Trace whole blood sample collection tube and hematology analyzer

Abstract

The utility model relates to the technical field of blood cell analysis, in particular to a trace whole blood sample collection tube and a blood cell analyzer. According to the trace whole blood sample collecting tube provided by the utility model, the magnetic beads are arranged to scatter liquid drops in an inverted uniform mixing process of trace whole blood, so that the liquid flowing stroke in the uniform mixing process can be increased, and the uniform mixing effect is improved; the trace whole blood sample collecting tube provided by the utility model can be further matched with a magnet to be applied to a hematology analyzer, so that the magnetic beads are attracted by the magnet to be fixed on the tube wall of the collecting tube in a trace whole blood sample injection process, and the influence on sample injection of a sample injection needle or the blockage of a liquid path are avoided; wherein the trace whole blood sample collection tube and the magnet are low in cost, but can improve the uniform mixing variable coefficient of a blood routine project, and have a wide application prospect.

Description

Technical Field

[0001] This utility model relates to the field of blood cell analysis technology, and in particular to a micro-volume whole blood sample collection tube and a blood cell analyzer. Background Technology

[0002] Peripheral whole blood (hereinafter referred to as "peripheral blood") is a very common type of specimen in clinical practice. Due to its convenient collection and small sample size, it is currently the preferred collection method in pediatric specialty hospitals. Routine tests such as blood cell count (complete blood count) are widely used in the laboratories of almost every hospital.

[0003] Whole blood is a suspension composed of plasma and various blood cells. Under gravity, blood cells easily settle and separate into layers. Therefore, it needs to be mixed thoroughly before loading to avoid uneven sample introduction and affecting the accuracy of test results. Peripheral blood, due to its small volume, is more difficult to mix and usually requires manual mixing before loading. In the laboratories of typical tertiary hospitals, the daily volume of routine blood tests exceeds 1000. This work consumes a large amount of manpower, and the low standardization of manual operation leads to significant errors, becoming a major pain point in laboratory work.

[0004] Currently, there are hematology analyzers with automatic mixing functions on the market, but they are mainly designed for venous blood. They present significant problems when used for mixing capillary blood, where mixing methods typically involve inverting or vortexing. Inverting is a gentler method, causing less damage to blood cells, and the mixing device is relatively simple in structure; most existing fully automated hematology analyzers use this method. Patent CN204723071U discloses a micro-capillary blood collection tube. By designing the tube bottom with a tapered rounded bottom, the depth of the sampling needle submerged in the blood sample is increased, allowing the needle to draw up more sample and thus avoiding the need to collect more blood from the sample body. However, capillary blood samples are small (usually less than 50 μL). Due to surface tension, the sample exists in droplet form and adheres to the bottom of the container during inverting, resulting in a short flow path or even no flow at all, leading to insufficient mixing. Therefore, the inverting method is commonly used for venous whole blood sampling and cannot be used for capillary blood analysis.

[0005] To address the issue of homogenization in trace amounts of peripheral blood, some hematology analyzers employ a vortex oscillation method. This involves installing a small vortex oscillator in the sample injector to homogenize the trace amounts of peripheral blood through vortex oscillation. For trace samples, this homogenization method is quite thorough, resulting in excellent sample uniformity. However, it presents two problems: (1) The vortex oscillation is quite intense, leading to significant cavitation within the liquid, which may damage blood cells, especially in patients with hemolytic diseases. (2) The vortex oscillator itself generates intense vibrations. To prevent these vibrations from affecting the precision detection components of the hematology analyzer (such as the microporous impedance detector, radio frequency detector, and optical path), it is necessary to increase the weight of the equipment base and add shock-absorbing protection devices, making it difficult to miniaturize the equipment.

