Combination packaging box for medicine and instrument, and assembling method therefor and use method therefor

Abstract

Disclosed are a combination packaging box for a medicine and an instrument, and an assembling method therefor and a use method therefor. The packaging box comprises: a box body (1); a syringe slot (2), formed on the box body; a vial slot (3), formed on the box body and engaging with the syringe groove, wherein the outer side surface of the vial slot and the inner side surface of the syringe slot define a mounting cavity for mounting a syringe assembly, and the vial slot is provided with a vial clip (301) for mounting a vial assembly; and a sealing film (4), detachably arranged on the box body and used for sealing the syringe slot. The front surface of the box body of the packaging box is provided with the syringe slot for placing the syringe assembly produced by a syringe manufacturer; and the back surface of the box body is provided with the vial slot for placing a bottled medicine produced by a medicine manufacturer. For the process in which a downstream medicine manufacturer mounts the bottled medicine, there is no need to execute the step of mounting a syringe, and mounting steps are simple.

Description

A combination packaging box for drugs and medical devices, and its assembly and usage methods. Technical Field

[0001] This invention belongs to the field of container technology for storing or transporting objects or materials, and particularly relates to components of other types or forms of rigid or semi-rigid containers, especially to a combination packaging box for drugs and medical devices, and its assembly method and usage method. Background Technology

[0002] Medical device packaging boxes are containers specifically designed for loading, protecting, and transporting medical devices, aiming to ensure the safety, effectiveness, and sterility of the devices. The packaging boxes effectively prevent damage to medical devices from the external environment, including physical impacts, moisture, and dust. Furthermore, many medical device packaging boxes are designed to maintain a sterile state, typically employing heat-sealing or vacuum packaging technologies to ensure no contamination during transportation and storage.

[0003] Medical device packaging boxes specifically designed for single-use sterile syringes have specific designs and functions to ensure the safety and sterility of the syringes before use. These boxes typically employ heat sealing, radiation sterilization, or gas sterilization techniques to ensure the syringes remain sterile within the packaging. The boxes are generally made of medical-grade plastics (such as polypropylene or polyester) or composite materials, ensuring they are harmless to the human body and possess good physical properties. With user convenience in mind, many boxes feature easy-tear or sliding opening designs to ensure quick removal of the syringe. Furthermore, the boxes are printed with relevant information such as syringe specifications, manufacturer, batch number, and expiration date for traceability and management.

[0004] For example, Chinese utility model patent with announcement number CN214525304U discloses a medical device packaging box and a medical device system, in which the medical device is fixed by a first fixing member and a second fixing member, making it difficult for the medical device to detach from the body between the first fixing member and the second fixing member, and also making it difficult to shake and be damaged. Technical issues

[0005] However, the aforementioned existing technology, which uses medical device packaging boxes for disposable sterile syringes, only has one side of easily tearable packaging paper for the syringes. This requires all medical devices to be manufactured before sealing and then packaged together to meet sterility requirements. In reality, however, a single packaging box may be used to package multiple medical devices to complete the entire injection process independently. This necessitates that it contain at least sterile syringes and the medication. For example, a freeze-dried human rabies vaccine requires at least the freeze-dried rabies vaccine in powder form, saline or other suitable solutions for reconstituted the freeze-dried vaccine, and a disposable syringe for drawing up the vaccine and administering the injection. Since vaccine manufacturers are often separate from syringe manufacturers, the existing packaging boxes with only one easily tearable side cannot achieve single-use loading, while multiple loadings cannot meet sterility requirements.

[0006] In summary, there is a need for a packaging box that can be used to load medical devices multiple times while maintaining sterility. Technical solutions

[0007] The purpose of this invention is to provide a medical device packaging box, its assembly method, and its usage method. The front of the box has a syringe slot for holding syringe assemblies produced by syringe manufacturers, and the back of the box has a medicine bottle slot for holding bottled medicines produced by pharmaceutical manufacturers. For downstream pharmaceutical manufacturers, the installation process for bottled medicines is very simple, eliminating the need for them to handle the syringe installation step.

[0008] The technical solution adopted by the present invention to solve the above problems is: a drug and medical device combination packaging box, comprising:

[0009] Box body;

[0010] A syringe slot is provided on the housing;

[0011] A medicine bottle holder is provided on the box body, and the medicine bottle holder extends into the syringe holder;

[0012] The outer side of the vial slot and the inner side of the syringe slot form a mounting cavity for mounting syringe assemblies.

