JP2005185747A - Gasket and pre-filled syringe - Google Patents

Gasket and pre-filled syringe Download PDF

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Publication number
JP2005185747A
JP2005185747A JP2003434374A JP2003434374A JP2005185747A JP 2005185747 A JP2005185747 A JP 2005185747A JP 2003434374 A JP2003434374 A JP 2003434374A JP 2003434374 A JP2003434374 A JP 2003434374A JP 2005185747 A JP2005185747 A JP 2005185747A
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Prior art keywords
gasket
agent
chamber
passage
front chamber
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Japanese (ja)
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Masayasu Miyazaki
政安 宮崎
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Sumitomo Rubber Industries Ltd
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Sumitomo Rubber Industries Ltd
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Priority to JP2003434374A priority Critical patent/JP2005185747A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst

Abstract

<P>PROBLEM TO BE SOLVED: To form a cylindrical container into a simple cylindrical shape without forming a bypassing passage in the cylindrical container by making a posterior agent flow into a front chamber through a gasket by providing a passage for the posterior agent in the gasket. <P>SOLUTION: The gasket provided in the cylindrical container 2 and divides an inner space of the cylindrical container 2 into the front chamber 6 for containing an anterior agent A and a back chamber 7 for containing the posterior agent B. A passage 8 communicating with both chambers is penetrated in a main body part 3a of the gasket separating the front chamber 6 from the back chamber 7. A partitioning means 11 which closes the passage 8 and releases the closing to make the posterior agent B flow into the front chamber 6 when the pressure increases in the back chamber 7 is provided in the main body part 3a of the gasket. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、ガスケット、及びこのガスケットを用いたプレフィルドシリンジに関するものである。   The present invention relates to a gasket and a prefilled syringe using the gasket.

従来この種の技術として、筒状容器にガスケットを嵌入してこの筒状容器の内部空間を前剤（薬剤）を収容する前室と後剤（薬液）を収容する後室とに分離するとともに、筒状容器の側壁の中途部を径方向外方に膨出形成してこの中途部の内面に注入溝（バイパス通路）を形成したプレフィルドシリンジがある（例えば特許文献１参照）。
特許公報第２９１１０８６号 Conventionally, as a technique of this type, a gasket is fitted into a cylindrical container, and the internal space of the cylindrical container is separated into a front chamber for storing a pre-agent (medicine) and a rear chamber for storing a post-agent (chemical). There is a prefilled syringe in which a middle part of a side wall of a cylindrical container is formed to bulge outward in the radial direction and an injection groove (bypass passage) is formed on the inner surface of the middle part (see, for example, Patent Document 1).
Japanese Patent No. 2911086

上記のような従来のプレフィルドシリンジでは、前室と後室を分離するガスケットには前室と後室とを連通する通路が設けられておらず、筒状容器の中途部を膨出成形してバイパス通路を形成していたため、形状が複雑になってその分製造コストが高くなっていた。この点、筒状容器については、その一部を膨出成形せずに単純な筒状とするのが製造コストを低減できる。つまり、このバイパス通路を筒状容器以外の部品に設けるようにすれば、筒状容器を単純な筒状とすることができる。
そこで、本発明は、ガスケットに後剤の通路を設けることによって、後剤をガスケットを通じて前室に流れ込むようにし、筒状容器にバイパス通路を形成せずに筒状容器を単純な筒形状にできるようにすることを目的とする。 In the conventional prefilled syringe as described above, the gasket that separates the front chamber and the rear chamber is not provided with a passage that connects the front chamber and the rear chamber, and the middle portion of the cylindrical container is bulged and formed. Since the bypass passage was formed, the shape was complicated and the manufacturing cost was increased accordingly. With respect to this point and the cylindrical container, it is possible to reduce the manufacturing cost by making a part of the cylindrical container into a simple cylindrical shape without bulging. That is, if this bypass passage is provided in parts other than the cylindrical container, the cylindrical container can be made into a simple cylindrical shape.
Therefore, the present invention can provide a rear agent passage in the gasket so that the rear agent flows into the front chamber through the gasket, and the cylindrical container can be formed into a simple cylindrical shape without forming a bypass passage in the cylindrical container. The purpose is to do so.

本願発明は上記課題を解決するために以下の技術的手段を講じた。
すなわち、筒状容器２内に設けられていて筒状容器２の内部空間を前剤Ａを収容する前室６と後剤Ｂを収容する後室７とに分離するガスケット３において、前記前室６と後室７と分離するガスケット本体部３ａ内に両室を連通する通路８が貫通形成されており、このガスケット本体部３ａには前記通路８を閉鎖していて後室７内が昇圧したときに前記閉鎖を解除して後剤Ｂを前室６に流入可能とする仕切手段１１が設けられていることを特徴とする。 In order to solve the above problems, the present invention has taken the following technical means.
That is, in the gasket 3 that is provided in the cylindrical container 2 and separates the internal space of the cylindrical container 2 into a front chamber 6 that stores the pre-agent A and a rear chamber 7 that stores the post-agent B, the front chamber 6 and the rear chamber 7 are separated from each other by a passage 8 communicating with both chambers, and the passage 8 is closed in the gasket main body 3a so that the pressure in the rear chamber 7 is increased. The partition means 11 which cancels | releases the said closure sometimes and can flow the back agent B into the front chamber 6 is provided.

これによれば、ガスケット３に後剤Ｂを後室７から前室６に通過させる通路８を形成し、ガスケット本体部３ａの通路８に仕切手段１１を設けたことによって、２薬剤混合前の未使用時は、後剤Ｂが後室７から前室６への流れ込むのを防止し、使用するときにのみ後剤Ｂを前室６に流入させることができる。
また、前記仕切手段１１は、前記通路８の前室６側に設けられていることを特徴とする。
これによれば、仕切手段１１をガスケット本体部３ａに容易に設けることができる。 According to this, the passage 8 through which the back agent B passes from the rear chamber 7 to the front chamber 6 is formed in the gasket 3, and the partitioning means 11 is provided in the passage 8 of the gasket main body 3a, so that the two-drug mixture before mixing. When not in use, the rear agent B can be prevented from flowing from the rear chamber 7 into the front chamber 6, and the rear agent B can be allowed to flow into the front chamber 6 only when used.
The partitioning means 11 is provided on the front chamber 6 side of the passage 8.
According to this, the partition means 11 can be easily provided in the gasket main body 3a.

