JP2013070788A - Prefilled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a prefilled syringe capable of surely preventing liquid leakage during the work of mounting a plunger on a gasket.SOLUTION: The prefilled syringe 1 includes a prefilled syringe body 10 having a gasket 3 in the inside, and a plunger 4. The plunger 4 includes a distal end part 41, a plunger side screw part 42 provided on the outer surface, and a pressurizing projection part 43. The gasket 3 includes a spiral screw part 66 to be screwed with the plunger side screw part, an annular recessed part 64 for housing the pressurizing projection part 43, and a pressurized projection part 65 to be pressurized by the pressurizing projection part 43. When screwing of the gasket 3 and the plunger 4 advances, the pressurizing projection part 43 pressurizes the pressurized projection part 65 in a distal end direction, the plunger side screw part 42 is brought into press contact with the spiral screw part 66 and pressurizes it in a rear end direction, and the movement of the gasket is prevented.

Description

  The present invention relates to a prefilled syringe prefilled with a chemical solution.

  In recent years, many prefilled syringes filled with a chemical solution in advance have been used. In the prefilled syringe, the gasket is inserted in a state where the medicine is filled in the outer cylinder whose tip opening is sealed, and the gasket is placed in the opening of the outer cylinder in an atmosphere under reduced pressure (vacuum atmosphere). It is common to use a so-called vacuum plugging method in which the gasket is inserted into the outer cylinder by setting the state. When the plunger is already mounted, it is difficult to dispose the gasket in the opening of the outer cylinder, and thus the above-described plugging operation is performed with the gasket alone. For this reason, as a prefilled syringe, it is common to require a subsequent plunger mounting operation. And, in order to make the plunger mounting operation to the gasket easy, and to prevent the occurrence of liquid leakage during the mounting operation and to suppress the increase in the internal pressure, the plunger is provided with a male screw portion, and the gasket is provided with a female screw portion. What has the mounting mechanism by both screwing is common.

The present applicant has proposed the following Patent Documents 1 and 2.
A syringe 10 of Patent Document 1 (Japanese Patent Laid-Open No. 2009-142508) includes a gasket 3, an outer cylinder 2, and a plunger 4. The plunger 4 includes a spiral rib 44 provided on the outer surface of the head portion 42, and the gasket includes a spiral screw portion 33 for screwing with the spiral rib, and the vicinity of the spiral screw portion 33. In addition, a plunger retaining annular rib 34 located on the distal end side and a helical rib forming portion storage portion 32 of the plunger head portion are provided. The annular rib 34 includes a rib deficient portion 35 for guiding the helical rib that has reached the annular rib to the storage portion by the progress of the screwing of the helical rib of the plunger and the helical screwing portion of the gasket. .
This syringe is effective for preventing the plunger from coming off. However, depending on the manner in which the plunger is mounted, a mounting failure may rarely occur.

  In the syringe of Patent Document 2 (International Publication WO01-97885), a head portion (connecting portion) 43 that is inserted into the hollow portion 33 of the gasket 3 and connected to the gasket 3 is formed at the tip of the plunger 4. ing. A male screw 51 is formed on the outer peripheral surface of the head portion 43. On the other hand, a female screw 52 that can be screwed with the male screw 51 is formed on the inner peripheral surface of the hollow portion 33 of the gasket 3. The head portion 43 includes an elastic piece 61 disposed on the tip side from the male screw 51 and a protrusion 62 formed in the vicinity of the end portion of each elastic piece 61 so as to protrude in the outer peripheral direction. A ring-shaped engagement protrusion 63 is formed to protrude from the inner peripheral surface on the distal end side by the female screw 52 of the hollow portion 33 of the gasket 3.

JP 2009-142508 A International Publication No. WO01-97885

In a plunger having a male screw part and a female screw part on the gasket as in Patent Documents 1 and 2, and having a mounting mechanism by screwing both of them, a force for pressing the gasket in the tip direction is applied during the mounting operation. This is difficult to avoid and can cause liquid leakage.
Therefore, the object of the present invention is to reliably prevent the occurrence of liquid leakage during the operation of mounting the plunger on the gasket, and to easily confirm that the plunger is mounted on the gasket. The prefilled syringe which can suppress reliably the detachment | leave of the gasket of this is provided.

