A pre-filled ampoule injection system based on BFS process

Abstract

The utility model discloses a pre -filling medicine bottle injection system of BFS process, belong to medical instrument technical field. The system includes BFS ampoule unit and puncture connection unit. BFS ampoule unit has liquid storage part, neck, install flange of neck outer wall and the sealing end face of end. Puncture connection unit includes the needle holder with the medicine bottle interface and the double -end administration needle fixed in it, and the inner wall of medicine bottle interface is equipped with the inner seat guide slot and inner seat slot of cooperation with install flange. When connecting, install flang along inner seat guide slot axial insertion, make double -end administration needle puncture sealing end face, then circumferential rotation makes install flange and lock into inner seat slot. The utility model discloses through "insert - rotation " locking mode, solved the problem of soft bottle body connection easy deformation, sealing failure and operation instability, and through linear puncture avoided the generation of debris, and the integrated safety cap effectively prevented the needle stick injury, improved the security and reliability of clinical use.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a pre-filled vial injection drug delivery system based on the blow-fill-seal (BFS) process. Background Technology

[0002] Blow-fill-seal (BFS) is an advanced aseptic manufacturing technology that, in a Class A aseptic environment, continuously completes the blow molding of plastic containers, aseptic filling of pharmaceutical solutions, and sealing of containers using a single machine. The entire process is highly automated, effectively avoiding human contamination. Due to its advantages of high production efficiency, high level of aseptic assurance, and low cost per dose, BFS is widely used in the production of pre-filled formulations such as vaccines and therapeutic drugs.

[0003] However, vials produced using the BFS process are typically made of soft plastics such as low-density polyethylene (LDPE). When used in conjunction with traditional drug delivery components, this material presents the following technical challenges: 1. Bottle body is prone to deformation and seal failure: When the soft BFS bottle neck is used with the threaded dosing assembly, a large rotational force is required. This can easily cause plastic deformation of the bottle neck, making it impossible for the sealing surface to fit effectively, thus creating a risk of drug leakage.

[0004] 2. Puncture can easily produce core-cutting and debris: When rotating the needle to insert it into the soft BFS vial seal, a "core-cutting" effect can easily occur, cutting off plastic debris. If this debris mixes with the medication and enters the body during injection, it will pose a serious medical safety hazard. Furthermore, the twisting puncture can also cause irregular tearing of the puncture site, exacerbating leakage problems.

[0005] 3. Poor stability of puncture operation: When connecting the soft BFS bottle to the rigid drug delivery component for puncture, especially during rotation, the bottle body is prone to twisting, which may cause the puncture needle to fail to accurately penetrate the intended position, or even cause the neck of the bottle to break due to excessive twisting, affecting the stability and reliability of drug delivery operation.

[0006] 4. Insufficient safety: Many existing drug delivery devices do not have integrated safety protection devices. After drug delivery, the exposed needle can easily cause accidental needlestick injuries to medical staff, which does not meet the requirements of modern clinical safety operation standards.

[0007] Therefore, there is an urgent need for a new drug delivery system to address the technical challenges encountered in the clinical application of BFS soft vials. Utility Model Content

[0008] The purpose of this invention is to provide a pre-filled vial injection drug delivery system based on BFS technology, which aims to solve the problems of easy deformation of the vial body, easy failure of the seal, easy generation of debris during puncture, poor operational stability and lack of safety protection in the existing technology when BFS soft vials are combined with drug delivery components.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: A pre-filled vial injection drug delivery system based on BFS technology includes a BFS ampoule unit and a puncture connection unit.

[0010] The BFS ampoule unit is integrally formed using a blow-fill-seal process. The BFS ampoule unit includes a liquid storage section and a neck that communicates with the liquid storage section. The end of the neck is provided with a sealing end face, and the outer wall of the neck is provided with an mounting flange.

[0011] The puncture connection unit includes: a needle hub, one end of which is provided with a medicine bottle interface for docking with the neck; the inner wall of the medicine bottle interface is provided with an inner seat guide groove adapted to the axial direction of the mounting flange and an inner seat retaining groove adapted to the radial direction; a double-ended drug delivery needle, which passes through and is fixed in the needle hub, the inner end of the double-ended drug delivery needle being the medicine bottle puncture end and the outer end being the drug delivery end.