また、前記仕切手段１１は、後室７が昇圧したときに後室７側から前室６側への後剤Ｂの流動を許容する一方向弁からなることを特徴とする。
これによれば、未使用時に前室６の前剤Ａが後室６に入り込むことを防止して、使用時に後剤Ｂを後室７から前室６に確実に流し込むことができる。
また、前記一方向弁は、ガスケット本体部３ａに設けられていて後剤Ｂを前室６側に吐出する吐出口１４が形成された弾性膜部１２と、弾性膜部１２内に配置されていて後室７側から吐出口１４への後剤Ｂの流動を閉栓可能な栓部材１３とを備え、前記栓部材１３は、弾性膜部１２が弾力的に密着する球状シール面１５を有することを特徴とする。 The partitioning means 11 is a one-way valve that allows the rear agent B to flow from the rear chamber 7 side to the front chamber 6 side when the rear chamber 7 is pressurized.
According to this, the pre-agent A in the front chamber 6 can be prevented from entering the rear chamber 6 when not in use, and the post-agent B can be reliably poured from the rear chamber 7 into the front chamber 6 during use.
The one-way valve is provided in the gasket main body 3a and is provided in the elastic membrane 12 with an elastic membrane 12 having a discharge port 14 for discharging the back agent B to the front chamber 6 side. And a plug member 13 capable of closing the flow of the post-agent B from the rear chamber 7 side to the discharge port 14, and the plug member 13 has a spherical seal surface 15 to which the elastic film portion 12 is elastically adhered. It is characterized by.

これによれば、栓部材１３と弾性膜部１２との密着により、後剤Ｂが未使用時に前室６に流れ込まないようにシールすることができる。
また、前記ガスケット本体部３ａの通路８の出口１０近傍位置に栓部材１３をシールする環状突起部１８が設けられていることを特徴とする。
これによれば、球状シール面１５と弾性膜部１２の密着によるシールとこの環状突起部１８と栓部材１３とのシールによる２重シール構造によって、より確実にシールできる。
また、前記仕切手段１１は、後室７が昇圧したときに通路８から離脱して通路８の閉鎖を解除するとともに前室６に入りこむ仕切部材２２を備えていることを特徴とする。 According to this, it can seal so that the back agent B may not flow into the front chamber 6 at the time of unused by close_contact | adherence with the plug member 13 and the elastic film part 12. FIG.
Further, an annular protrusion 18 for sealing the plug member 13 is provided in the vicinity of the outlet 10 of the passage 8 of the gasket body 3a.
According to this, it is possible to seal more reliably by the double seal structure by the seal by the close contact between the spherical seal surface 15 and the elastic film portion 12 and the seal between the annular projection 18 and the plug member 13.
Further, the partitioning means 11 includes a partition member 22 that separates from the passage 8 when the rear chamber 7 is pressurized and releases the closure of the passage 8 and enters the front chamber 6.

これによれば、仕切部材２２が前室６内に入り込んだ状態で振ることによって前剤Ａと後剤Ｂとを混合しやすくなる。
また、先端に混合剤を吐出可能な口部２ｂを有する筒状容器２と、この筒状容器２内に設けられていて筒状容器２の内部空間を前剤Ａと収容する前室６と後剤Ｂを収容する後室７とに分離するガスケット３と、筒状容器２内でガスケット３の後方に設けられていて後室７を昇圧する昇圧体４とを備えたプレフィルドシリンジ１において、前記ガスケット３のガスケット本体部３ａ内に前記前室６側と後室７側とを連通する通路８が貫通形成されており、このガスケット本体部３ａには前記通路８を閉鎖していて後室７内が昇圧したときに前記閉鎖を解除して後剤Ｂを前室６に流入可能とする仕切手段１１が前記通路８に設けられていることを特徴とする。 According to this, it becomes easy to mix the front agent A and the rear agent B by shaking in a state where the partition member 22 enters the front chamber 6.
Moreover, the cylindrical container 2 which has the opening part 2b which can discharge a mixture agent at the front-end | tip, The front chamber 6 which is provided in this cylindrical container 2 and accommodates the interior space of the cylindrical container 2 with the preparation A In the prefilled syringe 1 provided with a gasket 3 that separates into a rear chamber 7 that contains the post-agent B, and a pressurizer 4 that is provided behind the gasket 3 in the cylindrical container 2 and pressurizes the rear chamber 7. A passage 8 communicating with the front chamber 6 side and the rear chamber 7 side is formed in the gasket main body portion 3a of the gasket 3 so as to pass through the gasket main body portion 3a. A partition means 11 is provided in the passage 8 to release the closure and allow the back agent B to flow into the front chamber 6 when the pressure in the interior 7 is increased.

これによれば、ガスケット３に後剤Ｂを後室７から前室６に通過させる通路８を形成しているので、バイパス通路を筒状容器２に形成しなくてもよくなり、筒状容器２を単純な筒形状にできる。   According to this, since the passage 8 through which the back agent B passes from the rear chamber 7 to the front chamber 6 is formed in the gasket 3, it is not necessary to form the bypass passage in the cylindrical container 2, and the cylindrical container 2 can be made into a simple cylindrical shape.