What achieves the above object is as follows.
(1) An outer cylinder, a gasket that is slidably accommodated in the outer cylinder, and that has a lumen therein, a sealing member that seals a distal end opening of the outer cylinder, and the outer cylinder A prefilled syringe body composed of a prefilled syringe body made of a medicine housed in the formed medicine housing portion, and a plunger that can be attached to or attached to the gasket of the prefilled syringe body,
The plunger includes a main body portion having a flange portion on a front end side, a front end portion that protrudes forward from the main body portion and can be stored in the lumen portion of the gasket, and a plunger side provided on an outer surface of the front end portion A screw-engaging portion, and an outwardly projecting annular rib provided on the outer surface of the tip portion between the plunger-side screwing portion and the flange portion, or a pressing projection comprising a plurality of annularly arranged projecting portions; With
The gasket is a cylindrical body whose front end is closed and whose rear end is open, provided on the inner surface of the lumen portion, and a helical threaded portion for threadingly engaging with the plunger side threaded portion of the plunger; An annular recess provided on the rear end side of the helical threaded portion, for accommodating the pressing protrusion of the plunger, and formed on the proximal end side of the annular recess, and pressed by the pressing protrusion A pressed protrusion to be pressed,
When the plunger is attached to the gasket, the pushing protrusion of the plunger is pushed when the helical screwing portion of the gasket and the plunger side screwing portion of the plunger are engaged. A pressing force that abuts against the projecting portion, presses the pressed projecting portion toward the distal end side, and the plunger-side threaded portion of the plunger presses against the helical threaded portion of the gasket. Applying a pressing force to press the helical threaded portion toward the rear end side, and by the progress of the screwing, the pressing protrusion of the plunger gets over the pressed protrusion of the gasket, A prefilled syringe in which the plunger is attached to the gasket by being accommodated in the annular recess of the gasket.

(2) The prefilled syringe according to (1), wherein the plunger can idle with respect to the gasket in a mounted state in which the pressing protrusion of the plunger is accommodated in the annular recess of the gasket.
(3) The gasket accommodates the plunger side threaded portion of the plunger that has passed through the helical threaded portion at the distal end portion of the lumen portion, and allows idling of the plunger side threaded portion. The plunger-side threaded portion storage portion is provided, and the annular recess of the gasket allows the rotation of the plunger when the pressing protrusion of the plunger is accommodated in the annular recess. The prefilled syringe according to 1) or (2).
(4) The gasket accommodates the plunger side threaded portion of the plunger that has passed through the helical threaded portion at the distal end portion of the lumen portion, and allows the plunger side threaded portion to idle. A plunger-side threaded portion storage portion, and the distance between the rear end portion of the plunger-side threaded portion of the plunger and the pressing projection is the tip of the helical threaded portion of the gasket. The prefilled syringe according to any one of (1) to (3), which is substantially the same as or slightly longer than the distance between the annular recesses.
(5) The prefilled surface according to any one of (1) to (4), wherein a rear end surface of the pressed protruding portion of the gasket is an inclined surface inclined in the rear end direction and the peripheral direction of the gasket. Syringe.
(6) The above-described (1) to (5), wherein a portion of the pressing protrusion of the plunger that contacts the pressed protrusion of the gasket is an inclined surface that is inclined toward the distal end and toward the center. The prefilled syringe according to any one of the above.
(7) The prefilled syringe according to any one of (1) to (6), wherein the pressed protrusions are annular ribs or a plurality of annularly arranged protrusions.
(8) The distance between the front end of the plunger-side threaded portion of the plunger and the pressing protrusion is longer than the distance between the rear end of the helical threaded portion of the gasket and the annular recess. The prefilled syringe according to any one of (1) to (7).
(9) The prefilled syringe according to any one of (1) to (8), wherein the plunger side screwing portion is a spiral rib.

The prefilled syringe of the present invention comprises a prefilled syringe body and a plunger that can be attached to or attached to the gasket of the prefilled syringe body. The plunger has a main body part having a flange part on the front end side, a front end part that protrudes forward from the main body part and can be stored in the inner cavity part of the gasket, and a plunger side screwing part provided on the outer surface of the front end part, An outwardly projecting annular rib provided on the outer surface of the distal end portion between the plunger-side threaded portion and the flange portion or a pressing projecting portion comprising a plurality of projecting portions disposed in an annular shape. The gasket is a cylindrical body whose front end is closed and whose rear end is open. The gasket is provided on the inner surface of the lumen portion, and has a helical threading portion for screwing with a plunger side threading portion of the plunger, and a helical screw. An annular recess that is provided on the rear end side from the joint and accommodates the pressing projection of the plunger, and a pressed projection that is pressed by the pressing projection formed on the proximal end side of the annular recess. Prepare.
In the prefilled syringe of the present invention, when the plunger is mounted on the gasket, the protrusion for pressing the plunger is pressed when the helical screwed portion of the gasket and the plunger-side screwed portion of the plunger are engaged. A pressing force that abuts against the projecting portion and presses the pressed projecting portion toward the distal end, and the plunger-side threaded portion of the plunger is in pressure contact with the spiral threaded portion of the gasket, and the spiral threaded portion The pressing protrusion of the plunger gets over the pressed protrusion of the gasket and is accommodated in the annular recess of the gasket due to the progress of screwing. A plunger is attached to the.
Therefore, when the plunger is attached to the gasket, the pressing protrusion of the plunger abuts the pressed protrusion and presses the pressed protrusion to the tip side, and the plunger side screwing of the plunger is performed. The portion is in pressure contact with the helical threaded portion of the gasket and the pressing force that presses the helical threaded portion toward the rear end antagonizes, preventing the gasket from moving. Thereby, generation | occurrence | production of the liquid leak at the time of the plunger mounting | wearing operation | work to a gasket can be prevented reliably. Furthermore, the end of the mounting operation of the plunger on the gasket can be easily confirmed by housing the plunger pressing protrusion in the annular recess of the gasket. Further, the engagement of the plunger pressing protrusion and the annular recess of the gasket prevents the plunger from being detached from the gasket after mounting.

