WO2025035992A1 - Storage device for storage of biological liquid or pharmaceutical liquid, manufacturing method, and system - Google Patents

Abstract

A storage device for the storage of a biological liquid or pharmaceutical liquid, a manufacturing method, and a system. The storage device comprises: a tubular body (1), a first port sealing structure (10) and a second port sealing structure (20), wherein the tubular body (1) comprises an accommodating cavity (V) and has a first port (1A) and a second port (1B); the first port sealing structure (10) is connected to the first port (1A), comprising a first inlet channel (101) in communication with the accommodating cavity (V) and a first sealing member (102); and the second port sealing structure (20) is connected to the second port (1B), comprising a second inlet channel (201) in communication with the accommodating cavity (V) and a second sealing member (202). The storage device further comprises a port connection structure (11, 21), which is arranged between the tubular body (1) and at least one sealing structure among the first port sealing structure (10) and the second port sealing structure (20), in order to connect the at least one port sealing structure to the corresponding first port (1A) or second port (1B).

Description

Storage device for storing biological liquid or drug liquid and manufacturing method and system

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is based on and claims the priority of Chinese Patent Application No. 202311023643.3, filed on August 14, 2023, entitled “Storage device, manufacturing method and system for storing biological fluids or medicinal fluids”. The contents disclosed in the above-mentioned Chinese patent application are hereby cited in their entirety as part of this application.

Technical Field

The present invention relates to the field of biomedical storage technology, and in particular to a storage device for storing biological liquid or drug liquid, a manufacturing method thereof, and an infusion system.

Background Art

With the continuous progress of modern medical research, we have a deeper understanding of the pathogenesis of various diseases. Biological fluids such as cells, tissue fluids, and blood have gradually become valuable resources for basic medical research and clinical research. In recent years, a large number of biologically active pharmaceutical preparations such as vaccines, peptides, monoclonal antibodies, fusion proteins, and engineered immune cells have also emerged in the market. With the increasing demand for the storage of biological fluids or drug liquids, how to quickly and efficiently inject these liquids into storage devices is the primary problem that needs to be solved.

Summary of the invention

According to an embodiment of the present disclosure, a storage device for storing biological liquid or drug liquid, a manufacturing method thereof, and an infusion system are provided. In the storage device of the embodiment of the present disclosure, the first port (and/or the second port) of the tubular body is connected to the first port sealing structure (and/or the second port sealing structure) through a port connection structure, and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the liquid injection amount and the liquid injection speed, which is suitable for efficient automated continuous filling production. In addition, it also improves the convenience of clinical application, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

According to a first aspect of the present disclosure, there is provided a storage device for storing biological liquid or drug liquid, comprising: The invention comprises: a tubular body, which includes a receiving cavity for receiving the biological liquid or the drug liquid and has a first port and a second port opposite to each other in the extension direction of the tubular body; a first port sealing structure connected to the first port, the first port sealing structure includes a first access channel and a first sealing member connected to the receiving cavity, the first sealing member is arranged in the first access channel and is used to temporarily close the receiving cavity; a second port sealing structure connected to the second port, the second port sealing structure includes a second access channel and a second sealing member connected to the receiving cavity, the second sealing member is arranged in the second access channel and is used to temporarily close the receiving cavity; wherein the storage device also comprises: a port connection structure, which is arranged between at least one sealing structure of the first port sealing structure and the second port sealing structure and the tubular body, so as to connect the at least one port sealing structure to the corresponding first port or the second port.

In at least some embodiments, the storage device includes: a first port connecting structure arranged between the first port sealing structure and the first port, the first port connecting structure including: a first main protrusion located on the first port and protruding in a radial direction of the first port; a first auxiliary protrusion located on the first port sealing structure and protruding in a radial direction of the first access channel; the first auxiliary protrusion is connected to the first main protrusion so that the first port sealing structure is connected to the first port.

In at least some embodiments, the first main protrusion is a first main body circumferential flange arranged along the circumferential direction of the first port, and the first auxiliary protrusion is a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel, and the first auxiliary circumferential flange is connected to the first main body circumferential flange.

In at least some embodiments, there are multiple first main protrusions, and there are multiple first auxiliary protrusions. The multiple first main protrusions and the multiple first auxiliary protrusions are connected in a one-to-one correspondence.

In at least some embodiments, the first main protrusion and the tubular body are configured as an integral structure, and the first auxiliary protrusion and the first port sealing structure are configured as an integral structure.

In at least some embodiments, the storage device further comprises: a second port connection structure disposed between the second port sealing structure and the second port, the second port connection structure comprising: a second main protrusion located on the second port and protruding in a radial direction of the second port; a second auxiliary protrusion located on the second port sealing structure and protruding in a radial direction of the second access channel; the second auxiliary protrusion being connected to the second main protrusion so that the second port sealing structure is The structure is connected to the second port.

In at least some embodiments, the second main protrusion is a second main body circumferential flange arranged along the circumferential direction of the second port, and the second auxiliary protrusion is a second auxiliary circumferential flange arranged along the circumferential direction of the second access channel, and the second auxiliary circumferential flange is connected to the second main body circumferential flange.

In at least some embodiments, there are multiple second main protrusions, and there are multiple second auxiliary protrusions. The multiple second main protrusions and the multiple second auxiliary protrusions are connected in a one-to-one correspondence.

In at least some embodiments, the second main protrusion and the tubular body are configured as an integral structure, and the second auxiliary protrusion and the second port sealing structure are configured as an integral structure.

In at least some embodiments, the storage device further includes: a first limiting structure and/or a second limiting structure, wherein the first limiting structure is arranged between the first port sealing structure and the tubular body to maintain the relative position of the first port sealing structure and the tubular body; and the second limiting structure is arranged between the second port sealing structure and the tubular body to maintain the relative position of the second port sealing structure and the tubular body.

In at least some embodiments, the first limiting structure includes a first limiting protrusion disposed on one of the first port sealing structure and the first port, and the first limiting protrusion is inserted into the other of the first port sealing structure and the first port; the second limiting structure includes a second limiting protrusion disposed on one of the second port sealing structure and the second port, and the second limiting protrusion is inserted into the other of the second port sealing structure and the second port.

In at least some embodiments, the first limiting protrusion includes a first cylindrical wall, which is disposed at the first port and extends around the first port; the second limiting protrusion includes a second cylindrical wall, which is disposed at the second port and extends around the second port.

In at least some embodiments, the first port sealing structure further comprises a first detachable portion, which is disposed on a side of the first seal away from the tubular body; the second port sealing structure further comprises a second detachable portion, which is disposed on a side of the second seal away from the tubular body.

In at least some embodiments, the first port sealing structure further includes a first auxiliary separation structure, the first auxiliary separation structure including at least one pair of first fins connected to the first detachable portion; the second port sealing structure further includes a second auxiliary separation structure, the second auxiliary separation structure including The invention also includes at least one pair of second flaps connected to the second detachable portion.

In at least some embodiments, the first port sealing structure also includes a first tubular portion, which defines the first access channel and is connected to the first port; the second port sealing structure also includes a second tubular portion, which defines the second access channel and is connected to the second port; the inner wall of at least one of the first tubular portion and the second tubular portion has a guide surface.

In at least some embodiments, the tubular body has an inverted tapered shape such that a size of the first port is larger than a size of the second port.

In at least some embodiments, the first port connection structure includes: a first main body circumferential flange arranged along the circumferential direction of the first port of the tubular main body, and a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel, wherein the first auxiliary circumferential flange is connected to the first main body circumferential flange.

In at least some embodiments, the first port sealing structure includes a first tubular portion defining the first access channel and at least two pairs of first fins connected to the first tubular portion, the at least two pairs of first fins including a first pair of first fins and a second pair of first fins; the first pair of first fins are closer to the first auxiliary circumferential flange in the extension direction of the first tubular portion than the second pair of first fins, and the first pair of first fins are connected to the first auxiliary circumferential flange.

In at least some embodiments, the storage device also includes a first limiting structure arranged on the first port sealing structure, the first limiting structure includes an annular protrusion arranged on the side of the first auxiliary circumferential flange close to the first port, the annular protrusion protrudes toward the first port and is configured to be inserted into the first port.

