Double-cavity pre-filling and sealing injector with equal-diameter channels and pre-filling and sealing method

Abstract

According to the double-cavity prefilled syringe with the equal-diameter channels and the prefilling method, firstly, a middle piston is installed through mechanical plugging, then sterile powder in a first medicament cavity is filled, and after a rubber gasket, a Luer lock adapter and a protective cap assembly are assembled, sterile powder is filled in the first medicament cavity in a pressing mode; the Ruhr lock adapter annular buckle is guided by the auxiliary conical surface to be fixed to the limiting groove, at the moment, the rubber gasket is pressed by the mechanical sealing structure, meanwhile, the protective cap assembly seals the Ruhr lock medicine outlet, and a cavity close to the medicine outlet is well sealed. Then the double-cavity pre-filling syringe is turned over, the solvent is filled from a flange inlet, filling of the second medicament cavity is completed, a push rod piston is installed through mechanical plug adding, and a cavity far away from a medicament outlet is well sealed. According to the invention, the two ends of the needle cylinder are adopted to realize pre-encapsulation administration, so that the administration residue or pollution can be avoided, and the rubber gasket, the Luer lock adapter and the protective cap assembly are matched to realize high-precision sealing.

Description

Technical Field

[0001] The invention relates to a drug delivery device and a container, and more particularly to a double-chamber prefilled syringe with equal-diameter channels and a prefilling method. Background Art

[0002] In the pharmaceutical industry, many injectable APIs cannot be stored stably for a long time in a solution state. Through vacuum freeze drying, spray drying and other methods, APIs and excipients can be prepared into powders or blocks with extremely low moisture content. The long-term storage stability of these APIs in a low-moisture environment is significantly improved.

[0003] Traditional powder packaging or freeze-dried powder injections are stored in vials. Before administration, a syringe is used to extract the solvent, then the vial is punctured, the solvent is injected into the vial, and the mixture is shaken to fully dissolve the powder. The mixed solution is then extracted with a syringe to complete the administration. This process poses risks of particulate matter and microbial contamination. In addition, in order to offset the dose loss during the transfer process, overfilling is often required, which increases costs.

[0004] The double-chamber prefilled syringe effectively solves the above problems. It uses two rubber stoppers to divide the syringe barrel into two chambers. The chamber near the drug outlet is freeze-dried by vacuum freeze drying to form freeze-dried powder, and the chamber away from the drug outlet is filled with a corresponding volume of solvent. When in use, first apply pressure to the rubber stopper away from the drug outlet to force the solvent to flow into the chamber near the drug outlet through the flow channel on the inner wall of the syringe to mix with the drug powder. After the solvent and drug powder are completely dissolved, further pressure is applied to the rubber stopper away from the drug outlet to complete the administration. The double-chamber prefilled syringe greatly simplifies the operating procedures for reconstitution of powdered drugs for injection. The closed system ensures a sterile environment and controls the overfilling dose at a low level to reduce costs.

[0005] Furthermore, the chamber near the drug outlet of the double-chamber prefilled syringe can also be directly filled with sterile powder, such as freeze-dried powder or spray-dried powder, and its use method is basically the same as the above method. In addition, the chamber near the drug outlet and the chamber far from the drug outlet of the double-chamber prefilled syringe can be filled with different liquid medicines respectively to achieve sequential injection.

[0006] At present, the double-chamber prefilled syringe generally adopts two ways for filling (or dispensing), namely: needle-up and needle-down. The difference between the two is that when filling (or dispensing) the chamber near the drug outlet, the drug outlet faces upward and downward respectively. Needle-up first needs to install the rubber plug near the drug outlet, then flip the double-chamber prefilled syringe so that the drug outlet faces upward, fill (or dispensing) the drug from the drug outlet, then seal the drug outlet with the protective cap assembly, flip the double-chamber prefilled syringe again so that the drug outlet faces downward, fill the solvent from the side away from the drug outlet, and finally install the rubber plug away from the drug outlet. Needle-down always keeps the drug outlet facing downward, first fills (or dispensing) the drug from the side away from the drug outlet, then installs the rubber plug near the drug outlet, then fills the solvent from the side away from the drug outlet, and finally installs the rubber plug away from the drug outlet.