FIG. 1 is a front view of a prefilled syringe according to an embodiment of the present invention. FIG. 2 is a front view of a prefilled syringe according to another embodiment of the present invention. FIG. 3 is a longitudinal sectional view of the prefilled syringe body of the prefilled syringe shown in FIGS. 1 and 2. FIG. 4 is an enlarged front view of a gasket used in the prefilled syringe of the present invention. 5 is a cross-sectional view taken along line AA in FIG. FIG. 6 is a perspective view seen from the rear end side of the gasket shown in FIG. FIG. 7 is a front view of the plunger of the prefilled syringe shown in FIGS. 1 and 2. FIG. 8 is a perspective view of the plunger shown in FIG. FIG. 9 is a front view of an outer cylinder used in the prefilled syringe of the present invention. FIG. 10 is a cross-sectional view of a sealing member (seal cap) used in the prefilled syringe of the present invention. FIG. 11 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention. FIG. 12 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention. FIG. 13 is an explanatory diagram for explaining the operation when the prefilled syringe body and the plunger are mounted in the prefilled syringe of the present invention. FIG. 14 is a longitudinal sectional view of a gasket used for a prefilled syringe according to another embodiment of the present invention. FIG. 15 is a perspective view of a plunger used in a prefilled syringe according to another embodiment of the present invention.

Hereinafter, the prefilled syringe of the present invention will be described.
A prefilled syringe 1 of the present invention shown in FIG. 1 includes an outer cylinder 2, a gasket 3 slidably housed in the outer cylinder 2, a sealing member 5 that seals the tip opening of the outer cylinder 2, It consists of a prefilled syringe body 10 composed of a medicine 8 housed in a medicine housing part formed in the outer cylinder 2 and a plunger 4 that can be attached to the gasket 3 and is not attached.
A prefilled syringe 1a of the present invention shown in FIG. 2 includes an outer cylinder 2, a gasket 3 slidably accommodated in the outer cylinder 2, a sealing member 5 that seals the tip opening of the outer cylinder 2, It comprises a prefilled syringe body 10 composed of a medicine 8 housed in a medicine housing portion formed in the outer cylinder 2 and a plunger 4 attached to the gasket 3.

  The plunger 4 has a main body portion 40 having a flange portion 48 on the front end side, a front end portion 41 that protrudes forward from the main body portion 40 and can be stored in the lumen portion of the gasket 3, and is provided on the outer surface of the front end portion 41. A plunger-side threaded portion (specifically, a spiral rib) 42 and an annularly projecting outward provided on the outer surface of the tip 41 between the plunger-side threaded portion (spiral rib) 42 and the flange portion 48. And a pressing protrusion 43 including a plurality of protrusions arranged in a rib or ring shape. The gasket 3 is a cylindrical body whose front end is closed and whose rear end is open. The gasket 3 is provided on the inner surface of the inner cavity, and has a helical shape for screwing with a plunger-side threaded portion (spiral rib) 42 of the plunger 4. A threaded portion 66, an annular recess 64 that is provided on the rear end side of the spiral threaded portion 66 and accommodates the pressing projection 43 of the plunger 4, and a pressure formed on the proximal end side of the annular recess 64 And a pressed protrusion 65 to be pressed by the protrusion 43 for use.

  When the plunger 4 is attached to the gasket 3, the pushing protrusion of the plunger 4 is performed when the screwing of the helical screwing portion 66 of the gasket 3 and the plunger side screwing portion (spiral rib) 42 of the plunger 4 is advanced. The portion 43 abuts on the pressed protrusion 65 of the gasket 3, applies a pressing force to press the pressed protrusion 65 toward the tip, and the plunger-side screwed portion (spiral rib) of the plunger 4. 42 is in pressure contact with the helical threaded portion 66 of the gasket 3 and applies a pressing force that presses the helical threaded portion 66 to the rear end side, and the pushing protrusion 43 of the plunger 4 is moved by the progress of the threaded engagement. The plunger 4 is attached to the gasket 3 by overcoming the pressed protrusion 65 of the gasket 3 and being accommodated in the annular recess 64 of the gasket 3.

