Improved virus preparation preservation device for automatic closed system
By using luer lock components and sterile thermal connection technology in the viral preparation storage device, the closed storage and transduction of the virus is achieved, solving the problems of self-contamination and cross-contamination during the viral transduction process, and ensuring that under sterile conditions virus delivery.
Patent Information
- Application Number
- CN202420700119.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-07
- Publication Date
- 2024-12-27
- Estimated Expiration
- 2034-04-07
AI Technical Summary
In the prior art, there is a risk of self-contamination and cross-contamination during the virus transduction process, especially when the virus is extracted from the frozen duct, the lack of closed operations leads to an increase in the risk of contamination.
A virus preparation storage device with an automated enclosed system was designed, using Luer lock assembly and transparent syringe. Through the threaded connection and sterile thermal connection technology of male and female Luer lock assembly, the closed storage and transduction of viruses are achieved to avoid The virus contacts the outside world to ensure that the entire process takes place in a closed environment.
It effectively reduces the risks of self-contamination and cross-contamination, ensures sterile conditions during the virus transduction process, avoids the contamination problem when traditional syringes extract viruses, and realizes the closed delivery of the virus from frozen ducts to cells.
Smart Images
Figure CN222250681U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a virus preparation storage device for improving an automated closed system. Background Art
[0002] With the rise of cell therapy products, the requirements for processes are becoming more and more stringent. Many cell therapy products use viral transduction to genetically modify the target cells, thereby obtaining a genetically engineered cell, and then a series of subsequent production processes to obtain the final cell therapy product. Viral transduction, as a production process link in the production of cell therapy products, has an importance that cannot be ignored.
[0003] When using the CliniMACS Prodigy system to produce cell therapy products, the method of adding viruses to cells is: 1. Get the cryotube containing the virus; 2. Use a syringe to extract the virus from the open cryotube; 3. Connect the syringe to the transfer bag and transfer the virus to the transfer bag; 4. Connect the transfer bag to the pipeline on the CliniMACS Prodigy system and add the virus to the cells.
[0004] It can be seen that the method of extracting the virus from the cryopreservation tube with a syringe and then adding the virus to the cell bag is often a non-closed operation, and the extraction of the virus from the cryopreservation tube with a syringe is an open operation, which has a certain risk of self-contamination and cross-contamination. Therefore, in order to solve this problem, it is urgent to design a closed virus reagent storage device to reduce the self-contamination and cross-contamination caused by the virus transfer operation. Utility Model Content
[0005] The purpose of the utility model is to provide a virus preparation storage device for an automated closed system improvement to solve the problems raised in the above background technology. The following technical solution is provided: a virus preparation storage device for an automated closed system improvement, comprising:
[0006] A syringe, wherein a piston is sealed and slidable in the syringe, and the piston and the syringe form a closed chamber for filling a virus reagent; a male Luer lock assembly is provided at the upper end of the syringe, a female Luer lock assembly is installed at the upper end of the male Luer lock assembly, the male Luer lock assembly and the female Luer lock assembly are sealed and connected, and a filling assembly is connected to the upper end of the female Luer lock assembly.
[0007] The syringe is made of transparent material, and scale plates are evenly arranged on the outer surface of the syringe.
[0008] One end surface of the piston is conical and a push rod is arranged at the other end. The piston is interference connected with the inner wall of the syringe.
[0009] In this technical solution, in order to avoid self-contamination and cross-contamination caused by extracting the virus from the cryopreservation tube by using a syringe during the virus transduction operation, the syringe is cylindrical, with a scale plate arranged on the outside, a Luer lock (a whole formed by connecting a male Luer lock assembly and a female Luer lock assembly) is installed at the front end of the syringe, the virus is pre-filled in the syringe, and the piston connected to the push rod is ensured to be close to the pre-filled virus, thereby ensuring the sealing with the syringe.
[0010] When performing viral transduction in a sterile environment in a closed environment, after the Luer lock is connected, one end of the female Luer lock assembly is connected to the potting assembly. Since the syringe itself and the male Luer lock assembly are an integrated structure, the potting assembly is inserted into the transfer bag and the push rod is pushed and pulled. The pressure change is generated inside the syringe to achieve contactless transduction of the virus with the outside world, thereby avoiding self-contamination and cross-infection during the transduction process.