本発明によれば、ガスケットに後剤の通路を設けることによって、後剤をガスケットを通じて前室に流れ込むようにし、筒状容器にバイパス通路を形成せずに筒状容器を単純な筒形状にできる。   According to the present invention, by providing a passage for the rear agent in the gasket, the rear agent flows into the front chamber through the gasket, and the cylindrical container can be formed into a simple cylindrical shape without forming a bypass passage in the cylindrical container. .

以下、図面を参照して本発明の実施の形態を説明する。
図１は本発明の第１実施形態を示している。図１において、プレフィルドシリンジ１は、筒状容器２と、筒状容器２内に設けられるフロントガスケット３、リヤガスケット４と、リヤガスケット４の後部に設けられたプランジャロッド５を有している。
前記筒状容器２は、円筒状の胴部２ａの先端部に先細り状の口部２ｂを形成してゴム栓１９等で閉栓するとともに注射針２０を口部２ｂに装着して混合剤を吐出可能とし、前記胴部２ａの後端に開口部を形成してフロントガスケット３、リヤガスケット４、プランジャロッド５を挿入可能としている。前記開口部の外周にはフランジ部２ｃが形成されていて使用時に指等を掛けることができるようになっている。 Embodiments of the present invention will be described below with reference to the drawings.
FIG. 1 shows a first embodiment of the present invention. In FIG. 1, a prefilled syringe 1 has a cylindrical container 2, a front gasket 3 provided in the cylindrical container 2, a rear gasket 4, and a plunger rod 5 provided at the rear part of the rear gasket 4.
The cylindrical container 2 is formed with a tapered mouth 2b at the tip of a cylindrical body 2a and closed with a rubber stopper 19 or the like, and an injection needle 20 is attached to the mouth 2b to discharge the mixture. The front gasket 3, the rear gasket 4, and the plunger rod 5 can be inserted by forming an opening at the rear end of the body 2a. A flange 2c is formed on the outer periphery of the opening so that a finger or the like can be hooked during use.

フロントガスケット３は筒状容器２内に嵌入されていて筒状容器２の筒心方向（長手方向）中途部に配置されている。これによって筒状容器２の内部空間は、種々の薬剤を凍結乾燥製剤等に製剤化した前剤Ａを収容する前室６と、生理食塩水や分散液（薬液）等の流体からなる後剤Ｂを収容する後室７とに分離されている。
また、筒状容器２内には、フロントガスケット３の後方に所定間隔をおいてリヤガスケット４が嵌入配置されており、前記フロントガスケット３とリヤガスケット４の間に後室７が区画形成されている。リヤガスケット４は後室７の後部側をシールすると共に、プレフィルドシリンジ１の使用時に後室７を昇圧する昇圧体４として機能するものである。 The front gasket 3 is fitted in the cylindrical container 2 and is disposed in the middle of the cylindrical center (longitudinal direction) of the cylindrical container 2. As a result, the internal space of the cylindrical container 2 has an anterior chamber 6 containing an anterior agent A in which various drugs are formulated into freeze-dried preparations, and an after-treatment agent composed of a fluid such as physiological saline or a dispersion (medical solution). It is separated into a rear chamber 7 that accommodates B.
Further, a rear gasket 4 is fitted and arranged in the cylindrical container 2 at a predetermined interval behind the front gasket 3, and a rear chamber 7 is defined between the front gasket 3 and the rear gasket 4. Yes. The rear gasket 4 seals the rear side of the rear chamber 7 and functions as a booster 4 that pressurizes the rear chamber 7 when the prefilled syringe 1 is used.

リヤガスケット４の後部にはプランジャロッド５が固定されており、このプランジャロッド５を前方に押すことでリヤガスケット４を前方に摺動させて後室７内を昇圧できるようになっている。
プレフィルドシリンジ１は、後室７内をこのように昇圧させることで後室７の後剤Ｂを前室６に流入させ、後剤Ｂと前剤Ａを混合させて混合剤とし、その後に注射針２０を貫通させプランジャロッド５をさらに押して筒状容器２の口部２ｂからこの混合剤を注出できるようになっている。 A plunger rod 5 is fixed to the rear portion of the rear gasket 4, and by pushing the plunger rod 5 forward, the rear gasket 4 can be slid forward to increase the pressure in the rear chamber 7.
The pre-filled syringe 1 raises the pressure in the rear chamber 7 in this way, thereby allowing the rear agent B of the rear chamber 7 to flow into the front chamber 6, mixing the rear agent B and the front agent A into a mixture, and then injecting the mixture. The needle 20 is penetrated and the plunger rod 5 is further pushed so that the mixture can be poured out from the mouth 2b of the cylindrical container 2.

前記フロントガスケット３はゴムや熱可塑性エラストマ等の弾性体であり、円筒状のガスケット本体部３ａを有しており、このガスケット本体部３ａの外周には円形リブ３ｂが形成されている。前記円形リブ３ｂは、ガスケット本体部３ａの筒心方向に間隔をおいて複数（図例では３つ）形成されており、その外周面が筒状容器２の内面と密着してシールをしている。なお、リヤガスケット４もフロントガスケット３と同様に、円筒状のガスケット本体部４ａの外周に円形リブ４ｂが複数形成されている。
ガスケット本体部３ａには前室６と後室７とを連通する通路８が形成されている。この通路８は、ガスケット本体部３ａの中央（中心部）に筒心方向に沿って直線状に貫通した孔である。後室７の後剤Ｂは、プランジャロッド５を介してリヤガスケット４を前方に摺動させて、これによって後室７が昇圧したときの圧力により、この通路８を通じて前室６に流入するようになっている。前記通路８は後室７側に後剤Ｂが流入する入口９を有し、また、前室６側に後剤Ｂの出口１０を有している。 The front gasket 3 is an elastic body such as rubber or thermoplastic elastomer, and has a cylindrical gasket main body portion 3a. A circular rib 3b is formed on the outer periphery of the gasket main body portion 3a. The circular rib 3b is formed in plural (three in the illustrated example) at intervals in the cylinder center direction of the gasket main body 3a, and its outer peripheral surface is in close contact with the inner surface of the cylindrical container 2 for sealing. Yes. As with the front gasket 3, the rear gasket 4 also has a plurality of circular ribs 4b formed on the outer periphery of a cylindrical gasket body 4a.
A passage 8 for communicating the front chamber 6 and the rear chamber 7 is formed in the gasket body 3a. The passage 8 is a hole that penetrates linearly along the center of the gasket main body 3a in the center (center). The rear agent B of the rear chamber 7 slides the rear gasket 4 forward through the plunger rod 5 and flows into the front chamber 6 through this passage 8 by the pressure when the rear chamber 7 is pressurized. It has become. The passage 8 has an inlet 9 into which the rear agent B flows on the rear chamber 7 side, and an outlet 10 for the rear agent B on the front chamber 6 side.