The prefilled syringe 1 of the present invention includes a prefilled syringe body 10 and a plunger 4 that can be attached to or attached to the gasket 3 of the prefilled syringe body 10. In the prefilled syringe 1 of this embodiment, the plunger side screwing portion of the plunger 4 is constituted by a helical rib 42. The plunger side screwing portion is preferably a helical rib, but may be any one that can be screwed with a helical screwing portion of a gasket to be described later. For example, a lug (consisting of a plurality of protrusions) It may be. Examples of the lug include those in which partial protrusions are formed on the same circumferential portion of the outer surface of the distal end portion 41 described later of the plunger. For example, a plurality of, for example, two, two facing each other on the outer periphery of the distal end portion of the distal end portion 41 of the plunger can be considered.
The prefilled syringe body 10 is formed in the outer cylinder 2, the gasket 3 slidably accommodated in the outer cylinder 2, the sealing member 5 that seals the distal end opening of the outer cylinder 2, and the outer cylinder 2. And the medicine 8 stored in the medicine storage section.
As shown in FIGS. 4 to 6, the gasket 3 is a cylindrical body having a closed front end and a rear end opening. The gasket 3 includes a main body portion 60 and a tapered portion 61 that is provided on the distal end side of the main body portion 60 and decreases in a taper shape toward the distal end side. Further, the gasket 3 includes a front end side sliding contact portion 68 that is provided on the front end side portion and that is in sliding contact with the inner surface of the outer cylinder, and a rear end side sliding contact portion 69 that is provided on the rear end side portion. Moreover, it is preferable that the tip side sliding contact portion 68 has a large diameter near the center in the axial direction. Specifically, it is preferable that the tip side sliding contact portion 68 is formed in a somewhat drum drum shape. With such a configuration, the tip side sliding contact portion 68 is unlikely to be separated from the inner surface of the outer cylinder when the plunger is pressed, so that the chemical liquid is less likely to leak. Moreover, it is preferable that the front end side sliding contact portion 68 is formed wide in the axial direction as shown in FIGS.

The gasket 3 has a lumen portion, and on the inner surface of the lumen portion, a helical screw portion 66 for screwing with the helical rib 42 of the plunger 4, and a rear side of the helical screw portion 66. An annular recess 64 provided on the end side for accommodating the pressing projection 43 of the plunger 4 and a pressed projection 65 pressed by the pressing projection 43 formed on the proximal end side of the annular recess 64. With. Further, in the gasket 3 of this embodiment, the inner cavity portion includes a spiral rib storage portion 62 for storing the spiral rib 42 of the distal end portion 41 of the plunger 4 on the distal end side with respect to the spiral threaded portion 66. Yes.
Specifically, the inner cavity portion of the gasket 3 is provided with a helical rib storage portion 62, a helical screwing portion 66, an annular concave portion 64, and a pressed projection portion 65 in this order from the tip side. .
The spiral threaded portion 66 is formed by one or a plurality of screw threads, and the spiral rib 42 of the plunger 4 travels through the spiral space 63 formed by the threads. The spiral threaded portion 66 has a short spiral shape with the tip positioned at the rear end of the spiral rib storage portion 62 and the rear end positioned near the annular recess 64. In this embodiment, the helical threaded portions 66 are two (two) helically threaded portions 66 so as to correspond to spiral ribs 42 of the plunger 4 described later. In addition, although it is preferable to provide a plurality (specifically, two strips) of helical screw portions as described above, the spiral screw portion (spiral protrusion) may be only one (one). Good.

The annular recess 64 is an annular recess having an inner diameter larger than the inner diameter of the portion where the helical threading portion 66 is formed (the inner diameter at the helical space 63 portion), and the pressing protrusion 43 of the plunger 4 is replaced with the plunger. 4 is accommodated in an allowable manner. For this reason, the inner diameter of the annular recess is larger than the outer diameter of the pressing protrusion 43 portion of the plunger 4. In addition, a stepped portion is formed between the annular recess 64 and the spiral threaded portion forming portion, and the plunger 4 moves toward the distal end of the pressing projection 43 (in other words, toward the distal end of the plunger). Movement).
A pressed protrusion 65 is formed by the rear end portion of the annular recess 64. In this embodiment, the pressed protrusion 65 is formed at the rear end of the lumen. The inner diameter of the pressed protrusion 65 is smaller than the outer diameter of the pressing protrusion 43 portion of the plunger 4. The rear end surface 65a of the pressed protrusion 65 of the gasket 3 is an inclined surface that is inclined in the rear end direction and the peripheral direction of the gasket 3. For this reason, the pressed protrusion 65 is thinner toward its apex. This makes it easy for the pressing protrusion 43 of the plunger 4 to get over the pressed protrusion 65. Further, the pressing protrusion 43 of the plunger 4 constitutes a plunger retaining portion. In the gasket of this embodiment, the front end surface (the rear end surface of the annular recess 64) of the pressed protrusion 65 is an upright surface, and similarly, the pressing protrusion 43 of the plunger 4 that is the upstanding surface. Abuts the rear end face.