[0012] Wherein, after the mounting flange of the BFS ampoule unit is inserted into the vial interface along the axial direction of the inner seat guide groove, it is rotated circumferentially to make the mounting flange snap into the inner seat slot, thereby realizing the fixed connection between the BFS ampoule unit and the puncture connection unit, and during the connection process, the vial puncture end of the double-ended drug delivery needle punctures the sealing end face.

[0013] The puncture connection unit also includes a safety cap, which is hinged to the needle hub. The safety cap is provided with a needle hub hook and a steel needle hook, and the needle hub is provided with a locking plate that cooperates with the needle hub hook. After the drug administration is completed, the safety cap rotates to cover the drug administration end of the double-ended drug administration needle, the needle hub hook engages with the locking plate, and the steel needle hook hooks the double-ended drug administration needle.

[0014] In addition, the puncture connection unit also includes a common protective cap that is detachably covered on the drug delivery end of the double-ended drug delivery needle.

[0015] Preferably, the inner seat guide groove has an inclined surface on its groove wall for guiding the mounting flange to slide into the inner seat slot.

[0016] To enhance sealing, the puncture connection unit further includes a fluid sealing element, which is fixed inside the needle hub and surrounds the puncture end of the double-ended drug delivery needle. When the BFS ampoule unit is connected to the puncture connection unit, the fluid sealing element fits tightly against the sealing end face to form a seal.

[0017] Preferably, the fluid sealing element is a flexible element, one end of which protrudes from the inner end face of the medicine bottle interface and forms an interference fit with the sealing end face.

[0018] Preferably, the inner seat groove is a through groove that penetrates the side wall of the medicine bottle interface.

[0019] The beneficial effects of this utility model are as follows: 1. Reliable connection and excellent sealing: The "axial insertion-circumferential rotation" snap-fit ​​method avoids the high torque required for traditional threaded connections, effectively preventing deformation of the soft BFS bottle neck. The fit between the mounting flange and the inner seat groove forms a stable axial and circumferential limit, ensuring the reliability of the connection. Once the mounting flange is engaged in the inner seat groove, the BFS ampoule unit and the puncture connection unit cannot rotate relative to each other, providing a stable foundation for subsequent injection operations and avoiding the risk of bottle twisting or breakage.

[0020] 2. Optimized puncture process to avoid debris: The puncture process occurs during the axial insertion stage, which is a straight puncture rather than a spiral puncture. This greatly reduces the probability of the "core-cutting" effect, avoids plastic debris from contaminating the medication, and ensures medication safety.

[0021] 3. Integrated safety protection to prevent needlestick injuries: The integrated safety cap, which is hinged to the needle hub, can easily lock and cover the exposed needle tip after drug administration, effectively preventing needlestick injuries and improving the safety of clinical use.

[0022] 4. Enhanced sealing to prevent leakage: The fluid sealing element, after connection, forms a tight compression fit with the sealing end face of the BFS ampoule, providing a second layer of sealing protection for the puncture site and further eliminating the possibility of drug leakage. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the overall structure of this utility model; Figure 2 This is a schematic diagram of the puncture connection unit; Figure 3 This is a cross-sectional view of the puncture connection unit; Figure 4 This is a schematic diagram of the BFS ampoule unit; Figure 5This is one of the schematic diagrams of the docking process between the puncture connection unit and the BFS ampoule unit (axial advancement); Figure 6 This is the second schematic diagram of the docking process between the puncture connection unit and the BFS ampoule unit (circumferential rotation). Figure 7 This is a cross-sectional view after the puncture connection unit and the BFS ampoule unit are docked; Figure 8 This is a diagram showing the external end of the medication needle after the ordinary protective cap has been removed; Figure 9 This is a diagram showing how the safety cap is moved to fully engage and cover the outer end of the administration needle after the medication has been administered.

[0024] In the diagram: 1. Puncture connection unit; 11. Needle hub; 12. Safety cap; 13. Ordinary cap; 14. Double-ended drug delivery needle; 15. Fluid sealing element; 111. Medicine bottle interface; 112. Inner seat groove; 113. Clamping plate; 114. Inner seat guide groove; 115. Inclined surface; 121. Needle hub hook; 122. Steel needle hook; 2. BFS ampoule unit; 21. Liquid reservoir; 22. Neck; 23. Mounting flange; 24. Sealing end face. Detailed Implementation

[0025] The present invention will be further described below with reference to specific embodiments.

