Novel cell sampling device

Abstract

According to the novel sterile cell sampling device provided by the utility model, the sampling operation part is far away from the cell culture device by additionally arranging the pipeline and the sample storage bag, and the degerming air filter is additionally arranged, so that the problem that the sampling operation is difficult by directly hot melting a Luer taper to the sampling pipeline of the cell culture device in the traditional method is solved; the potential pollution risk problem caused by cracking of the Luer taper is solved; on the other hand, the sampling device disclosed by the utility model can be used for directly sampling sterile cells in a D-grade or C-grade clean area, and the sampling operation is simple, convenient and rapid.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of cell therapy, and particularly relates to a novel cell sampling device in the culture process of a cell therapy product. BACKGROUND

[0002] Cell therapy has emerged in the treatment of tumors and immune-related diseases. In particular, cell therapy products such as chimeric antigen receptor T cells (CAR-T cells), TCR-T cells and natural killer cells (NK cells) have achieved remarkable clinical results.

[0003] CAR-T and TCR-T cell therapy products, first, need to genetically edit immune cells such as T cells to increase the killing ability of target cells such as tumor cells, then expand and culture in vitro, and then reinfuse into the patient's body. During the culture process, the cell suspension in the culture device needs to be sampled to detect the number of cells or the growth state, and a luer connector usually needs to be hot-melt connected on the sampling pipeline of the culture device, and sampling is carried out in a sterile environment such as a biological safety cabinet. During the process of connecting the luer connector on the sampling pipeline with the sampling syringe, the female luer is prone to cracking, resulting in liquid leakage and a certain risk of contamination. As we all know, cell therapy products are costly to produce and prepare. If contaminated, not only will it cause a waste of hundreds of thousands of production costs, but also will delay the treatment process of tumor and other disease patients, and even endanger the lives of patients. CONTENT OF THE INVENTION

[0004] In order to solve the possible contamination problem during sampling detection of cell therapy product expansion preparation, the utility model provides a sterile sampling device, which can realize simple sterile sampling operation, even in low-level D or C clean environment still can realize sterile sampling operation.

[0005] The cell sampling device of the utility model, contain multi -pass pipeline (1), the first pipeline of multi -pass pipeline integrated sealing or connection sealing plug (2);The second pipeline of multi -pass pipeline is integrally connected with sample storage bag (4), and the sample storage bag is connected with a bacteria removal air filter (51) through a pipeline, and the bacteria removal air filter (51) is connected with a luer connector (61);The third pipeline of multi -pass pipeline is connected with a bacteria removal air filter (52), and the air filter (52) is connected with a luer connector (62);Pipeline opening and closing control devices (31 and 32) are respectively arranged on the second pipeline and the third pipeline;The other pipelines of the multi -pass pipeline are provided with any one of the first pipeline, the second pipeline or the third pipeline.

[0006] The first pipeline is connected to the sampling pipeline of the cell product culture device by a sterile hot melt pipe. The material of the pipeline should meet the requirements of sterile pipe connection and sterile pipe sealing. During use, suction is applied through the luer connector (61), the sterilization air filter (51), the sample storage capsule (4), the second pipeline, and the first pipeline in sequence to draw the cell solution sample from the sampling pipeline of the cell culture device into the sample storage capsule (4). The sample storage capsule (4) is a temporary storage device for the cell sample after sampling. It is integrally connected with the second pipeline. The sample storage capsule (4) can be in various shapes such as capsule, column, and sphere, and can realize the function of storing cell solution samples. In some embodiments, the sealing plug can also be a luer adapter or other airtight device.

[0007] In some embodiments, the multi-way pipeline (1) is a three-way pipeline. In some embodiments, the three-way pipeline is a Y-shaped or T-shaped three-way pipeline.

