Storage device for storage of biological liquid or pharmaceutical liquid, manufacturing method, and system

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 pharmaceutical liquid and manufacturing method and system

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is based on and claims priority to Chinese patent application No. 202311023643.3, filed on August 14, 2023, entitled “Storage device, manufacturing method and system for storing biological fluids or pharmaceutical liquids”. The contents disclosed in the above-mentioned Chinese patent application are hereby cited in their entirety as part of this application. Technical Field

[0003] The present invention relates to the field of biomedical storage technology, and in particular to a storage device for storing biological liquid or medicinal liquid, a manufacturing method thereof, and an infusion system. Background Art

[0004] Continuous advances in modern medical research have led to a deeper understanding of the pathogenesis of various diseases. Biological fluids, such as cells, tissue fluid, and blood, have become valuable resources for both basic and clinical medical research. In recent years, a large number of bioactive pharmaceutical preparations, such as vaccines, peptides, monoclonal antibodies, fusion proteins, and engineered immune cells, have emerged on the market. With the increasing demand for the storage of biological or pharmaceutical fluids, the rapid and efficient delivery of these fluids into storage devices has become a primary challenge.

[0005] Summary of the Invention

[0006] According to an embodiment of the present disclosure, a storage device for storing biological liquids or drug liquids, 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.

[0007] According to a first aspect of the present disclosure, a storage device for storing biological liquids or medicinal liquids is provided, comprising: a tubular body, which includes a accommodating cavity for accommodating the biological liquid or the medicinal 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 including a first access channel and a first seal communicating with the accommodating cavity, the first seal being arranged 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 including a second access channel and a second seal communicating with the accommodating cavity, the second seal being arranged in the second access channel and used for temporarily closing the accommodating cavity; wherein the storage device further comprises: a port connecting structure, 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.

[0008] 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 to connect the first port sealing structure to the first port.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] In at least some embodiments, the storage device further includes: a second port connecting structure arranged between the second port sealing structure and the second port, the second port connecting structure including: 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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 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; 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.

[0017] In at least some embodiments, the first limiting structure includes 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 provided 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.

[0018] In at least some embodiments, the first limiting protrusion includes a first cylindrical wall disposed at the first port and extending around the first port; the second limiting protrusion includes a second cylindrical wall disposed at the second port and extending around the second port.

[0019] 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.

[0020] In at least some embodiments, the first port sealing structure further includes a first auxiliary separation structure, which includes at least a pair of first fins connected to the first detachable part; the second port sealing structure further includes a second auxiliary separation structure, which includes at least a pair of second fins connected to the second detachable part.

[0021] In at least some embodiments, the first port sealing structure further includes a first tubular portion, which defines the first access channel and is connected to the first port; the second port sealing structure further 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.

[0022] 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.

[0023] 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 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.

[0024] 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 than the second pair of first fins in the extension direction of the first tubular portion, and the first pair of first fins are connected to the first auxiliary circumferential flange.

[0025] In at least some embodiments, the storage device also includes a first limiting structure arranged on the first port sealing structure, and the first limiting structure includes an annular protrusion arranged on the side of the first auxiliary circumferential flange close to the first port, and the annular protrusion protrudes toward the first port and is configured to be inserted into the first port.

[0026] 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.

[0027] In at least some embodiments, the material of the storage device includes a polymer.

[0028] 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.

[0029] In at least some embodiments, the polymer includes one or more of ethylene vinyl acetate copolymer, perfluoroethylene propylene copolymer, and polyolefin copolymer.

[0030] According to a second aspect of the present disclosure, a method for manufacturing a storage device for storing a biological liquid or a 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 holding chamber for holding the biological liquid or the medicinal liquid; injecting the biological liquid or the medicinal liquid into the holding chamber through the other of the first port and the second port; and 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 holding chamber.

[0031] 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.

[0032] 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;

[0033] The first auxiliary protrusion is connected to the first main protrusion.

[0034] 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.

[0035] 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 connection 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 connection structure.

[0036] 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.

[0037] In at least some embodiments, 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.

[0038] In at least some embodiments, the step of providing a 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 includes: using an integral molding process to form the tubular body and the second port sealing structure connected to the second port.

[0039] 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.

