WO2021047634A1

WO2021047634A1 - Disposable sampling device

Info

Publication number: WO2021047634A1
Application number: PCT/CN2020/114765
Authority: WO
Inventors: 陈志敏; 戚继南
Original assignee: 佧珐药业有限公司
Priority date: 2019-09-12
Filing date: 2020-09-11
Publication date: 2021-03-18
Also published as: CN210796460U

Abstract

The present invention provides a disposable sampling device. The disposable sampling device comprises a connecting mechanism, a power mechanism, a sample storage mechanism, and a waste liquid collecting mechanism which are sequentially connected by means of a main conveying pipe; the disposable sampling device and an upstream product storage device integrally form a sterile closed system. The sample storage mechanism comprises at least two multi-way joints and a plurality of branch conveying pipes; the multi-way joint comprises at least four joints; any two joints in the multi-way joint are connected to the main conveying pipe, the other joints are connected to one ends of the branch conveying pipes, and the other ends of the branch conveying pipes are connected to a liquid storage bag by means of a two-way reducing joint. A valve is provided on the branch conveying pipe, and a valve is provided on the main conveying pipe between the multi-way joints; a one-way valve is provided between the connecting mechanism and the power mechanism, and a one-way valve is provided between the sample storage mechanism and the waste liquid collecting mechanism. When in use, the sampling device is in a sealed state, so that the safety of biological samples is ensured, regular and repeated sampling can be achieved, and secondary pollution or cross pollution is avoided.

Description

One-time sampling device

This application claims the priority of the Chinese patent application CN2019215265427 whose filing date is September 12, 2019. This application quotes the full text of the aforementioned Chinese patent application.

Technical field

The invention relates to a disposable sampling device.

Background technique

In a typical dynamic cell culture process, cell samples are taken from the bioreactor for testing or storage at different time periods according to experimental requirements. Generally, a syringe is used for puncture or a Luer connector is used for sampling. In this process, because the sampling device is not sealed, the sample or product is exposed to the environment and contaminated, and disposable sampling devices such as syringes cannot take multiple samples. Due to the small pore size of the filter membrane, it can filter some bacteria. At present, some filter membranes are used to solve the above technical problems, but this method cannot guarantee absolute safety. Moreover, when the sampling port is connected and disconnected, the sample or product may also drop and cause environmental pollution or cross-contamination.

Therefore, there is an urgent need in the art to develop a sample and product in a completely sealed state during and after sampling. It can prevent samples from being contaminated due to exposure to the environment, or prevent samples from polluting the environment due to leakage, ensuring the safety of biological samples, and realizing a sampling system for regular sampling.

Summary of the invention

The technical problem to be solved by the present invention is to overcome the unsealed sampling device of the cell sample in the prior art, which causes the sample to be easily contaminated during the sampling process, and the sample is easy to flow out, resulting in environmental pollution or cross-contamination, and the sampling device cannot be repeated Sampling defects provide a disposable sampling device. It can realize that samples and products are completely sealed during the typical dynamic cell culture process and after sampling, which can prevent samples from being contaminated by exposure to the environment, or samples from contaminating the environment due to leakage, ensuring the safety of biological samples, and It can realize regular and multiple sampling, and avoid secondary pollution or cross-contamination.

The present invention solves the above technical problems through the following technical solutions:

A disposable sampling device, which includes a connecting mechanism, a power mechanism, a sample storage mechanism, and a waste liquid collection mechanism that are sequentially connected through a main transport pipe. The connecting mechanism is used to connect with an upstream product storage device to enable the disposable sampling The device and the upstream product storage device form an aseptic closed system as a whole;

The sample storage mechanism includes at least two multi-way joints and several branch transport pipes; the multi-way joint includes at least four joints; any two of the multi-way joints are connected to the main transport pipe, and the others The joint is connected to one end of the branch transportation pipe, and the other end of the branch transportation pipe is connected to the liquid storage bag through a two-way reducing joint; the branch transportation pipe is provided with a valve, and the connection between the multi-way joint A valve is provided on the main transport pipe;

A one-way valve is provided between the connecting mechanism and the power mechanism to prevent the sample from flowing back to the upstream product storage device;

A one-way valve is provided between the sample storage mechanism and the waste liquid collection mechanism to prevent the waste liquid in the waste liquid collection mechanism from flowing back to the main transport pipe where the sample storage mechanism is partially located.

Preferably, the connection mechanism is a Luer connector, an aseptic connection connector, or a connection part formed by aseptically welding the main transport tube with the upstream product storage device.

Preferably, the power mechanism is a peristaltic pump.

Preferably, the waste liquid collection mechanism is a sterile liquid storage bag.

Preferably, the waste liquid collection mechanism is sequentially connected to the sample storage mechanism via a two-way reducing joint and the one-way valve.

Preferably, the material of the main transport tube and the branch transport tube is PVC, EVA, silica gel or

Thermoplastic elastomer.

Preferably, the outer diameters of the main transport pipe and the branch transport pipes can be reasonably designed according to the outer diameters of transport pipes conventionally used in the field, preferably 6.4-19 mm.

