JP4378966B2

JP4378966B2 - Multi-chamber drug container

Info

Publication number: JP4378966B2
Application number: JP2003031175A
Authority: JP
Inventors: 千春宮嶋; 伝内武田
Original assignee: Ajinomoto Co Inc
Current assignee: Ajinomoto Co Inc
Priority date: 2003-02-07
Filing date: 2003-02-07
Publication date: 2009-12-09
Anticipated expiration: 2023-02-07
Also published as: JP2004236962A

Description

【０００１】
【発明の属する技術分野】
本発明は、輸液に混合するための少なくとも第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器に関する。特に本発明は、輸液、即ち、静脈投与用輸液製剤、液状栄養剤、腹膜透析液等の医療用液体に配合されるビタミン類その他の複数薬剤を分離して収容し無菌状態に保持し、投与直前にそれら複数薬剤を容易に混合可能な多室薬剤容器に関する。
【０００２】
【従来の技術】
従来、点滴により人体に供給される輸液成分、例えば、アミノ酸液、ブドウ糖液等は、混合すると変質するため、剥離可能な隔離手段により仕切られた輸液容器、特に輸液バッグ内の複数の個室へそれぞれ収容し、使用時に輸液バッグを外から押圧して隔離手段を剥離させて混合することが工夫されている（例えば、特許文献１参照）。
【０００３】
【特許文献】
特開昭６２−１７６４５１号公報
特開平８−１８２７３９号公報
特表平８−５０９６３１号公報
【０００４】
また点滴により患者に輸液を投与する場合、患者の病態により、アミノ酸液、ブドウ糖液等の輸液製剤に少量の各種薬液、例えば、トレースミネラル（微量元素）、ビタミン剤、鎮痛剤、脂肪輸液、抗生物質、ミネラル分、強心剤等を混合することが必要になる。通常、輸液製剤に少量の薬液を混合する作業（混注）は、病院内のクリーンブース内で行われ、混合すべき薬液を注射器を用いて輸液バッグ内の輸液へ注入する。この場合、薬液の細菌感染を起こさないように注意深く行われる。これらの混注操作は煩雑であり、簡便な操作で混注が行なえることが望まれている。
【０００５】
特開平１０−２４０８８号は、無菌保証が成された状態で、薬剤封入バイアル等を少ない部品で簡易に接続した輸液容器を提供することを目的とした薬剤封入容器セットを開示する。この薬剤封入容器セットは、樹脂製容器であり複数の室を有し、室と室との隔離条部の少なくとも一部が外側から開放可能なピールシール部又は弱シール部で形成され、第１室に薬液が収容され、第２室に充填容器が接続され、充填容器は薬液に混合される薬剤を収容し、充填容器の開口を閉じる蓋体又は膜体が第２室の外側から押圧することにより充填容器内へ押し込むことが可能であり、蓋体又は膜体が充填容器内へ押し込まれることにより第２室内と充填容器内が連通される。高圧蒸気滅菌処理した樹脂製容器と薬剤を収容したバイアルは、無菌、無塵室内で接続され、その後第２室のみが電子照射滅菌され、第２室内の一旦外界に晒された充填容器の外面と共に滅菌処理される。
【０００６】
注射剤、静脈投与用輸液、透析溶液、点眼剤、眼科用灌流液及び臓器保存液等の医療用溶液は、無菌状態に収容保存するため、熱可塑性樹脂製容器やガラス容器にほぼ液密に充填され、殺菌又は滅菌される。医療用溶液の製品形態のひとつにキット製品がある。キット製品は、薬剤と医療用具又は２つ以上の薬剤をひとつの投与体系として組み合わせたものであり、医療機関における投薬調剤時の負担軽減、細菌汚染防止、異物混入防止等を目的とする。キット製品の事例は、予充填式使い捨て注射剤（プレフィルドシリンジ製品）、ダブルバッグと呼ばれる２室混合式輸液剤、例えば味の素ファルマ社製の「ピーエヌツイン」（商品名）等である。キット製品は、調剤時の過誤防止、緊急時の迅速な対応を可能にする等の利点を備える。
【０００７】
