An automated whole blood sample preparation instrument and a working method thereof

Abstract

The application discloses an automatic whole blood sample preparation instrument, which comprises a blood collection tube loading bin, a blood collection tube conveying belt, a blood sample mixing device, a code scanner, a blood collection tube automatic alignment device located at the end of the blood collection tube conveying belt, a blood collection tube alignment position and a cap screwing position; the blood collection tube falls horizontally into the blood collection tube conveying belt from the blood collection tube loading bin; the blood collection tube conveying belt cooperates with the blood sample mixing device to drive the blood collection tube to rotate, mix and transfer; the mixed blood collection tube falls into the blood collection tube alignment position in a tube cap upward posture under the action of gravity and the blood collection tube automatic alignment device; the blood collection tube alignment position and the cap screwing position are the same position or two independent positions, and a first mechanical hand device transfers the blood collection tube between the two positions; the cap screwing position is provided with an automatic cap opening and closing device for the blood collection tube; the opened whole blood sample is sucked and distributed by a second mechanical hand device; and the instrument automatically records the blood sample source and distributed reagent distributed to each blood sample loading structure.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to an automated whole blood sample preparation instrument and its working method. Background Technology

[0002] In medical research and clinical practice, whole blood is frequently tested. Testing whole blood samples often requires dividing the blood sample into multiple fractions. During fractionation, it is crucial to ensure the blood samples are thoroughly mixed to guarantee that each fraction contains a uniform number of cells. This ensures that the test results obtained from each fraction are consistent with those obtained from the original blood sample, thus guaranteeing the quality of the test results.

[0003] The applicant found that existing devices are limited to dispensing small amounts (not exceeding 50 μL) of whole blood from each blood sample. However, in medical laboratory work, it is often necessary to prepare and dispense larger amounts of blood samples and reagents simultaneously. Currently, the preparation and dispensing of larger amounts (more than 100 μL) of whole blood samples mainly relies on manual labor. There is a lack of equipment that can automatically prepare and dispense larger amounts of blood samples and dispense reagents at high speed and with full automation. This results in some experimental operations being cumbersome and inefficient. Summary of the Invention

[0004] Purpose of the invention: The technical problem to be solved by the present invention is to provide an automated whole blood sample preparation instrument that can meet the requirements of preparing and processing a large number of whole blood samples. The instrument has automated transmission and mixing of large numbers of whole blood samples, automatic barcode reading, multiple large numbers of blood samples, and automated devices that can automatically add quantitative amounts of different reagents to each of the distributed blood samples.

[0005] In this application, the allocation of multiple large-volume blood samples refers to preparing the blood sample from the blood collection tube into multiple equal and uniformly mixed blood samples according to the testing requirements, and then allocating them to the respective loading vessels used for the blood sample testing.

[0006] To solve the above technical problems, the present invention discloses an automated whole blood sample preparation instrument. The automated whole blood sample preparation instrument includes a blood collection tube loading bin for storing blood collection tubes to be processed, a blood collection tube conveyor belt disposed below the blood collection tube loading bin, a blood sample mixing device matching the blood collection tube conveyor belt, a barcode scanner, a blood collection tube gravity automatic alignment device at the end of the blood collection tube conveyor belt, a blood collection tube alignment position, a cap unscrewing position, a first robotic arm device, a second robotic arm device, and a loading structure supporting a blood sample detection structure. The blood collection tube conveyor belt is in the shape of strips symmetrically arranged on both sides, and a number of spaced separation baffles are provided on each blood collection tube conveyor belt. For each blood collection tube conveyor belt, the distance between two adjacent separation baffles only allows one blood collection tube to be placed. The blood collection tubes to be processed are neatly placed in the blood collection tube loading bin with the tube caps facing the same side, and the blood collection tubes can fall horizontally one by one from the blood collection tube loading bin between two adjacent separation baffles on the blood collection tube conveyor belt and move along the conveying direction under the drive of the blood collection tube conveyor belt and the separation baffles. The blood collection tube conveyor belt cooperates with the blood sample mixing device to drive the blood collection tube to rotate and mix and transfer. The barcode scanner is disposed above the conveyor belt for scanning and identifying the barcode on the rotating blood collection tube. After the blood sample is rotated and mixed, the blood collection tube automatically falls into the blood collection tube alignment position at the end of the blood collection tube conveyor belt in an aligned posture with the tube cap upward and the tube tail downward under the combined action of gravity and the blood collection tube gravity automatic alignment device. The blood collection tube alignment position and the cap unscrewing position are the same working station or two independent working stations, and the first robotic arm device transfers the blood collection tube between the two independent working stations. An automatic cap opening and closing device for blood collection tubes is provided at the cap unscrewing position. The whole blood sample in the blood collection tube after the tube cap is opened at the cap unscrewing position is sucked by a sampling tip loaded by the second robotic arm device and distributed to the blood sample detection structure on the loading structure. The preparation instrument automatically records the source of the whole blood sample distributed to each blood sample detection structure on the loading structure and the reagents distributed.

[0007] Specifically, the second robotic arm device includes a sample extractor, and the sampling tip is loaded on the sample extractor. The sampling tip is a disposable liquid suction tip, and the disposable liquid suction tip is communicated with a sampling passage inside the sample extractor. The preparation instrument further includes a first storage area for storing unused disposable liquid suction tips, a first discard bin for collecting used disposable liquid suction tips, and a first collection bin for collecting discarded blood collection tubes after distribution. The first robotic arm device is further used to grab the blood collection tube that has been distributed and capped from the cap unscrewing position to the first collection bin for discarding, and to grab the blood collection tube with unqualified blood sample collection volume from the blood collection tube alignment position to the unqualified sample position.

[0008] Furthermore, the preparation instrument further includes more than 1 reagent dispensing device for dispensing specific reagents to the sample detection structure for detection before or after the distribution of the whole blood sample.

