A cell preparation bag
By designing a cell preparation bag with an independent cavity and a manually opened connecting tube, combined with the filtration design of the cell sieve, the problems of the traditional cell preparation bag being numerous, time-consuming and high pollution risks are solved, and convenient cell preparation operation and efficient filtration effect are achieved.
Patent Information
- Application Number
- CN202421467644.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-06-26
- Publication Date
- 2025-04-11
- Estimated Expiration
- 2034-06-26
AI Technical Summary
The traditional cell preparation bag has many steps, long time, low efficiency and high pollution risk during the transfer and exhaust of cells, and it is difficult to recover residual cells, and requires multiple unplugging and inserting operations.
A cell preparation bag including a bag body, a connecting tube and a cell injection tube is designed. A manually opened connecting tube is provided between the two chambers. A cell sieve is set on the cell injection tube. The sieve is composed of a sieve body, a syringe connecting tube, a branch tube and a cell sieve mesh, which is used to filter the cell preparations at one time and discharge bubbles.
It realizes convenient blood vessel and residual cell operation of normal saline, reduces open operation, reduces contamination risk, improves the filtration effect and efficiency of cell suspension, and pre-prepared sterile normal saline and albumin in the GMP workshop, ensuring the quality of cell preparations.
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Figure CN222738247U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of mixer auxiliary devices, in particular to a cell preparation bag. Background Art
[0002] Cell therapy is the use of the patient's own (or allogeneic) adult cells (or stem cells) to repair tissues and organs. It has been widely used in diseases such as bone marrow transplantation, advanced liver cirrhosis, femoral head necrosis, malignant tumors, myocardial infarction, etc.
[0003] The cell preparations prepared in the cell purification workshop need to be filtered out of impurities such as cell clumps with a cell screen, and then loaded into cell preparation bags and added with human serum albumin to prevent cell agglomeration. All the air in the bag must be carefully discharged because if there is air in the bag, a large number of bubbles will appear in the bag due to vibration during the transportation of the preparation, and the bubble rupture process will cause a large number of surrounding cells to die due to surface tension. However, after the air is discharged, a large amount of cell preparations are more likely to remain in the bag during infusion. Normal saline is usually required multiple times during infusion, such as flushing the blood vessels with normal saline before infusion, and flushing the cells remaining in the infusion tube with normal saline after infusion.
[0004] Traditional cell preparation bags have many steps in the cell transfer process, the exhaust process is time-consuming, the efficiency is low and the risk of contamination is high. Physiological saline is required for infusion, and it is difficult to recover the residual cells in the preparation bag. Physiological saline needs to be manually injected into the preparation bag to dilute the cell suspension and then re-injected into the patient's body, involving multiple insertion and removal operations. Utility Model Content
[0005] In order to solve the above problems, the utility model provides a cell preparation bag, and the technical solution adopted is as follows:
[0006] A cell preparation bag, characterized by comprising:
[0007] The bag body has a first cavity and a second cavity independently arranged therein, the first cavity is connected to an albumin injection tube and a cell preparation infusion port, and the second cavity is connected to a saline injection tube and a saline infusion port;
[0008] A connecting pipe, the two ends of which are connected to the first cavity and the second cavity respectively, and one end of which is provided with an easy-to-fold interface;
[0009] One end of the cell injection tube is connected to the first cavity, and the other end is connected to the cell screen.
[0010] Furthermore, the cell sieve includes a sieve body, a syringe connecting tube, a branch tube and a cell sieve mesh. The sieve body is a shell with a hollow interior. One end of the syringe connecting tube is open, and the other end has a bottom cover and is connected to the sieve body. The branch tubes are provided in multiple groups. One end of the branch tube passes through the bottom cover of the syringe connecting tube and is connected to the inner cavity of the syringe connecting tube, and the other end extends to the interior of the sieve body. The cell sieve mesh is fixedly connected to the interior of the sieve body, and the cell sieve mesh is located between the water outlet of the branch tube and the water outlet of the sieve body.
[0011] Furthermore, one end of the connecting pipe is connected to the first cavity through an easily foldable interface.
[0012] Furthermore, a hanging ring is fixedly connected to the bag body.
[0013] Furthermore, the cell sieve inlet is provided with a first protective cap.
[0014] Furthermore, the inlet ends of the albumin injection tube and the physiological saline injection tube are both provided with silicone plugs, and the silicone plug sleeves are provided with protective caps.