ガスケット本体部３ａの前室６側には、前記通路８の出口１０を閉鎖していて後室７が昇圧したときにこの閉鎖を解除して後剤Ｂが前室６に流入可能とする仕切手段１１が設けられている。図１において、仕切手段１１は一方向弁からなり、後室７が昇圧したときに後室から前室６に向かう方向（前方向）にのみ後剤Ｂを流すようになっている。
仕切手段１１は、後剤Ｂを前室６側に吐出する吐出口１４を有する弾性膜部１２と、弾性膜部１２内に配置されていて後室７側から吐出口１４への後剤Ｂの流動を閉栓可能な栓部材１３とを有している。 On the side of the front chamber 6 of the gasket body 3a, a partition that closes the outlet 10 of the passage 8 and releases the closing when the rear chamber 7 is pressurized so that the rear agent B can flow into the front chamber 6. Means 11 are provided. In FIG. 1, the partitioning means 11 is composed of a one-way valve, and when the rear chamber 7 is pressurized, the rear agent B flows only in the direction from the rear chamber toward the front chamber 6 (front direction).
The partition means 11 includes an elastic film portion 12 having a discharge port 14 for discharging the back agent B to the front chamber 6 side, and the post agent B disposed in the elastic film portion 12 from the rear chamber 7 side to the discharge port 14. And a plug member 13 capable of closing the fluid flow.

弾性膜部１２は、薄膜製でガスケット本体部３ａと一体に成形されていて、ガスケット本体部３ａの前面から前方に突出するように形成されている。このように弾性膜部１２を本体部３ａ前面から前方（外方）突出状に形成するのが成形上容易であり、フロントガスケットの成形において有利なものである。
弾性膜部１２の胴部１２ａは円筒状に形成されていて、胴部１２ａの上部が半球状のドーム形状となっている。弾性膜部１２の先端部１２ｂには、後剤Ｂを前室６側に吐出するための吐出口（孔）１４が形成されている。 The elastic membrane portion 12 is made of a thin film and is formed integrally with the gasket body portion 3a, and is formed so as to protrude forward from the front surface of the gasket body portion 3a. In this way, it is easy to form the elastic film portion 12 so as to protrude forward (outward) from the front surface of the main body portion 3a, which is advantageous in forming the front gasket.
The body part 12a of the elastic film part 12 is formed in a cylindrical shape, and the upper part of the body part 12a has a hemispherical dome shape. A discharge port (hole) 14 for discharging the back agent B to the front chamber 6 side is formed at the distal end portion 12 b of the elastic film portion 12.

栓部材１３は、例えば、硬質樹脂等によって形成された中実状の球状体からなる。この栓部材１３の直径は、弾性膜部１２の胴部１２ａの内径よりも大きく形成されている。したがって、栓部材１３が弾性膜部１２の胴部１２ａに設けられると、栓部材１３は、弾性膜部１２内面に密着し、栓部材１３と接触している弾性膜部１２の胴部１２ａ部分は外方に膨張するように弾性変形する。栓部材１３は、弾性膜部１２が弾性変形することによって生じた弾性力によって押さえ付けられ、弾性膜部１２内で保持されている。
栓部材１３は球状体であるので、その表面は球面となっており、この球面に弾性膜部１２が弾力的に密着することによりシールされる。以下、このようにシールを行う栓部材１３の表面（球面）を球状シール面１５といい、これによるシールを第１のシールという。この球状シール面１５は球面形状であるので、平坦面の場合よりも広いシール面積を確保できる。 The plug member 13 is made of, for example, a solid spherical body made of hard resin or the like. The diameter of the plug member 13 is formed larger than the inner diameter of the body portion 12a of the elastic membrane portion 12. Therefore, when the plug member 13 is provided on the body portion 12 a of the elastic film portion 12, the plug member 13 is in close contact with the inner surface of the elastic film portion 12 and is in contact with the plug member 13. Elastically deforms to expand outward. The plug member 13 is pressed by an elastic force generated by elastic deformation of the elastic film portion 12 and is held in the elastic film portion 12.
Since the plug member 13 is a spherical body, the surface thereof is a spherical surface, and the elastic film portion 12 is elastically adhered to the spherical surface to be sealed. Hereinafter, the surface (spherical surface) of the plug member 13 that performs the sealing in this way is referred to as a spherical sealing surface 15, and the sealing by this is referred to as a first sealing. Since the spherical sealing surface 15 has a spherical shape, a larger sealing area can be secured than in the case of a flat surface.

