JP3982855B2 - Syringe combining two chambers - Google Patents

Syringe combining two chambers Download PDF

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JP3982855B2
JP3982855B2 JP24332696A JP24332696A JP3982855B2 JP 3982855 B2 JP3982855 B2 JP 3982855B2 JP 24332696 A JP24332696 A JP 24332696A JP 24332696 A JP24332696 A JP 24332696A JP 3982855 B2 JP3982855 B2 JP 3982855B2
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container
sealing plug
screw
syringe
cylinder
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JPH09154945A (en
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茂 杉原
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Daikyo Seiko Ltd
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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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle 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
    • A61M5/31—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
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • 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
    • A61M5/3129—Syringe barrels
    • A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

【０００１】
【発明の属する技術分野】
本発明は２室を結合した注射器に関し、詳しくは該注射器の各室内にはそれぞれ規定量の薬品を安定に保存し、投与の際は両容器内を連通させ一方の室の薬品を他の室に移動させることにより両者を混合して投与可能な注射液とするタイプの注射器の改良に関する。
【０００２】
【従来の技術】
注射器の筒の内部に薬剤（薬液）を収納して保存しておけるキット製品は、緊急時に速やかに衛生的に投与できる注射器として知られており、プレフィルド ディスポーザブル シリンジ（ Pre filled disposable syring ) と呼称されている。
一方注射液として溶液状態での保存が不安定な薬品は、一般に凍結乾燥等の処理により粉末の薬剤としておき、使用時に溶解液と混和して注射液とした後、直ちに投与されるが、緊急を要することもある使用時での混和操作は煩雑で汚染の危険がある。そこで注射筒を二室に分割してそれぞれの室内に予め粉末薬剤と溶解液を分離して充填，保存しておき、使用時に二室を連通して注射液を生成できる二室式の容器兼注射器製剤が開発され、操作の簡便性，確実性と衛生的な迅速投与が可能等の利点を有するため、使用者に喜ばれその使用量も増大しつつある。
【０００３】
図１８は従来品の一例の概略断面図であり、注射器兼容器５０（筒と略す）の先端部５１は注射針が装着できるように筒５０の本体部分より外径が細くなって管状に突出した構造をしており、他の開放端には押棒を係合できる滑栓５２を密に嵌入してある。また、筒５０のほぼ中央の外周に突出する注入溝５３を設け、注入溝５３より開放端側の位置に筒５０内を摺動可能な滑栓５４を設けて筒５０内を前後二室に分離し、前室５５には粉末薬を、後室５７には溶解液を充填している。このような製剤は、前室５５に粉末薬５６を直接充填した後滑栓５４を筒内に挿入して前室内を密封し、次いで後室５７には溶解液５８を充填した後滑栓５２で開放部を密封して製造する。使用時には、滑栓５２の後方に押棒を取り付けてこれで該滑栓５２を後室内に押し込み、押圧をかけられた滑栓５４が注入溝５３に達すると、該滑栓５４の長さは注入溝５３の長さより短く設計されているので両室が連通し、溶解液５８は前室５５内に流入して粉末薬５６と混和し注射液となる。注射針を先端部５１に取り付けることにより直ちに投与可能となる。このような一つの注射筒内を密封栓（滑栓）等により二室に分割した構造の容器兼注射器（以下「分割式容器兼注射器」と略記する場合もある）としては、例えば実公昭４９−１４４６５に記載のものが挙げられる。
【０００４】
また、上記の注入溝の代わりに、注射筒の内壁に針を接着しておき、使用時に二室を分離している滑栓を摺動すると該滑栓が該針に刺通され、該針内部を通路となって二室が連通される容器兼注射器が実公昭５４−２２３１５号に提案されている。このような分割式容器兼注射器の更なる改良として、特開昭５８−４１５６８号、特開昭６１−４８３７７号、特開昭６２−１４８６３号、特開昭６２−１１７５６６号、特開昭６２−２７０１６９号、特開昭６４−８０３７１号、特開平２−５９７３号、特開平３−８２４７６号、特開平６−５４９０８号などが提案されている。
【０００５】
一方特開昭５１−１１６９１号、米国特許明細書第４０３１８９２号には、図１９に示すように、ガラス製の小型容器６１内には粉末薬５９を充填して容器両端をフランジ付きゴム栓６３と滑栓６５で密封し、容器６２内には希釈薬６０を充填してフランジ付きゴム栓６４及びゴム栓６６で密封し、両容器をプラスチック包装体６７で一体にした、二容器結合型の注射器兼容器が提案されている。投与の際には図２０に示すホルダー６８に小型容器６１、６２をはめ込み、ホルダーに固定された注射針６９でゴム栓６２、フランジ付ゴム栓６４、６３を順次穿刺、貫通してゆく。注射針６９の針先が粉末薬５９に達すると、希釈薬６０は注射針６９の中程の開口７１より注射針内を経由して容器６１内に流入し、粉末薬５９と混和、溶解して薬液となる。注射液投与には、滑栓６５に押棒を付けて押すと、薬液は注射針６９内を通って、注射針７０から流出できる。
【０００６】
このように、二つの小容器（室）を連結したタイプの注射器は、凍結乾燥等を要する薬品と溶解液等を別容器内に充填、製剤できるので、製剤工程等における作業性が高く、また一つの容器サイズが小さいため分割タイプよりも一度に処理できる数が多くなり、有利である。さらなる改良として、特開平４−３５４９５４号、特開平５−３１１９１号、特開平６−７４４６号、特開平６−１４２２０３号、特開平７−１３６２６７、特開平７−１３６２６４号、特開平７−１４８２６１号、実開平５−１５２、実開平５−８６３５３、実開平６−１３８３２号などに記載される提案がある。
【０００７】
【発明が解決しようとする課題】
上記従来技術では依然として、注射器への薬剤充填には複雑な作業工程を要するに加え、加熱減菌による薬剤力価の低下など品質保持上の問題があり、さらには減菌工程の簡素化、製剤装置と薬剤コスト低減による商品価格の低減等、解決すべき問題が多々残っている。
本発明はこのような現状に鑑み、二室を結合した注射器のさらなる改良を目的とし、二種類の薬品を別容器に保存することにより特に不安定な薬や力価保持の必要のある薬品の安定性をより高度に保つことができること、使用に際してはより簡単な操作で両薬品を混合できてただちに衛生的に投与できること、製剤工程においては滅菌が簡単に操作できること、滅菌下クリーンルーム内で衛生的に高度な製剤技術をしかも簡単に適用できる構造とすること、等の要求を満足できて現在の医薬品に求められている高性能、高品質な注射器兼容器を提供することを課題とするものである。
【０００８】
【課題を解決するための手段】
本発明は、以下を要旨とする。
〔１〕 （１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内の該注射針取り付け用ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体内の該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製の容器ｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、上記該容器ａと該容器ｂの結合が、該容器ａの後端開放部壁面に螺設したねじと、該容器ｂの先端開口部壁面に螺設したねじの螺合によるものであり、ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。
〔２〕 上記容器ａのねじは後端部の内周壁面に螺設されためねじであり、上記容器ｂのねじは先端開口部の外周壁面に螺設されたおねじであることを特徴とする〔２〕記載の２室を結合した注射器。
〔３〕 （１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内の該注射針取り付け用ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体内の該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製の容器ｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、該容器ａと該容器ｂの結合が、該容器ａの後端開放部壁面に螺設したねじと、該容器ｂの先端開口部壁面に螺設したねじの螺合によるものであり、かつ該容器ａの後端の開放端部から筒軸方向に向かう切欠き又は凹窪を１個以上有し、ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。
〔４〕 該容器ａのねじは後端部の外周壁面に螺設されたおねじであり、該容器ｂのねじは先端開口部の内周壁面に螺設されためねじであることを特徴とする〔１〕又は〔３〕記載の２室を結合した注射器。
〔５〕 （１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内に該ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体と該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製の容器ｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、上記該容器ａと該容器ｂの結合が、容器ａの後端開放部外周壁面に螺設したねじと、容器ｂの先端開口部外周壁面に螺設したねじを、該容器ａ，該容器ｂの外径より大きい内径を有する筒状のコネクターの内周壁面に螺設したねじとそれぞれ螺合することによるものであり、ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。
〔６〕 上記容器ａ本体の外径が上記容器ｂ本体の外径と実質的に等しく、上記容器ａ本体の内径が上記容器ｂ本体の内径と実質的に等しいか又は若干大きいものであることを特徴とする〔１〕ないし〔５〕のいずれかに記載の２室を結合した注射器。
〔７〕 上記容器ａ本体の内径が上記容器ｂ本体の内径より大きいものであることを特徴とする〔１〕ないし〔６〕のいずれかに記載の２室を結合した注射器。
〔８〕 上記容器ａ本体の壁厚さと上記容器ｂ本体の壁厚さは等しいか又は一方が他方より厚いものであることを特徴とする〔１〕ないし〔７〕のいずれかに記載の２室を結合した注射器。
〔９〕 上記不連続部が筒軸方向に沿って設けた凹状溝であることを特徴とする〔１〕ないし〔８〕のいずれかに記載の２室を結合した注射器。
〔１０〕 上記不連続部が筒軸方向に沿って一列に周期的に並ぶ断面三角形の山部と谷部からなることを特徴とする〔１〕ないし〔９〕のいずれかに記載の２室を結合した注射器。
〔１１〕 上記容器ａの先端開口部を封止するゴム栓が、脚を有し、該脚には切り欠きと、外周面に環状突起を設けてあり、該ゴム栓にはスカート部に切り欠きを有し天面には突出した円筒状の管部を有するキャップを被せ、該キャップを被せたゴム栓を容器ａの先端開口部に半打栓状態で係止させることにより、容器ａ内部とゴム栓の切り欠き及びキャップの切り欠きが連通した通路を形成できるものであることを特徴とする〔１〕ないし〔１０〕のいずれかに記載の２室を結合した注射器。
【０００９】
【発明の実施の形態及び実施例】
本発明は二室結合型の容器兼注射器において、該容器の結合を容器端部に形成したねじ（螺子）の螺合による点を第一の特徴とするものであるが、本発明の構造、その作用機構等の特徴を実施例により詳細に説明する。
図１は本発明の一実施態様を示す断面図であり、注射器兼容器（以下「注射器」と略記する場合もある）１は、それぞれが粉末又は濃縮薬品、液状薬品（薬液ともいう）を図示のように収納する容器である、円筒体ａ（以下筒ａとも略記する）及び円筒体ｂ（以下筒ｂとも略記する）を筒ａ，ｂそのものに設けたねじで結合してなる構造体である。図２は薬品充填以前の図１の注射器を筒ａ，筒ｂに分離した状態を示す断面図である。
【００１０】
筒ａは円筒状の本体２と本体２より細い管状に突出した先端部を有し、該先端部の開放口にゴム栓３を打栓して封止しさらにキャップＣ1 でゴム栓３を開放口に固定してある。投与の際に該ゴム栓３とキャップＣ1 をつけたまま注射針の装着が可能な構造をしている。筒ａの他の開放端部すなわち筒ｂと結合する側の端部の内部には第１密封栓４を密嵌して容器を構成する。ゴム栓３と第１密封栓４との間に形成される空間（室）内には濃縮薬、凍結乾燥薬、結晶、顆粒、粉末薬、錠剤薬などの固形の薬品（以下、濃縮薬と総称する）５を充填し、該ゴム栓３と第１密封栓４により容器内を完全に密封し、気密に保持して、長期間にわたり濃縮薬５の品質を維持する。筒ａ本体２の内壁表面には、筒軸方向中央部よりやや第１密封栓よりの位置において、二室の間にバイパス流路を形成するための不連続部６が筒軸方向に沿って凹溝状に設けられ、該不連続部６の筒軸方向長さは、第１密封栓４と後述する第２密封栓１０の各筒軸方向長さの合計よりも大きくしてある。該第１密封栓４は筒内における摺動性も確保できるように、その材質については充分考慮して選択することが望ましい。
【００１１】
筒ａ本体２の開放端部内周には内壁に彫り込んだめがたのねじ７（凹状螺子）を設けてある。また、筒ｂの先端部の外周には、前記めがたのねじ（螺子）７に螺合できるピッチでおがたのねじ（凸状螺子）８が螺設してあり、ねじ８の外径の最大値は筒ｂ本体９の外径より小さくされている。このねじ７，８を螺合することにより筒ａと筒ｂを簡単かつ強固に結合でき、本例では筒ａの外径Ｄ1 と筒ｂの外径Ｄ2 はほぼ同じであるため結合部分に凹凸を生ずることなく１本の円筒体を形成できる。なお、図示の例では筒ａにめがたのねじ、筒ｂにおがたのねじを螺設していが、筒ａにおがたのねじ、筒ｂにめがたのねじを設けることもできる。
【００１２】
筒ｂの先端側内部には摺動可能な第２密封栓１０を密嵌して密封してあり、もう一方の端部である後端内には、第３密封栓１１を密嵌し、上記第２密封栓１０と該第３密封栓１１との間に形成される室内に溶解液、分散液、生理用食塩水液、注射用蒸留水などの液状薬（以下、「薬液」と総称する）１２を水密に収容している。
【００１３】
上記筒ａ，ｂ及び第１〜第３密封栓は、高圧蒸気減菌の際の高温から凍結乾燥の際の約−５０℃といった低温に至っても変形に耐え且つ液漏れのない材質と構造となっている。即ち該第１，第２及び第３密封栓４，１０及び１１は筒本体２，本体９の内径より若干大きな外径を有し、筒ａ又はｂの内壁との摺動面には図３に示すようにリブ１３を３個以上設けて、筒内壁との密封性と摺動性という矛盾する特性を両立させてある。ただし本発明においては、表面に合成樹脂フイルムを積層したリブ無し密封栓を使用することにより、密封性と摺動性を両立させることもできる。また第３密封栓１１の後部には押棒を係合するためのねじ窪１４を設ける。
【００１４】
以上の構成でも本発明の目的は十分に達成できるが、本実施例ではさらに、リブ部分より大きい外径の螺子をその外周に有するゴム栓１５を第３密封栓１１の後方に設けて、該ゴム栓１５には筒ｂの内壁面に接する外周部に環状の突起１６を設けたことにより、密封性をより向上している。
【００１５】
本実施例の注射器は、容器ａ，容器ｂ内にそれぞれ薬品を充填した後、両容器を結合して製造する。具体的には、筒ａの後端と筒ｂの先端を合わせ、ねじ（螺子）７及び８を螺合して約１〜３回転、好ましくは１〜２回転することにより、簡単かつ確実に筒ａと筒ｂを直列に結合できる。第１密封栓４と第２密封栓１０とをできるだけ衛生的にかつ気密に密着させるために、クリンルーム内において真空下で筒ａと筒ｂを螺合することが好ましい。
【００１６】
