Transfusion packaging system with medicine mixing function

By welding the combined cover structure with the drug mixing function with the infusion container to form a reliable sealing packaging system, the problems of puncture operation and contamination risks in the prior art are solved, ensuring the safety of the drugs during high-temperature sterilization and transportation, and reducing equipment costs.

CN222930057UActive Publication Date: 2025-06-03RENOLIT HENGXUN PACKAGING TECH BEIJING CO LTD
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Patent Information

Application Number
CN202421091531.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-05-20
Publication Date
2025-06-03
Estimated Expiration
2034-05-20

AI Technical Summary

Technical Problem

The prior art has puncture operation risks, pollution risks and equipment limitations in large infusion packaging systems, and is not tightly sealed during high-temperature sterilization and transportation, which affects drug safety.

Method used

The combined cover structure with drug mixing function is welded into one with the infusion container to form a reliable sealing packaging system, flexible operation is achieved through the easy-to-tear pull structure, and sealing is maintained during high-temperature sterilization and transportation.

Benefits of technology

Effectively avoid puncture operations and contamination risks, ensure the safety of drugs during high-temperature sterilization and transportation, reduce equipment costs and improve production efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The infusion packaging system with the medicine mixing function comprises an infusion container, and a combined cover structure with the medicine mixing function is connected to an opening of the infusion container in a sealed mode. The combined cover structure with the medicine mixing function comprises a protective sleeve, a puncture needle with the medicine mixing function and a combined cover. The protective sleeve is provided with an easy-to-tear line structure used for removing the protective sleeve in a segmented mode. The combined cover comprises an inner cover, the outer side of the inner cover is hermetically buckled with an outer cover, a sealing cavity is formed between the top end of the inner cover and the top end of the outer cover, and a sealing gasket is arranged in the sealing cavity; the puncture needle is arranged in the protective sleeve in a sliding mode. A combined cover structure with a medicine mixing function is adopted, and the combined cover can be welded with an infusion container into a whole to form a packaging system which is reliable in sealing. The sealing can effectively ensure that the puncture needle in the protective sleeve and the exposed area of the sealing gasket are prevented from being polluted by the outside in high-temperature steam sterilization and subsequent storage and transportation in the large-delivery medicine production process, and the safety of medicine use is ensured.
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Description

Technical Field

[0001] The utility model relates to the technical field of pharmaceutical packaging, in particular to an infusion packaging system with a function of mixing medicines. Background Art

[0002] Large-volume injection solutions (hereinafter referred to as large infusions) are directly infused into the human vein and have the characteristics of rapid action and complete absorption. When preparing medicines, the following solutions are usually adopted:

[0003] Prior Art One: In the medicine preparation operation of the traditional upright soft bag (hereinafter referred to as: straight soft) and the plastic infusion packaging system, basically, a syringe is used to pierce the gasket of the combined cap of the straight soft or the large infusion packaging container, suck out the liquid, then pierce the rubber stopper of the vial cap to inject the liquid, mix it evenly, and then suck out the evenly mixed liquid medicine and inject it into the large infusion packaging. If repeated medicine addition is required, the above operation steps need to be repeated.

[0004] Prior Art Two: When using the existing medicine mixer, first pierce the rubber stopper of the vial cap with the medicine mixer and connect it to the vial, then pierce the gasket of the combined cap of the straight soft or the large infusion packaging container, squeeze the large infusion packaging container to inject the liquid into the vial, and mix it evenly. After the liquid medicine is evenly mixed, squeeze the large infusion packaging container again to inject the liquid medicine into the large infusion packaging. If repeated medicine addition is required, the above steps need to be repeated.

[0005] Prior Art Three: Use an interface soft bag packaging with a medicine mixer. The combined cap and the medicine mixer port are two channels. When mixing medicines, first pierce the rubber stopper of the vial cap with the medicine mixer and connect it to the vial, then pierce the gasket of the combined cap of the large infusion packaging container, squeeze the large infusion packaging container to inject the liquid into the vial, and mix it evenly. After the liquid medicine is evenly mixed, squeeze the large infusion packaging container again to inject the liquid medicine into the large infusion packaging. If repeated medicine addition is required, the above steps need to be repeated.

[0006] Prior Art Four: When using a combined cap with a medicine mixing function, first open the upper end of the combined cap to expose the medicine mixer. First pierce the rubber stopper of the vial cap with the medicine mixer and connect it to the vial, then pierce the gasket of the combined cap of the straight soft or the large infusion packaging container, squeeze the large infusion packaging container to inject the liquid into the vial, and mix it evenly. After the liquid medicine is evenly mixed, squeeze the large infusion packaging container again to inject the liquid medicine into the large infusion packaging. If repeated medicine addition is required, the above steps need to be repeated. After completing the medicine mixing, remove the medicine mixer component and leave the combined cap component to complete the subsequent infusion function.