[0026] The description of this utility model is merely a structural or even functional description of the embodiments, and the scope of this utility model is not limited by the embodiments described herein.

[0027] like Figures 1-9 As shown, this embodiment is achieved through the following technical solution: This utility model provides a pre-filled vial injection drug delivery system based on BFS technology, which mainly includes a puncture connection unit 1 and a BFS ampoule unit 2.

[0028] like Figure 4 As shown, the BFS ampoule unit 2 is a pre-filled medicine bottle produced in one piece using a blow-fill-seal (BFS) process. It includes a squeezeable reservoir 21 for storing the medicine, a neck 22 communicating with the reservoir 21, a sealing end face 24 located at the top of the neck 22, and a pair of mounting flanges 23 extending radially from the outer wall of the neck 22.

[0029] like Figure 2 and Figure 3As shown, the puncture connection unit 1 is a modular drug delivery assembly. It includes a needle hub 11 as the main structure. A double-ended drug delivery needle 14 is coaxially fixed to the center of the needle hub 11. Its inner end is the puncture end of the drug vial, used to puncture the sealing end face 24 of the BFS ampoule unit 2; its outer end is the drug delivery end, used for injection into the patient.

[0030] One end of the needle holder 11 forms a cylindrical vial interface 111 for accommodating and connecting the neck 22 of the BFS ampoule unit 2. Two symmetrical inner guide grooves 114 are formed on the inner wall of the vial interface 111 to guide the axial insertion of the mounting flange 23. A pair of inner retaining grooves 112 are also formed on the inner wall of the vial interface 111, with the ends of the inner retaining grooves 112 axially flush with the ends of the inner guide grooves 114. Preferably, the inner retaining grooves 112 are through grooves penetrating the side wall of the vial interface 111. To facilitate a smooth transition of the mounting flange 23 from the inner guide groove 114 to the inner retaining groove 112, a slope 115 is provided on the groove wall of the inner guide groove 114.

[0031] To ensure a tight seal after connection, an annular fluid sealing element 15 is provided inside the needle hub 11 at the bottom of the vial interface 111. This fluid sealing element 15 is made of an elastic material (such as medical silicone), surrounds the vial puncture end of the double-ended drug delivery needle 14, and its end facing the BFS ampoule unit 2 protrudes from the bottom surface of the interface so as to form a tight interference fit with the sealing end face 24 during connection to prevent drug leakage.

[0032] The puncture connection unit 1 also integrates a comprehensive safety protection structure. At the drug delivery end of the double-ended drug delivery needle 14, a removable standard protective cap 13 is fitted to protect the needle tip from sterility and sharpness before drug delivery. Additionally, the end of a safety cap 12 is hinged to the needle hub 11. The inner wall of the safety cap 12 has a steel needle catch 122 for securing the needle body, and a pair of needle hub catches 121 are located at the end near the needle hub 11. Correspondingly, the outer wall of the needle hub 11 has a protruding retaining plate 113.

[0033] The usage process of this utility model is as follows: Connection: The operator aligns the neck 22 of the BFS ampoule unit 2 with the vial interface 111 of the puncture connection unit 1, aligns the mounting flange 23 with the inner seat guide groove 114, and then applies axial thrust. During this process, the vial puncture end of the double-ended administration needle 14 pierces the sealing end face 24 in a straight line, making the inside of the vial connected to the administration needle channel. Simultaneously, the fluid sealing element 15 is compressed and pressed tightly against the sealing end face 24, forming a reliable seal.

[0034] Locking: After the mounting flange 23 is pushed to the bottom along the inner seat guide groove 114, rotate the BFS ampoule unit 2 approximately 90 degrees circumferentially relative to the puncture connection unit 1. Guided by the inclined surface 115, the mounting flange 23 slides out of the guide groove and fully engages in the inner seat retaining groove 112. At this point, the two are firmly locked and cannot be axially disengaged or rotated relative to each other.

