Cell preparation aliquoting method and system

The automated cell preparation dispensing system solves the problems of low dispensing efficiency and accuracy caused by manual operation, realizes precise dispensing of cell preparations, improves dispensing efficiency and accuracy, and ensures treatment efficacy and timing.

WO2026032113A1PCT designated stage Publication Date: 2026-02-12BEIJING CELLBRI FUTURE BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
PCT/CN2025/111629
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-08-09
Filing Date
2025-07-30
Publication Date
2026-02-12

AI Technical Summary

Technical Problem

Existing cell preparation dispensing methods suffer from low dispensing efficiency and accuracy due to manual operation, and are susceptible to vibrations in pipelines and devices, affecting treatment efficacy and timing.

Method used

The automated cell preparation dispensing system includes a mixing device and an injection device. By precisely controlling the lever stroke of the injection device, the cell preparation can be accurately dispensed, avoiding the effects of manual operation and vibration.

Benefits of technology

It improves dispensing efficiency and accuracy, ensuring that the therapeutic effect of cell preparations and the timing of patient treatment are not affected, and avoids waste of cell preparations.

✦ Generated by Eureka AI based on patent content.

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Abstract

A cell preparation aliquoting method and system, the method comprises: controlling a mixing apparatus to perform a mixing operation on a cell preparation in a mixing bag to obtain a mixed cell preparation (101); controlling an injection apparatus to draw in the mixed cell preparation, and sequentially aliquoting the mixed cell preparation in the injection apparatus into each aliquot bag according to a preset aliquot volume (102). Since the entire process relies on automated machine control, it avoids low aliquoting efficiency and accuracy caused by manual operation. At the same time, controlling the injection apparatus to accurately aliquot the cell preparation into each aliquot bag according to the preset aliquot volume avoids using manual weighing for volume control, thereby avoiding the impact of vibrations from pipelines and other apparatuses on volume control, further improving aliquoting accuracy and ensuring that the therapeutic effect of the cell preparation and the timing of patient treatment are not affected.
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Description

Cell preparation dispensing method and system

[0001] The present application claims priority to the Chinese patent application No. 202411094286.4 filed on August 9, 2024, and entitled "Cell preparation dispensing method and system", the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present application relates to the technical field of dispensing, in particular to a cell preparation dispensing method and system. BACKGROUND

[0003] Cell preparation dispensing technology is an important part of the biological medical technology field and is crucial for cell therapy and pharmaceutical preparation.

[0004] The cell preparation cannot directly contact the sensor during dispensing, so the contact type sensor with high accuracy for directly detecting flow cannot be used to measure the volume of the dispensed cell preparation, resulting in that the main dispensing technology used in the market is to control the dispensing of the volume of the cell preparation by manually starting and stopping the peristaltic pump, weighing and manually recording.

[0005] The inventors realize that these dispensing methods, on the one hand, due to manual operation, result in low dispensing efficiency and dispensing accuracy, and on the other hand, due to manual weighing, are easily affected by the vibration of the pipeline and other devices, further reducing the dispensing accuracy. The reduction of the dispensing efficiency and the dispensing accuracy directly affects the therapeutic effect of the cell preparation and delays the treatment opportunity of the patient. SUMMARY

[0006] The present application provides a cell preparation dispensing method and system to solve the technical problem that the existing dispensing method, due to manual operation, results in low dispensing efficiency and dispensing accuracy, and due to manual weighing, is easily affected by the vibration of the pipeline and other devices, further reducing the dispensing accuracy, thereby directly affecting the therapeutic effect of the cell preparation and delaying the treatment opportunity of the patient.

[0007] In a first aspect, the present application provides a cell preparation dispensing method, comprising:

[0008] controlling a mixing device to mix the cell preparation in a mixing bag to obtain a mixed cell preparation;

[0009] controlling an injection device to inject the mixed cell preparation, and dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume.

[0010] In a second aspect, the present application provides a cell preparation dispensing system, comprising: a control module, a refrigerated mixing module and a dispensing module.

[0011] The control module, the refrigeration and mixing module, and the dispensing module are detachably connected in pairs;

[0012] The refrigeration and mixing module comprises a mixing device and a mixing bag;

[0013] The dispensing module comprises an injection device and a plurality of dispensing bags;

[0014] The control module is configured to:

[0015] control the mixing device to perform a mixing operation on the cell preparation in the mixing bag to obtain a mixed cell preparation;

[0016] control the injection device to inject the mixed cell preparation, and sequentially dispense the mixed cell preparation in the injection device into each of the dispensing bags according to a preset dispensing volume.

[0017] In a third aspect, an electronic device is provided, comprising a processor and a memory storing a computer program, wherein the processor executes the program to implement the steps of the cell preparation dispensing method of the first aspect.

[0018] The cell preparation dispensing method and system provided by the present application control the mixing device to perform a mixing operation on the cell preparation in the mixing bag to obtain a mixed cell preparation, and control the injection device to inject the mixed cell preparation, and sequentially dispense the mixed cell preparation in the injection device into each of the dispensing bags according to a preset dispensing volume. The present application first performs a mixing operation on the cell preparation, and then controls the injection device to sequentially dispense the mixed cell preparation into each of the dispensing bags after extracting the mixed cell preparation. Since the volume of gas and / or liquid in the injection device can be accurately controlled by controlling the stroke of the pull rod in the injection device, the volume of the cell preparation extracted by the injection device and the volume of the cell preparation dispensed into each of the dispensing bags can be accurately controlled during the dispensing process, thereby realizing accurate dispensing of the cell preparation in each of the dispensing bags. On the one hand, since the entire process is automatically controlled by machines, the low dispensing efficiency and dispensing accuracy caused by manual operation are avoided. On the other hand, the injection device accurately dispenses the cell preparation with a preset dispensing volume into each of the dispensing bags, avoiding the use of manual weighing to control the volume of the cell preparation, thereby avoiding the influence of pipeline and other device vibration on volume control, thereby further improving the dispensing accuracy. Under the conditions of improved dispensing efficiency and dispensing accuracy, the therapeutic effect of the cell preparation and the treatment opportunity of the patient can be ensured.

[0019] The details of one or more embodiments of the present application are set forth in the accompanying drawings and the description below. Other features and advantages of the present application will become apparent from the description, the drawings, and the claims. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings described below are some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0021] Fig. 1 is a flowchart of a cell preparation dispensing method according to an embodiment of the application;

[0022] Fig. 2 is a flowchart of a cell preparation dispensing method according to an embodiment of the application;

[0023] Fig. 3 is a flowchart of a cell preparation dispensing method according to an embodiment of the application;

[0024] Fig. 4 is a flowchart of a cell preparation dispensing method according to an embodiment of the application;

[0025] Fig. 5 is a flowchart of a cell preparation dispensing method according to an embodiment of the application;

[0026] Fig. 6 is a rotation coordinate diagram of the stopcock valves in a cell preparation dispensing system according to an embodiment of the application;

[0027] Fig. 7 is a structural diagram of a cell preparation dispensing system according to an embodiment of the application;

[0028] Fig. 8 is a structural diagram of an electronic device according to an embodiment of the application.

[0029] Reference signs: 1-first sterile filter; 2-second sterile filter; 3-third sterile filter; 4-pressure sensor; 5-visual identification area; 51-first area; 52-second area; 6-dispensing stopcock valve; 7-injection device stopcock valve; 8-first filtration stopcock valve; 9-second filtration stopcock valve; 10-first peristaltic pump; 11-first counting bag; 12-second counting bag; 13-first counting stopcock valve; 14-second counting stopcock valve; 15-fourth sterile filter; 16-second peristaltic pump; 17-first bubble sensor; 18-second bubble sensor; 19-fifth sterile filter; 20-liquid transfer stopcock valve. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solutions and advantages of the application clearer, the technical solutions in the application will be described clearly and completely below in combination with the drawings in the embodiments of the application. Obviously, the described embodiments are some embodiments of the application, but not all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the application.