In at least some embodiments, the second port sealing structure includes a second tubular portion defining the second access channel and at least two pairs of second fins connected to the second tubular portion, the at least two pairs of second fins including a first pair of second fins and a second pair of second fins; the first pair of second fins are closer to the tubular body than the second pair of second fins in the extension direction of the second tubular portion, and the first pair of second fins are connected to the bottom of the tubular body.

In at least some embodiments, the material of the storage device includes a polymer.

In at least some embodiments, the polymer is configured to be suitable for storing the biological fluid or the pharmaceutical fluid at a cryopreservation temperature.

In at least some embodiments, the polymer includes ethylene-vinyl acetate copolymer, perfluoroethylene propylene One or more of olefin copolymers and polyolefin copolymers.

According to a second aspect of the present disclosure, a method for manufacturing a storage device for storing biological liquid or medicinal liquid is provided, comprising: providing a tubular body, the tubular body comprising a first port and a second port opposite to each other in an extension direction of the tubular body; connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port to form a containing cavity for containing the biological liquid or the medicinal liquid; injecting the biological liquid or the medicinal liquid into the containing cavity through the other of the first port and the second port; connecting the other of the first port sealing structure and the second port sealing structure to the other of the first port and the second port to seal the biological liquid or the medicinal liquid in the containing cavity.

In at least some embodiments, connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port includes: forming a first port connecting structure between the first port sealing structure and the first port; and connecting the first port sealing structure to the first port using the first port connecting structure.

In at least some embodiments, a first port connection structure is formed between the first port sealing structure and the first port, comprising: forming a first main protrusion on the first port, the first main protrusion protruding in a radial direction of the first port; forming a first auxiliary protrusion on the first port sealing structure, the first auxiliary protrusion protruding in a radial direction of the first access channel;

The first auxiliary protrusion is connected to the first main protrusion.

In at least some embodiments, the first main protrusion and the tubular body are formed by an integral molding process, and the first auxiliary protrusion and the first port sealing structure are formed by an integral molding process.

In at least some embodiments, connecting the other of the first port sealing structure and the second port sealing structure to the other of the first port and the second port includes: forming a second port connecting structure between the second port sealing structure and the second port; and connecting the second port sealing structure to the second port using the second port connecting structure.

In at least some embodiments, a second port connection structure is formed between the second port sealing structure and the second port, including: forming a second main protrusion on the second port, the second main protrusion protruding in a radial direction of the second port; forming a second auxiliary protrusion on the second port sealing structure, the second auxiliary protrusion protruding in a radial direction of the second access channel; and connecting the second auxiliary protrusion to the second main protrusion.

In at least some embodiments, the second main protrusion and the tubular body are formed in one piece. The second auxiliary protrusion and the second port sealing structure are formed by an integral molding process.

In at least some embodiments, the step of providing a tubular body and the step of connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port are completed in the same process, and the same process includes: forming the tubular body and the second port sealing structure connected to the second port by an one-piece molding process.

According to a third aspect of the present disclosure, there is provided an infusion system, comprising the storage device of any one of the aforementioned embodiments.

In at least some embodiments, the infusion system further includes: an infusion pipeline, the infusion pipeline including a first liquid inlet end and a first liquid outlet end, the first liquid inlet end being connected to the accommodating chamber via a second access channel of the second port sealing structure, so that the biological liquid or the drug liquid flows into the first liquid inlet end via the second access channel.

In at least some embodiments, the first liquid inlet end is provided with a first piercer, and the first piercer is configured to pierce the second sealing member to allow the second access channel to communicate with the accommodating chamber.

In at least some embodiments, the infusion system further includes: a container for containing a liquid, wherein the liquid is different from the biological liquid or the drug liquid; and a liquid transferor, wherein the liquid transferor includes a liquid channel and a second liquid inlet and a second liquid outlet located at both ends of the liquid channel, wherein the second liquid inlet is connected to the container, and the second liquid outlet is connected to the accommodating cavity via a first access channel of the first port sealing structure, so that the liquid flows into the accommodating cavity via the first access channel.

In at least some embodiments, the second liquid outlet is provided with a second puncture device, and the second puncture device is configured to puncture the first sealing member to allow the first access channel to communicate with the accommodating cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not intended to limit the present disclosure.

FIG1 is a schematic diagram of the structure of a storage device provided in an embodiment of the present disclosure;

FIG2 is a longitudinal cross-sectional view of a storage device provided in an embodiment of the present disclosure;

FIG3 is a cross-sectional view of a first port sealing structure provided with a first auxiliary protrusion according to an embodiment of the present disclosure;

FIG4 is a top view of FIG3;

FIG5 schematically shows various variations of the first auxiliary protrusion;

FIG6 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

FIG7 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

FIG8 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

FIG9 is a schematic structural diagram of a storage device according to another embodiment of the present disclosure;

FIG10 is a schematic structural diagram of a storage device provided by another embodiment of the present disclosure;

FIG11 is a longitudinal cross-sectional view of a storage device provided by another embodiment of the present disclosure;

FIG12A is a schematic structural diagram of the first port sealing structure of FIG11;

FIG12B is a top view of the first port sealing structure of FIG12A;

FIG12C is a bottom view of the first port sealing structure of FIG12A;

FIG13 is a schematic diagram of a use process of a storage device according to an embodiment of the present disclosure;

FIG14 is a schematic structural diagram of an infusion system according to an embodiment of the present disclosure;

FIG. 15 is a flow chart of a method for manufacturing a storage device according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

In order to make the purpose, technical solution and advantages of the embodiments of the present disclosure clearer, the technical solution of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present invention belongs. The words "first", "second" and similar words used in the specification and claims of the present patent application do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" and similar words mean that the elements or objects appearing before "include" or "comprise" include the elements or objects listed after "include" or "comprise" and their equivalents, and do not exclude other elements or objects. Words such as "connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

In order to make the purpose, technical solutions and advantages of the embodiments of the present disclosure clearer, the following will be combined with the present disclosure The accompanying drawings of the embodiments clearly and completely describe the technical solutions of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar words used in the patent application specification and claims of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" and the like mean that the elements or objects appearing before "include" or "comprise" include the elements or objects listed after "include" or "comprise" and their equivalents, and do not exclude other elements or objects. Words such as "connect" or "connected" and the like are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

According to an embodiment of the present disclosure, a storage device for storing biological liquid or drug liquid is provided, comprising: a tubular body, a first port sealing structure and a second port sealing structure. The tubular body comprises a receiving cavity for receiving biological liquid or drug liquid and has a first port and a second port opposite to each other in the extension direction of the tubular body; the first port sealing structure is connected to the first port and comprises a first access channel and a first seal communicating with the receiving cavity, the first seal is arranged in the first access channel and is used to temporarily close the receiving cavity; the second port sealing structure is connected to the second port and comprises a second access channel and a second seal communicating with the receiving cavity, the second seal is arranged in the second access channel and is used to temporarily close the receiving cavity. The storage device also comprises: a port connection structure, which is arranged between at least one of the first port sealing structure and the second port sealing structure and the tubular body, so as to connect at least one port sealing structure to the corresponding first port or second port.

In the storage device provided by the above-mentioned embodiment of the present disclosure, the first port (and/or the second port) of the tubular body is connected to the first port sealing structure (and/or the second port sealing structure) through the port connection structure, and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the liquid injection amount and the liquid injection speed, which is suitable for efficient automated continuous filling production. By respectively providing the first seal and the second seal in the first port sealing structure and the second port sealing structure, it is convenient to insert the puncture device from both ends of the storage device, thereby improving the convenience of clinical application and the flexibility of adapting the infusion device. It saves a lot of materials, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

The present disclosure is described below by specific embodiments. In order to keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and known components may be omitted. When any component of the embodiments of the present disclosure appears in more than one figure, the component may be represented by the same reference numeral in each figure.

Fig. 1 is a schematic diagram of the structure of a storage device provided in an embodiment of the present disclosure. Fig. 2 is a longitudinal cross-sectional view of a storage device provided in an embodiment of the present disclosure.