一般的に２つの円筒体を結合して一つの円筒体にする方法として、結合部分を接着する方法やセロファン又は合成樹脂製テープで両筒の外周を巻き固定する方法がある。しかし市販の接着剤あるいは市販のセロファン又は合成樹脂製テープに塗布されている接着剤は合成樹脂系接着剤であり、低発揮性、有毒性の不純物を多量に含むため、これらを用いて簡単に結合することは、衛生性、安全性の面で危険である。本発明のような物理的な結合手段によれば上記の危険性はすべて解消される。
【００１７】
図３は筒ｂ内の薬液１２が筒ａへと移動して濃縮薬５と混合される状態を示す概略断面図である。即ち筒ｂ後部の第３密封栓１１のねじ窪１４に押棒１８を取り付け、該押棒１８を筒９内に押し込むことにより圧力が薬液１２に伝わり、第２密封栓１０と第１密封栓４は一緒に移動し、第１密封栓４、第２密封栓１０とが不連続部６に達した状態を示す断面図である。不連続部６は筒ｂ本体２の内壁面に彫り込まれた筒長さにのびる細い凹溝であり、その長さを第１密封栓４と第２密封栓１０の筒軸方向長さの合計より長くなるように設計してあるので、第１及び第２密封栓４，１０は不連続部６の中にはまりこみ、一方不連続部６の反対側の筒内壁面には突起１９を設けてあるので第１密封栓４の先端はこの突起１９で一時係止する。この状態で第１密封栓４及び第２密封栓１０と不連続部６の間が筒ａと筒ｂの間を連通する通路となる。押棒１８の環状突起２０は一時係止の目印となる。この第１密封栓４の一時係止の状態で押棒１８を徐々に押し込むことにより薬液１２は筒ａ内へと流れ込み、第３密封栓１１の先端が第２密封栓後端に当接するまで押棒を押し込むことにより薬液１２は筒ｂから完全に筒ａ内に流出する。筒ａ内で薬液１２と濃縮薬５は混和して規定の濃度の薬剤になる。不連続部６での薬液、残留気体等の流れを容易にするために振動を与えることも好ましい動作である。
【００１８】
図４は図３のＡ−Ａ′方向断面図であり、筒ａの不連続部６の筒軸方向に垂直な断面を示している。
【００１９】
図５は本発明の注射器で注射液を投与し終わった状態を示す概略断面図である。筒ａの先端に注射針２１（図示の例で両頭針）を取り付け、押棒１８を押しこみ、第１密封栓４，第２密封栓５及び第３密封栓１１を筒ａ内部の先端まで移動させることにより、溶解薬液（注射液）は注射針２１を経由して流出し、投与が完了する。Ｃ2 はキャップである。
【００２０】
本発明は図５に示されるように第１密封栓の先端側に窪みを設けて、注射器内、先端内壁、第１密封栓、注射針の周囲の間隙をなくして投与後に注射器内に残存する薬液１７の量を極少値にすることができる。従って本発明は例えば０．２〜１ｍｌという小容積の注射器にして、極めて少量でかつ力価が高く規定量を確実に投与する必要のある高価な薬品を投与する目的に好適である。
【００２１】
図６に本発明の他の実施例を示す。図６の実施例においては、筒ａの本体２の内径ｄ1 を筒ｂの内径ｄ2 よりも若干太く設計した。ｄ2 を１００とするときｄ1 を１０２〜１０８の範囲に設計することによって第２密封栓１０の筒ａ内での摺動が容易になる。
また、本例においては不連続部を筒軸方向断面において断面三角形の山部２２と谷部２３が周期的に繰り返される凹凸を有する形状にしてあり、不連続部の筒軸方向長さをＬ、第１密封栓４の筒軸方向長さ（厚さ）をｌ4 第２密封栓１０の筒軸方向長さ（厚さ）をｌ10とすればＬ＞ｌ4 ＋ｌ10になるように設計する。図６の例では筒ａ内の末端内壁の第１密封栓との接触部に、環状の低い突起２４を設けて濃縮薬５を密封している。
【００２２】
図７は図６の筒ａの不連続部のＢ−Ｂ′断面図である。該不連続部は筒ａの内壁面に断面三角形の突起２２と谷部２３が連続することにより形成されているので、第１密封栓４、第２密封栓１０が変形して通路２５を形成し、薬液１２が通過できる。
【００２３】
図１，図２及び図６に示した本発明の各実施例では筒ａと筒ｂの本体の内径と外径はそれぞれほぼ等しいサイズであった。そのために結合部分の螺子は壁厚を薄くし形成されているが、本発明は螺子外径をほぼ本体部分外径と同じにすることもできる。
【００２４】
図８は本発明のさらなる実施態様を示す概略断面図であり、本実施例では筒ａ本体２０１の後端外周におがたのねじ（螺子）７１を、筒ｂ本体９０１の筒ａ後端に接続する側の端部におがたのねじ（螺子）８１を設け、別の筒ｃの内壁面に前記ねじ７１，８１と螺合するめがたのねじ（螺子）２６を設けてコネクター２７とし、図示のように筒ａ，筒ｂはそれぞれコネクター２７と螺合することにより一体化される。本実施例では筒ａ本体２０１の外径Ｄ1 と筒ｂ本体９０１の外径Ｄ2 及びコネクター２７の内径ｄ3 はほぼ同じである
コネクター２７の使用は結合部に若干の凹凸を生じるが、テープ巻き固定に比較すると前記した接着剤による弊害がないこと、固定がより確実であることにおいて優れている。
【００２５】
以上の例では二つの筒の本体はほぼ同じサイズであったが、本発明においては螺合という結合を採用したことにより、２つの筒の本体部分は必ずしも同じ内径と外径にする必要はなく、以下の例に示すように筒の壁厚さや内径を変化させることが可能となった。すなわち、本発明においては各筒内に収容する薬品の製剤処理や滅菌処理使用上に対応して適切な壁厚、内径の容器を設計できるという大きな利点がある。
【００２６】
図９は本発明の実施例の筒ａと筒ｂの螺子と筒外径との関係を示す断面図である。筒ａ本体２０２の後端部の内壁をめがたのねじ（凹部）７２とし、筒ｂ本体９０２の先端部外周におがたのねじ（螺子）８２を設け、筒ａの内径をｄ1 ，外径をＤ1 、筒ｂの内径をｄ2 ，外径をＤ2 とするとき、本例ではｄ1 ＝ｄ2 かつＤ1 ＞Ｄ2 と筒ａの壁厚を大きくしたことにより、図示のように筒ａ，ｂを直列に結合して一本の注射筒１としている。
【００２７】
図１０は本発明の他の実施例を概略説明する断面図であり、本実施例では、筒ａ本体２０３の壁厚ｍを非常に厚くし、図示は省略した筒ｂの先端側（筒ａ側）の外周を包み込むように延長部２８を設けてある。本実施例では筒ａの端部からかなり先端よりの内壁部分に段差をつけてねじが設けられ、図示は省略しているが筒ｂにも同様に段差をつけて設けてある。これにより筒ａ内に筒ｂを誘導して内部に螺設したねじ７３との螺合が容易になる。なお、螺子７３のピッチ（巾）を広めにすると、筒の回転角度を３０〜３６０℃、すなわち１回転までのねじりで強く結合でき、分離も容易である。
この筒ｂのねじ部分にすぐ続く本体部分の肩になる部分が上記筒ａの段差部分と当接する位置に環状パッキン２９を配置しておくと、さらに密着性が向上するので、好ましい実施の態様である。
【００２８】
図１１は本発明の他の実施例を概略説明する断面図であり、本実施例では筒ａの本体２０４の外径Ｄ1 を大きくし、壁厚さｍを厚くした。このように筒の壁を厚く設計することにより、筒ａ自体の容器としての物理的、化学的安定性を向上できると共に、筒ａの外周面形状を種々に加工して操作性の向上等を図れる。また模様として他のものとの区別を図ることもできる。すなわち、筒ａの外周面には指型凹部３０を設けたり、ほぼ円板型のフランジ３１を係合するための環状凹部３２を設けることができる。または筒ａの外周面に斜線状の凹凸、その他の形状の凹凸を設けることもできる。なお、筒ｂの外周面にも指型凹部あるいは斜線状凹凸等を設けることもある。７４はねじを表す。
【００２９】
次に本発明により筒ａ，ｂ内に濃縮薬，薬液を製剤し、一本の注射筒として組み立てる工程を説明する。筒ａ，筒ｂ，ゴム栓、各密封栓等の薬剤に接触する部品はすべて予め、アルカリ洗浄、精製水洗浄などにより異物を除き、乾燥の後、高圧上記滅菌又はγ線滅菌工程を経たものを用いる。
なお、筒ａ、筒ｂの筒本体の合成樹脂素材と密封栓の材質は高圧蒸気滅菌に耐える素材を選択する。
【００３０】
本発明の筒ｂに液状薬を製剤する工程は、従来この種の製剤工程として公知の工程に従えばよい。簡単に説明すると、上記の洗浄、滅菌された筒ｂに第２密封栓１０を打栓した後に、溶解液、分散液、生理食塩水液、注射用蒸留水などの液状薬１２を充填し、次いで筒内に空気（酸素）が残留しないように真空下で第３密封栓１１を打栓した後に、高圧蒸気滅菌（蒸気温度１２５〜１３０℃）を行なう。
【００３１】
次に本発明の筒ａ内に例えば抗生物質，酵素，血清，ワクチン，蛋白，ビタミン製剤などの濃縮薬を製剤する工程を説明する。従来汎用される方法では、注射筒の先端口をゴム栓、キャップで封止し、無菌室内で注射筒の後端側から無菌混合した濃縮薬を充填し、濃縮後、該密封栓で封止した。
これに対し、本発明の注射筒ａの一具体例においては図１２を参照して説明するように、後端側を密封栓で封止し先端側を上にした状態で濃縮薬を充填した後、先端側から濃縮することができる。後端側の方が断面積が広いため注射器の位置が安定している。すなわち、無菌室，クリーンルーム内等の滅菌環境下において、筒ａの開放端は第１密封栓で封止し、第１密封栓側を下にして先端口４１側から原料の希い薬液を規定量仕込む。図１２に示すように脚４２付きで、該脚４２には切欠き４３及び環状の突起４４を有するゴム栓Ｓ1 を筒ａの先端口４１に半打栓し、ゴム栓Ｓ1 の上にはキャップＣ4 を被せる。該キャップＣ4 にはキャップのスカート部３７の壁内側に溝３８を有しているので、半打栓状態で突起４４が先端口４１に係止して、先端口４１、切り欠き４３、溝３８が連続する通路を形成できる。真空条件下で筒ａ内の希い原料薬液は蒸発し、蒸気３９は該通路から排気され、濃縮薬（凍結真空乾燥薬）となる。完全に乾燥濃縮薬になると、同じ滅菌環境の室（槽）内に配置してある図示は省略した打栓装置により直ちにゴム栓Ｓ1 とキャップＣ4 を共に完全に打栓、封止することにより、筒ａ内に非常に衛生的に濃縮薬を密封することができる。この後、別工程により濃縮薬を混合、溶解する薬液を充填、封止した筒ｂと、上記で得た筒ａとを、螺合することにより一体の注射器として組み立てる。
【００３２】
また、本発明において筒ａ内への製剤は筒ａの先端側を封止して後端側から薬剤を充填し、第１密封栓を半打栓状態にして濃縮することもできる。
図１３は本発明の他の実施例において減圧槽室（又は凍結乾燥槽室）内で筒ａ内に充填した原料の薄い薬液５′を濃縮する工程を説明する図である。筒ａの本体２０５の先端はゴム栓Ｓ2 ，キャップＣ5 で封止し、後端は第１密封栓４５を半打栓してある〔（イ）〕。（イ）部分のＣ−Ｃ′断面から矢印方向に見た俯瞰図を（ロ）に示す。該ゴム栓Ｓ2 ，該第１密封栓４５の薬液，濃縮薬に接触する面には樹脂製フィルム４７を積層してある。また該第１密封栓４５は筒２０５との摺動面にリブ４８を３個有する。このリブ４８の１個だけを筒ａ後端内に入れ、第２番目のリブを筒ａの後端のネジ７５の部分に係止することにより半打栓状態を保てる。本実施例は筒ａに設けたおがたのねじ７５の内壁面の対称の位置に筒軸方向に沿う２個の凹窪４９を有しており、半打栓状態で該凹窪４９は筒本体２０５の内壁との間に空隙を形成できるので、薬液の蒸気３９はこの凹窪４９を通路として排出される。十分に濃縮、乾燥した時点で、減圧槽室内においてそのまま第１密封栓を完全に打栓することにより、非常に衛生的に封止できる。
【００３３】
図１４は図１３の製剤された筒ａ２０５のねじ７５と、別途薬液を製剤された筒ｂ本体９０５のめがたのねじ８５を螺合して組み立てた本発明の注射器の概略断面図である。筒ｂ本体９０５の先端の第２密封栓１０５と後端の第３密封栓１１５も、薬液接触面には樹脂製フィルム４７が積層されている。第３密封栓１１５の後ろには更にキャップ１５′を装着して固定を強化している。また筒ｂ９０５は後端側の内壁に凹部３０を有し、キャップ１５′との係合を強化してある。
【００３４】
図１５は本発明のさらなる他の実施例において減圧槽室（又は凍結乾燥槽室）内で筒ａ内に充填した原料の薄い薬液５′を濃縮する工程を説明する図である。筒ａの本体２０６のリブＲを有する先端はゴム栓Ｓ3 ，キャップＣ6 で封止し、後端は第１密封栓４６を半打栓してある〔（イ）〕。（イ）部分のＤ−Ｄ′断面から矢印方向に見た俯瞰図を（ロ）に示す。該第１密封栓４６は筒２０６との摺動面にリブ４８を３個有し、このリブ４８の１個だけを筒ａ２０６後端内に入れ、第２番目のリブを筒ａ２０６の後端のおがたのねじ７６の部分に係止することにより半打栓状態を保っている。本実施例は筒ａのねじ７６を対称な位置において２個所で開放端部から筒軸方向に向けて切り欠いており、半打栓状態で筒本体２０６の内壁との間に図１３の場合より広い通路を形成できる。薬液の蒸気３９はこの切欠き４９′を通路として排出される。十分に濃縮、乾燥した時点で、減圧槽室内においてそのまま第１密封栓４６を完全に打栓することにより、非常に衛生的に封止できる。なお６′は不連続部である。
【００３５】
図１６は図１５の製剤された筒ａ２０６のねじ７６と、別途薬液を製剤された筒ｂ９０６のめがたのねじ８６をパッキング２９を介在させて螺合し、組み立てた本発明の注射器の概略断面図である。筒ｂ９０６の先端の第２密封栓１０６と後端の第３密封栓１１６も、薬液接触面には樹脂製フィルム４７が積層されている。第３密封栓１１６の後ろには更にキャップ１５′′を装着して固定を強化している。また筒ｂ９０６は後端側の内壁に突起を有し、キャップ１５′′との係合を強化してある。
上記の筒ａ２０６と筒ｂ９０６との結合工程もクリンルーム内で行なうことが好ましい。本発明は結合工程を簡単かつ確実に実施できるので、作業工程上有利である。
【００３６】
図示は省略したが、本発明のさらに他の実施例においては、筒ａの後端の開放部近傍に孔を設けることによって、図１３、図１５の例と同様の作用効果を得ることができる。
【００３７】
次に本発明の注射器の筒ａの注射針取り付け側である先端部の構造を説明する。図１０の実施例においては、筒ａの先端口の外周面に突起を設け、図示は省略したゴム栓の内壁には該突起と係合する環状凹部を設けて、先端の密封を確実にしてある。
また図１５及び図１６に示す本発明の一具体例では、筒ａの先端口の外周に本体２０６から突出した筒状のカラ−Ｃ7 を有し、該カラーＣ7 は内壁面にリブＲが２本形成されている。このカラーＣ7 内にフランジ付ハブ注射針基を容易に固定することができる。また該筒ａの先端口はゴム栓Ｓ3 で密封され、該ゴム栓Ｓ3 はキャップＣ6 で固定されている。
【００３８】
本発明注射器は０．２〜１ｍｌという小容量から５０ｍｌ程度の大容量まで広いサイズ範囲に適合でき、しかも大容量の筒内に収納した、吸湿性大で易酸化性の不安定な薬についても３〜５年間という長期保存を実現することを目指した。この目的のために、本発明の第１、第２、第３密封栓（以下滑栓とも総称する）は高い密封栓と摺動性の両立が要求される。該滑栓の材質としては、例えばＪＩＳ硬度３０近傍の比較的軟かい材質で、耐熱性を有し、圧縮歪のない加熱ゴム弾性体、例えば１００℃で圧縮歪量約１０％のゴム弾性体などが好ましい。また密封栓の形状としては、筒内壁との摺動部分に環状のリブを３個以上設けたものが好ましい。その他、この種の分野における公知技術を最高度に適用することが望ましい。
【００３９】
図１７は本発明の注射器を包装した完成製品の一実施例を示す概略断面図である。濃縮薬５を筒ａ内に、薬液１２は筒ｂ内に収容し、ゴム栓３′、第１密封栓４′、第２密封栓１０、第３密封栓１１で各々を密封している。該筒ａと筒ｂは端部に形成されたねじ７とねじ８を螺合することにより強固に結合一体化して、凹凸のない一本の円筒形をなしている。製剤された本発明の注射器は、例えば図１７に示すような包装体３４に入れ、防振ゴム３５を配置し、ゴム栓３６で密封する。これにより運搬による振動から保護できる。この形状は容器全体の包装が簡単である。
【００４０】
なお、図１７の実施例では押棒１８′が両頭の注射針（両頭針）３３の収納容器を兼ねていて、使用時には、第３密封栓１１に係合している押棒１８′を筒ｂの内部に押し込み、液状薬１２が全部濃縮薬５と混合、移動終了した後に、筒ａと筒ｂの螺合を解除して両者を分離する。次に押棒１８′から両頭針３３を取り出して先端ゴム栓３′に穿刺，貫通し、両頭針３３内部を通路として薬液を投与する。前記押棒１８′は筒ｂ、又は筒ａの長さであれば充分効果を奏する。このように２室結合タイプにすると押棒長さは従来より短いものでよくなる。
【００４１】
本発明の注射器は螺合しているので、従来品より結合部分の間隙や凹凸が少ないこと、外径が同サイズの容器を採用すれば、全体で凹凸が少ない一本の円筒体を形成するので容器との間隙も小さくコンパクトに包装でき、携帯にも便利である。また、包装体との間の間隙が少ないほど、注射器内に侵入するおそれのある空気等の酸化促進物質の存在量も低減でき、薬品の品質保持に有効である。
【００４２】
また、本発明は筒ａ、筒ｂの結合が容易であると共に分離することも可能であるため、筒ａ内の薬と筒ｂの液状薬の組合せを種々に変化できる。例えば筒ａ内には抗癌薬あるいは抗生物質を製剤しておき、筒ｂの液状薬は注射用蒸留水又は生理食塩水を組み合わせる等であり、一室を分割するタイプに比較して製造工程が簡単で、能率的であることは言うまでもない。この場合には筒ａと筒ｂを別個に選択できる形態で製品とすることもできる。さらに、医師等が組合せを選択して投与したいケースにも対応でき、研究用途等にも好適である。
【００４３】
