CN215828755U - Aseptic cell sampling device based on syringe - Google Patents

Aseptic cell sampling device based on syringe Download PDF

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Publication number
CN215828755U
CN215828755U CN202121582139.3U CN202121582139U CN215828755U CN 215828755 U CN215828755 U CN 215828755U CN 202121582139 U CN202121582139 U CN 202121582139U CN 215828755 U CN215828755 U CN 215828755U
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sampling
cell
sterile
conduit
container
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郑伟武
姚嘉林
郭霄亮
商院芳
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Shenzhen Saiqiao Biological Innovation Technology Co Ltd
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Shenzhen Saiqiao Biological Innovation Technology Co Ltd
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Abstract

The utility model relates to a sterile cell sampling device based on a syringe, which comprises a sampling container, a sterile filter, the syringe, a control valve, a first conduit and a second conduit; the top of the sampling container is provided with a first interface and a second interface; the first catheter is connected with the first interface and the cell medicine production device; the second conduit is connected with the second interface and the sterile filter; the injector comprises a needle cylinder, a piston and a piston core rod; the needle cylinder is communicated with the sterile filter; the control valve is arranged in the middle of the first conduit, has an opening state and a closing state, and is used for controlling the on-off of the first conduit. Above-mentioned aseptic cell sampling device has sample simple, convenient, can accurate control sample volume, effectively ensures aseptic sample, greatly reduced the contaminated probability of cell, can avoid the extravagant characteristics of cell sap in the pipe.

Description

Aseptic cell sampling device based on syringe
Technical Field
The utility model relates to the technical field of medicine sampling, in particular to a sterile cell sampling device based on an injector.
Background
The production process of cell medicines has the characteristics of multiple preparation links and complex process, so that the complex process operation and the cell in vitro environment have obvious influence on the cell bioactivity; therefore, cell sampling is required periodically during the production process of cell-based drugs to monitor the cell's activity, loss rate and density. When the existing sampling device is used for sampling, an experimenter usually uses the sterile sampling device for sampling, and the existing sterile sampling method generally moves equipment into a sterile environment and opens a cover for sampling. However, the existing sampling device is complicated in operation, uncontrollable in sampling, and frequent opening of the cover easily causes pollution.
SUMMERY OF THE UTILITY MODEL
The utility model provides a sterile cell sampling device based on an injector, which has the characteristics of simple and convenient sampling, accurate control of sampling quantity, effective guarantee of sterile sampling, great reduction of the probability of cell contamination, avoidance of cell sap waste in a conduit and realization of quantitative, sterile and disposable high-precision cell sampling.
In order to achieve the purpose, the utility model adopts the following specific technical scheme:
the utility model provides a sterile cell sampling device based on a syringe, which comprises a sampling container, a sterile filter, the syringe, a control valve, a first conduit and a second conduit;
the sampling container is internally provided with an accommodating cavity, and the top of the sampling container is provided with a first interface and a second interface which are communicated with the accommodating cavity and are used for realizing the maximum sampling capacity of the sampling container;
one end of the first conduit is connected with the first interface, and the other end of the first conduit is used for connecting a cell medicine production device;
the second conduit is connected between the second interface and the sterile filter and is used for discharging and supplementing sterile air in the sampling container;
the sterile filter is used for filtering air into sterile air;
the injector is used for supplying air to the sterile filter or extracting air from the sterile filter and comprises a syringe, a piston and a piston core rod; the needle cylinder is communicated with the sterile filter; the piston is in sealing fit with the needle cylinder and can be slidably arranged in the needle cylinder; the piston core rod is fixedly connected with the piston and is used for driving the piston to slide along the needle cylinder;
the control valve is arranged in the middle of the first guide pipe, has an opening state and a closing state, and is used for controlling the on-off of the first guide pipe; when the control valve is in an opening state, two ends of the first conduit are communicated; when the control valve is in a closed state, two ends of the first conduit are in a cut-off state.
Further, the sampling container is a transparent container provided with scales.
Further, the outer surface of the cylinder is provided with graduations.
Further, the control valve is a pipe clamp, a solenoid valve, an electric valve, a pneumatic valve or a hydraulic valve.
