JP7501705B2 - Container with sampling function - Google Patents

Description

The present invention relates to a container with a sampling function.

Conventionally, there has been known a technique for sampling a portion of the contents of a storage container, such as a cell suspension, a pharmaceutical liquid, or a food-related liquid, which needs to be protected from contamination by foreign matter or bacteria, for the purpose of inspecting the contents, while maintaining the inside of an apparatus including the storage container in a closed system that is closed off from the external environment.

For example, Patent Document 1 describes a closed system cell culture device constructed by connecting a culture vessel for culturing cells and a culture medium supply vessel for adding culture medium to the culture vessel, and having a tubular sample extraction flow path with a closed end in a storage vessel such as the culture vessel.The device describes a closed system cell culture device in which a portion of the contents stored in the storage vessel is flowed into the sample extraction flow path, and when the flow path is filled with the contents, the flow path is cut while being heat-sealed, thereby allowing a portion of the contents to be sampled while maintaining the inside of the cell culture device as a closed system.

Furthermore, Patent Document 2 describes a closed system cell culture device in which a culture vessel for culturing cells, a culture medium storage vessel for storing culture medium, etc., a cell injection vessel for injecting cells, and a cell recovery vessel for recovering cell suspension after culture are connected by tubes, and a dedicated sampling vessel is further connected to the culture vessel by a tube, and the device describes an apparatus that can sample while maintaining the inside of the cell culture device as a closed system by transferring a portion of the cell suspension stored in the culture vessel to the dedicated sampling vessel via the tube.

JP 2017-12051 A JP 2018-61519 A

However, in the structure of the cell culture device described in Patent Document 1, the end of the sample extraction flow path is blocked, so when flowing part of the contents in the storage container into the sample extraction flow path, it is necessary to perform a cumbersome operation of compressing the flow path to move any air or other substances that have naturally entered the flow path into the storage container, and then opening the flow path to the storage container.This manual operation is cumbersome, and special auxiliary tools are required to perform this operation.

On the other hand, the structure of the cell culture device described in Patent Document 2 is a complex structure in which a dedicated sampling container for sampling a portion of the contents stored in a storage container such as a culture vessel is installed separately from the storage container such as a culture vessel, and multiple containers including the dedicated sampling container and other containers are connected by tubes. In such a structure, when a portion of the contents stored in a storage container such as a culture vessel is taken out into the dedicated sampling container, the portion of the contents is transferred to the dedicated sampling container via the tube using a tube pump.
There was a concern that the control of the flow path for transporting a portion of the content would become complicated. Therefore, there has been a demand for a technology that allows for easy sampling of a portion of the content while maintaining the inside of an apparatus including a storage container in which the content is stored as a closed system, without requiring troublesome operations or complicated controls.

The present invention has been made in consideration of these points, and its object is to provide a container with a sampling function that can easily sample a portion of the contents while maintaining the inside of the storage container in which the contents are stored as a closed space that is closed off from the external environment.

In order to solve the above problem, the container with sampling function of the present invention is a container with sampling function comprising a storage container and a sampling flow path having a communication port at one end, communicating with the storage container via the communication port, and the other end being a closed end, wherein the sampling flow path has a small diameter portion on the one end side that communicates with the storage container via the communication port, and a large diameter portion on the other end side including the closed end, and is characterized in that while maintaining the inside of the container with sampling function as a closed space, a portion of the contents stored in the storage container is caused to flow into the large diameter portion through the communication port and the small diameter portion of the sampling flow path, and then the large diameter portion of the sampling flow path is cut out, thereby allowing a portion of the contents to be sampled.

According to the present invention, it is possible to easily maintain the inside of a storage container containing contents as a closed space,
A portion of the contents can be sampled.

FIG. 2 is a schematic diagram showing an example of a container with sampling function according to the present embodiment. FIG. 2 is a schematic process diagram showing an example of a sampling method using the container with sampling function shown in FIG. 1. 13 is a cross-sectional view including the central axis of a sampling tube in another example of a container with sampling function according to the present embodiment. FIG. 13 is a cross-sectional view including the central axis of a sampling tube in another example of a container with sampling function according to the present embodiment. FIG. 10 is a schematic diagram showing another example of a container with sampling function according to the present embodiment. FIG. 6 is a schematic diagram showing an example of a method for fixing a container in a sampling method using the container with sampling function shown in FIG. 5 . 10 is a schematic diagram showing another example of a container with sampling function according to the present embodiment. FIG. 1 is a schematic diagram showing an example of a kit used to prepare a container with sampling function according to this embodiment. FIG.

The following describes an embodiment of a container with sampling function according to the present invention.

The container with sampling function in this embodiment is a container with sampling function comprising a storage container and a sampling flow path having a communication port at one end, communicating with the storage container via the communication port, and the other end being a closed end, and is characterized in that the sampling flow path has a small diameter portion on the one end side that communicates with the storage container via the communication port, and a large diameter portion on the other end side including the closed end, and has a structure in which a portion of the contents stored in the storage container can be sampled by flowing a portion of the contents into the large diameter portion through the communication port and the small diameter portion of the sampling flow path while maintaining the inside of the container with sampling function as a closed space, and then cutting out the large diameter portion of the sampling flow path.

Here, "closed space" means a space that is closed from the external environment so as to prevent contamination by foreign matter, bacteria, etc. in the external environment of the container with sampling function, for example, an airtight space that is sealed from the external environment.

First, an example of a container with sampling function according to this embodiment will be illustrated and described.
FIG. 1(a) is a schematic diagram showing an example of a container with a sampling function according to this embodiment, and FIG. 1(b) is a photograph showing an example of a portion X in FIG. 1(a).