As shown in FIGS. 1 and 2 , a storage device for storing biological liquid or drug liquid according to an embodiment of the present disclosure includes: a tubular body 1, a first port sealing structure 10, and a second port sealing structure 20. The tubular body 1 includes a receiving chamber V for receiving biological liquid or drug liquid and has a first port 1A and a second port 1B opposite to each other in the extension direction of the tubular body 1 (e.g., the vertical direction shown in the figure). The first port sealing structure 10 is connected to the first port 1A and includes a first access channel 101 and a first sealing member 102 that are in communication with the receiving chamber V, and the first sealing member 102 is disposed in the first access channel 101 and is used to temporarily close the receiving chamber V. The second port sealing structure 20 is connected to the second port 1B and includes a second access channel 201 and a second sealing member 202 that are in communication with the receiving chamber V, and the second sealing member 202 is disposed in the second access channel 201 and is used to temporarily close the receiving chamber V.

Before the liquid is injected, the tubular body 1 has a hollow accommodating chamber V. After the liquid is injected, the accommodating chamber V is partially or completely filled. In the embodiment of the present disclosure, by providing the first access channel 101 and the second access channel 201, it is convenient for the injection needle to communicate with the tubular body 1 through the first port 1A or the second port 1B. Furthermore, by providing the first seal 102 and the second seal 202, on the one hand, it prevents the liquid from flowing out of the first port sealing structure 10 and the second port sealing structure 20 and is conducive to maintaining the sterile state in the accommodating chamber, and on the other hand, it facilitates the insertion of the injection needle, providing convenience during clinical use.

In the embodiment of the present disclosure, the first sealing member 102 and the second sealing member 202 may be made of a material suitable for being pierced by a needle-shaped tool, including but not limited to a thermoplastic material.

In the embodiment of the present disclosure, the first seal 102 and the first port sealing structure 10 can be an integral structure or a separable structure (i.e., they are manufactured separately and then assembled together); the second seal 202 and the second port sealing structure 20 can be an integral structure or a separable structure (i.e., they are manufactured separately and then assembled together); when they are an integral structure, it is conducive to being realized through an integrated molding process, and can further improve the sealing of the overall structure.

In the embodiment of the present disclosure, the cross-sectional shape of the tubular body 1 is taken as an example to illustrate that the cross-sectional shape of the tubular body 1 is circular. It is understood that the cross-sectional shape may also be elliptical, triangular, rectangular, etc., and the embodiments of the present disclosure are not limited to this.

In some embodiments, the storage device may further include a port connection structure disposed between at least one of the first port sealing structure 10 and the second port sealing structure 20 and the tubular body 1 to connect the at least one port sealing structure to the corresponding first port 1A or second port 1B.

For example, as shown in Figures 1 and 2, the storage device includes a first port connection structure 11 disposed between the first port sealing structure 10 and the first port 1A. That is, the first port connection structure 11 is connected between the first port sealing structure 10 and the first port 1A.

Compared with injecting liquid from the first access channel 101, in the embodiment of the present disclosure, the first port 1A, as the open end of the tubular body 1, has the same cross-sectional area as the tubular body 1, so liquid can be injected from the first port 1A, thereby increasing the liquid injection area and increasing the liquid injection amount per unit time, which is particularly suitable for mass production. In other embodiments of the present disclosure, liquid can also be injected from the second port 1B. Since the technical effects are the same, they will not be repeated here.

For example, the first port connection structure 11 includes a first main protrusion 111 and a first auxiliary protrusion 112. The first main protrusion 111 is located on the first port 1A and protrudes in the radial direction of the first port 1A (e.g., the diameter direction of the first port 1A). The first auxiliary protrusion 112 is located on the first port sealing structure 10 and protrudes in the radial direction of the first access channel 101 (e.g., the diameter direction of the first access channel 101). The first auxiliary protrusion 112 is connected to the first main protrusion 111 so that the first port sealing structure 10 is connected to the first port 1A.

In the embodiment of the present disclosure, the first main protrusion 111 and the first auxiliary protrusion 112 are provided, so that after the liquid is injected from the first port 1A, a sealed connection is achieved between the first port sealing structure 10 and the first port 1A. In some embodiments, the first auxiliary protrusion 112 and the first main protrusion 111 can be connected by welding, riveting, bolting, etc., and the embodiment of the present disclosure does not limit the specific connection method between the two. When welding is used for connection, for example, a high-frequency welding process and/or a hot melt welding process can be used.

In the embodiment of the present disclosure, the first main protrusion 111 and the first auxiliary protrusion 112 protrude from the outer surface of the first sealing structure 10 and the outer surface of the first port 1A respectively, which facilitates the connection between the two.

For example, as shown in FIG. 2 , the first access channel 101 includes a first wide end 101A and a first narrow end 101B opposite to each other in the extension direction thereof, the first narrow end 101B is a closed end, the size of the first wide end 101A is substantially the same as the size of the first port 1A, and the first auxiliary protrusion 112 is located at the first Through the above arrangement, the tight connection between the first main protrusion 111 and the first auxiliary protrusion 112 is further enhanced to prevent liquid from flowing out.

In the embodiment of the present disclosure, the first main protrusion 111 or the first auxiliary protrusion 112 can be arranged in various ways, as long as the sealing connection between the first port sealing structure 10 and the first port 1A is ensured. FIG3 is a cross-sectional view of the first port sealing structure provided with the first auxiliary protrusion in the embodiment of the present disclosure. FIG4 is a top view of FIG3. FIG5 schematically shows various variations of the first auxiliary protrusion.

For example, referring to Figures 1 and 4, the first main protrusion 111 is a first main body circumferential flange arranged along the circumferential direction of the first port 1A, and the first auxiliary protrusion 112 is a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel 101, and the first auxiliary circumferential flange is connected to the first main body circumferential flange. In other words, the first main protrusion 111 and the first auxiliary protrusion 112 constitute a first flange structure connecting the first port sealing structure 10 and the first port 1A.

In the embodiment of the present disclosure, by providing the first main body circumferential flange and the first auxiliary circumferential flange, the tight connection between the first port sealing structure 10 and the first port 1A can be further enhanced, thereby reducing the risk of liquid leakage.

In some embodiments, there are multiple first main protrusions, and there are multiple first auxiliary protrusions. The multiple first main protrusions and the multiple first auxiliary protrusions are connected in a one-to-one correspondence.

For example, as shown in FIG5 , the number of the first auxiliary protrusions may be two, three or four, and these first auxiliary protrusions are axially symmetrically distributed in the plane where the cross section of the first access channel 101 is located (e.g., the xy plane shown in the figure). For example, in FIG5 (a), the four first auxiliary protrusions 112a are symmetrically distributed about the x-axis or the y-axis, in FIG5 (b), the three first auxiliary protrusions 112b are symmetrically distributed relative to the y-axis, in FIG5 (c), the two first auxiliary protrusions 112c are symmetrically distributed relative to the x-axis or the y-axis, in FIG5 (d), the two first auxiliary protrusions 112d are symmetrically distributed relative to the x-axis or the y-axis, in FIG5 (e), the two first auxiliary protrusions 112e are symmetrically distributed relative to the x-axis or the y-axis, and in FIG5 (f), the two first auxiliary protrusions 112f are symmetrically distributed relative to the x-axis or the y-axis. Similarly, the number of the first main protrusions is the same as the number of the first auxiliary protrusions and has the same arrangement.

In the disclosed embodiment, by providing a variety of variations of the first main protrusion and the first auxiliary protrusion, the design flexibility of the connection structure can be improved to ensure a sealed connection between the first port sealing structure 10 and the first port 1A while meeting different production conditions or equipment requirements.

In the embodiment of the present disclosure, the first main protrusion 111 and the tubular body 1 can be an integral structure or a separable structure; when the two are an integral structure, it is convenient to realize the integration through an integrated molding process. It can also further improve the sealing of the overall structure, so it is preferred.

In the disclosed embodiment, the first auxiliary protrusion 112 and the first port sealing structure 10 can be an integral structure or a separable structure; when the two are an integral structure, it is conducive to being realized through an integrated molding process and can further improve the sealing performance of the overall structure, so it is preferred.

For example, as shown in Figures 1 and 2, the storage device may further include a first limiting structure 12, which is disposed between the first port sealing structure 10 and the tubular body 1 to maintain the relative position of the first port sealing structure 10 and the tubular body 1. In the embodiment of the present disclosure, by providing the first limiting structure, it is possible to avoid misalignment of the first port sealing structure 10 and the tubular body 1 during docking, thereby affecting the sealing performance during connection.

In some embodiments, the first limiting structure 12 includes a first limiting protrusion disposed on one of the first port sealing structure 10 and the first port 1A, and the first limiting protrusion is inserted into the other of the first port sealing structure 10 and the first port 1A.