以上のような構造の本発明の注射器を構成する材質について以下に説明する。本発明は注射器としての人体への安全性と耐薬品性は必須の要件であるが、さらに薬品容器として上記のように物理的特性、化学的特性、安定性、環境条件に対する感受性の異なるいずれの薬品に対しても充分気密に、空気（酸素）、水分（湿度）、温度等の環境からの影響を受けずに保存できる材質を選択する必要がある。滑栓についてはすでに説明したとおりである。本発明の注射器の容器本体（筒）の材料としては、合成樹脂等が挙げられるが、螺合により結合するので、精密な形状にねじを設けることが必須であり、成形性も考慮すると合成樹脂が好ましく、例えば環状オレフィン系化合物又は架橋多環式炭化水素化合物を重合体成分とする樹脂、ポリエチレン、ポリプロピレン、ポリカーボネート、ポリメチルペンテン、ポリエステル樹脂等の１種以上を用いることができる。また、２種以上の材料を積層することも好ましい。さらには合成樹脂表面に酸化珪素、酸化マグネシウムを蒸着したものも好ましい。合成樹脂の成形、加工はこの種技術分野における公知の技術のいずれをも利用できる。注射針部分についても公知技術を適用する。
【００４４】
本発明の包装体材料としては、例えばポリエステル、ポリスルホン、ポリアリレート、変性フェニレンオキシド樹脂、ポリアミド、ポリビニールアルコール、ポリ酢酸ビニルなどを相互に３〜５層に積層した材料が挙げられる。上記積層樹脂表面に酸化珪素、酸化アルミニウム、酸化マグネシウムなどを蒸着したものは、酸素、空気、水分（湿度）に対するバリア作用があり、注射器内に充填された医薬品の品質を保持して長期保存するために好適である。
【００４５】
【発明の効果】
本発明は各々薬品を充填した２個の容器を、容器自体に螺設した螺子の螺合により直列に結合してなる注射器兼容器であり、その効果は下記のとおりである。
(1)２個の円筒体容器を直接に螺子部で嵌合するので、小容積で強力に結合する、又円筒体の分離も容易である。
(2)容器自体に形成した螺子で物理的に結合するので、接着剤や熱溶着等の必要がないため、製剤工程上有利であるに加え、熱や接着剤等による品質低下の危険性を解消できた。
(3)螺子による結合であるため、２個の容器のサイズ、壁厚を任意に調整できて、内部に充填する薬品の製剤工程、剤形に応じて好適な組合せを選択できる。
(4)濃縮薬を充填する容器ａの本体円筒の内径を容器ｂの内径より若干太くしたタイプのものでは、小さい滑力で投与できる。
(5)容器サイズを適宜組み合わせることができるため、例えば規定された濃縮薬に対して、液状薬の種類、サイズを種々にを変えた組合せのものも容易に製造し、使用できる。
(6)２種の薬品を別々に製剤できるので、製造工程が簡略化される。
(7)従来の分割式注射器にくらべ小容積の容器であることに加え、押棒部分も従来品により短くできるので、一バッチで従来品より多量を処理できて、製造効率向上とコスト低下を実現できる。
(8)容器ａと容器ｂは完全に気密に遮断される構造となっており、濃縮薬の保存に液状薬が影響することを防止できるので、長期にわたり安定した高品質を保証できる。
(9)注射器は小さくまとまり、包装も簡素となり、携帯に便利である。
(10)容器本体、ゴム栓、密封栓、押棒、注射、包装体針等をすべて廃棄物処理 が簡単な合成樹脂製とすれば、環境保護問題にも対応できる。
【図面の簡単な説明】
【図１】 本発明の一実施例を説明する概略断面図である。
【図２】 図１の注射器の筒ａと筒ｂの構造を説明する断面図である。
【図３】 図１の注射器において筒ｂ内の薬液を筒ａ内に移送する状態を説明する概略断面図である。
【図４】 図３のＡ−Ａ′断面図である。
【図５】 図１の注射器の投与終了時の状態を説明する概略断面図である。
【図６】 本発明の実施例における不連続部近傍の構造を説明する部分断面図である。
【図７】 図６のＢ−Ｂ′断面図である。
【図８】 本発明の他の実施例におけるコネクターによる結合を説明する概略断面図である。
【図９】 本発明の他の実施例における筒ａと筒ｂのサイズの関係を説明する概略断面図である。
【図１０】 本発明の他の実施例おいて本体壁厚さが大きく異なる筒ａと筒ｂの構成を示す概略断面図である。
【図１１】 本発明の他の実施例における筒ａの外周面の加工を示す概略説明図である。
【図１２】 本発明の他の実施例において切り欠きを有するキャップとゴム栓を用いて凍結乾燥する工程を説明する部分断面図である。
【図１３】 本発明の他の実施例において筒ａ後端部の凹窪を蒸気の通路として原料の希い薬液を濃縮する工程を説明する図である。
【図１４】 図１３の製剤工程を終え筒ａと筒ｂを組み立てた本発明の注射器を説明する概略断面図である。
【図１５】 本発明の他の実施例において筒ａのねじ部分の切り欠きを蒸気の通路として原料の希い薬液を濃縮する工程を説明する図である。
【図１６】 図１５の製剤工程を終え筒ａと筒ｂを組み立てた本発明の注射器を説明する概略断面図である。
【図１７】 本発明の注射器を包装した一例を示す概略断面図である。
【図１８】 従来の一本の注射筒を滑栓により二分割した２室式容器兼注射器の概略断面図である。
【図１９】 従来の二室を結合するタイプの容器兼注射器の一例の注射筒部分の概略断面図である。
【図２０】 図１９の注射筒部分と組み合わせる注射針部分の概略断面図である。
【符号の説明】
１ 注射器兼容器、
２，２′，２′′，２０１，２０２，２０３，２０４，２０５及び２０６筒ａ本体、
３，３′，３６及び３８並びにＳ1 ，Ｓ2 及びＳ3 ゴム栓、
４，４′，４５及び４６ 第１密封栓、
５ 濃縮薬、
５′原料の希い薬液、
６，６′不連続部、
７，７１，７２，７３，７４，７５及び７６ ねじ、
８，８１，８２，８５及び８６ ねじ、
９，９０１，９０２，９０５及び９０６ 筒ｂ本体、
１０，１０５及び１０６ 第２密封栓、
１１，１１５及び１１６ 第３密封栓、
１２ 液状薬、 １３ リブ、 １４ ねじ窪、
１５及び１５′ ゴム栓、 １６ 突起、 １８及び１８′ 押し棒、
１９及び２０ 突起、 ２１ 注射針、 ２２ 山部、
２３ 谷部、 ２４ 突起、 ２５ 流路、
２６ コネクターのねじ、２７ コネクター、 ２８ 延長部、
２９ パッキン、 ３０ 指型凹部、 ３１ フランジ、
３２ 環状凹部、 ３３ 両頭針、 ３４ 包装体、
３５ 防振ゴム、
３７ スカート部、 ３８ 溝、 ３９ 蒸気、
４１ 先端口、 ４２ 脚 ４３ 切り欠き、
４４ 環状の突起、 ４７ 樹脂製フィルム、 ４８ リブ、
４９ 凹窪、 ４９′切り欠き、
Ｃ1 ，Ｃ2 ，Ｃ4 ，Ｃ5 及びＣ6 キャップ、
ｄ1 筒ａの内径、 ｄ2 筒ｂの内径、 ｄ3 コネクターの内径、
Ｄ1 筒ａの外径、 Ｄ2 筒ｂの外径、
ｌ4 第１密封栓長さ、 ｌ10 第２密封栓長さ、
Ｌ 不連続部長さ、 ｍ 壁厚さ、 ５０ 注射器兼容器、
５１ 先端部、 ５２ 滑栓、 ５３ 注入溝、
５４ 滑栓、 ５５ 前室、 ５６ 粉末薬、
５７ 後室、 ５８ 溶解液、 ５９ 粉末薬、
６０ 希釈液、 ６１，６２ 小型容器、 ６３ ゴム栓、
６４ フランジ付きゴム栓、 ６５ 滑栓、 ６７ 包装体、
６８ ホルダー、 ６９及び７０ 注射針、 ７１ 開口。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a syringe that combines two chambers. Specifically, each of the syringes stably stores a prescribed amount of medicine, and in administration, both containers are communicated with each other so that the medicine in one chamber is in another chamber. The present invention relates to an improvement of a syringe of a type in which both are mixed to give an injectable injection solution.
[0002]
[Prior art]
Kit products that can store and store medicines (medical solutions) inside the syringe barrel are known as syringes that can be quickly and hygienically administered in an emergency, and are called pre-filled disposable syrings. ing.
On the other hand, chemicals that are unstable in the solution state as injection solutions are generally put into powdered drugs by treatment such as freeze-drying. The mixing operation during use may be complicated and there is a risk of contamination. Therefore, the syringe barrel is divided into two chambers, and the powdered drug and the solution are separately filled and stored in each chamber. Syringe preparations have been developed and have advantages such as easy operation, certainty, and hygienic rapid administration, so that users are pleased with the amount used.
[0003]
FIG. 18 is a schematic cross-sectional view of an example of a conventional product. The tip 51 of a syringe / container 50 (abbreviated as a cylinder) has a smaller outer diameter than the main body of the cylinder 50 so that an injection needle can be attached and protrudes into a tubular shape. In the other open end, a sliding plug 52 capable of engaging with a push rod is closely fitted. In addition, an injection groove 53 protruding on the outer periphery of the center of the cylinder 50 is provided, and a stopper 54 that can slide in the cylinder 50 is provided at a position closer to the open end than the injection groove 53 so that the inside of the cylinder 50 is divided into two front and rear chambers. The front chamber 55 is filled with powdered medicine, and the rear chamber 57 is filled with a solution. In such a preparation, the front chamber 55 is directly filled with the powdered medicine 56 and then the slide plug 54 is inserted into the cylinder to seal the front chamber, and then the back chamber 57 is filled with the solution 58 and then the slide 52 To manufacture with the open part sealed. At the time of use, a push rod is attached to the rear of the faucet 52 so that the faucet 52 is pushed into the rear chamber, and when the pushed faucet 54 reaches the injection groove 53, the length of the faucet 54 is injected. Since it is designed to be shorter than the length of the groove 53, both chambers communicate with each other, and the solution 58 flows into the front chamber 55 and mixes with the powdered medicine 56 to form an injection solution. By attaching the injection needle to the distal end portion 51, administration can be performed immediately. As such a container / syringe having a structure in which the inside of one syringe barrel is divided into two chambers by a sealing plug (slipper plug) or the like (hereinafter sometimes abbreviated as “split type container / syringe”), for example, Japanese Utility Model Sho 49 The thing of 14465 is mentioned.
[0004]
In addition, instead of the injection groove, a needle is adhered to the inner wall of the syringe barrel, and when the sliding stopper separating the two chambers is slid during use, the sliding stopper is pierced by the needle. Japanese Utility Model Publication No. 54-22315 proposes a container and syringe in which two chambers communicate with each other through a passage. As further improvements of such a split type container / syringe, JP-A-58-41568, JP-A-61-48377, JP-A-62-14863, JP-A-62-117566, JP-A-62. JP-A-270169, JP-A-64-80371, JP-A-2-5973, JP-A-3-82476, JP-A-6-54908 and the like have been proposed.
[0005]
On the other hand, in Japanese Patent Laid-Open No. 51-11691 and US Pat. No. 4031892, as shown in FIG. 19, a powdered medicine 59 is filled in a small glass container 61, and both ends of the container are provided with rubber plugs 63 with flanges. The container 62 is filled with a diluent 60, sealed with a flanged rubber plug 64 and a rubber plug 66, and both containers are integrated with a plastic package 67. Syringe and containers have been proposed. At the time of administration, small containers 61 and 62 are fitted into the holder 68 shown in FIG. 20, and the rubber stopper 62 and the rubber stoppers 64 and 63 with flanges are sequentially punctured and penetrated by the injection needle 69 fixed to the holder. When the needle tip of the injection needle 69 reaches the powder medicine 59, the diluent 60 flows into the container 61 through the opening 71 in the middle of the injection needle 69 and mixes and dissolves with the powder medicine 59. It becomes a chemical solution. For injection injection, when a push rod is attached to the slide plug 65 and pushed, the drug solution can flow out of the injection needle 70 through the injection needle 69.