As shown in FIG. 1( a ) and FIG. 1 ( b ), the container 1 with sampling function of this embodiment is:
The device includes a storage container 2 and a sampling tube 4. The storage container 2 is transparent enough to visually recognize the interface between the liquid content and the air from the outside, and is flexible enough to be deformed by applying force. The sampling tube 4 has a substantially annular structure without any branching, and has a communication port 4a at one end, which is inserted into the storage container 2 and communicates with the storage container 2 through the communication port 4a, and the other end is a closed end 4b. The sampling tube 4 includes one end provided with the communication port 4a, and has a small diameter portion 4S at one end side communicating with the storage container 2 through the communication port 4a, and a large diameter portion 4L at the other end side including the closed end 4b. The small diameter portion 4S and the large diameter portion 4L have cylindrical internal cavities, and the inner diameter of the large diameter portion 4L is larger than that of the small diameter portion 4S. The small diameter portion 4S and the large diameter portion 4L are directly connected, and the inner diameter changes discontinuously between the small diameter portion 4S and the large diameter portion 4L. The small diameter portion 4S of the sampling tube 4 is connected and fixed to the storage container 2 by bonding the inside of the edge 2a of the storage container 2 to the insertion portion.

The inside of the container 1 with sampling function, including the attachment points of the storage container 2 and the sampling tube 4, is configured so that there are no gaps communicating with the external environment, forming a sealed space.
The sampling tube 4 can be cut while being heat fused at a desired axial location in the small diameter portion 4S. The large diameter portion 4L of the sampling tube 4 has flexibility such that it can be deformed so that its volume changes when force is applied. By being provided with these configurations, the container with sampling function 1 can extract a portion of the content liquid contained in the storage container 2 through the communication port 4a of the sampling tube 4 and the small diameter portion 4S to the large diameter portion 4L while maintaining the inside of the container with sampling function 1 as an airtight space.
After the liquid has flowed into the sampling tube 4, the large diameter portion 4L of the sampling tube 4 can be cut off to sample a portion of the liquid therein.

The small diameter portion 4S of the sampling tube 4 has a transparency sufficient to allow the interface between the content liquid and the air to be visually recognized from the outside, and has flexibility that allows it to deform when force is applied.
The large diameter portion 4L of the sampling tube 4 also has a degree of transparency that allows the interface between the content liquid and the air to be visually recognized from the outside. In addition, the large diameter portion 4L is provided with a scale 4c as shown in Figures 2(a) and 2(b) described later.

Next, an example of a sampling method using the container with sampling function shown in Fig. 1 will be described. Fig. 2(a) and Fig. 2(b) are schematic process diagrams showing an example of a sampling method using the container with sampling function shown in Fig. 1.

2(a), while maintaining the inside of the container with sampling function 1 as a sealed space, a desired minute amount of the liquid contained in the storage container 2 is made to flow into the large diameter portion 4L through the communication port 4a and the small diameter portion 4S of the sampling tube 4. In the container with sampling function 1, because of the influence of surface tension, it is difficult to move a part of the liquid so as to pass by the air in the small diameter portion 4S, so it is difficult to make the part of the liquid flow into the large diameter portion 4L through the small diameter portion 4S by its own weight alone, and because it is easy to move the part of the liquid that has flowed into the large diameter portion 4L by passing by the air in the large diameter portion 4L, it is easy to move the part of the liquid that has flowed into the large diameter portion 4L to the closed end 4b by its own weight alone. Therefore, in this case, the large diameter portion 4L is crushed, the air in the large diameter portion 4L is pushed out through the small diameter portion 4S into the storage container 2, and then the liquid content is moved toward the communication port 4a of the storage container 2, and the crushed large diameter portion 4L is returned to its original state, by performing a simple operation to allow a portion of the liquid content to flow into the large diameter portion 4L through the communication port 4a and the small diameter portion 4S as if sucked little by little. Also, by a simple method such as adjusting the number of times such an operation is performed or the amount of deformation when the large diameter portion 4L is crushed by such an operation, the amount of liquid content flowing into the large diameter portion 4L can be finely adjusted to a desired very small amount. The amount of liquid flowing into the large diameter portion 4L can be measured by the graduations 4c.

Next, the liquid content flowing into the small diameter portion 4S is pushed out into the storage container 2 by air, and then the air in the storage container 2 is introduced into the small diameter portion 4S through the communication port 4a.
In this case, due to the influence of surface tension, it is difficult for part of the liquid content to move past the air in the small diameter portion 4S, and it is easy for part of the liquid content to move past the air in the large diameter portion 4L. Therefore, in this case, by performing a simple operation of squashing the large diameter portion 4L to push the liquid content flowing into the small diameter portion 4S into the storage container 2 with air, and then moving the air toward the communication port 4a of the storage container 2 and returning the squashed large diameter portion 4L to its original state, the air in the storage container 2 can be introduced into the small diameter portion 4S through the communication port 4a.

Next, as shown in FIG. 2(b), while maintaining the inside of the container 1 with sampling function as an airtight space, the sampling tube 4 is cut while being heat-sealed at a point in the small diameter portion 4S where air is present in the axial direction, thereby cutting out the large diameter portion 4L, and a desired minute amount of the liquid content can be extracted as a sample.

