Prefilled syringe

Abstract

The pre-filled syringe (1) of the present application has an outer cylinder (2), a gasket (3), a push rod (4), and a medicament (9) housed in the outer cylinder (2). The outer cylinder (2) has a flange portion (6) at the rear end portion. The push rod (4) has a gasket push portion (43) and a shaft portion (41) extending from the gasket push portion (43) toward the rear end direction. The shaft portion has, at a position on the rear end side compared with the gasket push portion, mark portions (45a), (45b), (45c), (45d) that can be recognized by visually observing the appearance, the mark portions being located in the flange portion (6) of the outer cylinder (2) in a state in which the push rod is mounted to the gasket (3).

Description

Technical Field

[0001] This invention relates to a pre-filled syringe with a push rod mounted on a gasket. Background Technology

[0002] The pre-filled syringe contains the medication in a sterile state beforehand. Furthermore, the pre-filled syringe is administered to the patient through procedures such as direct puncture, injection into a medical container, or attachment to an infusion pump.

[0003] As a pre-filled syringe, it also includes a type in which the plunger is not installed on the gasket but is installed when in use, and a type in which the plunger is pre-installed on the gasket.

[0004] Pre-filled syringes with an insert rod mounted on the gasket use a so-called vacuum insert method to insert the gasket. This method involves filling the outer barrel, whose front opening is sealed, with medication in a sterile and reduced-pressure atmospheric environment (vacuum atmospheric environment). The gasket is then positioned at the opening of the outer barrel, and the pressure is adjusted to normal, thereby inserting the gasket into the outer barrel. The syringe is then manufactured by mounting the insert rod onto the gasket.

[0005] For types where the plunger is already installed on the washer, the aforementioned plunger insertion is performed using the washer alone because configuring the washer into the opening of the outer barrel is difficult. Therefore, as a pre-filled syringe, subsequent plunger installation is usually required.

[0006] In addition, pre-filled syringes usually have a label on the outer surface of the outer barrel that records the drug name, dosage, etc., and the gasket position is often not visible to the naked eye because the label cannot be seen.

[0007] Patent Document 1 (Japanese Patent Application Publication No. 8-504354) discloses a pre-filled syringe. The pre-filled syringe in Patent Document 1 uses... Figure 3 , Figure 8 as well as Figure 10 The push rod shown in the diagram has four disc-shaped parts that can be inserted into the outer cylinder.

[0008] Existing technical documents

[0009] Patent documents

[0010] Patent Document 1: Japanese Patent Application No. 8-504354 (WO94-013340, USP5370621, USP5472431)

[0011] In the invention of Patent Document 1, the push rod has four disc-shaped portions around an axis along its long side. Figure 11 In the middle, three disc-shaped parts are located inside the outer cylinder.

[0012] For example in Figure 11In the illustrated state, with the three-eyed disc-shaped portion protruding from the outer cylinder, it indicates that the gasket has moved rearward compared to its position within the syringe. However, this is not the case in cited reference 1. Even if the three-eyed disc-shaped portion is not protruding from the syringe body, there is still a possibility that the gasket has moved backward compared to its position within the syringe. Furthermore, since all four disc-shaped portions are of the same shape, even if the three-eyed disc-shaped portion protrudes from the outer cylinder, the user would not be able to discern that the gasket has moved backward compared to its position within the syringe.

[0013] Furthermore, the washer may sometimes retract before use. The main reason for this is likely unnecessary push rod retraction caused by the user before dispensing. In addition, push rod retraction (washer retraction) may also occur due to separation from environmental conditions such as temperature during the manufacturing, transportation, and storage of the pre-filled syringe.

[0014] When the push rod retracts, in other words, when the washer retracts beyond a certain level, a negative pressure is generated inside the syringe, which may cause air to flow into the pre-filled syringe's liquid from between the washer and the outer barrel, contaminating the liquid. Summary of the Invention

[0015] The purpose of this invention is to provide a pre-filled syringe in which, in a pre-filled syringe with a plunger mounted on a gasket, the retraction of the plunger beyond the permissible level can be easily and reliably visually confirmed.

[0016] The pre-filled syringe that achieves the above objectives is as follows.

[0017] A pre-filled syringe has an outer barrel, a washer slidably housed within the outer barrel, a push rod for pressing the washer, a sealing member for sealing the front end of the outer barrel, and a drug contained within the outer barrel. In the pre-filled syringe, the outer barrel has a flange portion at its rear end, the washer has a push rod front end mounting portion, the push rod has a washer pressing portion at its front end, a shaft portion extending from the washer pressing portion toward the rear end, and a pressing operation portion at the rear end of the shaft portion. The shaft portion has a marking portion that can be recognized by visual observation at a position relative to the rear end of the washer pressing portion. The push rod is mounted on the washer, and the marking portion is located within the flange portion of the outer barrel when the push rod is mounted on the washer, and cannot be recognized by visual observation. However, when the push rod is retracted, it is exposed behind the flange portion and can be recognized by visual observation. Attached Figure Description

[0018] Figure 1 This is a front view of a pre-filled syringe according to an embodiment of the present invention.

[0019] Figure 2 yes Figure 1 A partial sectional view along line AA.

