Storage device for storing biological or pharmaceutical liquids, and method and system for manufacturing same

Abstract

The invention discloses a storage device for storing biological liquid or medicine liquid and a manufacturing method and system. The storage device comprises a tubular body, a first port sealing structure and a second port sealing structure. The tubular main body comprises an accommodating cavity and is provided with a first port and a second port; the first port sealing structure is connected with the first port and comprises a first access channel and a first sealing piece which are communicated with the accommodating cavity; the second port sealing structure is connected with the second port and comprises a second access channel and a second sealing piece which are communicated with the containing cavity. The storage device further comprises a port connecting structure which is arranged between at least one of the first port sealing structure and the second port sealing structure and the tubular body so that the at least one port sealing structure can be connected to the corresponding first port or the second port. According to the storage device, liquid can be injected through the first port or the second port, so that the liquid injection amount is increased, the liquid injection speed is increased, and the storage device is suitable for efficient automatic continuous filling production.

Description

Technical Field

[0001] The present invention relates to the field of biomedical storage technology, and in particular to a storage device for storing biological liquid or drug liquid, a manufacturing method thereof, and an infusion system. Background Art

[0002] With the continuous progress of modern medical research, we have a deeper understanding of the pathogenesis of various diseases. Biological fluids such as cells, tissue fluids, and blood have gradually become valuable resources for basic medical research and clinical research. In recent years, a large number of biologically active pharmaceutical preparations such as vaccines, peptides, monoclonal antibodies, fusion proteins, and engineered immune cells have also emerged in the market. With the increasing demand for the storage of biological fluids or drug liquids, how to quickly and efficiently inject these liquids into storage devices is the primary problem that needs to be solved. Summary of the invention

[0003] According to an embodiment of the present disclosure, a storage device for storing biological liquid or drug liquid, a manufacturing method thereof, and an infusion system are provided. In the storage device of the embodiment of the present disclosure, the first port (and / or the second port) of the tubular body is connected to the first port sealing structure (and / or the second port sealing structure) through a port connection structure, and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the liquid injection amount and the liquid injection speed, which is suitable for efficient automated continuous filling production. In addition, it also improves the convenience of clinical application, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

[0004] According to a first aspect of the present disclosure, a storage device for storing biological liquid or medicinal liquid is provided, comprising: a tubular body, which includes a containing cavity for containing 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 containing cavity, the first seal being arranged in the first access channel and used for temporarily closing the containing 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 containing cavity, the second seal being arranged in the second access channel and used for temporarily closing the containing cavity; wherein the storage device further comprises: a port connection structure, which is arranged between at least one sealing structure of the first port sealing structure and the second port sealing structure and the tubular body, so as to connect the at least one port sealing structure to the corresponding first port or the second port.

[0005] In at least some embodiments, the storage device includes: a first port connecting structure arranged between the first port sealing structure and the first port, the first port connecting structure including: a first main protrusion located on the first port and protruding in a radial direction of the first port; a first auxiliary protrusion located on the first port sealing structure and protruding in a radial direction of the first access channel; the first auxiliary protrusion is connected to the first main protrusion so that the first port sealing structure is connected to the first port.

[0006] 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.

[0007] 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.

[0008] 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.

[0009] In at least some embodiments, the storage device further includes: a second port connecting structure disposed 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 being connected to the second main protrusion so that the second port sealing structure is connected to the second port.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] In at least some embodiments, the storage device further includes: a first limiting structure and / or a second limiting structure, wherein the first limiting structure is arranged between the first port sealing structure and the tubular body to maintain the relative position of the first port sealing structure and the tubular body; and the second limiting structure is arranged between the second port sealing structure and the tubular body to maintain the relative position of the second port sealing structure and the tubular body.

[0014] In at least some embodiments, the first limiting structure includes a first limiting protrusion disposed on one of the first port sealing structure and the first port, and the first limiting protrusion is inserted into the other of the first port sealing structure and the first port; the second limiting structure includes a second limiting protrusion disposed on one of the second port sealing structure and the second port, and the second limiting protrusion is inserted into the other of the second port sealing structure and the second port.

[0015] In at least some embodiments, the first limiting protrusion includes a first cylindrical wall, which is disposed at the first port and extends around the first port; the second limiting protrusion includes a second cylindrical wall, which is disposed at the second port and extends around the second port.

[0016] 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.

[0017] In at least some embodiments, the first port sealing structure also 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 also includes a second auxiliary separation structure, which includes at least a pair of second fins connected to the second detachable part.

[0018] In at least some embodiments, the first port sealing structure also includes a first tubular portion, which defines the first access channel and is connected to the first port; the second port sealing structure also includes a second tubular portion, which defines the second access channel and is connected to the second port; the inner wall of at least one of the first tubular portion and the second tubular portion has a guide surface.

[0019] In at least some embodiments, the material of the storage device includes a polymer.

[0020] 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.

[0021] In at least some embodiments, the polymer includes one or more of ethylene vinyl acetate copolymer, perfluoroethylene propylene copolymer, and polyolefin copolymer.