Therefore, in the container with sampling function according to this embodiment, by being characterized as described above, as in the above example, because of the influence of surface tension, it is difficult to move a part of the contents stored in the storage container so as to pass by the air in the small diameter part, so it is difficult to flow a part of the contents into the large diameter part through the small diameter part by its own weight alone, and because it is easy to move a part of the contents that has flowed into the large diameter part by passing by the air in the large diameter part, it is easy to move a part of the contents that has flowed into the large diameter part by its own weight alone to the closed end. Therefore, while maintaining the inside of the container with sampling function as a closed space, it is possible to flow a part of the contents into the large diameter part through the communication port and the small diameter part and take it out as a sample by performing a simple operation such as, for example, squashing the large diameter part and returning it to its original state without using any special auxiliary tool. Therefore, it is easy to
A portion of the contents can be sampled while maintaining the container in which the contents are stored as a closed space.

In addition, in the container with sampling function according to the present embodiment, as in the above example, for example,
The amount of the contents flowing into the large diameter portion can be finely adjusted by a simple method such as adjusting the number of times the large diameter portion is crushed and returned to its original state or the amount of deformation when the large diameter portion is crushed by the operation. Therefore, in the structure described in Patent Document 1, it is difficult to finely adjust the sampling amount by changing the way the sample extraction flow path is crushed, and even in the structure described in Patent Document 2, it is difficult to finely adjust the amount of sampled from a storage container such as a culture container to a dedicated sampling container. In contrast, in this embodiment, the sampling amount can be easily finely adjusted. In addition, this makes it easy to sample a very small amount with high accuracy, so that when the contents stored in the storage container are valuable, such as a cell suspension, the contents are not wasted in sampling.

Furthermore, in the container with sampling function according to this embodiment, as in the above example, by performing a simple operation of, for example, flowing a part of the contents into the large diameter portion and then squashing the large diameter portion to return it to its original state, the air in the storage container is introduced into the small diameter portion through the communication port, and then
By cutting the large diameter part of the sampling flow path while heat fusing it at the place where the air exists in the axial direction in the small diameter part, it is possible to extract a part of the content as a sample. Therefore, in the structure described in Patent Document 1, when cutting the flow path filled with the content to be sampled while heat fusing it, the culture medium, cells, etc. in the sample may be damaged by heat, which may hinder accurate testing of them. In contrast, in the present embodiment,
This prevents the sample from being damaged by heat.

Next, we will explain in detail each component of the container with sampling function according to this embodiment.

The sampling flow path is a hollow flow path member having a communication port at one end, communicating with the storage container via the communication port, and a closed end at the other end, and has a small diameter portion at the one end that communicates with the storage container via the communication port, and a large diameter portion at the other end that includes the closed end. The large diameter portion has an inner diameter larger than that of the small diameter portion.

The sampling flow path has a structure that allows a part of the contents stored in the storage container to flow into the large diameter part through the communication port and the small diameter part while maintaining the inside of the container with sampling function as a closed space. The sampling flow path is not particularly limited as long as it has such a structure, but it is usually flexible so that the large diameter part deforms so that its volume changes when a force is applied, as in the sampling tube 4 shown in Figure 1. In such a case, a part of the contents stored in the storage container can be caused to flow into the large diameter part through the communication port and the small diameter part by performing a simple operation such as squashing the large diameter part and returning it to its original state, and the amount of the contents flowing into the large diameter part can be finely adjusted by a simple method such as adjusting the number of times the operation is performed or the amount of deformation when the large diameter part is squashed by the operation.

Furthermore, the sampling flow path has a structure that allows the large diameter portion to be cut out while maintaining the inside of the container with sampling function as a closed space. Here, "a structure that allows the large diameter portion to be cut out while maintaining the inside of the container with sampling function as a closed space" specifically refers to a structure that allows the large diameter portion to be cut out while maintaining the inside of the remaining part of the sampling flow path and the inside of the storage container as closed spaces. The sampling flow path is not particularly limited as long as it has such a structure, but it is preferable that the small diameter portion can be cut while being heat fused at a desired axial position, like the sampling tube 4 shown in Figure 1.

The inner diameter of the small diameter part is not particularly limited as long as it is smaller than the large diameter part, but is preferably in the range of 1 mm or more and less than 10 mm, and more preferably in the range of 1 mm or more and less than 5 mm. When the inner diameter of the small diameter part is equal to or more than the lower limit of these ranges, it is easy to make a part of the contents stored in the storage container flow into the large diameter part through the small diameter part by a simple operation such as, for example, squashing the large diameter part and returning it to its original state. Also, when the inner diameter of the small diameter part is less than the upper limit of these ranges, the effect of making it difficult for a part of the contents stored in the storage container to move past the air in the small diameter part is effectively obtained due to the influence of surface tension, so that, for example, by performing a simple operation such as squashing the large diameter part and returning it to its original state, it is easy to make a part of the contents flow into the large diameter part through the communication port and the small diameter part and take it out as a sample. For example, by a simple method such as adjusting the number of times the operation of squashing the large diameter part and returning it to its original state is performed or the amount of deformation when the large diameter part is squashed by that operation, it is easy to fine-tune the amount of the contents flowing into the large diameter part.

The inner diameter of the large diameter part is not particularly limited as long as it is larger than the small diameter part, but is preferably in the range of 5 mm to 30 mm, and more preferably in the range of 10 mm to 30 mm. When the inner diameter of the large diameter part is equal to or greater than the lower limit of these ranges, the action of easily moving a part of the contents flowing into the large diameter part so as to pass by the air in the large diameter part is effectively obtained, so that, for example, by performing a simple operation such as squashing the large diameter part and returning it to its original state, it becomes easy to cause a part of the contents to flow into the large diameter part through the communication port and the small diameter part and take it out as a sample. Also, when the inner diameter of the large diameter part is equal to or less than the upper limit of these ranges, the workability can be improved.

The inner diameter of the large diameter portion refers to the diameter of the opening of the large diameter portion in a cross section perpendicular to the axial direction when converted into a perfect circle of the same area.Similarly, the inner diameter of the small diameter portion refers to the diameter of the opening of the small diameter portion in a cross section perpendicular to the axial direction when converted into a perfect circle of the same area.

