Disposable cell preparation device

Abstract

The utility model discloses a disposable cell preparation preparation device, and provides the following scheme aiming at the problems that the conventional cell suspension preparation needs to be carried out in a sterile environment, the requirement is higher and the like, the device comprises a sterile isolation bag, the top of the sterile isolation bag is provided with a bag opening, and the sterile isolation bag is provided with a water inlet and a water outlet. The disposable cell preparation device comprises a sterile isolation bag and a bag opening, the bag opening is used for enabling articles to be placed in the sterile isolation bag, the top end of the bag opening is in threaded connection with a sealing cover, and the disposable cell preparation device provides an economical and efficient sterile operation environment through the design of the sterile isolation bag and the sealing cover; due to the arrangement of the multi-needle filter, the high quality of the cell suspension is ensured; the waste liquid bag, the connecting intubation tube and the valve are arranged, so that waste liquid is effectively collected; due to the design of the preparation bag, the connecting pipe and the needle head filter, great convenience is provided for preparation of the cell suspension.

Description

Technical Field

[0001] This utility model relates to the field of cell biology technology, and in particular to a disposable cell preparation device. Background Technology

[0002] The preparation process of the injectable cell preparation is as follows: After thawing the cell cryopreservation solution in a 37°C water bath, wipe the mouth of the cell cryopreservation tube with a 75% alcohol swab; transfer the solution to a washing tube using a 50ml syringe, mix by pipetting 5 times, filter the washing solution through a 10μm filter membrane, and collect the cells on the filter membrane into the washing tube; then, use a 50ml syringe to transfer 20ml of washing solution from the second washing tube to the washing tube to suspend the cells, mix by pipetting 5 times, filter the washing solution through a 10μm filter membrane, and collect the cells on the filter membrane into the washing tube. Then, mix the washed cells with saline solution, human serum albumin, and filter to prepare the cell preparation. After appropriate testing, it can be injected into patients.

[0003] Cell preparations require a Class A clean environment, which is difficult for general hospitals such as county hospitals or field hospitals to meet. Therefore, it is necessary to provide a device that can provide a clean environment for the preparation of cell preparations. Utility Model Content

[0004] The purpose of this invention is to address the shortcomings of existing technologies, such as the need for traditional cell suspension preparation in a Class A cleanroom, which has high requirements, is cumbersome and prone to errors, and places high demands on the technical skills of laboratory personnel. Therefore, a disposable cell preparation device is proposed.

[0005] To achieve the above objectives, this utility model adopts the following technical solution: a disposable cell preparation device, comprising:

[0006] A sterile isolation bag, wherein the top of the sterile isolation bag has an opening for placing items into the sterile isolation bag, and a sealing cap is threaded to the top of the opening for sealing the opening.

[0007] It also includes two embedded gloves, which are integrally set on both sides of the sterile isolation bag. Both sides of the sterile isolation bag have glove openings, and both glove openings are connected to the inside of the corresponding embedded gloves, so as to facilitate the experimental operator to put his / her hands into the embedded gloves.

[0008] It also includes cell tubes, which are placed inside a sterile isolation bag. Both ends of the cell tubes are fixedly connected to infusion tubes. An injection port is opened on the outer wall of the cell tube, and a rubber stopper is placed inside the injection port. The cell tubes are used for preparing cell suspensions.

[0009] It also includes a first filter membrane and a second filter membrane, which are respectively disposed at both ends of the cell tube. The first filter membrane and the second filter membrane are used to provide corresponding filtration for washing the cells and preparations in the cell tube.

[0010] It also includes multiple vials, each of which is placed in a sterile isolation bag and contains a corresponding solution to assist in the preparation of cell suspension.

[0011] In one possible design, a syringe connector is fixedly installed at one end of each of the two infusion tubes, and the two syringe connectors cooperate with a syringe to draw out the liquid in the cell tube; each of the two infusion tubes is provided with a first valve to control the discharge of the liquid.

[0012] In one possible design, the sterile isolation bag contains two waste liquid bags, one end of each waste liquid bag is fixedly connected to a connecting tube, each connecting tube is equipped with a second valve, and one end of each connecting tube is connected to a syringe. The waste liquid bags are used to collect waste liquid generated during the preparation of cell suspension.

[0013] In one possible design, the sterile isolation bag contains a preparation bag, and connecting tubes are fixedly connected to both sides of the preparation bag. Each of the two connecting tubes is equipped with a third valve. The two connecting tubes are used for the entry and exit of liquid, respectively. A needle filter is fixedly connected to one end of each of the two connecting tubes. The two needle filters are used to filter the liquid entering and exiting the preparation bag. The preparation bag is used to store the prepared cell suspension.