[0007] Whether it is powder packaging or freeze drying, in the needle-down mode, during the packaging or freeze drying process, the drug powder may "raise dust" or "climb the wall", thereby contaminating the wall of the chamber where the solvent is located. In the needle-up mode, the drug powder is blocked by the piston installed first near the drug outlet and cannot contaminate the solvent chamber.

[0008] In summary, the needle-up method has obvious advantages for powder packaging and double-chamber prefilled syringes for freeze-dried drugs. However, the current needle-up double-chamber prefilled syringes for freeze-dried drugs require a sublimation channel to be reserved during the freeze-drying process, so a complex cap design is required to form the sublimation channel; on the other hand, the diameter of the drug outlet is small, which places extremely high demands on the positioning accuracy of the filling needle.

[0009] As mentioned above, the double-chamber prefilled syringe can directly dispense sterile powder. In this case, a complex cap design is no longer necessary. The cap only needs to perform the sealing function without forming a sublimation channel. At the same time, the diameter of the drug outlet is relatively small, and the positioning accuracy of the dispensing needle is extremely high, which will result in additional cost expenditure.

[0010] Therefore, for drugs that are directly packaged as sterile powder, the existing double-chamber prefilled syringes are too complicated. It is necessary to propose a double-chamber prefilled syringe and a sealing assembly suitable for directly packaging sterile powder, which can adapt to various filling equipment, is simple to assemble, has good sealing, and is convenient for dosing. Summary of the invention

[0011] The purpose of the present invention is to provide a double-chamber prefilled syringe with equal-diameter channels and a prefilling method, which is suitable for directly dispensing sterile powder medicines, can reduce the turning action during the filling process, is simple to assemble, has good sealing performance, and is convenient for drug administration.

[0012] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solution.

[0013] A double-chamber prefilled syringe with equal-diameter channels, the double-chamber prefilled syringe comprising a syringe, wherein the cavity of the syringe is divided into a first medicine chamber and a second medicine chamber by an intermediate piston, and the lower end of the second medicine chamber is sealed by a push rod piston; a concave bypass flow channel is provided on the inner wall of the syringe, and the first medicine chamber and the second medicine chamber can be communicated through the cooperation of the inner wall flow channel and the intermediate piston;

[0014] The first medicine cavity is close to the medicine outlet, and the diameter of the medicine outlet is equal to the diameter of the inner wall of the syringe;

[0015] A limiting groove and an auxiliary cone are provided near the medicine outlet of the syringe, and the Luer lock adapter is fixed at the medicine outlet through the limiting groove and the auxiliary cone, and the external thread in the protective cap assembly is connected through the internal thread on the Luer lock adapter;

[0016] The protective cap assembly is used for sealing the Luer lock adapter.

[0017] Furthermore, the end surface of the medicine outlet is in contact with a rubber gasket, the upper end surface of the rubber gasket is in contact with the mechanical sealing structure of the Luer lock adapter, and in a free state, the inner wall diameter of the rubber gasket is larger than the inner diameter of the needle tube, and the outer wall diameter of the rubber gasket is larger than the inner wall diameter of the Luer lock adapter;

[0018] The Luer lock adapter is connected to the limit groove of the syringe through an annular buckle, and the rubber gasket is compacted and pressed against the end face of the needle tube medicine outlet through a mechanical sealing structure to achieve sealing. The internal thread of the Luer lock adapter is connected to the external thread of the protective cap assembly so that the elastomeric plug is tightly against the Luer cone, thereby achieving the sealing of the Luer lock adapter on the medicine outlet.