Still further, the sampling container is a container made of a flexible material.
In addition, the present invention provides a cell sampling method using the above sterile cell sampling device, which forms a fluid driving force by a negative pressure generated by pulling a syringe open to introduce a cell fluid into a sampling vessel, the cell sampling method comprising the steps of:
closing a control valve of the sterile cell sampling device to enable the sterile cell sampling device to be in a closed state, connecting the sterile cell sampling device with a cell medicine production device through a first conduit, and enabling a first interface and a second interface to be located at the highest position of a sampling container;
opening a control valve of the sterile cell sampling device to enable the sterile cell sampling device to be in an open state, pulling a piston core rod of the injector towards the outside of the needle cylinder to enable negative pressure lower than atmospheric pressure to be generated in the sampling container, and then quantitatively pumping cell liquid of the cell medicine production device into the sampling container;
the control valve of the sterile cell sampling device is closed to be in a closed state, and the first conduit between the sampling container and the control valve is sealed, so that quantitative, sterile and disposable cell sampling can be realized.
Further, between opening the control valve of the sterile cell sampling apparatus and closing the control valve of the sterile cell sampling apparatus, the method further comprises the steps of:
and pushing the piston core rod into the needle cylinder, and sequentially pushing sterile air in the needle cylinder and the sampling container into the first conduit so as to guide the cell sap in the first conduit back to the cell medicine production device.
Further, when the first conduit between the sampling container and the control valve is subjected to the sealing treatment, the first conduit is subjected to the heat-melting sealing treatment by using the heat-melting device.
Further, after the sealing process of the first conduit between the sampling container and the control valve, the method further comprises the following steps:
and (4) connecting another sterile cell sampling device at the first catheter subjected to sealing treatment in a sterile manner, and repeating the steps to realize multiple times of sterile sampling.
Further, in the aseptic connection of another aseptic cell sampling apparatus at the first conduit of the sealing process, the another aseptic cell sampling apparatus is connected to the first conduit of the sealing process through an aseptic tube connector.
Compared with the prior art, the utility model has the following beneficial effects:
the sterile cell sampling device adopts the injector to provide a power source for sampling the cell sap, and the injector is simple and convenient to operate and can accurately control the sampling amount; the sterile filter is connected between the sampling container and the injector, and can carry out sterile filtration on air entering the sampling container through the sterile filter, thereby effectively ensuring sterile sampling and greatly reducing the probability of cell contamination; meanwhile, the cell sap in the catheter can be conveyed back to the cell drug production device through the injector, so that the waste of the cell sap in the catheter is avoided; meanwhile, the interfaces connected with the cell medicine production device and the sterile filter are positioned at the top of the sampling container, so that the cell sap entering the sampling container can reach the maximum, more cell sap volumes are provided for the sterile cell sampling device, the maximum sampling volume of the sampling container is realized, and the utilization rate of the sampling container is improved. Therefore, the sterile sampling device has the characteristics of simple and convenient sampling, accurate control of sampling amount, effective guarantee of sterile sampling, great reduction of the probability of cell contamination and avoidance of cell sap waste in the conduit.
In addition, by adopting the sterile cell sampling device and the cell sampling method, the function of aseptic sampling for multiple times can be realized by connecting a plurality of sterile cell sampling devices in the cell medicine production device; and a plurality of sterile cell sampling devices can be connected to the first conduit through the sterile pipe connecting machine, and the function of sampling for multiple times can also be realized.
Drawings
FIG. 1 is a schematic diagram of the sterile cell sampling apparatus of the present invention;
FIG. 2 is another schematic diagram of the sterile cell sampling device of the present invention;
FIG. 3 is a process flow diagram of the cell sampling method of the present invention.