[0013] The medicine bottle slot is provided with medicine bottle clips for installing medicine bottle components;

[0014] A sealing film, which can be torn off, is applied to the box body and is used to seal the syringe groove.

[0015] The syringe assembly refers to the various parts that make up the syringe, and typically includes:

[0016] The syringe barrel, which is the main part of the syringe, is usually a transparent cylindrical container used to hold liquid drugs (such as vaccines, medicines, etc.).

[0017] A needle is the end of a syringe, usually made of metal, with a sharp tip, used to penetrate the skin for injection. Needles can vary in length and diameter (needle size) depending on the need.

[0018] In addition, it may also include:

[0019] A liquid transfer device is a device or tool used to transfer liquid medications (such as vaccines, medicated solutions, etc.) from one container to another. Liquid transfer devices typically include an adapter that connects to medication containers (such as lyophilized vials) and syringes to facilitate smooth liquid transfer.

[0020] The needle connector is the part used to connect the needle to the syringe barrel, ensuring that the needle is securely fixed to the syringe and maintains a seal.

[0021] Regarding the vial components, taking freeze-dried human rabies vaccine as an example, it typically contains the following components:

[0022] Freeze-dried rabies vaccine, as a major drug, usually exists in the form of freeze-dried powder and needs to be reconstituted before use.

[0023] Solvents, used to redissolve lyophilized vaccines, can be physiological saline or other suitable solvents.

[0024] Specifically, syringe assemblies differ from vial assemblies in that syringe assemblies are larger and typically use medical-grade plastic for their outer packaging. This outer packaging is very thin and easily damaged, so it cannot be directly exposed to the outside environment during storage and transportation. An additional protective layer, such as a sealing film, is usually added to prevent direct contact with the outside environment before use. In contrast, the medication in a vial assembly is smaller. The medication is typically filled into the vial and sealed in a sterile environment to prevent bacteria or other contaminants from entering. Vials usually have a rubber stopper, which is pressed into the mouth of the vial after filling to form a seal, preventing air and contaminants from entering. Compared to the outer packaging bag, vials generally have higher abrasion resistance, especially high borosilicate glass (such as pharmaceutical glass), which is wear-resistant and not easily scratched. Therefore, vials generally do not require additional protection during transportation.

[0025] A further preferred technical solution is that the openings of the syringe groove and the medicine bottle groove are respectively located on the upper and lower sides of the box body.

[0026] In this context, "top" and "bottom" typically refer to two different sides of the box in the vertical direction. The top side of the box is usually the side closest to the top in the vertical direction, which is typically the part most easily accessed by the user during operation. The bottom side of the box is the side closest to the bottom in the vertical direction, which is usually used for supporting and fixing the structure of the box.

[0027] The syringe slot has its opening facing upwards on the box, allowing users to easily insert and remove syringes from above. The vial slot has its opening facing downwards on the box, typically designed for easy storage of vials, and allows for convenient flipping of the box to place or remove medication components.

[0028] A further preferred technical solution is that the sealing film is set as a plane.

[0029] In this context, a flat surface typically refers to a surface without curvature or unevenness in three-dimensional space. Setting the sealing film to be flat means that the film can evenly cover the opening of the medicine bottle or other container, ensuring a tight seal. Furthermore, it allows the sealing film to be placed horizontally on the platform after the box is flipped over, facilitating the installation of medicine bottles into the bottle holder.

[0030] A further preferred technical solution is that the box body is also provided with an easy-tear step for exposing the edge of the sealing film.

[0031] Easy-tear steps are typically one or more stepped cuts or protrusions designed to expose the edge of the sealing film, allowing for quicker subsequent operations and reducing complexity for users when opening the packaging.

[0032] Before being torn open, the easy-tear step is located outside the sealing line of the sealing film, ensuring the integrity of the sealing film.

[0033] A further preferred technical solution is that the syringe assembly includes a syringe, an injection needle, and a drug transfer device.

[0034] A further preferred technical solution is that the medicine bottle assembly includes one or more of ampoules and vials.

[0035] A further preferred technical solution is that the sealing film has an annotation surface.

[0036] The annotation surface on the sealing film typically refers to the surface used for labeling and providing information. The annotation surface is a specially designed area on the sealing film for printing or engraving important information related to the drug or vaccine. This information may include:

[0037] Drug name, trademark or generic name of the drug or vaccine;

[0038] Batch number, used to trace the batch number of a drug's production;

[0039] Expiry date: The expiry date of the medicine or vaccine; ensure it is used within the expiry date.

