Prefilled Syringes

Abstract

A pre-filled syringe 1 according to the present invention comprises an outer cylinder 2, a gasket 3, a plunger 4, and a medical agent 9 placed in the outer cylinder 2. The outer cylinder 2 has a flange part 6 positioned at the rear end part thereof. The plunger 4 comprises a gasket pressing part 43 and a shaft part 41 extending in the direction rearward of the gasket pressing part 43. The shaft part comprises indicator parts 45a, 45b, 45c, 45d that are positioned on the rear end side from the gasket pressing part and can be recognized by visual observation of the appearance. The indicator parts are positioned within the flange part 6 of the outer cylinder 2 in the state where the plunger is attached to the gasket 3.

Description

[Technical Field]

[0001] The present invention relates to a pre-filled syringe in which the plunger is attached to a gasket. [Background technology]

[0002] A prefilled syringe contains a sterile drug inside, and is administered to a patient by inserting the syringe directly into the patient's body, injecting the drug into a medical container, or attaching the syringe to a syringe pump. Prefilled syringes include those in which the plunger is not attached to the gasket but is attached when the syringe is used, and those in which the plunger is attached to the gasket in advance.

[0003] Prefilled syringes with a gasket attached to a plunger are manufactured by filling a drug into an outer cylinder with a sealed tip opening in a sterile environment under reduced pressure (vacuum atmosphere), placing a gasket on the opening of the outer cylinder, and then inserting the gasket into the outer cylinder by restoring the pressure to normal. This is called vacuum stoppering. The plunger is then attached to the gasket. If the plunger is already attached to the gasket, it is difficult to place the gasket into the opening of the outer cylinder, so the above-mentioned stoppering operation is performed with the gasket alone. For this reason, pre-filled syringes generally require subsequent plunger attachment. Furthermore, prefilled syringes generally have a label attached to the outer surface of the barrel that lists the name of the drug, the amount of drug, etc., and the label often makes it impossible to visually see the gasket position.

[0004] Patent Document 1 (JP-A-8-504354) discloses a pre-filled syringe. The pre-filled syringe of Patent Document 1 uses a plunger shown in Figures 3, 8, and 10. The plunger shown in the figures has four disk-shaped portions that can be inserted into the outer cylinder. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special table 8-504354 (WO94-013340, USP5370621, USP5472431) Summary of the Invention [Problem to be solved by the invention]

[0006] In Patent Document 1, the plunger has four disk-shaped portions around the longitudinal axis, and in FIG. 11, three disk-shaped portions are positioned inside the outer cylinder. For example, in the state shown in Figure 11, if the third disk-shaped portion is exposed from the barrel, it means that the gasket has moved rearward from the state in which it was positioned inside the syringe, but there is no recognition of this in Cited Document 1, and even if the third disk-shaped portion is not exposed from inside the syringe body, the gasket may have moved back from the state in which it was positioned inside the syringe. Furthermore, the four disk-shaped portions have the same shape, and even if the third disk-shaped portion is exposed from the barrel, a user would not recognize this as meaning that the gasket has moved back from the state in which it was positioned inside the syringe.

[0007] The gasket may retract before use. This is thought to be primarily due to unnecessary plunger retraction by the user immediately before administration. Plunger retraction (gasket retraction) may also occur due to deviations from environmental conditions, such as the temperature environment during manufacturing, transportation, and storage of the prefilled syringe.

[0008] When the plunger retracts, in other words, when the gasket retracts beyond a certain level, negative pressure is generated inside the syringe, and air may flow into the liquid medicine in the prefilled syringe from between the gasket and the outer cylinder, potentially contaminating the liquid medicine.

[0009] An object of the present invention is to provide a pre-filled syringe in which the plunger is attached to a gasket, and in which retraction of the plunger beyond an acceptable level can be easily and reliably visually confirmed. [Means for solving the problem]