The multi-way connector may be a multi-way connector conventionally used in the art, preferably a four-way connector or a five-way connector.

The valve provided on the main transport pipe between the multi-way joints is used to control the transport direction of the sample.

The liquid storage bag may be a liquid storage bag conventionally used in the art, preferably a sterile liquid storage bag, and more preferably a double-layer sterile liquid storage bag.

The size of the liquid storage bag can be reasonably designed according to the size of the liquid storage bag conventionally used in the field, and is preferably 5-50 mL.

The number of the liquid storage bags can be arbitrarily selected according to experimental requirements, preferably 4-10.

When sampling, the sample can be transported from the upstream product storage device to one storage bag, or to multiple storage bags at the same time; open the main transport pipe and branch transport pipe between the upstream product storage device and the target storage bag Close the valves on the main transport pipe and branch transport pipes leading to other liquid storage bags, and open the peristaltic pump for sampling.

After sampling, close the valve on the branch transport pipe where the peristaltic pump and the target liquid storage bag are located, and use a heat sealer to seal and cut the liquid storage bag containing the sample to avoid contamination of the sample due to exposure to the environment or leakage of the sample The pollution of the environment ensures the safety of biological samples. Open all the valves on the main transport pipe, and transport the residual samples in the main transport pipe and branch transport pipes to the waste liquid collection mechanism to avoid secondary pollution or cross-contamination.

During subsequent sampling, the valves on all branch transport pipes are closed, all valves on the main transport pipes are opened, the disposable sampling device is flushed with the sample to be taken, and the flushing liquid is transported to the waste liquid collection mechanism to further avoid the occurrence Secondary pollution or cross-contamination. After rinsing, just repeat the above sampling method. The disposable sampling device of the present invention can realize aseptic sampling of irregular and different amounts.

The positive improvement effect of the present invention is that the present invention can realize that the entire disposable sampling device is in a fully enclosed state during sampling, and can effectively prevent samples from being contaminated by exposure to the environment. After sampling, a heat sealing machine can be used to seal and cut the liquid storage bag containing the sample, which is convenient for operation; the fully enclosed state of the device can also avoid environmental pollution due to sample leakage and ensure the safety of biological samples; combined with the power mechanism to achieve Regular and quantitative sampling for multiple times; set up a waste liquid collection device to ensure that there are no sample residues in the main transport pipe and branch transport pipes during sampling, and avoid secondary pollution problems.

Description of the drawings

Figure 1 is a schematic diagram of the disposable sampling device of the present invention.

Description of Reference Signs

Connecting mechanism 1

Power mechanism 2

Waste liquid collection mechanism 3

Main transport pipe 4

Check valve 5

Multi-way connector 6

Valve 7

Liquid storage bag 8

Branch transport tube 9

Two-way reducer 10

detailed description

A preferred embodiment is given below to illustrate the present invention more clearly and completely in conjunction with the accompanying drawings, but the present invention is not limited to the scope of the described embodiments.

The present invention provides a disposable sampling device. As shown in FIG. 1, a disposable sampling device includes a connecting mechanism 1, a power mechanism 2, a sample storage mechanism, and a waste liquid collection mechanism 3 sequentially connected by a main transport tube 4. , The connecting mechanism 1 is used to connect with an upstream product storage device so that the disposable sampling device and the upstream product storage device form a sterile closed system as a whole;

The sample storage mechanism includes at least two multi-way joints 6 and a number of branch transport pipes 9; the multi-way joint 6 includes at least four joints; any two of the multi-way joints 6 and the main transport The pipe 4 is connected, and the other joints are connected to one end of the branch transportation pipe 9, and the other end of the branch transportation pipe 9 is connected to the liquid storage bag 8 through a two-way reducing joint 10; the branch transportation pipe 9 is provided with The valve 7 is provided with a valve 7 on the main transport pipe 4 between the multi-way joints 6;

A one-way valve 5 is provided between the connecting mechanism 1 and the power mechanism 2 to prevent the sample from flowing back to the upstream product storage device;

A one-way valve 5 is provided between the sample storage mechanism and the waste liquid collection mechanism 3 to prevent the waste liquid in the waste liquid collection mechanism 3 from flowing back to the main transport pipe 4 where the sample storage mechanism part is located.

In this embodiment, the upstream product storage device is a bioreactor.

In this embodiment, the connecting mechanism 1 is a luer connector. In other embodiments, the connecting mechanism 1 may also be an aseptic connecting joint or a connecting part formed by aseptically welding the main transport tube 4 with the upstream product storage device.

The power mechanism 2 is a peristaltic pump.

The waste liquid collection mechanism 3 is a sterile liquid storage bag. The waste liquid collection mechanism 3 is sequentially connected to the sample storage mechanism via a two-way reducing joint 10 and the one-way valve 5.

In this embodiment, the material of the main transport tube 4 and the branch transport tube 9 is

Thermoplastic elastomer; in other embodiments, the material of the main transport tube 4 and the branch transport tube 9 can also be PVC, EVA or silicone.

The outer diameters of the main transport pipe 4 and the branch transport pipe 9 can be reasonably designed according to the outer diameters of transport pipes in the field. In this embodiment, the outer diameters of the main transport pipe 4 and the branch transport pipe 9 are 6.4mm.