[0020] Figure 3 yes Figure 1 The rear view of the pre-filled syringe is shown.

[0021] Figure 4 Viewed from the bottom side Figure 1 The diagram shows a three-dimensional view of a pre-filled syringe.

[0022] Figure 5 yes Figure 1 The front view of the plunger used in the pre-filled syringe is shown.

[0023] Figure 6 yes Figure 5 BB line section view.

[0024] Figure 7 yes Figure 5 The push rod shown is a 3D diagram.

[0025] Figure 8 yes Figure 1 The image shows a longitudinal sectional view of the gasket used in the pre-filled syringe.

[0026] Figure 9 yes Figure 1 The diagram shown illustrates the outer barrel used in the pre-filled syringe.

[0027] Figure 10 This is a front view of a pre-filled syringe according to another embodiment of the present invention.

[0028] Figure 11 yes Figure 10 A partial sectional view along the CC line.

[0029] Figure 12 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0030] Figure 13 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0031] Figure 14 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0032] Figure 15 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0033] Figure 16 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0034] Figure 17 This is a front view of the plunger of another example used in the pre-filled syringe of the present invention.

[0035] Figure 18 yes Figure 5 The right-side view of the push rod shown.

[0036] Figure 19 yes Figure 5 The push rod shown is shown in top view. Detailed Implementation

[0037] The following description uses the embodiments shown in the accompanying drawings to illustrate pre-filled syringes.

[0038] like Figures 1 to 4 As shown, the pre-filled syringe 1 of the present invention has an outer cylinder 2, a washer 3 slidably housed within the outer cylinder 2, a push rod 4 for pressing the washer 3, a sealing member 5 for sealing the front end of the outer cylinder 2, and a medicine 9 housed within the outer cylinder 2.

[0039] The outer cylinder 2 has a flange portion 6 located at the rear end, the washer 3 has a push rod front end mounting portion 35, the push rod 4 has a washer mounting front end portion 42, a washer pushing portion 43 located at the rear end of the washer mounting front end portion 42, a shaft portion 41 extending from the washer pushing portion 43 toward the rear end, and a pushing operation portion 44 located at the rear end of the shaft portion 41.

[0040] The shaft portion has markings 45a, 45b, 45c, and 45d at a position on the rear end side compared to the washer pressing portion 43, which can be recognized by visual observation. The push rod 4 is installed on the washer 3. When the push rod 4 is installed on the washer 3, the markings 45a, 45b, 45c, and 45d are located inside the flange portion 6 of the outer cylinder 2 and cannot be recognized by visual observation. However, when the push rod is retracted, they are exposed behind the flange portion and can be recognized by visual observation.

[0041] like Figures 1 to 4 As shown, the pre-filled syringe 1 of the present invention includes an outer cylinder 2, a washer 3 slidably housed within the outer cylinder 2, a push rod 4 for pressing the washer 3, a sealing member 5 for sealing the front end of the outer cylinder 2, and a medicine 9 housed within the outer cylinder 2. Furthermore, Figure 2 In the middle, represented by cross-section Figure 1 The outer cylinder and sealing components at the AA line are shown, along with the appearance of the push rod and washer.

[0042] In the pre-filled syringe 1 of this embodiment, the plunger 4 can be installed on the washer 3 by rotating the plunger 4. In addition, when the plunger 4 is loose relative to the washer 3, the looseness can be eliminated by rotating the plunger.

[0043] In this embodiment, as Figures 1 to 4 as well as Figure 9 As shown, the outer cylinder 2 consists of an outer cylinder body 20 and a mounting component 60 installed at the rear end of the outer cylinder body 20.

[0044] The outer cylinder body 20 has a hollow main body portion 21, a hollow front end portion 22 extending from the front end portion of the hollow main body portion 21, and an outer cylinder flange 24 provided at the rear end portion of the hollow main body portion 21. In this embodiment, the mounting component 60 is fixed to the outer cylinder flange 24, forming a flange portion 6 through both sides.

[0045] Specifically, the mounting component 60 is fixed to the bottom part of the flange 24 of the outer cylinder body 20. The mounting component 60 is not limited to this type and may also be of the type that clamps the flange 24.

[0046] In the pre-filled syringe 1 of this embodiment, the mounting component 60 has anti-detachment parts 64a and 64b to prevent the push rod 4 from falling off the outer cylinder 2. The push rod 4 has a disc-shaped washer pressing part 43, which can abut against the anti-detachment parts 64a and 64b of the mounting component 60, thus having the function of preventing the push rod 4 from falling off.

[0047] The outer cylinder body 20 has a hollow front end portion 22 with an opening at the front end, a locking connector 8 that covers the mouth portion of the hollow front end portion 22, a hollow body portion 21, and a flange 24 provided at the base end of the hollow body portion 21. The mouth portion is a part that can be connected to other medical devices (e.g., injection needles, connectors, three-way valves). The locking connector 8 has a threaded portion on its inner surface that can be threaded to medical devices (e.g., ribs or threaded portions formed on the flange of injection needles, connectors, three-way valves, etc.) that are connected to the mouth portion.