[0007] The above prior arts have the following problems:

[0008] Prior Art One: Repeatedly piercing the gasket of the large infusion packaging container combined cap and the rubber stopper of the vial with a syringe has a probability of falling debris, increasing the risk. At the same time, medical staff using a syringe to pierce also increases the risk of injury.

[0009] Prior Art Two: Although it avoids the risks of syringe injury and high chip shedding caused by repeated punctures in Traditional Method 1, when mixing drugs multiple times, it is necessary to replace the drug mixer after each drug mixing; if not replaced, it will pose a risk of contamination, and the operation is relatively cumbersome.

[0010] Prior Art Three: Although it can avoid the problems in the operations of Method 1 and Method 2, currently, the form of the separate interfaces of this combination cap and the drug mixing component can only be used for the large infusion packaging form of soft bags, and cannot be used for the large infusion packaging forms of upright soft bags or plastic bottles, which has certain limitations and a relatively high cost.

[0011] Prior Art Four: While avoiding the operation problems of Prior Art One and Prior Art Two, it also solves the problem of not being applicable to plastic bottles and upright soft bags. However, the current solution has a certain risk of contamination for the current single-port plastic bottle and upright soft bag packaging. When the drug mixing component on the current product (the combination cap with drug mixing function) completes drug mixing or when a syringe is required for special drug addition and mixing operations, the drug mixing component needs to be removed. The drug mixing component of the current product is connected to the combination cap using a buckle (or thread), and in order to ensure effective sealing, a heat shrinkable film is used externally to protect this connection structure. During the high-temperature steam sterilization process of large infusion drugs, as well as during subsequent storage and transportation, there is a possibility of contamination inside the drug mixing component and on the surface of the rubber seal of the combination cap due to vibration or assembly sealing problems, which affects the safety of drug use.

[0012] Therefore, based on the experience and practice of being engaged in the relevant industry for many years, the inventor proposes an infusion packaging system with a drug mixing function to overcome the defects of the prior art. Summary of the Utility Model

[0013] The purpose of the present utility model is to provide an infusion packaging system with a drug mixing function. The present utility model adopts a combination cap structure with a drug mixing function, which can be welded integrally with the infusion container to form a packaging system with reliable sealing. This seal can effectively ensure that the puncture needle inside the protective sleeve and the exposed area of the sealing gasket are protected from external contamination during the high-temperature steam sterilization in the production process of large infusion drugs and during subsequent storage and transportation, ensuring the safety of drug use.

[0014] The object of the present utility model is achieved as follows. An infusion packaging system with a drug mixing function includes an infusion container, and a combined cap structure with a drug mixing function is hermetically connected to the opening of the infusion container; the combined cap structure with a drug mixing function includes a protective sleeve, a puncture needle with a drug mixing function, and a combined cap. The first end of the protective sleeve is closed and the second end is open. The second end of the protective sleeve is hermetically fastened to the outside of the combined cap. An easy tear line structure for segmentally removing the protective sleeve is provided on the protective sleeve; the combined cap includes an inner cap, and an outer cap is hermetically fastened to the outside of the inner cap. A sealing cavity is formed between the top end of the inner cap and the top end of the outer cap, and a sealing gasket is arranged in the sealing cavity; the end face of the second end of the protective sleeve, the bottom end face of the inner cap, and the bottom end face of the outer cap form a common welding surface to be connected to the opening of the infusion container; the puncture needle is slidably arranged in the protective sleeve. The puncture needle includes a first tip for puncturing a vial and a second tip for puncturing through the sealing gasket. A channel hole for communicating the vial and the infusion container is provided through the puncture needle.

[0015] In a preferred embodiment of the present utility model, the easy tear line structure includes a first easy tear line provided at the first end of the protective sleeve for tearing off the first end of the protective sleeve to expose the puncture needle.

[0016] The easy tear line structure further includes a second easy tear line provided at the second end of the protective sleeve for tearing off the protective sleeve and the puncture needle to expose the combined cap.

[0017] In a preferred embodiment of the present utility model, an outer edge portion fixedly sleeved on the outside of the outer cap is provided at the second end of the protective sleeve; the second easy tear line is provided on one side of the outer edge portion close to the first end of the protective sleeve.

[0018] In a preferred embodiment of the present utility model, a support cylinder for supporting and driving the puncture needle to slide is arranged in the protective sleeve. Both ends of the support cylinder are open. A support cylinder diaphragm is arranged in the support cylinder, and the puncture needle passes through the support cylinder diaphragm; a claw-shaped vial connecting member for clamping the vial is arranged on one side of the support cylinder diaphragm close to the first end of the protective sleeve.