The multi-way connector 6 can be a multi-way connector conventionally used in the art. In this embodiment, the multi-way connector 6 is a four-way connector; in other embodiments, the multi-way connector 6 can also be a bottom bracket. Connector.

In this embodiment, the number of the multi-way connector 6 is three; in other embodiments, the number of the multi-way connector 6 can also be four or five. The valve 7 provided on the main transport pipe 4 between the multi-way joints 6 is used to control the transport direction of the sample.

The liquid storage bag 8 may be a liquid storage bag conventionally used in the art. In this embodiment, the liquid storage bag 8 is a double-layer sterile liquid storage bag.

The size of the liquid storage bag 8 can be reasonably designed according to the size of the liquid storage bag conventionally used in the field. In this embodiment, the size of the liquid storage bag 8 is 5 mL.

The number of the liquid storage bags 8 can be arbitrarily selected according to experimental requirements, and the number of the liquid storage bags 8 in this embodiment is six.

When sampling, the sample can be transported from the upstream product storage device to one liquid storage bag 8, or to multiple liquid storage bags 8 at the same time; open the main transport tube 4 and the target liquid storage bag 8 between the upstream product storage device and the target liquid storage bag 8. The valve 7 on the branch transportation pipe 9 closes the main transportation pipe 4 and the valve 7 on the branch transportation pipe 9 leading to other liquid storage bags 8 and turns on the peristaltic pump for sampling.

After sampling, close the valve 7 on the branch transport pipe 9 where the peristaltic pump and the target liquid storage bag 8 are located, and use a heat sealer to seal and cut the liquid storage bag 8 containing the sample to avoid contamination of the sample due to exposure to the environment. Or the sample will pollute the environment due to leakage, ensuring the safety of biological samples. Open all the valves 7 on the main transport pipe 4, and transport the samples remaining in the main transport pipe 4 and the branch transport pipe 9 to the waste liquid collection mechanism 3 to avoid secondary pollution or cross-contamination.

During subsequent sampling, the valves 7 on all the branch transport pipes 9 are closed, the valves 7 on all the main transport pipes 4 are opened, the disposable sampling device is flushed with the sample to be taken, and the flushing liquid is transported to the waste liquid collection mechanism 3. , Can further avoid secondary pollution or cross-contamination. After rinsing, just repeat the above sampling method. The disposable sampling device of the present invention can realize aseptic sampling of irregular and different amounts.

Although the specific embodiments of the present invention are described above, those skilled in the art should understand that these are only examples, and various changes or modifications can be made to these embodiments without departing from the principle and essence of the present invention. modify. Therefore, the protection scope of the present invention is defined by the appended claims.

Claims

A disposable sampling device, which is characterized in that it comprises a connecting mechanism, a power mechanism, a sample storage mechanism, and a waste liquid collection mechanism that are sequentially connected by a main transport pipe. The connecting mechanism is used to connect with an upstream product storage device so that all The disposable sampling device and the upstream product storage device form a sterile closed system as a whole;

The sample storage mechanism includes at least two multi-way joints and several branch transport pipes; the multi-way joint includes at least four joints; any two of the multi-way joints are connected to the main transport pipe, and the others The joint is connected to one end of the branch transportation pipe, and the other end of the branch transportation pipe is connected to the liquid storage bag through a two-way reducing joint; the branch transportation pipe is provided with a valve, and the connection between the multi-way joint A valve is provided on the main transport pipe;

A one-way valve is provided between the connecting mechanism and the power mechanism to prevent the sample from flowing back to the upstream product storage device;

A one-way valve is provided between the sample storage mechanism and the waste liquid collection mechanism to prevent the waste liquid in the waste liquid collection mechanism from flowing back to the main transport pipe where the sample storage mechanism is partially located.
The disposable sampling device according to claim 1, wherein the connection mechanism is a Luer connector, an aseptic connection connector, or the main transport tube is formed by aseptic welding with the upstream product storage device. Connection part.
The disposable sampling device according to at least one of claims 1-2, wherein the power mechanism is a peristaltic pump.
The disposable sampling device according to at least one of claims 1 to 3, wherein the waste liquid collection mechanism is a sterile liquid storage bag.
The disposable sampling device according to at least one of claims 1 to 4, wherein the waste liquid collection mechanism is connected to the sample storage mechanism via a two-way reducing joint and the one-way valve in sequence.
The disposable sampling device according to at least one of claims 1-5, wherein the outer diameter of the main transport tube and the branch transport tube is 6.4-19 mm.
The disposable sampling device according to at least one of claims 1-6, wherein the multi-way joint is a four-way joint or a five-way joint.
The disposable sampling device according to at least one of claims 1-7, wherein the liquid storage bag is a sterile liquid storage bag.
The disposable sampling device according to at least one of claims 1-8, wherein the liquid storage bag is a double-layer sterile liquid storage bag.
The disposable sampling device according to at least one of claims 1-9, wherein the size of the liquid storage bag is 5-50 mL; and the number of the liquid storage bag is 4-10.