[0011] In any of the above technical solutions, further, the male Luer lock assembly includes: a support part, an assembly cavity is provided inside the support part, one end of the assembly cavity is communicated with the outside, a threaded groove is provided on the side wall of the assembly cavity, a plug is provided at the bottom of the assembly cavity, and a through hole is provided in the middle of the plug.
[0012] The female Luer lock assembly includes a clamping part, one end of which is provided with a mounting part, a threaded protrusion is provided at the outer ring end surface of the mounting part, and the threaded protrusion is threadedly matched with the plug, and a plug hole is provided in the middle of the mounting part, and the plug hole is plug-connected. A protective wing is provided on the ring side of the clamping part, and a pipe interface is provided in the middle of the clamping part, and the pipe interface is connected to the plug hole.
[0013] One end of the syringe is sealedly connected to the male Luer lock assembly and communicated with the through hole.
[0014] In the technical solution, the male Luer lock assembly and the female Luer lock assembly are snapped together and opened and closed by threads. When in use, the mounting portion is aligned with the assembly cavity, the protective wing is pinched by hand to rotate the clamping portion, and the mounting portion is screwed into the threaded groove to achieve closure.
[0015] During the screwing process, one end of the plug is inserted into the socket to complete the docking of the male Luer lock assembly and the female Luer lock assembly; the Luer locks are sealed by threaded connection, and the plug and the socket are interference fit, thereby ensuring the airtightness of the entire device at the connection.
[0016] In any of the above technical solutions, further, a conduit is connected to the pipeline interface.
[0017] In this technical solution, the catheter and the pipeline interface are connected by aseptic heat connection, and the other end of the catheter is connected to the puncture head. A cap is buckled on the puncture head. Once the outer packaging of the puncture head is opened, the puncture head needs to be heat-sealed and removed if it is not used immediately, because the puncture head with a channel is not in a completely sealed state. This ensures that the whole formed by the potting component connected to the female Luer lock component and the male Luer lock component is always isolated from the external closed environment, thereby eliminating the self-contamination and cross-contamination caused by the contact between the virus and the outside world during the traditional syringe extraction process. In addition, the pipelines involved in this application are all disposable sterile consumables, and the operation of adding viruses to cells is in a closed system throughout the process, avoiding the risk of contamination and cross-contamination.
[0018] It should be noted that the pipelines involved in the present invention are all disposable sterile consumables. Taking the production of cell therapy products using the automated closed system CliniMACS Prodigy as an example, after adopting the present invention, the method of adding viruses to the cells is as follows:
[0019] 1. Get the storage device containing the virus;
[0020] 2. Connect the device to the transfer bag and transfer the virus into the transfer bag;
[0021] 3. Connect the transfer bag to the tubing on the CliniMACS Prodigy system, and the virus is automatically added to the cell culture chamber through a pre-set program.
[0022] And the two ways of connecting the device to the transfer bag are as follows:
[0023] 1. The transfer bag comes with its own pipeline. Use a sterile pipe connection machine to heat-connect the pipeline of this device with the pipeline of the transfer bag;
[0024] 2. If the transfer bag does not come with a pipeline, use a sterile pipe connection machine to heat-connect the pipeline of this device to a new puncture head, and then insert the puncture head into the puncture port reserved in the transfer bag to complete the connection.
[0025] The beneficial effect of the utility model is that through the Luer lock structure, the interference fit mode of the threaded connection of the male and female parts of the Luer lock can achieve the effect of liquid-tight connection, thereby ensuring that when the virus is injected into the cell, the virus is transported along the pipeline in a closed system throughout the whole process, avoiding the risk of contamination and cross contamination. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Figure 1 It is a schematic diagram of the appearance of the utility model;
[0027] Figure 2 It is a partial exploded view of the utility model;
[0028] Figure 3 It is a structural schematic diagram of the utility model;
[0029] Figure 4 It is a schematic diagram of the assembly of the Luer lock in the utility model.
[0030] The reference numerals in the figure are: 10, syringe; 12, piston; 13, push rod; 20, virus reagent; 30, male Luer lock assembly; 31, support portion; 32, assembly cavity; 33, plug; 34, through hole; 35, threaded groove; 40, female Luer lock assembly; 41, clamping portion; 42, mounting portion; 43, threaded protrusion; 44, socket; 45, pipe interface; 46, wing; 50, potting assembly; 51, catheter; 60, scale plate. DETAILED DESCRIPTION
[0031] The following will be combined with the drawings in the embodiments of the present application to clearly describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the present application belong to the scope of protection of this application.