ダブルバッグやプレフィルドシリンジは、容器を２室に区画したものが販売されているが、追加の薬剤や栄養剤等を加える場合に対応できない欠点があった。この問題を解決するために、３室を備える医療用容器が、例えば特表２０００−５０１３２４号公報に提案されている。この公報の発明では、可撓性バッグを剥離可能なシールで区画し、第３の薬剤を収容する室を設けている。しかしながら多区画の部屋を備えた場合、確実にすべての区画を連通させ各成分を混合するには、極めて慎重な開通操作が必要となり、緊急時の迅速対応には問題がある。また、開通しない区画が残ったまま患者に投与された場合は、投与可能な液性とは異なる溶液が供給され副作用発現につながる問題がある。
【０００８】
特開２０００−８７３５０号公報は、液体薬剤を収納する第１の容器と固体薬剤を収納する第２の容器を一体化した複室輸液容器を開示する。この複室輸液容器は、第１の容器と第２の容器との間に仕切り部材を備え、仕切り部材は、隣接する第１及び第２の容器を連通可能に接続する中空部、及びこの中空部の一端を封止する蓋体を有する。蓋体は、薄肉部を介して仕切り部材の本体に連結され、仕切り部材を変形操作することにより開蓋される。この複室輸液容器は、少量の複数の薬剤を分離収納することができない短所を有する。
【０００９】
輸液を初めとする医療用溶液は、投与する患者の病態に応じ、抗生物質やビタミン類を配合して使用する場合がある。また、各種の有効成分を複数の室に分離収容することで保存安定性の向上が期待できるものの、容器を複数に区画もしくは分室を設けることは、容器の製造工程が複雑となり、また使用の際の便宜性が低下するなどの問題を有する。
【００１０】
ブドウ糖等を含む栄養輸液製剤は、投与されるとき、必須ビタミン１３種が混合されていることが必要である。総合ビタミンの内のビタミンＤは、比較的柔軟な樹脂フィルムに吸着される性質があり、吸着を避けるため、ビタミンＤを収容し保持する容器は、比較的硬質の環状ポリオレフィンで製造されることが必要である。しかしながら、樹脂フィルムバッグを環状ポリオレフィンで製造する場合、溶着部の形成、特に剥離容易な接着部の形成は、困難である。従来ビタミンＤは、他のビタミンとは別の容器に収容され、輸液の投与時に別途輸液に混合する操作が必要であった。典型的には、１つのシリンジに収容されたビタミンＤ剤及び他のシリンジに収容された他のビタミン剤から成る２本１組のビタミン剤をそれぞれ操作し輸液に注入して始めて総合ビタミン剤の注入が完了した。
【００１１】
【発明が解決しようとする課題】
輸液製剤に混注すべき、各種の少量の薬液を少ない操作で混注できる薬液容器においては、各薬液同志が混合によって汚濁を生じたり分解が促進されたりしないようにする必要がある。特に、ビタミン剤は、光や温度により品質劣化が促進されるばかりでなく、微量元素類と配合すると不溶性の析出物や微粒子が生じたり、分解が促進されたりする場合がある。
【００１２】
高カロリー輸液用糖・電解質・アミノ酸液には、ビタミンＢ₂他のビタミン剤、及び鉄供給源他の複数の微量元素を含有する微量元素製剤を混注する例が多くみられる。ビタミン剤と微量元素製剤を混合した薬液は、短期間に品質劣化し、とくにビタミンＢ₂と微量元素製剤に含まれる鉄供給源由来の析出物が確認できる。この析出物の生成には、温度、光、還元物質、酸素などの要因が関与するが、きわめて短時間に生成することから同一容器内に充填することは困難である。
【００１３】
本発明は、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液その他の薬液収容する輸液バッグ内へ患者に必要な少量の薬液を混注する作業を、安全に且つ容易に行うことができることを目的とする。本発明は、また混注すべき異種の薬液間の品質劣化の原因となる相互作用を排除し、隔壁手段で隔離された複数の室に薬液を選択的に分離収容することが可能な薬液容器を提供するとを目的とする。
【００１４】