In this embodiment, the pressed protrusion 65 is formed by an annular rib. It is preferable to form the pressed protrusion 65 with such an annular rib. However, as in the gasket 3a shown in FIG. 14, the pressed protrusion is formed by a plurality of annularly arranged protrusions. May be. In the gasket 3 a of this embodiment, the pressed protrusions are formed by a plurality of protrusions 85, and a gap 86 is formed between the protrusions 85. A plurality of protrusions 85 are provided at substantially equal intervals on the inner periphery of the base end of the lumen. Further, the rear end surface 85a of the projecting portion 85 is an inclined surface, similar to the annular rib described above.
Further, in the gasket 3 of this embodiment, the inner surface of the distal end portion of the lumen portion (spiral rib storage portion 62) of the gasket 3 is reduced in diameter toward the distal end of the gasket 3. A protrusion 67 is provided at the center of the inner surface of the tip.

The gasket 3 preferably has a main body 60 having a diameter of 5 to 30 mm, a total length of 5 to 30 mm, and a taper angle of 1 to 5 ° with respect to the inclination of the taper portion 61.
As a constituent material of the gasket 3, a known material conventionally used for a gasket for syringes can be used. Examples thereof include rubber, elastomer, polyolefin resin, fluorine resin, and polyester resin. As the rubber, for example, natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber are preferable, and vulcanized rubber is particularly preferable. As the elastomer, for example, a polyvinyl chloride elastomer, a polyolefin elastomer, a styrene elastomer, a polyester elastomer, a polyamide elastomer, a polyurethane elastomer, and a mixture thereof are preferable. Among the above rubbers and elastomers, styrene-butadiene rubber, butyl rubber, and styrene elastomers have suitable hardness and elastic properties, and various sterilization methods such as γ-ray sterilization, electron beam sterilization, and high-pressure steam sterilization can be adopted. Therefore, it is preferable.
Further, the tip portion of the syringe gasket may be coated with a low drug-adsorbing substance or the like.

As the material for the low drug adsorbing layer, known materials conventionally used for syringe gaskets can be used. Examples of the material for the low drug adsorption layer include polyolefin resins, fluorine resins, and polyester resins. Specifically, the polyolefin resin is preferably polypropylene, ultrahigh molecular weight polyethylene, poly (4-methylpentene-1), cyclic polyolefin or the like, and the fluorine resin is tetrafluoroethylene-perfluoroethoxyethylene copolymer. Polymers, polytetrafluoroethylene, tetrafluoroethylene / perfluoroalkyl vinyl ether copolymers, tetrafluoroethylene / hexafluoropropylene copolymers and the like are preferable.
Further, a lubricant or the like may be coated on both or at least one surface of the front end side sliding contact portion 68 and the rear end side sliding contact portion 69 of the gasket 3. Silicone oil is suitable as the lubricant.

As shown in FIGS. 7 and 8, the plunger 4 has a body portion 40 having a flange portion 48 that can press the proximal end surface of the gasket 3 on the distal end side, and projects forward from the body portion 40, so that the lumen of the gasket 3 And a tip portion 41 that can be stored in the portion.
The main body portion 40 includes a shaft portion 47 formed in a cross shape in cross section, and a flange portion 48 is provided at the tip thereof. The flange portion 48 is formed in a disc shape so that the proximal end surface of the plunger 3 can be pressed. A plunger pressing portion 49 is provided at the base end of the shaft portion 47.
The tip portion 41 is a small-diameter cylindrical portion that protrudes in the tip direction from the flange portion 48, and a spiral rib 42 that can be screwed with the spiral screw portion 66 of the gasket 3, and between the spiral rib 42 and the flange portion 48. Is provided with a pressing projection 43.

The spiral rib 42 is formed on the outer surface of the distal end portion of the cylindrical portion that forms the mounting distal end portion 41. In addition, the plunger 4 includes two (two) spiral ribs so as to correspond to the spiral threaded portion 66 of the gasket 3 described above. The spiral rib has a short spiral shape. Although it is preferable to provide such a plurality (specifically, two strips) of spiral ribs, the spiral rib may be only one strip (one).
The pressing projection 43 is between the spiral rib 42 and the flange 48, and is provided at a position spaced apart from the spiral rib 42 by a predetermined length and close to the pressing projection 43. In this embodiment, the pressing protrusion 43 is formed by an annular rib protruding outwardly provided on the outer surface of the tip 41. As in this embodiment, the pressing protrusion is preferably an annular rib, but the pressing protrusion 45 is annularly arranged on the outer surface of the tip 41 as in the gasket 4a shown in FIG. You may comprise by several protrusion part.

