Cell preparation subpackaging method and system

Abstract

The invention relates to the technical field of subpackaging, and provides a cell preparation subpackaging method and system. The method comprises the following steps: controlling a uniform mixing device to uniformly mix a cell preparation in a uniform mixing bag to obtain a uniformly mixed cell preparation; and controlling an injection device to inject the uniformly mixed cell preparation, and sequentially sub-packaging the uniformly mixed cell preparation in the injection device into each sub-packaging bag according to a preset sub-packaging volume. The whole process depends on machine automatic control, so that low subpackaging efficiency and subpackaging precision caused by manual operation are avoided, meanwhile, the injection device is controlled to accurately subpackage the cell preparation with the preset subpackaging volume into each subpackaging bag, the situation that the volume of the cell preparation is controlled through manual weighing is avoided, and the subpackaging efficiency and subpackaging precision are improved. Therefore, the influence of vibration of pipelines and other devices on volume control is avoided, the subpackaging precision is further improved, and the treatment effect of the cell preparation and the treatment opportunity of a patient are not influenced.

Description

Technical Field

[0001] This application relates to the field of packaging technology, specifically to a method and system for packaging cell preparations. Background Technology

[0002] Cell preparation packaging technology is an important component of the biomedical field, and is crucial for cell therapy and pharmaceutical preparation.

[0003] Cellular formulations cannot directly contact sensors during dispensing. Therefore, highly accurate contact sensors that directly detect flow rate cannot be used to measure the volume of dispensed cell formulations. As a result, the main dispensing technology currently used in the market achieves volume control of cell formulation dispensing through manual start-stop of peristaltic pumps, weighing, and manual recording.

[0004] These dispensing methods, due to manual operation, result in low dispensing efficiency and accuracy. Furthermore, manual weighing is susceptible to vibrations from pipelines and other equipment, further reducing dispensing accuracy. This decrease in dispensing efficiency and accuracy directly impacts the therapeutic efficacy of cell preparations and delays patients' treatment. Summary of the Invention

[0005] This application provides a cell preparation dispensing method and system to solve the technical problems of existing dispensing methods, which have low dispensing efficiency and accuracy due to manual operation, and whose dispensing accuracy is further reduced due to the susceptibility of manual weighing to vibration of pipelines and other devices, thereby directly affecting the therapeutic effect of cell preparations and delaying the treatment time of patients.

[0006] In a first aspect, embodiments of this application provide a method for dispensing cell preparations, including: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 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 the preset dispensing volume.

[0007] In one embodiment, after sequentially dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume, the process includes: Control the injection device to drain residual cell preparations from the dispensing tubing; Control the injection device to vent the gas from each dispensing bag.

[0008] In one embodiment, controlling the injection device to empty the residual cell preparation in the dispensing tubing includes: The injection device is controlled to draw in outside air; The injection device is controlled to inject the extracted outside air into the dispensing pipeline; If the volume of the outside air injected in a single injection is less than the second volume threshold, the process returns to the step of controlling the injection device to extract outside air, and the injection device is controlled again to inject the extracted outside air into the dispensing pipeline until the cumulative volume of the injected outside air reaches the second volume threshold, so as to empty the residual cell preparation in the dispensing pipeline into each dispensing bag.

[0009] In one embodiment, controlling the injection device to vent gas from each dispensing bag includes: Control the injection device to vent the residual gas inside itself; The injection device is controlled to vent the pre-vented dispensing bags in each dispensing bag; The injection device is controlled to vent the gas in each pre-vented dispensing bag according to different venting effects.

[0010] In one embodiment, controlling the injection device to vent the pre-vented dispensing bags in each dispensing bag includes: The injection device is controlled to extract gas from the pre-vented packaging bags in each packaging bag according to a preset gas flow rate; the preset gas flow rate varies according to the number of pre-vented packaging bags with unvented gas. If the sensor at the outlet of the target pre-venting dispensing bag does not detect liquid within a preset time period, the injection device is controlled to vent the residual gas inside itself. The injection device is controlled to extract gas from the target pre-vented dispensing bag at a preset gas flow rate until the sensor at the liquid outlet of each pre-vented dispensing bag detects liquid within a preset time period. The target pre-venting packaging bag is any one of the packaging bags in the pre-venting packaging bag series.

[0011] In one embodiment, controlling the injection device to vent the gas in each pre-vented dispensing bag according to different venting effects includes: If the cell preparation in the target pre-vented dispensing bag does not form a liquid column outside the outlet of the target pre-vented dispensing bag, the injection device is controlled to draw gas from the target pre-vented dispensing bag until the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is located in the sensor at the corresponding outlet. If the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, then control the injection device to inject gas into the target pre-vented 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-vented dispensing bag is lower than the sensor at the outlet of the target pre-vented dispensing bag, then the injection device is controlled to extract gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor. If the highest point of a portion of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, and the highest point of another portion of the liquid column is lower than the sensor, then the injection device is controlled to inject gas into the target pre-vented dispensing bag, and then the injection device is controlled to extract gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor. The target pre-venting packaging bag is any one of the packaging bags in the pre-venting packaging bag series.

[0012] In one embodiment, controlling the injection of the mixed cell preparation into the injection device includes: Control the injection device to draw the mixed cell preparation; The visual recognition device is controlled to identify whether the injection device is filled with the mixed cell preparation in real time. If not, the injection device is controlled to inject the gas-liquid mixture inside itself into the mixing bag, and then the process returns 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.

[0013] In one embodiment, the step of sequentially dispensing the mixed cell preparation within the injection device into various dispensing bags according to a preset dispensing volume includes: The injection device is controlled to inject the mixed cell preparation into the corresponding dispensing bags sequentially according to the preset dispensing volume of each dispensing bag; If the volume of the mixed cell preparation injected in a single injection is insufficient to complete the dispensing of each bag according to the preset dispensing volume, the process returns to the step of controlling the injection device to extract the mixed cell preparation, and the injection device is controlled again to inject the mixed cell preparation into the corresponding dispensing bags sequentially according to the preset dispensing volume of each bag, until the cumulative volume of the injected mixed cell preparation is sufficient to complete the dispensing of each bag according to the preset dispensing volume.

[0014] In one embodiment, the controlled mixing device performs a mixing operation on the cell preparation in the mixing bag, including: The mixing device is controlled to perform a mixing operation on the mixing bag according to preset mixing parameters to obtain a mixed cell preparation. Control the first peristaltic pump to pump the mixed cell preparation into a counting bag for manual cell counting or into a counting device for automatic cell counting; The first peristaltic pump is controlled to pump the mixed cell preparation, after cell counting is completed, back into the mixing bag to continue mixing.

[0015] In one embodiment, before the controlled mixing device performs a mixing operation on the cell preparation in the mixing bag, it includes: The cell preparation in the sample bag is prepared into a solution to obtain the prepared cell preparation. After the solution is prepared, the cell preparation enters the mixing preparation process.