[0015] The beneficial effects of the utility model are:
[0016] 1. The preparation bag has two chambers in one, and there is a manually opened connecting tube between the two chambers, which can facilitate the operation of flushing blood vessels and residual cells with physiological saline, without the need for multiple plugging and unplugging and other open operations;
[0017] 2. By setting a cell sieve on the cell injection tube, one-time cell preparation screening and bag body bubble removal operations can be realized, which minimizes open operations and reduces the risk of contamination;
[0018] 3. The cell sieve evenly distributes the cell suspension on the cell sieve through multiple sets of branch tubes, which can ensure that the cell suspension passes through the cell sieve evenly, avoid local accumulation, and effectively improve the filtration effect and filtration efficiency of the cell suspension;
[0019] 4. The cell preparation bags used in this scheme can pre-prepare physiological saline and albumin in the GMP workshop, ensuring the sterility effect and standardization level, and improving the quality of cell preparations. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 This is a schematic diagram of the explosion structure of the utility model
[0021] Figure 2 Schematic diagram of the cell sieve structure
[0022] Figure 3 Top view of the cell screen
[0023] Figure 4 Schematic diagram of the easy-to-fold interface structure
[0024] Figure 5 Schematic diagram of the finished cell preparation bag
[0025] Figure 6 Schematic diagram of injecting cell suspension into the cell preparation bag
[0026] Figure 7 Diagram of infusing the cell preparation bag
[0027] Among them, 1-first cavity, 2-second cavity, 3-connecting tube, 301-easy-to-fold interface, 4-hanging ring, 5-cell injection tube, 6-cell sieve, 601-sieve body, 602-syringe connecting tube, 603-branch tube, 604-cell sieve, 7-first protective cap, 8-albumin injection tube, 9-first silicone plug, 10-second protective cap, 11-cell preparation infusion port, 12-physiological saline injection tube, 13-second silicone plug, 14-third protective cap, 15-physiological saline infusion port, 16-albumin, 17-physiological saline, 18-syringe. DETAILED DESCRIPTION
[0028] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.
[0029] In the description of the utility model, it is necessary to understand that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the viewing direction or position relationship, and are only for the convenience of describing the utility model, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the utility model.
[0030] like Figure 1-Figure 7 A cell preparation bag shown in the figure comprises a bag body, wherein two groups of independent cavities are arranged in the bag body, namely a first cavity 1 and a second cavity 2, a connecting pipe 3 is connected above the first cavity 1 and the second cavity 2, and a hanging ring 4 is integrally formed above the bag body.
[0031] Specifically, the first cavity 1 on the bag body is connected to a cell injection tube 5, an albumin injection tube 8 and a cell preparation infusion port 11. One end of the cell injection tube 5 is connected to the interior of the first cavity 1, and the other end is connected to a cell sieve 6. The inlet end of the cell sieve 6 is provided with a first protective cap 7. The cell sieve 6 is as shown in FIG. Figure 2 and Figure 3As shown, it is composed of a sieve body 601, a syringe connecting tube 602, multiple groups of branch tubes 603 and a cell screen 604. The sieve body 601 is a shell with a hollow interior, an arc-shaped shell on the upper part, an inverted cone-shaped shell on the lower part and a water outlet at the bottom. The inlet end of the syringe connecting tube 602 is uncovered, and the outlet end is provided with a bottom cover, and four groups of mounting holes are evenly spaced along the circumferential direction on the bottom cover. Four groups of branch tubes 603 are provided, and one end of each group of branch tubes 603 is connected to and flush with the mounting holes on the bottom cover of the syringe connecting tube 602, and the other end extends to the interior of the sieve body 601, and the cell screen 604 is fixedly connected to the interior of the sieve body 601, and is located between the water outlet of the branch tube 603 and the water outlet of the sieve body 601, and And the four groups of water outlets of the four groups of branch tubes 603 are evenly distributed on the plane of the cell screen 604, so as to ensure that the cell suspension flowing out of the branch tubes 603 can evenly pass through the cell screen 604. When the cell suspension is injected into the first cavity 1 through the cell injection tube 5, it is connected to the syringe 18 through the syringe connecting tube 602. The cell suspension enters the sieve body 601 through the four groups of branch tubes 603 and is evenly spread on the cell screen 604. Finally, after sieving impurities, it is injected into the first cavity 1. Through the design of the cell screen 6, the cell suspension injected into the first cavity 1 can be filtered, and the use of multiple groups of branch tubes 603 evenly arranged can effectively improve the filtering effect and efficiency of the cell suspension.