For example, as shown in FIG1 , the first limiting projection includes a first cylindrical wall 121, which is disposed at the first port 1A and extends around the first port 1A. When in use, the first cylindrical wall 121 can be inserted into the first port sealing structure 10, for example, into the wide end 101A, to maintain the relative position of the first port sealing structure 10 and the first port 1A. In addition, since the first cylindrical wall 121 protrudes upward, by providing the first cylindrical wall 121, the length of the tubular body 1 can also be lengthened to accommodate more liquid.

The embodiment of the present disclosure is described by taking the first cylindrical wall 121 being arranged on the side of the first port 1A as an example. It can be understood that the first cylindrical wall 121 can also be arranged on the side of the first port sealing structure 10, for example, arranged on the wide mouth end 101A and extending around the wide mouth end 101A. When in use, the first cylindrical wall 121 can be inserted into the first port 1A, and can also maintain the relative positions of the first port sealing structure 10 and the first port 1A.

The embodiment of the present disclosure takes the first limiting protrusion as the first cylindrical wall 121 surrounding the first port 1A as an example for explanation. It can be understood that the first limiting protrusion can also have other structures, for example, it can also be one or more arc walls surrounding the first port 1A, etc. The embodiment of the present disclosure does not limit the specific structure of the first limiting protrusion.

For example, as shown in FIG. 1 and FIG. 2 , the first port sealing structure 10 may further include a first detachable portion 103, which is disposed on a side of the first sealing member 102 away from the tubular body 1. In some embodiments, the first detachable portion 103 includes some small and fragile connection portions. The connecting portion can be easily broken or twisted off to fully expose the first sealing member 102 , making it easier for the injection needle to pierce the exposed first sealing member 102 .

For example, the first port sealing structure 10 may further include a first auxiliary separation structure, which includes at least one pair of first fins 104 (e.g., two pairs as shown in the figure) connected to the first detachable part 103. By providing the first fins 104 on the first detachable part 103, it is convenient for the operator to apply external force to the first fins 104, thereby making it easier to separate the first detachable part 103.

For example, the planar shape of the first wing 104 in FIG. 1 is a straight wing, and the planar shape of the first wing 104 in FIG. 2 is a trapezoidal wing. In other embodiments, it can also be a delta wing, etc. The embodiment of the present disclosure does not limit the shape of the wing.

For example, as shown in Figures 1 and 2, the second port sealing structure 20 may further include a second detachable portion 203, which is disposed on a side of the second sealing member 202 away from the tubular body 1. In some embodiments, the second detachable portion 203 includes some small and fragile connecting portions, which can be easily broken or twisted off to fully expose the second sealing member 202, so that the injection needle can pierce the exposed second sealing member 202.

For example, the second port sealing structure 20 may further include a second auxiliary separation structure, which includes at least one pair of second fins 204 (e.g., two pairs as shown in the figure) connected to the second detachable part 203. By providing the second fins 204 on the second detachable part 203, it is convenient for the operator to apply external force to the second fins 204, thereby making it easier to separate the second detachable part 203.

In some embodiments, as shown in Figure 2, the first port sealing structure 10 may also include a first tubular portion 105, which defines a first access channel 101 and is connected to the first port 1A; the second port sealing structure 20 may also include a second tubular portion 205, which defines a second access channel 201 and is connected to the second port 1B; the inner wall of at least one of the first tubular portion 105 and the second tubular portion 205 has a guide surface.

In the embodiment of the present disclosure, by providing a guide surface on the inner wall of at least one of the first tubular portion 105 and the second tubular portion 205, liquid can be prevented from remaining on the inner wall, which is conducive to the complete discharge of the liquid. For example, as shown in FIG. 2 , the inner wall of the second tubular portion 205 is provided with a guide surface 205S.

In the embodiment of the present disclosure, at least one of the first port sealing structure 10 and the second port sealing structure 20 is separable from the tubular body 1, so as to facilitate the filling of liquid.

For example, in FIG. 1 and FIG. 2, the first port sealing structure 10 is separable from the first port 1A of the tubular body 1, so that the liquid can be injected from the first port 1A, and after the injection is completed, the liquid can be injected through the first port connection 1A. The joint structure 11 seals and connects the first port sealing structure 10 to the first port 1A. The second port sealing structure 20 and the tubular body 1 can be configured as an integral structure, which can minimize the number of joints on the overall structure and improve the sealing performance.

The storage device of the embodiment of the present disclosure may have many variations, and some variations are further described below. It can be understood that the following variations are only illustrative, and the storage device of the embodiment of the present disclosure is not limited to the cases listed in the description.

Fig. 6 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. Compared with Fig. 2, in Fig. 6, no first limiting structure 12 is provided between the first port sealing structure 10 and the tubular body 1. Nevertheless, liquid can still be injected through the first port, thereby increasing the liquid injection amount and the liquid injection speed.

FIG7 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. The storage device of FIG7 includes not only a first port connection structure 11 disposed between the first port sealing structure 10 and the first port 1A, but also a second port connection structure 21 disposed between the second port sealing structure 20 and the second port 1B. The above design reflects the flexibility of the storage device in manufacturing, and the first port 1A or the second port 1B can be used as a liquid injection port. After the liquid is injected from the second port 1B, the second port sealing structure 20 and the second port 1B are sealed and connected through the second port connection structure 21 to maintain the sealing of the injected liquid.

For example, the second port connection structure 21 includes a second main protrusion 211 and a second auxiliary protrusion 212. The second main protrusion 211 is located on the second port 1B and protrudes in the radial direction of the second port 1B (e.g., the diameter direction of the second port 1B). The second auxiliary protrusion 212 is located on the second port sealing structure 20 and protrudes in the radial direction of the second access channel 201 (e.g., the diameter direction of the second access channel 201). The second auxiliary protrusion 212 is connected to the second main protrusion 211, so that the second port sealing structure 20 is connected to the second port 1B.

In some embodiments, the second main protrusion 211 and the second auxiliary protrusion 212 can be connected by welding, riveting, bolting, etc., and the specific connection method between the two is not limited in the embodiments of the present disclosure. When welding is used for connection, for example, a high-frequency welding process and/or a hot melt welding process can be used.

The specific structures of the second main protrusion 211 and the second auxiliary protrusion 212 may refer to the specific structures of the first main protrusion 111 and the first auxiliary protrusion 112 in FIGS. 1 to 5 .

For example, the second main protrusion 211 is a second main body circumferential flange arranged along the circumferential direction of the second port 1B, and the second auxiliary protrusion 212 is a second auxiliary circumferential flange arranged along the circumferential direction of the second access channel 201, and the second auxiliary circumferential flange is connected to the second main body circumferential flange. The protrusion 211 and the second auxiliary protrusion 212 constitute a second flange structure connecting the second port sealing structure 20 and the second port 1B, thereby further enhancing the tight connection between the second port sealing structure 20 and the second port 1B and reducing the risk of liquid leakage.

For another example, there may be a plurality of second main protrusions, a plurality of second auxiliary protrusions, and the plurality of second main protrusions and the plurality of second auxiliary protrusions are connected in a one-to-one correspondence.

In the embodiment of the present disclosure, the second main protrusion 211 and the tubular body 1 can be set as an integral structure or a detachable structure, and the second auxiliary protrusion 212 and the second port sealing structure 20 can be set as an integral structure or a detachable structure. When set as an integral structure, it is conducive to realization through an integrated molding process and can further improve the sealing performance of the overall structure, so it is preferred.

FIG8 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. Compared with FIG7, FIG8 may further include a first limiting structure 12 and a second limiting structure 22. For example, the first limiting structure 12 is disposed between the first port sealing structure 10 and the tubular body 1 to maintain the relative position of the first port sealing structure 10 and the tubular body 1. For the arrangement of the first limiting structure 12, reference may be made to the description in the previous embodiment. For example, the second limiting structure 22 is disposed between the second port sealing structure 20 and the tubular body 1 to maintain the relative position of the second port sealing structure 20 and the tubular body 1. By providing the second limiting structure 22, it is possible to avoid misalignment of the second port sealing structure 20 and the tubular body 1 during docking, thereby affecting the sealing during connection.