[0006]
In this way, a syringe of a type in which two small containers (chambers) are connected can be filled and formulated in a separate container with chemicals that require freeze-drying, etc., and a solution, etc. Since the size of one container is small, the number that can be processed at one time is larger than that of the divided type, which is advantageous. As further improvements, Japanese Patent Application Laid-Open Nos. 4-354954, 5-31191, 6-74646, 6-142203, 7-136267, 7-136264, 7-148261, 7-148261. No., Japanese Utility Model Laid-Open No. 5-152, Japanese Utility Model Laid-Open No. 5-86353, Japanese Utility Model Laid-Open No. 6-13832, and the like.
[0007]
[Problems to be solved by the invention]
In the above-mentioned conventional technology, in addition to the complicated work process required for filling the syringe with the drug, there are problems in maintaining the quality such as a decrease in the drug titer due to heat sterilization. There are still many problems to be solved, such as a reduction in product prices due to drug cost reduction.
In view of such a current situation, the present invention aims to further improve a syringe coupled with two chambers, and by storing two kinds of medicines in separate containers, particularly unstable medicines and medicines that need to retain titers are used. Stability can be maintained at a higher level, and both chemicals can be mixed in a simpler operation and can be administered hygienically immediately during use. Sterilization can be easily operated in the formulation process. Hygienic in a clean room under sterilization. The objective is to provide a high-performance, high-quality syringe / container that can satisfy the demands of advanced pharmaceutical technology and that can be easily applied to the current pharmaceutical products. is there.
[0008]
[Means for Solving the Problems]
  The gist of the present invention is as follows.
[1] (1) Injection needle portion, (2) The distal end side opening of the substantially cylindrical first cylindrical body is an injection needle portion mounting portion, and the distal end opening portion is hermetically sealed with a syringe stopper rubber stopper. The open end of the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body, for attaching the injection needle in the cylindrical body An injection molded synthetic resin container a filled with a concentrated drug in a chamber formed by the rubber plug and the first sealing plug, and (3) a second sealing plug at the tip side opening of the second cylindrical body. The other open end is sealed with a third sealing plug, and an injection formed by filling a liquid medicine into a chamber formed by the second sealing plug and the third sealing plug in the second cylindrical body. (1) to (4) of a molded plastic container b, and (4) a push rod attached to a recess at the rear of the third sealing plug, The container a and the container b are integrated with each other by tightly adhering the rear end opening portion sealed with the first sealing plug of the container a and the tip opening portion sealed with the second sealing plug of the container b. At the time of use, the push rod is attached to the recess of the third sealing plug, and the third sealing plug is pushed into the container b, so that the first sealing plug and the second sealing plug are not attached. Since the length of the discontinuous portion in the cylinder axial direction is set to be longer than the sum of the cylinder axial length of the first sealing plug and the cylinder axial length of the second sealing plug, The discontinuous portion forms a passage communicating between the container a and the container b, and the liquid medicine in the container b flows into the container a through the passage and mixes with the concentrated medicine. In the syringe which becomes an injection, the connection between the container a and the container b is screwed on the wall at the rear end opening of the container a and screwed on the wall at the front end opening of the container b. By screwing the installed screwThe pitch of the screw of the container a and the screw of the container b was widened so that the container a and the container b could be firmly coupled when the screw rotation was 30 ° to 360 °.A syringe that combines two chambers.
[2] The screw of the container a is a screw for being screwed to the inner peripheral wall surface of the rear end portion, and the screw of the container b is a male screw screwed to the outer peripheral wall surface of the tip opening. [2] The syringe that combines the two chambers.
[3] (1) The injection needle portion, (2) The opening portion on the distal end side of the substantially cylindrical first cylindrical body is the injection needle portion attachment portion, and the distal end opening portion is hermetically sealed with a rubber stopper for attaching the injection needle. The open end of the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body, for attaching the injection needle in the cylindrical body An injection molded synthetic resin container a filled with a concentrated drug in a chamber formed by the rubber plug and the first sealing plug, and (3) a second sealing plug at the tip side opening of the second cylindrical body. The other open end is sealed with a third sealing plug, and an injection formed by filling a liquid medicine into a chamber formed by the second sealing plug and the third sealing plug in the second cylindrical body. (1) to (4) of a molded plastic container b, and (4) a push rod attached to a recess at the rear of the third sealing plug, The container a and the container b are integrated with each other by tightly adhering the rear end opening portion sealed with the first sealing plug of the container a and the tip opening portion sealed with the second sealing plug of the container b. At the time of use, the push rod is attached to the recess of the third sealing plug, and the third sealing plug is pushed into the container b, so that the first sealing plug and the second sealing plug are not attached. Since the length of the discontinuous portion in the cylinder axial direction is set to be longer than the sum of the cylinder axial length of the first sealing plug and the cylinder axial length of the second sealing plug, The discontinuous portion forms a passage communicating between the container a and the container b, and the liquid medicine in the container b flows into the container a through the passage and mixes with the concentrated medicine. In the syringe that becomes an injection drug, the connection between the container a and the container b is screwed on the wall surface of the rear end opening of the container a and screwed on the wall surface of the front end opening of the container b. And one or more notches or depressions from the open end of the rear end of the container a toward the cylinder axis.And the pitch of the screw of the container a and the screw of the container b is widened so that the container a and the container b can be firmly coupled when the rotation of the screw is 30 ° to 360 °.A syringe that combines two chambers.