[0019] The outer wall of the rubber gasket is conical, and the inner wall thereof includes a barrier film with microporous channels to prevent the sterile powder from leaking into the drug outlet of the Luer lock adapter before administration, thereby ensuring the full dissolution of the sterile powder.

[0020] The mechanical sealing structure of the Luer lock adapter is a plurality of spherical protrusions or a whole ring of protrusions distributed in an annular shape.

[0021] The annular buckle includes a three-claw buckle or a four-claw buckle.

[0022] Furthermore, the length of the inner wall flow channel is greater than the thickness of the middle piston.

[0023] The two ends of the syringe are provided with a medicine outlet and a flange inlet with equal diameters, and a flange is provided at the flange inlet.

[0024] Further, the needle tube of the double-chamber prefilled syringe comprises borosilicate glass, polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, cycloolefin copolymer, cycloolefin polymer and cycloolefin block polymer;

[0025] The materials of rubber gaskets include polyisoprene, brominated butyl rubber, chlorobutyl rubber, fluororubber and thermoplastic elastomer, with hardness ranging from 20 to 80HA;

[0026] The materials of Luer lock adapters include polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, and acrylonitrile-styrene-butadiene copolymer;

[0027] The materials of the hard shell of the protective cap assembly include polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate and acrylonitrile-butadiene-styrene copolymer; the materials of the elastomeric rubber plug include polyisoprene, brominated butyl rubber, chlorobutyl rubber, fluororubber and thermoplastic elastomer, with a hardness range of 20 to 80HA;

[0028] The materials of the intermediate piston and the push rod piston include polyisoprene, brominated butyl rubber, chlorobutyl rubber, fluororubber and thermoplastic elastomer, and the hardness ranges from 20 to 80HA.

[0029] Based on the above-mentioned double-chamber prefilled syringe, the present invention provides a prefilling method of a double-chamber prefilled syringe with equal-diameter channels, comprising the following steps:

[0030] First, the drug outlet of the double-chamber prefilled syringe faces upward, and the middle piston is installed at the drug outlet by mechanical plugging; then, sterile powder is dispensed from the drug outlet to complete the prefilling of the first medicine chamber; then, the sealing assembly including the rubber gasket, Luer lock adapter and cap assembly is pressed into place by the lower pressure plate layer; then, the double-chamber prefilled syringe is turned over with the drug outlet facing downward, and the solvent is filled from the flange inlet, and finally, the push rod piston is installed at the flange inlet by mechanical plugging to complete the double-chamber prefilling of the drug.

[0031] Beneficial effects: The double-chamber prefilled syringe provided by the present invention realizes the prefilling of drugs through a needle tube. The drug can be a powder or a solvent. For the filling of these two drugs, the present invention has the following significant effects:

[0032] (1) The needle tube used in the present invention is an equal-diameter channel, including a drug outlet, which makes it more convenient to fill the drug from both ends of the syringe. The first drug chamber and the second drug chamber are pre-filled separately. The existing method is to administer the drug through one end and then separate it through an intermediate piston. The present invention can avoid problems such as drug residue on the inner wall. For example, powdered drugs are added through the handle end of the syringe, and then the intermediate piston is pushed to fill the second drug chamber with drugs (solvents). At this time, there is powder residue on the inner wall of the second drug chamber.

[0033] (2) With regard to sealing performance, the present invention adopts a Luer lock adapter at the drug outlet of the syringe, and improves the sealing performance and installation convenience by setting a limit groove and an auxiliary cone surface on the syringe. The new structure of the rubber gasket further improves the sealing effect to avoid drug contamination. Finally, with the protective cap assembly, the present invention avoids designing a complicated sublimation channel, thereby achieving better sealing performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of the needle tube structure of the double-chamber prefilled syringe of the present invention;

[0035] FIG2 is a schematic diagram of the structure of the rubber gasket of the present invention;

[0036] Figure 3 is a schematic diagram of the structure of the Luer lock adapter of the present invention;

