Vacuum sampling suite for stem cell bagged preparation

Abstract

The utility model discloses a vacuum sampling suite for a stem cell bagged preparation, which belongs to the technical field of cell collection and comprises a vacuum negative pressure tube and a catheter component, a bottle plug is arranged at a tube opening of the vacuum negative pressure tube, and scales are arranged on a tube body of the vacuum negative pressure tube; the catheter assembly comprises a three-way connector, a pipetting catheter and a sampling catheter, the three-way connector is communicated with the stem cell preparation cryopreservation bag through a sampling needle, one end of the pipetting catheter is connected with the three-way connector, the other end of the pipetting catheter is used in cooperation with a pipettor through a suction head, and one end of the sampling catheter is connected with the three-way connector. And the other end of the sampling catheter is provided with a puncture needle connected with a vacuum negative pressure tube. The combined use of the pipetting catheter, the pipettor, the vacuum negative pressure tube and the sampling catheter is adopted, normal saline with a definite volume can be injected into the bag to dilute cell sap, then negative pressure is used for extraction, the cell sap can be prevented from remaining in the bag, and the operation is simple and easy to control.

Description

Technical Field

[0001] The utility model belongs to the technical field of cell collection, and specifically, it is a vacuum sampling kit for stem cell bagged preparations. Background Art

[0002] Stem cells can be used for the clinical treatment of various diseases, such as autoimmune diseases, cardiovascular diseases, neurological diseases, bone diseases, blood system diseases, etc., and also have the effect of anti-aging and wrinkle removal. At present, the common method for treating stem cell preparations before infusion to patients clinically is to use a disposable syringe, and directly draw the cell suspension from the sampling port on the stem cell bag with the syringe needle, and then inject it into a corresponding buffer solution such as physiological saline for dilution and then drip infusion. In addition, when conducting quality inspection after the production of stem cell preparations, the pharmacopoeia usually adopts the weighing method or the volumetric method (using a disposable syringe, directly drawing the cell suspension from the bag with the syringe needle and injecting it into a graduated cylinder for weighing and recording the corresponding volume); when it is necessary to conduct a re-inspection of stem cell preparations clinically, the cell fluid drawn by the syringe is also injected into a graduated cylinder for accurate weighing and then used for detection.

[0003] The existing method of drawing cell fluid with a syringe often has the following problems:

[0004] 1) There is often residual cell fluid in the frozen storage bag of the stem cell preparation that cannot be drawn, resulting in waste of samples during clinical liquid collection or inaccurate weighing during pre-clinical preparation quality inspection, which affects the clinical use dose, etc. Especially for small-sized cell preparations with a volume of less than 10 ml, the impact caused by clinical liquid collection or weighing errors is particularly serious.

[0005] 2) The pressure difference inside and outside the frozen storage bag of the stem cell preparation makes it difficult for the syringe to draw out the cell fluid, and mechanical force is likely to cause cell damage.

[0006] 3) Since the syringe itself cannot accurately measure the cell fluid when drawing cell fluid with a syringe, an additional graduated cylinder needs to be used for weighing during the pre-clinical quality inspection of stem cell preparations, which increases the risk of the cell fluid contacting the outside world and is likely to contaminate the sample.

[0007] In the prior art, the invention patent with the publication number CN113549536A discloses a sterile cell sampling device and method based on a fully enclosed syringe, the device adopts a fully enclosed syringe, the piston of the fully enclosed syringe is sealed with the syringe and can be slidably installed in the syringe, the syringe is connected to the cell drug production device through a catheter, the catheter is provided with a control valve in an open state and a closed state, the syringe constitutes a sampling container and is pre-installed with sterile air inside, which can achieve quantitative, sterile, disposable high-precision cell sampling. The utility model patent with the publication number CN221350702U discloses a sample collection component for storing and extracting cell fluid, including an upper bottle cap, a suction component, a lower bottle cap and a bottle body arranged in sequence from top to bottom, the suction component is used to suck the cell fluid, the bottle body is used to store the sucked cell fluid, and the lower bottle cap is provided with a sealing component for sealing the bottle body, which can realize re-sealing after negative pressure collection of cells, can ensure that the cell fluid in the sample bottle is not contaminated, prevent liquid volatilization, and simplify the operation steps.