[0009] Specifically, the automatic gravity-driven alignment device for the blood collection tube is a transverse baffle extending outward from the end of the blood collection tube conveyor belt near the cap end. The alignment position also includes a blood collection tube groove for receiving the tube, comprising a cylindrical pipe section and a flared section connected above the cylindrical pipe section, with the larger diameter end of the flared section facing upward. Alignment refers to adjusting the posture of the blood collection tube to a vertical position with the cap end facing upward and the tube tail end facing downward.

[0010] Specifically, when the blood collection tube alignment position and the capping position are two independent workstations, the blood collection tube alignment position is equipped with a blood collection tube liquid level position determination device for detecting blood sample height. The blood collection tube liquid level position determination device includes a light source and a light signal detector. The light source is used to illuminate the blood collection tube located at the blood collection tube alignment position. The light signal detector is set at the same height as the light source and in a position facing each other to receive the amount of light transmitted through the blood collection tube from the light source located at the blood collection tube alignment position. The blood collection tube liquid level position determination device determines whether the blood sample height in the blood collection tube located at the blood collection tube alignment position is qualified by comparing the transmitted light amount with a preset threshold.

[0011] When the blood collection tube is in the same position (aligned and capped), a pressure detection device is installed on the sampling passage. The pressure detection device is used to measure the negative pressure value formed when the disposable suction tip is inserted into the blood collection tube to a preset height for sampling. The preparation instrument determines whether there is a blood sample in the blood collection tube at the preset height by comparing the negative pressure value with a preset negative pressure threshold.

[0012] Specifically, the loading structure is a sample cup holder or a test card loading tray. When the loading structure is a sample cup holder, the sample detection structure is a sample cup. When the loading structure is a test card loading tray, the sample detection structure is a test card. Each sample cup holder is used to load one independent sample cup, or each sample cup holder is used to load multiple sample cups simultaneously. The sample cup holder is disc-shaped or strip-shaped.

[0013] Specifically, the preparation instrument has an identification code on each sample cup holder or test card loading tray after loading and dispensing. The identification code records the patient information and allocated reagents for the whole blood sample currently loaded at each designated location on each loading structure. The preparation instrument is also equipped with an identification and reading device paired with the identification code, which allows tracing back to the information of the original sample. The identification code can also be identified at the analyzer.

[0014] Specifically, the blood sample mixing device includes a mixing conveyor belt located in the middle of the blood collection tube conveyor belt, with its upper surface higher than the upper surface of the blood collection tube conveyor belt but lower than the top surface of the separation baffle. The mixing conveyor belt and the blood collection tube conveyor belt move in the same direction at a differential speed or in opposite directions. As the mixing conveyor belt continues to move, the friction between the blood collection tubes on the mixing conveyor belt and the mixing conveyor belt causes the blood collection tubes to move synchronously with the mixing conveyor belt. Under the obstruction of the separation baffle, the blood collection tubes are finally restricted to a position close to the separation baffle, resulting in rotational motion, thereby achieving rotational mixing of the whole blood sample in the blood collection tube.

[0015] Alternatively, the blood sample mixing device may be a set of one or more squeeze-type rotating devices. Each set of squeeze-type rotating devices includes a passive rotating device and an active rotating device, which are respectively positioned on opposite sides of the blood collection tube conveyor belt. When the blood collection tube conveyor belt pauses, the passive rotating device and the active rotating device press against the two ends of the corresponding blood collection tube, and the active rotating device drives the blood collection tube to rotate, thereby achieving rotational mixing of the whole blood sample within the blood collection tube. One set of squeeze-type rotating devices drives the rotation of the blood collection tube to enable a barcode scanner to scan and identify the barcode on the rotating blood collection tube.

[0016] Specifically, the two sides of the blood collection tube conveyor belt are in a state where one side is higher than the other, or the two sides are staggered in height, so that the whole blood sample is fully mixed by rotating and flowing back and forth along the axis of the blood collection tube during the transfer process.

[0017] This invention also provides a method for operating an automated whole blood sample preparation instrument, implemented using the aforementioned automated whole blood sample preparation instrument, the method comprising the following steps:

[0018] Step 1. Place the blood collection tubes to be processed horizontally into the blood collection tube loading chamber. During placement, the tubes should be arranged with the caps on one end and the tails on the other. Due to gravity, the blood collection tubes fall onto the blood collection tube conveyor belt, and each tube is separated by a separation baffle on the conveyor belt. The blood collection tubes move unidirectionally along the conveyor belt. During this unidirectional movement, the blood collection tubes are driven by the blood sample mixing device and rotated by the separation baffles on the conveyor belt to mix the blood sample. During this rotation, the barcode scanner identifies and records the barcode on the tube wall.

[0019] Step 2. After leaving the blood collection tube conveyor belt, the blood collection tube at the end of the blood collection tube is switched from a horizontal state to a vertical state with the cap end facing up and the tail end facing down under the combined action of gravity and the automatic gravity alignment device of the blood collection tube. The blood collection tube alignment position receives the blood collection tube falling in the vertical state.

[0020] Step 3: The first robotic arm moves to the positioning position of the blood collection tube, grabs the blood collection tube, and delivers it to the capping position.

[0021] Step 4: The blood collection tube is placed vertically in the capping position with the cap end facing upwards. The capping position is equipped with an automatic cap opening and closing device for the blood collection tube. The automatic cap opening and closing device is used to open the cap of the blood collection tube and remove the cap so that the upper end of the blood collection tube is completely unobstructed.

[0022] Step 5: The second robotic arm moves the disposable suction tip into the blood collection tube at the screw cap position to draw blood. After the disposable suction tip draws the whole blood sample, the second robotic arm moves the disposable suction tip to a sample detection structure and dispenses the drawn whole blood sample into that sample detection structure. This step is repeated as needed to dispense the whole blood sample into more than one sample detection structure.