In some embodiments, the second limiting structure 22 includes a second limiting protrusion disposed on one of the second port sealing structure 20 and the second port 1B, and the second limiting protrusion is inserted into the other of the second port sealing structure 20 and the second port 1B. For example, as shown in FIG8 , the second limiting protrusion includes a second cylindrical wall 221, which is disposed on the second port 1B and extends around the second port 1B. When in use, the second cylindrical wall 221 can be inserted into the second port sealing structure 20, for example, into the wide end of the second port sealing structure 20, to maintain the relative position of the second port sealing structure 20 and the second port 1B.

The embodiment of the present disclosure is described by taking the second cylindrical wall 221 being arranged on the second port 1B side as an example. It can be understood that the second cylindrical wall 221 can also be arranged on the second port sealing structure 20 side, for example, arranged on the wide mouth end and extending around the wide mouth end. When in use, the second cylindrical wall 221 can be inserted into the second port 1B, and can also maintain the relative position of the second port sealing structure 20 and the second port 1B.

The embodiment of the present disclosure takes the second limiting protrusion as the second cylindrical wall 221 surrounding the second port 1B as an example for explanation. It is understandable that the second limiting protrusion may also have other structures, for example, The second limiting protrusion may be one or more arc walls surrounding the second port 1B, and the embodiment of the present disclosure does not limit the specific structure of the second limiting protrusion.

Fig. 9 is a schematic diagram of the structure of a storage device according to another embodiment of the present disclosure. Compared with Fig. 1, the first port sealing structure 10 in Fig. 9 does not include the first auxiliary separation structure, that is, the first wing 104 is not provided on the first detachable part 103. The second port sealing structure 20 does not include the second auxiliary separation structure, that is, the second wing 204 is not provided on the second detachable part 203.

In the embodiment of the present disclosure, the first port sealing structure 10 and the second port sealing structure 20 can be set as an integral structure, or can be decomposed into multiple parts and assembled and bonded together. When set as an integral structure, it is conducive to the realization through the integrated molding process, and can further improve the sealing performance of the overall structure, so it is preferred.

For example, in Figures 2, 6, 7 and 9, the first port sealing structure 10 and the second port sealing structure 20 are each an integral structure, which is conducive to obtaining them through a one-time processing through a molding process. In Figure 8, the first port sealing structure 10 and the second port sealing structure 20 include two parts connected to each other. For example, taking the first port sealing structure 10 as an example, the first port sealing structure 10 includes a first part 10a and a second part 10b connected to each other, wherein the end of the first part 10a is inserted into and connected to the second part 10b. Through the above arrangement, the flexibility when processing parts can be improved.

In the embodiment of the present disclosure, the first part 10a and the second part 10b may be connected by welding, for example, by using a high-frequency welding process and/or a hot-melt welding process.

Figure 10 is a structural schematic diagram of a storage device provided in another embodiment of the present disclosure; Figure 11 is a longitudinal cross-sectional view of a storage device provided in another embodiment of the present disclosure; Figure 12A is a structural schematic diagram of a first port sealing structure of Figure 11; Figure 12B is a top view of the first port sealing structure of Figure 12A; and Figure 12C is a bottom view of the first port sealing structure of Figure 12A.

For example, a storage device for storing biological fluid or medicinal fluid provided according to an embodiment of the present disclosure includes: a tubular body 1, a first port sealing structure 10, a second port sealing structure 20, and a first port connecting structure 11 arranged between the first port sealing structure 10 and the first port 1A, and the first port connecting structure 11 is used to connect the first port sealing structure 10 and the tubular body 1.

In some embodiments, the second port sealing structure 20 and the tubular body 1 are an integral structure, so that the two are realized by an integrated molding process, such as an injection molding process. This process can be applied to mass production of products with complex shapes and precise size requirements.

For example, the tubular body 1 includes a receiving cavity V for receiving biological fluid or drug fluid and has The first port 1A and the second port 1B are opposite to each other in the extension direction (e.g., the vertical direction shown in the figure) of the tubular body 1. The tubular body 1 has an inverted cone shape so that the size of the first port 1A is larger than the size of the second port 1B. For example, in the direction from the bottom of the tubular body 1 to the top thereof, the radial size of the tubular body 1 gradually increases. In this way, when the tubular body 1 and the second port sealing structure 20 are integrally manufactured by injection molding, it is convenient to demould the whole from the mold.

As described in the previous embodiment, the first port sealing structure 10 is connected to the first port 1A and includes a first access channel 101 communicating with the accommodating chamber V and a first sealing member 102, the first sealing member 102 is disposed in the first access channel 101 and is used to temporarily close the accommodating chamber V. The second port sealing structure 20 is connected to the second port 1B and includes a second access channel 201 communicating with the accommodating chamber V and a second sealing member 202, the second sealing member 202 is disposed in the second access channel 201 and is used to temporarily close the accommodating chamber V.

For example, the first port connection structure 11 includes: a first main body circumferential flange 131 arranged along the circumferential direction of the first port 1A of the tubular main body 1, and a first auxiliary circumferential flange 132 arranged along the circumferential direction of the first access channel 101, wherein the first auxiliary circumferential flange 132 is connected to the first main body circumferential flange 131. By providing the first main body circumferential flange 131 and the first auxiliary circumferential flange 132, the tight connection between the first port sealing structure 10 and the first port 1A can be further enhanced, the risk of liquid leakage can be reduced, and continuous high-speed welding after liquid filling can be facilitated.

For example, the first port sealing structure 10 includes a first tubular portion 105 defining a first access channel 101 and at least two pairs of first fins connected to the first tubular portion 105, the at least two pairs of first fins including a first pair of first fins 104a and a second pair of first fins 104b. The first pair of first fins 104a are closer to the first auxiliary circumferential flange 132 than the second pair of first fins 104b in the extension direction of the first tubular portion 105 (e.g., the vertical direction shown in the figure), and the first pair of first fins 104a are connected to the first auxiliary circumferential flange 132.

In the embodiment shown in FIG2 , the upper and lower ends of the first access channel 101 have different sizes, for example, the size of the first wide end 101A is larger than the size of the first narrow end 101B, so when manufacturing the storage device shown in FIG2 , the structure of the mold used is relatively complex. In this embodiment, the upper and lower ends of the first access channel 101 have the same size, so that the first pair of first fins 104a can be directly connected to the first auxiliary circumferential flange 132, which not only reduces the complexity of mold design and manufacturing difficulty, but also reduces the overall height of the storage device and makes the structure more compact.

For example, the storage device further includes a first limiting structure 12, which is arranged at the first On the port sealing structure 10. As shown in Figures 12A and 12C, the first limiting structure 12 includes an annular protrusion 122 arranged on the side of the first auxiliary circumferential flange 132 close to the first port 1A, and the annular protrusion 122 protrudes toward the first port 1A and is configured to be inserted into the first port 1A. As can be seen from Figure 12C, the annular protrusion 122 surrounds the first access channel 101, and the first sealing member 102 is located in the first access channel 101. By providing the annular protrusion 122 on the first port sealing structure 10, on the one hand, it is possible to avoid misalignment between the first port sealing structure 10 and the tubular body 1 during docking, and on the other hand, the sealing effect of the storage device can be enhanced. In some embodiments, the annular protrusion 122 and the first port sealing structure 10 can be an integral structure, which can simplify the manufacturing process and improve the sealing of the overall structure.

For example, the second port sealing structure 20 includes a second tubular portion 205 and at least two pairs of second fins connected to the second tubular portion 205, the at least two pairs of second fins include a first pair of second fins 204a and a second pair of second fins 204b; the first pair of second fins 204a are closer to the tubular body 1 than the second pair of second fins 204b in the extension direction of the second tubular portion 205 (for example, the vertical direction shown in the figure), and the first pair of second fins 204a are connected to the bottom of the tubular body 1. By connecting the first pair of second fins 204a to the bottom of the tubular body 1, the overall height of the storage device can be reduced, the structure is more compact, and integrated manufacturing is also convenient.

In this embodiment, with the help of the second pair of second fins 204b, the operator can break or twist off the second detachable part 203 to expose the second sealing member 202, thereby facilitating the injection needle to pierce the second sealing member 202. Similarly, with the help of the second pair of first fins 104b, the operator can break or twist off the first detachable part 103 to expose the first sealing member 102, thereby facilitating the injection needle to pierce the first sealing member 102.