[0040] 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 cavity 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.

[0041] 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 cavity.

[0042] 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; 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, the second liquid inlet being connected to the container, and the second liquid outlet being connected to the accommodating cavity via the first access channel of the first port sealing structure, so that the liquid flows into the accommodating cavity via the first access channel.

[0043] 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

[0044] 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, rather than limiting the present disclosure.

[0045] FIG1 is a schematic structural diagram of a storage device provided in an embodiment of the present disclosure;

[0046] FIG2 is a longitudinal cross-sectional view of a storage device provided by an embodiment of the present disclosure;

[0047] 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;

[0048] FIG4 is a top view of FIG3;

[0049] FIG5 schematically shows various variations of the first auxiliary protrusion;

[0050] FIG6 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

[0051] FIG7 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

[0052] FIG8 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

[0053] FIG9 is a schematic structural diagram of a storage device according to another embodiment of the present disclosure;

[0054] FIG10 is a schematic structural diagram of a storage device provided by another embodiment of the present disclosure;

[0055] FIG11 is a longitudinal cross-sectional view of a storage device provided by another embodiment of the present disclosure;

[0056] FIG12A is a schematic structural diagram of the first port sealing structure of FIG11 ;

[0057] FIG12B is a top view of the first port sealing structure of FIG12A;

[0058] FIG12C is a bottom view of the first port sealing structure of FIG12A;

[0059] FIG13 is a schematic diagram of the use process of the storage device according to an embodiment of the present disclosure;

[0060] FIG14 is a schematic structural diagram of an infusion system according to an embodiment of the present disclosure;

[0061] FIG. 15 is a flow chart of a method for manufacturing a storage device according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0062] To make the purpose, technical solutions, and advantages of the embodiments of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the accompanying 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.

[0063] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by persons of ordinary skill in the field to which the invention belongs. The words "first", "second" and similar terms used in the specification and claims of this 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 object being described changes, the relative positional relationship may also change accordingly.

[0064] To make the purpose, technical solutions, and advantages of the embodiments of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the accompanying 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.

[0065] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar terms 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 similar terms 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 terms 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.

[0066] According to an embodiment of the present disclosure, a storage device for storing biological liquids or medicinal liquids is provided, comprising: a tubular body, a first port sealing structure, and a second port sealing structure. The tubular body includes a accommodating cavity for accommodating biological liquids or medicinal liquids 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 includes a first access channel and a first seal communicating with the accommodating cavity, the first seal being disposed in the first access channel and used to temporarily close the accommodating cavity; the second port sealing structure is connected to the second port and includes a second access channel and a second seal communicating with the accommodating cavity, the second seal being disposed in the second access channel and used to temporarily close the accommodating cavity. The storage device further comprises: a port connection structure disposed between at least one of the first and second port sealing structures and the tubular body to connect at least one port sealing structure to the corresponding first port or second port.

[0067] 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) via a port connection structure, and liquid can be injected into the tubular body using the first port or the second port, thereby increasing the amount of liquid injected and improving the liquid injection speed, which is suitable for efficient automated continuous filling production. By respectively providing a first seal and a 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, flexibly adapting to infusion equipment, avoiding complicated liquid preparation steps, and being more conducive to aseptic operation of medical staff.

[0068] The present disclosure is described below by way of specific embodiments. To keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and components may be omitted. When any component of an embodiment of the present disclosure appears in more than one drawing, the component may be represented by the same reference numeral in each drawing.

[0069] Figure 1 is a schematic diagram of the structure of a storage device provided in an embodiment of the present disclosure. Figure 2 is a longitudinal cross-sectional view of a storage device provided in an embodiment of the present disclosure.

[0070] As shown in Figures 1 and 2, a storage device for storing biological fluids or medicinal fluids 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 accommodating chamber V for accommodating biological fluids or medicinal fluids and has a first port 1A and a second port 1B that are opposite to each other in the extension direction of the tubular body 1 (for example, 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 accommodating chamber V. 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 and a second sealing member 202 that are in communication with the accommodating chamber V. The second sealing member 202 is disposed in the second access channel 201 and is used to temporarily close the accommodating chamber V.