[0010] The above objectives are achieved by the following: A pre-filled syringe comprising an outer cylinder, a gasket slidably housed in the outer cylinder, a plunger for pressing the gasket, a sealing member for sealing a tip end of the outer cylinder, and a drug housed in the outer cylinder, The outer cylinder has a hollow main body portion and a flange portion provided at a rear end portion, the flange portion of the outer cylinder is formed by an outer cylinder flange provided at the rear end portion of the hollow main body portion and an attachment member attached to the rear end side of the outer cylinder flange, Furthermore, the mounting member has a plunger insertion notch extending from a side portion to a center portion, the gasket includes a plunger tip mounting portion; the plunger includes a gasket pressing portion provided at a tip end of the plunger, a shaft portion extending rearward from the gasket pressing portion, and a pressing operation portion provided at a rear end of the shaft portion, the shaft portion includes an indicator portion that is visually recognizable on the rear end side of the gasket pressing portion, the shaft portion extends in the axial direction of the plunger, and has a unique outer shape portion or a unique outer surface portion whose outer surface has a different surface condition from other portions, the unique outer shape portion being a flat vertex portion, an inclined portion, a recessed portion, a protruding portion or a tapered portion whose outer surface has a different shape from other portions, and the indicator portion is formed by the unique outer shape portion or the unique outer surface portion, The plunger is attached to the gasket, The prefilled syringe comprises: When the plunger is attached to the gasket, the indicator portion is The mounting member Located within The mounting memberA part of the indicator portion is visible from the side of the plunger insertion notch. The remaining part of the indicator part is not visible to the naked eye, and In the pre-filled syringe, the rearward movement of the plunger can be confirmed when the indicator portion including the remaining portion is exposed behind the mounting member of the flange portion and can be visually recognized by appearance. Prefilled syringe. The above objectives are also achieved by the following: A pre-filled syringe comprising an outer cylinder, a gasket slidably housed in the outer cylinder, a plunger for pressing the gasket, a sealing member for sealing a tip end of the outer cylinder, and a drug housed in the outer cylinder, The outer cylinder has a hollow main body portion and a flange portion provided at a rear end portion, the gasket includes a plunger tip mounting portion; the plunger includes a gasket pressing portion provided at a tip end of the plunger, a shaft portion extending rearward from the gasket pressing portion, and a pressing operation portion provided at a rear end of the shaft portion, the shaft portion includes an indicator portion that is visually recognizable on the rear end side of the gasket pressing portion, the shaft portion extends in the axial direction of the plunger, and has a unique outer shape portion or a unique outer surface portion whose outer surface has a different surface condition from other portions, the unique outer shape portion being a flat vertex portion, an inclined portion, a recessed portion, a protruding portion or a tapered portion whose outer surface has a different shape from other portions, and the indicator portion is formed by the unique outer shape portion or the unique outer surface portion, The plunger is attached to the gasket, The prefilled syringe comprises: When the plunger is attached to the gasket, the indicator portion is located within the flange portion of the outer cylinder and is not visible to the naked eye; and In the prefilled syringe, the indicator portion is exposed behind the flange portion, and when the indicator portion can be visually recognized by appearance, the backward movement of the plunger can be confirmed. Prefilled syringe. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a front view of a pre-filled syringe according to an embodiment of the present invention. [Figure 2] FIG. 2 is a partial cross-sectional view taken along line AA in FIG. [Figure 3] FIG. 3 is a rear view of the pre-filled syringe shown in FIG. [Figure 4] FIG. 4 is a perspective view of the pre-filled syringe shown in FIG. 1 as viewed from the bottom end side. [Figure 5]FIG. 5 is a front view of a plunger used in the pre-filled syringe shown in FIG. [Figure 6] FIG. 6 is a cross-sectional view taken along line BB in FIG. [Figure 7] FIG. 7 is a perspective view of the plunger shown in FIG. [Figure 8] FIG. 8 is a vertical cross-sectional view of a gasket used in the pre-filled syringe shown in FIG. [Figure 9] FIG. 9 is an explanatory diagram of the outer cylinder used in the pre-filled syringe shown in FIG. [Figure 10] FIG. 10 is a front view of a pre-filled syringe according to another embodiment of the present invention. [Figure 11] FIG. 11 is a partial cross-sectional view taken along line CC in FIG. [Figure 12] FIG. 12 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 13] FIG. 13 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 14] FIG. 14 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 15] FIG. 15 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 16] FIG. 16 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 17] FIG. 17 is a front view of another example of a plunger used in the pre-filled syringe of the present invention. [Figure 18] FIG. 18 is a right side view of the plunger shown in FIG. [Figure 19] FIG. 19 is a plan view of the plunger shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0012] Hereinafter, the pre-filled syringe will be described using the embodiment shown in the drawings. As shown in Figures 1 to 4, the prefilled syringe 1 of the present invention comprises an outer cylinder 2, a gasket 3 slidably housed within the outer cylinder 2, a plunger 4 for pressing the gasket 3, a sealing member 5 for sealing the tip of the outer cylinder 2, and a drug 9 housed within the outer cylinder 2. The outer tube 2 has a flange portion 6 located at the rear end, the gasket 3 has a plunger tip portion mounting portion 35, and the plunger 4 has a gasket mounting tip portion 42, a gasket pressing portion 43 provided at the rear end of the gasket mounting tip portion 42, a shaft portion 41 extending toward the rear end from the gasket pressing portion 43, and a pressing operation portion 44 provided at the rear end of the shaft portion 41. The shaft portion is provided with indicator portions 45a, 45b, 45c, and 45d that can be recognized visually from the outside, located rearward of the gasket pressing portion 43, and the plunger 4 is attached to the gasket 3. When the plunger 4 is attached to the gasket 3, the indicator portions 45a, 45b, 45c, and 45d are located within the flange portion 6 of the outer tube 2 and cannot be recognized visually from the outside, and when the plunger is retracted, they are exposed behind the flange portion and can be recognized visually from the outside. In other words, in this pre-filled syringe, the indicator portion is exposed behind the flange portion, and when it can be visually recognized from the appearance, the rearward movement of the plunger can be confirmed.

[0013] 1 to 4, the prefilled syringe 1 of the present invention comprises an outer cylinder 2, a gasket 3 slidably housed in the outer cylinder 2, a plunger 4 for pressing the gasket 3, a sealing member 5 for sealing the tip of the outer cylinder 2, and a drug 9 housed in the outer cylinder 2. Note that in Fig. 2, the outer cylinder and the sealing member are shown in cross section along line AA in Fig. 1, and the plunger and the gasket are shown in external appearance. In the prefilled syringe 1 of this embodiment, the plunger 4 can be attached to the gasket 3 by rotating it, and when the plunger 4 becomes loose relative to the gasket 3, the looseness can be eliminated by rotating the plunger.

[0014] In this embodiment, the outer cylinder 2 comprises an outer cylinder main body 20 and an attachment member 60 attached to the rear end of the outer cylinder main body 20, as shown in FIGS. The outer cylinder body 20 has a hollow body portion 21, a hollow tip portion 22 extending from the tip portion of the hollow body portion 21, and an outer cylinder flange 24 provided at the rear end portion of the hollow body portion 21. In this embodiment, the mounting member 60 is fixed to the outer cylinder flange 24, and the two together form the flange portion 6. Specifically, the mounting member 60 is fixed to the bottom surface of the flange 24 of the outer cylinder body 20. The mounting member 60 is not limited to this type, and may be one that clamps the flange 24.