[0006] Therefore, developing a simple, efficient, universal, and minimally cellular-damaging automated method for mixing small amounts of whole blood is of great significance for improving the automation level, efficiency, and accuracy of clinical testing. Utility Model Content

[0007] To address the aforementioned problems, the purpose of this invention is to provide a micro-volume whole blood sample collection tube and a hematology analyzer. The magnetic beads in the micro-volume whole blood sample collection tube are used to disperse droplets during the inverted mixing process, increasing the liquid flow path and improving the mixing effect. Furthermore, the micro-volume whole blood sample collection tube can be further integrated with a magnet for use in a hematology analyzer. During the micro-volume whole blood injection process, the magnetic beads are attracted and fixed to the tube wall by the magnet, preventing interference with the injection needle or blockage of the liquid path. The micro-volume whole blood sample collection tube and magnet are relatively inexpensive, yet they can improve the coefficient of variation in blood routine tests, demonstrating broad application prospects.

[0008] The objective of this utility model can be achieved through the following technical solutions:

[0009] The first objective of this invention is to provide a micro-volume whole blood sample collection tube, comprising a collection tube and a spherical magnetic bead disposed in the inner cavity of the collection tube;

[0010] The magnetic beads are used to increase the flow path of the trace whole blood and enhance the thoroughness of mixing.

[0011] The collection tube is made of non-magnetic shielding materials, such as glass, polymer, or ceramic materials; the magnetic beads are allowed to move freely without restriction within the collection tube.

[0012] In one embodiment of this utility model, the collection tube includes a matching tube body and a tube cap;

[0013] The bottom of the tube is provided with a tapered round bottom.

[0014] In one embodiment of this utility model, the diameter of the tube is 10mm to 17mm, the length is 50mm to 100mm, and the effective volume is 1mL to 5mL;

[0015] Preferably, the tube has a diameter of 13mm, a length of 75mm, and an effective volume of 1.5mL (meeting relevant national and industry standards (such as YY0617) for blood collection tubes);

[0016] The angle of the tapered rounded bottom is 30° to 120°;

[0017] Preferably, the angle of the tapered bottom is 50-60°.

[0018] In one embodiment of this utility model, a skirt is provided at the bottom of the tube body, and the skirt extends along the height direction of the tube body.

[0019] In one embodiment of this utility model, the outer diameter of the skirt is the same as the outer diameter of the tube body.

[0020] In one embodiment of this utility model, one or more magnetic beads are provided;

[0021] Preferably, one magnetic bead is provided.

[0022] In one embodiment of this utility model, the diameter of the magnetic bead is 2mm to 5mm.

[0023] The magnetic beads are ferromagnetic or paramagnetic and can be attracted by a magnetic field; preferably, the diameter of the magnetic beads is 3 mm.

[0024] The second objective of this invention is to provide a blood cell analyzer, which includes an analyzer body, a micro-volume whole blood sample collection tube, and a magnet adapted to the magnetic beads in the micro-volume whole blood sample collection tube.

[0025] The magnet and the magnetic bead have opposite magnetic properties; the magnetic force of the magnet should be strong enough to attract the magnetic bead in the collection tube and fix the magnetic bead to the tube wall.

[0026] In one embodiment of this utility model, the magnet is disposed on the sample feed rack of the analyzer body.

[0027] The main body of the analyzer is the Sysmex 900i fully automated blood cell analyzer, which has a built-in sample loading device with inversion and mixing function for inverting and mixing micro-volume whole blood sample collection tubes.

[0028] The sample loading device allows for changing the tilt angle of the long axis of the collection tube in the horizontal direction; wherein the tilt angle is 90° to 180°, and along the height direction, during the inverted mixing process, there is a moment when the bottom of the collection tube is higher than the opening of the tube.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] (1) The magnetic beads in the micro-volume whole blood sample collection tube provided by this utility model are used to disperse the droplets during the inverted mixing process of micro-volume whole blood, which can increase the flow path of liquid during the mixing process and improve the mixing effect.