本発明の目的は、必要性が増大している３種以上の薬剤、特に総合ビタミンを外気に晒すことなく容器内に別々に保管し使用時に簡単な操作により混合することが可能な多室薬剤容器を提供することである。特に本発明は、ビタミンＤを収容する室の内壁をビタミンＤに対し非吸着性の比較的に硬質の樹脂、例えば環状ポリオレフィンにより製造することによりビタミンＤが容器に吸着されることを防止する構造の多室薬剤容器を提供することである。また本発明の他の目的は、比較的多量の薬液を袋状容器に収容し比較的少量の複数の薬剤を１組の多室薬剤容器に収容する薬剤のキット製品を提供することである。本発明の別の目的は、上記多室薬剤容器においてビタミンＤに対し非吸着性を有する樹脂から成る容器に剥離容易なシール部を必要としない構造を提供することである。
【００１５】
本発明の更に別の目的は、上記多室薬剤容器において、容器の外部から人手により力を加えることにより複数の室の間を容易に液体連通状態にすることができ、それらに収容された薬剤を簡易に誤りなく混合可能な構造を提供することである。本発明の更に別の目的は、多室容器に収容された複数の少量の薬剤を容器内で無菌状態を保持したまま混合可能であり、混合された薬剤を輸液バッグへ注入することができる多室薬剤容器を提供することである。本発明の更に別の目的は、多室薬剤容器において、単一の操作により順次に複数の少量の薬剤を輸液バッグへ注入するか又は単一の操作により複数の少量の薬剤を混合し輸液バッグへ注入することができるようにすることである。本発明のその他の目的及び利点は、図面及び以下の説明において明かにされる。
【００１６】
【課題を解決するための手段】
本発明の多室薬剤容器は、第１の薬剤、第２の薬剤及び第３の薬剤を分離して収容する第１室、第２室及び第３室を備え、第１の薬剤、第２の薬剤及び第３の薬剤を混合し或は混合しないで輸液バッグ内の輸液中へ混合することができる構造を備える。本発明の第１の形態によれば、多室薬剤容器は、開口端を有する第２容器、第２容器内に配置される一部樹脂フィルムからなる第１容器、第２容器の開口端と結合される開口端及び出口開口を有する第３容器、第２容器と第３容器の内部空間を連通可能な第１連通路、第1連通路を遮断する破断可能な薄膜、並びに第1端、第２端及び流路を有し投与時に薬剤を注出可能な連通具を含む。第１室は第１容器内の空間から成り、第２室は第２容器の内壁と前記第１容器の外壁とに囲まれた空間から成り、第３室は第３容器内の空間からなり、連通具の第１端を第１通路内へ移動させることにより前記薄膜及び第１容器の樹脂フィルムが連通具の第１端により破断され、第1室及び第２室の薬剤が第１連通路を通り第３室へ入り、第３室から連通具の流路を通り輸液へ混合される。
【００１７】
本発明の第１の形態の多室薬剤容器において、好ましくは、前記第３室を構成する第３容器の内壁がビタミンＤに対し非吸着性の比較的硬質の樹脂、例えば環状ポリオレフィンにより形成される。
また、連通具は、第３容器の出口開口に第３容器の密封を維持しつつ摺動可能に挿入される第１及び第２の栓体により支持されると共に、第１及び第２の栓体の間に流路の入口を備え、連通具の第１端を第１通路内へ移動させることにより流路の入口が第３室に連通される。
第１容器及び第２容器は、剛性の容器であり、薬剤と置換する気体が流入しないと薬剤の流出が生じ難いので、連通具は、薬剤の導出路と平行に輸液バッグ内の気体を第１又は第２容器へ導く気体通路を備える。
前記第１及び第２の栓体は、前記連通具の軸方向に離間して形成され、前記連通具とともに移動可能であってよい。
前記第３容器の出口開口は、円筒形に形成することができる。
【００１８】
本発明の第２の形態によれば、輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器は、１対の前壁及び後壁を備える第1容器、第1容器内の前壁と後壁の間に収容された樹脂フィルムバッグ、並びに薬剤を流出させるための連通具を有する。第１室及び第２室が樹脂フィルムバッグ内の空間から成り、第３室が第１容器の内面と前記樹脂フィルムバッグの外面により形成される。第1容器は変形されて１対の前壁と後壁の間の距離を変更可能である。第１容器の前壁が前記樹脂フィルムバッグへ向って伸長する２つの凸部を有する雄スパイクを支持し、第1容器を弾性変形させ１対の剛性の前壁と後壁の間の距離を減少させると雄スパイクにより樹脂フィルムバッグの壁が破断され、第１の薬剤、第２の薬剤及び第３の薬剤が混合され、連通具の流路を介し流出可能とされる。
【００１９】