Here, Fig. 3 is a cross-sectional view including the central axis of a sampling tube in another example of a container with a sampling function according to the present embodiment. The large diameter portion 4L of the sampling tube 4 in this example is
The closed end 4b has a thin portion 4t, and a surface 4s of the closed end 4b is a flat surface perpendicular to the axial direction of the large diameter portion 4L. Furthermore, a bottom surface 4u inside the large diameter portion 4L is a flat surface perpendicular to the axial direction of the large diameter portion 4L, and a side surface 4p inside the large diameter portion 4L is perpendicular to the bottom surface 4u.

The large diameter portion preferably has a thin wall portion 4t at the closed end, as in the large diameter portion 4L shown in FIG. 3, and the thickness of the thin wall portion is preferably within the range of 100 μm or less. This is because, when a syringe needle is inserted into the closed end of the large diameter portion to collect a part of the sample taken out of the large diameter portion for analysis, the needle can be easily inserted by inserting the needle into the thin wall portion, improving the workability during collection. In addition, the large diameter portion preferably has a flat surface at the closed end perpendicular to the axial direction of the large diameter portion, as in the large diameter portion 4L shown in FIG. 3. This is because, when a syringe needle is inserted into the surface of the closed end to collect a part of the sample taken out of the large diameter portion for analysis, the needle can be inserted into the flat surface perpendicular to the axial direction of the large diameter portion, making it easy to insert the syringe needle into the large diameter portion along the axial direction, improving the workability during collection. Furthermore, the large diameter portion preferably has a thin wall portion 4t at the closed end, as in the large diameter portion 4L shown in FIG. 3. This is because, when a syringe needle is inserted into the surface of the closed end to collect a part of the sample taken out of the large diameter portion for analysis, the needle can be inserted into the flat surface perpendicular to the axial direction of the large diameter portion, making it easy to insert the syringe needle into the large diameter portion along the axial direction, improving the workability during collection.
As shown in FIG. 1, it is preferable that the inner bottom surface 4u is a flat surface perpendicular to the axial direction of the large diameter portion, and the inner side surface of the large diameter portion is perpendicular to the bottom surface. This is because the amount of inflow into the large diameter portion can be accurately measured.

The shape of the small diameter portion is not particularly limited. For example, as shown in FIG. 1, the small diameter portion 4S may have a shape as follows:
Examples of such a shape include a tube with an internal cavity in the shape of a cylinder, an elliptical cylinder, or a polygonal cylinder. The small diameter portion becomes flexible and easily deformed by making it thick, and becomes hard and difficult to deform by making it thin. In addition, the small diameter portion is preferably transparent to such an extent that the interface between the contents and the air can be visually recognized from the outside, as in the small diameter portion 4S shown in FIG. 1. This is because it improves workability.

The shape of the large diameter portion is not particularly limited. For example, as shown in FIG. 1, the large diameter portion 4L may have a shape as follows:
Examples of the shape include a tube with an internal cavity in the shape of a cylinder, an elliptical cylinder, or a polygonal cylinder. The large diameter part becomes flexible and easily deformed by making it thick, and becomes hard and difficult to deform by making it thin. In addition, the large diameter part is preferably transparent to such an extent that the interface between the contents and the air can be visually recognized from the outside, as in the large diameter part 4L shown in FIG. 1. This is because it can improve workability. In addition, the large diameter part is preferably provided with a scale 4c, as in the large diameter part 4L shown in FIG. 2. This is because it can accurately measure the amount of inflow into the large diameter part.

The material of the small diameter portion is not particularly limited, but is preferably a material that can be cut while being heat fused, and among these, polyolefin resins such as polyethylene or polypropylene, polyvinyl chloride, ethylene-vinyl acetate copolymer resin, C-FLEX, etc. are preferred. This is because they have a low melting temperature and high flexibility, so they can be easily cut while being heat fused, and they can be easily deformed, so workability can be improved. In addition, the material of the small diameter portion is preferably a material that is suitable for low-temperature frozen storage, and among these, polyethylene, polypropylene, ethylene-vinyl acetate copolymer resin, etc. are preferred. This is because they have excellent low-temperature durability.

The material of the large diameter portion is not particularly limited, but is usually flexible enough to change its volume when a force is applied to it. Among them, polyolefin resins such as polyethylene or polypropylene, polyvinyl chloride, ethylene-vinyl acetate copolymer resin, or C-F
LEX and the like are preferred because they are highly flexible and can be easily deformed to change the volume. In addition, the material of the large diameter portion is preferably a material suitable for cryopreservation, for example, and among these, polyethylene, polypropylene, ethylene vinyl acetate copolymer resin and the like are preferred because they have excellent low-temperature durability.

4 is a cross-sectional view including the central axis of a sampling tube in another example of a container with a sampling function according to this embodiment. The sampling tube 4 in this example further has an intermediate portion 4M between the small diameter portion 4S and the large diameter portion 4L, the inner diameter of which changes continuously from the inner diameter of the small diameter portion 4S to the inner diameter of the large diameter portion 4L.

The sampling flow path may be, for example, like the sampling tube 4 shown in FIG. 1, in which the small diameter portion and the large diameter portion are directly connected and the inner diameter changes discontinuously between the small diameter portion and the large diameter portion, or may further have an intermediate portion between the small diameter portion and the large diameter portion, in which the inner diameter changes continuously from the inner diameter of the small diameter portion to the inner diameter of the large diameter portion, like the sampling tube 4 shown in FIG. 4. Such an intermediate portion makes it easy to return a part of the contents that has flowed into the large diameter portion to the storage container. The intermediate portion is preferably transparent enough to visually recognize the interface between the contents and air from the outside. The material of the intermediate portion is not particularly limited, but may be, for example, the same as that of the large diameter portion or the small diameter portion.