Wherein, 1-a sampling container, 2-a sterile filter, 3-an injector, 4-a control valve, 5-a first conduit, 6-a second conduit, 11-a first interface, 12-a second interface, 31-a needle cylinder, 32-a piston core rod
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example one
As shown in fig. 1 and 2, the present embodiment provides a syringe 3-based sterile cell sampling apparatus, which includes a sampling container 1, a sterile filter 2, a syringe 3, a control valve 4, a first conduit 5, and a second conduit 6;
the sampling container 1 is internally provided with a containing cavity for containing cell sap, and the top of the sampling container 1 is provided with a first interface 11 and a second interface 12 which are communicated with the containing cavity and are used for realizing the maximum sampling capacity of the sampling container 1; as shown in the structure of fig. 1, the first interface 11 is disposed at the top of the left side of the sampling container 1, the second interface 12 is disposed at the top of the right side of the sampling container 1, and the first interface 11 and the second interface 12 are disposed oppositely; as shown in the structure of fig. 2, the first interface 11 is arranged at the left side of the top of the sampling container 1, the second interface 12 is arranged at the right side of the top of the sampling container 1, and the first interface 11 and the second interface 12 are arranged side by side; wherein, when sampling, the first interface 11 is used as a cell fluid inlet, and the second interface 12 is used as a gas outlet; when the cell fluid in the first conduit 5 is returned to the cell-based drug production device, the first port 11 is used as a sterile gas outlet, and the second port 12 is used for allowing the sterile gas filtered by the sterile filter 2 to pass through; the sampling container 1 is a transparent container with scales, the transparent container is used as the sampling container 1, the scales are arranged on the transparent container, the transparent container and the scales are favorable for visually observing the sampling amount, the sampling amount is convenient to accurately control, and the sampling is controllable; the sampling container can be made of flexible materials such as plastic or rubber; when the sampling container 1 is extruded, the air in the sampling container 1 is guided to the cell medicine production device; when the sampling container 1 is loosened after the squeezing, the negative pressure in the sampling container 1 can suck the cell sap in the cell type medicine production device into the sampling container 1, and at the moment, the aseptic sampling can be realized without pulling the injector 3; the sampling container 1 may also be a rigid container made of plastic or glass;
one end of the first conduit 5 is connected with the first interface 11, and the other end is used for connecting a cell medicine production device; the first conduit 5 is communicated with the sampling container 1 and the cell medicine production device, so that cell sap in the cell medicine production device flows into the sampling container 1 along the first conduit 5 during sampling;
a second conduit 6 is connected between the second interface 12 and the sterile filter 2 for the evacuation and replenishment of sterile air inside the sampling container 1; the second conduit 6 is connected between the sampling container 1 and the sterile filter 2, when sampling, under the suction action of the syringe 3, negative pressure is formed in the sampling container 1, and sterile air in the sampling container 1 enters the syringe 3 through the sterile filter 2; when the cellular fluid is returned to the cell-based drug production apparatus in order to avoid waste of the cellular fluid, the second conduit 6 is used to introduce the sterile air filtered by the sterile filter 2 into the sampling vessel 1;
the aseptic filter 2 is used for filtering air into aseptic air; the sterile filter 2 can carry out sterile filtration on the air, and prevent a pollution source in the injector 3 from entering the sampling container 1 and even a cell medicine production device; the sterile filter 3 may be provided with a lid;
the syringe 3 is used for supplying air to the sterile filter 2 or extracting air from the sterile filter 2, and includes a cylinder 31, a plunger (not shown in the drawing), and a plunger core rod 32; the syringe 31 communicates with the sterile filter 2; the piston is in sealing fit with the needle cylinder 31 and can be slidably arranged in the needle cylinder 31; the piston core rod 32 is fixedly connected with the piston and is used for driving the piston to slide along the needle cylinder 31; the outer surface of the needle cylinder 31 is provided with scales;
the control valve 4 is arranged in the middle of the first conduit 5, has an opening state and a closing state, and is used for controlling the on-off of the first conduit 5; when the control valve 4 is in an opening state, two ends of the first conduit 5 are communicated; when the control valve 4 is in the closed state, both ends of the first conduit 5 are in the blocked state. The control valve 4 may be a pipe clamp, a solenoid valve, an electric valve, a pneumatic valve or a hydraulic valve.