[0031] It should be noted that in the description of the embodiments of the present application, the terms "comprising", "containing" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or further includes elements inherent to such a process, method, article or device. Without more limitations, the element defined by the statement "comprising a" does not exclude the presence of additional identical elements in the process, method, article or device comprising the element. The terms "upper", "lower" and the like indicate the orientation or positional relationship shown in the drawings, and are only used to facilitate the description of the present application and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. Unless otherwise specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be connected inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0032] The terms "first", "second", and the like used in the present application are used to distinguish similar objects, and are not used to describe a specific order or sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present application can be implemented in an order other than that illustrated or described herein, and the objects distinguished by "first", "second", etc. are generally of a kind and do not limit the number of objects, for example, the first object can be one or more. In addition, "and / or" means at least one of the connected objects, and the character " / ", generally indicates that the front and rear associated objects are in a "or" relationship.

[0033] Figure 1 is one of the flow schematic diagrams of the cell preparation dispensing method provided by the embodiments of the present application. Referring to Figure 1, the embodiments of the present application provide a cell preparation dispensing method, which can include:

[0034] 101, controlling the mixing device to mix the cell preparation in the mixing bag to obtain a mixed cell preparation;

[0035] 102, controlling the injection device to inject the mixed cell preparation, and dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume.

[0036] The mixed cell preparation in step 101 can be the cell preparation after mixing the current cell preparation, or the cell preparation after mixing the current cell preparation and other preparations.

[0037] In step 102, the injection device includes a syringe and a syringe pump, and the preset sub-packaging volume of each sub-packaging bag can be the same or different, which is not limited here, and the sub-packaging bag can be replaced by a sub-packaging tube.

[0038] Before the injection device injects the mixed cell preparation, the injection device can first extract the gas in each sub-packaging bag, and then inject the mixed cell preparation when the gas pressure in the sub-packaging pipeline is less than the first gas pressure threshold. If the volume of the gas extracted by the injection device at a time exceeds the preset volume, and the gas pressure in the sub-packaging pipeline is still greater than or equal to the first gas pressure threshold, the injection device is controlled to empty the gas in the injection device, and then continue to extract the gas in each sub-packaging bag until the gas pressure in the sub-packaging pipeline is less than the first gas pressure threshold, and then the injection device injects the mixed cell preparation, so as to achieve better sub-packaging effect.

[0039] It should be noted that in the case of replacing the sub-packaging bag with the sub-packaging tube, since it is difficult to extract the gas from the sub-packaging tube, it is not necessary to extract the gas in the sub-packaging tube and then judge the gas pressure in the sub-packaging pipeline, and step 102 can be directly executed.

[0040] The cell preparation sub-packaging method provided in the embodiment controls the mixing device to mix the cell preparation in the mixing bag to obtain the mixed cell preparation, controls the injection device to inject the mixed cell preparation, and sub-packs the mixed cell preparation in the injection device into each sub-packaging bag according to the preset sub-packaging volume. The embodiment first mixes the cell preparation, and then controls the injection device to extract the mixed cell preparation and sub-pack it into each sub-packaging bag. Since the volume of the gas and / or liquid in the injection device can be accurately controlled by controlling the stroke of the pull rod in the injection device, the volume of the cell preparation extracted by the injection device and the volume of the cell preparation sub-packed into each sub-packaging bag can be accurately controlled during the sub-packaging process, so that the cell preparation in each sub-packaging bag can be accurately sub-packaged. On the one hand, since the whole process is automatically controlled by the machine, the low sub-packaging efficiency and low sub-packaging accuracy caused by manual operation are avoided. On the other hand, the injection device accurately sub-packs the preset sub-packaging volume of the cell preparation into each sub-packaging bag, which avoids the volume control of the cell preparation by manual weighing, so that the influence of the vibration of the pipeline and other devices on the volume control is avoided, thereby further improving the sub-packaging accuracy. In the case of improving the sub-packaging efficiency and sub-packaging accuracy, the treatment effect of the cell preparation and the treatment time of the patient can be ensured.

[0041] Further, in the conventional split method, the cell preparation is subjected to contact treatment, and it is difficult to ensure the sterility of the split consumables, and the integrity and activity of the cell preparation can be damaged during the split process. In the embodiment, the cell preparation is not subjected to contact treatment during the split process, and the sterility of the consumables can be ensured by using the anti-pollution injection device, and the integrity and activity of the cell preparation are not affected.

[0042] FIG. 2 is a flowchart of a cell preparation split method according to an embodiment of the present application. Referring to FIG. 2, in one embodiment, after the mixed cell preparation in the injection device is split into each split bag according to the preset split volume, the method can include:

[0043] 201, controlling the injection device to empty the residual cell preparation in the split pipeline;

[0044] The split pipeline is a pipeline between the injection device and each split bag;

[0045] 202, controlling the injection device to empty the gas in each split bag.

[0046] Step 201 is specifically as follows:

[0047] 201a, controlling the injection device to draw external air;

[0048] 201b, controlling the injection device to inject the drawn external air into the split pipeline;

[0049] 201c, if the volume of the external air injected at one time is less than the first volume threshold, returning to step 201a and controlling the injection device to inject the drawn external air into the split pipeline again until the volume of the cumulative injected external air reaches the first volume threshold, so as to empty the residual cell preparation in the split pipeline into each split bag.

[0050] In step 201b to step 201c, the injection device can be controlled to inject the extracted ambient air into the sub-packaging pipeline according to the preset gas volume of each sub-packaging bag in sequence, so as to push the residual cell preparation in the sub-packaging pipeline into each sub-packaging bag in sequence by using the pressure of the preset gas volume of ambient air. For example, the first preset gas volume of ambient air is first injected into the sub-packaging pipeline by controlling the injection device, and part of the residual cell preparation in the sub-packaging pipeline is pushed into the first sub-packaging bag corresponding to the first preset gas volume by using the pressure of the first preset gas volume of ambient air. Then, the second preset gas volume of ambient air is injected into the sub-packaging pipeline by controlling the injection device, and part of the residual cell preparation in the sub-packaging pipeline is pushed into the second sub-packaging bag corresponding to the second preset gas volume by using the pressure of the second preset gas volume of ambient air. In this way, the injection of ambient air in the injection device into the sub-packaging pipeline is continued until all the ambient air in the injection device is injected into the sub-packaging pipeline. At this time, if the total amount of ambient air injected into the sub-packaging pipeline is insufficient, the injection device is controlled to continuously extract and inject ambient air into the sub-packaging pipeline, so that the extracted ambient air can continuously provide pressure, so as to push all the residual cell preparation in the sub-packaging pipeline into each sub-packaging bag as much as possible, thereby avoiding waste of the cell preparation in the sub-packaging pipeline.

[0051] It should be noted that, in the process of controlling the injection device to sub-packaging the mixed cell preparation in the injection device into each sub-packaging bag according to the preset sub-packaging volume, the preset sub-packaging volume corresponding to each sub-packaging bag is slightly smaller than the required product specification volume, so as to ensure that, after the residual cell preparation is added into each sub-packaging bag, the error between the total volume of the cell preparation and the required product specification volume is within an acceptable range.

[0052] In step 202, since a certain amount of ambient air is also injected into each sub-packaging bag in the process of emptying the residual cell preparation in the sub-packaging pipeline, the gas in each sub-packaging bag also needs to be emptied to form a cell preparation product that meets the standard.