[0023] Step 6: The instrument records or marks the loading structure containing the sample detection structure. The prepared sample is then ready for testing. Alternatively, after the second robotic arm device 16 dispenses the blood sample, the instrument's reagent dispensing device adds reagents to each of the dispensed blood sample detection structures, mixing the reagents with the blood sample to complete the preparation of the blood sample for testing.

[0024] Step 7: At the capping position, the automatically opening and closing cap device of the blood collection tubes is used to cap the allocated blood collection tubes. The first robotic arm then picks up the capped allocated blood collection tubes and places them in the first collection chamber for disposal. The second robotic arm then discards the used disposable suction tip into the first disposal chamber. A new disposable suction tip is then loaded onto the second robotic arm for later use. The blood collection tube conveyor belt moves forward and feeds a new blood collection tube into the correct position. The instrument then repeats the same process for each new blood collection tube until all blood collection tubes in the loading chamber have been processed.

[0025] Beneficial effects:

[0026] (1) The present invention provides an automated whole blood sample preparation instrument suitable for processing whole blood samples with a large volume of blood for testing. Each prepared blood sample is larger than 100 μL and is thoroughly mixed to achieve a mixing degree very close to or the same as the original blood sample, thus ensuring that the content of various cells and liquids in each blood sample is equal. The instrument has the functions of automatically transferring, mixing, barcode recognition and scanning, automatically opening and closing the cap, automatically distributing the blood sample, and automatically adding reagents to the distributed blood sample, and finally preparing a whole blood sample suitable for specific tests. The blood collection tubes to be processed fall horizontally from the blood collection tube loading bin onto the blood collection tube conveyor belt and move along the conveying direction under the drive of the blood collection tube conveyor belt. The blood collection tube conveyor belt and the blood sample mixing device work together to drive the blood collection tubes to rotate, and the barcode scanner is used to scan and identify the barcode on the rotating blood collection tubes. After the blood sample is rotated and mixed, the blood collection tubes are aligned and fall into the blood collection tube alignment position with the cap facing upward and the end of the tube facing downward under the combined action of gravity and the automatic alignment device of the blood collection tube gravity. The blood collection tube positioning and capping positions can be at the same workstation or two independent workstations, with a first robotic arm used to transfer the sampling tubes between the two independent workstations. The capping position is equipped with an automatic cap-opening device for the blood collection tubes. Whole blood samples from the capping position are dispensed to the blood sample testing structures on the loading structure via a second robotic arm. The instrument automatically records the source of the whole blood samples dispensed to each blood sample testing structure on the loading structure. Thus, the instrument achieves continuous and smooth transmission and mixing of large quantities of whole blood samples, automatic barcode reading, and automated dispensing. This instrument features a smooth sample processing flow, is suitable for dispensing and preparing blood samples larger than 100 μL each, and has a high sample processing speed, meeting the needs of various multi-item whole blood sample preparation and large-volume whole blood sample preparation, such as whole blood sample preparation for platelet function testing, thromboelastography testing, blood viscosity testing, and other blood cell component testing.

[0027] (2) An embodiment of the present invention provides an automated whole blood sample preparation instrument that also has the function of determining whether the blood sample height of the blood collection tube is qualified and the function of automatically removing blood collection tubes with unqualified blood sample height from the blood collection tube positioning position to the waste blood collection tube collection chamber.

[0028] (3) In an embodiment of the present invention, an automated whole blood sample preparation instrument is provided, wherein the automatic gravity alignment device for the blood collection tube is a transverse baffle extending outward from the end of the blood collection tube conveyor belt near the end of the blood collection tube cap. Under the action of the transverse baffle, the horizontally positioned blood collection tube deflects, the cap end deflects upward due to the stop of the transverse baffle, and the tail end deflects downward. Guided by the flared section of the blood collection tube groove, it finally falls into the cylindrical pipe section in a vertical posture with the tail end facing upward, thereby achieving the alignment of the blood collection tube.

[0029] (4) In an embodiment of the present invention, an automated whole blood sample preparation instrument is provided, wherein a plurality of spaced-apart separation baffles are provided on the blood collection tube conveyor belt. Two adjacent separation baffles and the blood collection tube conveyor belt form a space for accommodating only one blood collection tube. The blood sample mixing device includes a mixing transmission belt, which is located in the middle of the blood collection tube conveyor belts on both sides, and its upper surface is higher than the upper surface of the blood collection tube conveyor belt but lower than the top surface of the separation baffles. The mixing transmission belt and the blood collection tube conveyor belt transmit at different speeds in the same direction or in opposite directions. When the mixing transmission belt continues to transmit, the blood collection tube located on the mixing transmission belt moves synchronously with the mixing transmission belt due to the friction between the blood collection tube and the mixing transmission belt. Under the obstruction of the separation baffles, the blood collection tube eventually rotates at a position close to the separation baffles, thereby realizing the rotational mixing of the whole blood sample in the blood collection tube.

[0030] (5) The automated whole blood sample preparation instrument provided by the present invention can be used as an independent device or as a dedicated sample preparation unit before the analyzer to form an integrated whole instrument. Attached Figure Description

[0031] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments, and the advantages of the present invention in the above and / or other aspects will become clearer.

[0032] Figure 1 A top view of an automated whole blood sample preparation instrument provided for the first embodiment of this application;

[0033] Figure 2 for Figure 1 A cross-sectional view along line AA of the blood collection tube loading chamber and the lower blood collection tube delivery part of the automated whole blood sample preparation instrument.

[0034] Figure 3 For along Figure 1 Sectional view of the middle BB line;

[0035] Figure 4 A top view of an automated whole blood sample preparation instrument provided for the second embodiment of this application;

[0036] Figure 5 for Figure 4 The diagram shows a three-dimensional structure of a sample cup holder in an automated whole blood sample preparation instrument, which is equipped with a multi-hole cup.

