characterized in that, When the first switching component reconnects the first pipeline and the second pipeline, the end of the sampling needle away from the first pipeline forms a front-end air column; After step "the first switching element reconnects the first pipeline and the second pipeline", the sampling method further includes: The driving component pushes the front air column out of the sampling needle.

22. The sampling method as described in claim 20, characterized in that, The steps "the sampling needle leaves the test tube" and "the second switching element reconnects the second pipeline to the negative pressure source" are performed simultaneously.

23. The sampling method according to any one of claims 19 to 22, characterized in that, The steps "the sampling needle pierces the test tube cap and extends into the test tube" and "the second switching component connects the second pipeline to the negative pressure source" are performed simultaneously.

24. The sampling method according to any one of claims 19 to 22, characterized in that, The step "the sampling needle pierces the test tube cap and extends into the test tube" includes: The sampling needle pierces the test tube cap and extends into the test tube, remaining inside for a predetermined time; and The sampling needle continues to extend into the test tube so that the tip of the sampling needle is immersed in the biological sample.

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