[0032] One end of the albumin injection tube 8 is connected to the interior of the first cavity 1, and the other end is fixedly connected to the first silicone plug 9, and the first silicone plug 9 is provided with a second protective cap 10; the cell preparation infusion port 11 is arranged below the first cavity 1 and is connected to the interior of the first cavity 1.
[0033] The two ends of the connecting pipe 3 are connected to the first cavity 1 and the second cavity 2 respectively, and the end connected to the first cavity 1 is provided with an easy-to-fold interface 301. Figure 4 As shown, the connecting pipe 3 and the first cavity 1 are disconnected under normal conditions by means of a breakable plug. When connection is required, the breakable plug can be broken off by hand.
[0034] The second cavity 2 is connected to a saline injection tube 12 and a saline infusion port 15. One end of the saline injection tube 12 is connected to the interior of the second cavity 2, and the other end is provided with a second silicone plug 13. A third protective cap 14 is sleeved on the second silicone plug 13. The saline infusion port 15 is connected to the interior of the second cavity 2.
[0035] After the cell preparation bag is produced and sterilized, a syringe is used to inject saline into the second cavity 2 through the saline injection tube 12 in the GMP purification workshop, and albumin is injected into the first cavity 1 through the albumin injection tube 8. After the injection is completed, the redundant tubes are heat-sealed to form a Figure 5The cell preparation bag is prepared as shown and stored in a refrigerator at 4°C.
[0036] When the device is in use, the cell preparation bag is placed in the clean bench. Figure 6 As shown, the cell suspension is sucked into the syringe 18, and an appropriate amount of air is inhaled, the syringe 18 is connected to the syringe connecting tube 602, the cell suspension is filtered through the cell sieve 6 and then injected into the first cavity 1, and then the piston of the syringe 18 is pulled back to expel the air inside the first cavity 1, and then the cell sieve 6 and unnecessary pipelines are removed by heat sealing to make the cell preparation bag in a sealed state.
[0037] During infusion, Figure 7 As shown, the double-head infusion set is respectively inserted into the cell preparation infusion port 11 and the saline infusion port 15, and the flow regulator of the double-head infusion set is used to control the dripping of the cell suspension and the saline respectively. After the cell dripping is completed, the two sets of flow regulators on the double-head infusion set are closed, and the easy-to-break interface 301 on the connecting tube 3 is broken off, so that the first cavity 1 and the second cavity 2 are connected through the connecting tube 3, and the second cavity 2 is squeezed so that an appropriate amount of saline in the second cavity 2 enters the first cavity 1, and then the infusion is continued, so that all the residual cells in the first cavity 1 can be injected into the patient's body.
[0038] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements can be made without departing from the principle of the present invention, and these improvements should also be regarded as the protection scope of the present invention.
Claims
1. A cell preparation bag, characterized in that: include: The bag body has a first cavity and a second cavity independently arranged therein, the first cavity is connected to an albumin injection tube and a cell preparation infusion port, and the second cavity is connected to a saline injection tube and a saline infusion port; A connecting pipe, the two ends of which are connected to the first cavity and the second cavity respectively, and one end of which is provided with an easy-to-fold interface; A cell injection tube, one end of which is connected to the first cavity, and the other end of which is connected to a cell sieve, wherein the cell sieve comprises a sieve body, a syringe connecting tube, a branch tube and a cell sieve, wherein the sieve body is an internally hollow shell, one end of the syringe connecting tube is open, and the other end has a bottom cover and is connected to the sieve body, wherein multiple groups of branch tubes are provided, one end of the branch tube passes through the bottom cover of the syringe connecting tube and is connected to the inner cavity of the syringe connecting tube, and the other end extends to the interior of the sieve body, wherein the cell sieve is fixedly connected to the interior of the sieve body, and the cell sieve is located between the water outlet of the branch tube and the water outlet of the sieve body.
2. The cell preparation bag according to claim 1, characterized in that: One end of the connecting pipe is connected to the first cavity through an easily foldable interface.
3. The cell preparation bag according to claim 1, characterized in that: A hanging ring is fixedly connected to the bag body.
4. The cell preparation bag according to claim 1, characterized in that: A first protective cap is provided at one end of the inlet of the cell sieve.
5. The cell preparation bag according to claim 1, characterized in that: The inlet ends of the albumin injection tube and the physiological saline injection tube are both provided with silicone plugs, and the silicone plug sleeves are provided with protective caps.