[0037] The reference numerals in the accompanying drawings of this application are as follows:

[0038] Blood collection tube loading bin 1, blood collection tube 101, blood collection tube conveyor belt 201, blood sample mixing device 202, barcode scanner 203, separation baffle 204, blood collection tube alignment position 4, blood collection tube slot 401, automatic gravity alignment device for blood collection tube 5, cap unscrewing position 6, automatic cap opening and closing device for blood collection tube 601, test card 701, test card loading tray 801, sample cup bracket 802, first storage area 9, reagent loading station 11, first collection bin 12, first discard bin 13, reagent dispensing arm 14, first robotic device 15, second robotic device 16, light source 17, optical signal detector 18, drive wheel 19, driven wheel 20, unqualified sample position 21, first waiting area 22, preparation area 23, and second storage area 24. Detailed implementation mode

[0039] The technical solution of the present application will be described in detail below with reference to the accompanying drawings.

[0040] Embodiment 1

[0041] The first embodiment of the present invention provides an automated whole blood sample preparation instrument. As Figure 1 shown, the automated whole blood sample preparation instrument includes a blood collection tube loading bin 1 for storing blood collection tubes 101 to be processed, a blood collection tube conveyor belt 201 disposed below the blood collection tube loading bin 1, a blood sample mixing device 202, a barcode scanner 203, an automatic gravity alignment device for blood collection tubes 5 at the end of the blood collection tube conveyor belt, a blood collection tube alignment position 4, a cap unscrewing position 6, a first robotic device 15, a second robotic device 16, and a loading structure for supporting the blood sample detection structure. In this embodiment, as Figure 1 shown, the blood sample detection structure is a test card 701, and the loading structure for supporting the blood sample detection structure is the test card loading tray 801.

[0042] As Figure 1 and Figure 2 shown, the blood collection tube conveyor belt 201 is a strip symmetrically arranged on both sides, and a plurality of separation baffles 204 are arranged at intervals on each blood collection tube conveyor belt 201. For each blood collection tube conveyor belt 201, the distance between adjacent two separation baffles 204 only allows one blood collection tube 101 to be placed. That is to say, the adjacent two separation baffles 204 and the blood collection tube conveyor belt 201 form a space for only accommodating one of the blood collection tubes.

[0043] As Figure 1 and Figure 2As shown, the blood collection tubes 101 to be processed are neatly arranged in the blood collection tube loading bin 1 with the tube caps facing the same side. The blood collection tubes fall horizontally from the loading bin 1 one by one between two adjacent separating baffles 204 on the blood collection tube conveyor belt 201, and move along the conveying direction under the action of the conveyor belt 201 and the separating baffles 204. Simultaneously, the blood sample mixing device 202 drives the blood collection tubes on the conveyor belt 201 to rotate, mix, and transfer them. The barcode scanner 203 is located above the conveyor belt 201 to scan and identify the barcodes on the rotating blood collection tubes 101. After the blood sample is rotated and mixed, the blood collection tubes 101, under the combined action of gravity and the automatic gravity alignment device 5, are aligned at the end of the blood collection tube conveyor belt 201, forming a posture with the tube cap facing upwards and the tube end downwards, and automatically fall into the blood collection tube alignment position 4 located at the end of the blood collection tube conveyor belt 201. The blood collection tube alignment position 4 and the capping position 6 are the same station or two independent stations, such as... Figure 1 As shown, the first robotic arm device 15 transfers the blood collection tubes between two independent workstations. The capping station 6 is equipped with an automatic cap-opening device 601 for the blood collection tubes. After the cap is opened at the capping station 6, the whole blood sample in the blood collection tube is aspirated by the suction tip mounted on the second robotic arm device 16 and dispensed to the blood sample detection structures on the loading structure. The instrument automatically records the source of the whole blood sample dispensed to each blood sample detection structure on the loading structure and the reagents dispensed.

[0044] This application can automatically perform functions such as mixing a large number of whole blood samples, distributing the mixed whole blood samples, automatically adding different reagents to each distributed blood sample, and recording the original data information of each distributed blood sample.

[0045] In this application, "alignment" refers to adjusting the posture of the blood collection tube 101 to a vertical posture with the cap end facing upwards and the tail end facing downwards.

[0046] Specifically, the second robotic arm device 16 includes a sample extractor, and the suction tip is mounted on the sample extractor. The suction tip is a disposable liquid suction tip, and the disposable liquid suction tip is connected to the suction passage inside the sample extractor. (Not shown in the figure.) Figure 1 As shown, the preparation device also includes a first storage area 9 for storing unused disposable suction tips, a first disposal compartment 13 for collecting used disposable suction tips, and a first collection compartment 12 for collecting dispensed waste blood collection tubes. The first robotic arm device 15 is also used to pick up the dispensed and capped blood collection tubes 101 from the capping position 6 and discard them in the first collection compartment 12, and to pick up blood collection tubes 101 with unqualified blood sample volume from the blood collection tube alignment position 4 and discard them in the first collection compartment 12, or pick them up to the specially designated unqualified sample position 21.

[0047] Furthermore, the preparation instrument also includes one or more reagent dispensing devices for dispensing specific reagents to the sample detection structure before or after whole blood sample dispensing. The preparation instrument including the reagent dispensing device can be used as a whole blood sample preparation section of a fully automated instrument, or as a stand-alone whole blood sample preparation instrument. Specifically, such as... Figure 1 As shown, the reagent dispensing device includes a reagent loading station 11, a reagent bottle mounted on the reagent loading station 11, and a reagent dispensing arm 14. The reagent dispensing arm 14 has one or more reagent needles attached to its lower end. These reagent needles are connected to a diluent inside the instrument via pipes and valves. During reagent dispensing, the reagent needle is inserted into the reagent bottle. A certain amount of reagent is drawn into the reagent needle by the diluent connected inside the instrument. Subsequently, the reagent dispensing arm 14 moves the reagent needle to the blood sample detection structure where the blood sample is loaded. The diluent inside the instrument then pushes back, pushing the reagent drawn into the reagent needle into the blood sample detection structure.