[0037] Figure 4 It is a schematic diagram of the structure of the protective cap assembly of the present invention;

[0038] Figure 5 is a schematic diagram of the structure of the intermediate piston of the present invention;

[0039] Figure 6 It is a schematic diagram of the push rod piston structure of the present invention;

[0040] Figure 7 It is a schematic diagram of the combination of the medicine outlet sealing member of the present invention;

[0041] Figure 8 Schematic diagram of the sterile powder after packaging according to the present invention;

[0042] Fig. 9 This is a schematic diagram of the sterile powder after packaging according to the present invention;

[0043] Fig.10 It is a schematic diagram after the solvent filling is completed according to the present invention. DETAILED DESCRIPTION

[0044] In order to explain the technical solution disclosed by the present invention in detail, a further introduction is given below in conjunction with the accompanying drawings of the specification.

[0045] The structure of the double-chamber prefilled syringe with equal-diameter channels provided by the present invention is shown in FIG. Figure 1 to Figure 7 shown.

[0046] like Figure 1 As shown, the needle tube 1 of the double-chamber prefilled syringe includes a flange inlet 101, a flange 102, a cylindrical syringe 103, an inner wall flow channel 104, a limiting groove 105, an auxiliary cone surface 106 and a drug outlet 107.

[0047] As shown in FIG. 2 , the rubber gasket 2 includes an inner wall 201 , an outer wall 202 and an optional barrier film 203 .

[0048] like Figure 3 As shown, the Luer lock adapter 3 includes an annular buckle 301 , an inner wall 302 , a mechanical sealing structure 303 , an inner thread 304 , a Luer cone 305 and a Luer lock medicine outlet 306 .

[0049] like Figure 4 As shown, the protective cap assembly 4 includes an elastomeric plug 401 , a hard outer shell 402 and an external thread 403 .

[0050] like Figure 5 As shown, the intermediate piston 5 includes a sealing ring 501 and a push surface 502 .

[0051] like Figure 6 As shown, the push rod piston 6 includes a sealing ring 601 and a connecting thread 602 .

[0052] like Figure 7 As shown, the protective cap assembly 4 is connected to the internal thread 304 of the Luer lock adapter via the external thread 403, and the outer wall 202 of the rubber gasket 2 is tightly fixed to the inner wall 302 of the Luer lock adapter by elastic deformation.

[0053] like Figure 8 to Figure 10 As shown, firstly, the intermediate piston 5 is installed by mechanical plugging, then the sterile powder 7 is filled, and after the rubber gasket 2, the Luer lock adapter 3 and the protective cap assembly 4 are assembled, the Luer lock adapter annular buckle 301 is fixed to the limiting groove 105 under the guidance of the auxiliary cone 106 by pressing, at which time the rubber gasket 2 is pressed by the mechanical sealing structure 303, and the protective cap assembly 4 seals the Luer lock drug outlet 306, and the chamber near the drug outlet 107 forms a good seal. Then, the double-chamber prefilled syringe 1 is turned over, the solvent 8 is filled from the flange inlet 101, and the push rod piston 6 is installed by mechanical plugging, and the chamber away from the drug outlet 107 forms a good seal.

[0054] Specifically, the needle tube 1 of the double-chamber prefilled syringe with equal diameter provided by the present invention has a flange inlet 101 at the proximal end and a drug outlet 107 at the distal end, a cylindrical syringe 103 extends between the flange inlet 101 and the drug outlet 107, a concave bypass flow channel 104 is provided on the inner wall of the cylindrical syringe 103, an auxiliary cone 106 is provided on the outer wall of the cylindrical syringe near the drug outlet 107, and a limiting groove 105 is provided below the auxiliary cone 106. The diameter of the drug outlet 107 is equal to the diameter of the inner wall of the cylindrical syringe.