[0022] According to a second aspect of the present disclosure, a method for manufacturing a storage device for storing biological liquid or medicinal liquid is provided, comprising: providing a tubular body, the tubular body comprising a first port and a second port opposite to each other in an extension direction of the tubular body; connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port to form a containing cavity for containing the biological liquid or the medicinal liquid; injecting the biological liquid or the medicinal liquid into the containing cavity through the other of the first port and the second port; connecting the other of the first port sealing structure and the second port sealing structure to the other of the first port and the second port to seal the biological liquid or the medicinal liquid in the containing cavity.

[0023] 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.

[0024] 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;

[0025] The first auxiliary protrusion is connected to the first main protrusion.

[0026] 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.

[0027] In at least some embodiments, connecting the other of the first port sealing structure and the second port sealing structure to the other of the first port and the second port includes: forming a second port connecting structure between the second port sealing structure and the second port; and connecting the second port sealing structure to the second port using the second port connecting structure.

[0028] 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.

[0029] 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.

[0030] In at least some embodiments, the step of providing a tubular body and the step of connecting one of a first port sealing structure and a second port sealing structure to one of the first port and the second port are completed in the same process, and the same process includes: forming the tubular body and the second port sealing structure connected to the second port by an one-piece molding process.

[0031] 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.

[0032] In at least some embodiments, the infusion system further includes: an infusion pipeline, the infusion pipeline including a first liquid inlet end and a first liquid outlet end, the first liquid inlet end being connected to the accommodating chamber via a second access channel of the second port sealing structure, so that the biological liquid or the drug liquid flows into the first liquid inlet end via the second access channel.

[0033] In at least some embodiments, the first liquid inlet end is provided with a first piercer, and the first piercer is configured to pierce the second sealing member to allow the second access channel to communicate with the accommodating chamber.

[0034] In at least some embodiments, the infusion system further includes: a container for containing a liquid, wherein the liquid is different from the biological liquid or the drug liquid; and a liquid transferor, wherein the liquid transferor includes a liquid channel and a second liquid inlet and a second liquid outlet located at both ends of the liquid channel, wherein the second liquid inlet is connected to the container, and the second liquid outlet is connected to the accommodating cavity via a first access channel of the first port sealing structure, so that the liquid flows into the accommodating cavity via the first access channel.

[0035] 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

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not intended to limit the present disclosure.

[0037] Figure 1 A schematic diagram of the structure of a storage device provided in an embodiment of the present disclosure;

[0038] Figure 2 A longitudinal cross-sectional view of a storage device provided by an embodiment of the present disclosure;

[0039] Figure 3 A cross-sectional view of a first port sealing structure provided with a first auxiliary protrusion according to an embodiment of the present disclosure;

[0040] Figure 4 yes Figure 3 A top view of

[0041] Figure 5 Schematically showing various variations of the first auxiliary protrusion;

[0042] Figure 6 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

[0043] Figure 7 is a longitudinal cross-sectional view of a storage device according to yet another embodiment of the present disclosure;

[0044] Figure 8 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure;

[0045] Fig. 9 This is a schematic structural diagram of a storage device according to another embodiment of the present disclosure;

[0046] Fig.10 is a schematic diagram of the use process of the storage device according to an embodiment of the present disclosure;

[0047] Fig.11 is a schematic diagram of the structure of an infusion system according to an embodiment of the present disclosure;

[0048] Fig.12 The present invention is a flowchart of a method for manufacturing a storage device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0049] In order to make the purpose, technical solution and advantages of the embodiments of the present disclosure clearer, the technical solution of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0050] Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar words used in the patent application specification and claims of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" and the like mean that the elements or objects appearing before "include" or "comprise" include the elements or objects listed after "include" or "comprise" and their equivalents, and do not exclude other elements or objects. Words such as "connect" or "connected" and the like are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0051] According to an embodiment of the present disclosure, a storage device for storing biological liquid or drug liquid is provided, comprising: a tubular body, a first port sealing structure and a second port sealing structure. The tubular body comprises a receiving cavity for receiving biological liquid or drug liquid and has a first port and a second port opposite to each other in the extension direction of the tubular body; the first port sealing structure is connected to the first port and comprises a first access channel and a first seal communicating with the receiving cavity, the first seal is arranged in the first access channel and is used to temporarily close the receiving cavity; the second port sealing structure is connected to the second port and comprises a second access channel and a second seal communicating with the receiving cavity, the second seal is arranged in the second access channel and is used to temporarily close the receiving cavity. The storage device also comprises: a port connection structure, which is arranged between at least one of the first port sealing structure and the second port sealing structure and the tubular body, so as to connect at least one port sealing structure to the corresponding first port or second port.

[0052] In the storage device provided by the above-mentioned embodiment of the present disclosure, the first port (and / or the second port) of the tubular body is connected to the first port sealing structure (and / or the second port sealing structure) through the port connection structure, and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the amount of liquid injection and the speed of liquid injection, which is suitable for efficient automated continuous filling production. By respectively providing the first seal and the second seal in the first port sealing structure and the second port sealing structure, it is convenient to insert the puncture device from both ends of the storage device, thereby improving the convenience of clinical application, flexibly adapting to infusion equipment, avoiding complicated liquid preparation steps, and being more conducive to aseptic operation of medical staff.

[0053] The present disclosure is described below by specific embodiments. In order to keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and known components may be omitted. When any component of the embodiments of the present disclosure appears in more than one figure, the component may be represented by the same reference numeral in each figure.