[0019] In a preferred embodiment of the present utility model, a first buckle protruding outward is arranged at a position on the outer wall of the support cylinder close to the first end of the protective sleeve, and a second buckle protruding inward is arranged on the inner wall of the protective sleeve at a position of the first easy tear line away from the first end of the protective sleeve. The second buckle can stop the first buckle to perform upper limit positioning on the support cylinder.

[0020] In a preferred embodiment of the present utility model, a third buckle protruding outward is provided at one end of the outer wall of the support cylinder close to the combined cover, and a limiting convex rib protruding inward is provided on the inner wall of the protective sleeve at a position of the second easy-to-tear line close to the first end of the protective sleeve. The limiting convex rib can catch the third buckle to prevent the support cylinder from falling off the protective sleeve.

[0021] In a preferred embodiment of the present utility model, two parallel and spaced channels are provided on the puncture needle.

[0022] In a preferred embodiment of the present utility model, a through hole of the outer cover is provided at the top end of the outer cover to expose the puncture area of the sealing gasket. A first gasket groove is provided at the top end of the sealing gasket, and a first sealing convex rib surrounding the outside of the through hole of the outer cover and capable of being hermetically matched with the first gasket groove is provided on the bottom surface of the top end of the outer cover;

[0023] A cover top diaphragm is provided at the top end of the inner cover, a second gasket groove is provided at the bottom end of the sealing gasket, and a second sealing convex rib surrounding the outside of the cover top diaphragm and capable of being hermetically matched with the second gasket groove is provided at the top end of the inner cover.

[0024] In a preferred embodiment of the present utility model, the outer cover adopts a three-section cylindrical structure, including a first cylindrical part, a second cylindrical part and a third cylindrical part that are sequentially communicated. The outer diameter of the first cylindrical part is greater than the outer diameter of the second cylindrical part, and the outer diameter of the second cylindrical part is greater than the outer diameter of the third cylindrical part; a sealing cavity for accommodating the sealing gasket is formed between the inner cavity of the third cylindrical part and the top end of the inner cover;

[0025] A fourth buckle is provided at the bottom of the inner wall of the first cylindrical part, and a fifth buckle is provided at the bottom end of the outer wall of the inner cover. The fourth buckle can catch the fifth buckle to limit the lower position of the inner cover; an outer cover convex rib is provided on the outer wall of the first cylindrical part, and a sixth buckle is provided at the bottom end of the inner wall of the outer edge part. The sixth buckle can catch the outer cover convex rib to limit the lower position of the outer cover; a seventh buckle is provided at the top end of the inner wall of the outer edge part. The seventh buckle can catch the top end of the outer wall of the first cylindrical part to limit the upper position of the outer cover.

[0026] In a preferred embodiment of the present utility model, the infusion container is a vertical flexible bag or a plastic bottle.

[0027] As described above, the infusion packaging system with a drug mixing function of the present utility model has the following beneficial effects:

[0028] The utility model adopts a combined cap structure with a medicine mixing function, which can be welded to an infusion container to form a packaging system with reliable sealing. This sealing can effectively ensure that the puncture needle inside the protective sleeve and the exposed area of the sealing gasket are protected from external contamination during high-temperature steam sterilization in the production process of large-volume infusion drugs and subsequent storage and transportation, ensuring the safety of drug use.

[0029] The combined cap structure with a medicine mixing function of the utility model adopts an integral structure, which reduces the components and processing procedures compared with the existing forms of using a protective cap or a film, is more reliable and has a relatively low cost.

[0030] This packaging system can select the required functions according to actual needs, and can be conveniently and flexibly realized by tearing the easy-tear texture structure, with simple operation.

[0031] On the existing large-volume infusion filling equipment, it is simply adapted to the combined cap structure with a medicine mixing function, without the need to add other additional equipment and production links, and the existing equipment can be fully utilized, greatly reducing the equipment cost and ensuring the production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The following drawings are only intended to illustrate and explain the utility model schematically and do not limit the scope of the utility model. Among them:

[0033] Figure 1 It is a schematic diagram of the infusion packaging system with a medicine mixing function of the utility model.

[0034] Figure 2 It is a perspective view of the combined cap structure with a medicine mixing function of the utility model.

[0035] Figure 3 It is a top view of the combined cap structure with a medicine mixing function of the utility model.

[0036] Figure 4 For Figure 3 The A-A cross-sectional view in

[0037] Figure 5 It is a cross-sectional view of the protective sleeve of the utility model.

[0038] Figure 6 It is a perspective view of the support cylinder and the puncture needle of the utility model.

[0039] Figure 7 It is a top view of the support cylinder and the puncture needle of the utility model.

[0040] Figure 8 For Figure 7 The B-B cross-sectional view in

[0041] Figure 9This is a perspective view of the combined cap of the present utility model.