[0048] The hollow main body 21 of the outer cylinder body 20 is formed into a cylindrical shape with a relatively small diameter. In this first embodiment, it is filled with a small amount (specifically 0.5 ml to 2 ml) of liquid medicine, etc., and the outer diameter of the hollow main body 21 is 6 to 12 mm.

[0049] The outer cylinder flange 24 has an arc-shaped outer edge that protrudes vertically from the base end of the hollow main body 21 along its entire outer periphery relative to the central axis of the hollow main body. Additionally, as... Figure 9 As shown, flange 24 has four recesses 26a, 26b, 26c, and 26d. Furthermore, as... Figure 9 As shown, the mounting member 60 has four protrusions 62a, 62b, 62c, and 62d provided on the upper surface of the plate-shaped portion 61 and engaging with four recesses of the flange 24. Furthermore, the mounting member 60 is mounted to the flange 24 of the outer cylinder body 20 by engaging the aforementioned protrusions with the recesses.

[0050] Furthermore, the mounting component 60 has a push rod insertion notch 63 extending from the outer side towards the center, the width of which is smaller than the outer diameter of the washer pressing portion 43 of the push rod 4. Anti-detachment portions 64a and 64b are formed on the inner edge facing the push rod insertion notch 63. Therefore, when the push rod 4 moves rearward, the washer pressing portion 43 abuts against the anti-detachment portions 64a and 64b, restricting further backward movement and detachment from the outer cylinder.

[0051] The hollow front end portion 22 has a diameter smaller than the outer diameter of the hollow main body portion 21, and its diameter tapers towards the front end. The hollow front end portion 22 has a front opening at its front end for discharging liquid medicine or the like from the outer cylinder. Furthermore, the hollow front end portion 22 has a locking rib at its base end (slightly towards the front end compared to the front end of the hollow main body portion 21) capable of locking the locking connector 8. In this embodiment, the locking rib is an annular rib.

[0052] Furthermore, the locking connector 8 is a cylindrical component installed at the hollow front end 22 of the outer cylinder body 20. Additionally, the locking connector 8 is held in its lower portion by a locking rib provided at the hollow front end 22. Moreover, the locking connector 8 has a connector-side threaded portion capable of engaging with the 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 helical ribs.

[0053] The sealing member 5 has a main body 51 and a closing member 52. The main body 51 has a lower hollow portion that houses the mouth portion of the hollow front end 22. The closing member 52 is housed within the main body 51 and disposed at the upper end of the lower hollow portion. In addition, a sealing member side threaded portion is formed on the outer surface of the lower hollow portion.

[0054] Examples of resins that can be used to form the outer cylinder body 20 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly-(4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene block copolymer, polyethylene terephthalate, polyesters, cyclic polyolefin polymers, and cyclic olefin copolymers. However, even among these, resins such as polypropylene, cyclic polyolefin polymers, and cyclic olefin copolymers are preferred from the perspective of ease of molding and heat resistance. Furthermore, cyclic olefin polymers and cyclic olefin copolymers that have high transparency, allowing the internal liquid medicine to be visually inspected from the outside, and heat resistance capable of withstanding high-pressure steam sterilization are particularly preferred as the forming material of the outer cylinder body 20.

[0055] As the forming material of the locking connector 8, rigid resins such as polyvinylidene chloride, polypropylene, polycarbonate, and polyamide are preferably used. As the forming material of the mounting component 60, the sealing component 5, and the push rod 4 (described later), rigid or semi-rigid resins such as high-density polyethylene, polypropylene, polystyrene, and polyethylene terephthalate are preferably used.

[0056] The forming material of the closed component 52 is preferably an elastic material such as synthetic rubber (e.g., natural rubber, isoprene rubber, butyl rubber, butadiene rubber, fluororubber, silicone rubber, etc.), or thermoplastic elastomer (e.g., olefin elastomer, styrene elastomer, etc.).

[0057] The washer 3 has a washer body 31, which has a closed front end 33, an open rear end, an inner cavity extending from the open rear end to the front end, and an inner cavity side threaded part (spiral recess, push rod front end mounting part) 35 provided on the inner surface of the inner cavity.

[0058] The washer 3 is housed within the base end of the outer cylinder body 20, specifically within a position near the front end of the opening at the base end of the outer cylinder body 20 by a predetermined length. The distance between the base end of the washer 3 and the base end of the outer cylinder body 20 is preferably 10–25 mm.

[0059] like Figure 1 as well as Figure 2 As shown, the washer 3 in this embodiment has a cylindrical main body extending with almost the same outer diameter and a conical closed portion extending from the main body towards the front end. Furthermore, multiple annular ribs are formed on the outer surface of the main body (in this embodiment, any number of three, two, or more is acceptable as long as they satisfy both liquid tightness and sliding properties). These ribs are in liquid-tight contact with the inner surface of the outer cylinder body 20.

[0060] Furthermore, the washer 3 has a recess located inside the cylindrical main body and extending from the rear opening towards the front. This recess can accommodate the washer mounting portion (wasp mounting front end) 42 of the push rod 4. Moreover, a washer-side threaded portion (push rod front end mounting portion) 35 is formed on the inner surface of the recess (the inner surface of the cylindrical main body). The washer-side threaded portion 35 can be threaded with the push rod-side threaded portion formed on the outer surface of the washer mounting portion 42 of the push rod 4. With both threads engaged, the push rod 4 will not detach from the washer 3.