[0054] Figure 1 A schematic diagram of the structure of a storage device provided in an embodiment of the present disclosure. Figure 2 A longitudinal cross-sectional view of a storage device provided in an embodiment of the present disclosure.

[0055] like Figure 1 and Figure 2 As shown, a storage device for storing biological liquid or drug liquid according to an embodiment of the present disclosure includes: a tubular body 1, a first port sealing structure 10 and a second port sealing structure 20. The tubular body 1 includes a receiving chamber V for receiving biological liquid or drug liquid and has a first port 1A and a second port 1B opposite to each other in the extension direction of the tubular body 1 (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 receiving chamber V, and the first sealing member 102 is disposed in the first access channel 101 and is used to temporarily close the receiving chamber V. The second port sealing structure 20 is connected to the second port 1B and includes a second access channel 201 and a second sealing member 202 that are in communication with the receiving chamber V, and the second sealing member 202 is disposed in the second access channel 201 and is used to temporarily close the receiving chamber V.

[0056] Before the liquid is injected, the tubular body 1 has a hollow accommodating chamber V. After the liquid is injected, the accommodating chamber V is partially or completely filled. In the embodiment of the present disclosure, by providing the first access channel 101 and the second access channel 201, it is convenient for the injection needle to communicate with the tubular body 1 through the first port 1A or the second port 1B. Furthermore, by providing the first seal 102 and the second seal 202, on the one hand, it prevents the liquid from flowing out of the first port sealing structure 10 and the second port sealing structure 20 and is conducive to maintaining the sterile state in the accommodating chamber, and on the other hand, it facilitates the insertion of the injection needle, providing convenience during clinical use.

[0057] 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.

[0058] In the embodiment of the present disclosure, the first seal 102 and the first port sealing structure 10 can be an integral structure or a separable structure (i.e., they are manufactured separately and then assembled together); the second seal 202 and the second port sealing structure 20 can be an integral structure or a separable structure (i.e., they are manufactured separately and then assembled together); when they are an integral structure, it is conducive to being realized through an integrated molding process, and can further improve the sealing of the overall structure.

[0059] In the embodiment of the present disclosure, the cross-sectional shape of the tubular body 1 is taken as an example for description. It can be understood that the cross-sectional shape can also be an ellipse, a triangle, a rectangle, etc., and the embodiment of the present disclosure does not limit this.

[0060] 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.

[0061] For example, Figure 1 and Figure 2 As shown, 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.

[0062] Compared with injecting liquid from the first access channel 101, in the embodiment of the present disclosure, the first port 1A, as the open end of the tubular body 1, has the same cross-sectional area as the tubular body 1, so liquid can be injected from the first port 1A, thereby increasing the liquid injection area and increasing the liquid injection amount per unit time, which is particularly suitable for mass production. In other embodiments of the present disclosure, liquid can also be injected from the second port 1B. Since the technical effects are the same, they will not be repeated here.

[0063] For example, the first port connection structure 11 includes a first main protrusion 111 and a first auxiliary protrusion 112. The first main protrusion 111 is located on the first port 1A and protrudes in the radial direction of the first port 1A (e.g., the diameter direction of the first port 1A). The first auxiliary protrusion 112 is located on the first port sealing structure 10 and protrudes in the radial direction of the first access channel 101 (e.g., the diameter direction of the first access channel 101). The first auxiliary protrusion 112 is connected to the first main protrusion 111 so that the first port sealing structure 10 is connected to the first port 1A.

[0064] In the embodiment of the present disclosure, the first main protrusion 111 and the first auxiliary protrusion 112 are provided, so that after the liquid is injected from the first port 1A, a sealed connection is achieved between the first port sealing structure 10 and the first port 1A. In some embodiments, the first auxiliary protrusion 112 and the first main protrusion 111 can be connected by welding, riveting, bolting, etc., and the embodiment of the present disclosure does not limit the specific connection method between the two. When welding is used for connection, for example, a high-frequency welding process and / or a hot melt welding process can be used.

[0065] In the embodiment of the present disclosure, the first main protrusion 111 and the first auxiliary protrusion 112 protrude from the outer surface of the first sealing structure 10 and the outer surface of the first port 1A respectively, which facilitates the connection between the two.

[0066] For example, Figure 2 As shown, the first access channel 101 includes a first wide end 101A and a first narrow end 101B opposite to each other in the extension direction thereof, the first narrow end 101B is a closed end, the size of the first wide end 101A is substantially the same as the size of the first port 1A, and the first auxiliary protrusion 112 is located at the first wide end 101A. Through the above arrangement, the tight connection between the first main protrusion 111 and the first auxiliary protrusion 112 is further enhanced to prevent liquid from flowing out.

[0067] In the embodiment of the present disclosure, there may be various ways to dispose the first main protrusion 111 or the first auxiliary protrusion 112 , as long as a sealed connection is achieved between the first port sealing structure 10 and the first port 1A. Figure 3 4 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. Figure 4 yes Figure 3 Top view of the . Figure 5 Various variations of the first auxiliary protrusion are schematically shown.