[0016] In one embodiment, controlling the cell preparation to enter the mixing preparation process after solution preparation includes: Control the second peristaltic pump to vent the gas in the liquid transfer pipeline; The refrigeration device is controlled to lower the ambient temperature of the mixing bag; The second peristaltic pump is controlled to pump the prepared cell preparation from the sample bag into the mixing bag; The second peristaltic pump is controlled to empty the residual cell preparation in the transfer pipeline into the mixing bag.

[0017] Secondly, embodiments of this application provide a cell preparation dispensing system, including: a control module, a cooling and mixing module, and a dispensing module; The control module, the cooling and mixing module, and the dispensing module are detachably connected in pairs. The cooling and mixing module includes a mixing device and a mixing bag; The dispensing module includes an injection device and multiple dispensing bags; The control module is used for: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 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 the preset dispensing volume.

[0018] Thirdly, embodiments of this application provide an electronic device, including 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 described in the first aspect.

[0019] The cell preparation dispensing method and system provided in this application 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 the preset dispensing volume. This application first mixes the cell preparation, then controls the injection device to extract the mixed cell preparation and sequentially dispense it into each dispensing bag. Because the volume of gas and / or liquid within the injection device can be precisely controlled by adjusting the lever stroke, the volume of cell preparation extracted by the injection device and dispensed into each dispensing bag can be precisely controlled during the dispensing process. This achieves precise dispensing of the cell preparation into each dispensing bag. On one hand, because the entire process relies on automated machine control, it avoids the low dispensing efficiency and accuracy caused by manual operation. On the other hand, controlling the injection device to precisely dispense the preset dispensing volume of cell preparation into each dispensing bag avoids the need for manual weighing for volume control, thus avoiding the impact of vibration from tubing and other devices on volume control, thereby further improving dispensing accuracy. With improved dispensing efficiency and accuracy, it ensures that the therapeutic effect of the cell preparation and the patient's treatment timing are not affected. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is one of the flowcharts illustrating the cell preparation dispensing method provided in the embodiments of this application; Figure 2 This is the second schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application. Figure 3 This is the third schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application; Figure 4 This is the fourth flowchart illustrating the cell preparation dispensing method provided in the embodiments of this application; Figure 5 This is the fifth flowchart illustrating the cell preparation dispensing method provided in the embodiments of this application; Figure 6 This is a rotation coordinate diagram of each stopcock valve in the cell preparation dispensing system provided in the embodiments of this application; Figure 7 This is a schematic diagram of the cell preparation dispensing system provided in the embodiments of this application; Figure 8This is a schematic diagram of the structure of the electronic device provided in the embodiments of this application.

[0022] Figure label: 1-First sterile filter; 2-Second sterile filter; 3-Third sterile filter; 4-Pressure sensor; 5-Visual recognition area; 51-First area; 52-Second area; 6-Dispensing stopcock valve; 7-Injection device stopcock valve; 8-First filter stopcock valve; 9-Second filter 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-Transfer stopcock valve. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0024] It should be noted that in the description of the embodiments of this application, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. The terms "upper," "lower," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly, for example, they can be fixed connections, detachable connections, or integral connections; they can be mechanical connections or electrical connections; they can be direct connections or indirect connections through an intermediate medium; and they can be internal connections between two elements. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0025] The terms "first," "second," etc., used in this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class, without limiting the number of objects; for example, a first object can be one or more. Furthermore, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects have an "or" relationship.

[0026] Figure 1 This is one of the schematic flowcharts of the cell preparation dispensing method provided in the embodiments of this application. (Refer to...) Figure 1 This application provides a method for dispensing cell preparations, which may include: 101. Control the mixing device to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 102. Control the injection of the mixed cell preparation into the injection device, and sequentially dispense the mixed cell preparation into each dispensing bag according to the preset dispensing volume.

[0027] In step 101, the cell preparation being mixed can be either a cell preparation that has not been mixed with any other preparations and is simply mixed with the current cell preparation, or a cell preparation that has been mixed with other preparations after the current cell preparation has been added.

[0028] In step 102, the injection device includes a syringe and an injection pump. The preset dispensing volume of each dispensing bag can be the same or different, which is not limited here. Each dispensing bag can also be replaced with a dispensing tube.

[0029] Before injecting the mixed cell preparation into the injection device, the device can be controlled to extract gas from each dispensing bag. The mixed cell preparation can be injected into the injection device only when the gas pressure in the dispensing pipeline is less than the first gas pressure threshold. If the volume of gas extracted by the injection device in a single operation exceeds the preset volume, and the gas pressure in the dispensing pipeline is still greater than or equal to the first gas pressure threshold, the device can be controlled to vent its own internal gas and then continue to extract gas from each dispensing bag until the gas pressure in the dispensing pipeline is less than the first gas pressure threshold. Only then can the mixed cell preparation be injected into the injection device to achieve a better dispensing effect.

[0030] It should be noted that when replacing the dispensing tube with a dispensing bag, since it is difficult to extract gas from the dispensing tube, it is not necessary to extract gas from the dispensing tube and then judge the gas pressure in the dispensing pipeline. Step 102 can be executed directly.

[0031] The cell preparation dispensing method provided in this embodiment controls the mixing device to mix the cell preparation in the mixing bag to obtain a mixed cell preparation, controls the injection device to inject the mixed cell preparation, and sequentially dispenses the mixed cell preparation in the injection device into each dispensing bag according to the preset dispensing volume. In this embodiment, the cell preparation is first mixed thoroughly, and then the injection device is controlled to extract the mixed cell preparation and sequentially dispense it into each dispensing bag. Because the volume of gas and / or liquid within the injection device can be precisely controlled by adjusting the lever stroke, the volume of cell preparation extracted by the injection device and dispensed into each dispensing bag can be precisely controlled during the dispensing process. This achieves precise dispensing of the cell preparation into each dispensing bag. On the one hand, since the entire process relies on automated machine control, the low dispensing efficiency and accuracy caused by manual operation are avoided. On the other hand, controlling the injection device to precisely dispense the preset dispensing volume of cell preparation into each dispensing bag avoids the need for manual weighing for volume control of the cell preparation, thus avoiding the impact of vibration from tubing and other devices on volume control, thereby further improving dispensing accuracy. With improved dispensing efficiency and accuracy, the therapeutic effect of the cell preparation and the patient's treatment timing can be ensured to remain unaffected.

[0032] Furthermore, in traditional dispensing methods, cell preparations are subjected to contact processing, and it is difficult to ensure the sterility of dispensing consumables. The integrity and activity of cell preparations may be damaged during the dispensing process. In this embodiment, cell preparations are not subjected to contact processing during the dispensing process, and the sterility of consumables can be ensured by using a contamination-proof injection device, which will not affect the integrity and activity of cell preparations.