[0032] In the description of the present application, it should be noted that the terms used herein are only for describing specific embodiments, and are not intended to limit the exemplary embodiments according to the present application. For ease of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be regarded as part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as merely exemplary, rather than as a limitation. Therefore, other examples of the exemplary embodiments may have different values. It should be noted that similar numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.
[0033] Embodiment 1:
[0034] like Figure 1-2 As shown, this embodiment provides a virus preparation storage device for automated closed system improvement, comprising:
[0035] A syringe 10, wherein a piston 12 is sealingly slidably disposed in the syringe 10, wherein the piston 12 and the syringe 10 form a sealed chamber for encapsulating a virus reagent 20; a male Luer lock assembly 30 is disposed at the upper end of the syringe 10, wherein a female Luer lock assembly 40 is mounted at the upper end of the male Luer lock assembly 30, wherein the male Luer lock assembly 30 and the female Luer lock assembly 40 are sealedly connected, and a sealing assembly 50 is connected to the upper end of the female Luer lock assembly 40.
[0036] The syringe 10 is made of a transparent material, and scale plates 60 are evenly arranged on the outer surface of the syringe 10 .
[0037] One end surface of the piston 12 is conical and a push rod 13 is provided at the other end. The piston 12 is interference-connected with the inner wall of the syringe 10 .
[0038] In the technical solution, in order to avoid self-contamination and cross-contamination caused by extracting the virus from the cryopreservation tube by using a syringe during the virus transduction operation, the syringe 10 is cylindrical, with a scale plate 60 arranged on the outside, a Luer lock (a whole formed by connecting a male Luer lock assembly 30 and a female Luer lock assembly 40) is installed at the front end of the syringe 10, the virus is pre-filled in the syringe 10, and the piston 12 connected to the push rod 13 is ensured to be close to the pre-filled virus, thereby ensuring the sealing with the syringe 10.
[0039] When performing virus transduction in a sterile room in a closed environment, after the Luer lock is connected, one end of the female Luer lock assembly 40 is connected to the potting assembly 50. Since the syringe 10 itself and the male Luer lock assembly 30 are an integrated structure, the potting assembly 50 is inserted into the transfer bag and the push rod 13 is pushed and pulled. The pressure change is generated inside the syringe 10 to achieve contactless transduction of the virus with the outside world, thereby avoiding self-contamination and cross-infection during the transduction process.
[0040] Embodiment 2:
[0041] like Figure 3-4 As shown, specifically, the male Luer lock assembly 30 includes: a support portion 31, an assembly cavity 32 is provided inside the support portion 31, one end of the assembly cavity 32 is communicated with the outside, a threaded groove 35 is provided on the side wall of the assembly cavity 32, a plug 33 is provided at the bottom of the assembly cavity 32, and a through hole 34 is provided in the middle of the plug 33.
[0042] The female Luer lock assembly 40 includes a clamping portion 41, one end of which is provided with a mounting portion 42, a threaded protrusion 43 is provided at the outer ring end surface of the mounting portion 42, and the threaded protrusion 43 is threadedly matched with the plug 33, and a plug hole 44 is provided in the middle of the mounting portion 42, and the plug hole 44 is plugged and connected with the plug 33. A protective wing 46 is provided on the ring side of the clamping portion 41, and a pipe interface 45 is provided in the middle of the clamping portion 41, and the pipe interface 45 is communicated with the plug hole 44.
[0043] One end of the syringe 10 is sealedly connected to the male Luer lock assembly 30 and communicates with the through hole 34 .
[0044] In the present technical solution, the male Luer lock assembly 30 and the female Luer lock assembly 40 are snapped together and opened and closed by threads. When in use, the mounting portion 42 is aligned with the assembly cavity 32, the protective wing 46 is pinched by hand to rotate the clamping portion 41, and the mounting portion 42 is screwed into the threaded groove 35 to achieve closure.
[0045] During the screwing process, one end of the plug 33 is inserted into the socket 44 to complete the docking of the male Luer lock assembly 30 and the female Luer lock assembly 40; the Luer locks are sealed by threaded connection, and the plug 33 and the socket 44 are interference fit, thereby ensuring the airtightness of the entire device at the connection.
[0046] Embodiment 3:
[0047] like Figure 1-2 As shown, specifically, the pipeline interface 45 is connected to a conduit 51 .