The pressing protrusion 43 has an outer diameter larger than the inner diameter of the pressed protrusion 65 of the gasket 3 and can press the pressed protrusion 65 of the gasket 3. Further, the portion of the pressing protrusion 43 of the plunger 4 that comes into contact with the pressed protrusion 65 of the gasket 4 may be an inclined surface that is inclined toward the tip and toward the center. In this case, the pressing protrusion 43 becomes thinner toward the distal direction. By doing so, it becomes easy to get over the pressed protrusion 65 of the gasket 3 of the pressing protrusion 43. Further, the outer diameter of the pressing projection 43 is smaller than the inner diameter of the annular recess 64 of the gasket 3, and the pressing projection 43 can be accommodated in the annular recess 64 of the gasket 3. The pressing protrusion 43 accommodated in the annular recess 64 of the gasket 3 constitutes a plunger retaining portion.
As a constituent material of the plunger 4, it is preferable to use a hard or semi-rigid resin such as high-density polyethylene, polypropylene, polystyrene, or polyethylene terephthalate.

In the prefilled syringe of the present invention, when the plunger 4 is attached to the gasket 3, the pushing protrusion of the plunger 4 when the screwing of the helical screw portion 66 of the gasket 3 and the helical rib 42 of the plunger 4 proceeds. The portion 43 abuts on the pressed protrusion 65 of the gasket 3 to apply a pressing force to press the pressed protrusion 65 toward the distal end, and the helical rib 42 of the plunger 4 A pressing force is applied to press the spiral threaded portion 66 toward the rear end side while being pressed against the threaded portion 66. For this reason, although screwing progress resistance becomes high, since both pressing force antagonizes, the movement of a gasket at the time of mounting of the plunger 4 to the gasket 3, ie, a liquid leak, is prevented.
The distance between the tip of the helical rib 42 of the plunger 4 and the pressing protrusion 43 is longer than the distance between the rear end of the helical screw 66 of the gasket 3 and the annular recess 64. . For this reason, when the helical screwing portion 66 of the gasket 3 and the helical rib 42 of the plunger 4 are screwed, the pressing protrusion 65 of the gasket 3 is surely pressed by the pressing protrusion 43 of the plunger 4. Then, the helical rib 42 of the plunger 4 and the helical threaded portion 66 of the gasket 3 are pressed against each other, and an antagonistic state of the pressing force appears.
As the screwing proceeds, the pressing protrusion 43 of the plunger 4 gets over the pressed protrusion 65 of the gasket 3 and is accommodated in the annular recess 64 of the gasket 3, so that the plunger 4 is attached to the gasket 3. Is done.

And in the prefilled syringe of this invention, it is preferable that the gasket 3 and the plunger 4 can idle | slow in the mounting state in which the protrusion part 43 for a plunger 4 was accommodated in the annular recessed part 64 of the gasket 3. FIG. By doing so, even if the plunger is rotated after the plunger is mounted on the gasket, the plunger cannot be detached from the gasket.
In this embodiment, as described above, the gasket 3 accommodates the spiral rib 42 of the plunger 4 that has passed through the spiral threaded portion 66 at the distal end portion of the lumen portion, and causes the spiral rib 42 to idle. It has a spiral rib storage portion 62 that is allowed. Specifically, the spiral rib 42 has an inner diameter wider than the outer diameter of the portion of the plunger 4 where the spiral rib 42 is formed. The annular recess 64 of the gasket 3 allows the plunger 4 to rotate when the annular recess 64 accommodates the pressing protrusion 43 of the plunger 4. Specifically, the inner diameter of the annular recess 64 of the gasket 3 is larger than the outer diameter of the pressing protrusion 43 of the plunger 4. Further, in this embodiment, the distance H between the rear end portion of the spiral rib 42 of the plunger 4 and the pressing projection 43 is set between the tip end portion of the spiral threaded portion 66 of the gasket 3 and the annular recess 64. It is almost the same as or slightly longer than the distance L. Therefore, the passage of the gasket of the helical rib 42 of the plunger 4 through the helical threaded portion 66 (in other words, the disengagement of the screwed relationship, the completion of the accommodation of the helical rib 42 in the helical rib storage portion 62) is almost the same. At the same time, the pressing protrusion 43 of the plunger 4 is accommodated in the annular recess 64 of the gasket 3. For this reason, the pressing operation only for accommodating the protrusion part 43 for a press of the plunger 4 in the annular recessed part 64 of the gasket 3 becomes unnecessary.