In addition, the sampling flow path usually has a small diameter portion that includes one end provided with a communication port, and the diameter of the communication port matches the inner diameter of the small diameter portion, as in the sampling pipe 4 shown in Fig. 1. In addition, the entire sampling flow path including the small diameter portion and the large diameter portion, or the entire sampling flow path including the small diameter portion, intermediate portion, and large diameter portion may be integrally molded from the same material, or the components including the small diameter portion and the large diameter portion, or the components including the small diameter portion, intermediate portion, and large diameter portion may be molded separately and connected.

The sampling flow path is preferably provided with a check valve, for example at the communication port, to prevent the contents from returning from the sampling flow path to the storage container. This is because it can prevent the contents from returning from the sampling flow path to the storage container when moving the contents in the sampling flow path, thereby improving operability. In addition, the sampling flow path is preferably provided with a clamp valve or solenoid valve, for example, to prevent the contents from returning from the sampling flow path to the storage container.
It is preferable that the valve is provided at the communication port, etc. This is because the flow of the contents in the sampling flow path can be controlled by opening and closing the sampling flow path with a clamp valve, solenoid valve, etc., thereby preventing the contents from unintentionally returning from the sampling flow path to the storage container, thereby improving operability.

2. Storage container The storage container is one in which the sampling flow path communicates through the communication port. The storage container can maintain the inside of the container with sampling function in a closed space and can store the contents in a sterile manner. Such a storage container may be one in which the inside of the storage container communicates with the external environment through a sterile filter. This is because it is possible to prevent bacteria from entering the inside of the storage container from the external environment and to prevent foreign matter larger than the pore size of the sterile filter from entering the inside of the storage container from the external environment, so that the inside of the container with sampling function can be maintained in a closed space and the contents can be stored in a sterile manner.

The container is not particularly limited as long as it is as described above, but it is preferable that the container is flexible, because it can be deformed when part of the contents stored in the container is to be poured into the large diameter portion, thereby improving workability.

The storage container is preferably transparent enough to allow the interface between the contents and the air to be visually recognized from the outside, because this improves workability since the contents stored in the storage container can be sampled while being visually recognized.

The container may be, for example, a bag made by laminating resin films at their periphery.
Examples include plastic molded products, among which bags are preferred because they are highly flexible and can improve workability.

The material of the container is not particularly limited as long as it can store the contents in a sterile manner. For example, polyolefin resins such as polyethylene or polypropylene, polyvinyl chloride,
Examples of the resin include ethylene vinyl acetate copolymer resin, C-FLEX, and polystyrene.

The material of the storage container is preferably, for example, a material suitable for cryopreservation, and among these, polyethylene, polypropylene, ethylene-vinyl acetate copolymer resin, etc. are preferable because they have excellent low-temperature durability. Furthermore, the material of the storage container is preferably, for example, the same as that of the sampling flow path, or one that can be fused to the sampling flow path. This is because there is no need to use an adhesive when connecting the sampling flow path to the storage container, and therefore contamination of the contents by the adhesive can be avoided.

A container with sampling function comprises a storage container and a sampling flow path having a communication port at one end, communicating with the storage container via the communication port and having a closed end at the other end, wherein the sampling flow path has a small diameter section at the one end that communicates with the storage container via the communication port and a large diameter section at the other end including the closed end, and has a structure in which, while maintaining the inside of the container with sampling function as a closed space, a portion of the content stored in the storage container is caused to flow into the large diameter section via the communication port and the small diameter section of the sampling flow path, and then the large diameter section of the sampling flow path is cut out, thereby allowing a portion of the content to be sampled.

The inside of the container with sampling function is a closed space that is closed off from the outside environment, including the connection points of the storage container and the sampling pipe, and is configured so that there are no gaps that communicate with the outside environment, including the connection points, and is a sealed, enclosed space.
Specifically, the above-mentioned structure of the container with sampling function refers to a structure in which a part of the contents stored in the storage container can be made to flow into the large diameter part through the communication port and the small diameter part while maintaining the inside of the container with sampling function as a closed space, and the large diameter part can be cut out after a part of the contents has flowed into the large diameter part, while maintaining the remaining part of the sampling flow path and the inside of the storage container as closed spaces. The structure of such a container with sampling function may be one in which the inside of the storage container communicates with the external environment through a sterile filter. This is because it is possible to prevent bacteria from entering the inside of the storage container from the external environment, and to prevent foreign matter larger than the pore size of the sterile filter from entering the inside of the storage container from the external environment, so that the inside of the container with sampling function can be maintained as a closed space and the contents can be stored in a sterile manner.

Fig. 5 is a schematic diagram showing another example of a container with sampling function according to the present embodiment. Fig. 6(a) is a schematic diagram showing an example of a method for fixing a container in a sampling method using the container with sampling function shown in Fig. 5, and Fig. 6(b) is a top view showing a schematic diagram of a method for fitting a fixing member of the container with sampling function into a fixing jig in the fixing method shown in Fig. 6(a).