[0053] Further, the injection device can also be controlled to empty the residual cell preparation in the mixing pipeline, which is the pipeline between the mixing bag and the injection device, as follows:

[0054] 1. Control the injection device to empty the residual cell preparation in the injection device into the mixing bag;

[0055] 2. Control the injection device to extract ambient air;

[0056] 3. Control the injection device to inject the extracted ambient air into the mixing pipeline;

[0057] 4. If the volume of the ambient air injected in one time is less than the second volume threshold, return to step 2, and control the injection device to inject the extracted ambient air into the mixing pipeline again until the volume of the accumulated injected ambient air reaches the second volume threshold, so as to empty the residual cell preparation in the mixing pipeline into the mixing bag.

[0058] In step 1, after the cell preparation is divided, there is residual cell preparation in the injection device, which needs to be emptied into the mixing bag to avoid waste of the residual cell preparation in the injection device.

[0059] In steps 3 to 4, the injection device is controlled to inject the extracted ambient air into the mixing pipeline, which can use the pressure of the ambient air to push the residual cell preparation in the mixing pipeline into the mixing bag, and continuously extract and inject the ambient air into the mixing pipeline when the ambient air is insufficient, so as to ensure that the extracted ambient air can form a continuous pressure to push all the residual cell preparation in the mixing pipeline into the mixing bag as much as possible, avoiding waste of the cell preparation in the mixing pipeline.

[0060] The embodiment controls the injection device to continuously extract ambient air and inject the ambient air into the mixing pipeline and the division pipeline respectively, so as to empty the residual cell preparation in the mixing pipeline and the residual cell preparation in the division pipeline into the mixing bag and the respective division bags, realizes recycling of the residual cell preparation, and avoids waste of the residual cell preparation.

[0061] FIG. 3 is a third flowchart of the cell preparation division method provided by the embodiment of the application. Referring to FIG. 3, in an embodiment, the control of the injection device to empty the gas in the respective division bags can include:

[0062] 301. Control the injection device to empty the residual gas in itself;

[0063] 302. Control the injection device to exhaust the pre-exhausted division bag in the respective division bags;

[0064] 303. Control the injection device to empty the gas in the respective pre-exhausted division bags according to different exhaust effects.

[0065] In step 301, during the control of the injection device to empty the residual cell preparation in the division pipeline, the injection device continuously performs the gas extraction and exhaust operation, and therefore some residual gas exists therein, which needs to be emptied before the gas in the respective division bags is exhausted, so as to better exhaust the gas in the division bags in the subsequent operation.

[0066] In step 302, the respective division bags do not necessarily need to be exhausted, but only the pre-exhausted division bag that needs to be exhausted needs to be exhausted after a certain preset period.

[0067] In step 303, the pre-venting bags can be adjusted according to the venting effect identified by the visual recognition device.

[0068] In this embodiment, the residual gas in the injection device is first emptied, and then the injection device is controlled to vent the pre-venting bags, and the pre-venting bags are adjusted according to the venting effect, so as to maximize the emptying of the gas in the pre-venting bags, while avoiding the cell preparation in the pre-venting bags being sucked back into the filling pipeline during the venting process, and increasing the residual cell preparation in the filling pipeline.

[0069] In one embodiment, the control of the injection device to vent the pre-venting bags can include:

[0070] The injection device is controlled to extract the gas in the pre-venting bags at a preset gas flow rate. If the sensor at the liquid outlet of the target pre-venting bag does not detect liquid within a preset time period, the injection device is controlled to empty the residual gas in the injection device, and the injection device is controlled to extract the gas in the target pre-venting bag at a preset gas flow rate until the sensors at the liquid outlets of all the pre-venting bags detect liquid within a preset time period.

[0071] The preset gas flow rate changes according to the number of pre-venting bags with unvented gas, and the target pre-venting bag is any one of the pre-venting bags.

[0072] First, the moving speed of the pull rod of the injection device is controlled to control the injection device to extract the gas in the pre-venting bags at a preset initial gas flow rate. If the sensor at the liquid outlet of any pre-venting bag detects liquid within a preset time period, it means that the gas in the pre-venting bag can be considered to have been vented, and the number of pre-venting bags with unvented gas is reduced by 1. Then, the moving speed of the pull rod of the injection device is controlled to control the injection device to adjust the initial gas flow rate to another preset gas flow rate corresponding to the current number of pre-venting bags with unvented gas, and the gas in the pre-venting bags with unvented gas is extracted at the preset gas flow rate. In this way, the preset gas flow rate is continuously adjusted according to the current number of pre-venting bags with unvented gas, and the gas in the remaining pre-venting bags with unvented gas is extracted at the adjusted preset gas flow rate.

[0073] If the injection device has been filled with gas and any sensor does not detect liquid within the preset time period, it indicates that a single gas extraction is not enough to empty all the gas in the pre-evacuation sub-packaging bags, so the gas extracted in the injection device needs to be emptied, and then the gas in the pre-evacuation sub-packaging bag corresponding to the sensor is extracted again at the preset gas flow rate until all the sensors detect liquid within the preset time period, indicating that the gas in the pre-evacuation sub-packaging bags can be considered to have been emptied.

[0074] In addition, the injection device can also control the evacuation of the pre-evacuation sub-packaging bags in the sub-packaging bags in another way, as follows:

[0075] If the gas pressure in the sub-packaging pipeline is greater than the second gas pressure threshold, return to the step of controlling the injection device to empty the residual gas in the injection device, and then control the injection device to extract the gas in the pre-evacuation sub-packaging bags in the sub-packaging bags again until the gas pressure in the sub-packaging pipeline reaches the second gas pressure threshold.

[0076] If the gas pressure in the sub-packaging pipeline is still greater than the second gas pressure threshold when the injection device has been filled with gas, it indicates that a single gas extraction is not enough to empty all the gas in the pre-evacuation sub-packaging bags, so the gas extracted in the injection device needs to be emptied, and then the gas in the pre-evacuation sub-packaging bags is extracted again until the gas pressure in the sub-packaging pipeline reaches the second gas pressure threshold, indicating that the gas in the pre-evacuation sub-packaging bags can be considered to have been emptied.

[0077] The embodiment provides a flexible evacuation scheme. The preset gas flow rate can be adjusted according to the number of pre-evacuation sub-packaging bags participating in the evacuation during the extraction of the gas in the pre-evacuation sub-packaging bags to extract the gas in the pre-evacuation sub-packaging bags that has not been evacuated, thereby achieving efficient evacuation of the gas in the pre-evacuation sub-packaging bags and as much emptying as possible. The gas pressure in the sub-packaging pipeline can be monitored to determine the evacuation stop time by comparing it with the second gas pressure threshold, thereby achieving as much emptying as possible of the gas in the pre-evacuation sub-packaging bags.

[0078] In one embodiment, controlling the injection device to empty the gas in the pre-evacuation sub-packaging bags according to different evacuation effects can include:

[0079] If the cell preparation in the target pre-evacuation sub-packaging bag does not form a liquid column outside the liquid outlet of the target pre-evacuation sub-packaging bag, the injection device extracts the gas in the target pre-evacuation sub-packaging bag until the highest point of the liquid column formed by the cell preparation in the target pre-evacuation sub-packaging bag is in the sensor corresponding to the liquid outlet;

[0080] If the highest point of the liquid column formed by the cell preparation in the target pre-evacuation sub-pack is higher than the sensor at the liquid outlet of the target pre-evacuation sub-pack, the injection device is controlled to inject gas into the target pre-evacuation sub-pack until the highest point of the liquid column is in the sensor;

[0081] If the highest point of the liquid column formed by the cell preparation in the target pre-evacuation sub-pack is lower than the sensor at the liquid outlet of the target pre-evacuation sub-pack, the injection device is controlled to extract gas from the target pre-evacuation sub-pack until the highest point of the liquid column is in the sensor;

[0082] If the highest point of a part of the liquid column formed by the cell preparation in the target pre-evacuation sub-pack is higher than the sensor at the liquid outlet of the target pre-evacuation sub-pack, and the highest point of another part of the liquid column is lower than the sensor, the injection device is controlled to inject gas into the target pre-evacuation sub-pack, and then the injection device is controlled to extract gas from the target pre-evacuation sub-pack until the highest point of the liquid column is in the sensor.