[0071] Before 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 a first access channel 101 and a 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 a first seal 102 and a second seal 202, on the one hand, liquid is prevented from flowing out of the first port sealing structure 10 and the second port sealing structure 20 and it is conducive to maintaining the sterile state in the accommodating chamber. On the other hand, it facilitates the insertion of the injection needle, providing convenience during clinical use.

[0072] 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.

[0073] 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 performance of the overall structure.

[0074] In the embodiment of the present disclosure, the cross-sectional shape of the tubular body 1 is circular for illustration. It is understandable that the cross-sectional shape may also be elliptical, triangular, rectangular, etc., and the embodiment of the present disclosure does not limit this.

[0075] 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.

[0076] 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.

[0077] Compared to injecting liquid through first access channel 101, in the embodiment of the present disclosure, first port 1A, as the open end of tubular body 1, has the same cross-sectional area as tubular body 1. Therefore, liquid can be injected through first port 1A, thereby increasing the liquid injection area and the amount of liquid injected per unit time, which is particularly suitable for mass production. In other embodiments of the present disclosure, liquid can also be injected through second port 1B. Since the technical effects are the same, the description will not be repeated here.

[0078] 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 to connect the first port sealing structure 10 to the first port 1A.

[0079] In the disclosed embodiment, the provision of the first main protrusion 111 and the first auxiliary protrusion 112 facilitates a sealed connection between the first port sealing structure 10 and the first port 1A after liquid is injected through 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, or other methods. The disclosed embodiment does not limit the specific connection method between the two. When welding is used, for example, high-frequency welding and / or hot melt welding can be used.

[0080] 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, so as to facilitate the connection between the two.

[0081] For example, as shown in FIG2 , first access channel 101 includes a first wide end 101A and a first narrow end 101B that are opposite to each other in the direction of their extension. First narrow end 101B is a closed end. The dimensions of first wide end 101A are substantially the same as those of first port 1A. First auxiliary protrusion 112 is located at first wide end 101A. This arrangement further strengthens the tight connection between first main protrusion 111 and first auxiliary protrusion 112, preventing liquid from leaking out.

[0082] In the disclosed embodiment, the first main protrusion 111 or the first auxiliary protrusion 112 can be arranged in a variety of ways, as long as a sealed connection between the first port sealing structure 10 and the first port 1A is achieved. Figure 3 is a cross-sectional view of the first port sealing structure provided with the first auxiliary protrusion according to the disclosed embodiment. Figure 4 is a top view of Figure 3. Figure 5 schematically illustrates various variations of the first auxiliary protrusion.

[0083] For example, referring to Figures 1 and 4 , first main protrusion 111 is a first main body circumferential flange disposed along the circumference of first port 1A, and first auxiliary protrusion 112 is a first auxiliary circumferential flange disposed along the circumference of first access channel 101. The first auxiliary circumferential flange is connected to the first main body circumferential flange. In other words, first main protrusion 111 and first auxiliary protrusion 112 constitute a first flange structure connecting first port sealing structure 10 and first port 1A.

[0084] 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.

[0085] 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.

[0086] For example, as shown in FIG5 , the number of first auxiliary protrusions can be two, three, or four, and these first auxiliary protrusions are symmetrically distributed in the plane of the cross-section of the first access channel 101 (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 about the y-axis, in FIG5(c), the two first auxiliary protrusions 112c are symmetrically distributed about the x-axis or the y-axis, in FIG5(d), the two first auxiliary protrusions 112d are symmetrically distributed about the x-axis or the y-axis, in FIG5(e), the two first auxiliary protrusions 112e are symmetrically distributed about the x-axis or the y-axis, and in FIG5(f), the two first auxiliary protrusions 112f are symmetrically distributed about the x-axis or the y-axis. Similarly, the number of first main protrusions is the same as the number of first auxiliary protrusions and they are arranged in the same manner.

[0087] In the embodiment of the present disclosure, 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.

[0088] In the disclosed embodiment, 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 advantageous to realize it through an integrated molding process and can further improve the sealing performance of the overall structure, so it is preferred.

[0089] In the embodiment of the present disclosure, 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.

[0090] 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 positions of the first port sealing structure 10 and the tubular body 1. In the disclosed embodiment, the provision of the first limiting structure can prevent the first port sealing structure 10 and the tubular body 1 from being misaligned during docking, thereby preventing the sealing performance of the connection.