[0015] In the prefilled syringe 1 of this embodiment, the mounting member 60 has retaining portions 64a and 64b for preventing the plunger 4 from coming out of the outer tube 2. The plunger 4 has a disk-shaped gasket pressing portion 43, which can come into contact with the retaining portions 64a and 64b of the mounting member 60 and has a function of preventing the plunger 4 from coming out.

[0016] The outer cylinder body 20 includes a hollow tip portion 22 having an opening at its tip, a lock adapter 8 that encloses the nozzle portion of the hollow tip portion 22, a hollow main body portion 21, and a flange 24 provided at the base end of the hollow main body portion 21. The nozzle portion is capable of being connected to other medical devices (e.g., injection needles, connectors, three-way stopcocks). The lock adapter 8 has a threaded portion on its inner surface that can be threadedly engaged with a medical device that will be connected to the nozzle portion (e.g., a rib or threaded portion formed on the flange of an injection needle, connector, three-way stopcock, etc.). The hollow main body portion 21 of the outer tube main body 20 is formed in a cylindrical shape with a relatively small diameter, and in this first embodiment, it is intended to be filled with a small amount (specifically, 0.5 ml to 2 ml) of medicinal solution, etc., and the outer diameter of the hollow main body portion 21 is 6 to 12 mm.

[0017] The outer tube flange 24 has an arc-shaped outer edge formed to protrude from the entire circumference of the base end of the hollow main body 21 in a direction perpendicular to the central axis of the hollow main body 21. The flange 24 also has four recesses 26a, 26b, 26c, and 26d, as shown in Fig. 9. The mounting member 60 is provided on the upper surface of the plate-like portion 61, as shown in Fig. 9, and has four protrusions 62a, 62b, 62c, and 62d that fit into the four recesses of the flange 24. The mounting member 60 is mounted to the flange 24 of the outer tube main body 20 by the above-mentioned protrusions fitting into the recesses.

[0018] The mounting member 60 also has a plunger insertion notch 63 extending from the outer side toward the center, and the width of the plunger insertion notch 63 is smaller than the outer diameter of the gasket pressing portion 43 of the plunger 4. The opposing inner edge portions of the plunger insertion notch 63 form retaining portions 64a, 64b. As a result, when the plunger 4 moves rearward, the gasket pressing portion 43 abuts against the retaining portions 64a, 64b, preventing further backward movement and separation from the outer tube.

[0019] The hollow tip portion 22 has a smaller diameter than the outer diameter of the hollow main body portion 21 and tapers toward the tip. The hollow tip portion 22 has a tip opening at its tip for discharging a medicinal solution or the like from inside the outer cylinder. The hollow tip portion 22 also has a locking rib at its base end (slightly toward the tip side from the tip of the hollow main body portion 21) that can lock the lock adapter 8. In this embodiment, the locking rib is an annular rib.

[0020] The lock adapter 8 is a cylindrical member, and is attached to the hollow tip portion 22 of the outer tube main body 20. The lock adapter 8 is held at its lower part by a locking rib provided on the hollow tip portion 22. The lock adapter 8 also has an adapter-side threaded portion that can be threadedly engaged with a sealing member-side threaded portion of the sealing member (cap) 5, which will be described later. In this first embodiment, the threaded portion is formed by two spiral ribs. The sealing member 5 has a main body 51 having a lower hollow portion that houses the nozzle portion of the hollow tip 22, and a seal member 52 that is housed in the main body 51 and located at the upper end of the lower hollow portion. In addition, a sealing member-side screw portion is formed on the outer surface of the lower hollow portion.

[0021] Examples of materials for forming the outer cylinder body 20 include various resins such as polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyesters such as polyethylene terephthalate, cyclic polyolefin polymers, and cyclic olefin copolymers, among which resins such as polypropylene, cyclic polyolefin polymers, and cyclic olefin copolymers are preferred because they are easy to mold and have heat resistance. Note that cyclic olefin polymers and cyclic olefin copolymers are particularly preferred as materials for forming the outer cylinder body 20 because they are highly transparent so that the medicinal solution filled inside can be visually confirmed from the outside and have heat resistance that can withstand high-pressure steam sterilization.

[0022] The lock adapter 8 is preferably made of a hard resin such as polyvinylidene fluoride, polypropylene, polycarbonate, or polyamide. The mounting member 60, the sealing member 5, and the plunger 4 (described later) are preferably made of a hard or semi-hard resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate. The sealing member 52 is preferably made of an elastic material such as synthetic rubber, such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, fluororubber, or silicone rubber, or a thermoplastic elastomer, such as an olefin-based elastomer or a styrene-based elastomer. The gasket 3 comprises a gasket body 31 having a closed tip portion 33, an open rear end portion, an inner cavity portion extending from the open rear end portion toward the tip side, and an inner cavity side screw portion (helical recess, plunger tip portion mounting portion) 35 provided on the inner surface of the inner cavity portion.

[0023] The gasket 3 is housed within the base end of the outer cylinder body 20, specifically at a position a predetermined length toward the tip end from the base end opening of the outer cylinder body 20. The distance between the base end of the gasket 3 and the base end of the outer cylinder body 20 is preferably 10 to 25 mm.

[0024] 1 and 2, the gasket 3 of this embodiment comprises a cylindrical main body portion extending with approximately the same outer diameter and a tapered closing portion extending from the main body portion toward the tip. The outer surface of the main body portion is formed with a plurality of annular ribs (three in this embodiment, but any number greater than two may be used as long as liquid-tightness and sliding properties are satisfied). These ribs come into liquid-tight contact with the inner surface of the outer cylindrical body 20.