The outer cylinder 2 is a cylindrical body formed of a transparent or translucent material, preferably a material having low oxygen permeability and water vapor permeability.
As shown in FIGS. 1, 2, and 9, the outer cylinder 2 includes a nozzle portion 22 and a collar 23.
The nozzle portion 22 is provided at the distal end of the outer cylinder 2, and is provided with a distal end opening for discharging a chemical solution and the like in the outer cylinder, and is formed so as to decrease in diameter in a tapered shape toward the distal end. The collar 23 is formed in a cylindrical shape concentrically with the nozzle portion 22 so as to surround the nozzle portion 22. The collar 23 is open at the tip, and the inner diameter and outer diameter of the collar 23 are substantially the same from the base end to the tip. Further, the tip of the nozzle portion 22 projects from the tip opening of the collar 23, and the nozzle portion 22 and the tip of the collar 23 accommodate the nozzle portion 22 and the collar 23 in the sealing member (seal cap) 5. It is chamfered to make it easier.
On the inner peripheral surface of the collar, a screw groove (external cylinder side screwing) for screwing with a screw thread (cap side screwing part) 54 formed in a nozzle housing part 53 of a sealing member (seal cap) 5 described later. Part) 25 is formed. Thereby, the outer cylinder 2 and the seal cap 5 are screwed between the collar inner peripheral surface and the nozzle housing portion outer peripheral surface. Further, the thread groove (outer cylinder side screwing portion) 25 is a portion to which the injection needle (the hub of the injection needle) is attached after the seal cap 5 is removed from the outer cylinder.

As shown in FIGS. 1, 2, and 9, the outer cylinder has a flange 24. The flange 24 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder 2. As shown in FIGS. 1, 2, and 9, the flange 24 includes two gripping portions that are wide and face each other, and a plurality of ribs are formed on the front end surface side of the gripping portion.
Examples of the material for forming the outer cylinder 2 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin can be used, and among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance.

As shown in FIGS. 1, 2, and 10, the seal cap 5 that is a sealing member includes a closed end 51, a nozzle storage portion 53, and a color storage portion 52.
The nozzle storage portion 53 is provided in the center portion of the seal cap 5 and has a cylindrical shape with a closed end. The inner diameter of the nozzle storage portion 53 is made slightly larger than that of the nozzle portion 22 and is slightly tapered from the distal end to the proximal end toward the proximal end, and accommodates the entire nozzle portion from the proximal end opening. ing.
A seal member 55 for sealing the tip opening of the outer cylinder 2 in a liquid-tight manner is accommodated in the inner closed surface of the nozzle storage portion 53 (the inner surface of the closed end 51). The seal member 55 is preferably an elastic member so that the tip opening of the outer cylinder 2 can be sealed in a liquid-tight manner. As a material for forming the sealing member, it is preferable to use, for example, natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber or other synthetic rubber, or thermoplastic elastomer such as olefin elastomer or styrene elastomer.
Further, on the outer surface of the nozzle housing portion 53, a screw thread (cap side screwing portion) 54 for screwing with a screw groove (outer tube side screwing portion) 25 formed on the inner surface of the collar 23 of the outer tube 2. Is formed. Thereby, the outer cylinder 2 and the seal cap 5 are screwed between the outer surface of the nozzle housing portion and the inner surface of the collar.

The color storage unit 52 is a cylindrical body that is formed so as to surround the nozzle storage unit 53 and has a closed end, and stores the collar 23 between the inner surface of the color storage unit and the outer surface of the nozzle storage unit. Further, the color storage portion 52 formed in a cylindrical shape is concentric with the nozzle storage portion 53, and the inner diameter of the color storage portion 52 is substantially the same from the front end to the base end.
In addition, as shown in FIG. 1, the outer surface of the seal cap 5 (the outer peripheral surface of the color storage portion 52) is chopped in the vertical direction so that fingers do not slip when the seal cap is rotated. ing.
Examples of the material for forming the seal cap include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, and the like. Among these, various resins such as polyester and cyclic polyolefin are preferable. Among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance.

And in the prefilled syringe 1 of this invention, the chemical | medical agent 8 is filled in the chemical | medical agent storage part formed in the outer cylinder 2 of the prefilled syringe main body 10, as shown in FIG.
As the drug 8, any drug may be used. For example, cyclosporine, benzodiazepine drugs, sodium chloride injection, vitamins, minerals, and the like, powders such as antibiotics and protein preparations, or freeze-dried Drugs or liquids are used. The prefilled syringe of the present invention is particularly suitable for a prefilled syringe of the type that is administered using a syringe pump. Therefore, the medicine to be filled is preferably a medicine suitable for using such administration means, and nitro Examples include glycerin injection, isosorbide nitrate injection, dopamine hydrochloride (dopamine hydrochloride) injection, dobutamine hydrochloride injection, morphine hydrochloride injection, and the like.