[0014] In one possible design, the contents of the multiple vials are respectively filled with cell resuscitation fluid, washing fluid, and solvent, wherein at least two portions of the washing fluid are prepared.

[0015] In one possible design, the outer wall of the cell tube is fitted with multiple fixing frames, each consisting of a fixing ring and a storage tube. The storage tube is fixedly connected to one end of the fixing ring and is used to place the corresponding vial. A locking bolt is provided between the two ends of the fixing ring to tighten and fix the fixing ring, ensuring that the fixing frame can be stably fitted onto the outer wall of the cell tube.

[0016] In one possible design, a resuscitation bag protruding outward is provided on one side of the sterile isolation bag, the resuscitation bag being connected to the interior of the sterile isolation bag for reviving the cell cryopreservation tubes.

[0017] In one possible design, a liquid injection rubber stopper is fixedly inserted through the top of the sterile isolation bag, the liquid injection rubber stopper being used to enable additional liquid delivery to the sterile isolation bag.

[0018] In this application, during use, the experimental operator can place multiple items into the sterile isolation bag through the bag opening, and then seal the bag opening with the sealing cap. The experimental operator should ensure that both the sterile isolation bag and the items inside the sterile isolation bag have been disinfected to ensure that the sterile isolation bag is in a sterile state. After the device is transported to the designated hospital or laboratory by cold chain, the experimental operator can insert their hands into the embedded gloves and then operate on the items inside the sterile isolation bag.

[0019] Before operation, the experimenter can place the cell cryopreservation tube in a thawing bag, and then place the outer bag in a cup of water at 37°C to thaw the cells in the cell cryopreservation tube.

[0020] During washing, the operator uses a syringe to extract the cells from the pre-revived cryopreservation tubes and inject them into the cell tubes through the rubber stopper in the injection port. Then, the operator extracts the revival solution from the corresponding vial and injects it into the cell tubes as well. Next, the revival solution and cell suspension are resuspended and mixed thoroughly. The operator then connects the syringe to the syringe connector near the second filter membrane, ensuring the first valve is open during waste liquid extraction. Under pressure, the syringe draws out the liquid from the cell tubes and injects it into the waste bag. When the waste liquid is extracted, the cells in the cell tubes are blocked by the 10μm second filter membrane, ensuring that the cells are not discharged. The operator then uses washing solution to wash and agitate the cells back into the cell tubes.

[0021] During the washing process, the operator can draw the washing solution from the corresponding vial with a syringe, and then inject it into the cell tube according to the above operation to complete the washing. The washed liquid is filtered and transferred to the corresponding waste bag. This washing operation needs to be performed twice.

[0022] After cleaning, the operator can use a syringe to draw up the solvent and inject it into the cell tube for resuscitation. Then, the first filter membrane is connected to the cell tube, which can be rotated. The operator can use the syringe connector near the first filter membrane to extract the prepared cell suspension. During the extraction process, the liquid will pass through the 30μm first filter membrane for filtration. Afterward, it can be transferred to the cell preparation bag to complete the preparation of the cell preparation. Both ends of the preparation bag are equipped with connecting tubes and needle filters. The two connecting tubes are used for liquid inlet and outlet, respectively, and the two needle filters can filter the cell suspension again to ensure that the prepared cell suspension is free of impurities.

[0023] The beneficial effects of this utility model are as follows: In this utility model, the disposable cell preparation device provides a relatively sterile operating environment for the preparation of cell suspensions through the setting of a sterile isolation bag, and the sterile isolation bag is low in cost and easy to implement; the opening of the sterile isolation bag can be sealed with a sealing cap to ensure that external microorganisms cannot enter during the preparation process; at the same time, the setting of embedded gloves allows experimental operators to operate on the items inside the sterile isolation bag while maintaining a sterile state, which greatly reduces the risk of cell contamination;

[0024] In this invention, the disposable cell preparation device integrates all the tools and utensils required for cell suspension preparation, such as cell tubes, vials, filter membranes, and needle filters, making it convenient for laboratory operators to prepare cell suspensions, simplifying the operation steps, and improving work efficiency.

[0025] In this invention, the disposable cell preparation device, by setting two filter membranes with different pore sizes and corresponding needle filters, can filter the liquid entering and exiting the cell tube and preparation bag, effectively removing impurities and microorganisms from the cell suspension and ensuring the quality of the prepared cell suspension.