弾性膜部１２は薄膜製であるので、球状シール面１５との密着部分では、弾性膜部１２の内面及び外面は球状シール面１５の球面形状に対応して球面状に弾性変形される。したがって、この密着部分では、球状シール面１５と弾性膜部１２とによるシールが球面同士の密着によってなされるのである。このように、球面同士の密着では、密着部分における各接点における弾性膜部１２の弾性力は、球状シール面１５の球心に向かう求心方向に作用することになる。
すなわち、いずれの接点においても、求心方向への均一な弾性力（弾性復元力）が作用し、これによって、密着性が高まるとともに広い面でシールできるようになっている。 Since the elastic film portion 12 is made of a thin film, the inner surface and the outer surface of the elastic film portion 12 are elastically deformed into a spherical shape corresponding to the spherical shape of the spherical seal surface 15 at the close contact portion with the spherical seal surface 15. Therefore, in this close contact portion, sealing by the spherical seal surface 15 and the elastic film portion 12 is performed by close contact between the spherical surfaces. Thus, in the close contact between the spherical surfaces, the elastic force of the elastic film portion 12 at each contact point in the close contact portion acts in the centripetal direction toward the spherical center of the spherical seal surface 15.
That is, at any of the contacts, a uniform elastic force (elastic restoring force) in the centripetal direction acts, thereby improving adhesion and sealing on a wide surface.

弾性膜部１２内において、先端部１２ｂの吐出口１４の近傍の内面には、栓部材１３を係止する突起部が設けられており、この突起部が吐出口１４と栓部材１３の間に間隙１７を形成するための間隙形成手段１６とされている。この突起状の間隙形成手段１６は、弾性膜部１２内面の周方向に沿って間隔をおいて複数設けられている。
一方、弾性膜部１２の胴部１２ａ内面には、球状シール面１５と弾性膜部１２との密着によるシールとは別に、栓部材１３と接触して第２のシールを行う環状突起部１８（シールリング部）が弾性膜部１２の胴部１２ａと前記通路８の出口１０近傍に設けられている。この環状突起部１８は、吐出口１４と離間されて設けられ、栓部材１３を弾性膜部１２内に設けたときには、突起状の間隙形成手段１６と環状突起部１８とで栓部材１３を挟持した状態となる。 In the elastic film portion 12, a protrusion portion that locks the plug member 13 is provided on the inner surface of the distal end portion 12 b in the vicinity of the discharge port 14, and this protrusion portion is provided between the discharge port 14 and the plug member 13. The gap forming means 16 for forming the gap 17 is used. A plurality of the protrusion-like gap forming means 16 are provided at intervals along the circumferential direction of the inner surface of the elastic film portion 12.
On the other hand, on the inner surface of the body portion 12a of the elastic membrane portion 12, an annular projection 18 (second seal) that comes into contact with the plug member 13 separately from the seal by the close contact between the spherical seal surface 15 and the elastic membrane portion 12 A seal ring part) is provided in the vicinity of the body part 12 a of the elastic film part 12 and the outlet 10 of the passage 8. The annular protrusion 18 is provided so as to be separated from the discharge port 14. When the stopper member 13 is provided in the elastic film part 12, the stopper member 13 is sandwiched between the protrusion-like gap forming means 16 and the annular protrusion 18. It will be in the state.

換言すれば、突起状の間隙形成手段１６と環状突起部１８は栓部材１３の位置を規制するものである。このように弾性膜部１２内では、球状シール面１５と弾性膜部１２との密着部分、および栓部材１３（球状シール面１５）と環状突起部１８との接触部分の２箇所でシールを行う２重シール構造となっている。この２重シール構造によって、十分なシール性を発揮することができる。
第１実施形態では、間隙形成手段１６である突起部の数は４である。この突起状の間隙形成手段１６は、吐出口１４から所定間隔離間されて設けられている。したがって、突起状の間隙形成手段１６によって係止される栓部材１３は、吐出口１４から離間されて配置され、これによって栓部材１３と吐出口１４との間に間隙１７が形成される。このように間隙１７が形成されることによって、栓部材１３が吐出口１４と密着して塞ぐことなく、所望の圧力でシールを解除して後剤Ｂを吐出できるようになる。 In other words, the protruding gap forming means 16 and the annular protruding portion 18 regulate the position of the plug member 13. As described above, in the elastic film portion 12, sealing is performed at two locations, that is, a close contact portion between the spherical seal surface 15 and the elastic film portion 12 and a contact portion between the plug member 13 (spherical seal surface 15) and the annular protrusion 18. It has a double seal structure. With this double seal structure, sufficient sealing performance can be exhibited.
In the first embodiment, the number of protrusions that are the gap forming means 16 is four. The protruding gap forming means 16 is provided at a predetermined distance from the discharge port 14. Therefore, the plug member 13 locked by the protruding gap forming means 16 is disposed away from the discharge port 14, thereby forming a gap 17 between the plug member 13 and the discharge port 14. By forming the gap 17 in this way, the plug member 13 can be discharged with the desired pressure by releasing the seal at a desired pressure without the plug member 13 being in close contact with the discharge port 14.

プランジャロッド５を押してリヤガスケット（昇圧体）４を前方に移動させ、後室７内が昇圧したときの仕切手段１１の作用について説明する。
後室７内が昇圧すると、通路８内にある後剤Ｂを介して栓部材１３と弾性膜部１２に圧力が加わり、弾性膜部１２が引き伸ばされるように弾性変形する。弾性膜部１２がこのように弾性変形することによって、栓部材１３が環状突起部１８から離れて栓部材１３と環状突起部１８とのシールが解除される。この解除で後剤Ｂは、環状突起部１８を越えて球状シール面１５と弾性膜部１２とのシール部分（密着部分）に流入する。 The operation of the partitioning means 11 when the plunger rod 5 is pushed to move the rear gasket (pressurizer) 4 forward and the pressure in the rear chamber 7 is increased will be described.
When the pressure in the rear chamber 7 is increased, pressure is applied to the plug member 13 and the elastic film portion 12 via the post-agent B in the passage 8, and the elastic film portion 12 is elastically deformed to be stretched. As the elastic membrane portion 12 is elastically deformed in this manner, the plug member 13 is separated from the annular protrusion 18 and the seal between the plug member 13 and the annular protrusion 18 is released. With this release, the after-treatment agent B passes over the annular protrusion 18 and flows into the seal portion (contact portion) between the spherical seal surface 15 and the elastic film portion 12.