Next, the effect | action of the prefilled syringe 1 of this invention is demonstrated using FIG. 11 thru | or FIG.
The prefilled syringe body 10 is in a state in which the gasket 3 is housed in the proximal end portion of the outer cylinder 2. As shown in FIG. 11, the plunger 4 is caused to enter the plunger 3 while rotating from the tip portion 41. As a result, the helical screw 66 of the gasket 3 and the helical rib 42 of the mounting tip 41 of the plunger 4 are screwed together. When the screwing progresses, as shown in FIG. 12, the pressing projection 43 of the plunger 4 comes into contact with the inclined surface 65a of the pressed projection 65 of the gasket 3, and moves toward the tip of the gasket shown in FIG. A pressing force is applied, and the helical rib 42 of the plunger 4 and the helical threaded portion 66 of the gasket 3 are pressed against each other, and a pressing force in the rear end direction of the gasket shown in FIG. The state is developed, and the screwing can be progressed in a state where the movement of the gasket is restricted. Further, when the screwing is advanced, as shown in FIG. 13, the plunger 4 is pressed almost simultaneously with the passage (disengagement of the screwing relationship) of the gasket of the helical rib 42 of the plunger 4. The protrusion 43 is accommodated in the annular recess 64 of the gasket 3, and the mounting operation of the plunger 4 to the gasket 3 is completed.
Since the plunger 4 attached to the gasket 3 is idle with respect to the gasket, the rotation of the plunger 4 is not transmitted to the gasket 3.

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Outer cylinder 3 Gasket 4 Plunger 5 Sealing member 6 Gasket main body 7 Plunger mounting member 10 Prefilled syringe main body

Claims (9)

An outer cylinder, a gasket that is slidably accommodated in the outer cylinder, and has a lumen portion therein, a sealing member that seals a distal end opening of the outer cylinder, and the outer cylinder are formed in the outer cylinder A prefilled syringe body comprising a prefilled syringe body made of a medicine housed in a medicine housing section, and a plunger attachable to or attached to the gasket of the prefilled syringe body,
The plunger includes a main body portion having a flange portion on a front end side, a front end portion that protrudes forward from the main body portion and can be stored in the lumen portion of the gasket, and a plunger side provided on an outer surface of the front end portion A screw-engaging portion, and an outwardly projecting annular rib provided on the outer surface of the tip portion between the plunger-side screwing portion and the flange portion, or a pressing projection comprising a plurality of annularly arranged projecting portions; With
The gasket is a cylindrical body whose front end is closed and whose rear end is open, provided on the inner surface of the lumen portion, and a helical threaded portion for threadingly engaging with the plunger side threaded portion of the plunger; An annular recess provided on the rear end side of the helical threaded portion, for accommodating the pressing protrusion of the plunger, and formed on the proximal end side of the annular recess, and pressed by the pressing protrusion A pressed protrusion to be pressed,
When the plunger is attached to the gasket, the pushing protrusion of the plunger is pushed when the helical screwing portion of the gasket and the plunger side screwing portion of the plunger are engaged. A pressing force that abuts against the projecting portion, presses the pressed projecting portion toward the distal end side, and the plunger-side threaded portion of the plunger presses against the helical threaded portion of the gasket. Applying a pressing force to press the helical threaded portion toward the rear end side, and by the progress of the screwing, the pressing protrusion of the plunger gets over the pressed protrusion of the gasket, A prefilled syringe, wherein the plunger is attached to the gasket by being accommodated in the annular recess of the gasket. 2. The prefilled syringe according to claim 1, wherein the plunger can idle with respect to the gasket in a mounted state in which the pressing protrusion of the plunger is accommodated in the annular recess of the gasket. The gasket accommodates the plunger side threaded portion of the plunger that has passed through the helical threaded portion at the distal end portion of the lumen portion, and allows the plunger side threaded portion to idle. The said recessed part of the said gasket has a joint part accommodating part, and when the said protrusion part for a press of the said plunger is accommodated in the said annular recessed part, rotation of the said plunger is permitted. A prefilled syringe according to 1. The gasket accommodates the plunger side threaded portion of the plunger that has passed through the helical threaded portion at the distal end portion of the lumen portion, and allows the plunger side threaded portion to idle. A distance between a rear end portion of the plunger-side threaded portion of the plunger and the pressing protrusion, and a tip portion of the helical threaded portion of the gasket and the annular recess; The prefilled syringe according to any one of claims 1 to 3, which is substantially the same as or slightly longer than the distance between them. The prefilled syringe according to any one of claims 1 to 4, wherein a rear end surface of the pressed projecting portion of the gasket is an inclined surface inclined in a rear end direction and a peripheral direction of the gasket. The portion of the pressing protrusion of the plunger that contacts the pressed protrusion of the gasket is an inclined surface that is inclined toward the tip and toward the center. Prefilled syringe. The prefilled syringe according to any one of claims 1 to 6, wherein the pressed protrusions are annular ribs or a plurality of annularly arranged protrusions. The distance between the front end of the plunger-side threaded portion of the plunger and the pressing protrusion is longer than the distance between the rear end of the helical threaded portion of the gasket and the annular recess. The prefilled syringe according to any one of claims 1 to 7. The prefilled syringe according to any one of claims 1 to 8, wherein the plunger side screwing portion is a helical rib.

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