[4] The screw of the container a is a male screw screwed on the outer peripheral wall surface of the rear end, and the screw of the container b is a screw screwed on the inner peripheral wall surface of the tip opening. The syringe which couple | bonded two chambers as described in [1] or [3].
[5] (1) Injection needle portion, (2) The tip side opening of the substantially cylindrical first cylindrical body is the injection needle portion attachment portion, and the tip opening portion is hermetically sealed with a syringe stopper rubber stopper. The open end of the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body. An injection-molded synthetic resin container a filled with a concentrated drug in a chamber formed by the first sealing plug, (3) the second cylindrical plug is sealed with the second sealing plug at the distal end side opening; The other open end is sealed with a third sealing plug, and an injection molded composition is formed by filling a liquid medicine into a chamber formed by the second cylindrical body and the second sealing plug and the third sealing plug. (1) to (4) of a resin container b, and (4) a push rod attached to the recess at the rear of the third sealing plug, the first sealing of the container a The container a and the container b are joined together in an airtight manner by tightly sealing the rear end open part sealed with the front end opening sealed with the second sealing plug of the container b. The push rod is attached to the recess of the third sealing plug, and the third sealing plug is pushed into the container b to move the first sealing plug and the second sealing plug to the discontinuous portion, and Since the length of the continuous portion in the cylinder axis direction is set to be longer than the sum of the length of the first seal plug in the cylinder axis direction and the length of the second seal plug in the cylinder axis direction, the discontinuous portion is in the container a. A syringe communicating with the inside of the container b, and the liquid medicine in the container b flows into the container a through the passage, and is mixed with the concentrated medicine to become an injection medicine. The connection between the container a and the container b is a screw screwed on the outer peripheral wall surface of the rear end opening of the container a and a screw screwed on the outer peripheral wall surface of the tip opening of the container b. By screwing with screws screwed on the inner peripheral wall surface of the cylindrical connector having an inner diameter larger than the outer diameter of the container a and the container bThe pitch of the screw of the container a and the screw of the container b was widened so that the container a and the container b could be firmly coupled when the screw rotation was 30 ° to 360 °.A syringe that combines two chambers.
[6] The outer diameter of the container a body is substantially equal to the outer diameter of the container b body, and the inner diameter of the container a body is substantially equal to or slightly larger than the inner diameter of the container b body. The syringe which couple | bonded two chambers in any one of [1] thru | or [5] characterized by these.
[7] The syringe having two chambers according to any one of [1] to [6], wherein an inner diameter of the container a body is larger than an inner diameter of the container b body.
[8] The wall thickness of the container a main body and the wall thickness of the container b main body are equal to each other, or one is thicker than the other, [1] to [7] Syringe with combined chambers.
[9]The syringe having two chambers according to any one of [1] to [8], wherein the discontinuous portion is a concave groove provided along the cylinder axis direction.
[10][2] The two chambers according to any one of [1] to [9], wherein the discontinuous portion includes a peak portion and a valley portion having a triangular cross section that are periodically arranged in a line along the cylinder axis direction. Syringe.
[11]The rubber plug for sealing the tip opening of the container a has a leg, the leg has a notch and an annular protrusion on the outer peripheral surface, and the rubber plug has a notch in the skirt. The top surface is covered with a cap having a protruding cylindrical tube portion, and the rubber plug with the cap is locked to the tip opening of the container a in a half-plugged state so that the inside of the container a and the rubber plug The syringe which couple | bonds two chambers as described in any one of [1] thru | or [10] characterized by the ability to form the channel | path which the notch of this and the notch of a cap connected.
[0009]
BEST MODE FOR CARRYING OUT THE INVENTION
The present invention is characterized in that, in a two-chamber coupling type container / syringe, the first feature is a point by screwing of a screw (screw) formed at the end of the container for coupling of the container. The features of the action mechanism and the like will be described in detail with reference to examples.
FIG. 1 is a cross-sectional view showing an embodiment of the present invention. A syringe / container (hereinafter sometimes abbreviated as “syringe”) 1 is a powder, a concentrated chemical, or a liquid chemical (also called a chemical). And a cylindrical body a (hereinafter also abbreviated as a cylinder a) and a cylindrical body b (hereinafter also abbreviated as a cylinder b) connected by screws provided on the cylinders a and b themselves. is there. FIG. 2 is a cross-sectional view showing a state where the syringe of FIG.
[0010]
The cylinder a has a cylindrical main body 2 and a distal end projecting in a tubular shape thinner than the main body 2, and a rubber plug 3 is plugged into the opening of the distal end to seal the cap C.1The rubber plug 3 is fixed to the opening. Rubber stopper 3 and cap C at the time of administration1It has a structure that allows the injection needle to be attached while wearing. A first sealing plug 4 is tightly fitted inside the other open end of the cylinder a, that is, the end connected to the cylinder b, to form a container. In a space (chamber) formed between the rubber plug 3 and the first sealing plug 4, there is a solid drug such as a concentrated drug, freeze-dried drug, crystal, granule, powder drug, tablet drug (hereinafter referred to as a concentrated drug). 5) is filled, and the inside of the container is completely sealed by the rubber plug 3 and the first sealing plug 4 and is kept airtight, and the quality of the concentrate 5 is maintained over a long period of time. On the inner wall surface of the cylinder a main body 2, a discontinuous portion 6 for forming a bypass channel between the two chambers is located along the cylinder axis direction at a position slightly closer to the first sealing plug than the central part in the cylinder axis direction. It is provided in the shape of a concave groove, and the length in the cylinder axis direction of the discontinuous portion 6 is larger than the total length in the cylinder axis direction of the first sealing plug 4 and the second sealing plug 10 described later. It is desirable to select the first sealing plug 4 with sufficient consideration for the material so as to ensure slidability in the cylinder.
[0011]
A cylindrical screw 7 (concave screw) carved into the inner wall is provided on the inner periphery of the open end of the cylinder a body 2. Further, on the outer periphery of the distal end portion of the tube b, a saw screw (convex screw) 8 is screwed at a pitch that can be screwed onto the screw (screw) 7 of the eyeglass. The maximum value of the diameter is smaller than the outer diameter of the cylinder b main body 9. By screwing these screws 7 and 8, the cylinder a and the cylinder b can be easily and firmly connected. In this example, the outer diameter D of the cylinder a1And outer diameter D of tube b2Are substantially the same, so that one cylindrical body can be formed without causing unevenness in the joint portion. In the example shown in the figure, the screw for the eyeglasses is attached to the tube a and the screw for the eyeglasses to the tube b. However, the screw for the eyeglasses is attached to the tube a and the screw for eyeglasses is provided to the tube b. You can also.
[0012]
A slidable second sealing plug 10 is tightly fitted and sealed inside the front end side of the tube b, and a third sealing plug 11 is tightly fitted in the rear end which is the other end, Liquid medicine (hereinafter referred to as “medical solution”) such as a solution, a dispersion, a physiological saline solution, and distilled water for injection in a chamber formed between the second sealing plug 10 and the third sealing plug 11. Yes) 12 is stored watertight.
[0013]
The cylinders a and b and the first to third sealing plugs are made of a material and a structure that can withstand deformation and do not leak even at a low temperature of about −50 ° C. during lyophilization from high temperature during high-pressure steam sterilization. It has become. That is, the first, second and third sealing plugs 4, 10 and 11 have an outer diameter slightly larger than the inner diameter of the cylinder main body 2 and the main body 9, and the sliding surface with the inner wall of the cylinder a or b is shown in FIG. As shown in FIG. 3, the ribs 13 are provided in three or more to achieve both contradictory properties of sealing with the cylinder inner wall and slidability. However, in the present invention, it is possible to achieve both sealing performance and sliding performance by using a ribless sealing stopper having a synthetic resin film laminated on the surface. Further, a screw recess 14 for engaging a push rod is provided at the rear part of the third sealing plug 11.
[0014]
Even with the above configuration, the object of the present invention can be sufficiently achieved. However, in this embodiment, a rubber plug 15 having a screw having an outer diameter larger than that of the rib portion on the outer periphery is further provided behind the third sealing plug 11. Since the rubber plug 15 is provided with an annular protrusion 16 on the outer peripheral portion in contact with the inner wall surface of the tube b, the sealing performance is further improved.
[0015]
The syringe according to this embodiment is manufactured by filling the containers a and b with chemicals and then coupling both containers. Specifically, the rear end of the tube a and the tip of the tube b are matched, and screws (screws) 7 and 8 are screwed together to make about 1 to 3 rotations, preferably 1 to 2 rotations. Tube a and tube b can be coupled in series. In order to bring the first sealing plug 4 and the second sealing plug 10 into close contact with each other in a sanitary and airtight manner as much as possible, it is preferable to screw the cylinder a and the cylinder b in a clean room under vacuum.
[0016]
In general, as a method of joining two cylindrical bodies into one cylindrical body, there are a method of bonding the joint portions and a method of winding and fixing the outer circumferences of both cylinders with cellophane or synthetic resin tape. However, commercially available adhesives or adhesives applied to commercially available cellophane or synthetic resin tapes are synthetic resin adhesives, which contain a large amount of low-performance and toxic impurities, so it is easy to use them. Bonding is dangerous in terms of hygiene and safety. With the physical coupling means as in the present invention, all the above risks are eliminated.
[0017]
FIG. 3 is a schematic cross-sectional view showing a state where the chemical solution 12 in the cylinder b moves to the cylinder a and is mixed with the concentrated drug 5. In other words, a push rod 18 is attached to the screw recess 14 of the third sealing plug 11 at the rear of the tube b, and the pressure is transmitted to the chemical liquid 12 by pushing the push rod 18 into the tube 9, so that the second sealing plug 10 and the first sealing plug 4 are It is sectional drawing which moves together and shows the state which the 1st sealing plug 4 and the 2nd sealing plug 10 reached the discontinuous part 6. FIG. The discontinuous portion 6 is a thin groove extending in the cylinder length carved on the inner wall surface of the cylinder b body 2, and the length is the sum of the lengths in the cylinder axis direction of the first sealing plug 4 and the second sealing plug 10. Since it is designed to be longer, the first and second sealing plugs 4, 10 fit into the discontinuous portion 6, while a projection 19 is provided on the inner wall surface of the cylinder opposite to the discontinuous portion 6. Therefore, the tip of the first sealing plug 4 is temporarily locked by this projection 19. In this state, the space between the first sealing plug 4 and the second sealing plug 10 and the discontinuous portion 6 is a passage communicating between the cylinder a and the cylinder b. The annular protrusion 20 of the push rod 18 serves as a temporary locking mark. By gradually pushing the push rod 18 in a state where the first sealing plug 4 is temporarily locked, the chemical solution 12 flows into the cylinder a, and the push rod until the tip of the third sealing plug 11 contacts the rear end of the second sealing plug 11. Is pushed out completely from the tube b into the tube a. In the cylinder a, the drug solution 12 and the concentrated drug 5 are mixed to become a drug having a specified concentration. It is also a preferable operation to apply vibration to facilitate the flow of the chemical solution, residual gas, etc. in the discontinuous portion 6.
[0018]
FIG. 4 is a cross-sectional view in the AA ′ direction of FIG. 3 and shows a cross section perpendicular to the cylinder axis direction of the discontinuous portion 6 of the cylinder a.
[0019]
FIG. 5 is a schematic cross-sectional view showing a state in which the injection solution has been administered with the syringe of the present invention. Attach the injection needle 21 (double-ended needle in the illustrated example) to the tip of the tube a, push the push rod 18, and move the first sealing plug 4, the second sealing plug 5 and the third sealing plug 11 to the tip inside the tube a. By doing so, the dissolved drug solution (injection solution) flows out through the injection needle 21 and the administration is completed. C2Is a cap.
[0020]
In the present invention, as shown in FIG. 5, a recess is provided on the distal end side of the first sealing plug to eliminate the gap around the syringe, the inner wall of the distal end, the first sealing plug, and the injection needle and remain in the syringe after administration. The amount of the chemical solution 17 can be minimized. Therefore, the present invention is suitable for the purpose of administering an expensive drug that requires a very small amount, high titer, and reliable administration of a prescribed amount, for example, in a syringe having a small volume of 0.2 to 1 ml.