[0033] Figure 2 This is the second schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application. (Refer to...) Figure 2 In one embodiment, after the mixed cell preparation in the injection device is sequentially dispensed into each dispensing bag according to a preset dispensing volume, the process may include: 201. Control the emptying of residual cell preparations in the dispensing pipeline of the injection device; The dispensing pipeline is the pipeline between the injection device and each dispensing bag; 202. Control the injection device to vent the gas from each dispensing bag.

[0034] Step 201 is as follows: 201a. Control the injection device to draw in outside air; 201b. Control the injection device to inject the extracted outside air into the dispensing pipeline; 201c. If the volume of outside air injected in a single injection is less than the first volume threshold, return to step 201a and control the injection device again to inject the extracted outside air into the dispensing pipeline until the cumulative volume of injected outside air reaches the first volume threshold, so as to empty the residual cell preparation in the dispensing pipeline into each dispensing bag.

[0035] In steps 201b to 201c, the injection device can be controlled to inject extracted outside air into the dispensing tubing sequentially according to the preset gas volume of each dispensing bag. The pressure of the preset gas volume of outside air then pushes the residual cell preparation in the dispensing tubing into each dispensing bag sequentially. For example, first, the injection device is controlled to inject a first preset gas volume of outside air into the dispensing tubing. The pressure of the first preset gas volume of outside air pushes a portion of the residual cell preparation in the dispensing tubing into the first dispensing bag corresponding to the first preset gas volume. Then, the injection device is controlled to inject a second preset gas volume of outside air into the dispensing tubing. The pressure of the second preset gas volume of outside air pushes a portion of the residual cell preparation in the dispensing tubing into the second dispensing bag corresponding to the second preset gas volume, and so on, until all the outside air in the injection device is injected into the dispensing tubing. If there is insufficient outside air injected into the dispensing line, the injection device is controlled to continuously draw in outside air and inject it into the dispensing line to ensure that the drawn outside air can maintain continuous pressure, so as to push as much of the residual cell preparation in the dispensing line as possible into each dispensing bag and avoid wasting the cell preparation in the dispensing line.

[0036] It should be noted that during the process of controlling the injection device to sequentially dispense the mixed cell preparation inside it into each dispensing bag according to the preset dispensing volume, the preset dispensing volume corresponding to each dispensing bag is slightly smaller than the required finished product volume, so as to ensure that the error between the total cell preparation volume and the required finished product volume after adding the residual cell preparation in the dispensing pipeline is within an acceptable range.

[0037] In step 202, since a certain amount of outside air is also injected into each dispensing bag during the process of purging the residual cell preparation in the dispensing pipeline, it is also necessary to purge the gas in each dispensing bag in order to form a finished cell preparation product that meets the standards.

[0038] Furthermore, it is also possible to control the evacuation of residual cell preparations from the mixing tubing in the injection device. The mixing tubing is the tubing between the mixing bag and the injection device, as detailed below: 1. Control the injection device to empty the residual cell preparation inside itself into the mixing bag; 2. Control the injection device to draw in outside air; 3. Control the injection device to inject the extracted outside air into the mixing pipeline; 4. If the volume of outside air injected in a single injection is less than the second volume threshold, return to step 2 and control the injection device again to inject the extracted outside air into the mixing pipeline until the cumulative volume of injected outside air reaches the second volume threshold, so as to empty the residual cell preparation in the mixing pipeline into the mixing bag.

[0039] In step 1, after the cell preparation is dispensed, there will be residual cell preparation in the injection device. Therefore, it needs to be emptied into the mixing bag to avoid wasting the residual cell preparation in the injection device.

[0040] In steps 3 and 4, the injection device is controlled to inject extracted outside air into the mixing line. The pressure of the outside air can be used to push the residual cell preparation in the mixing line into the mixing bag. When the outside air is insufficient, it is continuously extracted and injected into the mixing line to ensure that the extracted outside air can form a continuous pressure, so as to push all the residual cell preparation in the mixing line into the mixing bag as much as possible and avoid wasting the cell preparation in the mixing line.

[0041] This embodiment controls the injection device to continuously draw in outside air and inject the outside air into the mixing pipeline and the dispensing pipeline respectively, so as to vent the residual cell preparation in the mixing pipeline and the dispensing pipeline to the mixing bag and each dispensing bag respectively, thereby realizing the recycling of residual cell preparation and avoiding waste of residual cell preparation.

[0042] Figure 3 This is the third schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application. (Refer to...) Figure 3 In one embodiment, controlling the injection device to vent gas from each dispensing bag may include: 301. Control the injection device to vent residual gas inside itself; 302. Control the injection device to vent the pre-vented dispensing bags in each dispensing bag; 303. Control the injection device to vent the gas in each pre-vented dispensing bag according to different venting effects.

[0043] In step 301, during the process of controlling the injection device to vent the residual cell preparation in the dispensing pipeline, the injection device continuously performs evacuation and venting operations. Therefore, there will be some residual gas. Before venting the gas in each dispensing bag, these residual gases need to be vented to better vent the gas in the dispensing bags in the subsequent process.

[0044] In step 302, not all dispensing bags need to be vented. Only the pre-vented dispensing bags that need to be vented need to be vented after a certain preset time period.

[0045] In step 303, the exhaust can be adjusted specifically for each pre-exhausted packaging bag based on the exhaust effect identified by the visual recognition device.

[0046] In this embodiment, the residual gas inside the injection device is first purged, and then the injection device is controlled to vent the pre-vented packaging bags in each packaging bag. Based on the venting effect, the venting of each pre-vented packaging bag is adjusted accordingly, thereby maximizing the venting of gas in each pre-vented packaging bag. At the same time, it avoids drawing the cell preparation in the pre-vented packaging bag back into the packaging pipeline during the venting process, which would increase the residue of cell preparation in the packaging pipeline.

[0047] In one embodiment, controlling the injection device to vent the pre-vented dispensing bags in each dispensing bag may include: The injection device is controlled to extract gas from the pre-vented packaging bags of each packaging bag at a preset gas flow rate. If the sensor at the liquid outlet of the target pre-vented packaging bag does not detect liquid within a preset time period, the injection device is controlled to vent the residual gas inside itself and to extract gas from the target pre-vented packaging bag at a preset gas flow rate until the sensor at the liquid outlet of each pre-vented packaging bag detects liquid within a preset time period.

[0048] The preset gas flow rate varies according to the number of pre-vented dispensing bags containing unvented gas, and the target pre-vented dispensing bag is any one of the dispensing bags in the pre-vented dispensing bags.

[0049] First, control the movement speed of the injection device's lever to control the injection device to extract gas from each pre-vented dispensing bag at a preset initial gas flow rate. If the sensor at the outlet of any pre-vented dispensing bag detects liquid within a preset time period, it indicates that the gas in that pre-vented dispensing bag can be considered emptied, and the number of pre-vented dispensing bags without vented air is reduced by 1. Then, control the movement speed of the injection device's lever 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-vented dispensing bags without vented air. Extract gas from the current pre-vented dispensing bags without vented air at this preset gas flow rate. This process is repeated, continuously adjusting the preset gas flow rate according to the current number of pre-vented dispensing bags without vented air, and extracting gas from the remaining pre-vented dispensing bags without vented air at the adjusted preset gas flow rate.