In the disclosed embodiments, the objects stored in the storage device are mainly biological liquids or drug liquids, including but not limited to small molecule drugs, peptide drugs, antibody drugs, protein drugs, nucleic acid drugs, cell drugs, vaccines, etc. For example, liquid drugs can be stored in the storage device. The liquid drugs can generally be divided into chemical small molecule drugs and biological macromolecule drugs. Taking chemical drugs as an example, the chemical drug research and development process includes target determination, model establishment, lead compound discovery, lead compound optimization, and preclinical and clinical research stages. Macromolecule drugs are drugs that rely on cell biosynthesis, also known as biological preparations. Advanced treatment methods for major diseases in the world, such as AIDS and tumors, are all related to biological macromolecule drugs. Although the number of biological products has increased, chemical drugs have always been an important part of drug research, and chemical small molecule drugs still account for the vast majority of drugs sold, while macromolecule drugs have great development prospects in drug research and development in the 21st century.

For example, small molecule drugs are small molecules of active substances that are chemically synthesized and can be made into Tablets or capsules that are absorbed by the body. For tablets that dissolve in the gastrointestinal tract, the dissolved active substance is absorbed by the body through the intestinal wall and enters the bloodstream. Due to their small size, small molecules can reach almost any target in the body. In addition, due to their compact structure and chemical composition, small molecules can generally easily penetrate cell membranes.

For example, biomacromolecule drugs are a type of biomacromolecules produced by modern biotechnology methods and derived from living organisms and used for the diagnosis, treatment or prevention of diseases. In a narrow sense, they are also called biotechnology drugs, including vaccines, blood and blood components, somatic cells, gene therapy and recombinant therapeutic proteins. Compared with chemically synthesized drugs, biomacromolecule drugs have the characteristics of large relative molecular weight, complex structure, difficulty in penetrating biological membranes, low dosage and easy degradation in the body. With the rapid development of biotechnology, biomacromolecule drugs have been widely used to treat a variety of diseases such as tumors, autoimmune diseases and metabolic diseases.

In the embodiments of the present disclosure, the material used to manufacture the storage device includes a polymer. Furthermore, the polymer is, for example, a high molecular polymer (or macromolecular polymer), that is, a polymer with a molecular weight of more than 10,000. The high molecular polymer has moisture-proof, anti-volatile, anti-oxidation and other effects, and is therefore widely used for storage in ultra-low temperature, ordinary low temperature or normal temperature environments.

In the embodiments of the present disclosure, the high molecular polymer suitable for use in the storage device includes, for example, one or more of polyolefins (such as polyethylene (PE), polypropylene (PP)), polyvinyl chlorides (polyvinyl chloride (PVC), polyvinylidene chloride), acrylic acid and derivatives (polyacrylic resin PMMA), polyether, polyurethane, polyamide, polyurethane, polysulfone, etc.

In some embodiments, the high molecular polymer includes but is not limited to: polytetrafluoroethylene (PTFE), perfluoroalkoxy polymer resin (PFA), ethylene tetrafluoroethylene (ETFE), polyetheretherketone (PEEK), polyvinyl chloride (PVC), polyethersulfone (PES), polyethylene (PE), polyurethane (PU), polyetherimide (PEI), cyclic olefin copolymer (COC), polycarbonate (PC), polysulfone (PS), polypropylene (PP), ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polyvinylidene fluoride, etc.

In the embodiments of the present disclosure, the polymer suitable for storing biological fluids or drug liquids at freezing temperatures includes one or more of ethylene-vinyl acetate copolymer (EVA), perfluoroethylene propylene copolymer (FEP) and polyolefin copolymer (PO), preferably ethylene-vinyl acetate copolymer (EVA).

According to an embodiment of the present disclosure, there is also provided an infusion system, comprising the storage device provided in any of the above embodiments. Figure 13 is a schematic diagram of the use process of the storage device in the embodiment of the present disclosure. Figure 14 is a structural schematic diagram of the infusion system in the embodiment of the present disclosure.

For example, as shown in FIG. 14 , the infusion system further includes: an infusion pipeline 3, the infusion pipeline 3 includes a first A liquid inlet 3A and a first liquid outlet 3B, the first liquid inlet 3A is connected to the accommodating chamber V through the second access channel 201 of the second port sealing structure 20, so that the biological liquid or drug liquid in the storage device flows into the first liquid inlet 3A through the second access channel 201.

For example, the first liquid inlet end 3A is provided with a first puncture tool 41, and the first puncture tool 41 is configured to pierce the second sealing member 202 so as to communicate the second access channel 201 with the accommodating chamber V. Referring to FIG. 13 (a), when in use, the second detachable portion 203 is first twisted off to expose the second sealing member 202, and then the first puncture tool 41 is inserted into the second access channel 201 and pierces the second sealing member 202, so as to communicate the first puncture tool 41 with the accommodating chamber V. For example, the infusion line 3 may be provided with a first liquid stop clamp 81 for connecting or closing the infusion line 3.

When it is necessary to mix other liquids with the biological liquid or drug liquid in the storage device, the first detachable part 103 of the storage device can be removed, and the other liquids can be directed into the accommodating chamber V.

For example, the infusion system may further include a container 4 for containing a liquid, which is different from the biological liquid or drug liquid in the storage device, such as physiological saline. For example, the infusion system may further include a liquid transfer device 5, which includes a liquid channel 51 and a second liquid inlet end 51A and a second liquid outlet end 51B located at both ends of the liquid channel 51, the second liquid inlet end 51A is connected to the container 4, and the second liquid outlet end 51B is connected to the accommodating chamber V through the first access channel 101 of the first port sealing structure 10, so that the liquid flows into the accommodating chamber V through the first access channel 101.

For example, the second liquid outlet 51B is provided with a second puncture tool 42, and the second puncture tool 42 is configured to puncture the first sealing member 102 so as to communicate the first access channel 101 with the accommodating chamber V. Referring to (b) and (c) of FIG. 13 , when in use, the first detachable portion 103 is first twisted off to expose the first sealing member 102, and then the second puncture tool 42 is inserted into the first access channel 101 and punctures the first sealing member 102, so that the second puncture tool 42 communicates with the accommodating chamber V.

For example, the infusion system may also include another infusion pipeline 6 and a third liquid inlet end 6A and a third liquid outlet end 6B located at both ends of the other infusion pipeline 6. The third liquid inlet end 6A can be connected to a container filled with liquid, and the third liquid outlet end 6B is connected to the first liquid outlet end 3B, so that both infusion pipelines 3 and 6 are connected to the total infusion pipeline 9.

For example, the third liquid inlet end 6A of another infusion line 6 is provided with a third puncture device 43, and the third puncture device 43 is connected to the container 4, so that the liquid in the container 4 can enter the infusion line 6 through the third puncture device 43, and finally flow into the main infusion line 9 for pre-flushing and pre-filling of the infusion line. Another infusion line 6 can also be provided with a second liquid stop clamp 82 for opening or closing the infusion line 6.

For example, the infusion system may further include a main infusion pipeline 9 , on which a filter 91 may be provided to filter out impurities in the liquid.

The method of using the storage device and the infusion system provided in the above embodiments of the present application is as follows:

1) Keep the infusion lines 3 and 6 in a closed state;

2) inserting the third puncture device 43 on the infusion line 6 into the adapted puncture hole of the container 4 (e.g., a saline bag), opening the lower valve of the third puncture device 43 to allow saline to pre-flush and fill the total infusion line, and adjusting the flow rate by adjusting the second stop clamp 82;

3) holding the storage device provided by the embodiment of the present disclosure, twisting off the second detachable part of the storage device to expose the second access channel, inserting the first puncture tool 41 into the second access channel and puncturing the second sealing member, so that the first puncture tool 41 is connected to the storage device;

4) twisting off the first detachable part of the storage device to expose the first access channel, inserting the second puncture device 42 at one end of the liquid transfer device (e.g., a disposable sealed liquid transfer device) into the first access channel and puncturing the first seal, and then inserting the puncture device (not shown) at the other end of the liquid transfer device into the matching puncture hole of the physiological saline bag, thereby connecting the physiological saline bag and the storage device;

5) Open the lower valve of the first puncture device 41 and the lower valve of the filter 91 on the main infusion pipeline 9, so that the physiological saline flows into the storage device, and flows into the main infusion pipeline 9 through the infusion pipeline 3 together with the drug liquid or biological liquid in the storage device, and then infuses the drug liquid after passing through the filter 91. The flow rate of the liquid can be adjusted by adjusting the first liquid stop clamp 81.