[0061] As the forming material of gasket 3, elastic rubber (such as butyl rubber, natural rubber, silicone rubber, etc.) and synthetic resin (such as styrene elastomers such as SBS elastomer and SEBS elastomer, olefin elastomers such as ethylene-α olefin block copolymer elastomer, etc.) are preferred.

[0062] Alternatively, a low-absorption agent substance can be coated onto the front side of the gasket body.

[0063] As the material for the low drug adsorption layer, known materials conventionally used in laminated gaskets can be used. Examples of materials for the low drug adsorption layer include polyolefin resins, fluorinated resins, and polyester resins. Specifically, as polyolefin resins, polypropylene, ultra-high molecular weight polyethylene, poly(4-methylpentene-1), cyclic polyolefins, etc., are preferred; as fluorinated resins, tetrafluoroethylene-perfluoroethyl vinyl ether block copolymers, polytetrafluoroethylene, tetrafluoroethylene / perfluoroalkyl vinyl ether block copolymers, tetrafluoroethylene / hexafluoropropylene block copolymers, etc., are preferred.

[0064] Furthermore, it is preferable to coat the outer surface of the gasket body 31 with a lubricant, at least on the surfaces of the front annular rib 36 and the rear annular rib 37. Alternatively, the lubricant can be coated on the inner surface of the outer cylinder. Silicone oil is preferred as the lubricant. Alternatively, a layer of silicone resin formed by curing on the surface of the gasket body and a layer composed of ultra-high molecular weight polyethylene or fluoropolymer resin can be provided, thereby eliminating the need for lubricants such as silicone oil.

[0065] like Figures 1 to 7 , Figure 18 as well as Figure 19 As shown, the push rod (syringe pusher) 4 has a washer mounting portion 42 at the upper end, a washer pushing portion 43 at the lower end of the washer mounting portion 42, a shaft portion 41 extending downward from the washer pushing portion 43, and a pushing operation portion 44 provided near the rear end of the shaft portion 41.

[0066] The washer mounting portion 42 is a protrusion located at the front end of the push rod 4, and can enter the inner cavity 34 of the washer 3. The washer mounting portion 42 protrudes from near the center of the disc-shaped washer pressing portion 43 towards the front end. The washer mounting portion 42 is preferably cylindrical, but it can also be rod-shaped. Alternatively, the washer mounting portion 42 can also be a cylindrical portion with a cross-shaped reinforcing portion on the inside.

[0067] Furthermore, on the outer surface of the washer mounting portion 42, there is a push rod side threaded portion that threads with the washer side threaded portion 35 formed on the inner surface of the inner cavity portion 34 of the washer 3. The push rod side threaded portion is formed by helical ribs. In this embodiment, two helical ribs are formed in a manner corresponding to the helical threaded portion of the washer 3. There may also be only one helical rib. Furthermore, in the pre-filled syringe of this embodiment, the washer 3 and the push rod 4 are mounted by rotating the push rod 4.

[0068] The washer pressing part 43 is a plate-shaped part that is almost circular and has a diameter slightly smaller than the inner diameter of the outer cylinder body 20. The washer mounting part 42 is arranged such that its center is located on the central axis of the washer pressing part 43.

[0069] The shaft portion 41 is formed by three or more (four in this embodiment) flat plate portions extending from the washer pressing portion 43 toward the rear end and parallel to the central axis of the push rod 4. Figures 1 to 7 , Figure 18 as well as Figure 19 As shown, especially as Figure 6 As shown, the shaft portion 41 in this embodiment is formed by four flat plate portions that extend radially at equal angles (specifically, at 90-degree intervals) relative to the central axis of the shaft portion 41. Furthermore, as... Figure 6 As shown, in the shaft portion 41 of this embodiment, an axially reinforcing portion extending along the entire length of the flat plate portion is provided at the joint of each flat plate portion. Therefore, the thickness of the central portion of the shaft portion 41 is large; in other words, it has a thick shaft core.

[0070] A pressing operation part 44 is provided at the rear end of the shaft part 41. The pressing operation part 44 is formed in the shape of a disc and is used as a push rod pressing part. In this embodiment, the pressing operation part 44 is a disc-shaped component with a larger diameter than the disc-shaped washer pressing part 43 described above.

[0071] Furthermore, in this embodiment, there are four disc-shaped, or in other words, quarter-circular, reinforcing portions 46 located midway along the shaft portion 41, specifically at the front end compared to the center. Therefore, each plate portion has front-side plate portions 41a, 41b, 41c, 41d and rear-side plate portions 41e, 41f, 41g, 41h. Moreover, the front-side plate portions 41a and the rear-side plate portions 41e are arranged in a straight line, and similarly, the front-side plate portions 41b and the rear-side plate portions 41f, the front-side plate portions 41c and the rear-side plate portions 41g, and the front-side plate portions 41d and the rear-side plate portions 41h are also arranged in a straight line.

