Dosing device capable of storing liquid or solid simultaneously

Abstract

The utility model discloses a dosing device capable of storing liquid or solid simultaneously, and belongs to the field of medicine packaging equipment. The device comprises a needle tube, a protective cap, a special-shaped rubber plug, a push rod piston and a solid piston, wherein the needle tube is used for storing and feeding medicine; the special-shaped rubber plug is located in the protective cap, the protective cap is arranged at the medicine outlet end of the needle tube, and the medicine outlet is sealed through the special-shaped rubber plug in the protective cap. According to the device, an injector cavity in a needle tube is divided into two cavities through a solid piston and a push rod piston, a bypass flow channel is formed in the inner wall of the needle tube, and when the solid piston is located at the position of the bypass flow channel, every two adjacent cavities can be communicated. The device can be used for medicine storage or injection, and the problems of pollution and the like possibly caused in the medicine transfer process are solved.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, specifically relating to a drug delivery device that can simultaneously store liquids or solids. Background Technology

[0002] Currently, there are many drugs and medical devices on the market that are used for intravenous, intramuscular, or subcutaneous injections. Because their APIs cannot be stored stably in solution for a long time, they are made into powder injections or lyophilized powder injections, which have higher stability.

[0003] Powder injection refers to a dosage form in which a drug solution containing APIs and excipients is spray-dried or dried using other methods to obtain a sterile powder with very low moisture content, and then dispensed into containers such as vials, pre-filled syringes, and soft bags using sterile powder dispensing technology. Lyophilized powder injection refers to a dosage form in which a drug solution containing APIs and excipients is aseptically filled into containers such as vials, and then lyophilized to remove more than 95% of the moisture from the drug solution, resulting in a dry sterile drug powder remaining in the container.

[0004] Most chemical reactions require free water as a catalyst or ion exchange medium. Powder injections and lyophilized powder injections, due to their very low water content (usually below 2%), exhibit high long-term storage stability. Both dosage forms require dissolution with a suitable solvent (usually sterile water for injection or sterile sodium chloride solution) before injection. Therefore, their packaging typically includes the appropriate amount of solvent and tools for reconstitution (sterile connector, syringe, filter needle, etc.).

[0005] Currently, most pharmaceutical storage or packaging equipment purchased on the market has the following main shortcomings:

[0006] a) The structure is complex and requires more than one packaging material, such as double vials, double pre-filled vials, or a single vial with pre-filled vials.

[0007] b) Complex operation: With the increase in the number of packaging materials, additional parts are needed to connect them, such as the configuration of double vials with connectors, or the configuration of double pre-filled seals; the high complexity will increase the learning cost of end-user medical staff, make it inconvenient to use, and increase the error rate; the packaging of multiple different products will increase the probability of confusion and errors for pharmaceutical manufacturers.

[0008] c) High residual amount of medicine liquid: After several transfers, the volume of medicine liquid remaining in the packaging material is relatively high, resulting in waste. Utility Model Content

[0009] Purpose of the utility model: In view of the fact that existing vials and related devices cannot meet the requirements for storage and injection, and cannot simultaneously store and administer two different drugs, this invention provides a dual-chamber drug delivery device that can be freeze-dried.

[0010] Technical solution: A drug delivery device capable of simultaneously storing liquids or solids, comprising a syringe for storing and delivering drugs, and further comprising a protective cap, a shaped rubber stopper, a push rod piston, and a solid piston; the shaped rubber stopper is located inside the protective cap, and the protective cap is disposed at the drug outlet end of the syringe, and the drug outlet is sealed by the shaped rubber stopper in the protective cap;

[0011] The device divides the syringe cavity inside the needle tube into two chambers through a solid piston and a push rod piston. The inner wall of the needle tube is provided with a bypass channel. When the solid piston is located in the bypass channel, the two adjacent chambers can be connected.

[0012] Furthermore, the syringe has a needle connector on the outside of the drug outlet, and the protective cap is located in the groove of the drug outlet and the needle connector. The drug outlet and the needle connector are coaxially arranged.