[0068] For example, refer to Figure 1 and Figure 4The first main protrusion 111 is a first main body circumferential flange arranged along the circumferential direction of the first port 1A, and the first auxiliary protrusion 112 is a first auxiliary circumferential flange arranged along the circumferential direction of the first access channel 101, and the first auxiliary circumferential flange is connected to the first main body circumferential flange. In other words, the first main protrusion 111 and the first auxiliary protrusion 112 constitute a first flange structure connecting the first port sealing structure 10 and the first port 1A.

[0069] 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.

[0070] 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.

[0071] For example, Figure 5 As shown, the number of the first auxiliary protrusions may be two, three or four, and these first auxiliary protrusions are axially symmetrically distributed in the plane where the cross section of the first access channel 101 is located (eg, the xy plane shown in the figure). Figure 5 In (a), the four first auxiliary protrusions 112a are symmetrically distributed about the x-axis or the y-axis. Figure 5 In (b), the three first auxiliary protrusions 112b are symmetrically distributed relative to the y-axis. Figure 5 In (c), the two first auxiliary protrusions 112c are symmetrically distributed relative to the x-axis or the y-axis. Figure 5 In (d), the two first auxiliary protrusions 112d are symmetrically distributed relative to the x-axis or the y-axis. Figure 5 In (e), the two first auxiliary protrusions 112e are symmetrically distributed relative to the x-axis or the y-axis. Figure 5 In (f), the two first auxiliary protrusions 112f are symmetrically distributed relative to the x-axis or the y-axis. Similarly, the number of the first main protrusions is the same as the number of the first auxiliary protrusions and they have the same arrangement.

[0072] In the disclosed embodiment, by providing a variety of variations of the first main protrusion and the first auxiliary protrusion, the design flexibility of the connection structure can be improved to ensure a sealed connection between the first port sealing structure 10 and the first port 1A while meeting different production conditions or equipment requirements.

[0073] 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 conducive to being realized through an integrated molding process and can further improve the sealing of the overall structure, so it is preferred.

[0074] In the disclosed embodiment, the first auxiliary protrusion 112 and the first port sealing structure 10 can be an integral structure or a separable structure; when the two are an integral structure, it is conducive to being realized through an integrated molding process and can further improve the sealing performance of the overall structure, so it is preferred.

[0075] For example, Figure 1 and Figure 2 As shown, the storage device may further include a first limiting structure 12, which is disposed between the first port sealing structure 10 and the tubular body 1 to maintain the relative position of the first port sealing structure 10 and the tubular body 1. In the embodiment of the present disclosure, by providing the first limiting structure, it is possible to avoid misalignment of the first port sealing structure 10 and the tubular body 1 during docking, thereby affecting the sealing performance during connection.

[0076] In some embodiments, the first limiting structure 12 includes a first limiting protrusion disposed on one of the first port sealing structure 10 and the first port 1A, and the first limiting protrusion is inserted into the other of the first port sealing structure 10 and the first port 1A.

[0077] For example, Figure 1 As shown, the first limiting protrusion includes a first cylindrical wall 121, which is arranged at the first port 1A and extends around the first port 1A. When in use, the first cylindrical wall 121 can be inserted into the first port sealing structure 10, for example, into the wide end 101A, to maintain the relative position of the first port sealing structure 10 and the first port 1A. In addition, since the first cylindrical wall 121 protrudes upward, by providing the first cylindrical wall 121, the length of the tubular body 1 can also be lengthened, thereby accommodating more liquid.

[0078] 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.

[0079] 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.

[0080] For example, Figure 1 and Figure 2As shown, the first port sealing structure 10 may further include a first detachable portion 103, which is disposed on a side of the first sealing member 102 away from the tubular body 1. In some embodiments, the first detachable portion 103 includes some small and fragile connecting portions, which can be easily broken or twisted off to fully expose the first sealing member 102, so that the injection needle can pierce the exposed first sealing member 102.

[0081] For example, the first port sealing structure 10 may further include a first auxiliary separation structure, which includes at least one pair of first fins 104 (e.g., two pairs as shown in the figure) connected to the first detachable part 103. By providing the first fins 104 on the first detachable part 103, it is convenient for an operator to apply an external force to the first fins 104, thereby making it easier to detach the first detachable part 103.

[0082] For example, Figure 1 The planar shape of the first wing 104 is a straight wing. Figure 2 The planar shape of the first wing 104 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.

[0083] For example, Figure 1 and Figure 2 As shown, the second port sealing structure 20 may further include a second detachable portion 203, which is disposed on a side of the second sealing member 202 away from the tubular body 1. In some embodiments, the second detachable portion 203 includes some small and fragile connecting portions, which can be easily broken or twisted off to fully expose the second sealing member 202, so that the injection needle can pierce the exposed second sealing member 202.

[0084] For example, the second port sealing structure 20 may further include a second auxiliary separation structure, which includes at least one pair of second fins 204 (e.g., two pairs as shown in the figure) connected to the second detachable part 203. By providing the second fins 204 on the second detachable part 203, it is convenient for the operator to apply external force to the second fins 204, thereby making it easier to separate the second detachable part 203.

[0085] In some embodiments, Figure 2 As shown, the first port sealing structure 10 may also include a first tubular portion 105, which defines a first access channel 101 and is connected to the first port 1A; the second port sealing structure 20 may also include a second tubular portion 205, which defines a second access channel 201 and is connected to the second port 1B; the inner wall of at least one of the first tubular portion 105 and the second tubular portion 205 has a guide surface.