[0008] In some embodiments, the multi-way pipeline (1) is a four-way pipeline, and the fourth pipeline of the four-way pipeline is arranged with any one of the first pipeline, the second pipeline, or the third pipeline. The arrangement of the fourth pipeline increases the selectivity of the use process to avoid the entire device being unable to be used due to defects in a single pipeline.

[0009] In some embodiments, the multi-way pipeline (1) is a five-way pipeline, and the fourth pipeline and the fifth pipeline of the five-way pipeline are arranged with any one of the first pipeline, the second pipeline, or the third pipeline. The fourth pipeline and the fifth pipeline can be the same or different. The arrangement of the fourth pipeline and the fifth pipeline increases the selectivity of the use process.

[0010] In some embodiments, the multi-way pipeline (1) is a six-way pipeline, and the other pipelines of the six-way pipeline are arranged with any one of the first pipeline, the second pipeline, or the third pipeline, increasing the selectivity of the use process of each pipeline.

[0011] In some embodiments, the pipeline opening and closing control device has an open state and a closed state, and is used to control the on-off of the second pipeline and the third pipeline. When the pipeline opening and closing control device is in the open state, the two ends of the second pipeline and the third pipeline are conductive. When the pipeline opening and closing control device is in the closed state, the two ends of the second pipeline and the third pipeline are in a cut-off state.

[0012] The pipeline opening and closing control device is selected from a pipe clamp, a solenoid valve, an electric valve, a pneumatic valve, or a hydraulic valve.

[0013] When sampling from the cell culture bottle, the pipeline opening and closing control device (31) is opened, the pipeline opening and closing control device (32) is closed, and the cell sample enters the sample storage capsule (4) through the first pipeline and the second pipeline. Then, the pipeline opening and closing control device (31) is closed, the pipeline opening and closing control device (32) is opened, and the cell sample in the pipeline is pushed back to the cell culture bottle through the luer joint (62) and the sterile air filter (51), so that the residual cell sample in the pipeline does not affect the representativeness of subsequent sampling.

[0014] In some embodiments, the sterile air filter (51) and the second pipeline are located on the adjacent side or the opposite side of the sample storage capsule (4).

[0015] In some embodiments, the sample storage capsule (4) is further connected with the luer joint (63) through a pipeline, so that the cell sample can be taken out from the sample storage capsule (4) through the luer joint (63) after the sampling device and the cell culture device are disconnected, and the convenience of sampling from the sample storage capsule for subsequent operation is improved.

[0016] In some embodiments, the luer joint (63) and the second pipeline are located on the adjacent side or the opposite side of the sample storage capsule (4).

[0017] In some embodiments, the sterile air filter and the pipeline are integrally connected or detachably connected, for example, threaded connection; the detachable connection needs to be sterilized before assembly and then packaged for subsequent use; the sterilization method can be radiation sterilization, dry heat sterilization, or wet heat sterilization. The detachable connection can reduce the production cost of the sampling device.

[0018] In some embodiments, the luer joint and the sterile air filter are integrally connected or detachably connected.

[0019] In some embodiments, the luer joint and the pipeline are integrally connected or detachably connected.

[0020] The beneficial technical effects of the utility model relative to the prior art are as follows:

[0021] By increasing the additional pipeline and the sample storage capsule, the sampling operation part is away from the cell culture device, and the sterile air filter is added, so that the potential pollution risk problem caused by the cracking of the luer joint in the traditional method of directly hot melting the luer joint to the sampling pipeline of the cell culture device is solved. On the other hand, the sampling device can directly sample the sterile cells in the D-level or C-level clean area, and the sampling operation is simple and fast. On the other hand, the sample storage capsule is further directly connected with the luer joint through a pipeline, so that the cell sample can be taken out from the sample storage capsule through the luer joint after the sampling device and the cell culture device are disconnected. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 This is a schematic diagram of a sterile sampling device composed of a Y-shaped tee pipe.