[0091] In some embodiments, the first limiting structure 12 includes a first limiting protrusion provided 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.

[0092] For example, as shown in Figure 1, the first retaining projection includes a first cylindrical wall 121, which is disposed on and extends around the first port 1A. During 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. Furthermore, because the first cylindrical wall 121 protrudes upward, the provision of the first cylindrical wall 121 can also extend the length of the tubular body 1, thereby accommodating more liquid.

[0093] 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.

[0094] 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.

[0095] For example, as shown in Figures 1 and 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 thin, fragile connecting portions that can be easily broken or twisted off to fully expose the first sealing member 102, thereby facilitating piercing of the exposed first sealing member 102 by an injection needle.

[0096] 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 portion 103. Providing the first fins 104 on the first detachable portion 103 facilitates an operator to apply external force to the first fins 104, thereby making it easier to separate the first detachable portion 103.

[0097] For example, the planar shape of the first wing 104 in Figure 1 is a straight wing, and the planar shape of the first wing 104 in Figure 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.

[0098] 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 thin and fragile connecting portions that can be easily broken or twisted off to fully expose the second sealing member 202, thereby facilitating piercing of the exposed second sealing member 202 by an injection needle.

[0099] 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. Providing the second fins 204 on the second detachable part 203 facilitates an operator to apply external force to the second fins 204, thereby making it easier to separate the second detachable part 203.

[0100] In some embodiments, as shown in Figure 2, the first port sealing structure 10 may further 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 further 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.

[0101] In the disclosed embodiment, 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, thereby facilitating complete drainage of the liquid. For example, as shown in FIG2 , the inner wall of the second tubular portion 205 is provided with a guide surface 205S.

[0102] 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 , which makes it convenient to load liquid.

[0103] For example, in Figures 1 and 2, the first port sealing structure 10 is separable from the first port 1A of the tubular body 1, so that liquid can be injected through the first port 1A. After the injection is completed, the first port sealing structure 10 and the first port 1A are sealed and connected via the first port connecting structure 11. The second port sealing structure 20 and the tubular body 1 can be provided as an integral structure, which can minimize the number of seams in the overall structure and improve the sealing performance.

[0104] The storage device of the embodiment of the present disclosure may have many variations. Some variations are further described below. It should 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.

[0105] Figure 6 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. Compared to Figure 2 , Figure 6 does not include the first retaining structure 12 between the first port sealing structure 10 and the tubular body 1. Despite this, liquid can still be injected through the first port, thereby increasing the amount of liquid injected and the speed of liquid injection.

[0106] 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 connecting structure 11 disposed between the first port sealing structure 10 and the first port 1A, but also a second port connecting structure 21 disposed between the second port sealing structure 20 and the second port 1B. The above design reflects the manufacturing flexibility of the storage device, and either 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 by the second port connecting structure 21, thereby maintaining the sealing of the injected liquid.

[0107] 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 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 of the second access channel 201). The second auxiliary protrusion 212 is connected to the second main protrusion 211 to connect the second port sealing structure 20 to the second port 1B.

[0108] In some embodiments, the second main protrusion 211 and the second auxiliary protrusion 212 can be connected by welding, riveting, bolting, etc., and the embodiments of the present disclosure do not limit the specific connection method between the two. When welding is used, for example, high-frequency welding and / or hot melt welding can be used.

[0109] For the specific structures of the second main protrusion 211 and the second auxiliary protrusion 212 , reference may be made to the specific structures of the first main protrusion 111 and the first auxiliary protrusion 112 in FIG. 1 to FIG. 5 .

[0110] For example, the second main protrusion 211 is a second main body circumferential flange disposed along the circumference of the second port 1B, and the second auxiliary protrusion 212 is a second auxiliary circumferential flange disposed along the circumference of the second access channel 201. The second auxiliary circumferential flange is connected to the second main body circumferential flange. In other words, the second main 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 strengthening the tight connection between the second port sealing structure 20 and the second port 1B and reducing the risk of leakage.