[0050] During this process, if the injection device is filled with gas but any sensor fails to detect liquid within a preset time period, it indicates that a single gas extraction is insufficient to empty all the gas in each pre-exhausted dispensing bag. Therefore, after emptying the gas extracted from the injection device, the gas in the pre-exhausted dispensing bag corresponding to that sensor is extracted again at a preset gas flow rate until all sensors detect liquid within a preset time period, indicating that the gas in each pre-exhausted dispensing bag can be considered to have been emptied.

[0051] In addition, the injection device can be controlled to vent the pre-vented dispensing bags in each dispensing bag in another way, as follows: The control injection device extracts gas from the pre-vented dispensing bags in each dispensing bag. If the gas pressure in the dispensing pipeline is greater than the second gas pressure threshold, the control injection device returns to the step of venting the residual gas inside itself, and the control injection device extracts gas from the pre-vented dispensing bags in each dispensing bag again until the gas pressure in the dispensing pipeline reaches the second gas pressure threshold.

[0052] When the injection device is full of gas but the gas pressure in the dispensing pipeline is still greater than the second gas pressure threshold, it means that a single pumping is insufficient to empty all the gas in each pre-emptied dispensing bag. Therefore, it is necessary to empty the gas already pumped into the injection device and then pump the gas in each pre-emptied dispensing bag again until the gas pressure in the dispensing pipeline reaches the second gas pressure threshold, indicating that the gas in each pre-emptied dispensing bag can be considered to have been emptied.

[0053] This embodiment provides a flexible venting scheme. It can adjust the preset gas flow rate according to the number of pre-venting bags currently participating in the venting process during the extraction of gas from each pre-venting bag to extract the gas from the pre-venting bags that have not yet been vented, thereby achieving efficient venting and emptying of the gas in each pre-venting bag as much as possible. Alternatively, it can monitor the venting status of each pre-venting bag by the gas pressure of the dispensing pipeline and confirm the venting stop time by comparing it with a second gas pressure threshold, thereby achieving emptying of the gas in each pre-venting bag as much as possible.

[0054] In one embodiment, controlling the injection device to vent gas from each pre-vented dispensing bag according to different venting effects may include: If the cell preparation in the target pre-vented dispensing bag does not form a liquid column outside the outlet of the target pre-vented dispensing bag, the injection device is controlled to draw gas from the target pre-vented dispensing bag until the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is located in the sensor at the corresponding outlet. If the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, the injection device is controlled to inject gas into the target pre-vented 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-vented dispensing bag is lower than the sensor at the outlet of the target pre-vented dispensing bag, the injection device is controlled to draw gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor. If the highest point of a portion of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, and the highest point of another portion of the liquid column is lower than the sensor, then the injection device is controlled to inject gas into the target pre-vented dispensing bag, and then the injection device is controlled to extract gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor.

[0055] The target pre-venting packaging bag is any one of the packaging bags in the pre-venting packaging bag series.

[0056] When venting the pre-vented packaging bags in each packaging bag, although the gas pressure or the detection of liquid by the sensor is taken as the venting endpoint to confirm that all the gas in each pre-vented packaging bag has been vented, in practice, due to the existence of unavoidable detection errors, some pre-vented packaging bags may still be incompletely vented. Therefore, further operations are required to ensure that all the gas in each pre-vented packaging bag is vented.

[0057] Since the final packaging of the dispensing bags is generally carried out on the dispensing branch away from the liquid outlet of the dispensing bag to facilitate the subsequent extraction and use of the cell preparation, the cell preparation inside the dispensing bag can be appropriately extracted to the corresponding dispensing branch. By comparing the height of the liquid column formed by the extracted cell preparation on the dispensing branch with the height of the sensors set on each dispensing branch between the liquid outlet and the packaging port, the gas evacuation status inside the dispensing bag can be further confirmed, and targeted treatment can be carried out to ensure that all the gas inside the dispensing bag is evacuated while also ensuring that no cell preparation residue is left in the dispensing pipeline.

[0058] Based on the exhaust effect identified by the visual recognition device, targeted gas extraction and / or gas injection operations can be performed on each pre-exhausted packaging bag: 1. If the cell preparation in any pre-vented dispensing bag does not form a liquid column outside the outlet of the pre-vented dispensing bag, it indicates that there is still gas inside the pre-vented dispensing bag that has not been discharged. At this time, it is necessary to control the injection device to extract the gas in the pre-vented dispensing bag until the highest point of the liquid column formed by the cell preparation in the pre-vented dispensing bag is located in the sensor at the corresponding outlet, to ensure that the height of the liquid column does not exceed the sealing port, so as to avoid entering the dispensing pipeline and causing cell preparation residue, resulting in waste of cell preparation; 2. If the highest point of the liquid column formed by the cell preparation in any pre-vented dispensing bag is higher than the sensor at the liquid outlet of the pre-vented dispensing bag, it indicates that the gas inside the pre-vented dispensing bag has been vented and the height of the liquid column may exceed the sealing port. At this time, it is necessary to control the injection device to inject gas into the pre-vented dispensing bag to reduce the height of the liquid column until the highest point of the liquid column is located in the sensor. This will prevent the gas from re-entering the pre-vented dispensing bag and also prevent the cell preparation from entering the dispensing pipeline, causing cell preparation residue and resulting in waste of cell preparation. 3. If the highest point of the liquid column formed by the cell preparation in any pre-vented dispensing bag is lower than the sensor at the liquid outlet of the pre-vented dispensing bag, it indicates that the gas inside the pre-vented dispensing bag has been vented, but there is still gas in the corresponding dispensing branch that has not been vented. Since the dispensing branch is also part of the finished product packaging, it is necessary to control the injection device to extract the gas in the dispensing branch until the highest point of the liquid column is located in the sensor, to ensure that the height of the liquid column does not exceed the packaging port, so as to avoid entering the dispensing pipeline and causing cell preparation residue, resulting in waste of cell preparation; 4. If, in any pre-vented dispensing bag, the highest point of a portion of the liquid column formed by the cell preparation is higher than the sensor at the outlet of the pre-vented dispensing bag, while the highest point of another portion is lower than the sensor, it indicates that the height of the liquid column may exceed the sealing port and that there is still unvented gas in the corresponding dispensing branch. In this case, it is necessary to control the injection device to inject gas into the pre-vented dispensing bag to reduce the excessively high liquid column height, and then control the injection device to extract the gas in the pre-vented dispensing bag to extract the gas in the dispensing branch, until the highest point of all liquid columns is located at the sensor. This will prevent gas from re-entering the pre-vented dispensing bag and also prevent the cell preparation from entering the dispensing pipeline, causing cell preparation residue and waste.