[0025] The gasket 3 is provided with a recess inside the cylindrical main body portion that extends from the rear end opening toward the tip. This recess is capable of accommodating a gasket mounting portion (gasket mounting tip portion) 42 of the plunger 4. Furthermore, a gasket side threaded portion (plunger tip portion mounting portion) 35 is formed on the inner surface of the recess (inner surface of the cylindrical main body). The gasket side threaded portion 35 can be threadedly engaged with a plunger side threaded portion formed on the outer surface of the gasket mounting portion 42 of the plunger 4. As the two thread together, the plunger 4 will not come off the gasket 3.

[0026] It is preferable to use elastic rubber (e.g., butyl rubber, latex rubber, silicone rubber, etc.), synthetic resin (e.g., styrene-based elastomers such as SBS elastomer and SEBS elastomer, olefin-based elastomers such as ethylene-α-olefin copolymer elastomer, etc.) as the material for forming the gasket 3.

[0027] The tip portion of the gasket body may also be coated with a substance having low drug adsorption properties. The low drug adsorption layer can be made of any known material that has been conventionally used in laminate gaskets. Examples of materials for the low drug adsorption layer include polyolefin resins, fluorine-based resins, and polyester resins. Specifically, preferred polyolefin resins include polypropylene, ultra-high molecular weight polyethylene, poly(4-methylpentene-1), and cyclic polyolefins, while preferred fluorine-based resins include tetrafluoroethylene-perfluoroethoxyethylene copolymers, polytetrafluoroethylene, tetrafluoroethylene / perfluoroalkyl vinyl ether copolymers, and tetrafluoroethylene / hexafluoropropylene copolymers.

[0028] It is also preferable to apply a lubricant to the outer surface of the gasket body 31, at least to the surfaces of the front annular rib 36 and the rear annular rib 37. A lubricant may also be applied to the inner surface of the outer cylinder. Silicone oil is a suitable lubricant. Alternatively, a lubricant such as silicone oil may be omitted by providing a silicone resin layer formed by solidification on the surface of the gasket body, or a layer made of the above-mentioned ultra-high molecular weight polyethylene or fluorine-based resin.

[0029] As shown in FIGS. 1 to 7, 18 and 19, plunger (syringe pusher) 4 includes a gasket mounting portion 42 provided at the upper end, a gasket pressing portion 43 located at the lower end of gasket mounting portion 42, a shaft portion 41 extending downward from gasket pressing portion 43, and a pressing operation portion 44 provided near the rear end of shaft portion 41. The gasket mounting portion 42 is a protrusion provided at the tip of the plunger 4 and is capable of entering the inner cavity 34 of the gasket 3. The gasket mounting portion 42 protrudes from near the center of the disk-shaped gasket pressing portion 43 toward the tip. The gasket mounting portion 42 is preferably a cylindrical portion, but may also be a rod-shaped portion. The gasket mounting portion 42 may also be a cylindrical portion having a cross-shaped reinforcing portion on the inside.

[0030] The outer surface of the gasket mounting portion 42 is provided with a plunger-side threaded portion that threadably engages with the gasket-side threaded portion 35 formed on the inner surface of the lumen portion 34 of the gasket 3. The plunger-side threaded portion is formed by a spiral rib. In this embodiment, two spiral ribs are provided to correspond to the spiral threaded portion of the gasket 3. The spiral rib may be only one. In the pre-filled syringe of this embodiment, the gasket 3 and the plunger 4 are both attached to each other by rotating the plunger 4. The gasket pressing portion 43 is a plate-like portion having a substantially circular shape, and has a diameter slightly smaller than the inner diameter of the outer cylinder body 20. The gasket mounting portion 42 is provided so that its center is positioned on the central axis of the gasket pressing portion 43.

[0031] The shaft portion 41 is formed from three or more (four in this embodiment) flat plate portions extending rearward from the gasket pressing portion 43 and parallel to the central axis of the plunger 4. As shown in FIGS. 1 to 7, 18, and 19, and particularly FIG. 6, the shaft portion 41 of this embodiment is formed from four flat plate portions extending radially at equal angles (specifically, at 90-degree intervals) with respect to the central axis of the shaft portion 41. Furthermore, as shown in FIG. 6, the shaft portion 41 of this embodiment has an axial reinforcing portion extending the entire length of each flat plate portion at the joint of each flat plate portion. Therefore, the shaft portion 41 has a thick central portion, in other words, a thick shaft axis.

[0032] A pressing operation portion 44 is provided at the rear end of the shaft portion 41. The pressing operation portion 44 is formed in a disk shape and is used as a plunger pressing portion. The pressing operation portion 44 in this embodiment is disk-shaped and has a larger diameter than the disk-shaped gasket pressing portion 43 described above.

[0033] In this embodiment, the shaft portion 41 is provided with four quarter-circle reinforcing portions 46, which are disk-shaped and located midway along the shaft portion 41, specifically, closer to the tip end than the center. Therefore, each flat plate portion has tip-side flat plate portions 41a, 41b, 41c, and 41d and rear-side flat plate portions 41e, 41f, 41g, and 41h. The tip-side flat plate portion 41a and the rear-side flat plate portion 41e are aligned on the same straight line, and similarly, the tip-side flat plate portion 41b and the rear-side flat plate portion 41f, the tip-side flat plate portion 41c and the rear-side flat plate portion 41g, and the tip-side flat plate portion 41d and the rear-side flat plate portion 41h are also aligned on the same straight line.