The sterile cell sampling device adopts the injector 3 to provide a power source for sampling the cell sap, and the injector 3 is adopted for sampling, so that the sterile cell sampling device is simple and convenient to operate and can accurately control the sampling amount; the sterile filter 2 is connected between the sampling container 1 and the injector 3, and can carry out sterile filtration on the air entering the sampling container 1 through the sterile filter 2, thereby effectively ensuring sterile sampling and greatly reducing the probability of cell contamination; meanwhile, the cell sap in the catheter can be conveyed back to the cell drug production device through the injector 3, so that the waste of the cell sap in the catheter is avoided;
meanwhile, the interfaces connected with the cell medicine production device and the sterile filter 2 are positioned at the top of the sampling container 1, so that the cell sap entering the sampling container 1 can reach the maximum, more cell sap volumes are provided for the cell sampling device, the maximum sampling volume of the sampling container 1 is realized, and the utilization rate of the sampling container 1 is improved.
Therefore, the sterile sampling device has the characteristics of simple and convenient sampling, accurate control of sampling amount, effective guarantee of sterile sampling, great reduction of the probability of cell contamination and avoidance of cell sap waste in the conduit.
Example two
The embodiment of the present invention also provides a cell sampling method using the above sterile cell sampling device, wherein a fluid driving force is formed by a negative pressure generated by pulling the syringe 3 to introduce a cell fluid into the sampling container 1, the cell sampling method comprising the following steps:
step S10, closing the control valve 4 of the sterile cell sampling device to make it in a closed state, connecting the sterile cell sampling device to the cell drug production device through the first conduit 5, and making the first interface 11 and the second interface 12 in the highest position of the sampling container 1;
step S20, opening the control valve 4 of the aseptic cell sampling device to make it in an open state, pulling the piston core rod 32 of the injector 3 towards the outside of the syringe 31 to generate a negative pressure lower than the atmospheric pressure in the sampling container 1, so that the cell sap of the cell medicine production device can be quantitatively pumped into the sampling container 1;
step S40, the control valve 4 of the aseptic cell sampling device is closed to be in a closed state, and the first conduit 5 between the sampling container 1 and the control valve 4 is sealed, so that quantitative, aseptic, and disposable cell sampling can be realized.
By adopting the cell sampling method, the sample can be simply and quickly sampled through the injector 3, the sampling is controllable, the aseptic sampling can be realized through the aseptic filter 2, the probability of cell contamination is greatly reduced, and the quantitative, aseptic and disposable high-precision cell sampling is realized.
As shown in fig. 3, the cell sampling method according to the embodiment of the present invention may further include the following specific steps:
step S10, closing the control valve 4 of the sterile cell sampling device to make it in a closed state, connecting the sterile cell sampling device to the cell drug production device through the first conduit 5, and making the first interface 11 and the second interface 12 in the highest position of the sampling container 1;
step S20, opening the control valve 4 of the aseptic cell sampling device to make it in an open state, pulling the piston core rod 32 of the injector 3 towards the outside of the syringe 31 to generate a negative pressure lower than the atmospheric pressure in the sampling container 1, so that the cell sap of the cell medicine production device can be quantitatively pumped into the sampling container 1;
step S30, the plunger rod 32 is pushed into the syringe 31, and the sterile air in the syringe 31 and the sampling container 1 is pushed into the first conduit 5 in turn, so as to guide the cellular fluid in the first conduit 5 back to the cell drug production device.
Step S40, the control valve 4 of the aseptic cell sampling device is closed to be in a closed state, and the first conduit 5 between the sampling container 1 and the control valve 4 is sealed, so that quantitative, aseptic, and disposable cell sampling can be realized.
Adopt above-mentioned cell sampling method to provide the power of sample through syringe 3, carry out simple, swiftly sample through the pull of syringe 3, the sample is controllable, can effectively ensure aseptic sample through aseptic filter 2, greatly reduced the contaminated probability of cell, realized when ration, aseptic, disposable high accuracy cell sample, can also push back the cell sap in first pipe 5 to cell class medicine production device through syringe 3, avoided the waste of cell sap.
In the cell sampling method, when the first conduit 5 between the sampling vessel 1 and the control valve 4 is sealed, the first conduit 5 is thermally fused and sealed by a thermal fusion device. Adopt hot melt to seal processing to first pipe 5, be favorable to carrying out quick seal processing to first pipe 5, improved disposable sample speed and efficiency.