[0042] Figure 10 This is a top view of the combined cap of the present utility model.

[0043] Figure 11 is Figure 10 the C-C cross-sectional view in

[0044] Figure 12 This is a schematic diagram after tearing the first easy tear line before mixing drugs using the present utility model.

[0045] Figure 13 This is a schematic diagram when aligning the vial with the puncture needle in the protective sleeve.

[0046] Figure 14 This is a schematic diagram when pressing down the vial to make the puncture needle pierce the sealing gasket.

[0047] Figure 15 This is a schematic diagram after tearing the second easy tear line to remove the protective sleeve.

[0048] In the figure:

[0049] 100, combined cap structure with drug mixing function; 200, infusion packaging system with drug mixing function;

[0050] 1, protective sleeve;

[0051] 11, first easy tear line;

[0052] 12, second easy tear line;

[0053] 13, outer edge part;

[0054] 14, support cylinder; 141, support cylinder diaphragm; 142, vial connector; 143, first buckle; 144, third buckle;

[0055] 15, second buckle;

[0056] 16, limiting convex rib;

[0057] 17, sixth buckle;

[0058] 18, seventh buckle;

[0059] 2, puncture needle;

[0060] 21, first tip;

[0061] 22, second tip;

[0062] 23, channel hole;

[0063] 3, combined cap;

[0064] 31. Inner lid;

[0065] 32. Outer lid; 320. Outer lid through-hole; 321. First cylindrical part; 322. Second cylindrical part; 323. Third cylindrical part;

[0066] 33. Sealing gasket;

[0067] 34. Fourth buckle;

[0068] 35. Fifth buckle;

[0069] 36. Outer lid raised rib;

[0070] 4. Infusion container;

[0071] 5. Vial. Detailed implementation manners

[0072] In order to have a clearer understanding of the technical features, purposes, and effects of the present utility model, the detailed implementation manners of the present utility model will now be described with reference to the accompanying drawings.

[0073] The detailed implementation manners of the present utility model described herein are only for the purpose of explaining the purpose of the present utility model and should not be construed in any way as a limitation of the present utility model. Under the teaching of the present utility model, those skilled in the art can conceive any possible variations based on the present utility model, and all of these should be regarded as belonging to the scope of the present utility model. It should be noted that when an element is referred to as being "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, it can be a mechanical connection or an electrical connection, or it can be the communication inside two elements. It can be directly connected or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms can be understood according to specific circumstances. The terms "vertical", "horizontal", "upper", "lower", "left", "right", and similar expressions used herein are only for the purpose of illustration and do not represent the only implementation manner.

[0074] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific implementation manners and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0075] As Figures 1 to 11As shown in the figure, the present utility model provides an infusion packaging system 200 with a drug mixing function, which includes an infusion container 4 (an upright flexible bag or a plastic bottle). A combined cap structure 100 with a drug mixing function is hermetically connected to the opening (bottle head or interface) of the infusion container 4; the combined cap structure 100 with a drug mixing function is welded to the bottle head of the infusion container to form a reliable and complete welded seal.

[0076] The combined cap structure 100 with a drug mixing function includes a protective sleeve 1, a puncture needle 2 with a drug mixing connection function, and a combined cap 3;

[0077] The protective sleeve 1 is of an integral structure. The first end of the protective sleeve 1 is closed and the second end is open. The second end of the protective sleeve 1 is hermetically buckled on the outside of the combined cap 3. The protective sleeve 1 and the combined cap 3 are assembled into one body. An easy-tearing texture structure for segmentally removing the protective sleeve is provided on the protective sleeve 1;

[0078] The combined cap 3 includes an inner cap 31. The outer side of the inner cap 31 is hermetically buckled with an outer cap 32. A sealed cavity is formed between the top end of the inner cap 31 and the top end of the outer cap 32. A sealing gasket 33 is arranged in the sealed cavity; the end face of the second end of the protective sleeve 1 and the bottom end faces of the inner cap 31 and the outer cap 32 form a common welding surface (i.e., in the same plane and are all welded to the opening of the infusion container) to be connected to the opening of the infusion container 4;

[0079] The puncture needle 2 is slidably arranged in the protective sleeve 1 and is located between the first end of the protective sleeve 1 and the combined cap 3. The puncture needle 2 includes a first tip 21 for puncturing a vial and a second tip 22 for puncturing through the sealing gasket. A through hole 23 for communicating the vial 5 (drug bottle, including but not limited to vial) and the infusion container is provided through the puncture needle 2.

[0080] The present utility model adopts a combined cap structure with a drug mixing function, which can be welded to the infusion container to form a packaging system with reliable sealing. This seal can effectively ensure that the puncture needle inside the protective sleeve and the exposed area of the sealing gasket are protected from external contamination during high-temperature steam sterilization in the production process of large-volume infusion drugs and subsequent storage and transportation, ensuring the safety of drug use.