この後剤Ｂは、球状シール面１５と弾性膜部１２とのシール部分が解除されるように、密着部分にある弾性膜部１２部分を外方に押し広げるように膨張状に弾性変形させて吐出口１４側の間隙１７に流入する。そして後剤Ｂによって間隙１７が充満され、その後に後剤Ｂが吐出口１４から前室６に吐出される。
上述のように、フロントガスケット３のガスケット本体部３ａに通路８を形成し、ガスケット本体部３ａの前室６側に仕切手段１１を設けたことによって、未使用時には前室６と後室７を分離しておいて、使用時に後室７を昇圧したときにのみ後剤Ｂを前室６に流し込むことができるようになる。 This post-agent B is elastically deformed in an inflated form so as to spread the elastic film part 12 in the close contact part outward so that the seal part between the spherical sealing surface 15 and the elastic film part 12 is released. It flows into the gap 17 on the discharge port 14 side. Then, the gap 17 is filled with the rear agent B, and then the rear agent B is discharged from the discharge port 14 to the front chamber 6.
As described above, the passage 8 is formed in the gasket main body 3a of the front gasket 3 and the partitioning means 11 is provided on the front chamber 6 side of the gasket main body 3a, so that the front chamber 6 and the rear chamber 7 can be opened when not in use. After separation, the rear agent B can be poured into the front chamber 6 only when the pressure in the rear chamber 7 is increased during use.

そして、フロントガスケット３に通路８を形成しているので、従来のように筒状容器２の一部を膨出成形してバイパス通路を形成する必要がなく、したがって筒状容器２を単純な筒形状に成形して製造コストを低減することができる。
図２において、フロントガスケット３の通路８は、入口９の口径よりも出口１０の口径が小さなテーパー状に形成されている。このフロントガスケット３の弾性膜部１２に栓部材１３を配置するには、栓部材１３を通路８の入口９から挿入して出口１０側の弾性膜部１２まで押し込むこととなるが、例えば、入口９側の口径を栓部材１３の直径よりも大きくしておけば栓部材１３の押し込みが楽にできる。 Since the passage 8 is formed in the front gasket 3, it is not necessary to form a bypass passage by bulging a part of the cylindrical container 2 as in the prior art. The manufacturing cost can be reduced by forming into a shape.
In FIG. 2, the passage 8 of the front gasket 3 is formed in a tapered shape in which the diameter of the outlet 10 is smaller than the diameter of the inlet 9. In order to arrange the plug member 13 on the elastic membrane portion 12 of the front gasket 3, the plug member 13 is inserted from the inlet 9 of the passage 8 and pushed into the elastic membrane portion 12 on the outlet 10 side. If the 9 side diameter is made larger than the diameter of the plug member 13, the plug member 13 can be pushed in easily.

また、出口１０側の口径を栓部材１３の直径よりもやや小さくしておいて、栓部材１３を通路８に押し込んで出口１０が広がるように弾性変形させて栓部材１３を弾性膜部１２内に挿入してやれば、出口１０が抜け止めとなって栓部材１３が通路８の入口９側に抜けはずれることがなくなる。
図３の第２実施形態では、仕切手段１１の構成が第１実施形態、第２実施形態の場合と異なる。すなわち、仕切手段１１は、後室７が昇圧したときに通路８から離脱して通路８の閉鎖を解除するとともに前室６に入りこむ仕切部材２２を備えている。仕切部材２２は、例えばガラス製、または硬質樹脂製の球状体からなる。弾性膜部１２の吐出口１４は、後室７が昇圧したときに仕切部材２２を前室６側に吐出可能な大きさに形成されている。 Further, the diameter on the outlet 10 side is made slightly smaller than the diameter of the plug member 13, and the plug member 13 is pushed into the passage 8 and elastically deformed so that the outlet 10 spreads, so that the plug member 13 is placed in the elastic membrane portion 12. If inserted, the outlet 10 is prevented from coming off and the plug member 13 is prevented from coming off to the inlet 9 side of the passage 8.
In 2nd Embodiment of FIG. 3, the structure of the partition means 11 differs from the case of 1st Embodiment and 2nd Embodiment. That is, the partitioning means 11 includes a partition member 22 that separates from the passage 8 to release the closing of the passage 8 and enters the front chamber 6 when the rear chamber 7 is pressurized. The partition member 22 is made of, for example, a spherical body made of glass or hard resin. The discharge port 14 of the elastic film part 12 is formed in such a size that the partition member 22 can be discharged to the front chamber 6 side when the rear chamber 7 is pressurized.

仕切部材２２は未使用時には、後剤Ｂが前室６に入らないように通路８を閉鎖しているが、プランジャロッド５を押して後室７が昇圧すると、仕切部材２２が吐出口１４から前室６側に吐出され、これによって後剤Ｂも前室６に流れ込むことになる。この状態で、筒状容器２を振って前剤Ａと後剤Ｂとを混合させるときに、前記仕切部材２２が前室６内をかき混ぜるように移動するため、前剤Ａと後剤Ｂの混合を容易にできるようになる。その他の構成は第１実施形態と同様の構成であり、同様の作用効果を奏する。
なお、本発明は上記の実施形態に限らず、以下のように種々の変更が可能である。 When the partition member 22 is not in use, the passage 8 is closed so that the back agent B does not enter the front chamber 6. However, when the rear chamber 7 is pressurized by pushing the plunger rod 5, the partition member 22 is moved from the discharge port 14 to the front. It discharges to the chamber 6 side, and the back agent B also flows into the front chamber 6 by this. In this state, when the cylindrical container 2 is shaken to mix the front agent A and the rear agent B, the partition member 22 moves so as to stir the inside of the front chamber 6. Mixing can be facilitated. Other configurations are the same as those in the first embodiment, and have the same effects.
The present invention is not limited to the above embodiment, and various modifications can be made as follows.