The container with sampling function 1 of this example will be described focusing on the differences from the container with sampling function 1 shown in Fig. 1. Therefore, the points that are not particularly described are the same as the container with sampling function 1 shown in Fig. 1. As shown in Fig. 5, the container with sampling function 1 of this example further includes a fixing member 6 provided at a portion of the storage container 2 where the container 2 is connected to the small diameter portion 4S of the sampling tube 4. The fixing member 6 is a cylindrical molded product that is harder than the storage container 2 and the small diameter portion 4S of the sampling tube 4 and has an outer diameter larger than that of the small diameter portion 4S, and is provided with an insertion hole 6h for communicating the small diameter portion 4S of the sampling tube 4 with the storage container 2.
The fixing member 6 has an end inserted into the storage container 2, and the insertion portion is connected to the edge 2a of the storage container 2.
The sampling tube 4 is connected and fixed to the storage container 2 by gluing the inside of the fixing member 6. The small diameter portion 4S of the sampling tube 4 is connected and fixed to the fixing member 6 by inserting the communication port 4a into the insertion hole 6h of the fixing member 6 and gluing the inside of the insertion hole 6h to the end of the sampling tube 4 on the communication port side. In this way, the small diameter portion 4S of the sampling tube 4 is connected and fixed to the storage container 2 on the communication port 4a side via the fixing member 6. Also, the communication port 4a of the small diameter portion 4S of the sampling tube 4 is inserted into the storage container 2, and the small diameter portion 4S of the sampling tube 4 communicates with the storage container 2 through the communication port 4a. The container 1 with sampling function further includes an extraction port 8 provided at a position on the storage container 2 separate from the fixing member 6. The extraction port 8 is also a molded product similar to the fixing member 6, and is connected and fixed to the storage container 2 in the same manner as the fixing member 6.

In the sampling method using the container 1 with sampling function of this embodiment, as shown in FIG. 6( a ) and FIG. 6 ( b ), a set of fixing jigs 30 is used, and the recesses 3 of the set of fixing jigs 30 are
By fitting the fixing member 6 and the extraction port 8 into the sampling tube 4, the fixing member 6 and the extraction port 8, which are harder than the storage container 2 and the small diameter portion 4S of the sampling tube 4, can be fixed, and thus the sampling tube 4 can be fixed.
This improves workability when, for example, flowing the liquid into the sampling tube 4A through the small diameter portion 4S, or when cutting the sampling tube 4 while heat fusing it at a desired axial location in the small diameter portion 4S.

FIG. 7 is a schematic diagram showing another example of the container with sampling function according to this embodiment.
The container 1 with sampling function of this example is equipped with two sampling tubes 4, and the small diameter portions 4S of the two sampling tubes 4 are connected to and fixed to the storage container 2 at the communication port 4a side via a single fixing member 6, and the communication port 4a of the small diameter portions 4S of the two sampling tubes 4 is fixed to the fixing member 6.
The two sampling tubes 4 are inserted into the insertion holes 6h of the respective sampling tubes 4, and are inserted into the storage container 2.
5 in that the small diameter portion 4S of the sampling tube 4 is connected to the storage container 2 via a communication port 4a. As a result, even if sampling fails with one sampling tube 4, sampling can be attempted again with the other sampling tube 4. Furthermore, compared to a case in which the small diameter portions of the two sampling tubes are connected and fixed to the storage container at their respective communication port sides via two fixing members, a single fixing member 6 can be more easily fitted into the recess of the fixing jig than two fixing members, making the fixing operation easier.

The container with sampling function is preferably one further including a fixing member provided at a portion of the storage container connected to the small diameter portion of the sampling flow path, as in the container with sampling function 1 shown in Fig. 5 and Fig. 7, and the small diameter portion of the sampling flow path is connected to the storage container via the fixing member. The sampling flow path can be fixed by fixing a fixing member harder than the storage container and the sampling flow path, so that the workability can be improved when a part of the contents stored in the storage container is made to flow into the large diameter portion, or when the sampling flow path is cut while being heat-sealed at a desired portion of the small diameter portion. Note that such an effect is remarkable when the storage container is a flexible container that is easily deformed, such as a thin-walled container formed by bag or blow molding. Furthermore, for example, when the outer diameter of the fixing member is larger than the small diameter portion of the sampling flow path, and the fixing member is connected to the storage container by inserting an end of the fixing member into the storage container and bonding the inside of the edge of the storage container to the insertion portion, the strength with which the small diameter portion of the sampling flow path is connected to the storage container is increased.

The fixing member is not particularly limited as long as it is harder than the container and the sampling flow path, and may be, for example, a plastic molded product. Furthermore, the fixing member may be integrally molded with the sampling flow path. The shape of the fixing member is not particularly limited as long as its outer diameter is larger than the small diameter part of the sampling flow path, and may be, for example, a cylindrical shape or a columnar shape with a boat-shaped cross section.

The container with sampling function is, as shown in FIG. 7, a container with sampling function 1.
It is preferable to have two or more sampling flow paths, and the small diameter parts of the two or more sampling flow paths communicate with the storage container through communication ports. This is because even if sampling fails in one sampling flow path, sampling can be redone in another sampling flow path. In addition, when two or more sampling flow paths are provided, the color or length of the sampling flow path for redoing the sampling can be made different from the other flow paths to make it easier to distinguish.

In addition, it is preferable that the container with sampling function is one in which the fixing member is a single fixing member and the small diameter parts of two or more sampling channels are connected to the storage container via the single fixing member, as in the container with sampling function 1 shown in Fig. 7. This is because the fixing work becomes easier.