[0034] In other words, the reinforcing portion 46 divides each flat plate portion into front-end flat plate portions 41a, 41b, 41c, and 41d and rear-end flat plate portions 41e, 41f, 41g, and 41h. The rear-end flat plate portions 41e, 41f, 41g, and 41h extend from the rear ends (reinforcing portion 46) of the front-end flat plate portions 41a, 41b, 41c, and 41d in parallel to the central axis of the plunger to the pressing operation portion 44. In this embodiment, the front-end flat plate portions 41a, 41b, 41c, and 41d are thicker than the rear-end flat plate portions 41e, 41f, 41g, and 41h.

[0035] The tip-side flat plate portions 41a, 41b, 41c, and 41d have a relatively large predetermined thickness and extend rearward from the gasket pressing portion 43 in parallel with the central axis of the plunger 4. The shaft portion 41 is provided with indicator portions 45a, 45b, 45c, and 45d that are located rearward of the gasket pressing portion 43 and forward of the reinforcing portion 46 and that can be visually recognized by external inspection.

[0036] The indicator portion can be formed by a unique contour portion that is visible because it has a different shape from the other portions of the shaft portion (specifically, the flat plate portion), a unique outer surface portion that is visible because it has a different surface condition from the other portions of the shaft portion (specifically, the flat plate portion), etc. The indicator portion may also be formed by a unique contour portion and a unique outer surface portion that have a different surface condition and shape from the other portions of the shaft portion.

[0037] In this embodiment, the indicator portions 45a, 45b, 45c, and 45d are formed by inclined portions formed on the outer surface of the shaft portion, specifically, on the outer surface of the tip-side flat portion 41a, 41b, 41c, and 41d. Furthermore, in this embodiment, the indicator portions (unique contour portions) 45a, 45b, 45c, and 45d include a vertex plane portion extending in the axial direction of the plunger 4 and inclined side portions provided on both sides of the vertex plane portion.

[0038] This makes it easy to see the indicator portions 45a, 45b, 45c, and 45d. In this embodiment, the tip-side flat portions 41a, 41b, 41c, and 41d each have a vertex plane and inclined side surfaces on both sides of the vertex plane over their entire length. Alternatively, only the indicator portions 45a, 45b, 45c, and 45d may have a vertex plane extending in the axial direction of the plunger 4 and inclined side surfaces on both sides of the vertex plane.

[0039] The inclination angle of indicator portions 45a, 45b, 45c, and 45d relative to the central axis of plunger 4 is preferably 6 to 27 degrees, and particularly preferably 9 to 22 degrees. The axial length of the plunger of the indicator portion is preferably 1 to 6 mm, and particularly preferably 2 to 6 mm. The axial length of the plunger of the indicator portion is preferably the allowable plunger travel distance, in other words, the plunger travel distance that does not affect sterility maintenance.

[0040] In the prefilled syringe 1 of the present invention, if unnecessary movement of the gasket occurs before the administration operation, the indicator portions 45a, 45b, 45c, and 45d are located behind the flange portion 6 and are visible behind the flange portion 6. This allows the administration operator to grasp the possibility of movement of the gasket 3. In particular, if the entire indicator portions 45a, 45b, 45c, and 45d are located behind the flange portion 6 and are visible, the amount of movement of the gasket is large, air may flow into the outer cylinder 2 from the side of the gasket 3, and sterility may not be maintained, and this possibility can be easily grasped.

[0041] In the prefilled syringe 1 of this embodiment, the plunger 4 and the gasket 3 are connected by screwing. There is a possibility that the plunger 4 may move backward due to loosening of the attachment of the plunger 4 to the gasket 3 (specifically, loosening of the screwing). Therefore, by rotating the plunger 4, when the indicator portions 45a, 45b, 45c, and 45d are housed within the flange portion 6, it can be confirmed that the gasket 3 has not moved back unnecessarily.

[0042] In the prefilled syringe 1 of this embodiment, the plunger 4 is attached to the gasket 3, and the indicator portions 45a, 45b, 45c, and 45d are entirely located within the flange portion 6 of the outer cylinder 2 when the plunger 4 is attached to the gasket 3. The rear ends of the indicator portions 45a, 45b, 45c, and 45d are located at the same position as the rear end of the flange portion 6 of the outer cylinder 2 or slightly inside.

[0043] Furthermore, in the prefilled syringe 1 of this embodiment, as described above, the flange portion 6 is formed by the mounting member 60 fixed to the outer tube flange 24, and the mounting member 60 has a plunger insertion notch 63 extending from the side to the center of the mounting member 60. In the plunger insertion notch 63, not the entire indicator portion but a portion of the entire indicator portion, specifically, a portion of the indicator portion 45d, is visible. However, the remaining indicator portions 45a, 45b, and 45c are not visible. Therefore, the presence of the indicator portion can be recognized by the visible indicator portion 45d, and the absence of unnecessary movement of the gasket can be easily recognized by the invisibility of the remaining indicator portions 45a, 45b, and 45c. Furthermore, as described above, in this prefilled syringe, if unnecessary movement of the gasket occurs before the administration operation, indicator portions 45a, 45b, 45c, and 45d are located behind flange portion 6 and are visible behind flange portion 6. This allows the administration operator to grasp the possibility of movement of gasket 3. In other words, in this prefilled syringe, the indicator portion including the remaining portion described above is exposed behind the mounting member of the flange portion, and the backward movement of the plunger can be confirmed when it can be visually recognized by appearance.

[0044] Furthermore, the prefilled syringe 1 of this embodiment is provided with a label 27 attached to the outer surface of the outer cylinder 2, and the gasket 3 is made invisible by the label 27. For this reason, it is not possible to visually check whether the gasket has moved in this prefilled syringe 1. However, by providing the indicator portion described above in the prefilled syringe 1 of this embodiment, it is possible to visually check for unnecessary backward movement of the gasket 3, even if the gasket 3 itself is not visible.