[0048] In the present technical solution, the catheter 51 is connected to the pipeline interface 45 by aseptic heat connection, and the other end of the catheter 51 is connected to the puncture head, which is buckled with a cap. Once the outer packaging of the puncture head is opened, the puncture head needs to be heat-sealed and removed if it is not used immediately, because the puncture head with a channel is not in a completely sealed state. This ensures that the whole formed by the potting component 50 connected with the female Luer lock component 40 and the male Luer lock component 30 is always isolated from the external closed environment, thereby preventing the self-contamination and cross-contamination caused by the contact between the virus and the outside world during the traditional syringe extraction process. In addition, the pipelines involved in this application are all disposable sterile consumables, and the operation of adding viruses to cells is in a closed system throughout the process, avoiding the risk of contamination and cross-contamination.
[0049] It should be noted that the pipelines involved in the present invention are all disposable sterile consumables. Taking the production of cell therapy products using the automated closed system Prodigy as an example, after adopting the present invention, the method of adding viruses to the cells is as follows:
[0050] 1. Get the storage device containing the virus;
[0051] 2. Connect the device to the transfer bag and transfer the virus into the transfer bag;
[0052] 3. Connect the transfer bag to the tubing on the Prodigy system and add the virus to the cell bag.
[0053] And the two ways of connecting the device to the transfer bag are as follows:
[0054] 1. The transfer bag comes with its own pipeline. Use a sterile pipe connection machine to heat-connect the pipeline of this device with the pipeline of the transfer bag;
[0055] 2. If the transfer bag does not come with a pipeline, insert the puncture head of this device into the puncture port reserved in the transfer bag to complete the connection.
[0056] The embodiments of the present application are described above in conjunction with the accompanying drawings. In the absence of conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The present application is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present application, ordinary technicians in this field can also make many forms without departing from the purpose of the present application and the scope of protection of the claims, all of which are within the protection of the present application.
Claims
1. A virus preparation storage device for an automated closed system improvement, characterized in that: include: A syringe (10), wherein a piston (12) is sealed and slidable in the syringe (10), and the piston (12) and the syringe (10) form a closed chamber for encapsulating a virus reagent (20); a male Luer lock assembly (30) is provided at the upper end of the syringe (10), a female Luer lock assembly (40) is installed at the upper end of the male Luer lock assembly (30), the male Luer lock assembly (30) and the female Luer lock assembly (40) are sealedly connected, and the upper end of the female Luer lock assembly (40) is connected to an encapsulation assembly (50).
2. A virus preparation storage device for automated closed system improvement according to claim 1, characterized in that: The male Luer lock assembly (30) comprises: A support portion (31), wherein an assembly cavity (32) is provided inside the support portion (31), one end of the assembly cavity (32) is communicated with the outside, a thread groove (35) is provided on the side wall of the assembly cavity (32), a plug (33) is provided at the bottom of the assembly cavity (32), and a through hole (34) is provided in the middle of the plug (33).
3. A virus preparation storage device for automated closed system improvement according to claim 2, characterized in that: One end of the syringe (10) is sealedly connected to the male Luer lock assembly (30) and communicates with the through hole (34).
4. The virus preparation storage device for automated closed system improvement according to claim 1, characterized in that: One end surface of the piston (12) is conical and a push rod (13) is arranged at the other end. The piston (12) is interference-connected with the inner wall of the syringe (10).
5. The virus preparation storage device for automated closed system improvement according to claim 2, characterized in that: The female Luer lock assembly (40) comprises: A clamping portion (41), one end of which is provided with a mounting portion (42), a threaded protrusion (43) is provided at an outer ring end surface of the mounting portion (42), and the threaded protrusion (43) is threadedly matched with the plug (33), and a plug hole (44) is provided in the middle of the mounting portion (42), and the plug hole (44) is plug-fitted and connected with the plug (33).
6. The virus preparation storage device for automated closed system improvement according to claim 5, characterized in that: The ring side of the clamping portion (41) is provided with a protective wing (46), and the middle part of the clamping portion (41) is provided with a pipeline interface (45), and the pipeline interface (45) is communicated with the insertion hole (44).
7. The virus preparation storage device for automated closed system improvement according to claim 6, characterized in that: The pipeline interface (45) is connected to a conduit (51).
8. The virus preparation storage device for automated closed system improvement according to claim 1, characterized in that: The syringe (10) is made of a transparent material, and scale plates (60) are evenly arranged on the outer surface of the syringe (10).