[0072] In other words, the reinforcing part 46 divides each plate portion into front-side plate portions 41a, 41b, 41c, 41d and rear-side plate portions 41e, 41f, 41g, 41h. The rear-side plate portions 41e, 41f, 41g, 41h extend parallel to the central axis of the push rod from the rear end (reinforcing part 46) of the front-side plate portions 41a, 41b, 41c, 41d to the pressing operation part 44. Furthermore, in this embodiment, the front-side plate portions 41a, 41b, 41c, 41d have a greater wall thickness than the rear-side plate portions 41e, 41f, 41g, 41h.

[0073] Furthermore, the front-end flat plates 41a, 41b, 41c, and 41d extend from the washer pressing portion 43 toward the rear-end direction with a specified thickness that is relatively large, and extend parallel to the central axis of the push rod 4.

[0074] Furthermore, the shaft portion 41 has marking portions 45a, 45b, 45c, and 45d that are located at the rear end compared to the washer pressing portion 43 and at the front end compared to the reinforcing portion 46, and can be recognized by visual observation.

[0075] The marking portion can be formed from a special shape portion, a special outer surface portion, etc. The special shape portion can be visually identified by its shape being different from that of the shaft portion (specifically, the flat plate portion), and the special outer surface portion can be visually identified by its surface condition being different from that of the shaft portion (specifically, the flat plate portion). Alternatively, the marking portion can also be formed from both a special shape portion and a special outer surface portion, whose surface condition and shape are different from those of the shaft portion.

[0076] In this embodiment, the marking portions 45a, 45b, 45c, and 45d are formed by inclined portions formed on the outer surface of the shaft portion, specifically on the outer side surfaces of the front end side plate portions 41a, 41b, 41c, and 41d. Furthermore, in this embodiment, the marking portions (special shape portions) 45a, 45b, 45c, and 45d have a vertex plane portion extending along the axial direction of the push rod 4, and inclined side surface portions provided on both sides of the vertex plane portion.

[0077] Therefore, the marking portions 45a, 45b, 45c, and 45d are easily visually identifiable. Furthermore, in this embodiment, the front-end side plate portions 41a, 41b, 41c, and 41d, along their entire length, have a vertex plane portion and inclined side portions provided on both sides of the vertex plane portion. Alternatively, it is also possible that only portions of the marking portions 45a, 45b, 45c, and 45d have a vertex plane portion extending along the axial direction of the push rod 4 and inclined side portions provided on both sides of the vertex plane portion.

[0078] Furthermore, the inclination angle of the marking portions 45a, 45b, 45c, and 45d relative to the central axis of the push rod 4 is preferably 6 to 27 degrees, and more preferably 9 to 22 degrees. Additionally, the axial length of the marking portions along the push rod axis is preferably 1 to 6 mm, and more preferably 2 to 6 mm. Moreover, the axial length of the marking portions along the push rod axis is preferably set to allow for the push rod to move a certain distance; in other words, a push rod movement distance that will not affect the maintenance of sterilization.

[0079] Before dispensing, the pre-filled syringe 1 of the present invention ensures that, in the event of unnecessary movement of the gasket 3, the markings 45a, 45b, 45c, and 45d are located behind the flange 6 and can be visually confirmed from behind the flange 6. This allows the dispenser to monitor the possibility of gasket 3 movement. In particular, if the markings 45a, 45b, 45c, and 45d are all located behind the flange 6 and can be visually confirmed, a large amount of gasket movement could lead to air flowing into the outer cylinder 2 from the side of the gasket 3, resulting in a lack of sterilization; this possibility can be easily monitored.

[0080] Furthermore, in the pre-filled syringe 1 of this embodiment, the connection between the plunger 4 and the washer 3 is based on a screw engagement. There is also a possibility that the plunger may move backward due to loosening of the installation of the plunger 4 onto the washer 3 (specifically, loosening of the screw engagement). Therefore, when the markings 45a, 45b, 45c, and 45d are housed within the flange 6 by rotating the plunger 4, it can be confirmed that no unnecessary backward movement of the washer 3 occurs.

[0081] Furthermore, in the pre-filled syringe 1 of this embodiment, the plunger 4 is mounted on the washer 3, and the marking portions 45a, 45b, 45c, and 45d are entirely located within the flange portion 6 of the outer cylinder 2 when the plunger 4 is mounted on the washer 3. Moreover, the rear ends of the marking 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 inward.

[0082] Furthermore, in the pre-filled syringe 1 of this embodiment, as described above, the flange portion 6 is formed by a mounting member 60 fixed to the outer cylinder flange 24. The mounting member 60 has a push rod insertion notch 63 extending from the side of the mounting member 60 towards the center. Not all markings are visible in the push rod insertion notch 63; rather, only a portion of the markings is visible. Specifically, a portion of the markings 45d is visible in the push rod insertion notch 63. However, the remaining markings 45a, 45b, and 45c are not visible. Therefore, the presence of the markings can be identified by the visible markings 45d, and unnecessary movement of the gasket can be easily detected by the remaining markings 45a, 45b, and 45c.