[0035] Drug administration: Remove the ordinary protective cap 13 to expose the drug delivery end of the double-ended drug delivery needle 14. After inserting the needle into the patient's injection site, squeeze the flexible reservoir 21 of the BFS ampoule unit 2, and the drug solution will be injected into the patient's body through the double-ended drug delivery needle 14.

[0036] Safety Precautions: After drug administration, the safety cap 12 is flipped along the hinge to cover the exposed needle tip. When flipped into place, the needle hub catch 121 crosses and engages with the catch plate 113, while the steel needle catch 122 engages with the needle body, securely locking the safety cap 12 in a safe position to prevent any accidental needlestick injuries. The entire drug administration system can then be safely disposed of as a whole.

[0037] Of course, the above description is only a preferred embodiment of this utility model and should not be considered as limiting the scope of the embodiments of this utility model. This utility model is not limited to the above examples, and all equivalent changes and improvements made by those skilled in the art within the scope of this utility model should be included in the patent coverage of this utility model.

Claims

1. A pre-filled vial injection drug delivery system based on BFS technology, characterized in that, include: BFS ampoule unit (2) is integrally formed by blow-fill-seal process. The BFS ampoule unit (2) includes a liquid storage part (21) and a neck (22) connected to the liquid storage part (21). The end of the neck (22) is a sealing end face (24). An installation flange (23) is provided on the outer wall of the neck (22). The puncture connection unit (1) includes: The needle holder (11) has a medicine bottle interface (111) at one end for docking with the neck (22); the medicine bottle interface (111) has an inner seat guide groove (114) adapted to the axial direction of the mounting flange (23) and an inner seat retaining groove (112) adapted to the radial direction on the inner wall. A double-ended drug delivery needle (14) is inserted through and fixed inside the needle hub (11). The inner end of the double-ended drug delivery needle (14) is the puncture end of the drug bottle, and the outer end is the drug delivery end. After the mounting flange (23) of the BFS ampoule unit (2) is inserted into the vial interface (111) along the inner seat guide groove (114) in the axial direction, it is rotated circumferentially so that the mounting flange (23) is engaged in the inner seat slot (112), thereby realizing the fixed connection between the BFS ampoule unit (2) and the puncture connection unit (1), and during the connection process, the vial puncture end of the double-ended drug delivery needle (14) punctures the sealing end face (24).

2. The pre-filled vial injection drug delivery system based on BFS process according to claim 1, characterized in that, The puncture connection unit (1) also includes a safety cap (12), which is hinged to the needle seat (11); the safety cap (12) is provided with a needle seat hook (121) and a steel needle hook (122), and the needle seat (11) is provided with a locking plate (113) that cooperates with the needle seat hook (121); after the drug administration is completed, the safety cap (12) rotates to cover the drug administration end of the double-ended drug administration needle (14), the needle seat hook (121) engages with the locking plate (113), and the steel needle hook (122) hooks the double-ended drug administration needle (14).

3. The pre-filled vial injection drug delivery system based on BFS process according to claim 1, characterized in that, The puncture connection unit (1) also includes a common protective cap (13) that is detachably placed on the drug delivery end of the double-ended drug delivery needle (14).

4. The pre-filled vial injection drug delivery system based on BFS process according to claim 1, characterized in that, The inner seat guide groove (114) has an inclined surface (115) on its groove wall for guiding the mounting flange (23) to slide into the inner seat slot (112).

5. The pre-filled vial injection drug delivery system based on BFS process according to claim 1, characterized in that, The puncture connection unit (1) further includes a fluid sealing element (15), which is fixed inside the needle seat (11) and surrounds the vial puncture end of the double-ended drug delivery needle (14). When the BFS ampoule unit (2) is connected to the puncture connection unit (1), the fluid sealing element (15) and the sealing end face (24) fit tightly together to form a seal.

6. The pre-filled vial injection drug delivery system based on BFS process according to claim 5, characterized in that, The fluid sealing element (15) is a flexible element, one end of which protrudes from the inner end face of the medicine bottle interface (111) and forms an interference fit with the sealing end face (24).

7. The pre-filled vial injection drug delivery system based on BFS process according to claim 1, characterized in that, The inner seat slot (112) is a through slot that penetrates the side wall of the medicine bottle interface (111).

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