後壁には雌スパイクが雄スパイクに対向して配置され、雄スパイクが後壁を損傷することを防止する。本発明の第２の形態の多室薬剤容器においては、好ましくは第３室を構成する第１容器の内壁及び樹脂フィルムバッグの外面がビタミンＤに対し非吸着性の樹脂により形成される。
【００２０】
本発明の第３の形態によれば、輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器は、プランジャの栓体が挿入される一端を有するシリンジ、シリンジ内の空間に挿入される樹脂フィルムバッグ及び流路を有する連通具を含む。連通具はシリンジの他端に固定され、シリンジ内おいて連通具に隣接して多孔板が配置される。第１室及び第２室は樹脂フィルムバッグ内に形成され、樹脂フィルムバッグの第１室及び第２室に隣接する縁部の少なくとも一部分に剥離容易なシールが形成される。第３室は樹脂バッグの外面とシリンジの内面との間の空間からなり、シリンジ内へプランジャの栓体を挿入することにより連通具の流路を介し第３の薬剤が流出されると共に樹脂フィルムバッグが破断され第１室及び第２室内の第１の薬剤及び第２の薬剤が連通具の流路を介し流出される。
【００２１】
本発明の第３の形態の多室薬剤容器においては、好ましくは、多孔板が円錐形とされ、上部が鋭利な凸部とされ、それにより第１室及び第２室を形成する樹脂フィルムバッグを破断開口し、第１の薬剤、第２の薬剤及び第３の薬剤を混合する。多孔板が樹脂フィルムバッグを止めるので、連通具の流路が詰まることがない。また第３室を構成するシリンジの内壁及び樹脂フィルムバッグの外面がビタミンＤに対し非吸着性の樹脂により形成される。
【００２２】
本発明の第４の形態によれば、輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器は、一端からプランジャが挿入され他端に導出路を備え第３室を画定するシリンジ、第１室及び第２室を画定する樹脂フィルムバッグ、及び樹脂フィルムバッグから薬剤を輸液バッグ内へ案内するための連通具を含む。シリンジの導出路は第１室又は第２室の内部に配置され且つシール部材により密封閉鎖され、シリンジ内へプランジャを挿入するときシリンジ内の液圧の上昇によりシール部材が導出路から離間しシリンジ内の薬剤が樹脂フィルムバッグ内へ注入される。第１室と第２室の間に剥離容易な第１弱接着部が設けられる。
【００２３】
本発明の第４の形態の多室薬剤容器においては、第１弱接着部は樹脂フィルムバッグの第１室又は第２室へシリンジ内の薬剤が注入されることによる圧力上昇又は樹脂フィルムバッグの外部から与えられる押圧力により剥離される。好ましくは樹脂フィルムバッグは更に第４室を含み、第２室と第４室の間に剥離容易な第２弱接着部が設けられ、第４室が連通具の流路に連通される。
【００２４】
本発明の第５の形態によれば、輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器は、第１連通具を備える樹脂フィルムバッグ、及び第２連通具を備える剛性容器を含み、第１室及び第２室は樹脂フィルムバッグ内に形成され、第１室と第２室との間に剥離容易なシールが配置され、第３室は剛性容器内の空間により形成される。第１連通具は第１室又は第２室と第３室を連通可能であり、第１連通具は第３室から薬剤をバッグ内の輸液中へ注入することができる。
【００２５】
本発明の第５の形態の多室薬剤容器においては、好ましくは、前記第３室を構成する剛性容器の内壁がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００２６】
本発明の第６の形態によれば、輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器は、一端から第１プランジャが挿入され他端に第１導出路を備える第１シリンジ、一端から第２プランジャが挿入され他端に第２導出路を備える第２シリンジ、第１プランジャ及び第２プランジャを一緒移動するよう結合するプランジャ結合部材、第１導出路及び第２導出路に連通し薬剤を混合しバッグ内の輸液中へ注入することができる連通具を含む。第１シリンジ内に可動仕切部材により分けられた第１室及び第２室が画成され、第２シリンジ内に第３室が形成される。
【００２７】