[0111] For another example, there may be multiple second main protrusions, and there may be multiple second auxiliary protrusions, and the multiple second main protrusions and the multiple second auxiliary protrusions are connected in a one-to-one correspondence.

[0112] 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.

[0113] 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 arranged 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 arranged 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 between the second port sealing structure 20 and the tubular body 1 during docking, thereby affecting the sealing during connection.

[0114] In some embodiments, the second retaining structure 22 includes a second retaining protrusion disposed on one of the second port sealing structure 20 and the second port 1B, the second retaining protrusion being inserted into the other of the second port sealing structure 20 and the second port 1B. For example, as shown in FIG8 , the second retaining protrusion includes a second cylindrical wall 221 disposed on and extending around the second port 1B. During 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.

[0115] The embodiment of the present disclosure is described by taking the second cylindrical wall 221 being arranged on the side of the second port 1B as an example. It can be understood that the second cylindrical wall 221 can also be arranged on the side of the second port sealing structure 20, for example, arranged at 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 positions of the second port sealing structure 20 and the second port 1B.

[0116] 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 can be understood that the second limiting protrusion can also have other structures, for example, it can also be one or more arc walls surrounding the second port 1B, etc. The embodiment of the present disclosure does not limit the specific structure of the second limiting protrusion.

[0117] FIG9 is a schematic structural diagram of a storage device according to yet another embodiment of the present disclosure. Compared to FIG1 , the first port sealing structure 10 in FIG9 does not include the first auxiliary separation structure, i.e., the first detachable portion 103 is not provided with the first fin 104. The second port sealing structure 20 does not include the second auxiliary separation structure, i.e., the second detachable portion 203 is not provided with the second fin 204.

[0118] In the disclosed embodiment, the first port sealing structure 10 and the second port sealing structure 20 can each be configured as an integral structure, or each can be decomposed into multiple components and assembled and bonded together. When configured as an integral structure, it is advantageous because it can be realized through an integrated molding process and can further improve the sealing performance of the overall structure, and is therefore preferred.

[0119] For example, in Figures 2, 6, 7, and 9, the first port sealing structure 10 and the second port sealing structure 20 are each integrally formed, facilitating a single-piece molding process. In Figure 8, the first port sealing structure 10 and the second port sealing structure 20 comprise two interconnected parts. For example, using the first port sealing structure 10 as an example, the first port sealing structure 10 comprises a first portion 10a and a second portion 10b that are interconnected, with the distal end of the first portion 10a inserted into and connected to the second portion 10b. This arrangement enhances flexibility when machining parts.

[0120] In the embodiment of the present disclosure, the first portion 10a and the second portion 10b may be connected by welding, for example, by using a high-frequency welding process and / or a hot melt welding process.

[0121] 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 the 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 an overhead view of the first port sealing structure of Figure 12A.

[0122] For example, a storage device for storing biological fluids or medicinal fluids 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.

[0123] In some embodiments, the second port sealing structure 20 and the tubular body 1 are integrally formed so that they can be formed by an integrated molding process, such as injection molding. This process can be applied to mass production of products with complex shapes and precise dimensions.

[0124] For example, the tubular body 1 includes a chamber V for accommodating biological or pharmaceutical fluids and has a first port 1A and a second port 1B that are opposed to each other in the direction of extension of the tubular body 1 (e.g., the vertical direction as shown in the figure). The tubular body 1 has an inverted tapered shape, such that the first port 1A is larger than the second port 1B. For example, the radial dimension of the tubular body 1 gradually increases from the bottom of the tubular body 1 toward the top. This facilitates the integral demolding of the tubular body 1 and the second port sealing structure 20 from the mold during injection molding.

[0125] 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 seal 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 seal the accommodating chamber V.

[0126] For example, the first port connection structure 11 includes: a first main body circumferential flange 131 disposed along the circumference of the first port 1A of the tubular body 1, and a first auxiliary circumferential flange 132 disposed along the circumference of the first access channel 101, wherein the first auxiliary circumferential flange 132 is connected to the first main body circumferential flange 131. The provision of the first main body circumferential flange 131 and the first auxiliary circumferential flange 132 further enhances the tight connection between the first port sealing structure 10 and the first port 1A, reduces the risk of liquid leakage, and facilitates continuous high-speed welding after liquid filling.