[0083] Furthermore, in the pre-filled syringe 1 of this embodiment, a label 27 is affixed to the outer surface of the outer cylinder 2, making it impossible to visually identify the gasket 3 due to the label 27. Therefore, it is impossible to visually confirm whether the gasket has moved in this pre-filled syringe 1. However, in the pre-filled syringe 1 of this embodiment, by having the aforementioned marking portion, even if the gasket 3 itself cannot be visually identified, unnecessary rearward movement of the gasket 3 can be visually confirmed.

[0084] The liquid medicine 9, which fills the space formed by the outer cylinder body 20, the gasket 3 and the sealing component 5, can be any medicine, but for example, it can be cyclosporine, benzodiazepines, sodium chloride injection, vitamin preparations, mineral preparations, etc. It can also be powdered or freeze-dried medicines or liquids such as antibiotics and protein preparations.

[0085] In addition, as a pre-filled syringe of the present invention, such as Figure 10 as well as Figure 11 As shown in the pre-filled syringe 1a, the outer barrel 2a may not have mounting parts. In the pre-filled syringe 1a of this embodiment, the flange portion is formed by the flange 24a of the outer barrel 2a. Furthermore, Figure 11 In, represented by cross-section Figure 10 The outer cylinder and sealing components at the CC line indicate the appearance of the push rod and washer.

[0086] The only differences between the pre-filled syringe 1a of this embodiment and the pre-filled syringe 1 described above are the presence or absence of the mounting components, and the fact that the washer 3 and the push rod 4 are slightly located at the front end of the outer cylinder. All other aspects are the same as those of the pre-filled syringe 1 described above.

[0087] Furthermore, in the pre-filled syringe 1a of this embodiment, the plunger 4 is also mounted on the washer 3. With the plunger 4 mounted on the washer 3, the markings 45a, 45b, 45c, and 45d are entirely located within the flange 24a of the outer cylinder 2a. The rear ends of the markings 45a, 45b, 45c, and 45d are located at the same position as the rear end of the flange 24a of the outer cylinder 2a, or slightly inward. Moreover, all the markings 45a, 45b, 45c, and 45d are not visually identifiable due to the flange 24a of the outer cylinder 2a.

[0088] Furthermore, in the pre-filled syringe 1a of this embodiment, the front ends or front portions of the marking portions 45a, 45b, 45c, and 45d can also be located at the base end of the hollow main body portion 21 of the outer cylinder 2a (the boundary portion with the flange 24a), and can be visually confirmed from the outer surface of the outer cylinder 2a. With such a configuration, the presence of the marking portions can be identified, and the marking portions 45a, 45b, 45c, and 45d cannot be visually confirmed except at their front portions. Therefore, it is easy to identify that the gasket has not moved unnecessarily.

[0089] Alternatively, the marking portion in the pre-filled syringe of the present invention may also take the form of... Figure 12 The shape of the push rod 4a shown.

[0090] The marking portions 48a, 48b, 48c, and 48d (not shown) of the push rod 4a in this embodiment are similar to the marking portions 45a, 45b, 45c, and 45d described above. The marking portions are special parts with shapes that can be visually confirmed by means of other parts that are different in shape from the shaft portion (specifically, the flat plate portion).

[0091] Furthermore, in this embodiment, the marking portions (special shapes) 48a, 48b, 48c, and 48d (not shown) are formed by recesses extending from the apex of each plate portion to the base end of the plate portion by a predetermined length, and in particular, the recesses are rectangular. The depth of the recesses is preferably 0.3 to 0.6 mm, and more preferably 0.4 to 0.5 mm.

[0092] In addition, the parts of markings 48a, 48b, 48c, and 48d (not shown) are slightly inclined, but compared with the inclination angle of the markings 45a, 45b, 45c, and 45d mentioned above, they are very gentle, and the concave parts are more obvious than the inclination.

[0093] The only difference between the push rod 4a in this embodiment and the push rod 4 described above is the shape of the marking portion and the shape of the front plate portions 41a, 41b, 41c, and 41d from the base end side of the marking portion.

[0094] Alternatively, the marking portion in the pre-filled syringe of the present invention may also take the form of... Figure 13 The shape of the push rod 4b shown.

[0095] The marking portions 49a, 49b, 49c, and 49d (not shown) of the push rod 4b in this embodiment are similar to the marking portions 45a, 45b, 45c, and 45d described above. The marking portions are special parts of a shape that can be visually confirmed by means of other parts that are different in shape from the shaft portion (specifically, the flat plate portion).

[0096] Furthermore, in this embodiment, the marking portions (special shape portions) 49a, 49b, 49c, and 49d (not shown) are formed by recesses extending from the apex of each plate portion to the base end of the plate portion by a predetermined length. In particular, the recesses are recesses with an arc-shaped lower surface. The depth of the recesses is preferably 0.3 to 0.6 mm, and more preferably 0.4 to 0.5 mm.

[0097] In addition, the parts marked 49a, 49b, 49c, and 49d (not shown) are slightly inclined, but their inclination angles are much gentler than those of the aforementioned parts marked 45a, 45b, 45c, and 45d. The recesses are more noticeable than the inclinations.

[0098] The only difference between the push rod 4b in this embodiment and the push rod 4 described above is the shape of the marking portion and the shape of the front plate portions 41a, 41b, 41c, and 41d from the base end side of the marking portion.