[0031] (2) The combination of magnetic beads and magnet in the micro-volume whole blood sample collection tube provided by this utility model allows the magnetic beads to be attracted and fixed on the tube wall by the magnet during the micro-volume whole blood injection process, thus avoiding affecting the injection of the injection needle or blocking the liquid path. The combination of this micro-volume whole blood sample collection tube and magnet can be further applied to blood cell analyzers (especially fully automated blood cell analyzers). The magnetic beads and magnet have low cost, but can improve the homogenization variation coefficient of blood routine items, and have broad application prospects. Attached Figure Description

[0032] Figure 1 A schematic diagram of the structure of a micro-volume whole blood sample collection tube (vertically placed);

[0033] Figure 2 A schematic diagram of the structure of a micro-volume whole blood sample collection tube (placed horizontally);

[0034] Figure 3 Schematic diagrams of existing micro-volume whole blood sample collection tubes: vertical placement (A), horizontal placement (B);

[0035] Figure 4 This is a schematic diagram showing the combination of a micro-volume whole blood sample collection tube and a magnet.

[0036] Figure 5 Comparative images of a blood smear (A) of a small amount of whole blood collected using an existing micro-whole blood collection tube after vortexing and a blood smear (B) of a small amount of whole blood collected using the micro-whole blood collection tube of this invention after mixing (Wright staining and oil immersion observation).

[0037] The following are the labels in the diagram: 1. Tube body; 2. Tube cap; 3. Tapered bottom; 4. Magnetic bead; 5. Skirt; 6. Magnet; 7. Injection needle. Detailed Implementation

[0038] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0039] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0040] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0041] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0042] In the following embodiments, unless otherwise specified, the components or structures used are conventional components or structures in the art, as long as they can achieve the corresponding functions.

[0043] Example 1

[0044] This embodiment provides a micro-volume whole blood sample collection tube, such as... Figures 1-2 As shown, it includes a collection tube and a spherical magnetic bead 4 disposed inside the collection tube; the magnetic bead 4 is used to increase the flow path of the trace whole blood and enhance the thorough mixing of the trace whole blood. Figure 3 (This is a schematic diagram of the structure of a data acquisition tube using existing technology).

[0045] The collection tube includes a matching tube body 1 and a cap 2. The bottom of the tube body 1 is provided with a tapered round bottom 3 (to increase the depth of the sampling needle into the blood sample, so that the sampling needle can draw more sample in the subsequent sampling, thereby avoiding the need to collect more blood sample from the sample body). The bottom of the tube body 1 is provided with a skirt 5 extending along the height direction of the tube body 1 (so that the sampling tube can be adapted to various types of automatic analyzers). The diameter of the tube body 1 is 10mm to 17mm, the length is 50mm to 100mm, and the effective volume is 1mL to 5mL. The angle of the tapered round bottom 3 is 30° to 120°.

[0046] Preferably, the tube body 1 has a diameter of 13mm, a length of 75mm, and an effective volume of 1.5mL (meeting relevant national and industry standards (such as YY0617) for blood collection tubes), and the angle of the tapered bottom 3 is 50-60°; the outer diameter of the skirt 5 is the same as the outer diameter of the tube body 1, and the height of the skirt 5 is 45mm.

[0047] The magnetic bead 4 is provided with one or more (preferably, the magnetic bead 4 is provided with one). Figures 1-2 The magnetic bead 4 is provided in one part, with a diameter of 2mm to 5mm; the magnetic bead 4 is ferromagnetic or paramagnetic and can be attracted by a magnetic field; preferably, the diameter of the magnetic bead 4 is 3mm.

[0048] Example 2

[0049] This embodiment provides a blood cell analyzer, including an analyzer body, a micro-volume whole blood sample collection tube (the micro-volume whole blood sample collection tube described in Embodiment 1), and a magnet 6 adapted to the magnetic beads 4 in the micro-volume whole blood sample collection tube; the magnet 6 and the magnetic beads 4 have opposite magnetic properties; the magnetic strength of the magnet 6 should be sufficient to attract the magnetic beads 4 in the collection tube and fix the magnetic beads 4 to the tube wall; the magnet 6 is disposed on the sample feed rack of the analyzer body.