[0086] In the embodiment of the present disclosure, by providing a guide surface on the inner wall of at least one of the first tubular portion 105 and the second tubular portion 205, liquid can be prevented from remaining on the inner wall, which is conducive to the complete discharge of the liquid. Figure 2 As shown, the inner wall of the second tubular portion 205 is provided with a flow guide surface 205S.

[0087] In the embodiment of the present disclosure, at least one of the first port sealing structure 10 and the second port sealing structure 20 is separable from the tubular body 1, so as to facilitate the filling of liquid.

[0088] For example, Figure 1 and Figure 2 In the embodiment, the first port sealing structure 10 and the first port 1A of the tubular body 1 are separable, so that liquid can be injected from the first port 1A, and after the injection is completed, the first port sealing structure 10 is sealed and connected to the first port 1A through the first port connecting structure 11. The second port sealing structure 20 and the tubular body 1 can be set as an integral structure, which can minimize the number of seams on the overall structure and improve the sealing performance.

[0089] The storage device of the embodiment of the present disclosure may have many variations, and some variations are further described below. It can be understood that the following variations are only illustrative, and the storage device of the embodiment of the present disclosure is not limited to the cases listed in the description.

[0090] Figure 6 FIG. 1 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. Figure 2 compared to, Figure 6 Although the first limiting structure 12 is not provided between the first port sealing structure 10 and the tubular body 1, liquid can still be injected through the first port, thereby increasing the liquid injection amount and improving the liquid injection speed.

[0091] Figure 7 It is a longitudinal cross-sectional view of a storage device according to yet another embodiment of the present disclosure. Figure 7 The storage device includes not only a first port connection structure 11 disposed between the first port sealing structure 10 and the first port 1A, but also a second port connection structure 21 disposed between the second port sealing structure 20 and the second port 1B. The above design reflects the flexibility of the storage device in manufacturing, and the first port 1A or the second port 1B can be used as a liquid injection port. After the liquid is injected from the second port 1B, the second port sealing structure 20 and the second port 1B are sealed and connected through the second port connection structure 21, so that the sealing of the injected liquid can be maintained.

[0092] For example, the second port connection structure 21 includes a second main protrusion 211 and a second auxiliary protrusion 212. The second main protrusion 211 is located on the second port 1B and protrudes in the radial direction of the second port 1B (e.g., the diameter direction of the second port 1B). The second auxiliary protrusion 212 is located on the second port sealing structure 20 and protrudes in the radial direction of the second access channel 201 (e.g., the diameter direction of the second access channel 201). The second auxiliary protrusion 212 is connected to the second main protrusion 211, so that the second port sealing structure 20 is connected to the second port 1B.

[0093] In some embodiments, the second main protrusion 211 and the second auxiliary protrusion 212 can be connected by welding, riveting, bolting, etc., and the specific connection method between the two is not limited in the embodiments of the present disclosure. When welding is used for connection, for example, high-frequency welding and / or hot-melt welding can be used.

[0094] For the specific structure of the second main protrusion 211 and the second auxiliary protrusion 212, please refer to the previous Figures 1 to 5 The specific structure of the first main protrusion 111 and the first auxiliary protrusion 112.

[0095] For example, the second main protrusion 211 is a second main body circumferential flange arranged along the circumferential direction of the second port 1B, and the second auxiliary protrusion 212 is a second auxiliary circumferential flange arranged along the circumferential direction of the second access channel 201, and the second auxiliary circumferential flange is connected to the second main body circumferential flange. 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 enhancing the tight connection between the second port sealing structure 20 and the second port 1B and reducing the risk of leakage.

[0096] For another example, there may be a plurality of second main protrusions, a plurality of second auxiliary protrusions, and the plurality of second main protrusions and the plurality of second auxiliary protrusions are connected in a one-to-one correspondence.

[0097] 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.

[0098] Figure 8 FIG. 1 is a longitudinal cross-sectional view of a storage device according to another embodiment of the present disclosure. Figure 7 compared to, Figure 8It may also 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. The arrangement of the first limiting structure 12 can refer 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 setting the second limiting structure 22, it is possible to avoid the second port sealing structure 20 and the tubular body 1 from being misaligned during docking, which affects the sealing during connection.

[0099] In some embodiments, the second limiting structure 22 includes a second limiting protrusion disposed on one of the second port sealing structure 20 and the second port 1B, and the second limiting protrusion is inserted into the other of the second port sealing structure 20 and the second port 1B. Figure 8 As shown, the second limiting protrusion includes a second cylindrical wall 221, which is disposed at the second port 1B and extends around the second port 1B. When in use, the second cylindrical wall 221 can be inserted into the second port sealing structure 20, for example, into the wide end of the second port sealing structure 20, to maintain the relative position of the second port sealing structure 20 and the second port 1B.

[0100] The embodiment of the present disclosure is described by taking the second cylindrical wall 221 being arranged on the second port 1B side as an example. It can be understood that the second cylindrical wall 221 can also be arranged on the second port sealing structure 20 side, for example, arranged on the wide mouth end and extending around the wide mouth end. When in use, the second cylindrical wall 221 can be inserted into the second port 1B, and can also maintain the relative position of the second port sealing structure 20 and the second port 1B.