[0081] The combined cap structure with a drug mixing function of the present utility model adopts an integral structure, which reduces components and processing procedures compared with the existing forms of using a protective cap or a film, is more reliable and has a relatively low cost.

[0082] This packaging system can select the required functions according to actual needs, and can be conveniently and flexibly realized by tearing the easy-tearing texture structure, and the operation is simple.

[0083] On the existing large infusion filling equipment, a simple adaptation to the combined cap structure with a mixing function is made. There is no need to add other additional equipment and production processes, and the existing equipment can be fully utilized, greatly reducing the equipment cost and ensuring production efficiency.

[0084] Further, as shown in Figure 2 , Figure 3 , Figure 4 , Figure 5 , the tear - off groove structure includes a first tear - off groove 11 provided at the first end (closed end) of the protective sleeve 1 and used for tearing off the first end of the protective sleeve 1 to expose the puncture needle. As shown in Figure 12 , when the first tear - off groove 11 is opened, the closed end above the first tear - off groove 11 is removed, and the puncture needle 2 with a connection function is exposed, enabling the mixing function.

[0085] As shown in Figure 2 , Figure 3 , Figure 4 , Figure 5 , the tear - off groove structure further includes a second tear - off groove 12 provided at the second end of the protective sleeve 1 and used for tearing off the protective sleeve 1 and the puncture needle 2 to expose the combined cap 3. As shown in Figure 15 , when the second tear - off groove 12 is opened, the part of the protective sleeve 1 above the second tear - off groove 12 and the puncture needle 2 with a connection function inside the protective sleeve 1 can be removed, making the combined cap 3 completely exposed. At this time, the combined cap 3 can be used in the traditional conventional way to complete the corresponding functions.

[0086] Since the protective sleeve has two tear - off grooves, it can be selected according to the actual usage situation. Open the first tear - off groove 11 to remove the top seal protection and use the mixing function for mixing, or open the second tear - off groove 12 to remove the mixing component and directly use a traditional syringe to complete the drug addition and mixing functions on the combined cap 3.

[0087] Further, as shown in Figure 2 , Figure 3 , Figure 4 , Figure 5 , an outer edge portion 13 is fixedly sleeved on the outside of the outer cap 32 at the second end of the protective sleeve 1; the second tear - off groove 12 is provided on one side of the outer edge portion 13 close to the first end of the protective sleeve 1.

[0088] When welding the combined cap structure 100 with a mixing function and the bottle head of a standing flexible bag (or plastic bottle), the outer edge portion 13 of the protective sleeve can be used as an orientation component, making it more convenient to suck up the cap; at the same time, as the bearing surface of the downward pressure during welding, it can ensure the welding effect and prevent the downward welding pressure from damaging the seals of the two tear - off grooves.

[0089] Further, as shown inFigure 2 , Figure 6 , Figure 7 , Figure 8 As shown in Figure 2 , Figure 6 , Figure 7 , and Figure 8 , a support cylinder 14 (cylindrical tube) for supporting and driving the sliding of the puncture needle 2 is provided inside the protective cover 1. Both ends of the support cylinder 14 are open. A support cylinder diaphragm 141 is provided inside the support cylinder 14, and the puncture needle 2 passes through the support cylinder diaphragm 141. The part of the support cylinder 14 near the first end of the protective cover 1 is provided with a claw structure, having a radial micro-deformation function, and the support cylinder 14 can ensure the smooth movement of the puncture needle 2 inside the protective cover 1.

[0090] Furthermore, as shown in Figure 7 , Figure 8 , a claw-shaped vial connector 142 for clamping the vial is provided on one side of the support cylinder diaphragm 141 near the first end of the protective cover. The vial connector 142 is provided with a claw structure (capable of radially expanding and contracting under pressure), and a bottle mouth clamping portion for clamping the vial is provided on its inner wall. When the vial is punctured in place, the function of the vial connector 142 is to clamp the vial to prevent it from moving or falling off, ensuring the smooth introduction and export of the liquid from the vial.

[0091] Furthermore, as shown in Figure 7 , Figure 8 , a first buckle 143 protruding outward is provided at a position on the outer wall of the support cylinder 14 near the first end of the protective cover 1, and a second buckle 15 protruding inward is provided at a position on the inner wall of the protective cover 1 located away from the first end of the protective cover at the first tear line 11. The second buckle 15 can clamp the first buckle 143 to perform an upper limit on the support cylinder 14, ensuring that when the vial is pulled out during the mixing operation, the support cylinder 14 and the puncture needle 2 are prevented from being pulled out of the protective cover 1 simultaneously, avoiding the loss of product function.