[0083] The target pre-evacuation sub-pack is any one of the pre-evacuation sub-packs.

[0084] When the pre-evacuation sub-packs are evacuated, although the gas in the pre-evacuation sub-packs is confirmed to be completely evacuated by detecting the liquid with the gas pressure or the sensor as the end point of evacuation, in practice, due to the existence of unavoidable detection errors, some pre-evacuation sub-packs may still not be completely evacuated, so further operation is needed to ensure that the gas in each pre-evacuation sub-pack is completely evacuated.

[0085] Since the product packaging of the sub-packs is generally performed on the sub-pack branch away from the liquid outlet side of the sub-pack for the convenience of subsequent extraction and use of the cell preparation, the cell preparation in the sub-pack can be appropriately extracted to the corresponding sub-pack branch, and the gas evacuation in the sub-pack is further confirmed and processed according to the comparison of the sensor arranged on the sub-pack branch between each liquid outlet and the packaging port and the liquid column height formed by the extracted cell preparation on the sub-pack branch, so as to ensure that the gas in the sub-pack is completely evacuated and the cell preparation in the sub-pack branch is not left.

[0086] According to the evacuation effect identified by the visual recognition device, the gas extraction and / or gas injection operation can be continued for each pre-evacuation sub-pack:

[0087] 1、If the liquid column formed by the cell preparation in any pre-evacuation sub-pack is not outside the liquid outlet of the pre-evacuation sub-pack, it indicates that there is still gas in the pre-evacuation sub-pack that has not been evacuated. At this time, the injection device needs to be controlled to extract the gas in the pre-evacuation sub-pack until the highest point of the liquid column formed by the cell preparation in the pre-evacuation sub-pack is in the sensor corresponding to the liquid outlet, ensuring that the height of the liquid column does not exceed the packaging port, so as to avoid the cell preparation entering the sub-packaging pipeline and causing the waste of the cell preparation.

[0088] 2、If the highest point of the liquid column formed by the cell preparation in any pre-evacuation sub-pack is higher than the sensor at the liquid outlet of the pre-evacuation sub-pack, it indicates that the gas in the pre-evacuation sub-pack has been evacuated and the height of the liquid column may exceed the packaging port. At this time, the injection device needs to be controlled to inject gas into the pre-evacuation sub-pack to lower the height of the liquid column until the highest point of the liquid column is in the sensor, while avoiding the re-entry of gas into the pre-evacuation sub-pack and the entry of the cell preparation into the sub-packaging pipeline, which causes the waste of the cell preparation.

[0089] 3、If the highest point of the liquid column formed by the cell preparation in any pre-evacuation sub-pack is lower than the sensor at the liquid outlet of the pre-evacuation sub-pack, it indicates that the gas in the pre-evacuation sub-pack has been evacuated, but there is still gas in the corresponding sub-packaging branch that has not been evacuated. Since the sub-packaging branch also belongs to the part of the finished product packaging, the injection device needs to be controlled to extract the gas in the sub-packaging branch until the highest point of the liquid column is in the sensor, ensuring that the height of the liquid column does not exceed the packaging port, so as to avoid the cell preparation entering the sub-packaging pipeline and causing the waste of the cell preparation.

[0090] 4、If the highest point of part of the liquid column formed by the cell preparation in any pre-evacuation sub-pack is higher than the sensor at the liquid outlet of the pre-evacuation sub-pack, and the highest point of the other part of the liquid column is lower than the sensor, it indicates that the height of the liquid column may exceed the packaging port and there is still gas in the corresponding sub-packaging branch that has not been evacuated. At this time, the injection device needs to be controlled to inject gas into the pre-evacuation sub-pack to lower the height of the liquid column that is too high, and then control the injection device to extract the gas in the pre-evacuation sub-pack to extract the gas in the sub-packaging branch, until the highest point of all the liquid columns is in the sensor, while avoiding the re-entry of gas into the pre-evacuation sub-pack and the entry of the cell preparation into the sub-packaging pipeline, which causes the waste of the cell preparation.

[0091] It should be noted that during the above gas extraction and gas injection process, the visual recognition device identifies the effect of gas extraction and gas injection in real time, so that the amount of injected gas and the amount of extracted gas can be adjusted in real time according to the effect, so that the highest point of the liquid column formed by the cell preparation in each pre-evacuation sub-pack can be quickly adjusted to the corresponding sensor.

[0092] The embodiment can adjust the liquid column highest point according to the position relationship between the liquid column highest point formed by the cell preparation in the pre-evacuation sub-packaging bag identified by the visual recognition device and the sensor arranged on the sub-packaging branch between each liquid outlet and the packaging port, by injecting gas and / or extracting gas, so that the highest point is located in the sensor, thereby further ensuring that the gas in each pre-evacuation sub-packaging bag is evacuated without affecting the volume of the cell preparation after packaging of the finished product. The whole process can avoid the re-entry of gas into the pre-evacuation sub-packaging bag and the entry of cell preparation into the sub-packaging pipeline to cause cell preparation residue, resulting in waste of cell preparation.

[0093] In one embodiment, the control of the injection device to inject the mixed cell preparation can include:

[0094] The control of the injection device to extract the mixed cell preparation, the control of the visual recognition device to identify whether the injection device is filled with the mixed cell preparation in real time, if not, the control of the injection device to inject the gas-liquid mixture in the injection device to the mixing bag, and then returning to the step of controlling the injection device to extract the mixed cell preparation until the injection device is filled with the mixed cell preparation.

[0095] During the extraction of the cell preparation, the gas in the mixing pipeline can also be extracted into the injection device, resulting in that the injection device is not filled with the cell preparation when the stroke of the pull rod of the injection device is fully extended. Therefore, when the visual recognition device identifies this problem, the gas-liquid mixture in the injection device needs to be pushed out to the mixing bag, and then the mixed cell preparation is extracted again until the injection device is filled with the mixed cell preparation. At this time, the stroke of the pull rod of the injection device is in the fully extended state, and the volume of the mixed cell preparation in the injection device reaches the maximum volume of the injection device.

[0096] The embodiment can accurately identify the extraction of the mixed cell preparation by the injection device through the visual recognition device, and re-extract the mixed cell preparation when the injection device is not filled with the mixed cell preparation, so as to ensure that the injection device is filled with the mixed cell preparation, improve the subsequent sub-packaging efficiency, and reduce the subsequent evacuation burden.

[0097] In one embodiment, the mixed cell preparation in the injection device can be sequentially sub-packaged into each sub-packaging bag according to the preset sub-packaging volume, which can include:

[0098] The control of the injection device to sequentially inject the mixed cell preparation into the corresponding sub-packaging bag according to the preset sub-packaging volume of each sub-packaging bag;

[0099] If the volume of the mixed cell preparation in a single injection is not enough to complete the preset volume of each sub-packaging bag, the step of extracting the mixed cell preparation by the control injection device is returned, and the mixed cell preparation is injected into the corresponding sub-packaging bag according to the preset volume of each sub-packaging bag by the control injection device again until the volume of the mixed cell preparation accumulated by the injection is enough to complete the preset volume of each sub-packaging bag.