[0101] 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.

[0102] Fig. 9 Schematic diagram of the structure of a storage device according to another embodiment of the present disclosure. Figure 1 compared to, Fig. 9 The first port sealing structure 10 in the embodiment does not include the first auxiliary separation structure, that is, the first wing 104 is not provided on the first detachable part 103. The second port sealing structure 20 does not include the second auxiliary separation structure, that is, the second wing 204 is not provided on the second detachable part 203.

[0103] In the embodiment of the present disclosure, the first port sealing structure 10 and the second port sealing structure 20 can be set as an integral structure, or can be decomposed into multiple parts and assembled and bonded together. When set as an integral structure, it is conducive to the realization through the integrated molding process, and can further improve the sealing performance of the overall structure, so it is preferred.

[0104] For example, Figure 2 , Figure 6 , Figure 7 and Fig. 9 In the embodiment, the first port sealing structure 10 and the second port sealing structure 20 are both integral structures, which is advantageous for obtaining them through one-step processing through a molding process. Figure 8 In the embodiment, the first port sealing structure 10 and the second port sealing structure 20 include two parts connected to each other. For example, taking the first port sealing structure 10 as an example, the first port sealing structure 10 includes a first part 10a and a second part 10b connected to each other, wherein the end of the first part 10a is inserted into and connected to the second part 10b. Through the above arrangement, the flexibility of processing parts can be improved.

[0105] In the embodiment of the present disclosure, the first part 10a and the second part 10b may be connected by welding, for example, by using a high-frequency welding process and / or a hot-melt welding process.

[0106] In the disclosed embodiments, the objects stored in the storage device are mainly biological liquids or drug liquids, including but not limited to small molecule drugs, peptide drugs, antibody drugs, protein drugs, nucleic acid drugs, cell drugs, vaccines, etc. For example, liquid drugs can be stored in the storage device. The liquid drugs can generally be divided into chemical small molecule drugs and biological macromolecule drugs. Taking chemical drugs as an example, the chemical drug research and development process includes target determination, model establishment, lead compound discovery, lead compound optimization, and preclinical and clinical research stages. Macromolecule drugs are drugs that rely on cell biosynthesis, also known as biological preparations. Advanced treatment methods for major diseases in the world, such as AIDS and tumors, are all related to biological macromolecule drugs. Although the number of biological products has increased, chemical drugs have always been an important part of drug research, and chemical small molecule drugs still account for the vast majority of drugs sold, while macromolecule drugs have great development prospects in drug research and development in the 21st century.

[0107] For example, small molecule drugs are small molecules of active substances that are chemically synthesized. Small molecule ingredients can be made into tablets or capsules that are easily absorbed by the body. For gastrointestinal dissolving tablets, the dissolved active substances will be absorbed by the body through the intestinal wall and enter the blood. Due to their small size, small molecules can reach almost any target in the body. In addition, due to their small structure and chemical composition, small molecules can generally easily penetrate cell membranes.

[0108] For example, biomacromolecule drugs are a type of biomacromolecules produced by modern biotechnology methods and derived from living organisms and used for the diagnosis, treatment or prevention of diseases. In a narrow sense, they are also called biotechnology drugs, including vaccines, blood and blood components, somatic cells, gene therapy and recombinant therapeutic proteins. Compared with chemically synthesized drugs, biomacromolecule drugs have the characteristics of large relative molecular weight, complex structure, difficulty in penetrating biological membranes, low dosage and easy degradation in the body. With the rapid development of biotechnology, biomacromolecule drugs have been widely used to treat a variety of diseases such as tumors, autoimmune diseases and metabolic diseases.

[0109] In the embodiments of the present disclosure, the material used to manufacture the storage device includes a polymer. Furthermore, the polymer is, for example, a high molecular polymer (or macromolecular polymer), that is, a polymer with a molecular weight of more than 10,000. The high molecular polymer has moisture-proof, anti-volatile, anti-oxidation and other effects, and is therefore widely used for storage in ultra-low temperature, ordinary low temperature or normal temperature environments.

[0110] In the embodiments of the present disclosure, the high molecular polymer suitable for use in the storage device includes, for example, one or more of polyolefins (such as polyethylene (PE), polypropylene (PP)), polyvinyl chlorides (polyvinyl chloride (PVC), polyvinylidene chloride), acrylic acid and derivatives (polyacrylic resin PMMA), polyether, polyurethane, polyamide, polyurethane, polysulfone, etc.

[0111] 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.

[0112] In the embodiments of the present disclosure, the polymer suitable for storing biological fluids or drug liquids at freezing temperatures includes one or more of ethylene-vinyl acetate copolymer (EVA), perfluoroethylene propylene copolymer (FEP) and polyolefin copolymer (PO), preferably ethylene-vinyl acetate copolymer (EVA).

[0113] According to an embodiment of the present disclosure, there is also provided an infusion system, comprising the storage device provided by any of the previous embodiments. Fig.10 It is a schematic diagram of the use process of the storage device according to an embodiment of the present disclosure. Fig.11 Schematic diagram of the structure of the infusion system according to the embodiment of the present disclosure.

[0114] For example, Fig.11 As shown, 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 chamber V through the second access channel 201 of the second port sealing structure 20, so that the biological liquid or drug liquid in the storage device flows into the first liquid inlet end 3A through the second access channel 201.