[0045] The medicinal solution 9 filled in the space formed by the outer cylinder body 20, the gasket 3, and the sealing member 5 may be any medicinal agent, but examples thereof include medicinal solutions such as cyclosporine, benzodiazepine drugs, sodium chloride injections, vitamins, minerals, and even powdered or freeze-dried or liquid medicines such as antibiotics and protein preparations.

[0046] In addition, as the pre-filled syringe of the present invention, the outer tube 2a may not have an attachment member, as in the pre-filled syringe 1a shown in Figures 10 and 11. In the pre-filled syringe 1a of this embodiment, the flange portion is formed by the flange 24a of the outer tube 2a. Note that Figure 11 shows a cross section of the outer tube and the sealing member along line CC in Figure 10, and the plunger and gasket show their appearance.

[0047] The only differences between the pre-filled syringe 1a of this embodiment and the above-described pre-filled syringe 1 are the presence or absence of an attachment member and the positioning of the gasket 3 and plunger 4 slightly toward the tip of the outer cylinder. The rest is the same as the above-described pre-filled syringe 1.

[0048] In the prefilled syringe 1a of this embodiment, the plunger 4 is also attached to the gasket 3, and the entire indicator portions 45a, 45b, 45c, and 45d are located within the flange 24a of the outer cylinder 2a when the plunger 4 is attached to the gasket 3. The rear ends of the indicator portions 45a, 45b, 45c, and 45d are located at the same position as or slightly inside the rear end of the flange 24a of the outer cylinder 2a. All of the indicator portions 45a, 45b, 45c, and 45d are invisible due to the flange 24a of the outer cylinder 2a.

[0049] In the prefilled syringe 1a of this embodiment, the tips or tip portions of the indicator portions 45a, 45b, 45c, and 45d may be visible from the outer surface of the outer cylinder 2a at the base end (boundary with the flange 24a) of the hollow main body portion 21 of the outer cylinder 2a. In this case, the presence of the indicator portions can be recognized, and since the parts other than the tip portions of the indicator portions 45a, 45b, 45c, and 45d are not visible, it can be easily recognized that there is no unnecessary movement of the gasket.

[0050] The indicator portion in the pre-filled syringe of the present invention may have a form similar to that provided on the plunger 4a shown in FIG. The indicator portions 48a, 48b, 48c, and 48d (not shown) provided on the plunger 4a of this embodiment are, similar to the indicator portions 45a, 45b, 45c, and 45d described above, uniquely shaped portions that are visible because the indicator portions have a different shape from the other portions of the shaft portion (specifically, the flat portion).

[0051] In this embodiment, indicator portions (unique contour portions) 48a, 48b, 48c, 48d (not shown) are formed by recesses extending a predetermined length from the apex of each flat plate toward the base end of the flat plate, and the recesses are particularly rectangular. The depth of the recesses is preferably 0.3 to 0.6 mm, and more preferably 0.4 to 0.5 mm.

[0052] Furthermore, indicator portions 48a, 48b, 48c, and 48d (not shown) are slightly inclined, but the inclination angle is much gentler than that of indicator portions 45a, 45b, 45c, and 45d described above, and the recesses are more noticeable than the inclination. The plunger 4a of this embodiment differs from the plunger 4 described above only in the form of the indicator portion and the shapes of the distal end side flat plate portions 41a, 41b, 41c, and 41d located proximal to the indicator portion.

[0053] The indicator portion in the pre-filled syringe of the present invention may be in the form of a portion provided on the plunger 4b shown in FIG. The indicator portions 49a, 49b, 49c, and 49d (not shown) provided on the plunger 4b of this embodiment are, similar to the indicator portions 45a, 45b, 45c, and 45d described above, uniquely shaped portions that are visible because the indicator portions have a different shape from the other portions of the shaft portion (specifically, the flat portion).

[0054] In this embodiment, indicator portions (unique contour portions) 49a, 49b, 49c, 49d (not shown) are formed by recesses extending a predetermined length from the apex of each flat portion toward the base end of the flat portion, and in particular, the recesses have arc-shaped undersides. The depth of the recesses is preferably 0.3 to 0.6 mm, and more preferably 0.4 to 0.5 mm.

[0055] Furthermore, indicator portions 49a, 49b, 49c, and 49d (not shown) are slightly inclined, but the inclination angle is much gentler than that of indicator portions 45a, 45b, 45c, and 45d described above, and the recesses are more noticeable than the inclination. The plunger 4b of this embodiment differs from the plunger 4 described above only in the form of the indicator portion and the shapes of the distal end side flat plate portions 41a, 41b, 41c, and 41d located proximal to the indicator portion.

[0056] The indicator portion in the pre-filled syringe of the present invention may be in the form of a plunger 4c shown in FIG. The indicator portion 47 of the plunger 4c of this embodiment is formed by a unique outer surface portion that is visible due to its surface condition being different from that of the rest of the shaft portion. The indicator portion 47 (unique outer surface portion) can be formed by a strip-shaped colored portion, a roughened portion, or a patterned portion formed on the outer surface of the shaft portion. The width of the strip-shaped indicator portion 47 (unique outer surface portion) (axial length of the plunger 4c) is preferably 1 to 6 mm, and particularly preferably 2 to 6 mm.