[0059] It should be noted that during the gas extraction and gas injection processes described above, the visual recognition device identifies the effects of gas extraction and gas injection in real time. Therefore, it can adjust the amount of injected gas and extracted gas in real time based on the effects, so that the highest point of the liquid column formed by the cell preparation in each pre-vented packaging bag can be quickly adjusted to the corresponding sensor.

[0060] In this embodiment, based on the relationship between the highest point of the liquid column formed by the cell preparation in the pre-vented dispensing bag identified by the visual recognition device and the position of the sensor set on the dispensing branch between each liquid outlet and the packaging port, the highest point of the liquid column is adjusted in a targeted manner by injecting and / or extracting gas so that the highest point is located in the sensor. This further ensures that the gas in each pre-vented dispensing bag is emptied without affecting the volume of the cell preparation after packaging. The whole process can prevent gas from re-entering the pre-vented dispensing bag and prevent the cell preparation from entering the dispensing pipeline and causing cell preparation residue, thus avoiding waste of cell preparation.

[0061] In one embodiment, controlling the injection of a mixed cell preparation into the injection device may include: The system controls the injection device to extract the mixed cell preparation and controls the visual recognition device to identify whether the injection device is full of the mixed cell preparation in real time. If not, the system controls the injection device to inject the gas-liquid mixture inside itself into the mixing bag and then returns to the step of controlling the injection device to extract the mixed cell preparation until the injection device is full of the mixed cell preparation.

[0062] During the extraction of cell preparations, gas in the mixing line may be drawn into the injection device. This can result in the injection device not being filled with cell preparations when the lever is fully extended. Therefore, when the visual recognition device detects this problem, the gas-liquid mixture in the injection device needs to be pushed out into the mixing bag, and the cell preparations need to be extracted and mixed again until the injection device is filled with mixed cell preparations. At this point, the lever of the injection device is fully extended, and the volume of mixed cell preparations in the injection device reaches the maximum capacity of the injection device.

[0063] This embodiment uses a visual recognition device to accurately identify when the injection device is drawing and mixing cell preparations. If the injection device is not completely filled with the mixed cell preparations, it can be re-drawn to ensure that the injection device is filled with the mixed cell preparations, thereby improving the efficiency of subsequent dispensing and reducing the burden of subsequent venting.

[0064] In one embodiment, dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume may include: The injection device is controlled to inject the mixed cell preparation into the corresponding dispensing bags in sequence according to the preset dispensing volume of each bag; If the volume of the mixed cell preparation injected in a single injection is insufficient to complete the dispensing of each bag according to the preset dispensing volume, the process returns to the step of controlling the injection device to extract the mixed cell preparation, and then controls the injection device again to inject the mixed cell preparation into the corresponding bags sequentially according to the preset dispensing volume of each bag, until the cumulative volume of the mixed cell preparation injected is sufficient to complete the dispensing of each bag according to the preset dispensing volume.

[0065] The injection device can be selected according to the total dispensing volume required. If the total dispensing volume is large, a small injection device is selected, and if the total dispensing volume is large, a large injection device is selected. When injecting the mixed cell preparation into each dispensing bag in sequence, the preset dispensing volume of each dispensing bag can be precisely controlled by controlling the injection device, thereby improving dispensing efficiency and accuracy.

[0066] During the dispensing process, if the volume of the mixed cell preparation in any dispensing bag does not reach the corresponding preset dispensing volume after all the mixed cell preparation in the injection device has been injected, it is necessary to continue to extract the mixed cell preparation and inject it into the dispensing bag until the volume of the mixed cell preparation in each dispensing bag reaches the corresponding preset dispensing volume.

[0067] In this embodiment, the cell preparation is sequentially dispensed into each dispensing bag according to the preset dispensing volume of each dispensing bag. The dispensing device is controlled to continuously extract the mixed cell preparation and inject it into each dispensing bag, so that the mixed cell preparation in each dispensing bag reaches the corresponding preset dispensing volume, thereby improving the dispensing accuracy.

[0068] Figure 4 This is the fourth schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application. (Refer to...) Figure 4 In one embodiment, controlling the mixing device to mix the cell preparation in the mixing bag may include: 401. Control the mixing device to perform a mixing operation on the mixing bag according to the preset mixing parameters to obtain a mixed cell preparation; 402. Control the first peristaltic pump to pump the mixed cell preparation to the counting bag for manual cell counting or to the counting device for automatic cell counting; 403. Control the first peristaltic pump to pump the mixed cell preparation that has completed cell counting back into the mixing bag to continue mixing.

[0069] In step 401, the preset mixing parameters may include mixing frequency, mixing amplitude, mixing speed, mixing time, etc., which can control the mixing device to squeeze or tap the mixing bag according to these parameters, causing the cell preparation in the mixing bag to flow upward and then sink, thereby achieving a mixing effect. The preset mixing parameters can be adjusted according to the volume of the cell preparation in the mixing bag to achieve a better mixing effect.

[0070] In the above steps, you can first perform the mixing operation, then stop the mixing operation, extract the mixed cell preparation for cell counting, pump the mixed cell preparation after cell counting is completed back into the mixing bag, and then restart the mixing operation, and repeat this cycle; or you can continue the mixing operation without stopping, but instead perform the mixing operation while extracting the mixed cell preparation for cell counting, and pump the mixed cell preparation after cell counting is completed back into the mixing bag to continue mixing, which is not limited here.

[0071] In the mixing cycle 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 counting and automatic counting, a variety of counting methods can be provided to meet different counting needs.

[0072] Figure 5 This is the fifth schematic flowchart of the cell preparation dispensing method provided in the embodiments of this application. (Refer to...) Figure 5 In one embodiment, before controlling the mixing device to perform a mixing operation on the cell preparation in the mixing bag, it may include: 501. Prepare the cell preparation solution in the sample bag to obtain the prepared cell preparation solution; 502. After the cell preparation solution is prepared, it enters the mixing preparation process.

[0073] In step 501, if it is determined that the cell preparation in the sample bag needs to be prepared, the cell preparation in the sample bag is prepared to obtain the prepared cell preparation.

[0074] Step 502 specifically includes: 502a. Control the second peristaltic pump to vent the gas in the liquid transfer pipeline; The transfer tubing is the tubing between the sample bag and the mixing bag; 502b. Control the refrigeration device to cool down the ambient temperature of the mixing bag; 502c. Control the second peristaltic pump to pump the prepared cell preparation from the sample bag into the mixing bag; 502d. Control the second peristaltic pump to empty the residual cell preparation in the transfer pipeline into the mixing bag.

[0075] In step 502a, purging the gas in the transfer tubing can prevent gas from being introduced into the mixing bag when transferring the cell preparation from the sample bag to the mixing bag through the transfer tubing, which could cause the mixing bag to burst.