[0099] Furthermore, the shape of the marking portion in the pre-filled syringe of the present invention can be, Figure 14 The shape of the push rod 4c shown.

[0100] The marking portion 47 of the push rod 4c in this embodiment is formed by a special outer surface portion that can be visually identified by means of a surface condition different from other parts of the shaft portion. The marking portion 47 (special outer surface portion) can be formed by a strip of colored portion, rough surface, or patterned portion formed on the outer surface of the shaft portion. The width (axial length of the push rod 4c) of the strip-shaped marking portion 47 (special outer surface portion) is preferably 1 to 6 mm, and more preferably 2 to 6 mm.

[0101] The preferred color for the coloring part is one that is easily recognizable and can be used to display a warning; for example, a red color is preferred, but yellow, blue, etc., are also acceptable. The rough surface can be an embossed surface, a textured surface, a ribbed surface with multiple ribs, etc. The patterned surface can use various patterns, such as checkered patterns, wavy patterns, etc.

[0102] The only difference between the push rod 4c in this embodiment and the push rod 4 described above is the shape of the marking portion and the shape of the front plate portions 41a, 41b, 41c, and 41d from the base end side of the marking portion.

[0103] Alternatively, the marking portion in the pre-filled syringe of the present invention may also take the form of... Figure 15 The shape of the push rod 4d shown.

[0104] The marking portion 47 of the push rod 4d in this embodiment is formed by both a special part of the outer shape that can be visually confirmed by means of other parts that have a different shape from the shaft portion and a special part of the outer surface that can be visually confirmed by means of a different surface condition. The marking portion described above can be appropriately used as the marking portion 47.

[0105] In this embodiment, the push rod 4d has the same marking portions (special shape portions) 45a, 45b, 45c, and 45d as the push rod 4 described above. Furthermore, at the locations where the marking portions (special shape portions) 45a, 45b, 45c, and 45d are provided, it also has the strip-shaped marking portion 47 (special outer surface portion) found in the push rod 4c described above. Therefore, the marking portions are easier to identify.

[0106] Alternatively, the marking portion in the pre-filled syringe of the present invention may also take the form of... Figure 16The shape of the push rod 4e shown.

[0107] The marking portion 47 of the push rod 4e in this embodiment is formed by both a special part of the outer shape that can be visually confirmed by means of other parts that have a different shape from the shaft portion and a special part of the outer surface that can be visually confirmed by means of a different surface condition. The marking portion described above can be appropriately used as the marking portion 47.

[0108] In this embodiment, the push rod 4e has marking portions (special shape portions) 49a, 49b, 49c, and 49d (not shown) that are the same as those in the push rod 4b described above. The marking portions (special shape portions) 49a, 49b, 49c, and 49d (not shown) are formed by recesses extending from the apex of each flat plate portion by a predetermined length toward the base end of the flat plate portion. In particular, the recesses have an arc-shaped lower surface. Alternatively, the recesses may be rectangular. Furthermore, the marking portions 49a, 49b, 49c, and 49d (not shown) are slightly inclined portions, but their inclination angle is much gentler than that of the marking portions 45a, 45b, 45c, and 45d described above; the recesses are more pronounced than the inclination.

[0109] In this embodiment, the push rod 4e has the same marking portions (special shape portions) 49a, 49b, 49c, and 49d (not shown) as the push rod 4b described above. Furthermore, at the locations where the marking portions (special shape portions) 49a, 49b, 49c, and 49d (not shown) are provided, it also has the strip-shaped marking portion 47 (special outer surface portion) found in the push rod 4c described above. Therefore, the marking portions are easier to identify.

[0110] Furthermore, the shape of the marking portion in the pre-filled syringe of the present invention can be, Figure 17 The shape of the push rod 4f shown.

[0111] The marking portion 47 of the push rod 4f in this embodiment is formed by both a special part of the outer shape that can be visually confirmed by means of other parts that have a different shape from the shaft portion and a special part of the outer surface that can be visually confirmed by means of a different surface condition. The marking portion described above can be appropriately used as the marking portion 47.

[0112] In this embodiment, the push rod 4f has the same marking portions (special shape portions) 45a, 45b, 45c, and 45d (not shown) as the push rod 4 described above. Furthermore, the upper surfaces of the marking portions (special shape portions) 45a, 45b, 45c, and 45d (not shown) are special outer surface portions like the marking portion 47. Therefore, the marking portions are easier to identify. All of the aforementioned forms, such as colored portions, roughened surfaces, or pattern-retaining portions, can be used as special outer surface portions.

[0113] Industrial applicability

[0114] The pre-filled syringe of the present invention is as follows.

[0115] (1) A pre-filled syringe having an outer barrel, a washer slidably housed within the outer barrel, a push rod for pressing the washer, a sealing member for sealing the front end of the outer barrel, and a medicine housed within the outer barrel, wherein the outer barrel has a flange portion at a rear end, the washer has a push rod front end mounting portion, the push rod has a washer pressing portion at the front end of the push rod, a shaft portion extending from the washer pressing portion toward the rear end, and a pressing operation portion at the rear end of the shaft portion, the shaft portion having a marking portion at a position relative to the rear end of the washer pressing portion that can be recognized by visual observation, the push rod being mounted on the washer, the marking portion being located within the flange portion of the outer barrel when the push rod is mounted on the washer and cannot be recognized by visual observation, and being exposed behind the flange portion when the push rod is retracted, and being recognizable by visual observation.