[0013] Furthermore, the bypass channel is located in the chamber near the drug outlet and is set by a recess in the inner wall of the needle tube. The solid piston is driven by pressure to the recess, and the two chambers can be connected through the bypass channel.

[0014] The bypass channel has a length along the needle tube wall that is greater than the thickness of the solid piston, including being configured as a rectangular groove or a racetrack shape.

[0015] Furthermore, the protective cap includes a fastening part that connects to the needle connection part, and the needle connection part and the fastening part include a threaded structure.

[0016] The cap is equipped with anti-slip ribs to facilitate the separation of the cap and the irregularly shaped rubber stopper.

[0017] Furthermore, the cap is provided with an exhaust hole and a limiting protrusion, and the irregularly shaped rubber plug is provided with a limiting groove. The limiting protrusion and the limiting groove work together to limit the irregularly shaped rubber plug to different positions in the cap.

[0018] The irregularly shaped rubber stopper has a groove at the contact position with the drug outlet to seal the drug outlet, including a concave ring.

[0019] A sealing ring is provided on the side wall where the solid piston contacts the needle tube.

[0020] Furthermore, the push rod is provided with a push plate and reinforcing ribs, and its end is provided with a piston connector, which is connected to the push rod piston by means of embedding or threaded connection.

[0021] Beneficial effects: Compared with the prior art, the present invention firstly utilizes a syringe as a drug storage or administration device. The drug storage chamber is divided by a solid piston inside the syringe, and a protective cap assembly is provided. Different forms of drugs can be stored in different chambers, such as freeze-dried powder and solvents for filling during use. Compared with the prior art which uses vials for storage, the risk of contamination caused by freeze-drying or transfer and aspiration during use is avoided. The device structure provided by the present invention is simpler and more stable, and facilitates drug storage and administration operations. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of the device described in this utility model;

[0023] Figure 2 This is a schematic diagram of the structure of the device described in this utility model for completing drug mixing;

[0024] Figure 3 This is a schematic diagram of the syringe structure;

[0025] Figure 4 This is a structural diagram of the cap;

[0026] Figure 5 This is a schematic diagram of the structure of the irregularly shaped rubber stopper;

[0027] Figure 6 This is a schematic diagram of the push rod structure;

[0028] Figure 7 This is a schematic diagram of the push rod piston structure;

[0029] Figure 8 This is a schematic diagram of a solid piston. Detailed Implementation

[0030] To provide a detailed explanation of the technical solution disclosed in this utility model, further details are provided below in conjunction with the accompanying drawings.

[0031] refer to Figure 1-2 This invention provides a drug delivery device capable of simultaneously storing liquids or solids, comprising a syringe 1, a protective cap 2, a shaped rubber stopper 3, a push rod 4, a push rod piston 5, and a solid piston 6. The drug delivery device provided by this invention divides the syringe 1 (pre-filled syringe) into two chambers via the elastic solid piston 6. The front end near the drug outlet 104 can be used for filling with liquids, for storage, or for freeze-drying; the rear end can also be used for filling with liquids. This allows downstream users to complete the storage and delivery of two different drugs within a single package, offering convenience and minimizing drug residue.

[0032] Specifically, refer to Figure 3The needle tube 1 can be a cylindrical structure with a slender, frustum-shaped drug outlet 104 at the top. A needle connection portion 103 is located on the outer side of the drug outlet 104. The needle connection portion 103 has a fastening structure, including threads or grooves for stability. The needle connection portion 103 is fastened by connecting to the needle via internal threads. A recessed bypass channel 102 is provided on the inner wall of the needle tube 1. The bypass channel 102 can be rectangular or racetrack-shaped, with at least one channel, and can be multi-sectioned. It should be noted that, based on the basic solution provided by this utility model, other embodiments include multiple solid pistons 6, thus the number of chambers is not limited in other embodiments. A booster plate 101 is provided at the bottom of the needle tube 1. The needle tube 1 can be made of glass, including but not limited to borosilicate glass or soda-lime glass, or polymer materials, but not limited to polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, cyclic olefin copolymers, cyclic olefin polymers, and cyclic olefin block polymers. The preferred material for the syringe is a polymer material.