[0076] In step 502b, cooling can be performed using a compressor based on preset cooling parameters to reduce the ambient temperature of the mixing bag to a preset temperature. This ambient temperature includes the temperature of the cooling plate in the cooling device and the temperature of the space containing the mixing bag. The cooling plate is fitted to the mixing bag to ensure the mixing temperature of the bag through centralized cooling. Furthermore, the cooling plate can be separated from the surrounding devices by a heat insulation layer to prevent energy dissipation, further ensuring the mixing temperature of the mixing bag.

[0077] In step 502c, during the process of transferring the cell preparation to the mixing bag after solution preparation, the amount of liquid entering the mixing bag is monitored in real time. When the cumulative amount of liquid entering reaches the preset amount, the liquid entry is stopped and the mixing operation is performed; or the mixing operation begins as soon as the cell preparation is detected entering the mixing bag, that is, the mixing operation is performed while the liquid is being entered. During the liquid entry process, the liquid entry speed can be adjusted according to the liquid entry volume. During the mixing process, the preset mixing parameters of the mixing device can be adjusted according to the liquid entry volume to achieve a better mixing effect.

[0078] In step 502d, waste of cell preparation can be avoided by emptying the residual cell preparation in the transfer tubing into the mixing bag.

[0079] Furthermore, if it is determined that the cell preparation in the sample bag does not require solution preparation, the sample bag can be directly used as a mixing bag for cooling to ambient temperature and subsequent mixing operations, without the need for operations such as purging gas from the transfer tubing, transferring the solution, and purging residual cell preparation from the transfer tubing.

[0080] In this embodiment, the pre-mixing treatment is adapted 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 carried out smoothly under any circumstances.

[0081] Figure 6 This is a rotation coordinate diagram of each stopcock valve in the cell preparation dispensing system provided in the embodiments of this application, wherein the arrows represent the rotation coordinate direction of the stopcock valve; Figure 7 This is a schematic diagram of the cell preparation dispensing system provided in the embodiments of this application.

[0082] Reference Figure 7 This application provides a cell preparation dispensing system, which may include: a control module, a cooling and mixing module, and a dispensing module; The control module, the refrigeration mixing module, and the dispensing module are detachably connected in pairs. The cooling and mixing module includes a mixing device and a mixing bag; The packaging module includes an injection device and multiple packaging bags; The control module is used for: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; The mixed cell preparation is injected into the injection device and then sequentially dispensed into each dispensing bag according to the preset dispensing volume.

[0083] The control module includes a central processing unit, a control circuit, and a data acquisition circuit. The injection device and multiple dispensing bags of the dispensing module are connected in sequence to the dispensing pipeline. The end of the dispensing pipeline closer to the injection device is also connected to a first sterile filter 1, and the end of the dispensing pipeline further away from the injection device is also connected to a second sterile filter 2 and a third sterile filter 3. The sterile environment in the dispensing pipeline can be guaranteed by these three sterile filters.

[0084] The first sterile filter 1 and the third sterile filter 3 are connected to 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 dispensing pipeline in real time and transmit the pressure to the acquisition circuit. After receiving the pressure and other input commands from the acquisition circuit, the central processing unit of the control module processes the information and transmits it to the control circuit. The control circuit then controls other modules based on the processed information.

[0085] Before dispensing, the injection device can be controlled to extract or inject gas into the dispensing pipeline to depressurize or pressurize it. The control module collects the pressure in the dispensing pipeline through pressure sensor 4 and compares it with a threshold to detect the airtightness of the dispensing pipeline, so as to ensure the smooth progress of subsequent dispensing.

[0086] The system also includes a visual recognition device. The visual recognition area 5 of the device includes a first area 51 and a second area 52. After the dispensing module receives the dispensing instruction issued by the control module, the visual recognition device or the internal sensor of the dispensing module will identify or detect whether the consumables inside the dispensing module are installed in place, whether there are residual cell preparations in the dispensing pipeline, and whether the sterile connector is unscrewed, so as to ensure that there are no abnormalities inside the dispensing module.

[0087] In the dispensing module, a dispensing stopcock valve 6 is provided at the connection between the main dispensing line and each dispensing branch line, an injection device stopcock valve 7 is provided at the connection between the main dispensing line and the injection device branch line, a first filter stopcock valve 8 is provided at the connection between the main dispensing line and the first sterile filter 1, and a second filter stopcock valve 9 is provided at the common connection between the main dispensing line and the second sterile filter 2 and the third sterile filter 3.

[0088] Reference Figure 6 Before controlling the injection device to extract gas from each dispensing bag, the second filter stopcock valve 9 can be turned to position 5 to connect the dispensing pipeline and pressure sensor 4, and the injection device stopcock valve 7 can be turned to position 7 to connect the dispensing pipeline and the injection device. When the gas pressure in the dispensing pipeline is less than the first gas pressure threshold, each dispensing stopcock valve 6 can be turned to position 5, which helps to reduce the overall time of the subsequent venting steps. If venting is required, the injection device stopcock valve 7 can be turned to position 3, and the first filter stopcock valve 8 can be turned to position 7 to connect the first sterile filter 1 and the injection device, so as to facilitate the venting of gas from the injection device to the outside of the system. Then, the injection device stopcock valve 7 can be turned to position 7 to continue extracting gas from each dispensing bag until the gas pressure in the dispensing pipeline is less than the first gas pressure threshold.

[0089] Before filling the injection device with the mixed cell preparation, the first filter stopcock valve 8 needs to be turned to position 5, and the injection device stopcock valve 7 needs to be turned to position 3 to connect the mixing bag and the injection device.

[0090] Before dispensing the mixed cell preparation in the injection device into each dispensing bag according to the preset dispensing volume, the stopcock valve 7 of the injection device needs to be turned to position 7 to connect the dispensing pipeline and the injection device. Then, from left to right, each dispensing stopcock valve 6 should be turned to position 3 for dispensing. After dispensing is completed, each dispensing stopcock valve 6 should be turned to position 5.

[0091] After the dispensing step is completed, turn the first filter stopcock valve 8 to position 7 to connect the first sterile filter 1 and the injection device, so that the injection device can draw in outside air; turn the injection device stopcock valve 7 to position 7 to connect the dispensing pipeline and the injection device; turn each dispensing stopcock valve 6 to position 3 from left to right to control the injection device to inject the drawn outside air into the dispensing pipeline, so as to empty the residual cell preparation in the dispensing pipeline into each dispensing bag; after emptying, turn each dispensing stopcock valve 6 to position 5.