[0048] Specifically, such as Figure 1 and Figure 3 As shown, the automatic gravity-based alignment device 5 for the blood collection tube is a transverse baffle extending outward from the end of the blood collection tube conveyor belt 201 near the end of the blood collection tube cap. The blood collection tube alignment position 4 is also provided with a blood collection tube groove 401 for receiving the blood collection tube. The blood collection tube groove 401 includes a cylindrical pipe section and a flared section connected above the cylindrical pipe section, with the larger diameter end of the flared section facing upward.

[0049] To remove blood collection tubes with excessively high blood sample levels, the preparation instrument has a function to detect whether the blood sample volume in the collection tube is sufficient to meet the requirements. In one specific embodiment, such as... Figure 1 As shown, the blood collection tube alignment position 4 and the cap tightening position 6 are two independent workstations. The blood collection tube alignment position 4 is equipped with a blood collection tube liquid level determination device for detecting the blood sample height. Figure 2As shown, the blood collection tube liquid level position determination device includes a light source 17 and a light signal detector 18, both located at the same height and facing each other. The light source 17 is used to illuminate the blood collection tube located at the blood collection tube alignment position 4, and the light signal detector 18 is used to receive the amount of light transmitted through the blood collection tube from the light source 17 at the blood collection tube alignment position 4. The blood collection tube liquid level position determination device is set at a certain height outside the blood collection tube at the blood collection tube alignment position 4. This device determines whether the blood sample height in the blood collection tube at the blood collection tube alignment position 4 is qualified by comparing the transmitted light amount with a preset threshold, thereby evaluating whether the blood sample volume in each blood collection tube is sufficient. Specifically, when the blood collection tube falls into the blood collection tube alignment position 4, the instrument automatically activates the light source 17 and the corresponding light signal detector 18. The light source 17 is a long wavelength light source of 600nm or above, and the positions of the light source 17 and the light signal detector 18 are located at the height that the blood sample in the blood collection tube must reach. When the blood sample volume reaches the desired height, the light emitted by the light source 17 cannot pass through due to the obstruction of the blood sample in the blood collection tube. Therefore, the light signal detector 18 cannot detect the signal from the light source 17, or the signal is very weak, with a measurable absorbance value > 2.0 OD. However, when the blood sample in the blood collection tube is insufficient, the blood sample cannot reach the desired height. In this case, the light emitted by the light source 17 can pass through even if there is a blood-coated membrane on the tube wall, as there is no blood sample obstruction in that area. The light signal detector 18 can then detect a strong signal from the light source 17, and the measured absorbance value is less than 1.0 OD. In another specific embodiment, the blood collection tube alignment position 4 and the capping position 6 are at the same workstation. A pressure detection device is installed on the sampling passage. The pressure detection device measures the negative pressure value formed when the disposable suction tip is inserted into the blood collection tube to a preset height for sampling. The preparation instrument determines whether there is a blood sample in the blood collection tube at the preset height by comparing the negative pressure value with a preset negative pressure threshold. Specifically, during blood sample collection, the second robotic arm 16 drives the disposable suction tip to a certain depth into the blood collection tube, where the sample extractor aspirates. If no blood sample is found at this location, the pressure detection device installed on the suction path will not detect a pressure change, indicating that there is no blood sample at that height in the blood collection tube. However, if there is blood sample at that height in the blood collection tube, the pressure detection device installed on the suction path will detect a decrease in pressure during sample extraction, indicating that there is blood sample at that height in the blood collection tube. Therefore, it can be concluded that the blood collection tube has collected a sufficient amount of blood.

[0050] Specifically, the preparation instrument assigns an identification code to each loading structure after loading and dispensing. This identification code records the patient information and allocated reagents for the whole blood sample currently loaded at each designated location on each loading structure. The preparation instrument is also equipped with an identification and reading device paired with the identification code, allowing tracing back to the original sample information based on the code. The identification code can also be identified at the analyzer.

[0051] This system is capable of driving and mixing blood collection tubes. In one specific embodiment, such as Figures 1 to 3 As shown, the blood sample mixing device 202 includes a mixing conveyor belt, which is located in the middle of the blood collection tube conveyor belt 201, and, as... Figure 3 As shown, its upper surface is higher than the upper surface of the blood collection tube conveyor belt 201 but lower than the top surface of the separation baffle 204. The mixing conveyor belt and the blood collection tube conveyor belt 201 transmit at different speeds in the same direction or in opposite directions. When the mixing conveyor belt continues to transmit, the friction between the blood collection tubes on the mixing conveyor belt and the mixing conveyor belt causes the blood collection tubes to move synchronously with the mixing conveyor belt. Under the obstruction of the separation baffle 204, the blood collection tubes cannot move in a straight line, but are ultimately restricted to a position close to the separation baffle 204 and thus rotate, thereby achieving rotational mixing of the whole blood sample in the blood collection tube. In another specific embodiment, the blood sample mixing device 202 is a group of more than one squeeze-type rotating device, not shown in the figure. Each group of squeeze-type rotating devices includes a passive rotating device and an active rotating device, and the passive rotating device and the active rotating device are respectively arranged on opposite sides of the blood collection tube conveyor belt 201. When the blood collection tube conveyor belt 201 pauses transmission, the passive rotating device and the active rotating device respectively press against the two ends of the corresponding positions of the blood collection tube. The active rotating device drives the blood collection tube to rotate, thereby achieving rotational mixing of the whole blood sample inside the blood collection tube. At least one set of squeeze-type rotating devices is provided at the barcode scanner 203. This set of squeeze-type rotating devices drives the blood collection tube to rotate, thereby enabling the barcode scanner 203 to scan and identify the barcode on the rotating blood collection tube 101.