[0100] The injection device can be selected according to the actual total volume of the sub-packaging. If the total volume is large, a small injection device is selected, and if the total volume is large, a large injection device is selected. When the mixed cell preparation is injected into each sub-packaging bag in turn, the preset volume of each sub-packaging bag can be accurately controlled by the control injection device, thereby improving the sub-packaging efficiency and accuracy.

[0101] During the sub-packaging process, if the volume of the mixed cell preparation in any sub-packaging bag does not reach the corresponding preset volume when the mixed cell preparation in the injection device is completely injected, the mixed cell preparation needs to be continuously extracted and injected into the sub-packaging bag until the volume of the mixed cell preparation in each sub-packaging bag reaches the corresponding preset volume.

[0102] The embodiment according to the preset volume of each sub-packaging bag, the mixed cell preparation is sub-packaged in each sub-packaging bag, and the mixed cell preparation is continuously extracted by the control injection device and injected into each sub-packaging bag, so that the mixed cell preparation in each sub-packaging bag reaches the corresponding preset volume, thereby improving the sub-packaging accuracy.

[0103] FIG. 4 is a flowchart of a cell preparation sub-packaging method according to an embodiment of the present application. Referring to FIG. 4, in an embodiment, the control of the mixing device to mix the cell preparation in the mixing bag can include:

[0104] 401. Control the mixing device to mix the mixing bag according to the preset mixing parameters to obtain the mixed cell preparation;

[0105] 402. Control the first peristaltic pump to pump the mixed cell preparation into the counting bag for manual cell counting or into the counting device for automatic cell counting;

[0106] 403. Control the first peristaltic pump to pump the mixed cell preparation after cell counting back to the mixing bag to continue mixing.

[0107] In step 401, the preset mixing parameters can include mixing frequency, mixing amplitude, mixing speed, mixing time, etc. The mixing device can be controlled to squeeze or pat the mixing bag according to these parameters, so that the cell preparation in the mixing bag flows upward and then sinks, thereby achieving the mixing effect. The preset mixing parameters can be adjusted according to the volume of the cell preparation in the mixing bag to achieve better mixing effect.

[0108] In the above steps, the homogenization operation can be performed first, then stopped, and the homogenized cell preparation is extracted for cell counting, and the homogenized cell preparation after cell counting is pumped back to the homogenization bag, and the homogenization operation is restarted, and the cycle is repeated; or the homogenization operation can be performed without stopping, and the homogenized cell preparation is extracted for cell counting while the homogenization operation is performed, and the homogenized cell preparation after cell counting is pumped back to the homogenization bag for continuous homogenization, which is not limited here.

[0109] In the homogenization cycle operation of the embodiment, on the one hand, by combining the cell counting of the homogenized cell preparation, the homogenization effect can be verified, and the uniformity of the cell preparation is continuously detected, and on the other hand, by manual counting and automatic counting, diversified counting methods can be provided for selection to meet different counting needs.

[0110] FIG. 5 is a flowchart of a cell preparation dispensing method according to an embodiment of the present application. Referring to FIG. 5, in an embodiment, before the homogenization device is controlled to perform homogenization operation on the cell preparation in the homogenization bag, the method can include:

[0111] 501, liquid preparation is performed on the cell preparation in the sample bag to obtain a liquid-prepared cell preparation;

[0112] 502, control the liquid-prepared cell preparation to enter the homogenization preparation process.

[0113] In step 501, if it is determined that the cell preparation in the sample bag needs to be liquid-prepared, liquid preparation is performed on the cell preparation in the sample bag to obtain a liquid-prepared cell preparation.

[0114] Step 502 specifically includes:

[0115] 502a, control the second peristaltic pump to empty the gas in the transfer liquid pipeline;

[0116] The transfer liquid pipeline is a pipeline between the sample bag and the homogenization bag;

[0117] 502b, control the refrigeration device to perform temperature reduction operation on the environment temperature of the homogenization bag;

[0118] 502c, control the second peristaltic pump to pump the liquid-prepared cell preparation in the sample bag into the homogenization bag;

[0119] 502d, control the second peristaltic pump to empty the residual cell preparation in the transfer liquid pipeline into the homogenization bag.

[0120] In step 502a, emptying the gas in the transfer liquid pipeline can avoid the gas from being brought into the homogenization bag when the cell preparation in the sample bag is transferred to the homogenization bag through the transfer liquid pipeline, which can prevent the homogenization bag from being blown open.

[0121] In step 502b, the refrigeration is performed in a compressor refrigeration mode according to the preset refrigeration parameter, so as to reduce the environment temperature of the mixing bag to the preset temperature. The environment temperature includes the temperature of the refrigeration plate in the refrigeration device and the temperature of the space where the mixing bag is located. The refrigeration plate is attached to the mixing bag to ensure the mixing temperature of the mixing bag in a concentrated refrigeration mode. Further, the refrigeration plate and the surrounding device can be separated by a heat insulation layer, so that the energy is not dissipated outward, further ensuring the mixing temperature of the mixing bag.

[0122] In step 502c, during the process of transferring the cell preparation to the mixing bag after the liquid preparation, the liquid entering amount into the mixing bag is monitored in real time, and the liquid entering is stopped when the cumulative liquid entering amount reaches the preset liquid entering amount, and the mixing operation is performed; or the mixing operation is started as soon as the cell preparation enters the mixing bag, that is, the liquid entering and the mixing operation are performed at the same time. During the liquid entering process, the liquid entering speed can be adjusted according to the liquid entering amount, and during the mixing process, the preset mixing parameter of the mixing device can be adjusted according to the liquid entering amount, so as to achieve better mixing effect.

[0123] In step 502d, the waste of the cell preparation can be avoided by emptying the residual cell preparation in the transfer pipeline into the mixing bag.

[0124] Further, if it is determined that the cell preparation in the sample bag does not need to be prepared, the sample bag can be directly used as the mixing bag for the temperature reduction operation of the environment temperature, and the subsequent mixing operation is performed, without the need for the operations of the gas emptying of the transfer pipeline, the liquid transferring, and the residual cell preparation emptying of the transfer pipeline.

[0125] The embodiment adaptively performs the processing before the mixing operation according to whether the cell preparation in the sample bag needs to be prepared, so as to ensure that the subsequent mixing operation can be smoothly performed in any case.

[0126] FIG. 6 is a rotation coordinate diagram of each cock valve in the cell preparation split charging system provided by the embodiment of the application, in which the arrow represents the rotation coordinate direction of the cock valve;

[0127] FIG. 7 is a structural schematic diagram of the cell preparation split charging system provided by the embodiment of the application.

[0128] Referring to FIG. 7, the embodiment of the application provides a cell preparation split charging system, which can include a control module, a refrigeration and mixing module, and a split charging module.

[0129] The control module, the refrigeration and mixing module, and the split charging module are detachably connected in pairs.

[0130] The refrigeration and mixing module includes a mixing device and a mixing bag.

[0131] The split charging module includes an injection device and a plurality of split charging bags.

[0132] The control module is configured to:

[0133] The control mixing device mixes the cell preparation in the mixing bag to obtain a mixed cell preparation;

[0134] The injection device injects the mixed cell preparation, and the mixed cell preparation in the injection device is sequentially distributed to each distribution bag according to a preset distribution volume.

[0135] The control module includes a central processing unit, a control circuit and an acquisition circuit; the injection device and the plurality of distribution bags of the distribution module are sequentially connected to the distribution pipeline, the first sterile filter 1 is further connected to one end of the distribution pipeline close to the injection device, the second sterile filter 2 and the third sterile filter 3 are further connected to one end of the distribution pipeline away from the injection device, and the three sterile filters can ensure the sterile environment in the distribution pipeline.