[0057] The colored portion is preferably a color that is easily identifiable and can be recognized as a warning indication, for example, a red color is preferable, but yellow, blue, etc. are also acceptable. The rough surface portion may be an embossed surface, a knurled surface, a surface with multiple ribs, etc. The patterned surface may be various patterns, checkered patterns, wave patterns, etc. The plunger 4c of this embodiment differs from the plunger 4 described above only in the form of the indicator portion and the shapes of the distal end side flat plate portions 41a, 41b, 41c, and 41d located proximal to the indicator portion.

[0058] The indicator portion in the pre-filled syringe of the present invention may be in the form of a plunger 4d shown in FIG. The indicator portion 47 of the plunger 4d of this embodiment is formed by both a unique outer shape portion that is visible because it has a different shape from the rest of the shaft portion, and a unique outer surface portion that is visible because it has a different surface condition. The indicator portion 47 can be suitably made of the above-mentioned materials.

[0059] The plunger 4d of this embodiment has the same indicator portions (unique outer surface portions) 45a, 45b, 45c, and 45d as the plunger 4 described above, and also has a band-shaped indicator portion 47 (unique outer surface portion) that the plunger 4c described above has at the locations where the indicator portions (unique outer surface portions) 45a, 45b, 45c, and 45d are provided, making it easier to recognize the indicator portions.

[0060] The indicator portion in the pre-filled syringe of the present invention may be in the form of a plunger 4e shown in FIG. The indicator portion 47 of the plunger 4e of this embodiment is formed by both a unique outer shape portion that is visible because it has a different shape from the rest of the shaft portion, and a unique outer surface portion that is visible because it has a different surface condition. The indicator portion 47 can be suitably made of the above-mentioned materials.

[0061] The plunger 4e of this embodiment includes indicator portions (unique contour portions) 49a, 49b, 49c, and 49d (not shown) similar to those of the plunger 4b described above. Each of the indicator portions (unique contour portions) 49a, 49b, 49c, and 49d (not shown) is formed by a recess extending from the apex of each flat portion toward the base end of the flat portion for a predetermined length. In particular, the recess has an arc-shaped underside. The recess may also be rectangular. While the indicator portions 49a, 49b, 49c, and 49d (not shown) are slightly inclined, the inclination is much gentler than the inclination of the indicator portions 45a, 45b, 45c, and 45d described above, making the recess more noticeable than the inclination.

[0062] The plunger 4e of this embodiment has the same indicator portions (unique outer surface portions) 49a, 49b, 49c, and 49d (not shown) as the plunger 4b described above, and also has the band-shaped indicator portion 47 (unique outer surface portion) provided on the plunger 4c described above at the locations where the indicator portions (unique outer surface portions) 49a, 49b, 49c, and 49d (not shown) are provided, making it easier to recognize the indicator portions.

[0063] The indicator portion in the pre-filled syringe of the present invention may be in the form of a plunger 4f shown in FIG. The indicator portion 47 of the plunger 4f of this embodiment is formed by both a unique outer shape portion that is visible because it has a different shape from the other portions of the shaft portion, and a unique outer surface portion that is visible because it has a different surface condition. As the indicator portion 47, the above-mentioned ones can be suitably used.

[0064] The plunger 4f of this embodiment is provided with indicator portions (unique outer shape portions) 45a, 45b, 45c, and 45d (not shown) similar to those of the plunger 4 described above. Furthermore, the upper surfaces of the indicator portions (unique outer shape portions) 45a, 45b, 45c, and 45d (not shown) are made into a unique outer surface portion like the indicator portion 47. This makes it easier to recognize the indicator portions. As the unique outer surface portion, any of the patterns described above, such as a colored portion, a roughened portion, or a patterned portion, can be used. [Industrial Applicability]

[0065] The pre-filled syringe of the present invention is as follows. (1) a plunger attached to the gasket; a sealing member that seals the tip of the outer cylinder; and a drug contained in the outer cylinder; wherein the outer cylinder has a flange portion provided at a rear end, the gasket has a plunger tip portion attachment portion, the plunger has a gasket pressing portion provided at the tip of the plunger, a shaft portion that extends rearward from the gasket pressing portion, and a pressing operation portion provided at the rear end of the shaft portion, the shaft portion has an indicator portion that can be recognized by visual inspection, rearward of the gasket pressing portion, the plunger is attached to the gasket, and the indicator portion is located within the flange portion of the outer cylinder when the plunger is attached to the gasket and cannot be recognized by visual inspection, and when the plunger is retracted, it is exposed behind the flange portion and can be recognized by visual inspection.

[0066] In this prefilled syringe, when the plunger attached to the gasket moves rearward beyond the allowable level, the indicator located within the flange of the outer cylinder is exposed to the outside from the rear end of the flange of the outer cylinder and is easily visible. Therefore, by visually checking the indicator, the user can easily recognize that the gasket has moved beyond the allowable level and that air may have entered the medicine, in other words, that the medicine may have been contaminated.

[0067] The above embodiment may also be as follows. (2) The prefilled syringe according to (1) above, wherein the prefilled syringe has a label attached to the outer surface of the outer cylinder, and the gasket is made invisible by the label. (3) A prefilled syringe according to (1) or (2) above, wherein the flange portion of the outer tube is formed by an outer tube flange provided at the rear end of the hollow main body portion and an attachment member attached to the rear end side of the outer tube flange. (4) A prefilled syringe as described in (3) above, wherein the mounting member has a plunger insertion notch extending from the side of the mounting member to the center, and a portion of the indicator portion is visible in the plunger insertion notch. (5) The pre-filled syringe according to any one of (1) to (4) above, wherein the axial length of the plunger of the indicator part is 1 to 6 mm. (6) A prefilled syringe according to any one of (1) to (5) above, wherein the indicator portion is formed by a unique outer shape portion that is visible because it has a shape different from that of the other portions of the shaft portion. (7) A prefilled syringe according to any one of (1) to (5) above, wherein the indicator portion is formed by a unique outer surface portion that is visible due to a surface condition different from that of the other portions of the shaft portion. (8) A pre-filled syringe according to any one of (1) to (6) above, wherein the indicator portion is an inclined portion, a recessed portion, a protruding portion or a tapered portion formed on the outer surface of the shaft portion. (9) A prefilled syringe according to any one of (1) to (5) above, wherein the indicator portion is a colored portion, a roughened portion, or a patterned portion formed on the outer surface of the shaft portion. (10) A prefilled syringe according to any one of (1) to (9) above, wherein the indicator portion is formed by a visually recognizable irregularly shaped portion that has a surface condition and shape different from those of the other portions of the shaft portion.