[0026] In this invention, the disposable cell preparation device, by setting up a waste liquid bag and corresponding connecting tubes and valves, allows experimental operators to conveniently collect and store the waste liquid generated during the preparation process, thus avoiding environmental pollution from the waste liquid.

[0027] In this invention, the disposable cell preparation device, by setting up a preparation bag and corresponding connecting tubes and needle filters, provides convenience for experimental operators to easily prepare the prepared cell suspension;

[0028] The disposable cell preparation device provided by this utility model offers an economical and efficient aseptic operating environment through the design of a sterile isolation bag and a closed cap, reducing the risk of cell contamination. The device integrates all necessary tools and utensils, simplifying the operation steps and improving work efficiency. The inclusion of a filter membrane and needle filter ensures the high quality of the cell suspension. The configuration of the waste liquid bag, connecting tubing, and valves effectively collects waste liquid and avoids environmental pollution. Overall, this device effectively improves the efficiency and quality of cell suspension preparation. Attached Figure Description

[0029] Figure 1 This is a three-dimensional structural diagram of the disposable cell preparation device proposed in this utility model;

[0030] Figure 2 This is a cross-sectional view of the disposable cell preparation device proposed in this utility model;

[0031] Figure 3 This is a schematic diagram of the cell tube connection structure of the disposable cell preparation device proposed in this utility model;

[0032] Figure 4 This is a schematic diagram of the fixing frame structure of the disposable cell preparation device proposed in this utility model;

[0033] Figure 5 This is a schematic diagram of the waste liquid bag structure of the disposable cell preparation device proposed in this utility model;

[0034] Figure 6 This is a schematic diagram of the preparation bag structure of the disposable cell preparation device proposed in this utility model.

[0035] In the diagram: 1. Sterile isolation bag; 2. Bag opening; 3. Sealing cap; 4. Inner glove; 5. Glove opening; 6. Cell tube; 7. Fixation frame; 8. Waste fluid bag; 9. Preparation bag; 10. Injection port; 11. First filter membrane; 12. Second filter membrane; 13. Infusion tubing; 14. First valve; 15. Syringe connector; 16. Fixing collar; 17. Storage tube; 18. Locking bolt; 19. Vial; 20. Connecting cannula; 21. Second valve; 22. Connecting tube; 23. Third valve; 24. Needle filter; 25. Resuscitation bag; 26. Injection rubber stopper. Detailed Implementation

[0036] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0037] Example 1: Refer to Figure 1-6A liquid preparation device, comprising:

[0038] The sterile isolation bag 1 is made of flexible, transparent material. Support rods can be used to support the bag's four sides, facilitating observation and manipulation of its interior by laboratory personnel. The top of the sterile isolation bag 1 has an opening 2, allowing items to be easily placed inside. A sealing cap 3 is threaded onto the top of the opening 2, ensuring a sterile environment inside the bag. A rubber stopper is fixedly embedded in the top of the sterile isolation bag 1, allowing laboratory personnel to puncture the stopper externally with a syringe (the stopper ensures no air leakage after syringe puncture) to deliver additional fluid into the bag.

[0039] In this embodiment, two embedded gloves 4 are integrally provided on each side of the sterile isolation bag 1, and glove openings 5 ​​are provided on both sides of the sterile isolation bag 1. Both glove openings 5 ​​are connected to the interior of the corresponding embedded gloves 4. This design allows experimental operators to easily insert their hands into the embedded gloves 4 to perform operations such as preparing cell suspensions in a sterile environment.

[0040] In this embodiment, a cell tube 6 is disposed inside the sterile isolation bag 1. The cell tube 6 is used for preparing cell suspensions. Both ends of the cell tube 6 are fixedly connected to infusion tubes 13. An injection port 10 is opened on the outer wall of the cell tube 6, and a rubber stopper is provided in the injection port 10 to facilitate the experimental operator to inject the corresponding liquid into the cell tube 6.

[0041] To ensure that the liquid entering and exiting the cell tube 6 is filtered, in this embodiment, a first filter membrane 11 and a second filter membrane 12 are respectively provided at both ends of the cell tube 6. The first filter membrane 11 has a pore size of 30 μm and is used to filter impurities in the cell suspension. The second filter membrane 12 has a pore size of 10 μm and is used for washing and filtering the cells.

[0042] In this embodiment, a syringe connector 15 is fixedly installed at one end of each of the two infusion tubes 13. Both syringe connectors cooperate with syringes to draw out the liquid in the cell tube 6. A first valve 14 is provided on each of the two infusion tubes 13 to control the discharge of the liquid.