[0008] Although the above-mentioned cell syringe and sampler have solved the problems of contamination and convenient operation during cell fluid collection to a certain extent, they have not completely solved the above-mentioned problems existing in the prior art when using syringes to extract cell fluid from frozen bags of stem cell preparations. Therefore, it is imperative to provide a new collection device for bagged stem cell preparations. Utility Model Content

[0009] The purpose of the utility model is to provide a vacuum collection kit for stem cell bag preparations, which adopts the combined use of a pipette catheter and a pipette, a vacuum negative pressure tube and a sampling catheter, can inject a clear volume of physiological saline into the bag to dilute the cell fluid, and then use negative pressure to extract it, which can avoid the cell fluid from remaining in the bag, and the operation is simple and easy to control.

[0010] The utility model is realized through the following technical scheme: a vacuum sampling kit for a bagged stem cell preparation, comprising a vacuum negative pressure tube and a catheter assembly, wherein the tube mouth of the vacuum negative pressure tube is provided with a bottle stopper, and the tube body thereof is provided with scales; the catheter assembly comprises a three-way joint, a pipetting catheter and a sampling catheter, the three-way joint is connected to a frozen storage bag of the stem cell preparation through a sampling needle, one end of the pipetting catheter is connected to the three-way joint, and the other end of the pipetting catheter is used in conjunction with a pipette through a suction head, one end of the sampling catheter is connected to the three-way joint, and the other end of the sampling catheter is provided with a puncture needle connected to the vacuum negative pressure tube.

[0011] The vacuum negative pressure tube comprises at least two sections of tube bodies with different inner diameters. All tube bodies are provided with scales, and the inner diameter of the tube body near the tube mouth is the smallest, and its scale is a precision scale.

[0012] The pipetting conduit and the sampling conduit are both provided with liquid stop valves.

[0013] Both the pipetting catheter and the sampling catheter are flexible hoses.

[0014] The sampling catheter is sleeved at one end of the pipette tip, and the other end of the pipette tip is matched with the liquid outlet of the pipettor.

[0015] The vacuum negative pressure tube is made of polypropylene or polystyrene material.

[0016] It also includes a sterile packaging bag for storing the catheter assembly and the pipette tip.

[0017] Compared with the prior art, the present utility model has the following advantages and beneficial effects:

[0018] (1) The present utility model realizes the connection between the stem cell preparation cryopreservation bag and the vacuum negative pressure tube through the sampling tube, and uses negative pressure to extract the cell liquid, which can replace the inconvenient operation of using a syringe in the prior art, and is convenient to use and simple to operate.

[0019] (2) By designing the position near the pipe orifice of the vacuum negative pressure tube to have a smaller inner diameter and cooperating with precise scales, the present utility model can achieve precise measurement of the cell liquid, avoid the operation of measuring again with a measuring cylinder, not only provide accurate data for subsequent quality inspection, reduce the measurement steps, but also reduce the pollution of the cell liquid.

[0020] (3) Through the design of the pipetting catheter, by using the cooperation of the pipetting catheter and the pipettor, before extracting the cell liquid, a definite volume of physiological saline can be injected into the stem cell preparation cryopreservation bag through the pipetting catheter by the pipettor, so that the cell liquid is not easily left in the bag after being diluted, avoiding waste of the cell liquid. In addition, the pre-dilution of physiological saline is also beneficial to reducing the probability of cell aggregation when directly sucking high-concentration cell preparations, and at the same time ensuring the accuracy of the quality inspection and clinical use dose after the production of the dry preparation. Description of the Drawings

[0021] Figure 1 It is a schematic structural diagram of the present utility model.

[0022] Among them, 1 - vacuum negative pressure tube, 2 - bottle stopper, 3 - scale, 4 - three-way joint, 5 - pipetting catheter, 6 - sampling catheter, 7 - sampling needle, 8 - stem cell preparation cryopreservation bag, 9 - pipette tip, 10 - pipettor, 11 - puncture needle, 12 - precise scale, 13 - liquid stop valve. Detailed Embodiments

[0023] The following further describes the present utility model in detail with reference to embodiments, but the embodiments of the present utility model are not limited thereto. The following embodiments are all described by taking a stem cell bagged preparation formed by filling 5 ml of stem cell preparation into a 10 ml specification cell cryopreservation bag as an example.