[0127] For example, the first port sealing structure 10 includes a first tubular portion 105 defining a first access passage 101 and at least two pairs of first fins connected to the first tubular portion 105. The at least two pairs of first fins include 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 extending 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.

[0128] In the embodiment shown in Figure 2 , the upper and lower ends of the first access channel 101 have different dimensions. For example, the first wide end 101A is larger than the first narrow end 101B. Therefore, when manufacturing the storage device shown in Figure 2 , the mold structure used is relatively complex. In this embodiment, the upper and lower ends of the first access channel 101 have the same dimensions, allowing the first pair of first fins 104a to be directly connected to the first auxiliary circumferential flange 132. This not only reduces the complexity of the mold design and the difficulty of manufacturing, but also reduces the overall height of the storage device, making the structure more compact.

[0129] For example, the storage device also includes a first limiting structure 12, which is arranged on the first 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, it is possible to enhance the sealing effect of the storage device. In some embodiments, the annular protrusion 122 and the first port sealing structure 10 may be an integral structure, which can simplify the manufacturing process and improve the sealing performance of the overall structure.

[0130] 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 (e.g., 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 facilitated.

[0131] In this embodiment, with the help of the second pair of second fins 204b, the operator can break or twist off the second detachable portion 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 portion 103 to expose the first sealing member 102, thereby facilitating the injection needle to pierce the first sealing member 102.

[0132] 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. Chemical small molecule drugs still account for the vast majority of drugs sold, and macromolecule drugs have great development prospects in drug research and development in the 21st century.

[0133] For example, small molecule drugs are chemically synthesized active substances. These ingredients can be formulated into tablets or capsules that are easily absorbed by the body. For tablets that dissolve in the gastrointestinal tract, the dissolved active substance is absorbed through the intestinal wall and enters the bloodstream. Due to their small size, small molecules can reach virtually any target in the body. Furthermore, their compact structure and chemical composition generally allow them to easily penetrate cell membranes.

[0134] For example, biomacromolecule drugs are a class of biological macromolecules produced using modern biotechnology methods and derived from living organisms for the diagnosis, treatment, or prevention of diseases. In a narrower sense, they are also referred to as biotechnology drugs. These drugs include 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 molecular weight, complex structure, poor permeability of 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, including tumors, autoimmune diseases, and metabolic diseases.

[0135] In the embodiment 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.

[0136] In the embodiments of the present disclosure, the 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 its derivatives (polyacrylic resin PMMA), polyether, polyurethane, polyamide, polyurethane, polysulfone, etc.

[0137] 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.

[0138] In the embodiment of the present disclosure, the polymer suitable for storing biological fluids or drug liquids at freezing storage temperature includes one or more of ethylene-vinyl acetate copolymer (EVA), perfluoroethylene propylene copolymer (FEP) and polyolefin copolymer (PO), preferably ethylene-vinyl acetate copolymer (EVA).

[0139] According to an embodiment of the present disclosure, an infusion system is also provided, 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 according to an embodiment of the present disclosure. Figure 14 is a schematic diagram of the structure of the infusion system according to an embodiment of the present disclosure.

[0140] For example, as shown in Figure 14, the infusion system also includes: an infusion pipeline 3, the infusion pipeline 3 includes a first liquid inlet end 3A and a first liquid outlet end 3B, the first liquid inlet end 3A is connected to the accommodating cavity 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 end 3A through the second access channel 201.

[0141] For example, the first liquid inlet end 3A is provided with a first puncture tool 41, which is configured to pierce the second sealing member 202 to establish communication between the second access channel 201 and the accommodating chamber V. Referring to FIG13(a), during use, the second detachable portion 203 is first twisted off to expose the second sealing member 202. The first puncture tool 41 is then inserted into the second access channel 201 and pierces the second sealing member 202, establishing communication between the first puncture tool 41 and the accommodating chamber V. For example, the infusion line 3 may be provided with a first liquid stop clamp 81 for connecting or disconnecting the infusion line 3.

[0142] 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.

[0143] 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 51A and a second liquid outlet 51B located at both ends of the liquid channel 51. The second liquid inlet 51A is connected to the container 4, and the second liquid outlet 51B is connected to the accommodating chamber V via 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.