[0136] The first sterile filter 1 and the third sterile filter 3 are respectively in communication with the outside air, the second sterile filter 2 is connected to the acquisition circuit of the control module through the pressure sensor 4, the pressure sensor 4 can monitor the pressure in the distribution pipeline in real time and transmit the pressure to the acquisition circuit, the central processing unit of the control module receives the pressure collected by the acquisition circuit and other input instructions, processes the information and transmits it to the control circuit, and the control circuit controls other modules according to the processed information.

[0137] Before distribution, the injection device can be controlled to perform gas extraction or gas injection on the distribution pipeline to reduce or increase the pressure in the distribution pipeline, the control module collects the pressure in the distribution pipeline through the pressure sensor 4 and compares it with a threshold value to detect the airtightness of the distribution pipeline, so as to ensure the smooth progress of subsequent distribution.

[0138] The system further includes a visual recognition device, and the visual recognition area 5 of the device includes a first area 51 and a second area 52; after the distribution module receives the distribution instruction issued by the control module, the visual recognition device or the internal sensor of the distribution module identifies or detects whether each consumable in the distribution module is in place, whether there is residual cell preparation in the distribution pipeline, and whether the sterile connection pipe is twisted off, etc., to ensure that there is no abnormality in the distribution module.

[0139] In the distribution module, a distribution stopcock valve 6 is arranged at the connection between the distribution main pipeline and each distribution branch pipeline, an injection device stopcock valve 7 is arranged at the connection between the distribution main pipeline and the injection device branch pipeline, a first filter stopcock valve 8 is arranged at the connection between the distribution main pipeline and the first sterile filter 1, and a second filter stopcock valve 9 is arranged at the common connection between the distribution main pipeline and the second sterile filter 2 and the third sterile filter 3.

[0140] Referring to FIG. 6, before the injection device is controlled to extract the gas in each sub-packaging bag, the second filter stopcock valve 9 can be turned to position 5 to connect the sub-packaging pipeline and the pressure sensor 4, and the injection device stopcock valve 7 can be turned to position 7 to connect the sub-packaging pipeline and the injection device; when the gas pressure in the sub-packaging pipeline is less than the first gas pressure threshold, each sub-packaging stopcock valve 6 is turned to position 5 to help reduce the overall time of the subsequent gas extraction step; if it is necessary to continue to extract the gas, the injection device stopcock valve 7 is turned to position 3, the first filter stopcock valve 8 is turned to position 7 to connect the first sterile filter 1 and the injection device, which facilitates the extraction of the gas in the injection device to the outside of the system, and then the injection device stopcock valve 7 is turned to position 7 to continue to extract the gas in each sub-packaging bag until the gas pressure in the sub-packaging pipeline is less than the first gas pressure threshold.

[0141] Before the injection device is controlled to be filled with the mixed cell preparation, the first filter stopcock valve 8 is turned to position 5, and the injection device stopcock valve 7 is turned to position 3 to connect the mixed bag and the injection device.

[0142] Before the mixed cell preparation in the injection device is sub-packaged into each sub-packaging bag according to the preset sub-packaging volume, the injection device stopcock valve 7 is turned to position 7 to connect the sub-packaging pipeline and the injection device, each sub-packaging stopcock valve 6 is turned to position 3 from left to right for sub-packaging, and after the sub-packaging is completed, each sub-packaging stopcock valve 6 is turned to position 5.

[0143] After the sub-packaging step is completed, the first filter stopcock valve 8 is turned to position 7 to connect the first sterile filter 1 and the injection device, which facilitates the extraction of the gas in the injection device; the injection device stopcock valve 7 is turned to position 7 to connect the sub-packaging pipeline and the injection device, each sub-packaging stopcock valve 6 is turned to position 3 from left to right, the injection device is controlled to inject the extracted external air into the sub-packaging pipeline to empty the residual cell preparation in the sub-packaging pipeline into each sub-packaging bag, and after the emptying is completed, each sub-packaging stopcock valve 6 is turned to position 5.

[0144] After the residual cell preparation in the sub-packaging pipeline is emptied, the injection device stopcock valve 7 is turned to position 3, the first filter stopcock valve 8 is turned to position 7 to connect the first sterile filter 1 and the injection device, which facilitates the extraction of the gas in the injection device to the outside of the system; the injection device stopcock valve 7 is turned to position 7 to connect the sub-packaging bag and the injection device, and the sub-packaging stopcock valve corresponding to the pre-exhaustion sub-packaging bag is turned to position 1, and the remaining sub-packaging stopcock valves are turned to position 5 to balance the pressure in the sub-packaging pipeline, and then the pre-exhaustion sub-packaging bags can be exhausted in two ways:

[0145] 1. The injection device is controlled to extract the gas in each pre-exhaustion sub-packaging bag, whether each pre-exhaustion sub-packaging bag is completed to be exhausted is determined according to the comparison between the gas pressure and the threshold, when the gas pressure in the sub-packaging pipeline reaches the second gas pressure threshold, the sub-packaging stopcock valves corresponding to all the pre-exhaustion sub-packaging bags are turned to position 5, and the exhaustion is completed.

[0146] 2. Controlling the injection device to extract the gas in the pre-evacuation sub-packaging bag according to the preset gas flow rate, a sensor is arranged on the first area 51 of the visual identification device, which can be a bubble sensor, and whether the liquid is detected by the bubble sensor is used to determine whether the pre-evacuation sub-packaging bag is completed evacuation, and the sub-packaging cock valve corresponding to the pre-evacuation sub-packaging bag is turned to No. 5 position until all the sub-packaging cock valves corresponding to the pre-evacuation sub-packaging bag are turned to No. 5 position, and the evacuation is completed.

[0147] After the evacuation step is completed, the gas in each pre-evacuation sub-packaging bag is emptied according to the evacuation effect, and then the next round of sub-packaging can be carried out. Another same sub-packaging module is connected through the sterile connecting pipe machine at the position of the pipeline before the first filter cock valve 8, and similar sub-packaging operation is carried out on the newly connected sub-packaging module in the next round of sub-packaging.

[0148] In addition, the residual cell liquid in the mixing pipeline can also be emptied at appropriate time by the following method:

[0149] The first filter cock valve 8 is turned to No. 5 position, and the injection device cock valve 7 is turned to No. 3 position to connect the mixing bag and the injection device, so as to control the injection device to empty the residual cell preparation in the injection device into the mixing bag; the first filter cock valve 8 is turned to No. 7 position to connect the first sterile filter 1 and the injection device, so as to facilitate the injection device to extract external gas; the first filter cock valve 8 is turned to No. 5 position to connect the mixing bag and the injection device, and control the injection device to inject the extracted external air into the mixing pipeline, so as to empty the residual cell preparation in the mixing pipeline into the mixing bag.

[0150] The cell preparation sub-packaging system provided by the embodiment can mix the cell preparation first, and then control the injection device to extract the mixed cell preparation and sub-packaging into each sub-packaging bag in turn. Since the volume of the gas and / or liquid in the injection device can be accurately controlled by controlling the stroke of the pull rod in the injection device, the volume of the cell preparation extracted by the injection device and the volume of the cell preparation sub-packaged into each sub-packaging bag can be accurately controlled during the sub-packaging process, so that the cell preparation in each sub-packaging bag can be accurately sub-packaged. On the one hand, since the whole process is automatically controlled by the machine, the low sub-packaging efficiency and low sub-packaging accuracy caused by manual operation are avoided. On the other hand, the injection device accurately sub-packages the cell preparation with a preset sub-packaging volume into each sub-packaging bag, which avoids the influence of the volume control caused by the vibration of the pipeline and other devices by using manual weighing to control the volume of the cell preparation, so as to further improve the sub-packaging accuracy. Under the condition of improving the sub-packaging efficiency and sub-packaging accuracy, the treatment effect of the cell preparation and the treatment time of the patient can be ensured not to be affected.