According to an embodiment of the present disclosure, a method for manufacturing a storage device for storing biological fluid or medicinal fluid is also provided.

FIG15 is a flow chart of a method for manufacturing a storage device according to an embodiment of the present disclosure. As shown in FIG15 , the method for manufacturing a storage device according to an embodiment of the present disclosure may be used to manufacture a storage device according to any of the previous embodiments, and the method may include the following steps:

S100: providing a tubular body 1, wherein the tubular body 1 includes a first port 1A and a second port 1B which are opposite to each other in an extending direction of the tubular body 1;

S200: Connect one of the first port sealing structure 10 and the second port sealing structure 20 to one of the first port 1A and the second port 1B to form a receiving chamber V for receiving biological liquid or drug liquid;

S300: injecting biological liquid or drug liquid into the containing cavity V through the other of the first port 1A and the second port 1B;

S400 : Connect the other of the first port sealing structure 10 and the second port sealing structure 20 to the other of the first port 1A and the second port 1B to seal the biological liquid or the drug liquid in the containing cavity V.

In the manufacturing method of the storage device provided by the above-mentioned embodiment of the present disclosure, the first port (and/or the second port) of the tubular body is connected to the first port sealing structure (and/or the second port sealing structure) through the first port sealing structure 10 (and/or the second port sealing structure 20), and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the liquid injection amount and the liquid injection speed, which is suitable for efficient automated continuous filling production. In actual use, it is convenient to insert the puncture device from both ends of the storage device, which improves the convenience of clinical application, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

For example, in step S200, connecting one of the first port sealing structure 10 and the second port sealing structure 20 to one of the first port 1A and the second port 1B includes:

S201: forming a first port connecting structure 11 between the first port sealing structure 10 and the first port 1A;

S202 : Using the first port connecting structure 11 , connect the first port sealing structure 10 to the first port 1A.

In the embodiment of the present disclosure, the first port 1A, as the open end of the tubular body 1, has the same cross-sectional area as the tubular body 1, so liquid can be injected from the first port 1A. Compared with injecting liquid from the first access channel 101, not only the liquid injection area is increased, but also the liquid injection amount per unit time is increased, which is particularly suitable for mass production.

For example, in step S201, a first port connection structure 11 is formed between the first port sealing structure 10 and the first port 1A, including:

S2011: forming a first main protrusion 111 on the first port 1A, wherein the first main protrusion 111 protrudes in a radial direction of the first port 1A;

S2012: forming a first auxiliary protrusion 112 on the first port sealing structure 10, wherein the first auxiliary protrusion 112 protrudes in a radial direction of the first access channel 101;

S2013 : Connect the first auxiliary protrusion 112 to the first main protrusion 111 .

In the embodiment of the present disclosure, by forming the first main protrusion 111 and the first auxiliary protrusion 112 , it is beneficial to achieve a sealed connection between the first port sealing structure 10 and the first port 1A after the liquid is injected from the first port 1A.

For example, in step S2011, the first main protrusion 111 and the tubular body 1 may be formed by an integral molding process; in step S2012, the first auxiliary protrusion 112 and the first port sealing structure 10 may be formed by an integral molding process.

For example, in step S400, connecting the other of the first port sealing structure 10 and the second port sealing structure 20 to the other of the first port 1A and the second port 1B includes:

S401: forming a second port connection structure 21 between the second port sealing structure 20 and the second port 1B;

S402 : Using the second port connecting structure 21 , connect the second port sealing structure 20 to the second port 1B.

In the embodiment of the present disclosure, by forming the second port connection structure 21 between the second port sealing structure 20 and the second port 1B, the manufacturing flexibility of the storage device is reflected, and the first port 1A or the second port 1B can be used as a liquid injection port.

For example, in step S401, a second port connection structure 21 is formed between the second port sealing structure 20 and the second port 1B, including:

S4011: forming a second main protrusion 211 on the second port 1B, wherein the second main protrusion 211 protrudes in a radial direction of the second port 1B;

S4012: forming a second auxiliary protrusion 212 on the second port sealing structure 20, wherein the second auxiliary protrusion 212 protrudes in a radial direction of the second access channel 201;

S4013 : Connect the second auxiliary protrusion 212 to the second main protrusion 211 .

In the embodiment of the present disclosure, the second main protrusion 211 and the second auxiliary protrusion 212 are formed, so as to facilitate a sealed connection between the second port sealing structure 20 and the second port 1B after the liquid is injected from the second port 1B.

For example, in step S4011, the second main protrusion 211 and the tubular body 1 are formed by an integrated molding process; in step S4012, the second auxiliary protrusion 212 and the second port sealing structure 20 are formed by an integrated molding process, which can facilitate processing and reduce manufacturing difficulty.

For example, step S100 and step S200 may be completed in the same process, which includes an integrated molding process. In some embodiments, the tubular body 1 and the first port sealing structure 10 connected to the first port 1A thereof may be formed by an integrated molding process; or the tubular body 1 and the second port sealing structure 20 connected to the second port 1B thereof may be formed by an integrated molding process.

In the embodiment of the present disclosure, both the first port 1A and the second port 1B can be used as liquid injection ports. When liquid is injected into the storage device through the first port 1A, it is preferred to form the tubular body 1 and the second port sealing structure 20 connected to the second port 1B thereof by an integral molding process, which can further improve the sealing performance of the overall structure.

In the storage device and its manufacturing method and infusion system provided by the above-mentioned embodiment of the present disclosure, by designing the first port connection structure or the second port connection structure, the first port or the second port can be effectively used to inject liquid into the tubular body, thereby increasing the amount of liquid injected and the speed of liquid injection, which is suitable for mass production. Moreover, by setting a first seal in the first port sealing structure and a second seal in the second port sealing structure, both the upper and lower ends of the storage device can be connected to the outside world, which improves the diversity of the storage device in the application environment and the convenience in clinical use, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

In this article, there are a few points to note:

(1) The drawings of the embodiments of the present disclosure only relate to the structures related to the embodiments of the present disclosure, and other structures may refer to the general design.

(2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to obtain new embodiments.

(3) The above description is merely an exemplary embodiment of the present disclosure and is not intended to limit the scope of protection of the present disclosure. The scope of protection of the present disclosure is determined by the appended claims.

Claims (36)