[0055] The rubber gasket 2 is in contact with the end face of the drug outlet 107 on the needle tube 1, and its upper end face is in contact with the mechanical sealing structure 303 of the Luer lock adapter 3. The mechanical sealing structure 303 is used to achieve a snap-fit ​​seal by applying pressure during the pre-filling process. The drug outlet 107 of the syringe 103 includes a groove, which can also provide certain installation assistance and precise positioning.

[0056] When the rubber gasket 2 is in a free state, the diameter of the inner wall 201 is larger than the inner diameter of the double-chamber prefilled syringe needle tube 1, and the diameter of the outer wall 202 is larger than the inner wall diameter of the Luer lock adapter 3. Preferably, the outer wall 202 of the rubber gasket 2 has a certain taper (as shown in FIG. 2 (a)), and further cooperates with the inner wall 201 to form a barrier membrane 203 with microporous channels (as shown in FIG. 2 (b)), so as to prevent the sterile powder from leaking into the drug outlet of the Luer lock adapter 3 before administration, thereby ensuring the full dissolution of the sterile powder.

[0057] The Luer lock adapter 3 is connected to the limiting groove 105 of the needle tube 1 through the annular buckle 301, and the mechanical sealing structure 303 is used to compact the rubber gasket 2 and close to the end face of the drug outlet 107 of the needle tube 1 to achieve sealing, and the internal thread 304 of the Luer lock adapter 3 is connected to the external thread 403 of the protective cap assembly 4, so that the elastomer rubber 401 is close to the Luer cone, and the Luer lock adapter 3 and the drug outlet 107 are sealed. Preferably, the annular buckle 301 is a three-claw buckle or a four-claw buckle. The mechanical sealing structure 303 of the Luer lock adapter 3 is a multi-segment spherical convex point or a full-ring convexity distributed in an annular manner.

[0058] The sealing members for sealing the first medicine chamber near the medicine outlet 107 and the second medicine chamber far from the medicine outlet 107 are respectively called the intermediate piston 5 and the push rod piston 6. The intermediate piston 5 and the push rod piston 6 are both tightly attached to the inner wall of the syringe 1 through elastic deformation, and the push rod piston 6 is connected to the push rod through the connecting thread 602. When in use, the push rod is pushed to drive the push rod piston 6 to move toward the medicine outlet 107. After the push rod piston 6 contacts the push surface of the intermediate piston 5, they move toward the medicine outlet 107 together under the push of the push rod until the drug is administered.

Claims

1. A double-chamber prefilled syringe with equal-diameter channels, characterized in that: The double-chamber prefilled syringe comprises a syringe (103), wherein the interior of the syringe (103) is divided into a first medicine chamber and a second medicine chamber by an intermediate piston (5), and the lower part of the second medicine chamber is sealed by a push rod piston (6); a recessed bypass flow channel (104) is provided on the inner wall of the syringe (3), and the first medicine chamber and the second medicine chamber can be communicated through the cooperation of the inner wall flow channel (104) and the intermediate piston (5); The first medicine cavity is close to the medicine outlet (107), and the diameter of the medicine outlet (107) is equal to the diameter of the inner wall of the syringe (103); A limiting groove (105) and an auxiliary conical surface (106) are provided on the syringe (103) near the medicine outlet (107); the Luer lock adapter (3) is fixed at the medicine outlet (107) via the limiting groove (105) and the auxiliary conical surface (106); and the external thread (403) in the protective cap assembly (4) is connected via the internal thread (304) on the Luer lock adapter (3); The protective cap assembly (4) is used for sealing the Luer lock adapter (3).