[0092] Furthermore, as shown in Figure 7 , Figure 8 , a third buckle 144 protruding outward is provided at one end of the outer wall of the support cylinder 14 near the combination cap 3, and a limiting protruding rib 16 (in the middle part of the protective cover 1) protruding inward is provided at a position on the inner wall of the protective cover 1 located near the first end of the protective cover at the second tear line 12. The limiting protruding rib 16 can clamp the third buckle 144 to prevent the support cylinder 14 from falling off from inside the protective cover 1, ensuring that after the mixing is completed, when the puncture needle is pulled up, it can be limited and stay here, ensuring that after the lower puncture needle is pulled out from the rubber stopper, it stays inside the protective cover 1, ensuring that when the second tear line 12 is opened to remove the protective cover, the puncture needle 2 remains inside the protective cover 1, reducing the harm to the user.

[0093] Furthermore, as shown in Figure 6 , Figure 7 , Figure 8As shown, two channel holes 23 are arranged on the puncture needle 2 at parallel intervals. The double channels facilitate the introduction and export of liquid.

[0094] Furthermore, as Figure 9 , Figure 10 , Figure 11 shown, a cover through hole 320 (round hole) for exposing the puncture area of the sealing gasket 33 is provided at the top end of the outer cover 32. The size of the cover through hole 320 matches that of the sealing gasket 33, completely exposing the puncture area of the sealing gasket 33.

[0095] A first gasket groove is provided at the top end of the sealing gasket 33, and a first sealing rib is provided on the bottom surface of the top end of the outer cover 32, which is arranged on the outside of the cover through hole and can be hermetically matched with the first gasket groove, preventing side leakage after the puncture needle pierces the inner cover during use.

[0096] The shape of the inner cover 31 matches that of the outer cover. A cover top diaphragm is provided at the top end of the inner cover 31, and the diaphragm gate is offset at the edge of the diaphragm. The puncture port of the sealing gasket 33 is at the central part. After the sealing gasket (rubber stopper) is placed into the corresponding cavity of the outer cover 32, the inner cover 31 is placed in. At the connection between the cover top diaphragm at the top end of the inner cover 31 and the sealing gasket, a support is formed.

[0097] A second gasket groove is provided at the bottom end of the sealing gasket 33, and a second sealing rib is provided on the top end of the inner cover 31, which is arranged on the outside of the cover top diaphragm and can be hermetically matched with the second gasket groove.

[0098] Furthermore, as Figure 9 , Figure 10 , Figure 11 shown, the outer cover 32 adopts a three-section cylindrical structure, including a first cylindrical part 321, a second cylindrical part 322, and a third cylindrical part 323 that are sequentially connected. The first cylindrical part 321 is a welded disc, and its outer diameter is larger than that of the second cylindrical part 322. The outer diameter of the second cylindrical part 322 is larger than that of the third cylindrical part 323. The inner cavity of the third cylindrical part 323 matches the shape of the sealing gasket 33, and a sealing cavity for accommodating the sealing gasket 33 is formed between it and the top end of the inner cover 31.

[0099] A fourth buckle 34 is provided at the bottom of the inner wall of the first cylindrical part 321, and a fifth buckle 35 is provided at the bottom end of the outer wall of the inner cover 31. The fourth buckle 34 can lock the fifth buckle 35 to limit the lower position of the inner cover 31; ensure that the inner cover 31 stays in the appropriate position, and the welding surfaces at the lower ends of the inner cover 31 and the outer cover 32 are in the same plane.

[0100] An outer cover protruding rib 36 is provided on the outer wall of the first cylindrical portion 321, and a sixth buckle 17 is provided at the bottom end of the inner wall of the outer edge portion 13. The sixth buckle 17 can latch the outer cover protruding rib 36 to limit the lower position of the outer cover 32; a seventh buckle 18 is provided at the top end of the inner wall of the outer edge portion 13. The seventh buckle 18 can latch the top end of the outer wall of the first cylindrical portion 321 to limit the upper position of the outer cover 32.

[0101] Limit buckles (outer cover protruding rib 36, sixth buckle 17, seventh buckle 18) are provided at the mating part of the outer edge portion 13 of the protective sleeve 1 and the combined cover 3, which can make the protective sleeve 1 and the combined cover 3 reach an accurate position during assembly and form a flat welding plane, so as to ensure that when the combined cover structure 100 with a mixing function and the bottle head of the upright flexible bag (or plastic bottle) are welded, they can be welded firmly and a reliable seal can be formed inside the protective sleeve 1.

[0102] Furthermore, the infusion container 4 is an upright flexible bag or a plastic bottle.