[0023] Explanation of reference numerals in the attached figures:

[0024] 1. Y-type tee pipe; 2. Plug; 31, 32. Pipe opening and closing control device; 4. Sample storage tank; 51, 52. Sterilizing air filter; 61, 62, 63. Luer connector. Detailed Implementation

[0025] The following detailed description, in conjunction with the accompanying drawings, illustrates the specific embodiments of the cell sampling device involved in this utility model.

[0026] Example 1

[0027] Taking a cell sampling device composed of a Y-shaped three-way tube as an example, such as Figure 1 As shown, when using this application, firstly, confirm that the tubing opening and closing control devices (31 and 32) are in the closed state. Then, aseptically heat-fused the first tubing of the Y-type three-way tubing to the sampling tubing of the cell culture device. Next, mix the cell suspension in the cell culture device. Then, connect the syringe or other suction device to the Luer connector (61), open the tubing opening and closing control device (31), and use the syringe or other suction device to draw the cell suspension from the cell culture device into the sample reservoir. After sampling, close the tubing opening and closing control device (31). Afterward, open the tubing opening and closing control device (32), use the syringe to draw out some air (or use other pushing devices), connect to the Luer connector (62) of the sterile air filter (52), and push the cell suspension remaining in the tubing during sampling back into the cell culture device to avoid residual cell samples in the tubing, which could affect the representativeness of subsequent sampling. Finally, the sampling tube of the cell culture device and the first tubing of the cell sampling device are aseptically sealed to complete the aseptic sampling operation. In addition, the user can take out the sample through the Luer connector (63) at the sample storage sac (4) for various tests such as cell number and cell status, according to actual needs.

[0028] The above description is merely a specific embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the scope of the claims.

Claims

1. A novel cell sampling device characterized in that, It comprises a multi-pass pipeline (1), the first pipeline of which is integrally formed with a sealing plug (2); the second pipeline of the multi-pass pipeline is integrally connected with a sample storage bag (4), which is connected with a sterile air filter (51) through a pipeline, and the sterile air filter (51) is connected with a luer connector (61); the third pipeline of the multi-pass pipeline is connected with a sterile air filter (52), and the sterile air filter (52) is connected with a luer connector (62); pipeline opening and closing control devices (31 and 32) are respectively arranged on the second pipeline and the third pipeline; the other pipelines of the multi-pass pipeline are arranged in the same way as any one of the first pipeline, the second pipeline or the third pipeline.

2. The sampling device of claim 1, wherein, The multi-pass pipeline is a three-pass pipeline.

3. The sampling device of claim 2, wherein, The three-pass pipeline is a Y-shaped or T-shaped three-pass pipeline.

4. The sampling device of claim 1, wherein, The multi-pass pipeline is a four-pass pipeline, and the fourth pipeline of the four-pass pipeline is arranged in the same way as any one of the first pipeline, the second pipeline or the third pipeline.

5. The sampling device of claim 1, wherein, The multi-pass pipeline is a five-pass pipeline, and the fourth pipeline and the fifth pipeline of the five-pass pipeline are arranged in the same way as any one of the first pipeline, the second pipeline or the third pipeline.

6. The sampling device of claim 1, wherein, The pipeline opening and closing control device comprises a control clamp and a control valve.

7. The sampling device of claim 1, wherein, The sterile air filter (51) and the second pipeline are located on the adjacent side or the opposite side of the sample storage bag.

8. The sampling device of claim 1, wherein, The sample storage bag (4) is further directly connected with a luer connector (63) through a pipeline.

9. The sampling device of claim 8, wherein, The luer connector (63) and the second pipeline are located on the adjacent side or the opposite side of the sample storage bag.

10. The sampling device of any one of claims 1-9, wherein, The sterile air filter and the pipeline are integrally connected or detachably connected.

11. The sampling device of any one of claims 1-9, wherein, The luer connector and the sterile air filter are integrally connected or detachably connected.

12. The sampling device of claim 8 or 9, wherein, The luer connector and the pipeline are integrally connected or detachably connected.

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