[0040] Instructions for use, a brief explanation of how to properly use or handle the medication;

[0041] Storage conditions, including requirements for the drug storage environment (such as temperature, light, etc.).

[0042] Warning information, possible side effects, precautions, or tips for special users.

[0043] A further preferred technical solution is that the openings of the syringe groove and the medicine bottle groove are located on the same side of the box body.

[0044] The advantage of having the syringe slot and medicine bottle slot on the same side with their openings facing the same direction is that when installing the medicine bottle assembly later, it is not necessary to flip the box so that the sealing film faces downwards, which provides a certain degree of protection for the printed text on the annotation side of the sealing film.

[0045] The assembly method for the above-mentioned medical device packaging box includes the following steps:

[0046] S01. Place the syringe assembly into the syringe slot;

[0047] S02. Seal the syringe groove opening by covering the sealing film with adhesive;

[0048] S03. Install the medicine bottle assembly into the medicine bottle slot through the locking action of the medicine bottle clip.

[0049] In step S01, the syringe assembly is placed into the pre-set syringe slot to ensure its stable position within the packaging box. The well-designed slot allows medical personnel to quickly and easily retrieve the syringe for use.

[0050] In S02, the adhesive is selected within a suitable range of peel strength to ensure proper sealing and easy tearing.

[0051] In S03, the well-designed latches allow medical professionals to quickly and easily retrieve the medicine bottle when needed. Furthermore, the bottle holder design prevents the bottle from being bumped or damaged during storage or transportation.

[0052] The method of using the above-mentioned medical device packaging box is characterized by including the following steps:

[0053] S11. Connect the pipette tip to the drug transfer device, and connect the drug transfer device to the syringe;

[0054] S12. Extract sterile water for injection from the vial assembly;

[0055] S13. Unscrew the pipette tip from the medication transfer device and discard it;

[0056] S14. Inject the sterile water for injection from the syringe into the medicine in the vial assembly, reconstitute and shake well, and then draw out the medicine solution;

[0057] S15. Attach the injection needle to the syringe and administer the injection. Beneficial effects

[0058] In summary, the present invention has the following advantages:

[0059] 1. The present invention features a syringe slot on the front of the box for holding syringe assemblies manufactured by syringe manufacturers, and a medicine bottle slot on the back of the box for holding bottled medicines manufactured by pharmaceutical manufacturers. For downstream pharmaceutical manufacturers, the installation process for bottled medicines is very simple, eliminating the need for them to handle the syringe installation step.

[0060] 2. This invention combines the syringe assembly and the vial assembly using a box as packaging material, enabling one-time packaging at the terminal, facilitating use by relevant personnel in actual operation, and ensuring consistency between the syringe and the vial. Attached Figure Description

[0061] Figure 1 is a structural schematic diagram of the box from the top view;

[0062] Figure 2 is a structural schematic diagram of the box from the bottom view;

[0063] Figure 3 is a schematic diagram of the structure after the sealing film is glued onto the box.

[0064] In the attached diagram, the components represented by each number are as follows: box body 1, syringe slot 2, medicine bottle slot 3, sealing film 4, syringe assembly 91, medicine bottle assembly 92, easy-tear step 101, and medicine bottle buckle 301. Embodiments of the present invention

[0065] The present invention will be further described in detail below with reference to the accompanying drawings.

[0066] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention. Example

[0067] A combination drug and medical device packaging box, comprising a box body 1;

[0068] Injector slot 2 is provided on the housing 1;

[0069] A medicine bottle slot 3 is provided on the box body 1, and the medicine bottle slot 3 is inserted into the syringe slot 2;

[0070] The outer side of the medicine bottle slot 3 and the inner side of the syringe slot 2 form a mounting cavity for mounting the syringe assembly 91.

[0071] The medicine bottle slot 3 is provided with a medicine bottle buckle 301 for installing the medicine bottle assembly 92;

[0072] The sealing film 4 is tearably applied to the box body 1 and is used to seal the syringe groove 2.

[0073] The box body 1 is a blister pack structure, a common packaging form made of transparent plastic material, such as polyvinyl chloride (PVC) or polystyrene (PS). The syringe slot 2 and vial slot 3 are formed directly on the blister pack. Specifically, in the early stages of blister manufacturing, a specialized mold is designed to form the required slot shape and depth during the molding process. The selected plastic sheet is heated to a formable temperature, softening it. The heated plastic sheet is placed into the pre-designed mold and pressed into the mold using vacuum or pressure, thus forming the blister slot. This process can be completed in a vacuum forming machine. After the plastic sheet fills the mold, it is cooled to room temperature, remaining solid within the mold's shape. After cooling, the formed blister is removed from the mold, excess edge material is removed, and the shape and size of the slot are ensured to meet design requirements.