[0050] The main body of the analyzer is a Sysmex 900i fully automated hematology analyzer. This Sysmex 900i fully automated hematology analyzer has a sample loading device with an inversion and mixing function, which is used to invert and mix a small amount of whole blood sample collection tube. The sample loading device allows the tilt angle of the long axis of the collection tube in the horizontal direction to be changed. The tilt angle is 90° to 180°, and along the height direction, there is a moment when the bottom of the collection tube is higher than the opening of the tube during the inversion and mixing process (during the inversion and mixing, due to the effect of gravity, the magnetic bead 4 rolls off the droplet, breaking the droplet (the droplet is scattered), further increasing the flow path of the droplet, making the mixing more thorough).

[0051] During sample loading, the collection tube is placed on the sample holder. The magnetic bead 4 is attracted by the magnet 6, causing the droplets to adhere to the tube wall of the tube body 1. This does not affect the injection of the device's injection needle 7. Figure 4 ).

[0052] When using the micro-volume whole blood sample collection tube of this invention for inverting and mixing, compared with other existing mixing methods, this method has the lowest CV% (as shown in Table 1); and the vortexing method causes more damage and breakage of red blood cells. Figure 5 (As indicated by arrow B), while the cell morphology was normal after mixing using the micro-volume whole blood sample collection tube of this invention. Figure 5 A).

[0053] Table 1. Coefficient of Variation (CV%) of Major Complete Blood Count Items

[0054] hemoglobin Platelet count Red blood cell count White blood cell count This utility model 0.74％ 0.66％ 1.02％ 1.20％ Existing inversion processing methods 1.01％ 5.01％ 1.38％ 1.87％ Existing vortex processing methods 1.00％ 3.17％ 1.81％ 3.73％

[0055] It should be noted that when operating the blood cell analyzer of this utility model, you can refer to the user manual of the Sysmex 900i fully automated blood cell analyzer. This utility model emphasizes that the magnet 6 will draw the magnetic bead 4 out of the droplet and attach it to the tube wall of the tube body 1 without affecting the sample injection of the device's injection needle 7.

[0056] The above description of the embodiments is provided to enable those skilled in the art to understand and use the utility model. It will be apparent to those skilled in the art that various modifications can be easily made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present utility model is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the interpretation of the present utility model without departing from its scope should be within the protection scope of the present utility model.

Claims

1. A micro whole blood sample collection tube characterized by, The collection tube and the magnetic beads (4) in the spherical shape arranged in the inner cavity of the collection tube are included. The magnetic beads (4) are used to increase the flow distance of the micro whole blood and enhance the mixing sufficiency of the micro whole blood.

2. A micro-whole blood sample collection tube according to claim 1, wherein, The collection tube includes a matched tube body (1) and a tube cap (2). The bottom of the tube body (1) is provided with a tapered round bottom (3).

3. A micro-whole blood sample collection tube according to claim 2, wherein, The diameter of the tube body (1) is 10mm-17mm, the length is 50mm-100mm, and the effective volume is 1mL-5mL; the angle of the tapered round bottom (3) is 30°-120°.

4. The micro-whole blood sample collection tube of claim 2, wherein, The bottom of the tube body (1) is provided with a skirt (5) extending along the height direction of the tube body (1).

5. A micro-whole blood sample collection tube according to claim 4, wherein, The outer diameter of the skirt (5) is the same as that of the tube body (1).

6. The micro-whole blood sample collection tube of claim 1, wherein, The magnetic beads (4) are more than one.

7. A micro-whole blood sample collection tube according to claim 6, wherein, The magnetic beads (4) are one.

8. The micro-whole blood sample collection tube of claim 1, wherein, The diameter of the magnetic beads (4) is 2mm-5mm.

9. A blood cell analyzer characterized by comprising: The blood cell analyzer includes an analyzer main body, the micro whole blood sample collection tube according to any one of claims 1-8, and a magnet (6) matched with the magnetic beads (4) in the micro whole blood sample collection tube. The magnet (6) is opposite to the magnetism of the magnetic beads (4) in the micro whole blood sample collection tube; the magnetic force strength of the magnet (6) should ensure that the magnetic beads (4) in the collection tube can be attracted and fixed on the tube wall of the collection tube.

10. The blood cell analyzer of claim 9 wherein, The magnet (6) is arranged on the sample rack of the analyzer main body.

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