[0033] refer to Figure 4 The cap 2 has a fastening part 201 at the bottom of its outer wall, anti-slip ribs 202 and an exhaust channel 203 at the top of its outer wall, and a limiting structure 204 at the top of its inner wall. The fastening part 201 can be fastened to the needle tube connection part 103 through external threads. There are no fewer than 6 anti-slip ribs 202, which are evenly distributed around the exhaust channel 203. The exhaust channel 203 can be rectangular, circular, or round-headed square, and there is no fewer than 1 such channel. The limiting structure 204 on the cap 2 is a snap-fit ​​structure with no fewer than 1 snap-fit ​​claw, used to connect to the annular groove on the irregularly shaped rubber stopper.

[0034] For irregularly shaped rubber stopper 3, refer to Figure 5 As shown, one end of the irregularly shaped rubber stopper 3 is provided with a drug outlet sealing structure 301, which can be provided with a groove to fit the drug outlet 104 to achieve a seal. The rubber stopper body is provided with a limiting groove 302, including one or more. The limiting groove 302 cooperates with the limiting protrusion on the cap 2 to achieve a locking, such as the buckle mentioned above, which is snapped into the limiting groove 302. It is further pointed out that the bottom of the irregularly shaped rubber stopper 3 includes a sealing structure, including a sealing ring or a raised rubber edge. The top structure cooperates with the sealing of the drug outlet 104 and can be set as a concave ring that locks into the drug outlet 104. The push rod piston is made of an elastomer, including but not limited to polyisoprene, brominated butyl rubber, chlorinated butyl rubber, fluororubber and thermoplastic elastomer, with a hardness of 20 to 80 HA. It is pointed out in this structure that in some other embodiments, the sealing structure can be an interference fit concave rubber cap. The limiting structure is an annular groove, with a number of not less than two.

[0035] For push rod piston 5 and push rod 4, please refer to Figure 6 and Figure 7The bottom of the push rod 4 is a push plate 401 for pressing, and the middle is a load-bearing structure with reinforcing ribs 402. This load-bearing structure is a cross-shaped rib plate, the ends of which need to distribute force to evenly apply force to the push rod piston 5, forcing it closer to the drug outlet 104. A piston connector 403 is then provided, which can be embedded into the push rod piston 5 or connected via a threaded structure. The push rod 4 is made of polymer materials, including but not limited to polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, and acrylonitrile-butadiene-styrene copolymer. The surface of the push rod piston 5 can be bare, coated, or plated, including a sealing ring on the contact surface with the needle tube 1, the number of which can be one or more.

[0036] See Figure 8 The solid piston 6 has a cylindrical structure and is provided with sealing rings 601 on the side wall, with a quantity of not less than 2. The solid piston 6 is made of an elastomer, including but not limited to polyisoprene, brominated butyl rubber, chlorinated butyl rubber, fluororubber and thermoplastic elastomer, with a hardness of 20 to 80 HA. Its surface condition can be bare piston, coated and plated.

[0037] The solid piston 6 needs to work with the bypass channel 102 to facilitate the flow of medication between adjacent chambers. Therefore, in terms of size, it needs to be combined with... Figure 7 It is understandable that the height (thickness) of the solid piston 6 should be 0.5 to 1.0 times the height (length) of the bypass channel 102 on the needle tube 1.

[0038] Overall, the drug delivery device provided by this utility model, which can simultaneously store liquids or solids, can be regarded as a syringe. The cap 2 and the irregular rubber stopper 3 cooperate to seal the medicine. The push rod 4 is connected to the push rod piston 5. The push rod piston 5 and the solid piston 6 cooperate to slide with the inner wall of the needle tube 1. The solid piston 6 and the push rod piston 5 divide the syringe cavity into two chambers. The chamber near the drug outlet 104 is the drug delivery chamber, and the chamber near the push plate 101 is the drug delivery chamber, which respectively contains the drug 8 and the solvent 7.