[0074] Syringe slot 2 holds a drug transfer device, a disposable syringe, and an injection needle. All three are pre-packaged sterile products, typically in blister packs or paper-plastic packaging. If pre-packaged items are used, the blister pack does not need to be sterile, but it must meet general cleanliness standards. While it may not be completely sterile, the number of microorganisms in the environment is relatively low. However, if the drug transfer device, disposable syringe, and injection needle are placed directly inside the blister pack, then the blister pack must meet sterility requirements.

[0075] Bottle slot 3 holds vials and / or ampoules, commonly two vials or one vial and one ampoule. Vials typically contain lyophilized powder, while ampoules usually contain sterile water for injection.

[0076] All disposable syringes are custom-made to reduce volume, and the total length of the packaged disposable drug transfer device is 115~135mm; the disposable syringes are common 1ml and 2ml sizes.

[0077] The blister pack, which serves as box 1, has a length of 135-145mm, a width of 60-75mm, and a height of 16-23mm. During storage, the product will be placed in refrigerators at hospitals and vaccination sites, so the volume occupied must be carefully considered. This volume allows for more product to be stored, is easier to manage, has lower costs, and is more readily accepted.

[0078] The openings of the syringe groove 2 and the medicine bottle groove 3 are respectively located on the upper and lower sides of the box body 1, so that the medicine bottle groove 3 can be exposed after the box body 1 is turned over and a vial and / or ampoule can be installed.

[0079] The sealing film 4, also known as the cover material, is made of PET, dialysis paper, or Teflon. Dialysis paper is often made of materials such as cellulose or polyester. Teflon is a brand name, usually referring to polytetrafluoroethylene (PTFE) material. The sealing film 4 has an annotation surface. This surface allows for high-definition printing in multiple colors for a more aesthetically pleasing appearance; it includes operating instructions, the pharmaceutical company's logo and product name, and a QR code for an operating video. The reverse side of the sealing film 4 has an oil-based screen-printed adhesive around the perimeter, with a peel strength of 1~3N / 25mm. This adhesive ensures that the product will not delaminate during a three-year aging test at low temperatures (2~8℃), and will not delaminate during transportation. Nurses can tear it without using excessive force; no debris is produced during the tearing process. PET thickness: 0.05~0.25mm.

[0080] The box body 1 is also provided with an easy-tear step 101 for exposing the edge of the sealing film 4. The easy-tear step is typically designed as a groove with a clearly defined edge, or it can be a protrusion, with appropriate height and width to allow the user to easily find the tearing point. The easy-tear step is usually made of the same material as the box body 1 or is formed by pressing the box body 1 to ensure the stability and consistency of the overall structure. The easy-tear step provides a physical "grip" point, allowing the user to easily tear the sealing film, avoiding tearing or damage that may be caused by uneven force.

[0081] The syringe assembly 91 includes a syringe, an injection needle, a suction tip, and a drug transfer device. The vial assembly 92 includes one or more of ampoules and vials. The syringe and injection needle are common components in the prior art. The structure of the drug transfer device and suction tip is referenced from the adapter housing and suction tip in Chinese Invention Patent Publication No. CN116531255A. Ampoules and vials are common components in the prior art.

[0082] The assembly method for medical device packaging boxes includes the following steps:

[0083] S01. Place the syringe assembly 91 into the syringe slot 2;

[0084] S02. Seal the syringe groove 2 by covering the sealing film 4 with adhesive;

[0085] S03. Install the medicine bottle assembly 92 into the medicine bottle slot 3 through the locking action of the medicine bottle clip 301.

[0086] In step S01, the syringe assembly 91 is fed from the storage area into the syringe slot 2 using the syringe manufacturer's automatic feeding device. The syringe assembly is accurately positioned using a robotic arm or a manual hand-held gripper to ensure it is securely placed in the syringe slot 2.

[0087] In step S02, an automatic supply sealing film 4 is used and cut to the appropriate size. The sealing film 4 is a roll material, with an annotation surface on the front and an adhesive ring on the back for bonding the groove.