第１シリンジの内壁に凹所が形成され、第１プランジャが挿入され可動仕切部材が内壁の凹所に一致すると第１室と第２室が流体連通され、第１室及び第２室内の薬剤が第１導出路を介して輸液バッグ内へ導出される。本発明の第５の形態によれば、第２プランジャが第２シリンジ内へ挿入されることにより第２プランジャ内の薬液が第２導出路を介して輸液バッグ内へ導出される。
【００２８】
本発明の第６の形態の多室薬剤容器においては、好ましくは、前記第３室を構成する第２シリンジの内壁がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００２９】
本発明の第６の形態の輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器（変形）は、一端から第１プランジャが挿入され他端に第１導出路を備える第１シリンジ、一端から第２プランジャが挿入され他端に第２導出路を備える第２シリンジ、第１プランジャ及び第２プランジャを一緒移動するよう結合するプランジャ結合部材、第１導出路及び第２導出路に連通し薬剤を輸液バッグ内の輸液中へ注入することができる連通具を含む。
【００３０】
本発明の第６の形態によれば、第１シリンジの内部空間は樹脂フィルムバッグから成る第１室を含み且つ第２室を画成し、第２シリンジ内に第３室が画定され、第１導出路付近に多孔板が配置される。第１プランジャが第１シリンジに挿入されると樹脂フィルムバッグのフィルムが破られ第１室内の薬剤が第２室内の薬剤と共に第１導出路を介し導出され、同時に第２プランジャが第２シリンジに挿入され、第２室内の薬剤が第２導出路を介し導出される。好ましくは、第３室を構成する第２シリンジの内壁がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００３１】
本発明の多室薬剤容器は、ポリエチレン、ポリプロピレン、ポリ４−メチルペンテンや環状ポリオレフィン等の熱可塑性樹脂で製造することができる。なお、環状ポリオレフィンとポリエチレンとをＴダイ押出機、インフレーション成形機又はブロー成型期機により２層あるいは３層に積層した多層フィルムを形成し薬剤容器として使用することが好ましい。また、ポリエチレンに替えて、ポリプロピレンあるいはポリエチレンとポリプロピレンの混合組成の樹脂との多層フィルムを形成してもよい。本発明の多室薬剤容器は、脱酸素剤と共に着色遮光フィルムもしくはアルミラミネートフィルムからなる酸素難透過性の外装袋に封入され最終製品とすることが好ましい。
【００３２】
輸液バッグに混注されるべきビタミン剤としては、ビタミンＡ、Ｂ₁、Ｂ₆、Ｂ₁₂、Ｃ、Ｄ、Ｅ、Ｋ、パントテン酸、ビオチン、ニコチン酸及び葉酸の１３種類の必須ビタミンを挙げることができる。１３種類のビタミンはそれぞれ薬液に調整する際、至適なｐＨが存在し、また同一薬液に配合するとビタミン間で配合変化することがあるので、適切な群に分離して各室に充填、収容することが好ましい。また、ビタミン剤を含有する薬液の量としては1〜５ｍｌが好ましいが、各室には薬液とともに窒素ガス、二酸化炭素ガス等の不活性ガスを充填し操作性の良い薬液容器容量に調整することが好ましい。薬液容器の薬液収容部の容量が５ｍｌ以下と小さすぎると混注操作が困難となり、また２００ｍｌ以上の容量とすると片手で混注することが困難となりかつ容器材料のコストがかさみ好ましくない。
【００３３】
ビタミン剤と共に本発明の薬剤容器分離収容される薬剤としてはトレースミネラル（微量元素）が好適である。微量元素を含む薬液に配合される鉄供給源としては、硫酸鉄、塩化第一鉄、塩化第二鉄及びグルコン酸鉄を挙げることができる。亜鉛供給源としては硫酸亜鉛、塩化亜鉛、グルコン酸亜鉛、乳酸亜鉛、酢酸亜鉛を挙げることができる。マンガン供給源としては硫酸マンガン、銅供給源としては硫酸銅を挙げることができる。微量元素製剤の好ましい各供給源の組合せについては、特願２００１−５４３７０号に記載の表１記載の塩化第ニ鉄（六水和物）、塩化マンガン（四水和物）、硫酸亜鉛（七水和物）、硫酸銅（五水和物）及びヨウ化カリウムを含有することが好ましい。なお、特願２０００−３９４２６０号記載の微量元素配合製剤は、肝機能障害患者用に混注する微量元素製剤としてマンガンを含有しないので薬液として好適に使用される。また特開２０００−１７８１８１号のセレンが配合された微量元素製剤も本発明の多室薬剤容器に収容することができる。