[0115] For example, the first liquid inlet end 3A is provided with a first piercer 41, and the first piercer 41 is configured to pierce the second sealing member 202 so that the second access channel 201 is connected to the accommodating chamber V. Fig.10 (a), when in use, first twist off the second detachable part 203 to expose the second sealing member 202, then insert the first puncture tool 41 into the second access channel 201 and pierce the second sealing member 202, so that the first puncture tool 41 is connected to the accommodating cavity V. For example, the infusion line 3 may be provided with a first liquid stop clamp 81 for opening or closing the infusion line 3.

[0116] 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.

[0117] For example, the infusion system may further include a container 4 for containing a liquid, which is different from the biological liquid or drug liquid in the storage device, such as physiological saline. For example, the infusion system may further include a liquid transfer device 5, which includes a liquid channel 51 and a second liquid inlet end 51A and a second liquid outlet end 51B located at both ends of the liquid channel 51, the second liquid inlet end 51A is connected to the container 4, and the second liquid outlet end 51B is connected to the accommodating cavity V through the first access channel 101 of the first port sealing structure 10, so that the liquid flows into the accommodating cavity V through the first access channel 101.

[0118] For example, the second liquid outlet 51B is provided with a second puncture device 42, and the second puncture device 42 is configured to puncture the first sealing member 102 so that the first access channel 101 and the accommodating chamber V are connected. Fig.10 (b) and (c), when in use, first twist off the first detachable part 103 to expose the first sealing member 102, then insert the second puncture device 42 into the first access channel 101 and pierce the first sealing member 102, so that the second puncture device 42 is connected to the accommodating chamber V.

[0119] 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.

[0120] For example, the third liquid inlet end 6A of another infusion line 6 is provided with a third puncture device 43, and the third puncture device 43 is connected to the container 4, so that the liquid in the container 4 can enter the infusion line 6 through the third puncture device 43, and finally flow into the main infusion line 9 for pre-flushing and pre-filling of the infusion line. Another infusion line 6 can also be provided with a second liquid stop clamp 82 for opening or closing the infusion line 6.

[0121] For example, the infusion system may further include a main infusion pipeline 9 , on which a filter 91 may be provided to filter out impurities in the liquid.

[0122] The method of using the storage device and the infusion system provided in the above embodiments of the present application is as follows:

[0123] 1) Keep the infusion lines 3 and 6 in a closed state;

[0124] 2) inserting the third puncture device 43 on the infusion line 6 into the adapted puncture hole of the container 4 (e.g., a saline bag), opening the lower valve of the third puncture device 43 to allow saline to pre-flush and fill the total infusion line, and adjusting the flow rate by adjusting the second stop clamp 82;

[0125] 3) holding the storage device provided by the embodiment of the present disclosure, twisting off the second detachable part of the storage device to expose the second access channel, inserting the first puncture tool 41 into the second access channel and puncturing the second sealing member, so that the first puncture tool 41 is connected to the storage device;

[0126] 4) twisting off the first detachable part of the storage device to expose the first access channel, inserting the second puncture device 42 at one end of the liquid transfer device (e.g., a disposable sealed liquid transfer device) into the first access channel and puncturing the first seal, and then inserting the puncture device (not shown) at the other end of the liquid transfer device into the matching puncture hole of the physiological saline bag, thereby connecting the physiological saline bag and the storage device;

[0127] 4) Open the lower valve of the first puncture device 41 and the lower valve of the filter 91 on the main infusion pipeline 9, so that the physiological saline flows into the storage device, and flows into the main infusion pipeline 9 through the infusion pipeline 3 together with the drug liquid or biological liquid in the storage device, and then infuses the drug liquid after passing through the filter 91. The flow rate of the liquid can be adjusted by adjusting the first liquid stop clamp 81.

[0128] According to an embodiment of the present disclosure, a method for manufacturing a storage device for storing biological fluid or medicinal fluid is also provided.

[0129] Fig.12 FIG. 1 is a flow chart of a method for manufacturing a storage device according to an embodiment of the present disclosure. Fig.12As shown, the manufacturing method of the embodiment of the present disclosure can be used to manufacture the storage device of any of the previous embodiments, and the manufacturing method may include the following steps:

[0130] S100: providing a tubular body 1, wherein the tubular body 1 includes a first port 1A and a second port 1B which are opposite to each other in an extending direction of the tubular body 1;

[0131] S200: Connect one of the first port sealing structure 10 and the second port sealing structure 20 to one of the first port 1A and the second port 1B to form a receiving chamber V for receiving biological liquid or drug liquid;

[0132] S300: injecting biological liquid or drug liquid into the containing cavity V through the other of the first port 1A and the second port 1B;

[0133] S400 : Connect the other of the first port sealing structure 10 and the second port sealing structure 20 to the other of the first port 1A and the second port 1B to seal the biological liquid or the drug liquid in the containing cavity V.