[0021]
FIG. 6 shows another embodiment of the present invention. In the embodiment of FIG. 6, the inner diameter d of the body 2 of the cylinder a1The inner diameter d of the cylinder b2Designed slightly thicker than. d2Where d is 1001Is designed in the range of 102 to 108, the sliding of the second sealing plug 10 in the cylinder a is facilitated.
Further, in this example, the discontinuous portion is formed into a shape having irregularities in which the crest portion 22 and the trough portion 23 having a triangular cross section are periodically repeated in the cross section in the tube axis direction, and the length of the discontinuous portion in the tube axis direction is L The length (thickness) in the cylinder axis direction of the first sealing plug 4 is lFourThe length (thickness) in the cylinder axis direction of the second sealing plug 10 is lTenIf L> lFour+ LTenDesign to be In the example of FIG. 6, the concentrated medicine 5 is sealed by providing an annular low protrusion 24 at the contact portion of the inner end wall of the cylinder a with the first sealing plug.
[0022]
FIG. 7 is a cross-sectional view taken along the line BB ′ of the discontinuous portion of the cylinder a in FIG. Since the discontinuous portion is formed by the projection 22 and the trough 23 having a triangular cross section on the inner wall surface of the cylinder a, the first sealing plug 4 and the second sealing plug 10 are deformed to form the passage 25. And the chemical | medical solution 12 can pass.
[0023]
In each of the embodiments of the present invention shown in FIGS. 1, 2 and 6, the inner and outer diameters of the main bodies of the cylinder a and the cylinder b are substantially equal. For this purpose, the screw of the coupling portion is formed with a thin wall thickness, but in the present invention, the screw outer diameter can be made substantially the same as the main body portion outer diameter.
[0024]
FIG. 8 is a schematic sectional view showing a further embodiment of the present invention. In this embodiment, a screw (screw) 71 on the outer periphery of the rear end of the cylinder a body 201 is connected to the rear end of the cylinder b body 901. A screw (screw) 81 is provided at the end on the side connected to the connector, and a screw 26 (screw) 26 is provided on the inner wall surface of another cylinder c to be screwed with the screws 71, 81. As shown in the figure, the cylinder a and the cylinder b are integrated by screwing with the connector 27, respectively. In this embodiment, the outer diameter D of the cylinder a body 2011And the outer diameter D of the cylinder b body 9012And the inner diameter d of the connector 27ThreeAre almost the same
The use of the connector 27 causes a slight unevenness in the coupling portion, but is superior in that there is no adverse effect due to the adhesive and the fixing is more reliable than the tape winding fixing.
[0025]
In the above example, the main bodies of the two cylinders are substantially the same size. However, in the present invention, by adopting the coupling called screwing, the main body portions of the two cylinders do not necessarily have the same inner diameter and outer diameter. As shown in the following examples, the wall thickness and inner diameter of the cylinder can be changed. In other words, in the present invention, there is a great advantage that a container having an appropriate wall thickness and inner diameter can be designed in accordance with the preparation processing and sterilization processing of the medicine contained in each cylinder.
[0026]
FIG. 9 is a cross-sectional view showing the relationship between the threads of the cylinder a and cylinder b and the cylinder outer diameter according to the embodiment of the present invention. The inner wall of the rear end portion of the cylinder a main body 202 is set as a screw (concave) 72, and a screw (screw) 82 is provided on the outer periphery of the tip end of the cylinder b main body 902 so that the inner diameter of the cylinder a is d.1, The outer diameter is D1, The inner diameter of the cylinder b is d2, The outer diameter is D2In this example, d1= D2And D1> D2Since the wall thickness of the tube a is increased, the tubes a and b are connected in series as shown in the drawing to form a single syringe tube 1.
[0027]
FIG. 10 is a cross-sectional view schematically illustrating another embodiment of the present invention. In this embodiment, the wall thickness m of the cylinder a main body 203 is very thick, and the tip side of the cylinder b (cylinder a) is omitted. The extension portion 28 is provided so as to wrap around the outer periphery of the side. In the present embodiment, a screw is provided with a step from the end of the tube a to the inner wall part from the tip, and although not shown, the step is similarly provided to the tube b. As a result, the tube b is guided into the tube a and is easily screwed with the screw 73 screwed therein. When the pitch (width) of the screw 73 is increased, the rotation angle of the tube can be strongly coupled by 30 to 360 ° C., that is, by twisting up to one rotation, and separation is easy.
Since the adhesion is further improved if the annular packing 29 is disposed at a position where the portion of the body portion immediately following the threaded portion of the tube b comes into contact with the stepped portion of the tube a, the preferred embodiment is provided. It is.
[0028]
FIG. 11 is a cross-sectional view schematically illustrating another embodiment of the present invention. In this embodiment, the outer diameter D of the body 204 of the cylinder a is shown.1And the wall thickness m was increased. Thus, by designing the cylinder wall to be thick, the physical and chemical stability of the cylinder a itself as a container can be improved, and the outer peripheral surface shape of the cylinder a can be variously processed to improve operability. I can plan. The pattern can also be distinguished from other things. That is, a finger-type concave portion 30 can be provided on the outer peripheral surface of the tube a, or an annular concave portion 32 for engaging a substantially disc-shaped flange 31 can be provided. Alternatively, the outer circumferential surface of the cylinder a can be provided with oblique irregularities or other irregularities. In addition, a finger-type concave portion or a hatched uneven portion may be provided on the outer peripheral surface of the tube b. 74 represents a screw.
[0029]
Next, the process of formulating concentrated drugs and drug solutions in the tubes a and b according to the present invention and assembling them as a single syringe will be described. All parts that come into contact with chemicals such as tube a, tube b, rubber plugs, and sealing plugs are preliminarily removed of foreign matter by washing with alkali, purified water, etc., dried and then subjected to high pressure sterilization or γ-ray sterilization process. Is used.
In addition, the material which can endure high pressure steam sterilization is selected for the synthetic resin material of the cylinder main body of the cylinder a and the cylinder b and the material of the sealing plug.
[0030]
The step of formulating the liquid medicine in the cylinder b of the present invention may be performed according to a conventionally known step as this type of formulation step. Briefly, after the second sealing plug 10 is plugged into the washed and sterilized tube b, a liquid medicine 12 such as a solution, a dispersion, a physiological saline solution, or distilled water for injection is filled, Next, after the third sealing plug 11 is plugged under vacuum so that air (oxygen) does not remain in the cylinder, high-pressure steam sterilization (steam temperature of 125 to 130 ° C.) is performed.
[0031]
Next, a process of formulating a concentrated drug such as an antibiotic, enzyme, serum, vaccine, protein, vitamin preparation, etc. in the cylinder a of the present invention will be described. In the conventional method, the tip end of the syringe barrel is sealed with a rubber stopper and a cap, filled with a concentrated drug aseptically mixed from the rear end side of the syringe barrel in a sterile room, concentrated and sealed with the seal plug did.
On the other hand, in one specific example of the syringe barrel a of the present invention, as described with reference to FIG. 12, the concentrated drug is filled with the rear end side sealed with a sealing plug and the front end side facing up. Then, it can concentrate from the front end side. Since the rear end side has a larger cross-sectional area, the position of the syringe is stable. That is, in a sterile environment such as an aseptic room or a clean room, the open end of the tube a is sealed with the first sealing plug, and the rare chemical solution of the raw material is defined from the distal end 41 side with the first sealing plug side down. Prepare a quantity. As shown in FIG. 12, the rubber stopper S is provided with a leg 42 and has a notch 43 and an annular protrusion 44 on the leg 42.1Is plugged halfway into the tip 41 of the tube a, and the rubber plug S1Cap C on topFourPut on. Cap CFourHas a groove 38 on the inner wall of the skirt portion 37 of the cap, so that the projection 44 is locked to the tip opening 41 in a half-plugged state, and the tip opening 41, the notch 43, and the groove 38 are continuous. A passage can be formed. Under vacuum conditions, the rare raw chemical solution in the cylinder a evaporates, and the vapor 39 is exhausted from the passage to become a concentrated drug (freeze vacuum drying drug). When it becomes a completely dry concentrated drug, the rubber plug S is immediately placed by a stopper device (not shown) placed in a chamber (tank) of the same sterilization environment.1And cap CFourBy completely plugging and sealing the two together, the concentrated drug can be sealed in the tube a in a very hygienic manner. Thereafter, the cylinder b filled and sealed with a chemical solution for mixing and dissolving the concentrated drug in a separate step and the cylinder a obtained above are screwed together to assemble as an integral syringe.
[0032]
Further, in the present invention, the preparation in the tube a can be concentrated by sealing the front end side of the tube a and filling the drug from the rear end side with the first sealing plug in a half-plugged state.
FIG. 13 is a diagram for explaining a process of concentrating a thin chemical solution 5 ′ of a raw material filled in a cylinder a in a decompression tank chamber (or freeze-drying tank chamber) in another embodiment of the present invention. The tip of the body 205 of the tube a is a rubber stopper S2, Cap CFiveThe rear end is half-plugged with the first sealing plug 45 [(A)]. (B) An overhead view seen in the direction of the arrow from the C-C 'cross section of the part is shown in (b). Rubber stopper S2A resin film 47 is laminated on the surface of the first sealing plug 45 that comes into contact with the chemical solution and the concentrated drug. The first sealing plug 45 has three ribs 48 on the sliding surface with the cylinder 205. Only one of the ribs 48 is placed in the rear end of the tube a, and the second rib is locked to the screw 75 at the rear end of the tube a, so that the half-plugged state can be maintained. In the present embodiment, there are two recesses 49 along the tube axis direction at symmetrical positions on the inner wall surface of the screw 75 provided on the tube a. Since a gap can be formed between the inner wall of the cylinder main body 205, the chemical vapor 39 is discharged through the recess 49. When fully concentrated and dried, the first sealing plug can be completely plugged as it is in the decompression chamber so that it can be sealed in a sanitary manner.
[0033]
FIG. 14 is a schematic cross-sectional view of the syringe of the present invention assembled by screwing the screw 75 of the prepared cylinder a205 of FIG. 13 and the screw 85 of the eyeglass b of the cylinder b body 905 separately prepared with a drug solution. . The second sealing plug 105 at the front end of the cylinder b body 905 and the third sealing plug 115 at the rear end are also laminated with a resin film 47 on the chemical solution contact surface. A cap 15 'is further attached behind the third sealing plug 115 to strengthen the fixing. The cylinder b905 has a recess 30 in the inner wall on the rear end side, and the engagement with the cap 15 'is reinforced.
[0034]
FIG. 15 is a diagram for explaining a process of concentrating a thin chemical solution 5 ′ of a raw material filled in a cylinder a in a decompression tank chamber (or freeze-drying tank chamber) in still another embodiment of the present invention. The tip of the body 206 of the cylinder a having the rib R is a rubber plug SThree, Cap C6The first sealing plug 46 is half-plugged at the rear end [(A)]. (B) An overhead view as seen in the direction of the arrow from the DD ′ section of the part is shown in (b). The first sealing plug 46 has three ribs 48 on the sliding surface with the cylinder 206, and only one of the ribs 48 is placed in the rear end of the cylinder a206, and the second rib is inserted into the rear end of the cylinder a206. A half-plugged state is maintained by locking to the portion of the screw 76 of the back. In the present embodiment, the screw 76 of the cylinder a is notched in two positions at symmetrical positions from the open end toward the cylinder axis, and in the half-plugged state between the inner wall of the cylinder body 206 in the case of FIG. A wider passage can be formed. The chemical vapor 39 is discharged through the notch 49 '. When fully concentrated and dried, the first sealing plug 46 is completely plugged as it is in the decompression chamber so that it can be sealed in a sanitary manner. In addition, 6 'is a discontinuous part.
[0035]
FIG. 16 shows an outline of the syringe of the present invention assembled by screwing the screw 76 of the prepared tube a206 of FIG. 15 and the screw 86 of the eyeglass b of the tube b906 separately prepared with a packing 29 through the packing 29. It is sectional drawing. The second sealing plug 106 at the front end of the tube b906 and the third sealing plug 116 at the rear end are also laminated with a resin film 47 on the chemical solution contact surface. A cap 15 ″ is further attached behind the third sealing plug 116 to strengthen the fixing. Further, the cylinder b906 has a protrusion on the inner wall on the rear end side, and the engagement with the cap 15 ″ is strengthened.
It is preferable that the joining process of the cylinder a206 and the cylinder b906 is also performed in the clean room. The present invention is advantageous in terms of work process because the joining process can be carried out easily and reliably.
[0036]
Although not shown in the drawings, in still another embodiment of the present invention, by providing a hole in the vicinity of the opening at the rear end of the tube a, it is possible to obtain the same effect as the example of FIGS. .
[0037]
Next, the structure of the tip portion on the injection needle mounting side of the tube a of the syringe of the present invention will be described. In the embodiment of FIG. 10, a protrusion is provided on the outer peripheral surface of the tip end of the cylinder a, and an annular recess that engages with the protrusion is provided on the inner wall of the rubber stopper (not shown) to ensure sealing of the tip. is there.