[0024] Example 1:

[0025] This example relates to a vacuum sampling kit for stem cell bagged preparations, which is applicable to the sampling and volume detection of animal cell samples such as stem cell preparations, etc., and is designed to solve the many inconveniences existing when using a syringe to extract cell fluid from the stem cell preparation cryopreservation bag 8 and then for quality inspection.

[0026] See Figure 1 As shown in the structure, this example mainly consists of a vacuum negative pressure tube 1, a catheter assembly, and a tip 9 matching a pipette 10. Among them, the catheter assembly is connected by a three-way joint 4, a pipetting catheter 5, and a sampling catheter 6. The pipetting catheter 5 and the sampling catheter 6 are respectively connected to two ports of the three-way joint 4, and the remaining port of the three-way joint 4 is connected to a sampling needle 7. This sampling needle 7 can be inserted into the nozzle of the stem cell preparation cryopreservation bag 8 to realize the connection between the pipetting catheter 5 / sampling catheter 6 and the stem cell preparation cryopreservation bag 8. Since the pipetting catheter 5 in this example is used to connect the pipette 10 and the sampling catheter 6 is used to connect the vacuum negative pressure tube 1, it is possible to first dilute the cell fluid in the bag and then extract the diluted cell fluid, avoiding the residue of the cell fluid in the bag, and at the same time, the operation is convenient and easy to control.

[0027] Specifically, in this example, the combined use of the pipetting catheter 5 and the tip 9 can realize the injection of physiological saline for dilution into the stem cell preparation cryopreservation bag 8 by the pipette 10. The tip 9 can replace the adsorption tip on the existing pipette 10, so that one end of the tip 9 is connected to the liquid outlet of the pipette 10 to match the pipette 10, and the other end of the tip 9 is used to connect the pipetting catheter 5. During use, the stem cell preparation cryopreservation bag 8, the three-way joint 4, the pipetting catheter 5, the tip 9, and the pipette 10 are connected in sequence. The pipette 10 is used to accurately inject a definite volume (such as 5.0 ml, the same below) of physiological saline into the stem cell preparation cryopreservation bag 8 to dilute the cell fluid for subsequent sampling extraction. Preferably, the tip 9 and the pipetting catheter 5 can be designed as an integrated structure. After directly connecting the tip 9 to the pipette 10, the connection between the pipetting catheter 5 and the pipette 10 can be realized.

[0028] During sampling extraction, it is connected through the sampling catheter 6 and the vacuum negative pressure tube 1, and the cell fluid in the stem cell preparation cryopreservation bag 8 is directly extracted into the vacuum negative pressure tube 1 by using negative pressure. As Figure 1 shown in the structure, the vacuum negative pressure tube 1 is sealed by a stopper 2 at the opening, and the inside of the tube is in negative pressure. The sampling catheter 6 inserts the puncture needle 11 connected to its end into the rubber stopper inside the stopper 2 to connect the stem cell preparation cryopreservation bag 8, the three-way joint 4, the sampling catheter 6, and the vacuum negative pressure tube 1, and uses the negative pressure inside the tube to realize the extraction of the cell fluid. In order to accurately measure the extracted cell fluid, the structure of the vacuum negative pressure tube 1 in this example is also improved. As Figure 1As shown in the structure, the vacuum negative pressure tube 1 is composed of two tube bodies with different inner diameters. Scales 3 are provided on both tube bodies. The tube body with a smaller inner diameter is arranged near the tube mouth. Due to its smaller inner diameter, the scale 3 on it can be set as a precise scale 12 for accurately measuring the volume of cell fluid.

[0029] In a specific embodiment, to better facilitate the use of the vacuum sampling kit, the pipetting catheter 5 and the sampling catheter 6 can be designed as flexible tubes, and stop valves 13 are provided on the pipetting catheter 5 and the sampling catheter 6 to conveniently control the opening and closing of the corresponding catheter as needed during use. At the same time, components such as the pipetting catheter 5, the sampling catheter 6, the three-way joint 4, the sampling needle 7, the pipette tip 9, and the puncture needle 11 can be stored in a sterile packaging bag and taken out for installation when needed, which can effectively reduce bacterial contamination during the extraction of cell fluid. For the vacuum negative pressure tube 1, it can be made of a low-adsorption material, such as polypropylene or polystyrene materials, etc.