[0151] Further, the modules of the system are independently designed and detachably connected, and can be increased or decreased according to requirements, and support simultaneous control of multiple same modules, and are compatible with different unpacking requirements.

[0152] Referring to FIG. 7, in one embodiment, the cell preparation unpacking system further comprises a counting module;

[0153] The counting module is detachably connected with the refrigeration and mixing module, the unpacking module and the control module;

[0154] The counting module comprises a first peristaltic pump 10, counting bags and a counting device;

[0155] The control module is used for:

[0156] controlling the mixing device to perform mixing operation on the mixing bag according to preset mixing parameters, to obtain mixed cell preparation;

[0157] controlling the first peristaltic pump 10 to pump the mixed cell preparation into the counting bag for manual cell counting or into the counting device for automatic cell counting;

[0158] controlling the first peristaltic pump 10 to pump the mixed cell preparation after cell counting back to the mixing bag to continue participating in mixing.

[0159] The first peristaltic pump 10 is arranged on a pipeline between the mixing bag and the counting bag, the first counting bag 11 is provided with a first counting stopcock valve 13 on the side close to the first peristaltic pump 10, the second counting bag 12 is provided with a second counting stopcock valve 14 on the side close to the first peristaltic pump 10, and each counting bag is provided with a fourth sterile filter 15 on the side away from the first peristaltic pump 10; the side of each counting bag close to the first peristaltic pump 10 is further connected with one end of the counting device, the mixing bag is further connected with the other end of the counting device, and the mixing bag, the first peristaltic pump 10 and the counting device are connected to form a circulation loop.

[0160] Referring to FIG. 6, before manual counting, the first counting stopcock valve 13 is turned to No. 1 or No. 7 position, or the second counting stopcock valve 14 is turned to No. 3 or No. 5 position, the mixed cell preparation of the mixing bag is extracted according to requirements, and then the pipeline between the first counting bag 11 and the first counting stopcock valve 13 is heat sealed, and the mixed cell preparation in the first counting bag 11 is manually counted, or the pipeline between the second counting bag 12 and the second counting stopcock valve 14 is heat sealed, and the mixed cell preparation in the second counting bag 12 is manually counted; before automatic counting, the first counting stopcock valve 13 is turned to No. 5 position, the second counting stopcock valve 14 is turned to No. 7 position, the circulation loop formed by the mixing bag, the first peristaltic pump 10 and the counting device is started, and then the counting device is controlled to automatically count the mixed cell preparation flowing in.

[0161] In the mixing operation of this embodiment, on the one hand, by combining cell counting of the mixed cell preparation, the mixing effect can be verified and the uniformity of the cell preparation can be continuously detected. On the other hand, by using manual and automatic counting devices, a variety of counting methods can be provided to meet different counting needs.

[0162] Furthermore, each module of this system is designed independently and can be detached and connected. Modules can be added or removed as needed, and multiple identical modules can be controlled simultaneously, making it compatible with different mixing and counting requirements.

[0163] Referring to Figure 7, in one embodiment, the cell preparation dispensing system further includes a transfer module;

[0164] The liquid transfer module can be detachably connected to the refrigeration and mixing module, the counting module, and the control module.

[0165] The transfer module includes a sample bag and a second peristaltic pump 16;

[0166] The control module is used for:

[0167] The cell preparation in the sample bag is prepared into a solution to obtain the prepared cell preparation.

[0168] After the solution is prepared, the cell preparation enters the mixing preparation process, i.e.

[0169] Control the second peristaltic pump 16 to vent the gas in the liquid transfer line; the liquid transfer line is the line between the sample bag and the mixing bag.

[0170] The refrigeration unit is controlled to lower the ambient temperature of the mixing bag.

[0171] Control the second peristaltic pump 16 to pump the prepared cell preparation from the sample bag into the mixing bag;

[0172] Control the second peristaltic pump 16 to empty the residual cell preparation in the transfer line into the mixing bag;

[0173] In addition, if the cell preparation in the sample bag does not require solution preparation, the sample bag is used as a mixing bag, and the cooling device is used to cool the ambient temperature of the sample bag.

[0174] The sample bag is equipped with a first bubble sensor 17 at the outlet, a fifth sterile filter 19 is located on the side of the first bubble sensor 17 away from the sample bag, a transfer stopcock valve 20 is installed on the pipeline between the first bubble sensor 17 and the fifth sterile filter 19, a second peristaltic pump 16 is installed on the pipeline between the transfer stopcock valve 20 and the mixing bag, and a second bubble sensor 18 is also installed on this pipeline.

[0175] Referring to FIG. 6, before the second peristaltic pump 16 is controlled to pump the post-dilution cell preparation in the sample bag into the mixing bag, the liquid transfer stopcock valve 20 is turned to position 1 to connect the fifth sterile filter 19 and the mixing bag, the second peristaltic pump 16 is controlled to reverse to discharge the gas in the liquid transfer pipeline from the fifth sterile filter 19 out of the system, the liquid transfer stopcock valve 20 is then turned to position 5 to connect the sample bag and the mixing bag, and the refrigeration device is controlled to cool the ambient temperature of the mixing bag. A temperature control sensor can be arranged in the refrigeration mixing module to monitor the ambient temperature.

[0176] During the process of controlling the second peristaltic pump 16 to pump the post-dilution cell preparation in the sample bag into the mixing bag, the first bubble sensor 17 in the liquid transfer module, the liquid flow rate in the second peristaltic pump 16, and the weighing sensor can be used to monitor the liquid outflow of the sample bag, and the second bubble sensor 18 in the refrigeration mixing module can be used to monitor the liquid inflow of the mixing bag, so as to adjust the preset mixing parameters and achieve better mixing effect.

[0177] After the post-dilution cell preparation in the sample bag is pumped into the mixing bag by the second peristaltic pump 16, the liquid transfer stopcock valve 20 is turned to position 1 to connect the fifth sterile filter 19 and the mixing bag, so as to control the second peristaltic pump 16 to draw gas from the outside and use the outside gas to empty the residual cell preparation in the liquid transfer pipeline into the mixing bag.

[0178] According to whether the cell preparation in the sample bag needs to be diluted, the embodiment adaptively processes before the mixing operation to ensure that the subsequent mixing operation can be smoothly performed in any case.

[0179] Further, the modules of the system are independently designed and detachably connected, can be increased or decreased according to the needs, and support simultaneous control of multiple same modules, and can be compatible with different liquid transfer needs.

[0180] FIG. 8 is a structural schematic diagram of an electronic device provided by the embodiment of the application. As shown in FIG. 8, the electronic device can include a processor 810, a communication interface 820, a memory 830, and a communication bus 840. The processor 810, the communication interface 820, and the memory 830 can complete mutual communication through the communication bus 840. The processor 810 can invoke a computer program in the memory 830 to execute the steps of the cell preparation split method, for example, including:

[0181] controlling the mixing device to perform a mixing operation on the cell preparation in the mixing bag to obtain mixed cell preparation;

[0182] The mixed cell preparation is injected into the injection device, and the mixed cell preparation in the injection device is sequentially dispensed into each dispensing bag according to a preset dispensing volume.