A storage device for storing biological liquid or drug liquid, comprising: a tubular body including a receiving chamber for receiving the biological fluid or the drug fluid and having a first port and a second port opposite to each other in an extending direction of the tubular body; a first port sealing structure connected to the first port, the first port sealing structure comprising a first access channel communicating with the accommodating cavity and a first sealing member, the first sealing member being disposed in the first access channel and used for temporarily closing the accommodating cavity; a second port sealing structure connected to the second port, the second port sealing structure comprising a second access channel communicating with the accommodating cavity and a second sealing member, the second sealing member being disposed in the second access channel and used for temporarily closing the accommodating cavity; Wherein, the storage device further comprises: A port connection structure is disposed between at least one of the first port sealing structure and the second port sealing structure and the tubular body to connect the at least one port sealing structure to the corresponding first port or the second port. The storage device according to claim 1, wherein the storage device comprises: a first port connection structure disposed between the first port sealing structure and the first port, the first port connection structure comprising: a first main protrusion, located on the first port and protruding in a radial direction of the first port; a first auxiliary protrusion, located on the first port sealing structure and protruding in a radial direction of the first access channel; The first auxiliary protrusion is connected to the first main protrusion so that the first port sealing structure is connected to the first port. The storage device according to claim 2, wherein: The first main protrusion is a first main body circumferential flange arranged along the circumferential direction of the first port, and the first auxiliary protrusion is a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel. The first auxiliary circumferential flange is connected to the first main body circumferential flange. The storage device according to claim 2 or 3, wherein the number of the first main protrusions is The number of the first main protrusions is multiple, the number of the first auxiliary protrusions is multiple, and the multiple first main protrusions and the multiple first auxiliary protrusions are connected one-to-one. The storage device according to any one of claims 2 to 4, wherein the first main protrusion and the tubular body are provided as an integral structure, and the first auxiliary protrusion and the first port sealing structure are provided as an integral structure. The storage device according to any one of claims 2 to 5, wherein the storage device further comprises: a second port connection structure provided between the second port sealing structure and the second port, the second port connection structure comprising: a second main protrusion, located on the second port and protruding in a radial direction of the second port; a second auxiliary protrusion, located on the second port sealing structure and protruding in a radial direction of the second access channel; The second auxiliary protrusion is connected to the second main protrusion so that the second port sealing structure is connected to the second port. The storage device according to claim 6, wherein The second main protrusion is a second main body circumferential flange arranged along the circumferential direction of the second port, and the second auxiliary protrusion is a second auxiliary circumferential flange arranged along the circumferential direction of the second access channel. The second auxiliary circumferential flange is connected to the second main body circumferential flange. The storage device according to claim 6 or 7, wherein the number of the second main protrusions is plural, the number of the second auxiliary protrusions is plural, and the plurality of second main protrusions and the plurality of second auxiliary protrusions are connected in a one-to-one correspondence. The storage device according to claim 6 or 7, wherein the second main protrusion and the tubular body are provided as an integral structure, and the second auxiliary protrusion and the second port sealing structure are provided as an integral structure. The storage device according to any one of claims 1 to 9, wherein the storage device further comprises: a first limiting structure and/or a second limiting structure, wherein: The first limiting structure is arranged between the first port sealing structure and the tubular body to maintain the relative position of the first port sealing structure and the tubular body; The second limiting structure is arranged between the second port sealing structure and the tubular body. To maintain the relative position of the second port sealing structure and the tubular body. The storage device according to claim 10, wherein The first limiting structure comprises a first limiting protrusion provided on one of the first port sealing structure and the first port, and the first limiting protrusion is inserted into the other of the first port sealing structure and the first port; The second limiting structure includes a second limiting protrusion disposed on one of the second port sealing structure and the second port, and the second limiting protrusion is inserted into the other of the second port sealing structure and the second port. The storage device according to claim 11, wherein The first limiting protrusion includes a first cylindrical wall, which is disposed at the first port and extends around the first port; The second limiting protrusion includes a second cylindrical wall, and the second cylindrical wall is disposed at the second port and extends around the second port. The storage device according to any one of claims 1 to 12, wherein: The first port sealing structure further comprises a first detachable portion, the first detachable portion being disposed on a side of the first sealing member away from the tubular body; The second port sealing structure further includes a second detachable portion, which is disposed on a side of the second sealing member away from the tubular body. The storage device according to claim 13, wherein The first port sealing structure further includes a first auxiliary separation structure including at least a pair of first fins connected to the first detachable portion; The second port sealing structure further includes a second auxiliary separation structure including at least one pair of second tabs connected to the second detachable portion. The storage device according to any one of claims 1 to 14, wherein: The first port sealing structure further includes a first tubular portion defining the first access passage and connected to the first port; The second port sealing structure further includes a second tubular portion defining the second access passage and connected to the second port; An inner wall of at least one of the first tubular portion and the second tubular portion has a flow guide surface. The storage device according to any one of claims 1 to 15, wherein the tubular body The device has an inverted tapered shape so that the size of the first port is larger than the size of the second port. A storage device according to any one of claims 1 to 16, wherein the first port connection structure comprises: a first main body circumferential flange arranged along the circumferential direction of the first port of the tubular main body, and a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel, wherein the first auxiliary circumferential flange is connected to the first main body circumferential flange. The storage device according to claim 17, wherein The first port sealing structure includes a first tubular portion defining the first access channel and at least two pairs of first fins connected to the first tubular portion, the at least two pairs of first fins including a first pair of first fins and a second pair of first fins; The first pair of first fins is closer to the first auxiliary circumferential flange than the second pair of first fins in the extending direction of the first tubular portion, and the first pair of first fins is connected to the first auxiliary circumferential flange. The storage device according to claim 17, wherein the storage device further comprises a first limiting structure arranged on the first port sealing structure, the first limiting structure comprising an annular protrusion arranged on a side of the first auxiliary circumferential flange close to the first port, the annular protrusion protruding toward the first port and configured to be inserted into the first port. The storage device according to claim 18, wherein The second port sealing structure includes a second tubular portion defining the second access passage and at least two pairs of second fins connected to the second tubular portion, the at least two pairs of second fins including a first pair of second fins and a second pair of second fins; The first pair of second fins are closer to the tubular body than the second pair of second fins in an extending direction of the second tubular portion, and the first pair of second fins connect a bottom portion of the tubular body. A storage device according to any one of claims 1 to 20, wherein the material of the storage device comprises a polymer. The storage device of claim 21, wherein the polymer is configured to be suitable for storing the biological fluid or the pharmaceutical fluid at a cryopreservation temperature. The storage device of claim 22, wherein the polymer comprises one or more of ethylene vinyl acetate copolymer, perfluoroethylene propylene copolymer, and polyolefin copolymer. A method for manufacturing a storage device for storing biological liquid or drug liquid, comprising: providing a tubular body including a first port and a second port opposite to each other in an extending direction of the tubular body; Connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port to form a receiving chamber for receiving the biological fluid or the drug fluid; injecting the biological liquid or the drug liquid into the containing chamber through the other of the first port and the second port; The other of the first port sealing structure and the second port sealing structure is connected to the other of the first port and the second port to seal the biological fluid or the drug fluid in the containing chamber. The manufacturing method according to claim 24, wherein connecting one of the first port sealing structure and the second port sealing structure to one of the first port and the second port comprises: forming a first port connecting structure between the first port sealing structure and the first port; The first port sealing structure is connected to the first port by using the first port connecting structure. The manufacturing method according to claim 25, wherein forming a first port connection structure between the first port sealing structure and the first port comprises: forming a first main protrusion on the first port, wherein the first main protrusion protrudes in a radial direction of the first port; forming a first auxiliary protrusion on the first port sealing structure, wherein the first auxiliary protrusion protrudes in a radial direction of the first access channel; The first auxiliary protrusion is connected to the first main protrusion. The manufacturing method according to claim 26, wherein the first main protrusion and the tubular body are formed by an integral molding process, and the first auxiliary protrusion and the first port sealing structure are formed by an integral molding process. The manufacturing method according to any one of claims 24 to 27, wherein connecting the other of the first port sealing structure and the second port sealing structure to the other of the first port and the second port comprises: forming a second port connecting structure between the second port sealing structure and the second port; The second port sealing structure is connected to the second port by using the second port connecting structure. The manufacturing method according to claim 28, wherein forming a second port connection structure between the second port sealing structure and the second port comprises: forming a second main protrusion on the second port, wherein the second main protrusion protrudes in a radial direction of the second port; forming a second auxiliary protrusion on the second port sealing structure, wherein the second auxiliary protrusion protrudes in a radial direction of the second access channel; The second auxiliary protrusion is connected to the second main protrusion. The manufacturing method according to claim 29, wherein the second main protrusion and the tubular body are formed by an integral molding process, and the second auxiliary protrusion and the second port sealing structure are formed by an integral molding process. The manufacturing method according to any one of claims 24 to 30, wherein the step of providing the tubular body and the step of connecting one of the first port sealing structure and the second port sealing structure to one of the first port and the second port are completed in the same process, and the same process comprises: The tubular body and the second port sealing structure connected to the second port are formed by an integral molding process. An infusion system, comprising the storage device according to any one of claims 1-23. The infusion system according to claim 32, wherein the infusion system further comprises: An infusion pipeline, the infusion pipeline includes a first liquid inlet end and a first liquid outlet end, the first liquid inlet end is connected to the accommodating cavity through a second access channel of the second port sealing structure, so that the biological liquid or the drug liquid flows into the first liquid inlet end through the second access channel. The infusion system according to claim 33, wherein the first liquid inlet end is provided with a first puncture device, and the first puncture device is configured to puncture the second sealing member to connect the second access channel and the accommodating cavity. The infusion system according to claim 33 or 34, wherein the infusion system further comprises: a container for containing a liquid, the liquid being different from the biological liquid or the pharmaceutical liquid; The liquid transfer device comprises a liquid channel and a second liquid inlet end and a second liquid outlet end located at both ends of the liquid channel, the second liquid inlet end is connected to the container, and the second liquid outlet end is connected to the accommodating cavity through the first access channel of the first port sealing structure, so that the liquid Flowing into the accommodating chamber through the first access channel. The infusion system according to claim 35, wherein the second liquid outlet is provided with a second puncture device, and the second puncture device is configured to puncture the first sealing member to connect the first access channel and the accommodating cavity.