Further, in one specific example of the present invention shown in FIGS. 15 and 16, a cylindrical color C projecting from the main body 206 on the outer periphery of the tip end of the cylinder a.7The color C7Two ribs R are formed on the inner wall surface. This color C7The flanged hub needle base can be easily fixed inside. The tip end of the tube a is a rubber stopper S.ThreeThe rubber stopper SThreeIs cap C6It is fixed with.
[0038]
The syringe of the present invention can be adapted to a wide range of sizes from a small volume of 0.2 to 1 ml to a large volume of about 50 ml, and also has a hygroscopic and easily oxidizable unstable drug stored in a large capacity cylinder. The aim was to achieve long-term storage for 3 to 5 years. For this purpose, the first, second and third sealing plugs (hereinafter also collectively referred to as sliding plugs) of the present invention are required to have both high sealing plugs and slidability. As the material of the sliding plug, for example, a relatively soft material having a JIS hardness of about 30 and having heat resistance and no compression strain, for example, a rubber elastic body having a compression strain of about 10% at 100 ° C. Etc. are preferable. Further, the shape of the sealing plug is preferably one in which three or more annular ribs are provided at the sliding portion with the inner wall of the cylinder. In addition, it is desirable to apply a known technique in this kind of field to the highest degree.
[0039]
FIG. 17 is a schematic cross-sectional view showing an example of a finished product in which the syringe of the present invention is packaged. Concentrated medicine 5 is stored in cylinder a and chemical liquid 12 is stored in cylinder b, and each is sealed with rubber plug 3 ′, first sealing plug 4 ′, second sealing plug 10, and third sealing plug 11. The cylinder a and the cylinder b are firmly coupled and integrated by screwing screws 7 and 8 formed at the end portions into a single cylindrical shape without irregularities. The prepared syringe of the present invention is put in a package 34 as shown in FIG. 17, for example, and a vibration-proof rubber 35 is arranged and sealed with a rubber stopper 36. Thereby, it can protect from the vibration by conveyance. This shape allows easy packaging of the entire container.
[0040]
In the embodiment of FIG. 17, the push rod 18 ′ also serves as a container for the double-headed injection needle (double-ended needle) 33. In use, the push rod 18 ′ engaged with the third sealing plug 11 is used as the tube b. After the liquid medicine 12 is completely mixed with the concentrated medicine 5 and finished moving, the screwing of the cylinder a and the cylinder b is released to separate them. Next, the double-ended needle 33 is taken out from the push rod 18 ′, pierced and penetrated into the distal rubber plug 3 ′, and a chemical solution is administered through the double-ended needle 33 as a passage. If the push bar 18 'is the length of the cylinder b or the cylinder a, the effect is sufficiently obtained. In this way, when the two-chamber combination type is used, the length of the push rod may be shorter than the conventional one.
[0041]
Since the syringe of the present invention is screwed, if there are fewer gaps and irregularities in the coupling part than the conventional product, and a container with the same outer diameter is used, a single cylindrical body with fewer irregularities as a whole is formed. Therefore, the gap between the container and the container is small and can be packed compactly, making it convenient to carry. In addition, the smaller the gap between the package and the body, the more the amount of oxidation promoting substances such as air that may enter the syringe can be reduced, which is effective in maintaining the quality of the medicine.
[0042]
Further, in the present invention, since the cylinder a and the cylinder b can be easily combined and separated, the combination of the medicine in the cylinder a and the liquid medicine in the cylinder b can be variously changed. For example, an anticancer drug or antibiotic is prepared in the tube a, and the liquid drug in the tube b is combined with distilled water for injection or physiological saline. It goes without saying that it is simple and efficient. In this case, it is also possible to obtain a product in a form in which the cylinder a and the cylinder b can be selected separately. Furthermore, it is possible to cope with a case where a doctor or the like wants to select and administer a combination, which is also suitable for research use.
[0043]
  The material which comprises the syringe of this invention of the above structures is demonstrated below. In the present invention, safety and chemical resistance to the human body as a syringe are indispensable requirements, and as a chemical container, any of physical properties, chemical properties, stability, and sensitivity to environmental conditions differ as described above. It is necessary to select a material that is sufficiently airtight against chemicals and that can be stored without being affected by the environment such as air (oxygen), moisture (humidity), and temperature. The sliding plug has already been described. As a material of the container body (cylinder) of the syringe of the present invention,,Synthetic resins and the like are mentioned, but since they are joined by screwing, it is essential to provide screws in a precise shape, and taking into account moldability, synthetic resins are preferable, for example, cyclic olefin compounds or crosslinked polycyclic hydrocarbons One or more resins such as a resin having a compound as a polymer component, polyethylene, polypropylene, polycarbonate, polymethylpentene, and polyester resin can be used. It is also preferable to laminate two or more materials. Furthermore, what vapor-deposited silicon oxide and magnesium oxide on the synthetic resin surface is also preferable. For molding and processing of the synthetic resin, any known technique in this kind of technical field can be used. A well-known technique is applied also about an injection needle part.
[0044]
Examples of the packaging material of the present invention include materials in which polyester, polysulfone, polyarylate, modified phenylene oxide resin, polyamide, polyvinyl alcohol, polyvinyl acetate and the like are laminated in 3 to 5 layers. Vapor deposited with silicon oxide, aluminum oxide, magnesium oxide, etc. on the surface of the laminated resin has a barrier action against oxygen, air, and moisture (humidity), and preserves the quality of the medicine filled in the syringe for a long period of time. Therefore, it is suitable.
[0045]
【The invention's effect】
The present invention is a syringe-and-container in which two containers each filled with a medicine are connected in series by screwing of a screw threaded on the container itself, and the effects thereof are as follows.
(1) Since two cylindrical containers are directly fitted to each other by a screw portion, they are strongly coupled with a small volume, and separation of the cylindrical bodies is easy.
(2) Since it is physically connected with a screw formed on the container itself, there is no need for adhesives or heat welding, which is advantageous in the formulation process, and there is a risk of quality deterioration due to heat, adhesives, etc. It was solved.
(3) Since the connection is made by screws, the size and wall thickness of the two containers can be arbitrarily adjusted, and a suitable combination can be selected according to the preparation process and dosage form of the medicine to be filled therein.
(4) In the type in which the inner diameter of the main body cylinder of the container a filled with the concentrated drug is slightly larger than the inner diameter of the container b, administration can be performed with a small sliding force.
(5) Since the container sizes can be combined as appropriate, for example, a combination of various types and sizes of liquid medicine can be easily manufactured and used with respect to the prescribed concentrated medicine.
(6) Since the two kinds of chemicals can be formulated separately, the manufacturing process is simplified.
(7) In addition to the smaller volume of the conventional split type syringe, the push bar can be made shorter than the conventional product, so a larger amount can be processed in a single batch than the conventional product, improving manufacturing efficiency and reducing costs. it can.
(8) The container a and the container b have a structure that is completely hermetically blocked and can prevent the liquid medicine from affecting the storage of the concentrated medicine, so that stable high quality can be ensured over a long period of time.
(9) The syringe is small and easy to pack, making it convenient to carry.
(10) If all of the container body, rubber stopper, sealing stopper, push rod, injection, package needle, etc. are made of synthetic resin that can be easily disposed of, it can cope with environmental protection problems.
[Brief description of the drawings]
FIG. 1 is a schematic sectional view for explaining an embodiment of the present invention.
2 is a cross-sectional view for explaining the structure of a tube a and a tube b of the syringe shown in FIG. 1. FIG.
3 is a schematic cross-sectional view illustrating a state in which a drug solution in a cylinder b is transferred into a cylinder a in the syringe of FIG.
4 is a cross-sectional view taken along the line AA ′ of FIG. 3. FIG.
FIG. 5 is a schematic cross-sectional view illustrating a state at the end of administration of the syringe of FIG.
FIG. 6 is a partial cross-sectional view for explaining the structure near the discontinuous portion in the embodiment of the present invention.
7 is a cross-sectional view taken along the line BB ′ of FIG.
FIG. 8 is a schematic cross-sectional view illustrating coupling by a connector in another embodiment of the present invention.
FIG. 9 is a schematic cross-sectional view illustrating the relationship between the sizes of a cylinder a and a cylinder b in another embodiment of the present invention.
FIG. 10 is a schematic cross-sectional view showing the configuration of a cylinder a and a cylinder b having greatly different body wall thicknesses in another embodiment of the present invention.
FIG. 11 is a schematic explanatory view showing processing of the outer peripheral surface of a cylinder a in another embodiment of the present invention.
FIG. 12 is a partial cross-sectional view illustrating a step of freeze-drying using a cap having a notch and a rubber plug in another embodiment of the present invention.
FIG. 13 is a diagram for explaining a process of concentrating a rare chemical solution as a raw material using a recess at the rear end of a cylinder a as a vapor passage in another embodiment of the present invention.
14 is a schematic cross-sectional view illustrating a syringe of the present invention in which a tube a and a tube b are assembled after finishing the preparation process of FIG.
FIG. 15 is a diagram for explaining a process of concentrating a rare chemical solution as a raw material using a notch in a threaded portion of a cylinder a as a steam passage in another embodiment of the present invention.
16 is a schematic cross-sectional view illustrating a syringe of the present invention in which a tube a and a tube b are assembled after finishing the preparation process of FIG.
FIG. 17 is a schematic sectional view showing an example in which the syringe of the present invention is packaged.
FIG. 18 is a schematic cross-sectional view of a two-chamber container / syringe in which a conventional syringe barrel is divided into two by a sliding plug.
FIG. 19 is a schematic cross-sectional view of a syringe barrel portion of an example of a conventional container / syringe that joins two chambers.
20 is a schematic cross-sectional view of an injection needle portion combined with the syringe barrel portion of FIG.
[Explanation of symbols]
1 Syringe and container,
2, 2 ', 2 ", 201, 202, 203, 204, 205 and 206 cylinder a body,
3, 3 ', 36 and 38 and S1, S2And SThree  Rubber stopper,
4, 4 ', 45 and 46 first sealing plugs,
5 Concentrated medicine,
5 'raw chemical,
6, 6 'discontinuity,
7, 71, 72, 73, 74, 75 and 76 screws,
8, 81, 82, 85 and 86 screws,
9, 901, 902, 905 and 906 cylinder b body,
10, 105 and 106 second sealing plug,
11, 115 and 116 third sealing plugs;
12 liquid medicine, 13 ribs, 14 screw recesses,
15 and 15 ′ rubber stoppers, 16 protrusions, 18 and 18 ′ push rods,
19 and 20 protrusions, 21 needles, 22 peaks,
23 trough, 24 protrusion, 25 flow path,
26 Connector screw, 27 Connector, 28 Extension,
29 packing, 30 finger type recess, 31 flange,
32 annular recess, 33 double-ended needle, 34 package,
35 Anti-vibration rubber,
37 Skirt, 38 grooves, 39 steam,
41 Tip opening, 42 Leg 43 Notch,
44 annular projections, 47 resin film, 48 ribs,
49 concave, 49 'notch,
C1, C2, CFour, CFiveAnd C6  cap,
d1  Inner diameter of cylinder a, d2  Inner diameter of tube b, dThree  The inner diameter of the connector,
D1  Outer diameter of tube a, D2  The outer diameter of the tube b,
lFour  1st sealing plug length, lTen  Second sealing plug length,
L discontinuity length, m wall thickness, 50 syringe and container,
51 tip, 52 slide, 53 injection groove,
54 slipper, 55 anterior chamber, 56 powder medicine,
57 back chamber, 58 solution, 59 powder medicine,
60 diluent, 61,62 small container, 63 rubber stopper,
64 rubber plug with flange, 65 slipper, 67 package,
68 holders, 69 and 70 needles, 71 openings.