[0103] The manufacturing process of the infusion packaging system 200 with a mixing function of the present utility model is as follows:

[0104] When producing the infusion packaging system 200 (large infusion product) with a mixing function, the combined cover structure 100 with a mixing function is added to the feeding system of the caps of the filling machine (prior art). After the filling machine completes the bottle making (or bag making) work of the upright flexible bag / plastic bottle (or flexible bag packaging), the above infusion container is transferred to the lower part of the filling head, and the liquid medicine is filled into the infusion container. Then, the welding disc (first cylindrical portion 321) at the lower part of the combined cover structure 100 with a mixing function and the bottle head (or interface) of the infusion container are heated and melted, and finally welded together to form a sealed infusion packaging system.

[0105] This sealed packaging system can reliably ensure that the medicine, the puncture needle 2 for mixing medicine, and the sealing gasket of the combined cover are not contaminated during subsequent sterilization, storage, and transportation.

[0106] When using the infusion packaging system 200 with a mixing function, (as Figure 11 shown), if the mixing function needs to be used, the first easy tear line 11 can be torn open by hand, as Figure 12 shown. In this way, the first end (closed end) of the protective sleeve will be opened, exposing the medicine bottle connecting piece 142.

[0107] Break open the aluminum-plastic composite cover of the vial (prior art), as Figure 13 shown, and press the puncture hole of the vial rubber stopper against the puncture needle 2 inside the protective sleeve 1; as Figure 14As shown, press the puncture needle 2 to the bottom, and at the same time, snap the vial head into the buckle of the vial connector 142. Flip the upright flexible bag (or plastic bottle) infusion container so that the liquid medicine in the upright flexible bag (or plastic bottle) enters the vial. Shake well to completely dissolve the medicine powder. Then flip the infusion container again so that the liquid medicine in the vial flows back into the infusion container. Then pull up the vial to disengage the puncture needle 2 from the sealing gasket 33 of the combined cap 3. When it reaches the upper end of the protective sleeve 1, shake the vial appropriately to disengage it from the vial connector 142.

[0108] If continuous medicine mixing is required, repeat the above steps. After completing the medicine mixing operation, the vial can be pulled up so that the puncture needle is pulled out from the sealing gasket 33 of the combined cap 3, and the support cylinder 14 and the puncture needle 2 stay on the limiting convex ribs 16 (to prevent the puncture needle from being exposed and hurting the hand during the removal process).

[0109] Then, tear open the second easy tear line 12 by hand so that the protective sleeve 1 and its internal components fall off as a whole, and at the same time expose the combined cap 3 and the sealing gasket 33, as Figure 15 shown. After that, the infusion operation can be completed using an infusion set.

[0110] If the medicine mixing function of the present utility model is not required, the second easy tear line 12 can be directly torn open by hand. After the second easy tear line 12 is torn open, the protective sleeve 1 on the upper part of the combined cap 3 and the internal puncture needle 2 will fall off simultaneously, and the sealing gasket 33 of the combined cap 3 will be exposed. After that, a syringe can be used to complete traditional medicine addition and mixing, and an infusion set can be used for infusion (equivalent to the functions of existing ordinary large infusion products packaged in upright flexible bags or plastic bottles).

[0111] As described above, the infusion packaging system with a medicine mixing function of the present utility model has the following beneficial effects:

[0112] The present utility model adopts a combined cap structure with a medicine mixing function, which can be welded to the infusion container to form a packaging system with reliable sealing. This sealing can effectively ensure that the puncture needle inside the protective sleeve and the exposed area of the sealing gasket are protected from external contamination during high-temperature steam sterilization in the production process of large infusion drugs, as well as subsequent storage and transportation, ensuring the safety of drug use.

[0113] The combined cap structure with a medicine mixing function of the present utility model adopts an integral structure, which reduces the number of components and processing procedures compared with the existing forms of using protective caps or films, is more reliable and has a relatively low cost.

[0114] This packaging system can select the required function according to actual needs, and can be conveniently and flexibly realized by tearing open the easy tear line structure, with simple operation.

[0115] The simple adaptation of the combined cap with mixing function on the existing large infusion filling equipment does not require adding other additional equipment and production links, and can fully utilize the existing equipment, greatly reducing the equipment cost and ensuring production efficiency.

[0116] The above are only illustrative specific embodiments of the present invention and are not intended to limit the scope of the present invention. Any equivalent changes and modifications made by those skilled in the art without departing from the concept and principles of the present invention shall fall within the scope of protection of the present invention.