[0088] In addition, an automated adhesive applicator can be used at the opening of the syringe groove 2 to evenly apply the adhesive. A robotic arm is then used to accurately cover the sealing film 4 at the opening and apply appropriate pressure to ensure good adhesion. In short, any adhesive method that can bond the sealing film 4 to the opening of the groove is acceptable.

[0089] In step S03, an automated supply system from the pharmaceutical manufacturer is set up on the production line to deliver the vial assembly 92 to the installation position in the vial slot 3. The vial assembly 92 is accurately placed into the vial slot 3 using a robotic arm or a manual gripper, and then secured using the vial clip 301. Sensors can be installed to ensure the vial assembly is correctly positioned.

[0090] Sensors or cameras can be installed after each step to automatically detect the correctness and integrity of the product. An automatic alarm system can be set up if an anomaly is detected at any step.

[0091] The method for using medical device packaging boxes includes the following steps:

[0092] S11. Connect the pipette tip to the drug transfer device, and connect the drug transfer device to the syringe;

[0093] S12. Extract sterile water for injection from the vial assembly 92;

[0094] S13. Unscrew the pipette tip from the medication transfer device and discard it;

[0095] S14. Inject the sterile water for injection from the syringe into the medicine in the vial assembly 92, reconstitute and shake well, and then draw out the medicine solution;

[0096] S15. Attach the injection needle to the syringe and administer the injection.

[0097] For instructions on using the medical device packaging box, please refer to Chinese invention patent publication number CN116531255A. The structure of the drug transfer device and suction tip is similar to that of the adapter housing and suction tip in that patent.

[0098] Furthermore, the same or similar element symbols are used as far as possible in the accompanying drawings and description to refer to the same or similar parts or steps. The drawings are presented in a simplified form and are not drawn to scale. For convenience and clarity only, directional terms such as top, bottom, front, back, left, right, front, back, upward, above, above, below, behind, and front may be used to refer to the drawings. These and similar directional terms should not be construed as limiting the scope of this disclosure in any way.

Claims

1. A combination packaging box for drugs and medical devices, characterized in that, include: Box body (1); Injector slot (2) is provided on the box body (1); A medicine bottle slot (3) is provided on the box body (1), and the medicine bottle slot (3) penetrates into the syringe slot (2); The outer side of the vial slot (3) and the inner side of the syringe slot (2) form an installation cavity for installing the syringe assembly (91). The medicine bottle slot (3) is provided with a medicine bottle buckle (301) for installing the medicine bottle assembly (92); A sealing film (4) is tearably disposed on the box body (1) and is used to seal the syringe groove (2).

2. A drug and medical device combination packaging box according to claim 1, characterized in that, The openings of the syringe groove (2) and the medicine bottle groove (3) are respectively located on the upper and lower sides of the box body (1).

3. A drug and medical device combination packaging box according to claim 1, characterized in that, The sealing film (4) is set to be flat.

4. A drug and medical device combination packaging box according to claim 1, characterized in that, The box body (1) is also provided with an easy-tear step (101) for exposing the edge of the sealing film (4).

5. A drug and medical device combination packaging box according to claim 1, characterized in that, The syringe assembly (91) includes a syringe, an injection needle, a suction tip, and a drug transfer device.

6. A drug and medical device combination packaging box according to claim 1, characterized in that, The vial assembly (92) includes one or more of ampoules and vials.

7. A drug and medical device combination packaging box according to claim 1, characterized in that, The sealing film (4) has an annotation surface.

8. A drug and medical device combination packaging box according to claim 1, characterized in that, The openings of the syringe groove (2) and the medicine bottle groove (3) are located on the same side of the box body (1).

9. A method for assembling a drug and medical device combination packaging box as described in any one of claims 1-8, characterized in that, Includes the following steps: S01. Place the syringe assembly (91) into the syringe slot (2); S02. Seal the syringe groove (2) by covering the sealing film (4) with adhesive; S03. Install the medicine bottle assembly (92) in the medicine bottle slot (3) by means of the locking action of the medicine bottle buckle (301).

10. A method of using the drug and medical device combination packaging box as described in claim 5, characterized in that, Includes the following steps: S11. Connect the pipette tip to the drug transfer device, and connect the drug transfer device to the syringe; S12. Extract sterile water for injection from the vial assembly (92); S13. Unscrew the pipette tip from the medication transfer device and discard it; S14. Inject the sterile water for injection in the syringe into the medicine in the vial assembly (92), reconstitute and shake well, and then draw out the medicine solution; S15. Attach the injection needle to the syringe and administer the injection.

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