Claims (11)

（１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内の該注射針取り付け用ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体内の該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製の容器ｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、上記該容器ａと該容器ｂの結合が、該容器ａの後端開放部壁面に螺設したねじと、該容器ｂの先端開口部壁面に螺設したねじの螺合によるものであり、
ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。(1) an injection needle part, (2) the tip side opening of the substantially cylindrical first cylindrical body is an injection needle part attachment part, and the tip opening part is hermetically sealed with a rubber stopper for injection needle attachment, The open end of the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body, and the rubber stopper for attaching the injection needle in the cylindrical body and An injection molded synthetic resin container a filled with a concentrated drug in the chamber formed by the first sealing plug, and (3) the second cylindrical body is sealed with the second sealing plug at the distal end side opening. The other open end is sealed with a third sealing plug, and an injection mold is formed by filling a liquid medicine into a chamber formed by the second sealing plug and the third sealing plug in the second cylindrical body. (1) to (4) of a synthetic resin container b, (4) a push rod attached to the recess at the rear of the third sealing plug, The container a and the container b are integrally coupled with the rear end opening portion sealed with the first sealing plug and the tip opening portion sealed with the second sealing plug of the container b in an airtight manner. At the time of use, the first sealing plug and the second sealing plug are moved to the discontinuous portion by attaching the push rod to the recess of the third sealing plug and pushing the third sealing plug into the container b. The length of the discontinuous portion in the cylinder axis direction is set to be longer than the sum of the length of the first seal plug in the tube axis direction and the length of the second seal plug in the tube axis direction. A passage communicating between the container a and the container b is formed, and the liquid medicine in the container b flows into the container a through the passage, and is mixed with the concentrated medicine to form an injection medicine. In the syringe, the connection between the container a and the container b is screwed on the wall surface of the rear end opening of the container a and screwed on the wall surface of the front end opening of the container b. Flip is due to screwed,
The two chambers are characterized in that the pitch of the screw of the container a and the screw of the container b is widened so that the container a and the container b can be firmly coupled when the rotation of the screw is 30 ° to 360 °. Syringe. 上記容器ａのねじは後端部の内周壁面に螺設されためねじであり、上記容器ｂのねじは先端開口部の外周壁面に螺設されたおねじであることを特徴とする請求項１記載の２室を結合した注射器。  The screw of the container a is a screw to be screwed on the inner peripheral wall surface of the rear end portion, and the screw of the container b is a male screw screwed to the outer peripheral wall surface of the tip opening portion. The syringe which couple | bonded two chambers of 1 description. （１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内の該注射針取り付け用ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体内の該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製のｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、該容器ａと該容器ｂの結合が、該容器ａの後端開放部壁面に螺設したねじと、該容器ｂの先端開口部壁面に螺設したねじの螺合によるものであり、かつ該容器ａの後端の開放端部から筒軸方向に向かう切欠き又は凹窪を１個以上有し、
ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。(1) an injection needle part, (2) the tip side opening of the substantially cylindrical first cylindrical body is an injection needle part attachment part, and the tip opening part is hermetically sealed with a rubber stopper for injection needle attachment, The open end of the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body, and the rubber stopper for attaching the injection needle in the cylindrical body and An injection molded synthetic resin container a filled with a concentrated drug in the chamber formed by the first sealing plug, and (3) the second cylindrical body is sealed with the second sealing plug at the distal end side opening. The other open end is sealed with a third sealing plug, and an injection mold is formed by filling a liquid medicine into a chamber formed by the second sealing plug and the third sealing plug in the second cylindrical body. (1) to (4) of a synthetic resin b, (4) a push rod attached to the recess at the rear of the third sealing plug, and the container a The container a and the container b are integrally coupled with the rear end open part sealed with the sealing plug and the tip opening sealed with the second sealing plug of the container b in an airtight manner, In use, the push rod is attached to the recess of the third sealing plug, and the third sealing plug is pushed into the container b to move the first sealing plug and the second sealing plug to the discontinuous portion, The length of the discontinuous portion in the cylinder axis direction is set to be longer than the sum of the length of the first sealing plug in the tube axis direction and the length of the second sealing plug in the tube axis direction. a syringe that forms a passage communicating between the inside of the container a and the inside of the container b, and the liquid medicine in the container b flows into the container a through the passage and is mixed with the concentrated medicine to become an injection medicine In this case, the connection between the container a and the container b is made by screwing a screw screwed to the wall surface of the rear end opening of the container a and a screw screwed to the wall surface of the front end opening of the container b. It is due, and a notch or recessed toward the open end of the rear end of the vessel a in the cylinder axis direction possess one or more,
The two chambers are characterized in that the pitch of the screw of the container a and the screw of the container b is widened so that the container a and the container b can be firmly coupled when the rotation of the screw is 30 ° to 360 °. Syringe. 該容器ａのねじは後端部の外周壁面に螺設されたおねじであり、該容器ｂのねじは先端開口部の内周壁面に螺設されためねじであることを特徴とする請求項１又は請求項３記載の２室を結合した注射器。  The screw of the container a is a male screw screwed on the outer peripheral wall surface of the rear end portion, and the screw of the container b is a screw screwed on the inner peripheral wall surface of the tip opening portion. The syringe which couple | bonded two chambers of Claim 1 or Claim 3. （１）注射針部、（２）略円筒状の第１の円筒体の先端側開口部を注射針部取り付け部分とし、該先端開口部は注射針取り付け用ゴム栓で気密に封止し、後端の開放部は第１密封栓で封止して、円筒体の内壁表面には筒軸方向に沿って延びる不連続部を設けてあり、該円筒体内に該ゴム栓及び該第１密封栓により形成される室内に濃縮薬を充填された射出成形された合成樹脂製の射出成形された合成樹脂製の容器ａ、（３）第２の円筒体の先端側開口部を第２密封栓で封止し、他の開放端部は第３密封栓で封止し、該第２の円筒体と該第２密封栓及び第３密封栓により形成される室内に液状薬を充填されてなる射出成形された合成樹脂製の射出成形された合成樹脂製の容器ｂ、（４）上記第３密封栓の後部の窪に取り付けられる押棒、の（１）〜（４）を有してなり、該容器ａの該第１密封栓で封止された後端開放部と、該容器ｂの第２密封栓で封止された先端開口部を気密に密着して該容器ａと該容器ｂが一体に結合されており、使用時には該第３密封栓の該窪に該押棒を取り付けて該第３密封栓を該容器ｂ内に押し込むことにより該第１密封栓及び該第２密封栓を該不連続部まで移動し、該不連続部の筒軸方向長さは上記第１密封栓の筒軸方向長さと上記第２密封栓の筒軸方向長さの和より長く設定してあるために該不連続部が該容器ａ内と該容器ｂ内を連通する通路を形成し、該容器ｂ内の該液状薬が該通路を経由して該容器ａ内に流入し、該濃縮薬と混和して注射薬となる注射器において、上記該容器ａと該容器ｂの結合が、容器ａの後端開放部外周壁面に螺設したねじと、容器ｂの先端開口部外周壁面に螺設したねじを、該容器ａ，該容器ｂの外径より大きい内径を有する筒状のコネクターの内周壁面に螺設したねじとそれぞれ螺合することによるものであり、
ねじの回転が３０°〜３６０°で上記容器ａと上記容器ｂとを強固に結合できるように該容器ａのねじと該容器ｂのねじのピッチを広くしたことを特徴とする２室を結合した注射器。(1) an injection needle part, (2) the tip side opening of the substantially cylindrical first cylindrical body is an injection needle part attachment part, and the tip opening part is hermetically sealed with a rubber stopper for injection needle attachment, The open portion at the rear end is sealed with a first sealing plug, and a discontinuous portion extending along the cylinder axis direction is provided on the inner wall surface of the cylindrical body. The rubber plug and the first sealing plug are provided in the cylindrical body. An injection-molded synthetic resin container a made of an injection-molded synthetic resin in which a concentrating agent is filled in a chamber formed by the plug; and (3) a second sealing plug at the distal end side opening of the second cylindrical body. The other open end is sealed with a third sealing plug, and a liquid medicine is filled in the chamber formed by the second cylindrical body, the second sealing plug, and the third sealing plug. (1) an injection-molded synthetic resin container b made of injection-molded synthetic resin, (4) a push rod attached to a recess at the rear of the third sealing plug (1 To (4), the rear end opening portion sealed with the first sealing plug of the container a and the front end opening portion sealed with the second sealing plug of the container b are hermetically adhered. The container a and the container b are integrally coupled, and in use, the first stick is inserted into the recess of the third sealing plug and the third sealing plug is pushed into the container b. The sealing plug and the second sealing plug are moved to the discontinuous portion, and the length of the discontinuous portion in the cylinder axis direction is the length of the first sealing plug in the cylinder axis direction and the length of the second sealing plug in the cylinder axis direction. Therefore, the discontinuous portion forms a passage communicating between the container a and the container b, and the liquid medicine in the container b passes through the passage and passes through the container a. In a syringe that flows into the mixture and becomes an injection by mixing with the concentrated drug, the connection between the container a and the container b is a screw screwed on the outer peripheral wall surface of the rear end opening of the container a According screws that screwed to the distal end opening portion outer peripheral wall surface of the container b, container a, the screwing respectively screw which is screwed into the inner peripheral wall surface of the tubular connector having an inner diameter larger than the outer diameter of the container b Is,
The two chambers are characterized in that the pitch of the screw of the container a and the screw of the container b is widened so that the container a and the container b can be firmly coupled when the rotation of the screw is 30 ° to 360 °. Syringe. 上記容器ａ本体の外径が上記容器ｂ本体の外径と実質的に等しく、上記容器ａ本体の内径が上記容器ｂ本体の内径と実質的に等しいか又は若干大きいものであることを特徴とする請求項１ないし請求項５のいずれかに記載の２室を結合した注射器。  The outer diameter of the container a body is substantially equal to the outer diameter of the container b body, and the inner diameter of the container a body is substantially equal to or slightly larger than the inner diameter of the container b body. The syringe which couple | bonded two chambers in any one of Claim 1 thru | or 5. 上記容器ａ本体の内径が上記容器ｂ本体の内径より大きいものであることを特徴とする請求項１ないし請求項６のいずれかに記載の２室を結合した注射器。  The syringe having two chambers according to any one of claims 1 to 6, wherein an inner diameter of the container a main body is larger than an inner diameter of the container b main body. 上記容器ａ本体の壁厚さと上記容器ｂ本体の壁厚さは等しいか又は一方が他方より厚いものであることを特徴とする請求項１ないし請求項７のいずれかに記載の２室を結合した注射器。  8. The two chambers according to claim 1, wherein the wall thickness of the container a main body and the wall thickness of the container b main body are equal or one is thicker than the other. Syringe. 上記不連続部が筒軸方向に沿って設けた凹状溝であることを特徴とする請求項１ないし請求項８のいずれかに記載の２室を結合した注射器。The syringe having two chambers according to any one of claims 1 to 8 , wherein the discontinuous portion is a concave groove provided along the cylinder axis direction. 上記不連続部が筒軸方向に沿って一列に周期的に並ぶ断面三角形の山部と谷部からなることを特徴とする請求項１ないし請求項９のいずれかに記載の２室を結合した注射器。The two chambers according to any one of claims 1 to 9 , wherein the discontinuous portion includes a peak portion and a trough portion having a triangular cross section that are periodically arranged in a line along the cylinder axis direction. Syringe. 上記容器ａの先端開口部を封止するゴム栓が、脚を有し、該脚には切り欠きと、外周面に環状突起を設けてあり、該ゴム栓にはスカート部に切り欠きを有し天面には突出した円筒状の管部を有するキャップを被せ、該キャップを被せたゴム栓を容器ａの先端開口部に半打栓状態で係止させることにより、容器ａ内部とゴム栓の切り欠き及びキャップの切り欠きが連通した通路を形成できるものであることを特徴とする請求項１ないし請求項１０のいずれかに記載の２室を結合した注射器。The rubber plug for sealing the tip opening of the container a has a leg, the leg has a notch and an annular protrusion on the outer peripheral surface, and the rubber plug has a notch in the skirt. The top surface is covered with a cap having a protruding cylindrical tube portion, and the rubber plug with the cap is locked to the tip opening of the container a in a half-plugged state so that the inside of the container a and the rubber plug 11. The syringe having two chambers according to any one of claims 1 to 10, wherein a notch and a notch in the cap can form a passage communicating with each other.
JP24332696A 1995-10-06 1996-09-13 Syringe combining two chambers Expired - Lifetime JP3982855B2 (en)

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US7927316B2 (en) 2002-04-26 2011-04-19 Millipore Corporation Disposable, sterile fluid transfer device
EP2237819B1 (en) * 2007-09-27 2013-09-18 Becton, Dickinson and Company Cartridge for powder and liquid drug
EP2214639A2 (en) * 2007-11-06 2010-08-11 Stuart L. Weg Anesthetic composition, formulation and method of use
SG153002A1 (en) 2007-11-16 2009-06-29 Millipore Corp Fluid transfer device
FR2940439B1 (en) 2008-12-18 2011-02-11 Millipore Corp DEVICE FOR TRANSFERRING A MEDIUM
FR2940440B1 (en) 2008-12-18 2010-12-24 Millipore Corp DEVICE FOR TRANSFERRING A MEDIUM
US8544497B2 (en) 2009-10-30 2013-10-01 Emd Millipore Corporation Fluid transfer device and system
CN110464917A (en) * 2013-03-15 2019-11-19 温德加普医疗股份有限公司 Portable medication mixing and delivery system and method
KR101508218B1 (en) * 2014-12-26 2015-04-07 삼양화학공업주식회사 2-chamber injector
KR101508217B1 (en) * 2014-12-26 2015-04-07 삼양화학공업주식회사 2-chamber injector
US10159973B2 (en) * 2016-08-31 2018-12-25 Toshiba Medical Systems Corporation Sample liquid preparing apparatus, test kit, and sample liquid preparing method

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