[0116] In this pre-filled syringe, if the plunger attached to the gasket moves rearward beyond the permissible range, a marking inside the flange of the outer barrel will protrude from the rear end of the flange, allowing for easy visual confirmation. Therefore, by visually confirming the marking, the user can easily identify the possibility of air entering the medication due to the gasket moving beyond the permissible range; in other words, the user can easily identify the possibility of medication contamination.

[0117] Alternatively, the above-described implementation method can also be as follows.

[0118] (2) In the pre-filled syringe described in (1) above, the pre-filled syringe has a label affixed to the outer surface of the outer cylinder, and the gasket cannot be visually identified by the label.

[0119] (3) In the pre-filled syringe described in (1) or (2) above, the flange portion of the outer cylinder is formed by an outer cylinder flange provided at the rear end of the hollow main body portion and a mounting component installed on the rear end side of the outer cylinder flange.

[0120] (4) In the pre-filled syringe described in (3) above, the mounting component has a push rod insertion notch extending from the side of the mounting component toward the center, and a portion of the marking portion can be visually identified in the push rod insertion notch.

[0121] (5) In any one of (1) to (4) above, the axial length of the marking part in the direction of the push rod is 1 to 6 mm.

[0122] (6) In any one of (1) to (5) above, the marking portion is formed by a special shape portion that can be visually confirmed by means of other portions that are different in shape from the shaft portion.

[0123] (7) In any one of (1) to (5) above, the marking portion is formed by a special portion of the outer surface that can be visually confirmed by means of other portions of the shaft portion with a surface condition different from that of the shaft portion.

[0124] (8) In any one of (1) to (6) above, the marking portion is an inclined portion, a recessed portion, a convex portion or a tapered portion formed on the outer surface of the shaft portion.

[0125] (9) In any one of (1) to (5) above, the marking portion is a colored portion, rough surface or patterned portion formed on the outer surface of the shaft portion.

[0126] (10) In any of the pre-filled syringes described in (1) to (9) above, the marking portion is formed by a visually verifiable irregular shape portion with a surface condition and shape different from other portions of the shaft portion.

Claims

1. A pre-filled syringe comprising an outer barrel, a washer slidably housed within the outer barrel, a push rod for pressing the washer, a sealing member for sealing the front end of the outer barrel, and a pharmaceutical preparation housed within the outer barrel, characterized in that... The outer cylinder has a hollow main body and a flange portion located at the rear end. The flange portion of the outer cylinder is formed by an outer cylinder flange located at the rear end of the hollow main body portion and a mounting component installed on the rear end side of the outer cylinder flange. The washer has a push rod front end mounting portion. The push rod has a washer pressing part at the front end of the push rod, a shaft part extending from the washer pressing part toward the rear end, and a pressing operation part at the rear end of the shaft part. The shaft portion has a marking portion that is visually perceptible at its rear end relative to the washer pressing portion. The push rod is mounted on the washer, and the mounting member has a push rod insertion notch extending from the side of the mounting member towards the center. Multiple markings are provided along the circumference of the shaft. When the push rod is installed on the washer, all of the markings are located inside the flange of the outer cylinder and cannot be recognized by visual observation. Furthermore, when the push rod is retracted, a portion of the markings can be visually confirmed in the push rod insertion notch, while the remaining markings cannot be visually observed. The shaft portion includes a flat plate portion extending from the washer pressing portion toward the rear end. The marking portion is formed on the outer side of the flat plate portion and has a vertex plane portion extending along the axial direction of the push rod.

2. The pre-filled syringe according to claim 1, characterized in that, The pre-filled syringe has a label affixed to the outer surface of the outer cylinder, and the gasket cannot be visually identified by the label.

3. The pre-filled syringe according to claim 1 or 2, characterized in that, The axial length of the marking part along the axis of the push rod is 1 to 6 mm.

4. The pre-filled syringe according to claim 1 or 2, characterized in that, The marking portion is formed by a special shape that can be visually confirmed by means of other parts of the shaft portion.

5. The pre-filled syringe according to claim 1 or 2, characterized in that, The marking portion is formed by a special portion of the outer surface that can be visually identified by means of a surface condition different from that of other portions of the shaft portion.

6. The pre-filled syringe according to claim 1 or 2, characterized in that, The marking portion is an inclined portion, a recessed portion, a convex portion, or a tapered portion formed on the outer surface of the shaft portion.

7. The pre-filled syringe according to claim 1 or 2, characterized in that, The marking portion is a colored portion, a rough surface, or a pattern-retaining portion formed on the outer surface of the shaft portion.

8. The pre-filled syringe according to claim 1 or 2, characterized in that, The marking portion is formed by a visually identifiable irregular shape that differs from other parts of the shaft portion in surface condition and shape.

9. The pre-filled syringe according to claim 1, characterized in that, The marking portion has inclined side portions located on both sides of the vertex plane portion.

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