[0144] For example, the second liquid outlet 51B is provided with a second piercer 42, which is configured to pierce the first sealing member 102 to establish communication between the first access channel 101 and the accommodating chamber V. Referring to FIG. 13 (b) and (c), during use, the first detachable portion 103 is first twisted off to expose the first sealing member 102. The second piercer 42 is then inserted into the first access channel 101 and pierces the first sealing member 102, establishing communication between the second piercer 42 and the accommodating chamber V.

[0145] 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.

[0146] For example, a third puncture device 43 is provided at the third liquid inlet end 6A of another infusion line 6. This third puncture device 43 is connected to the container 4. Thus, liquid in the container 4 can enter the infusion line 6 through the third puncture device 43 and ultimately flow into the main infusion line 9 for pre-flushing and pre-filling 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.

[0147] For example, the infusion system may further include a main infusion pipeline 9 , and a filter 91 may be provided on the main infusion pipeline 9 to filter out impurities in the liquid.

[0148] The method of using the storage device and the infusion system provided in the above embodiments of the present application is as follows:

[0149] 1) Keep the infusion lines 3 and 6 in a closed state;

[0150] 2) Insert the third puncture device 43 on the infusion line 6 into the puncture hole of the container 4 (e.g., a saline bag). Open the lower valve of the third puncture device 43 to allow saline to pre-flush and fill the main infusion line. Adjust the flow rate by adjusting the second stop clamp 82.

[0151] 3) Holding the storage device provided by the embodiment of the present disclosure, twisting off the second detachable portion 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 to connect the first puncture tool 41 to the storage device;

[0152] 4) twisting off the first detachable portion of the storage device to expose the first access channel, inserting the second puncture tool 42 at one end of a 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 tool (not shown) at the other end of the liquid transfer device into the matching puncture hole of the saline bag, thereby connecting the saline bag to the storage device;

[0153] 5) Open the lower valve of the first puncture device 41 and the lower valve of the filter 91 on the main infusion line 9, allowing the physiological saline to flow into the storage device. The saline, along with the medication or biological fluid in the storage device, flows through the infusion line 3 into the main infusion line 9. After passing through the filter 91, the medication is infused. The flow rate of the liquid can be adjusted by adjusting the first stop clamp 81.

[0154] According to an embodiment of the present disclosure, a method for manufacturing a storage device for storing biological fluid or medicinal liquid is also provided.

[0155] 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 can be used to manufacture any of the storage devices according to the previous embodiments. The method for manufacturing may include the following steps:

[0156] S100: Providing a tubular body 1, wherein the tubular body 1 includes a first port 1A and a second port 1B that are opposite to each other in an extending direction of the tubular body 1;

[0157] 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 to form a receiving cavity V for receiving a biological fluid or a drug liquid;

[0158] S300: injecting biological liquid or drug liquid into the receiving chamber V through the other of the first port 1A and the second port 1B;

[0159] 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 to seal the biological fluid or the drug fluid in the receiving chamber V.

[0160] In the manufacturing method of the storage device provided in 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) via the first port sealing structure 10 (and / or the second port sealing structure 20). Liquid can be injected into the tubular body using the first port or the second port, thereby increasing the amount of liquid injected and the speed of liquid injection, 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.

[0161] 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:

[0162] S201: forming a first port connecting structure 11 between the first port sealing structure 10 and the first port 1A;

[0163] S202 : Using the first port connecting structure 11 , connect the first port sealing structure 10 to the first port 1A.

[0164] In the disclosed embodiment, first port 1A, serving as the open end of tubular body 1, has the same cross-sectional area as tubular body 1. Therefore, liquid can be injected through first port 1A. Compared to injecting liquid through first access channel 101, this not only increases the liquid injection area but also the amount of liquid injected per unit time, making it particularly suitable for mass production.

[0165] 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:

[0166] 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;

[0167] 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;

[0168] S2013 : Connect the first auxiliary protrusion 112 to the first main protrusion 111 .

[0169] In the embodiment of the present disclosure, the first main protrusion 111 and the first auxiliary protrusion 112 are formed to facilitate a sealed connection between the first port sealing structure 10 and the first port 1A after liquid is injected from the first port 1A.