Here, FIG. 8 is a schematic diagram showing an example of a kit used to prepare a container with a sampling function according to this embodiment. The kit 10 of this embodiment includes a main body 10A and a sampling tube 10B. The main body 10A has a storage container 2 and a container-side small diameter portion 4S1. The container-side small diameter portion 4S1 has a communication port 4a at one end, which is inserted into the storage container 2 and communicates with the storage container 2 via the communication port 4a, and the other end is a connection end 4c1. The sampling tube 10B has a large-diameter-side small diameter portion 4S2 on one end side including one end that is a connection end 4c2, and a large-diameter portion 4L on the other end side including the other end that is a closed end 4b. Using the kit 10 of this embodiment, the connection end 4c of the large-diameter-side small diameter portion 4S2 of the sampling tube 10B is connected to the connection end 4c of the large-diameter-side small diameter portion 4S2.
By aseptically connecting 2 to the connection end 4c1 of the container side small diameter portion 4S1 of the main body portion 10A, a container with sampling function similar to the container with sampling function 1 shown in Figure 1 can be produced, which has a small diameter portion to which the large diameter side small diameter portion 4S2 and the container side small diameter portion 4S1 are connected.

The container with sampling function may be prepared, for example, like a container with sampling function prepared using kit 10 shown in Figure 8, by aseptically connecting the connection end of the large diameter portion side small diameter portion of the sampling flow path portion to the connection end of the container side small diameter portion of the main body portion using a kit having a storage container and a container side small diameter portion having a communication port at one end that communicates with the storage container via the communication port and the other end serving as a connection end, and a large diameter portion at the other end including the other end serving as a closed end.

4. Uses of the container with sampling function The contents to be sampled using the container with sampling function are not particularly limited, and are usually solutions that require aseptic handling, such as cell suspensions, food-related liquids, and pharmaceutical liquids. Examples of food-related liquids include beverages and seasonings. Examples of pharmaceutical liquids include electrolyte infusions such as physiological saline, carbohydrate injections such as glucose, blood preparations, antibiotics, protein drugs such as antibodies, low molecular weight proteins, peptide drugs such as hormones, nucleic acid drugs, cell drugs, vaccines to prevent various infectious diseases, steroids, insulin, anticancer drugs, protease inhibitors, analgesics, antipyretic analgesics, anti-inflammatory drugs, anesthetics, fat emulsions, blood pressure lowering drugs, vasodilators, electrolyte correction injections such as heparin sodium chloride and potassium lactate, vitamins, and contrast agents. Among them, cell suspensions are preferable as the contents. This is because the amount of sampling can be easily fine-tuned or damage to the sample caused by heat can be reduced, which provides particularly advantageous effects.

The use of the container with sampling function is not particularly limited, but is preferably used for sampling and inspecting the content liquid easily, without causing significant damage, and with high accuracy even in small amounts, while maintaining the inside of the container as a closed space to prevent contamination by foreign matter, bacteria, etc. from the external environment in a sealed container that contains a solution, etc. Specific examples include general containers related to cells, such as a culture container for culturing cells, a culture medium supply container for supplying a culture medium, a cell recovery container for recovering a cell suspension after culture, a waste liquid container for recovering a culture medium during or after culture, or a temporary cell storage container, or a cell culture system, etc., among which a cell culture system is preferable.

A cell culture system is, for example, a closed system in which multiple containers such as a culture container, a culture medium supply container, a cell collection container, or a waste liquid container are aseptically connected and closed off from the external environment to reduce the risk of contamination. When a container with a sampling function is used in a cell culture system, the cell culture system can be, for example, a system in which the container with a sampling function is aseptically connected to any one of the multiple containers, a system in which a connection port that can be aseptically connected to the container with a sampling function is provided, or a system in which any one of the multiple containers itself has the same configuration as the container with a sampling function and is also used as the container with a sampling function.

5. Sampling Method A sampling method using a container with a sampling function is a method in which, while maintaining the inside of the container with a sampling function as a closed space, a portion of the content stored in the storage container is caused to flow into the large diameter portion of the sampling flow path through the communication port and the small diameter portion, and then the large diameter portion of the sampling flow path is cut out, thereby sampling a portion of the content.

The sampling method is not particularly limited, but may be, for example, as shown in Fig. 2(a) and Fig. 2(b), a method in which a part of the contents stored in the storage container is flowed into the large diameter part, air is introduced into the small diameter part, and the sampling flow path is cut while being heat-sealed at the location where the axial air exists in the small diameter part, to cut out the large diameter part, or a method in which a part of the contents stored in the storage container is flowed into the large diameter part, and the sampling flow path is cut while being heat-sealed at the location where the contents exist in the axial direction in the small diameter part, without introducing air into the small diameter part, to cut out the large diameter part. Among these methods, the method in which the sampling flow path is cut while being heat-sealed at the location where the axial air exists in the small diameter part is preferable. This is because it is easy to suppress damage to the sample by heat.

The method for cutting out the large diameter part of the sampling flow path is not particularly limited, but examples include a method of cutting the sampling flow path while heat fusing it at a desired axial position in the small diameter part, etc. The method of cutting the sampling flow path while heat fusing it at a desired axial position in the small diameter part may be performed entirely manually, or may be performed using a jig that fixes the sampling flow path and cuts it while heat fusing it at a desired axial position in the small diameter part.

The sampling method is not particularly limited, but may be a method in which, after performing at least one sampling using a container with sampling function, the sampling flow path is cut at a desired location in the small diameter part, and the connection end of the remaining cut part of the small diameter part on the container side is aseptically connected to the connection end of a new sampling flow path part such as the sampling pipe part 10B shown in Figure 8, thereby regenerating the container with sampling function and performing sampling using the regenerated container, since multiple samplings can be performed with one container.

The method for aseptically connecting the connection end of the small diameter part on the large diameter part side of the new sampling flow path part to the connection end where the small diameter part on the container side is cut is not particularly limited, but examples include a method using a general sterile connection port or a sterile connection device.

The container with sampling function according to this embodiment will be described in more detail below with reference to examples.