Claims

1. An infusion packaging system with a drug mixing function, characterized in that: The invention comprises an infusion container, wherein the opening of the infusion container is sealed and connected to a combined cover structure with a medicine mixing function; the combined cover structure with a medicine mixing function comprises a protective cover, a puncture needle with a medicine mixing function and a combined cover, wherein the first end of the protective cover is closed and the second end is open, the second end of the protective cover is sealed and buckled with the outer side of the combined cover, and the protective cover is provided with an easy-tear pattern structure for removing the protective cover in sections; the combined cover comprises an inner cover, the outer side of the inner cover is sealed and buckled with the outer cover, a sealed cavity is formed between the top end of the inner cover and the top end of the outer cover, and a sealing gasket is provided in the sealed cavity; the end face of the second end of the protective cover and the bottom end face of the inner cover and the bottom end face of the outer cover form a common welding surface to be connected to the opening of the infusion container; the puncture needle is slidably arranged in the protective cover, the puncture needle comprises a first tip for puncturing a cillin bottle and a second tip for puncturing through the sealing gasket, and a channel hole is provided through the puncture needle for connecting the cillin bottle and the infusion container.

2. The infusion packaging system with drug mixing function as claimed in claim 1, characterized in that: The tear-away pattern structure includes a first tear-away pattern disposed at the first end of the protective sleeve and used for tearing and removing the first end of the protective sleeve to expose the puncture needle; The tear-away pattern structure also includes a second tear-away pattern disposed at the second end of the protective sleeve and used for tearing off the protective sleeve and the puncture needle to expose the combined cover.

3. The infusion packaging system with drug mixing function as claimed in claim 2, characterized in that: The second end of the protective sleeve is provided with an outer edge portion fixedly sleeved on the outer side of the outer cover; the second easy-tear pattern is provided on one side of the outer edge portion close to the first end of the protective sleeve.

4. The infusion packaging system with drug mixing function as claimed in claim 2, characterized in that: A support tube for supporting and driving the puncture needle to slide is arranged in the protective sleeve, and both ends of the support tube are open. A support tube diaphragm is arranged in the support tube, and the puncture needle is penetrated on the support tube diaphragm; a claw-shaped medicine bottle connector that can clamp the syringe bottle is arranged on one side of the support tube diaphragm close to the first end of the protective sleeve.

5. The infusion packaging system with drug mixing function as claimed in claim 4, characterized in that: A first buckle protruding outward is provided on the outer wall of the support tube near the first end of the protective cover, and a second buckle protruding inward is provided on the inner wall of the protective cover at a position away from the first end of the protective cover and located at the first tearable pattern. The second buckle can stop the first buckle to limit the support tube.

6. The infusion packaging system with drug mixing function as claimed in claim 5, characterized in that: A third buckle protruding outward is arranged on the outer wall of the support tube near one end of the combination cover, and a limiting protrusion rib protruding inward is arranged on the inner wall of the protective cover at a position of the second tearable pattern near the first end of the protective cover, and the limiting protrusion rib can clamp the third buckle to prevent the support tube from falling off from the protective cover.

7. The infusion packaging system with drug mixing function as claimed in claim 4, characterized in that: The puncture needle is provided with two parallel and spaced channel holes.

8. The infusion packaging system with drug mixing function as claimed in claim 3, characterized in that: The top end of the outer cover is provided with an outer cover through hole capable of exposing the puncture area of ​​the sealing gasket, the top end of the sealing gasket is provided with a first gasket groove, and the bottom surface of the top end of the outer cover is provided with a first sealing protrusion rib which is arranged around the outer side of the outer cover through hole and can be sealed and matched with the first gasket groove; A cover top diaphragm is arranged at the top end of the inner cover, a second gasket groove is arranged at the bottom end of the sealing gasket, and a second sealing protrusion rib is arranged at the top end of the inner cover, which is surrounded by the outer side of the cover top diaphragm and can be sealed and matched with the second gasket groove.

9. The infusion packaging system with drug mixing function as claimed in claim 8, characterized in that: The outer cover adopts a three-section cylindrical structure, including a first cylindrical part, a second cylindrical part and a third cylindrical part which are sequentially connected, the outer diameter of the first cylindrical part is larger than the outer diameter of the second cylindrical part, and the outer diameter of the second cylindrical part is larger than the outer diameter of the third cylindrical part; the inner cavity of the third cylindrical part and the top end of the inner cover form the sealing cavity for accommodating the sealing gasket; A fourth buckle is provided at the bottom of the inner wall of the first cylindrical portion, and a fifth buckle is provided at the bottom end of the outer wall of the inner cover, and the fourth buckle can lock the fifth buckle to limit the lower position of the inner cover; an outer cover protruding rib is provided on the outer wall of the first cylindrical portion, and a sixth buckle is provided at the bottom end of the inner wall of the outer edge portion, and the sixth buckle can lock the outer cover protruding rib to limit the lower position of the outer cover; a seventh buckle is provided at the top end of the inner wall of the outer edge portion, and the seventh buckle can lock the top end of the outer wall of the first cylindrical portion to limit the outer cover.

10. The infusion packaging system with drug mixing function as claimed in claim 1, characterized in that: The infusion container is an upright soft bag or a plastic bottle.