[0052] Example 2

[0053] In the second embodiment of this application, the loading structure is a sample cup holder 802, and the sample detection structure is a sample cup 702. The sample cup holder 802 can be a holder for loading a single sample cup 702, or it can be a holder capable of loading multiple sample cups 702 simultaneously. This holder can be disc-shaped or strip-shaped. For the same sample cup holder 802, the multiple sample cups 702 can be multiple independent single-cup sample cups, or they can be connected together to form a multi-hole connected cup. In a specific embodiment, such as... Figure 4 and Figure 5 As shown, the sample cup holder 802 is used to simultaneously load multiple sample cups 702, and the multiple sample cups 702 are connected together to form a multi-hole cup.

[0054] like Figure 4 As shown, sample cup holders 802 containing unused sample cups 702 are placed in the first waiting area 22 to await loading blood samples. These holders are then progressively transferred to the preparation area 23. In the preparation area 23, a second robotic arm 16 dispenses whole blood samples from the blood collection tubes (after the caps are opened) from the capping position 6 into the corresponding sample cups 702 of the sample cup holders 802. Reagents are added to each of the dispensed blood sample cups 702 by the reagent dispensing arm 14. The specified reagents are mixed with the blood sample to obtain the blood sample used for testing. Subsequently, sample cup holders 802 containing the processed sample cups 702 are transferred to the second storage area 24 for storage. Figure 4 The double-headed arrows indicate the direction of movement of the reagent dispensing arm 14 used in this embodiment. The transfer of sample cups by the sample cup holder 802 is prior art and will not be described in detail in this application.

[0055] In any of the above embodiments, the two sides of the blood collection tube conveyor belt 201 are either higher on one side than on the other, or the two sides are staggered in height. When the two sides of the blood collection tube conveyor belt 201 are staggered in height, the whole blood sample rotates and flows back and forth along the axis of the blood collection tube during the transfer process, thereby making the blood sample more thoroughly mixed.

[0056] In any of the above embodiments, such as Figure 2 As shown, the preparation device includes a driving wheel 19 and a driven wheel 20, and the blood collection tube conveyor belt 201 is rotatably connected to the outer peripheral surfaces of the driving wheel 19 and the driven wheel 20. In a specific embodiment, a stepper motor drives the driving wheel to rotate, which in turn drives the blood collection tube conveyor belt 201 to move in cooperation with the driven wheel.

[0057] This invention also provides a method for operating an automated whole blood sample preparation instrument, implemented using the aforementioned automated whole blood sample preparation instrument, the method comprising the following steps:

[0058] Step 1. Place the blood collection tubes to be processed horizontally into the blood collection tube loading chamber 1. When placing them, the sampling tubes are arranged flat in the blood collection tube loading chamber 1 with the cap end on one end and the tail end on the other. The blood collection tubes in the blood collection tube loading chamber 1 fall onto the blood collection tube conveyor belt 201 due to gravity, and each blood collection tube is separated by the separation baffle 204 set on the conveyor belt. The blood collection tubes move unidirectionally along the conveying direction with the blood collection tube conveyor belt 201. During the unidirectional movement of the blood collection tubes along the conveying direction, the blood collection tubes are driven by the blood sample mixing device 202 and rotate under the obstruction of the separation baffle 204 on the blood collection tube conveyor belt 201 to mix the blood sample. During the rotation of the blood collection tubes, the barcode scanner 203 identifies and records the barcode on the wall of the blood collection tube.

[0059] Step 2. After leaving the blood collection tube conveyor belt 201, the blood collection tube at the end of the blood collection tube conveyor belt 201 switches from a horizontal state to a vertical state with the cap end facing up and the tail end facing down under the combined action of gravity and the automatic gravity alignment device 5. The blood collection tube alignment position 4 receives the blood collection tube falling in the vertical state.

[0060] Step 3. A blood collection tube liquid level position judgment device is set in the blood collection tube positioning position 4. The blood collection tube liquid level position judgment device is used to detect whether the amount of blood sample in the blood collection tube is sufficient for the required blood sample. If it is insufficient, the blood collection tube will be prompted and will not be processed as a qualified blood collection tube. If it is qualified, the blood collection tube will continue to be processed normally.

[0061] Step 4: The first robotic arm device 15 moves to the blood collection tube alignment position 4 to grab the blood collection tube. If the blood collection tube meets the requirements, the first robotic arm device 15 grabs it and sends it to the capping position 6; however, for blood samples that cannot pass the label barcode reading or have insufficient blood volume detected by the liquid level detection, the first robotic arm device 15 sends them to the unqualified sample position 21 for processing.

[0062] Step 5: The blood collection tube is placed vertically in the capping position 6 with the cap end facing upward. The capping position 6 is equipped with an automatic cap opening and closing device 601 for the blood collection tube. The automatic cap opening and closing device 601 is used to open the cap of the blood collection tube and remove the cap so that the upper end of the blood collection tube is completely unobstructed.

[0063] Step 6: The second robotic arm device 16 drives the disposable suction tip to enter the blood collection tube at the capping position 6 to draw blood; after the disposable suction tip draws the whole blood sample, the second robotic arm device 16 drives the disposable suction tip to a sample detection structure and distributes the drawn whole blood sample into the structure; according to the detection needs, this step is repeated to distribute the whole blood sample into more than one sample detection structure;

[0064] Step 7: The instrument records or marks the loading structure of the sample detection structure; the prepared sample can then be used for detection; or, after the second robotic arm device 16 dispenses the blood sample, the instrument's reagent dispensing device adds reagents to each of the above-dispensed blood sample detection structures, mixes the reagents with the blood sample, and completes the preparation of the blood sample for detection.