2. The double-chamber prefilled syringe with equal-diameter channels according to claim 1, characterized in that: The end surface of the drug outlet (107) is in contact with a rubber gasket (2), and the upper end surface of the rubber gasket (2) is in contact with the mechanical sealing structure (303) of the Luer lock adapter (3). In a free state, the inner wall diameter of the rubber gasket (2) is greater than the inner diameter of the needle tube (1), and the outer wall diameter of the rubber gasket (2) is greater than the inner wall diameter of the Luer lock adapter; The Luer lock adapter (3) is connected to the limiting groove (105) of the syringe (103) via an annular buckle (301), and the rubber gasket (2) is pressed against the end face of the drug outlet of the syringe (1) via a mechanical sealing structure (303) to achieve sealing. The internal thread (304) of the Luer lock adapter (3) is connected to the external thread (403) of the protective cap assembly (4) so ​​that the elastomeric rubber plug (401) is in close contact with the Luer cone (305), thereby achieving sealing of the Luer lock adapter (3) on the drug outlet (107).

3. The double-chamber prefilled syringe with equal-diameter channels according to claim 2, characterized in that: The outer wall (202) of the rubber gasket (2) is conical, and the inner wall (201) thereof includes a barrier membrane (203) having a microporous channel, which is used to prevent the sterile powder from leaking into the drug outlet of the Luer lock adapter (3) before administration, while ensuring the full dissolution of the sterile powder.

4. The double-chamber prefilled syringe with equal-diameter channels according to claim 3, characterized in that: The mechanical sealing structure (303) of the Luer lock adapter (3) is a plurality of spherical protrusions or a full ring of protrusions distributed in an annular shape.

5. The double-chamber prefilled syringe with equal-diameter channels according to claim 2, characterized in that: The annular buckle (301) may be configured as a three-claw buckle or a four-claw buckle.

6. The double-chamber prefilled syringe with equal-diameter channels according to claim 1, characterized in that: The needle tube (1) of the double-chamber prefilled syringe comprises borosilicate glass, polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, cycloolefin copolymer, cycloolefin polymer and cycloolefin block polymer; The material of the rubber gasket (2) includes polyisoprene, brominated butyl rubber, chlorobutyl rubber, fluororubber and thermoplastic elastomer, and the hardness ranges from 20 to 80HA; The material of the Luer lock adapter (3) includes polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate, and acrylonitrile-styrene-butadiene copolymer; The material of the hard shell (402) of the protective cap assembly (4) includes polypropylene, polyethylene, polystyrene, polycarbonate, polymethyl methacrylate and acrylonitrile-butadiene-styrene copolymer; the material of the elastomer plug (401) includes polyisoprene, brominated butyl rubber, chlorinated butyl rubber, fluororubber and thermoplastic elastomer, and the hardness ranges from 20 to 80HA; The materials of the intermediate piston (5) and the push rod piston (6) include polyisoprene, brominated butyl rubber, chlorinated butyl rubber, fluororubber and thermoplastic elastomer, and the hardness ranges from 20 to 80 HA.

7. The double-chamber prefilled syringe with equal-diameter channels according to claim 1, characterized in that: The length of the inner wall flow channel (104) is greater than the thickness of the middle piston (5).

8. The double-chamber prefilled syringe with equal-diameter channels according to claim 1, characterized in that: The two ends of the syringe (103) are provided with a medicine outlet (107) and a flange inlet (101) with equal diameters, and a flange (102) is provided at the flange inlet (101).

9. A method for prefilling a double-chamber prefilled syringe with equal-diameter channels, characterized in that: The method includes the following steps for pre-filling the drug: First, the drug outlet (107) of the double-chamber prefilled syringe faces upward, and the middle piston (5) is installed on the drug outlet (107) by mechanical plugging. Then, sterile powder is dispensed from the drug outlet (107) to complete the prefilling of the first drug chamber. Then, the sealing components including the rubber gasket (2), the Luer lock adapter (3) and the protective cap component (4) are pressed into place by the lower pressure plate layer. Then, the double-chamber prefilled syringe is turned over, with the drug outlet (107) facing downward, and the solvent is filled from the flange inlet (101) to complete the prefilling of the second drug chamber. Finally, the flange inlet (101) is installed with a push rod piston (6) by mechanical plugging to complete the double-chamber prefilling of the drug.

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