[0134] In the manufacturing method of the storage device provided by the above-mentioned embodiment of the present disclosure, the first port (and / or the second port) of the tubular body is connected to the first port sealing structure (and / or the second port sealing structure) through the first port sealing structure 10 (and / or the second port sealing structure 20), and the first port or the second port can be used to inject liquid into the tubular body, thereby increasing the liquid injection amount and the liquid injection speed, which is suitable for efficient automated continuous filling production. In actual use, it is convenient to insert the puncture device from both ends of the storage device, which improves the convenience of clinical application, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

[0135] 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:

[0136] S201: forming a first port connecting structure 11 between the first port sealing structure 10 and the first port 1A;

[0137] S202 : Using the first port connecting structure 11 , connect the first port sealing structure 10 to the first port 1A.

[0138] In the embodiment of the present disclosure, the first port 1A, as the open end of the tubular body 1, has the same cross-sectional area as the tubular body 1, so liquid can be injected from the first port 1A. Compared with injecting liquid from the first access channel 101, not only the liquid injection area is increased, but also the liquid injection amount per unit time is increased, which is particularly suitable for mass production.

[0139] 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:

[0140] 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;

[0141] 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;

[0142] S2013 : Connect the first auxiliary protrusion 112 to the first main protrusion 111 .

[0143] In the embodiment of the present disclosure, by forming the first main protrusion 111 and the first auxiliary protrusion 112 , it is beneficial to achieve a sealed connection between the first port sealing structure 10 and the first port 1A after the liquid is injected from the first port 1A.

[0144] 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.

[0145] 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:

[0146] S401: forming a second port connection structure 21 between the second port sealing structure 20 and the second port 1B;

[0147] S402 : Using the second port connecting structure 21 , connect the second port sealing structure 20 to the second port 1B.

[0148] In the embodiment of the present disclosure, by forming the second port connection structure 21 between the second port sealing structure 20 and the second port 1B, the manufacturing flexibility of the storage device is reflected, and the first port 1A or the second port 1B can be used as a liquid injection port.

[0149] For example, in step S401, a second port connection structure 21 is formed between the second port sealing structure 20 and the second port 1B, including:

[0150] 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;

[0151] 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;

[0152] S4013 : Connect the second auxiliary protrusion 212 to the second main protrusion 211 .

[0153] In the embodiment of the present disclosure, the second main protrusion 211 and the second auxiliary protrusion 212 are formed, so as to facilitate a sealed connection between the second port sealing structure 20 and the second port 1B after the liquid is injected from the second port 1B.

[0154] For example, in step S4011, the second main protrusion 211 and the tubular body 1 are formed by an integrated molding process; in step S4012, the second auxiliary protrusion 212 and the second port sealing structure 20 are formed by an integrated molding process, which can facilitate processing and reduce manufacturing difficulty.

[0155] For example, step S100 and step S200 may be completed in the same process, which includes an integrated molding process. In some embodiments, the tubular body 1 and the first port sealing structure 10 connected to the first port 1A thereof may be formed by an integrated molding process; or the tubular body 1 and the second port sealing structure 20 connected to the second port 1B thereof may be formed by an integrated molding process.

[0156] 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 the second port 1B, which can further improve the sealing performance of the overall structure.

[0157] In the storage device and its manufacturing method and infusion system provided by the above-mentioned embodiment of the present disclosure, by designing the first port connection structure or the second port connection structure, the first port or the second port can be effectively used to inject liquid into the tubular body, thereby increasing the amount of liquid injected and the speed of liquid injection, which is suitable for mass production. Moreover, by setting a first seal in the first port sealing structure and a second seal in the second port sealing structure, both the upper and lower ends of the storage device can be connected to the outside world, which improves the diversity of the storage device in the application environment and the convenience in clinical use, flexibly adapts to infusion equipment, avoids complicated liquid preparation steps, and is more conducive to aseptic operation of medical staff.

[0158] In this article, there are a few points to note:

[0159] (1) The drawings of the embodiments of the present disclosure only relate to the structures related to the embodiments of the present disclosure, and other structures may refer to the general design.

[0160] (2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to obtain new embodiments.

[0161] (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, 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 claim 2, 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 claim 2, 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, 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, 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 claim 1, 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 claim 1, 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 claim 1, 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 claim 1, wherein: The material of the storage device includes a polymer.

17. The storage device according to claim 16, wherein: The polymer is configured to be suitable for storing the biological fluid or the pharmaceutical fluid at a cryopreservation temperature.

18. The storage device according to claim 17, wherein: The polymer includes one or more of ethylene-vinyl acetate copolymer, perfluoroethylene propylene copolymer and polyolefin copolymer.

19. 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.

20. The manufacturing method according to claim 19, 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.

21. The manufacturing method according to claim 20, 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.

22. The manufacturing method according to claim 21, 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.

23. The manufacturing method according to claim 19, 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.

24. The manufacturing method according to claim 23, 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.

25. The manufacturing method according to claim 24, 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.

26. The manufacturing method according to claim 19, 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.

27. An infusion system comprising the storage device according to any one of claims 1-18.

28. The infusion system according to claim 27, 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.

29. The infusion system according to claim 28, 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.

30. The infusion system according to claim 28, wherein: The infusion system further comprises: a container for containing a liquid, the liquid being different from the biological liquid or the pharmaceutical liquid; A liquid transferor, the liquid transferor comprising 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, the second liquid outlet being connected to the accommodating cavity via a first access channel of the first port sealing structure, so that the liquid flows into the accommodating cavity via the first access channel.

31. The infusion system according to claim 30, 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.

Images