[0092] After purging the residual cell preparation in the dispensing line, turn the injection device stopcock valve 7 to position 3 and the first filter stopcock valve 8 to position 7 to connect the first sterile filter 1 and the injection device, facilitating the venting of gas from the injection device to the outside of the system. Turn the injection device stopcock valve 7 to position 7 to connect the dispensing bag and the injection device, and turn the dispensing stopcock valve corresponding to the pre-vented dispensing bag to position 1, and the remaining dispensing stopcock valves to position 5 to balance the pressure in the dispensing line. Afterwards, venting can be performed on each pre-vented dispensing bag in two ways: 1. Control the injection device to extract gas from each pre-vented dispensing bag. Determine whether each pre-vented dispensing bag has completed venting based on the comparison between the gas pressure and the threshold. When the gas pressure in the dispensing pipeline reaches the second gas pressure threshold, turn the dispensing stopcock valves corresponding to all pre-vented dispensing bags to position 5 to end the venting process. 2. The injection device is controlled to extract gas from the pre-vented sub-bags of each sub-bag according to a preset gas flow rate. A sensor is set on the first area 51 of the visual recognition device. This sensor can be a bubble sensor. Whether the bubble sensor detects liquid determines whether each pre-vented sub-bag has completed venting. The sub-bag corresponding to the pre-vented sub-bag that has completed venting is turned to position 5. The venting ends when all the sub-bags corresponding to the pre-vented sub-bags are turned to position 5.

[0093] After the venting step is completed, the gas in each pre-vented dispensing bag is emptied according to the venting effect. Then the next round of dispensing can be carried out. Another identical dispensing module is heat-sealed at the pipeline position before the first filter stop valve 8 using a sterile connector. In the next round of dispensing, a similar dispensing operation is performed on the newly connected dispensing module.

[0094] Additionally, residual cell preparations in the mixing tubing can be emptied when appropriate using the following methods: Turn the first filter stopcock valve 8 to position 5 and the injection device stopcock valve 7 to position 3 to connect the mixing bag and the injection device, so as to control the injection device to vent the residual cell preparation inside itself into the mixing bag; turn the first filter stopcock valve 8 to position 7 to connect the first sterile filter 1 and the injection device, so as to facilitate the injection device to draw in outside air; turn the first filter stopcock valve 8 to position 5 to connect the mixing bag and the injection device, so as to control the injection device to inject the drawn outside air into the mixing line, so as to vent the residual cell preparation in the mixing line into the mixing bag.

[0095] The cell preparation dispensing system provided in this embodiment first mixes the cell preparation, then controls the injection device to extract the mixed cell preparation and sequentially dispense it into each dispensing bag. Because the volume of gas and / or liquid within the injection device can be precisely controlled by adjusting the lever stroke, the volume of cell preparation extracted by the injection device and dispensed into each dispensing bag can be precisely controlled during the dispensing process. This achieves precise dispensing of the cell preparation into each dispensing bag. On one hand, because the entire process relies on automated machine control, it avoids the low dispensing efficiency and accuracy caused by manual operation. On the other hand, controlling the injection device to precisely dispense the preset dispensing volume of cell preparation into each dispensing bag avoids the need for manual weighing for volume control, thus avoiding the impact of vibration from pipelines and other devices on volume control, thereby further improving dispensing accuracy. With improved dispensing efficiency and accuracy, it ensures that the therapeutic effect of the cell preparation and the patient's treatment timing are not affected.

[0096] 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 packaging requirements.

[0097] Reference Figure 7 In one embodiment, the cell preparation dispensing system further includes a counting module; The counting module is detachably connected to the refrigeration mixing module, the dispensing module, and the control module. The counting module includes a first peristaltic pump 10, a counting bag, and a counting device; The control module is used for: The mixing device is controlled to mix the mixing bag according to the preset mixing parameters to obtain the mixed cell preparation; Control the first peristaltic pump 10 to pump the mixed cell preparation into a counting bag for manual cell counting or into a counting device for automatic cell counting; The first peristaltic pump 10 is controlled to pump the mixed cell preparation, after cell counting, back into the mixing bag to continue mixing.

[0098] The first peristaltic pump 10 is installed on the pipeline between the mixing bag and the counting bag. The first counting bag 11 is provided with a first counting stop valve 13 on the side near the first peristaltic pump 10. The second counting bag 12 is provided with a second counting stop valve 14 on the side near the first peristaltic pump 10. 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 near the first peristaltic pump 10 is also connected to one end of the counting device, and the mixing bag is also connected to the other end of the counting device. The mixing bag, the first peristaltic pump 10, and the counting device are connected in a circulation loop.

[0099] Reference Figure 6 Before manual counting, turn the first counting stopcock valve 13 to position 1 or 7, or the second counting stopcock valve 14 to position 3 or 5, and extract the mixed cell preparation from the mixing bag as needed. Then, heat-seal the pipeline between the first counting bag 11 and the first counting stopcock valve 13 before manually counting the mixed cell preparation in the first counting bag 11, or heat-seal the pipeline between the second counting bag 12 and the second counting stopcock valve 14 before manually counting the mixed cell preparation in the second counting bag 12. Before automatic counting, turn the first counting stopcock valve 13 to position 5 and the second counting stopcock valve 14 to position 7. The circulation loop connecting the mixing bag, the first peristaltic pump 10, and the counting device is activated, and then the counting device is controlled to automatically count the flowing mixed cell preparation.

[0100] 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.

[0101] 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.

[0102] Reference Figure 7 In one embodiment, the cell preparation dispensing system further includes a transfer module; The liquid transfer module can be detachably connected to the refrigeration and mixing module, the counting module, and the control module. The transfer module includes a sample bag and a second peristaltic pump 16; The control module is used for: The cell preparation in the sample bag is prepared into a solution to obtain the prepared cell preparation. After the solution is prepared, the cell preparation enters the mixing preparation process, i.e.

[0103] 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. The refrigeration unit is controlled to lower the ambient temperature of the mixing bag. Control the second peristaltic pump 16 to pump the prepared cell preparation from the sample bag into the mixing bag; Control the second peristaltic pump 16 to empty the residual cell preparation in the transfer line into the mixing bag; 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.

[0104] 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.

[0105] Reference Figure 6 Before the second peristaltic pump 16 pumps the prepared cell preparation from the sample bag into the mixing bag, the 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 then reversed to discharge the gas in the transfer pipeline from the fifth sterile filter 19 out of the system. The transfer stopcock valve 20 is then turned to position 5 to connect the sample bag and the mixing bag. The cooling device is then controlled to cool the ambient temperature of the mixing bag. A temperature control sensor can be set in the cooling mixing module to monitor the ambient temperature.

[0106] During the process of controlling the second peristaltic pump 16 to pump the prepared cell preparation from the sample bag to the mixing bag, the liquid output of the sample bag can be monitored by the first bubble sensor 17 in the transfer module, the liquid flow rate in the second peristaltic pump 16, and the weighing sensor, and the liquid inlet of the mixing bag can be monitored by the second bubble sensor 18 in the cooling mixing module, so as to adjust the preset mixing parameters and achieve a better mixing effect.

[0107] After the second peristaltic pump 16 pumps the prepared cell preparation from the sample bag into the mixing bag, the transfer stopcock valve 20 is turned to position 1 to connect the fifth sterile filter 19 and the mixing bag. This controls the second peristaltic pump 16 to draw gas from the outside and uses the outside gas to vent the residual cell preparation in the transfer pipeline into the mixing bag.