[Example]
The container with sampling function of the embodiment is the container with sampling function 1 shown in Figure 1, in which the storage container 2 is constructed by heat sealing a Unipack F-4 film manufactured by Seisan Nippon Sha, the small diameter section 4S of the sampling tube 4 is constructed from T4306 manufactured by QOSINA and has an inner diameter of 3 mm, and the large diameter section 4L of the sampling tube 4 is constructed from a polyethylene material tube manufactured by injection molding and has an inner diameter of 10 mm.

When the container 1 with sampling function of the embodiment is arranged so that the sampling tube 4 is vertical, the liquid content (water) stored in the storage container 2 hardly flows into the small diameter portion 4S due to its own weight.

The sampling method using the container with sampling function 1 of the embodiment is a method shown in the schematic process diagrams of FIG. 2(a) and FIG. 2(b).

In this sampling method, first, as shown in Fig. 2(a), while maintaining the inside of the container 1 with sampling function as a sealed space, a desired minute amount of the liquid content (water) contained in the container 2 is made to flow into the large diameter portion 4L through the communication port 4a and the small diameter portion 4S of the sampling tube 4. Specifically, the large diameter portion 4L is crushed to push the air in the large diameter portion 4L out through the small diameter portion 4S into the container 2, and then the liquid content is brought toward the communication port 4a side of the container 2,
By performing a simple operation of returning the crushed large diameter portion 4L to its original state, a part of the liquid content was gradually sucked into the large diameter portion 4L through the communication port 4a and the small diameter portion 4S. At this time, a part of the liquid content moved in the small diameter portion 4S without passing through the air, and a part of the liquid content that was flowed into the large diameter portion 4L moved in the large diameter portion 4L so as to pass through the air, and moved to the closed end 4b by its own weight. In addition, the amount of liquid content that flowed into the large diameter portion 4L was finely adjusted to 300 μl by a simple method of adjusting the number of times such an operation was performed. The amount of liquid content that flowed into the large diameter portion 4L was measured using the scale 4c.

Next, the liquid contents flowing into the small diameter portion 4S were pushed out into the storage container 2 by air, and the air in the storage container 2 was then introduced into the small diameter portion 4S through the communication port 4a. Specifically, the large diameter portion 4L was crushed to push out the liquid contents flowing into the small diameter portion 4S into the storage container 2 by air, and then the air was moved toward the communication port 4a of the storage container 2, and the crushed large diameter portion 4L was returned to its original state. This simple operation allowed the air in the storage container 2 to be introduced into the small diameter portion 4S through the communication port 4a.

Next, as shown in FIG. 2(b), while maintaining the inside of the container 1 with sampling function as an airtight space, the sampling tube 4 was cut while being heat-sealed at a point in the small diameter portion 4S where air was present in the axial direction, thereby cutting out the large diameter portion 4L, and 300 μl of the liquid content was extracted as a sample.

Although the embodiment of the container with sampling function according to the present invention has been described in detail above,
The present invention is not limited to the embodiments described above, and various design modifications can be made without departing from the spirit of the present invention as described in the claims.

1 Container with sampling function 2 Storage container 4 Sampling tube 4a Communication port 4b Closed end 4S Small diameter portion 4L Large diameter portion

Claims (8)

A container with a sampling function, comprising: a storage container; and a sampling tube having a communication port at one end, communicating with the storage container via the communication port, and a closed end at the other end, and having no branching;
the sampling pipe has a small diameter portion at the one end where the communication port is provided and a large diameter portion at the other end including the closed end,
The communication port of the small diameter portion is inserted into the storage container,
the small diameter portion and the large diameter portion are directly connected;
The inner diameter of the large diameter portion is larger than the inner diameter of the small diameter portion,
an inner diameter discontinuously changes between the small diameter portion and the large diameter portion;
a structure in which, while maintaining the inside of the sampling container as a closed space, a portion of the content stored in the storage container is caused to flow into the large diameter portion through the communication port and the small diameter portion of the sampling tube, and then the large diameter portion of the sampling tube is cut out, thereby sampling a portion of the content ;
a surface of the closed end of the large diameter portion is a flat surface perpendicular to an axial direction of the large diameter portion,
the large diameter portion has a thin wall portion at the closed end,
A container with sampling function, characterized in that a bottom surface on the closed end side inside the large diameter portion is a flat surface perpendicular to the axial direction of the large diameter portion . 2. The container with sampling function according to claim 1, wherein the thickness of the thin-walled portion at the closed end of the large-diameter portion is within a range of 100 μm or less. 2. The container with sampling function according to claim 1, wherein the large diameter portion is provided with a scale. The container with sampling function according to claim 1, characterized in that the axial length of the large diameter portion is longer than the axial length of the small diameter portion. A container with sampling function as described in any one of claims 1 to 4, characterized in that it has a structure in which a portion of the contents stored in the storage container can be caused to flow into the large diameter portion through the communication port and the small diameter portion by performing an operation such as crushing the large diameter portion and returning the crushed large diameter portion to its original state, and in which air within the storage container can be introduced into the small diameter portion through the communication port by performing an operation such as crushing the large diameter portion and returning the crushed large diameter portion to its original state . 5. A container with sampling function according to claim 1, wherein the inner diameter of the small diameter portion is within a range of 1 mm or more and less than 5 mm, and the inner diameter of the large diameter portion is within a range of 5 mm or more and 30 mm or less. A container with sampling function as described in any one of claims 1 to 4, further comprising a fixing member provided at a point on the storage container where the storage container is connected to the small diameter portion of the sampling tube, and the small diameter portion of the sampling tube is connected to the storage container via the fixing member. 5. The container with sampling function according to claim 1, wherein the entire sampling pipe including the small diameter portion and the large diameter portion is integrally molded from the same material.

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