[0043] To facilitate the preparation of the cell suspension, in this embodiment, the sterile isolation bag 1 is also equipped with multiple vials 19, each filled with solutions such as resuscitation fluid, cleaning fluid, and solvent. At least two portions of the cleaning fluid are prepared to meet the corresponding needs during the preparation process.

[0044] In this embodiment, two waste liquid bags 8 are also provided inside the sterile isolation bag 1 for collecting waste liquid generated during the preparation of cell suspension. One end of the waste liquid bag 8 is connected to a syringe via a connecting tube 20, and a second valve 21 is provided on the connecting tube 20 to control the discharge of waste liquid.

[0045] In addition, in this embodiment, a preparation bag 9 is also provided inside the sterile isolation bag 1 for storing the prepared cell suspension. Connecting tubes 22 are fixedly connected to both sides of the preparation bag 9, and a third valve 23 is provided on the connecting tube 22 for controlling the inflow and outflow of liquid. A needle filter 24 is fixedly connected to one end of the connecting tube 22, and both needle filters 24 are equipped with 30µm filter membranes for filtering the cell suspension entering and exiting the preparation bag 9.

[0046] This application can be used in the field of cell biology technology, or in other fields applicable to this application.

[0047] Example 2: Reference Figure 2 , 3 4. Improvement based on Example 1: a disposable cell preparation device, which is applied to the field of cell biology technology;

[0048] In this embodiment, a resuscitation bag 25 protruding outward is provided on one side of the sterile isolation bag 1, and the bag body is connected to the interior of the sterile isolation bag 1. The experimental operator can place the cell cryopreservation tubes in the resuscitation bag 25, and then place the outer bag body in a cup containing 37°C warm water to revive the cells in the cell cryopreservation tubes.

[0049] To facilitate the placement and fixation of vials 19, in this embodiment, multiple fixing brackets 7 are fitted onto the outer wall of the cell tube 6. Each fixing bracket 7 consists of a fixing ring 16 and a storage tube 17. The storage tube 17 is fixedly connected to one end of the fixing ring 16, and the inner wall of the storage tube 17 engages with the corresponding vial 19, allowing for the placement of multiple vials 19 for easy access by laboratory personnel. A single locking bolt 18 is provided between the two ends of the fixing ring 16, which tightens and fixes the fixing ring 16, ensuring that the fixing bracket 7 is stably fitted onto the outer wall of the cell tube 6.

[0050] The working principle and usage process of this technical solution are as follows:

[0051] In use, the operator can place multiple items into the sterile isolation bag 1 through the opening 2, and then seal the opening 2 with the sealing cap 3. The operator should ensure that both the sterile isolation bag 1 and the items inside it have been disinfected to ensure that the sterile isolation bag 1 is in a sterile state. Afterwards, the operator can insert their hands into the inner gloves 4 and then operate on the items inside the sterile isolation bag 1.

[0052] Before operation, the experimenter can place the cell cryopreservation tubes in the thawing bag 25, and then place the outer bag in a cup containing water at 37°C to thaw the cell cryopreservation tubes.

[0053] The experimenter needs to use a syringe to extract the cells from the pre-revived cryopreservation tube and inject them into the cell tube 6 through the rubber stopper in the injection port 10. Then, the revival fluid from the corresponding vial 19 is extracted and injected into the cell tube 6 as well. The revival fluid and cell suspension are then resuspended and mixed. The experimenter can then connect the syringe to the syringe connector 15 near the second filter membrane 12, ensuring that the corresponding first valve 14 is open during waste fluid extraction. Under a certain pressure, the syringe can draw out the liquid inside the cell tube 6, which can then be injected into the waste fluid bag. When the waste fluid is extracted, the cells in the cell tube 6 are blocked by the 10μm second filter membrane 12, ensuring that the cells are not discharged. The experimenter can then use washing solution to wash and filter the cells.

[0054] During washing, the experimenter can draw the cleaning solution from the corresponding vial 19 using a syringe, and then inject it into the cell tube 6 according to the above operation. After injecting the cleaning solution, shaking the cell tube 6 can wash the cells off the second filter membrane 12, thus completing the washing. The washed liquid is then filtered out and transferred to the corresponding waste bag 8. This washing operation needs to be performed twice.