[0170] 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.

[0171] 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:

[0172] S401: forming a second port connecting structure 21 between the second port sealing structure 20 and the second port 1B;

[0173] S402 : Using the second port connecting structure 21 , connect the second port sealing structure 20 to the second port 1B.

[0174] In the embodiment of the present disclosure, the second port connecting structure 21 is formed between the second port sealing structure 20 and the second port 1B, thereby embodying the manufacturing flexibility of the storage device. Either the first port 1A or the second port 1B can be used as a liquid injection port.

[0175] For example, in step S401, forming a second port connection structure 21 between the second port sealing structure 20 and the second port 1B includes:

[0176] 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;

[0177] 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;

[0178] S4013 : Connect the second auxiliary protrusion 212 to the second main protrusion 211 .

[0179] In the embodiment of the present disclosure, the second main protrusion 211 and the second auxiliary protrusion 212 are formed to facilitate a sealed connection between the second port sealing structure 20 and the second port 1B after liquid is injected from the second port 1B.

[0180] For example, in step S4011, the second main protrusion 211 and the tubular body 1 are formed by an integral molding process; in step S4012, the second auxiliary protrusion 212 and the second port sealing structure 20 are formed by an integral molding process, which facilitates processing and reduces manufacturing difficulty.

[0181] For example, step S100 and step S200 may be completed in the same process, which may include 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 using an integrated molding process; alternatively, the tubular body 1 and the second port sealing structure 20 connected to the second port 1B thereof may be formed using an integrated molding process.

[0182] 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 use an integrated molding process to form the tubular body 1 and the second port sealing structure 20 connected to its second port 1B, which can further improve the sealing performance of the overall structure.

[0183] 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 utilized to inject liquid into the tubular body, thereby increasing the amount of liquid injected and improving the liquid injection speed, which is suitable for mass production. Moreover, by providing 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, thereby increasing the diversity of the storage device in application environments and the convenience in clinical use, flexibly adapting to infusion equipment, avoiding complicated liquid preparation steps, and being more conducive to aseptic operation of medical staff.

[0184] In this article, there are several points to note:

[0185] (1) The drawings of the embodiments of the present disclosure only relate to the structures related to the embodiments of the present disclosure. Other structures may refer to conventional designs.

[0186] (2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to form new embodiments.

[0187] (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

1. 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.

2. 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.

3. 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.

4. The storage device according to claim 2 or 3, wherein: 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.

5. 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.

6. The storage device according to any one of claims 2 to 5, wherein: 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 is connected to the second main protrusion so that the second port sealing structure is connected to the second port.

7. 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.

8. The storage device according to claim 6 or 7, wherein: 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. The storage device according to any one of claims 1 to 15, wherein: 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.

17. The storage device according to any one of claims 1 to 16, wherein: 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.

18. 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.

19. The storage device according to claim 17, wherein: 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 a 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.

20. 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.

21. The storage device according to any one of claims 1 to 20, wherein: The material of the storage device includes a polymer.

22. The storage device according to claim 21, wherein The polymer is configured to be suitable for storing the biological fluid or the pharmaceutical fluid at a cryopreservation temperature.

23. The storage device according to claim 22, wherein: The polymer includes one or more of ethylene-vinyl acetate copolymer, perfluoroethylene propylene copolymer and polyolefin copolymer.

24. A method for manufacturing a storage device for storing biological fluid 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.

25. The manufacturing method according to claim 24, wherein: Connecting one of a first port sealing structure and a 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.

26. The manufacturing method according to claim 25, wherein: 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, 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.

27. 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.

28. 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.

29. The manufacturing method according to claim 28, wherein: A second port connection structure is formed between the second port sealing structure and the second port, comprising: 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.

30. 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.

31. 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 includes: The tubular body and the second port sealing structure connected to the second port are formed by an integral molding process.

32. An infusion system comprising the storage device according to any one of claims 1-23.

33. 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.

34. The infusion system according to claim 33, wherein: The first liquid inlet end is provided with a first piercer, and the first piercer is configured to pierce the second sealing member so as to communicate the second access channel with the accommodating cavity.

35. 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.

36. 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 so as to communicate the first access channel with the accommodating cavity.

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