栓部材１３は球状体を例示したが、これに限らず、例えば楕円体、ラグビーボール状等の形状としてもよく、弾性膜部１２と接触する部分（表面）を球面状に形成したものであればよい。
フロントガスケット３は、弾性膜部１２とガスケット本体部３ａとが一体成形されたものを例示したが、両者を別体に成形しておいて凹凸嵌合、接着、溶着等の手段により一体としてもよい。
仕切手段１１は、通路８の出口１０側（前室６側）以外に通路８の中途部や、入口９側（後室７側）に設けてもよい。 The plug member 13 is exemplified as a spherical body, but is not limited to this. For example, the plug member 13 may have an elliptical shape, a rugby ball shape, or the like, and a portion (surface) that contacts the elastic film portion 12 is formed into a spherical shape. That's fine.
The front gasket 3 is exemplified by the elastic membrane portion 12 and the gasket main body portion 3a integrally formed. However, the front gasket 3 may be formed as a separate body and integrated by means such as concave-convex fitting, adhesion, and welding. Good.
The partitioning means 11 may be provided in the middle of the passage 8 or on the inlet 9 side (rear chamber 7 side) other than the outlet 10 side (front chamber 6 side) of the passage 8.

本発明の第１実施形態を示すプレフィルドシリンジの縦断面図である。It is a longitudinal cross-sectional view of the prefilled syringe which shows 1st Embodiment of this invention. 本発明の第１実施形態を示すガスケットの縦断面図である。It is a longitudinal cross-sectional view of the gasket which shows 1st Embodiment of this invention. 本発明の第２実施形態を示すプレフィルドシリンジの縦断面図である。It is a longitudinal cross-sectional view of the prefilled syringe which shows 2nd Embodiment of this invention. 本発明の第２実施形態を示すガスケットの縦断面図である。It is a longitudinal cross-sectional view of the gasket which shows 2nd Embodiment of this invention.

符号の説明Explanation of symbols

１ プレフィルドシリンジ
２ 筒状容器
３ ガスケット（フロントガスケット）
３ａ ガスケット本体部
４ 昇圧体（リヤガスケット）
６ 前室
７ 後室
８ 通路
１１ 仕切手段
１２ 弾性膜部
１３ 栓部材
１４ 吐出口
１５ 球状シール面
１８ 環状突起部
２２ 仕切部材
Ａ 前剤
Ｂ 後剤 1 Prefilled syringe 2 Tubular container 3 Gasket (front gasket)
3a Gasket body part 4 Booster body (Rear gasket)
6 front chamber 7 rear chamber 8 passage 11 partition means 12 elastic membrane portion 13 plug member 14 discharge port 15 spherical sealing surface 18 annular projection 22 partition member A front agent B rear agent

Claims (7)