[0108] In this embodiment, the pre-mixing treatment is adapted 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 carried out smoothly under any circumstances.

[0109] 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 liquid transfer requirements.

[0110] Figure 8 is a schematic diagram of the structure of the electronic device provided in an embodiment of this application, as shown below. Figure 8 As shown, the electronic device may include: a processor 810, a communication interface 820, a memory 830, and a communication bus 840, wherein the processor 810, the communication interface 820, and the memory 830 communicate with each other via the communication bus 840. The processor 810 can call a computer program stored in the memory 830 to execute steps of the cell preparation dispensing method, such as: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 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 the preset dispensing volume.

[0111] Furthermore, the logical instructions in the aforementioned memory 830 can be implemented as software functional units and, when sold or used as independent products, can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0112] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A method for dispensing cell preparations, characterized in that, include: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 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 the preset dispensing volume.

2. The cell preparation dispensing method according to claim 1, characterized in that, After the mixed cell preparation in the injection device is sequentially dispensed into each dispensing bag according to a preset dispensing volume, the process includes: Control the injection device to drain residual cell preparations from the dispensing tubing; Control the injection device to vent the gas from each dispensing bag.

3. The cell preparation dispensing method according to claim 2, characterized in that, The control of the injection device to empty the residual cell preparation in the dispensing tubing includes: The injection device is controlled to draw in outside air; The injection device is controlled to inject the extracted outside air into the dispensing pipeline; If the volume of the outside air injected in a single injection is less than the first volume threshold, the process returns to the step of controlling the injection device to extract outside air, and the injection device is controlled again to inject the extracted outside air into the dispensing pipeline until the cumulative volume of the injected outside 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, characterized in that, The control of the injection device to vent gas from each dispensing bag includes: Control the injection device to vent the residual gas inside itself; The injection device is controlled to vent the pre-vented dispensing bags in each dispensing bag; The injection device is controlled to vent the gas in each pre-vented dispensing bag according to different venting effects.

5. The cell preparation dispensing method according to claim 4, characterized in that, The control of the injection device to vent the pre-vented dispensing bags in each dispensing bag includes: The injection device is controlled to extract gas from the pre-vented packaging bags in each packaging bag according to a preset gas flow rate; the preset gas flow rate varies according to the number of pre-vented packaging bags with unvented gas. If the sensor at the outlet of the target pre-venting dispensing bag does not detect liquid within a preset time period, the injection device is controlled to vent the residual gas inside itself. The injection device is controlled to extract gas from the target pre-vented dispensing bag at a preset gas flow rate until the sensor at the liquid outlet of each pre-vented dispensing bag detects liquid within a preset time period. The target pre-venting packaging bag is any one of the packaging bags in the pre-venting packaging bag series.

6. The cell preparation dispensing method according to claim 4, characterized in that, The control of the injection device to vent gas from each pre-vented dispensing bag according to different venting effects includes: If the cell preparation in the target pre-vented dispensing bag does not form a liquid column outside the outlet of the target pre-vented dispensing bag, the injection device is controlled to draw gas from the target pre-vented dispensing bag until the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is located in the sensor at the corresponding outlet. If the highest point of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, then control the injection device to inject gas into the target pre-vented 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-vented dispensing bag is lower than the sensor at the outlet of the target pre-vented dispensing bag, then the injection device is controlled to extract gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor. If the highest point of a portion of the liquid column formed by the cell preparation in the target pre-vented dispensing bag is higher than the sensor at the outlet of the target pre-vented dispensing bag, and the highest point of another portion of the liquid column is lower than the sensor, then the injection device is controlled to inject gas into the target pre-vented dispensing bag, and then the injection device is controlled to extract gas from the target pre-vented dispensing bag until the highest point of the liquid column is located in the sensor. The target pre-venting packaging bag is any one of the packaging bags in the pre-venting packaging bag series.

7. The cell preparation dispensing method according to claim 1, characterized in that, The control of injecting the mixed cell preparation into the injection device includes: Control the injection device to draw the mixed cell preparation; The visual recognition device is controlled to identify whether the injection device is filled with the mixed cell preparation in real time. If not, the injection device is controlled to inject the gas-liquid mixture inside itself into the mixing bag, and then the process returns 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.

8. The cell preparation dispensing method according to claim 7, characterized in that, The step of sequentially dispensing the mixed cell preparation in the injection device into each dispensing bag according to a preset dispensing volume includes: The injection device is controlled to inject the mixed cell preparation into the corresponding dispensing bags sequentially according to the preset dispensing volume of each dispensing bag; If the volume of the mixed cell preparation injected in a single injection is insufficient to complete the dispensing of each bag according to the preset dispensing volume, the process returns to the step of controlling the injection device to extract the mixed cell preparation, and the injection device is controlled again to inject the mixed cell preparation into the corresponding dispensing bags sequentially according to the preset dispensing volume of each bag, until the cumulative volume of the injected mixed cell preparation is sufficient to complete the dispensing of each bag according to the preset dispensing volume.

9. The cell preparation dispensing method according to claim 1, characterized in that, The controlled mixing device performs a mixing operation on the cell preparation in the mixing bag, including: The mixing device is controlled to perform a mixing operation on the mixing bag according to preset mixing parameters to obtain a mixed cell preparation. Control the first peristaltic pump to pump the mixed cell preparation into a counting bag for manual cell counting or into a counting device for automatic cell counting; The first peristaltic pump is controlled to pump the mixed cell preparation, after cell counting is completed, back into the mixing bag to continue mixing.

10. The cell preparation dispensing method according to claim 1, characterized in that, Before the controlled mixing device performs the mixing operation on the cell preparation in the mixing bag, it includes: The cell preparation in the sample bag is prepared into a solution to obtain the prepared cell preparation. After the solution is prepared, the cell preparation enters the mixing preparation process.

11. The cell preparation dispensing method according to claim 10, characterized in that, The process of controlling the cell preparation after solution preparation to enter the mixing preparation process includes: Control the second peristaltic pump to vent the gas in the liquid transfer pipeline; The refrigeration device is controlled to lower the ambient temperature of the mixing bag; The second peristaltic pump is controlled to pump the prepared cell preparation from the sample bag into the mixing bag; The second peristaltic pump is controlled to empty the residual cell preparation in the transfer pipeline into the mixing bag.

12. A cell preparation dispensing system, characterized in that, include: Control module, cooling and mixing module, and dispensing module; The control module, the cooling and mixing module, and the dispensing module are detachably connected in pairs. The cooling and mixing module includes a mixing device and a mixing bag; The dispensing module includes an injection device and multiple dispensing bags; The control module is used for: The mixing device is controlled to mix the cell preparation in the mixing bag to obtain a mixed cell preparation; 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 the preset dispensing volume.

13. An electronic device comprising a processor and a memory storing a computer program, characterized in that, When the processor executes the computer program, it implements the steps of the cell preparation dispensing method according to any one of claims 1 to 11.

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