[0183] In addition, the logic instructions in the memory 830 described above can be implemented in the form of a software function unit and sold or used as an independent product, and can be stored in a computer readable storage medium. Based on such understanding, the technical solutions of the present application essentially or the part that contributes to the prior art or part of the technical solutions can be embodied in the form of a software product. The computer software product is stored in a storage medium, and includes several instructions to make a computer device (which can be a personal computer, a server, or a network device, etc.) execute all or part of the steps of the methods described in the embodiments of the present application. The foregoing storage medium includes: a U disk, a mobile hard disk, a read-only memory (ROM, Read-Only Memory), a random access memory (RAM, Random Access Memory), a magnetic disk or an optical disk, and various media that can store program codes.

[0184] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A method of dispensing a cell preparation, wherein, The method comprises the following steps: controlling a mixing device to mix the cell preparation in a mixing bag to obtain a mixed cell preparation; controlling an injection device to inject the mixed cell preparation into the injection device, and sequentially dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume.

2. The cell preparation dispensing method according to claim 1, wherein, After the step of sequentially dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume, the method comprises the following steps: controlling the injection device to empty residual cell preparation in a dispensing pipeline; controlling the injection device to empty gas in each dispensing bag.

3. The cell preparation dispensing method according to claim 2, wherein, The step of controlling the injection device to empty residual cell preparation in the dispensing pipeline comprises the following steps: controlling the injection device to draw external air; controlling the injection device to inject the drawn external air into the dispensing pipeline; if the volume of the external air injected at one time is less than a first volume threshold, returning to the step of controlling the injection device to draw external air, and again controlling the injection device to inject the drawn external air into the dispensing pipeline, until the volume of the cumulative injected external air reaches the first volume threshold, so as to empty the residual cell preparation in the dispensing pipeline into each dispensing bag.

4. The cell preparation dispensing method according to claim 2, wherein, The step of controlling the injection device to empty gas in each dispensing bag comprises the following steps: controlling the injection device to empty residual gas in itself; controlling the injection device to perform degassing on a pre-degassing dispensing bag in each dispensing bag; controlling the injection device to empty gas in each pre-degassing dispensing bag according to different degassing effects.

5. The cell preparation dispensing method according to claim 4, wherein, The step of controlling the injection device to perform degassing on a pre-degassing dispensing bag in each dispensing bag comprises the following steps: controlling the injection device to draw gas in a pre-degassing dispensing bag in each dispensing bag according to a preset gas flow rate; the preset gas flow rate changes according to the number of pre-degassing dispensing bags that are not degassed; if a sensor at a liquid outlet of a target pre-degassing dispensing bag does not detect liquid within a preset time period, controlling the injection device to empty residual gas in itself; controlling the injection device to draw gas in the target pre-degassing dispensing bag according to the preset gas flow rate, until the sensors at the liquid outlets of each pre-degassing dispensing bag all detect liquid within a preset time period; the target pre-degassing dispensing bag is any pre-degassing dispensing bag in each pre-degassing dispensing bag.

6. The cell preparation dispensing method according to claim 4, wherein, The step of controlling the injection device to empty gas in each pre-degassing dispensing bag according to different degassing effects comprises the following steps: if cell preparation in a target pre-degassing dispensing bag does not form a liquid column outside a liquid outlet of the target pre-degassing dispensing bag, controlling the injection device to draw gas in the target pre-degassing dispensing bag, until the highest point of the liquid column formed by the cell preparation in the target pre-degassing dispensing bag is located in the sensor corresponding to the liquid outlet; if the highest point of the liquid column formed by the cell preparation in a target pre-degassing dispensing bag is higher than the sensor at the liquid outlet of the target pre-degassing dispensing bag, controlling the injection device to inject gas into the target pre-degassing dispensing bag, until the highest point of the liquid column is located in the sensor. If the highest point of the liquid column formed by the cell preparation in the target pre-evacuation sub-packaging bag is lower than the sensor at the liquid outlet of the target pre-evacuation sub-packaging bag, the injection device is controlled to extract the gas in the target pre-evacuation sub-packaging bag until the highest point of the liquid column is in the sensor; If the highest point of a part of the liquid column formed by the cell preparation in the target pre-evacuation sub-packaging bag is higher than the sensor at the liquid outlet of the target pre-evacuation sub-packaging bag, and the highest point of another part of the liquid column is lower than the sensor, the injection device is controlled to inject gas into the target pre-evacuation sub-packaging bag, and then the injection device is controlled to extract the gas in the target pre-evacuation sub-packaging bag until the highest point of the liquid column is in the sensor; The target pre-evacuation sub-packaging bag is any one of the pre-evacuation sub-packaging bags.

7. The cell preparation dispensing method according to claim 1, wherein, The control of the injection of the mixed cell preparation in the injection device includes: controlling the injection device to extract the mixed cell preparation; controlling the visual recognition device to identify whether the injection device is full of the mixed cell preparation in real time; If not, the injection device is controlled to inject the gas-liquid mixture in the injection device to the mixing bag, and then the step of controlling the injection device to extract the mixed cell preparation is returned to until the injection device is full of the mixed cell preparation.

8. The cell preparation dispensing method according to claim 7, wherein, The step of controlling the injection of the mixed cell preparation in the injection device according to the preset sub-packaging volume into each sub-packaging bag includes: controlling the injection device to inject the mixed cell preparation into the corresponding sub-packaging bag according to the preset sub-packaging volume of each sub-packaging bag; If the volume of the mixed cell preparation injected at a time is insufficient to complete the sub-packaging of each sub-packaging bag according to the preset sub-packaging volume, the step of controlling the injection device to extract the mixed cell preparation is returned to, and the injection device is controlled again to inject the mixed cell preparation into the corresponding sub-packaging bag according to the preset sub-packaging volume of each sub-packaging bag until the volume of the mixed cell preparation accumulated by injection is sufficient to complete the sub-packaging of each sub-packaging bag according to the preset sub-packaging volume.

9. The cell preparation dispensing method according to claim 1, wherein, The control of the mixing operation of the cell preparation in the mixing bag by the mixing device includes: controlling the mixing device to perform a mixing operation on the mixing bag according to the preset mixing parameters to obtain a mixed cell preparation; controlling the first peristaltic pump to pump the mixed cell preparation to a counting bag for manual cell counting or to a counting device for automatic cell counting; controlling the first peristaltic pump to pump the mixed cell preparation after cell counting back to the mixing bag to continue participating in mixing.

10. The cell preparation dispensing method according to claim 1, wherein, Before the control of the mixing operation of the cell preparation in the mixing bag by the mixing device, it includes: controlling the cell preparation in the sample bag to be liquid prepared to obtain a liquid prepared cell preparation; controlling the liquid prepared cell preparation to enter a mixing preparation process.

11. The cell preparation dispensing method according to claim 10, wherein, The control of the liquid prepared cell preparation entering the mixing preparation process includes: controlling the second peristaltic pump to empty the gas in the liquid transfer pipeline; controlling the refrigeration device to perform a temperature reduction operation on the environment of the mixing bag; controlling the second peristaltic pump to pump the liquid prepared cell preparation in the sample bag to the mixing bag; controlling the second peristaltic pump to empty the residual cell preparation in the transfer line into the mixing bag.

12. A cell preparation dispensing system, wherein, comprising: a control module, a refrigeration mixing module, and a dispensing module; the control module, the refrigeration mixing module, and the dispensing module are detachably connected in pairs; the refrigeration mixing module comprises a mixing device and a mixing bag; the dispensing module comprises an injection device and a plurality of dispensing bags; the control module is configured to: control the mixing device to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; control the injection device to inject the mixed cell preparation, and sequentially dispense the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume.

13. An electronic device comprising a processor and a memory having a computer program stored therein, wherein, The processor executes the computer program to implement the steps of the cell preparation dispensing method according to any one of claims 1-11.

Citation Information

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