筒状容器（２）内に設けられていて筒状容器（２）の内部空間を前剤（Ａ）を収容する前室（６）と後剤（Ｂ）を収容する後室（７）とに分離するガスケット（３）において、
前記前室（６）と後室（７）と分離するガスケット本体部（３ａ）内に両室を連通する通路（８）が貫通形成されており、このガスケット本体部（３ａ）には前記通路（８）を閉鎖していて後室（７）内が昇圧したときに前記閉鎖を解除して後剤（Ｂ）を前室（６）に流入可能とする仕切手段（１１）が設けられていることを特徴とするガスケット。 A front chamber (6) for storing the pre-agent (A) and a rear chamber (7) for storing the post-agent (B) provided in the cylindrical container (2), and the internal space of the cylindrical container (2); In the gasket (3) separated into
A passage (8) communicating the two chambers is formed through the gasket body (3a) that separates the front chamber (6) and the rear chamber (7), and the gasket body (3a) includes the passage. (8) is provided with partition means (11) for releasing the closure and allowing the rear agent (B) to flow into the front chamber (6) when the pressure in the rear chamber (7) is increased. A gasket characterized by being. 前記仕切手段（１１）は、前記通路（８）の前室（６）側に設けられていることを特徴とする請求項１に記載のガスケット。   The gasket according to claim 1, wherein the partition means (11) is provided on the front chamber (6) side of the passage (8). 前記仕切手段（１１）は、後室（７）が昇圧したときに後剤（Ｂ）の後室（７）側から前室（６）側への流動を許容する一方向弁からなることを特徴とする請求項１または２に記載のガスケット。   The partition means (11) comprises a one-way valve that allows the rear agent (B) to flow from the rear chamber (7) side to the front chamber (6) side when the rear chamber (7) is pressurized. The gasket according to claim 1, wherein the gasket is characterized. 前記一方向弁は、ガスケット本体部（３ａ）に設けられていて後剤（Ｂ）を前室（６）側に吐出する吐出口（１４）が形成された弾性膜部（１２）と、弾性膜部（１２）内に配置されていて後室（７）側から吐出口（１４）への後剤（Ｂ）の流動を閉栓可能な栓部材（１３）とを備え、前記栓部材（１３）は、弾性膜部（１２）が弾力的に密着する球状シール面（１５）を有することを特徴とする請求項３に記載のガスケット。   The one-way valve is provided on the gasket main body (3a) and has an elastic membrane part (12) in which a discharge port (14) for discharging the back agent (B) to the front chamber (6) side is formed, A plug member (13) disposed in the membrane part (12) and capable of closing the flow of the post-agent (B) from the rear chamber (7) side to the discharge port (14); The gasket according to claim 3, characterized in that it has a spherical sealing surface (15) to which the elastic membrane part (12) elastically adheres. 前記ガスケット本体部（３ａ）の通路（８）の出口（１０）近傍位置に栓部材（１３）をシールする環状突起部（１８）が設けられていることを特徴とする請求項４に記載のガスケット。   The annular protrusion (18) for sealing the plug member (13) is provided in the vicinity of the outlet (10) of the passage (8) of the gasket main body (3a). gasket. 前記仕切手段（１１）は、後室（７）が昇圧したときに通路（８）から離脱して通路（８）の閉鎖を解除するとともに前室（６）に入りこむ仕切部材（２２）を備えていることを特徴とする請求項１または２に記載のガスケット。   The partition means (11) includes a partition member (22) that is released from the passage (8) when the rear chamber (7) is pressurized and releases the closure of the passage (8) and enters the front chamber (6). The gasket according to claim 1 or 2, wherein the gasket is provided. 先端に混合剤を吐出可能な口部（２ｂ）を有する筒状容器（２）と、この筒状容器（２）内に設けられていて筒状容器（２）の内部空間を前剤（Ａ）を収容する前室（６）と後剤（Ｂ）を収容する後室（７）とに分離するガスケット（３）と、筒状容器（２）内でガスケット（３）の後方に設けられていて後室（７）を昇圧する昇圧体（４）とを備えたプレフィルドシリンジ（１）において、
前記ガスケット（３）のガスケット本体部（３ａ）内に前記前室（６）と後室（７）とを連通する通路（８）が貫通形成されており、このガスケット本体部（３ａ）には前記通路（８）を閉鎖していて後室（７）内が昇圧したときに前記閉鎖を解除して後剤（Ｂ）を前室（６）に流入可能とする仕切手段（１１）が設けられていることを特徴とするプレフィルドシリンジ。 A cylindrical container (2) having a mouth part (2b) capable of discharging the mixed agent at the tip, and the internal space of the cylindrical container (2) provided in the cylindrical container (2) is pre-agent (A ) And a gasket (3) that is separated into a rear chamber (7) that stores the back agent (B), and a gasket (3) that is provided behind the gasket (3). And a prefilled syringe (1) provided with a booster (4) for boosting the rear chamber (7),
A passage (8) communicating the front chamber (6) and the rear chamber (7) is formed through the gasket body (3a) of the gasket (3). When the passage (8) is closed and the inside of the rear chamber (7) is pressurized, partition means (11) is provided to release the closure and allow the rear agent (B) to flow into the front chamber (6). A prefilled syringe characterized by being made.
JP2003434374A 2003-12-26 2003-12-26 Gasket and pre-filled syringe Pending JP2005185747A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2565006A2 (en) 2011-08-31 2013-03-06 Sumitomo Rubber Industries Limited Mold for gasket for prefilled syringe
EP2926851A1 (en) 2014-03-31 2015-10-07 (1/2) Sumitomo Rubber Industries, Ltd. Gasket for prefilled syringe, and production method therefor
WO2016109339A1 (en) * 2014-12-30 2016-07-07 3M Innovative Properties Company Container for mixing and dispensing fluid medication components
EP3120886A1 (en) 2015-07-23 2017-01-25 Sumitomo Rubber Industries, Ltd. Medical syringe, gasket for use in the syringe, and gasket production method
US9717858B2 (en) 2014-02-19 2017-08-01 Sumitomo Rubber Industries, Ltd. Gasket for prefilled syringe and prefilled syringe
US10507286B2 (en) 2014-12-30 2019-12-17 3M Innovative Properties Company Container for mixing and dispensing two components
US10744265B2 (en) 2014-12-30 2020-08-18 Kindeva Drug Delivery L.P. Container for mixing and dispensing components

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JPS58120748U (en) * 1982-02-10 1983-08-17 河村　純郎 Backflow prevention adapter for injections, etc.
JPS59155264A (en) * 1982-12-27 1984-09-04 メデイテツク・エス・ア−・ Double partition chamber type syringe
JPH0531191A (en) * 1991-07-30 1993-02-09 Nippon Chem Res Kk Injector filled with immediate solution type medicine

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58120748U (en) * 1982-02-10 1983-08-17 河村　純郎 Backflow prevention adapter for injections, etc.
JPS59155264A (en) * 1982-12-27 1984-09-04 メデイテツク・エス・ア−・ Double partition chamber type syringe
JPH0531191A (en) * 1991-07-30 1993-02-09 Nippon Chem Res Kk Injector filled with immediate solution type medicine

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2565006A2 (en) 2011-08-31 2013-03-06 Sumitomo Rubber Industries Limited Mold for gasket for prefilled syringe
KR20130024735A (en) 2011-08-31 2013-03-08 스미토모 고무 고교 가부시키가이샤 Mold for gasket for prefilled syringe
US9452264B2 (en) 2011-08-31 2016-09-27 Sumitomo Rubber Industries, Ltd. Mold for gasket for prefilled syringe
KR102028755B1 (en) 2011-08-31 2019-10-04 스미토모 고무 고교 가부시키가이샤 Mold for gasket for prefilled syringe
US9717858B2 (en) 2014-02-19 2017-08-01 Sumitomo Rubber Industries, Ltd. Gasket for prefilled syringe and prefilled syringe
EP2926851A1 (en) 2014-03-31 2015-10-07 (1/2) Sumitomo Rubber Industries, Ltd. Gasket for prefilled syringe, and production method therefor
WO2016109339A1 (en) * 2014-12-30 2016-07-07 3M Innovative Properties Company Container for mixing and dispensing fluid medication components
US10327990B2 (en) 2014-12-30 2019-06-25 3M Innovative Properties Company Container for mixing and dispensing fluid medication components
US10507286B2 (en) 2014-12-30 2019-12-17 3M Innovative Properties Company Container for mixing and dispensing two components
US10744265B2 (en) 2014-12-30 2020-08-18 Kindeva Drug Delivery L.P. Container for mixing and dispensing components
EP3120886A1 (en) 2015-07-23 2017-01-25 Sumitomo Rubber Industries, Ltd. Medical syringe, gasket for use in the syringe, and gasket production method
US10463799B2 (en) 2015-07-23 2019-11-05 Sumitomo Rubber Industries, Ltd. Medical syringe, gasket for use in the syringe, and gasket production method

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