[0055] After cleaning, the operator can use a syringe to draw up the solvent and inject it into the cell tube 6. After injecting the solvent, an empty syringe can be used to inject air in the opposite direction through the syringe connector 15 and shake the cell tube 6. The solution in the cell tube can wash the cells off the second filter membrane 12 and complete the resuspension. Then, the operator can use the syringe connector 15 near the first filter membrane 11 to extract the prepared cell suspension. During the extraction process, the liquid will pass through the 30μm first filter membrane 11 for filtration. After that, it can be transferred to the preparation bag 9 to complete the preparation of the cell preparation. Both ends of the preparation bag 9 are equipped with connecting tubes 22 and needle filters 24. The two connecting tubes 22 are used for liquid inlet and liquid outlet, respectively. At the same time, the two needle filters 24 can filter the cell suspension again to further reduce impurities in the prepared cell suspension.

[0056] The above description is only a preferred embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Any equivalent substitutions or changes made by those skilled in the art within the technical scope disclosed in the present utility model, based on the technical solution and the inventive concept of the present utility model, should be included within the protection scope of the present utility model.

Claims

1. A disposable cell preparation device, characterized in that, include: A sterile isolation bag (1) has an opening (2) at the top. The opening (2) is used to allow items to be placed into the sterile isolation bag (1). A sealing cap (3) is threaded onto the top of the opening (2). The sealing cap (3) is used to close the opening (2). It also includes two embedded gloves (4), which are integrally set on both sides of the sterile isolation bag (1). Both sides of the sterile isolation bag (1) have glove openings (5), and both glove openings (5) are connected to the inside of the corresponding embedded gloves (4) to facilitate the experimental operator to put his / her hands into the embedded gloves (4). It also includes a cell tube (6), which is placed inside a sterile isolation bag (1). Both ends of the cell tube (6) are fixedly connected to infusion tubes (13). An injection port (10) is opened on the outer wall of the cell tube (6). A rubber stopper is provided in the injection port (10). The cell tube (6) is used to prepare cell suspension. It also includes a first filter membrane (11) and a second filter membrane (12), which are respectively disposed at both ends of the cell tube (6). The first filter membrane (11) and the second filter membrane (12) are used to provide corresponding filtration for washing the cells and preparations in the cell tube (6). It also includes multiple vials (19), each of which is placed inside a sterile isolation bag (1), and each of the multiple vials (19) is filled with a corresponding solution.

2. The disposable cell preparation device according to claim 1, characterized in that, One end of each of the two infusion tubes (13) is fixedly equipped with a syringe connector (15), and the two syringe connectors are used to cooperate with a syringe to extract the liquid in the cell tube (6); a first valve (14) is provided on each of the two infusion tubes (13).

3. The disposable cell preparation device according to claim 2, characterized in that, The sterile isolation bag (1) contains two waste liquid bags (8), one end of each of the two waste liquid bags (8) is fixedly connected to a connecting tube (20), and each of the two connecting tubes (20) is equipped with a second valve (21). One end of each of the two connecting tubes (20) is connected to a syringe. The waste liquid bags (8) are used to collect the waste liquid generated during the preparation of the cell suspension.

4. The disposable cell preparation device according to claim 2, characterized in that, The sterile isolation bag (1) contains a preparation bag (9). Both sides of the preparation bag (9) are fixedly connected to connecting tubes (22). Each of the two connecting tubes (22) is equipped with a third valve (23). The two connecting tubes (22) are used for the entry and exit of liquid, respectively. One end of each of the two connecting tubes (22) is fixedly connected to a needle filter (24). The two needle filters (24) are used to filter the liquid entering and exiting the preparation bag (9). The preparation bag (9) is used to store the prepared cell suspension.

5. The disposable cell preparation device according to claim 1, characterized in that, The contents of each of the vials (19) are respectively filled with resuscitation fluid, cleaning fluid and solvent.

6. The disposable cell preparation device according to claim 5, characterized in that, The outer wall of the cell tube (6) is fitted with multiple fixing frames (7). Each fixing frame (7) consists of a fixing ring (16) and a storage tube (17). The storage tube (17) is fixedly connected to one end of the fixing ring (16). The storage tube (17) is used to place the corresponding vials (19). The two ends of the fixing ring (16) are provided with the same locking bolt (18). The locking bolt (18) is used to tighten and fix the fixing ring (16) to ensure that the fixing frame (7) can be stably fitted on the outer wall of the cell tube (6).

7. The disposable cell preparation device according to claim 1, characterized in that, The sterile isolation bag (1) has an outwardly protruding resuscitation bag (25) on one side, and the resuscitation bag (25) is connected to the interior of the sterile isolation bag (1).

8. The disposable cell preparation device according to claim 1, characterized in that, The top of the sterile isolation bag (1) is fixedly perforated with a liquid injection rubber stopper (26).

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