[0065] Step 8: At the capping position 6, the automatic capping device 601 of the blood collection tubes is used to cap the distributed blood collection tubes. The first robotic arm device 15 picks up the capped distributed blood collection tubes and places them in the first collection chamber 12 for disposal. The second robotic arm device 16 discards the used disposable suction tip into the first disposal chamber 13. Then, a new disposable suction tip is loaded onto the second robotic arm device 16 for later use. The blood collection tube conveyor belt 201 moves forward and sends a new blood collection tube into the blood collection tube alignment position 4. The instrument then repeats the same process for the new blood collection tube until all the blood collection tubes in the blood collection tube loading chamber 1 have been processed.

[0066] This invention provides an automated whole blood sample preparation instrument and its working method. Many methods and approaches exist for implementing this technical solution; the above description is merely a preferred embodiment of the invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention. All components not explicitly stated in this embodiment can be implemented using existing technologies.

Claims

1. An automated whole blood blood sample preparation instrument, characterized by, The device comprises a blood collection tube loading bin (1) for storing blood collection tubes to be processed, a blood collection tube conveying belt (201) arranged below the blood collection tube loading bin (1), a blood sample mixing device (202) matched with the blood collection tube conveying belt (201), a code scanner (203), a blood collection tube gravity automatic alignment device (5) at the end of the blood collection tube conveying belt, a blood collection tube alignment position (4), a cap screwing position (6), a first mechanical arm device (15), a second mechanical arm device (16), and a loading structure supporting a blood sample detection structure; the blood collection tube conveying belt (201) is a strip arranged symmetrically on both sides, and a plurality of separation baffles (204) are arranged on each blood collection tube conveying belt (201); for each blood collection tube conveying belt (201), the distance between two adjacent separation baffles (204) only allows one blood collection tube (101) to be placed; the blood collection tube (101) to be processed is placed in the blood collection tube loading bin (1) with the caps facing the same side, and the blood collection tubes can fall one by one horizontally between the two adjacent separation baffles (204) on the blood collection tube conveying belt (201) from the blood collection tube loading bin (1) and move along the conveying direction under the driving of the blood collection tube conveying belt (201) and the separation baffles (204); the blood collection tube conveying belt (201) drives the blood collection tube to rotate and mix under the cooperation of the blood sample mixing device (202), and the blood collection tube is transferred; the code scanner (203) is arranged above the conveying belt (201) to scan and identify the barcode on the rotating blood collection tube; after the blood sample is rotated and mixed, the blood collection tube falls into the blood collection tube alignment position (4) at the end of the blood collection tube conveying belt (201) in an alignment posture with the cap upward and the tail end downward under the joint action of gravity and the blood collection tube gravity automatic alignment device (5); the blood collection tube alignment position (4) and the cap screwing position (6) are the same station or two independent stations, and the first mechanical arm device (15) transfers the blood collection tube between the two independent stations; the cap screwing position (6) is provided with an automatic cap opening and closing device (601) for the blood collection tube; the whole blood sample in the blood collection tube with the cap opened on the cap screwing position (6) is sucked by a sample suction tip of the second mechanical arm device (16) and distributed to the blood sample detection structure on the loading structure; the preparation instrument automatically records the source of the whole blood sample of each blood sample detection structure distributed on the loading structure and the distributed reagent. The blood sample mixing device (202) comprises a mixing transmission belt, which is located in the middle of the blood collection tube conveying belt (201) and has an upper surface higher than the upper surface of the blood collection tube conveying belt (201) and lower than the top surface of the separation baffle (204); the mixing transmission belt and the blood collection tube conveying belt (201) are conveyed in the same direction at different speeds or are conveyed in opposite directions; when the mixing conveying belt continuously conveys, the blood collection tube located on the mixing conveying belt is driven to move synchronously with the mixing conveying belt by the friction between the blood collection tube and the mixing conveying belt, and finally rotates under the restriction of the separation baffle (204) close to the separation baffle (204), so as to realize the rotational mixing of the whole blood sample in the blood collection tube. The blood collection tube conveying belt (201) is higher on one side than on the other side, or the two sides are staggered in height, so that the whole blood sample rotates and flows in the axial direction of the blood collection tube during the conveying process to be fully mixed.

2. An automated whole blood sample preparation instrument according to claim 1, characterized in that The second mechanical hand device (16) comprises a sample extractor, and the sample suction tip is loaded on the sample extractor; the sample suction tip is a disposable liquid suction tip, and the disposable liquid suction tip is in communication with a sample suction channel in the sample extractor; the preparation instrument further comprises a first storage area (9) for storing unused disposable liquid suction tips, a first discard bin (13) for collecting used disposable liquid suction tips, and a first collection bin (12) for collecting discarded blood collection tubes; the first mechanical hand device (15) is further used for grabbing the blood collection tube with a completed distribution and a tube cap from the cap screwing position (6) to the first collection bin (12) for discarding, and grabbing the blood collection tube with an unqualified blood sample collection amount from the blood collection tube alignment position (4) to an unqualified sample position (21).

3. An automated whole blood sample preparation instrument according to claim 2, wherein, The preparation instrument further comprises one or more reagent distribution devices for distributing specific reagents in a blood sample detection structure for detection before or after the distribution of the whole blood sample.

4. An automated whole blood sample preparation instrument according to any one of claims 1 to 3, characterized in that The blood collection tube gravity automatic alignment device (5) is a transverse baffle extending outward from the end of the blood collection tube conveying belt (201) close to the end of the blood collection tube cap; the blood collection tube alignment position (4) is further provided with a blood collection tube groove (401) for receiving the blood collection tube, the blood collection tube groove (401) comprises a cylindrical pipeline segment and a horn segment connected above the cylindrical pipeline segment, and the large-diameter end of the horn segment faces upward; the alignment refers to adjusting the posture of the blood collection tube to a vertical posture with the tube cap end facing upward and the tube tail end facing downward.