Claims

1. A pre-filled syringe comprising an outer cylinder, a gasket slidably housed in the outer cylinder, a plunger for pressing the gasket, a sealing member for sealing a tip end of the outer cylinder, and a drug housed in the outer cylinder, The outer cylinder has a hollow main body portion and a flange portion provided at a rear end portion, the flange portion of the outer tube is formed by an outer tube flange provided at the rear end of the hollow main body and an attachment member attached to the rear end side of the outer tube flange, and the attachment member further includes a plunger insertion notch extending from a side portion to a center portion, the gasket includes a plunger tip mounting portion; the plunger includes a gasket pressing portion provided at a tip end of the plunger, a shaft portion extending rearward from the gasket pressing portion, and a pressing operation portion provided at a rear end of the shaft portion, the shaft portion includes an indicator portion that is visually recognizable on the rear end side of the gasket pressing portion, the shaft portion extends in the axial direction of the plunger, and has a unique outer shape portion or a unique outer surface portion whose outer surface has a different surface condition from other portions, the unique outer shape portion being a flat vertex portion, an inclined portion, a recessed portion, a protruding portion or a tapered portion whose outer surface has a different shape from other portions, and the indicator portion is formed by the unique outer shape portion or the unique outer surface portion, The plunger is attached to the gasket, In the prefilled syringe, when the plunger is attached to the gasket, the indicator portion is located within the attachment member of the flange portion of the outer cylinder, and a part of the indicator portion is visible from the side of the plunger insertion notch of the attachment member, while the remaining part of the indicator portion cannot be recognized by visual inspection of the exterior, and The prefilled syringe is characterized in that the backward movement of the plunger can be confirmed when the indicator portion including the remaining portion is exposed behind the mounting member of the flange portion and can be recognized visually by appearance.

2. A pre-filled syringe comprising an outer cylinder, a gasket slidably housed in the outer cylinder, a plunger for pressing the gasket, a sealing member for sealing a tip end of the outer cylinder, and a drug housed in the outer cylinder, The outer cylinder has a hollow main body portion and a flange portion provided at a rear end portion, the gasket includes a plunger tip mounting portion; the plunger includes a gasket pressing portion provided at a tip end of the plunger, a shaft portion extending rearward from the gasket pressing portion, and a pressing operation portion provided at a rear end of the shaft portion, the shaft portion includes an indicator portion that is visually recognizable on the rear end side of the gasket pressing portion, the shaft portion extends in the axial direction of the plunger, and has a unique outer shape portion or a unique outer surface portion whose outer surface has a different surface condition from other portions, the unique outer shape portion being a flat vertex portion, an inclined portion, a recessed portion, a protruding portion or a tapered portion whose outer surface has a different shape from other portions, and the indicator portion is formed by the unique outer shape portion or the unique outer surface portion, The plunger is attached to the gasket, In the pre-filled syringe, when the plunger is attached to the gasket, the indicator portion is located within the flange portion of the outer cylinder and cannot be recognized visually from the outside, and The pre-filled syringe is characterized in that the indicator portion is exposed behind the flange portion, and when the indicator portion can be visually recognized by appearance, the rearward movement of the plunger can be confirmed.

3. A prefilled syringe as described in claim 1 or 2, wherein the indicator portion is formed by the unique outer shape portion, and the unique outer shape portion is formed by the apex plane portion.

4. A prefilled syringe as described in Claim 3, wherein the unique outer shape portion is formed by the apex plane portion, and further, the unique outer shape portion has inclined side portions provided on both sides of the apex plane portion.

5. A prefilled syringe as described in claim 1 or 2, wherein the indicator portion is formed by the unique outer surface portion, and the unique outer surface portion is formed by a colored portion, a rough surface portion or a pattern-retaining portion formed on the outer surface of the flat portion of the shaft portion.

6. A prefilled syringe as described in claim 1 or 2, wherein the indicator portion is formed by a unique outer shape portion and a unique outer surface portion that has a surface condition and shape different from those of other portions.

7. A prefilled syringe as described in claim 1, wherein the shaft portion is provided with a plurality of the indicator portions, and when the plunger is attached to the gasket, one indicator portion is visible from the side of the plunger insertion notch of the attachment member, and the other indicator portions are not visible by visual inspection.

8. A prefilled syringe as described in any one of claims 1 to 7, wherein the shaft portion has three or more flat plate portions extending rearward from the gasket pressing portion, and the outer surface of each of the flat plate portions has the unique outer shape portion or the unique outer surface portion formed thereon.

9. 9. The pre-filled syringe according to claim 1, wherein the axial length of the plunger of the indicator portion is 1 to 6 mm.

10. 10. The pre-filled syringe according to claim 1, wherein the pre-filled syringe includes a label attached to an outer surface of the outer cylinder, and the gasket is made invisible by the label.

Images