[0030] Example 2:

[0031] This example relates to the usage method of the vacuum sampling kit described in Example 1.

[0032] The vacuum sampling kit consists of a vacuum negative pressure tube 1, a three-way joint 4, a sampling needle 7, a pipetting catheter 5, a sampling catheter 6, a pipette tip 9, and a puncture needle 11 encapsulated in a sterile packaging bag.

[0033] During use, first take out each part from the sterile packaging bag, install the sampling needle 7, the pipetting catheter 5, and the sampling catheter 6 on the three ports of the three-way joint 4 respectively, and close the stop valves 13 of the pipetting catheter 5 and the sampling catheter 6. Then install the puncture needle 11 on the sampling catheter 6 and insert the puncture needle 11 into the vacuum negative pressure tube 1.

[0034] Before starting sampling, first use an (electric) pipettor 10 to aspirate 5.0 ml of physiological saline, then replace the pipette tip 9 at the liquid outlet of the pipettor 10, use the pipette tip 9 to connect the pipetting catheter 5 and the pipettor 10, insert the sampling needle 7 into the catheter of the stem cell preparation cryopreservation bag 8, open the stop valve 13 of the pipetting catheter 5, and inject 5.0 ml of physiological saline into the stem cell preparation cryopreservation bag 8 through the pipettor 10.

[0035] After the cell solution in the cryopreservation bag 8 of the stem cell preparation is diluted with physiological saline, the liquid stop valve 13 of the pipetting catheter 5 is closed, and the liquid stop valve 13 of the sampling catheter 6 is opened. Under negative pressure, the cell solution is automatically drawn into the vacuum negative pressure tube 1. After the drawing is completed, the liquid stop valve 13 of the sampling catheter 6 is closed. At this time, the cell solution in the cryopreservation bag 8 of the stem cell preparation is completely drawn out without residue. The cell solution drawn into the vacuum negative pressure tube 1 can display its accurate measured volume by the precision scale 12, and can be directly used for quality inspection during the production of stem cell preparations or for clinical reexamination, without the need to inject it into a measuring cylinder for measurement.

[0036] The above is only a preferred embodiment of the present invention, and does not impose any form of limitation on the present invention. Any simple modification or equivalent change made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A vacuum sampling kit for a packaged stem cell preparation, characterized in that: The invention comprises a vacuum negative pressure tube (1) and a catheter assembly, wherein the tube mouth of the vacuum negative pressure tube (1) is provided with a bottle stopper (2), and the tube body thereof is provided with a scale (3); the catheter assembly comprises a three-way joint (4), a pipetting catheter (5) and a sampling catheter (6); the three-way joint (4) is connected to a stem cell preparation freezing bag (8) via a sampling needle (7); one end of the pipetting catheter (5) is connected to the three-way joint (4), and the other end of the pipetting catheter (5) is used in conjunction with a pipette (10) via a suction head (9); one end of the sampling catheter (6) is connected to the three-way joint (4), and the other end of the sampling catheter (6) is provided with a puncture needle (11) connected to the vacuum negative pressure tube (1).

2. The vacuum sampling kit according to claim 1, characterized in that: The vacuum negative pressure tube (1) comprises at least two sections of tube bodies with different inner diameters, all of which are provided with scales (3), and the inner diameter of the tube body near the tube mouth is the smallest, and its scale (3) is a precision scale (12).

3. The vacuum sampling kit according to claim 1, characterized in that: The liquid transfer conduit (5) and the sampling conduit (6) are both provided with liquid stop valves (13).

4. The vacuum sampling kit according to claim 1, characterized in that: The pipetting catheter (5) and the sampling catheter (6) are both soft tubes.

5. The vacuum sampling kit according to claim 4, characterized in that: The sampling catheter (6) is sleeved on one end of the suction head (9), and the other end of the suction head (9) cooperates with the liquid outlet of the pipette (10).

6. The vacuum sampling kit according to claim 1, characterized in that: The vacuum negative pressure tube (1) is made of polypropylene or polystyrene.

7. The vacuum sampling kit according to claim 1, characterized in that: Also included is a sterile packaging bag for storing the catheter assembly and the suction tip (9).

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