In order to realize multiple aseptic sampling, the cell sampling method according to the embodiment of the present invention may further include the following steps after the first conduit 5 between the sampling container 1 and the control valve 4 is sealed, on the basis of the above-described various cell sampling methods:
step S50, connecting another aseptic cell sampling device at the first conduit 5 which is sealed, and repeating the above steps to realize aseptic sampling for multiple times; that is, after one sterile cell sampling device is used to complete cell sap sampling, another sterile cell sampling device may be continuously connected to the first conduit 5 which is fused and sealed, and steps S10, S20 and S40 may be repeatedly completed, or steps S10, S20, S30 and S40 may be repeatedly completed, so that second cell sap sampling may be completed; repeated operation can realize the cell sap sampling function for many times.
Aseptic sampling for the second time can be realized by aseptic connection of another aseptic cell sampling device at the first catheter 5 subjected to sealing treatment and circulation of the steps S10-S40, and the steps S50, S10, S20 and S40 are circularly executed according to the aseptic cell sampling for the second time, or the steps S50, S10, S20, S30 and S40 are circularly executed according to the aseptic cell sampling for the first time, so that aseptic sampling for multiple times can be conveniently and quickly realized under the condition of avoiding pollution, and the flexibility of aseptic sampling is improved.
To achieve sterile connection of a further sterile cell sampling device at the first conduit 5 of the sealing process, the further sterile cell sampling device may be connected into the first conduit 5 of the sealing process by means of a sterile tubing connector.
It will be apparent to those skilled in the art that various changes and modifications may be made in the embodiments of the present invention without departing from the spirit and scope of the utility model. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (5)

1. A syringe-based sterile cell sampling device comprising a sampling vessel, a sterile filter, a syringe, a control valve, a first conduit and a second conduit;
the sampling container is internally provided with an accommodating cavity, and the top of the sampling container is provided with a first interface and a second interface which are communicated with the accommodating cavity and are used for realizing the maximum sampling capacity of the sampling container;
one end of the first conduit is connected with the first interface, and the other end of the first conduit is used for connecting a cell medicine production device;
the second conduit is connected between the second interface and the sterile filter and is used for discharging and supplementing sterile air in the sampling container;
the sterile filter is used for filtering air into sterile air;
the injector is used for supplying air to the sterile filter or extracting air from the sterile filter and comprises a syringe, a piston and a piston core rod; the needle cylinder is communicated with the sterile filter; the piston is in sealing fit with the needle cylinder and can be slidably arranged in the needle cylinder; the piston core rod is fixedly connected with the piston and is used for driving the piston to slide along the needle cylinder;
the control valve is arranged in the middle of the first guide pipe, has an opening state and a closing state, and is used for controlling the on-off of the first guide pipe; when the control valve is in an opening state, two ends of the first conduit are communicated; when the control valve is in a closed state, two ends of the first conduit are in a cut-off state.
2. The sterile cell sampling device according to claim 1, wherein the sampling container is a transparent container provided with a scale.
3. The sterile cell sampling device of claim 1, wherein the outer surface of the barrel is provided with a scale.
4. The sterile cell sampling device according to any of claims 1-3, wherein the control valve is a tube clamp, a solenoid valve, an electrically operated valve, a pneumatically operated valve, or a hydraulically operated valve.
5. A sterile cell sampling device according to any of claims 1 to 3, wherein the sampling container is a container of flexible material.
CN202121582139.3U 2021-07-13 2021-07-13 Aseptic cell sampling device based on syringe Active CN215828755U (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113481082A (en) * 2021-07-13 2021-10-08 深圳赛桥生物创新技术有限公司 Sterile cell sampling device and method based on injector
CN115568461A (en) * 2022-10-25 2023-01-06 马鞍山普梅森医学检验实验室有限公司 Aseptic cell pathology liquid sample storage box

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113481082A (en) * 2021-07-13 2021-10-08 深圳赛桥生物创新技术有限公司 Sterile cell sampling device and method based on injector
CN115568461A (en) * 2022-10-25 2023-01-06 马鞍山普梅森医学检验实验室有限公司 Aseptic cell pathology liquid sample storage box
CN115568461B (en) * 2022-10-25 2024-01-26 马鞍山普梅森医学检验实验室有限公司 Aseptic cytopathology liquid sample storage box

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