5. The automated whole blood sample preparation instrument of any one of claims 2 to 3, wherein, When the blood collection tube righting position (4) and the cap screwing position (6) are two independent stations, the blood collection tube righting position (4) is provided with a blood collection tube liquid level position judging device for detecting the height of the blood sample, the blood collection tube liquid level position judging device comprises a light source (17) and a light signal detector (18), the light source (17) is used for irradiating the blood collection tube located in the blood collection tube righting position (4), and the light signal detector (18) is arranged at a position corresponding to the light source (17) at the same height and opposite to the light source (17), and is used for receiving the amount of light transmitted by the blood collection tube from the light emitted by the light source (17) located in the blood collection tube righting position (4), and the blood collection tube liquid level position judging device compares the amount of light transmitted with a preset threshold value, so as to judge whether the height of the blood sample in the blood collection tube located in the blood collection tube righting position (4) is qualified; When the blood collection tube righting position (4) and the cap screwing position (6) are the same station, the air pressure detection device is installed on the sample suction channel, and the air pressure detection device is used for measuring the negative pressure value formed when the disposable liquid suction tip is inserted into the blood collection tube to a preset height to perform sample suction, and the preparation instrument compares the negative pressure value with a preset negative pressure threshold value, so as to judge whether there is a blood sample at the preset height of the blood collection tube.

6. The automated whole blood sample preparation instrument according to any one of claims 1 to 3, characterized in that The loading structure is a sample cup holder (802) or a detection card loading disc (801); when the loading structure is the sample cup holder (802), the blood sample detection structure is a sample cup (702); when the loading structure is the detection card loading disc (801), the blood sample detection structure is a detection card (701); each sample cup holder (802) is used for loading an independent sample cup (702), or each sample cup holder (802) is used for simultaneously loading a plurality of sample cups (702), and the sample cup holder (802) is disc-shaped or strip-shaped.

7. An automated whole blood sample preparation instrument as defined in claim 6, characterized in that The preparation instrument The sample cup holder (802) or the detection card loading disc (801) loaded after distribution is provided with an identification code, the identification code records the patient information of the whole blood sample loaded in each specified position of each loading structure and the distributed reagent; the preparation instrument is also loaded with an identification reading device matched with the identification code, and the information of the original sample can be traced according to the identification code, and the identification code can also be identified at the analyzer end.

8. A method of operation of an automated whole blood sample preparation instrument, characterized by, The method is implemented by using the automatic whole blood sample preparation instrument according to claim 2, and the method comprises the following steps: Step 1. The blood collection tubes to be processed are placed horizontally in the blood collection tube loading bin (1), and the sampling tubes are placed flat in the blood collection tube loading bin (1) with the tube cap end on one side and the tube tail end on the other side; the blood collection tubes in the blood collection tube loading bin (1) fall onto the blood collection tube conveying belt (201) due to gravity and are separated by the separation baffles (204) provided on the blood collection tube conveying belt (201); the blood collection tubes move unidirectionally along the conveying direction with the blood collection tube conveying belt (201); in the process of unidirectional movement of the blood collection tubes along the conveying direction, the blood collection tubes are driven by the blood sample mixing device (202) and rotate under the obstruction of the separation baffles (204) on the blood collection tube conveying belt (201) to mix the blood sample, and the barcode on the wall of the blood collection tube is identified and recorded by the code scanner (203) during the rotation of the blood collection tube; Step 2. The blood collection tubes at the end of the blood collection tube conveying belt (201) fall from the horizontal state to the vertical state with the tube cap end upward and the tube tail end downward after leaving the blood collection tube conveying belt (201) under the combined action of gravity and the blood collection tube gravity automatic alignment device (5), and the blood collection tube alignment position (4) receives the blood collection tubes falling in the vertical state; Step 3: The first mechanical hand device (15) grabs the blood collection tubes at the blood collection tube alignment position (4) and sends them to the cap screwing position (6); Step 4: The blood collection tubes are vertically placed in the cap screwing position (6) with the tube cap end upward, and the cap screwing position (6) is provided with an automatic cap opening and closing device (601) for the blood collection tubes, which opens the cap of the blood collection tube and moves the cap away, so that the upper end of the blood collection tube is completely unobstructed; Step 5: The second mechanical hand device (16) drives the disposable liquid suction tip to extend into the blood collection tube in the cap screwing position (6) to suck; after the disposable liquid suction tip sucks the whole blood sample, the second mechanical hand device (16) drives the disposable liquid suction tip into a blood sample detection structure and distributes the sucked whole blood sample into the blood sample detection structure; according to the detection needs, the step is repeated to distribute the whole blood sample into more than one blood sample detection structure; Step 6: The instrument records or marks the loading structure loaded with the blood sample detection structure; the prepared sample can be used for detection; or, after the second mechanical hand device 16 distributes the blood sample, the reagent distribution device of the instrument adds reagents into each blood sample detection structure where the blood sample has been distributed, mixes the reagents with the blood sample, and completes the preparation of the blood sample for detection. Step 7: In the screwing position (6), the used blood collection tube is capped by the automatic capping device (601) for the blood collection tube, the capped used blood collection tube is grabbed by the first mechanical hand device (15) to the first collection bin (12) for disposal, the used disposable suction tip is disposed to the first disposal bin (13) by the second mechanical hand device (16), and then a new disposable suction tip is loaded on the second mechanical hand device (16) for use; the blood collection tube conveying belt (201) is conveyed forward, and a new blood collection tube is sent to the blood collection tube alignment position (4), and then the instrument processes the new blood collection tube according to the above process until all the blood collection tubes in the blood collection tube loading bin (1) are processed.

Images