[0039] During filling, the protective cap 2 is installed at the drug outlet 104, and the solid piston 6 is placed below the bypass channel 102. Drug 8 is filled through the drug outlet 104. The shaped rubber stopper 3 is pressed down. It should be noted that multiple sets of limiting rings and grooves can be set. At this point, the shaped rubber stopper 3 is initially inserted into the protective cap 2 and has not yet reached a completely sealed position. The exhaust channel 203 is not yet blocked. The registration device can be placed in the freeze-drying equipment to perform the freeze-drying operation of drug 8. Then, the shaped rubber stopper 3 is pressed down until the limiting ring 204 and limiting groove 302 at the final movement position are engaged. Solvent 7 is then filled from one side of the push plate 101, and the push rod piston 5 is then pressed in to complete the drug filling.

[0040] In use, the anti-slip ribs 202 separate the cap 2 and the shaped rubber stopper 3 from the syringe 1. At this time, the solid piston 6 is located below the bypass channel 102. The push plate 401 is pushed by the push plate 101, so that the push rod piston 5 squeezes the solvent 7. When the solid piston 6 is in the position with the bypass channel 102, the hydraulic pressure generated by the solvent 7 forces the solid piston 6 to pass over the bypass channel 102. At this time, the bypass channel 102 is unobstructed, and the solvent 7 enters the administration chamber through the bypass channel and mixes with the drug 8 to form the injection drug 9. The push rod 4 is pushed to complete the injection.

Claims

1. A drug delivery device capable of simultaneously storing liquids or solids, characterized in that, The device includes a syringe (1) for storing and administering drugs, a protective cap (2), a shaped rubber stopper (3), a push rod piston (5), and a solid piston (6); the shaped rubber stopper (3) is located inside the protective cap (2), which is set at the drug outlet (104) end of the syringe (1), and the drug outlet (104) is sealed by the shaped rubber stopper (3) in the protective cap (2); The device divides the syringe cavity inside the needle tube (1) into two chambers through a solid piston (6) and a push rod piston (5). The inner wall of the needle tube (1) is provided with a bypass channel (102). When the solid piston (6) is located at the bypass channel (102), the two adjacent chambers can be connected. The cap (2) is provided with an exhaust hole (203) and a limiting protrusion (204), and the shaped rubber plug (3) is provided with a limiting groove (302). The limiting protrusion (204) and the limiting groove (302) work together to limit the different positions of the shaped rubber plug (3) in the cap (2).

2. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, The needle tube (1) has a needle connection part (103) on the outside of the drug outlet (104), and the protective cap (2) is located in the groove of the drug outlet (104) and the needle connection part (103). The drug outlet (104) and the needle connection part (103) are coaxially arranged.

3. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, The bypass channel (102) is located in the chamber near the drug outlet (104) and is set by a recess in the inner wall of the needle tube. The solid piston (6) is driven by pressure to the recess, and the two chambers can be connected through the bypass channel (102).

4. The drug delivery device capable of simultaneously storing liquid or solid according to claim 3, characterized in that, The bypass channel (102) has an opening length along the needle tube wall that is greater than the thickness of the solid piston (6), including being configured as a rectangular groove or a racetrack shape.

5. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, The cap (2) includes a fastening part (201) connected to the needle connection part (103), and the needle connection part (103) and the fastening part (201) include a threaded structure.

6. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1 or 5, characterized in that, The cap (2) is provided with anti-slip ribs (202).

7. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, The contact portion between the irregular rubber stopper (3) and the drug outlet (104) is provided with a groove (301) for sealing the drug outlet, including a concave ring.

8. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, A sealing ring (601) is provided on the side wall of the solid piston (6) that contacts the needle tube.

9. The drug delivery device capable of simultaneously storing liquid or solid according to claim 1, characterized in that, The push rod (4) is provided with a push plate (401) and a reinforcing rib (402), and its end is provided with a piston connector (403). The piston connector (403) is connected to the push rod piston (5) by means of embedding or by threaded connection.

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