【００３４】
本発明の多室薬剤容器は、総合ビタミン剤及び微量元素製剤が好適に充填、収容されるが、それに加え注射液として上市されている各種の薬剤も収容することができる。患者の状態に応じて輸液組成を変化させることができる無機質塩類剤、アルギニンやグルタミンの投与量を増加することができるアルギニンとグルタミンが配合された注射用アミノ酸製剤、注射用ペプチド製剤、大豆油などの脂肪配合注射剤及びヘパリンナトリウム注射剤などの血液凝固防止剤も収容することができる。また特に高カロリー輸液が施行される際には、ビタミン剤、微量元素に加え、制吐剤や消化器用剤を収容した本発明の多室薬剤容器が好適に使用される。
【００３５】
ビタミン剤として配合されるビタミンＣは、ビタミンＣそのものであってもよく、その誘導体及びその塩であってもよい。具体的には、ビタミンＣ（アスコルビン酸）、アスコルビン酸ナトリウム、アスコルビン酸パルミテート、アスコルビン酸ジパルミテート、アスコルビン酸リン酸エステルマグネシウム塩などがあげられる。ビタミンＢ1としては、従来から使用されているものは何れも使用可能であり、たとえばチアミンであってもよく、その誘導体、具体的には、プロスルチアミン、アクトチアミン、チアミンジスルフィド、フルスルチアミンなどや、それらの塩、たとえば塩酸チアミン、硝酸チアミンなどであってもよい。ビタミンＢ1としては、従来から使用されているものは何れも使用可能であり、たとえばチアミンであってもよく、その誘導体、具体的には、プロスルチアミン、アクトチアミン、チアミンジスルフィド、フルスルチアミンなどや、それらの塩、たとえば塩酸チアミン、硝酸チアミンなどであってもよい。
【００３６】
ビタミンＡ、ビタミンＤ、ビタミンＥ及びビタミンＫは、そのものであってもよく、その誘導体の形で用いてもよい。具体的には、ビタミンＡ及びその誘導体としては、ビタミンＡ₁（レチノール）、ビタミンＡ₂（３−デヒドロレチノール）、ビタミンＡ₃（サブビタミンＡ）、レチネン（ビタミンＡアルデヒド）、ビタミンＡ酸、パルミチン酸レチノール、酢酸レチノールなどをあげることができる。ビタミンＤ及びその誘導体としてはビタミンＤ₂（エルゴカルシフェロール）、ビタミンＤ₃（コレカルシフェロール）、ビタミンＤ₄、プロビタミンＤ₂（エルゴステリン）、プロビタミンＤ₃（デヒドロコレステリン）などをあげることができる。ビタミンＥ及びその誘導体としてはα−トコフェロール、酢酸トコフェロール、β−トコフェロール、γ−トコフェロール、δ−トコフェロールなどをあげることができる。ビタミンＫ及びその誘導体としてはビタミンＫ1（フィロキノン、フィトナジオン）、ビタミンＫ₂（ファルノキノン）、ビタミンＫ₃（メナジオン）、ビタミンＫ₄、ビタミンＫ₅、ビタミンＫ₆、ビタミンＫ₇などをあげることができる。
【００３７】
【発明の実施の態様】
図１Ａ−図６Ｃは、本発明の第１実施例の多室薬剤容器を概略的に示す図である。図１Ａは、本発明の第１実施例の多室薬剤容器の縦断面図、図１Ｂは、薬剤混合抽出時の多室薬剤容器の縦断面図である。図２Ａ−２Ｄは、充填製造工程を示す第１室の縦断面図、図３Ａは、薄膜の変形例の断面図、図３Ｂは、図３Ａの薄膜の平面図、図４Ａは第２容器の縦断面図、図４Ｂは、図４Ａの第２容器の内部平面図、図５Ａ−５Ｃは、充填製造工程を示す第２室の縦断面図、図６Ａ−６Ｃは、充填製造工程を示す第３室の縦断面図である。図面全体を通じて同様の部材には同一の符号を付し、説明を省略する。
【００３８】
【第１実施例】
図１Ａ−図６Ｃに示す本発明の第１実施例の多室薬剤容器１は、開口端２２を有する第２容器２０、第２容器２０内に配置される一部樹脂フィルムからなる第１容器１０、第２容器２０の開口端２２と結合される開口端３２及び出口開口３９を有する第３容器３０、第２容器２０と第３容器３０の内部空間を連通可能な第１通路２３、第1通路２３を遮断する破断可能な薄膜３４、並びに連通具４０を含む。連通具４０は、第1端４１、第１端と反対側の第２端４２、流入孔４５及び流路４３を有し、多室薬剤容器１内の薬剤を流入孔４５及び流路４３を介し第２端４２から輸液バッグ９１内の輸液収容室９３中へ注入可能に構成される。第１容器１０内の空間により第１室１１が構成される。第２室２１が第２容器２０の内壁と第１容器１０の外壁とに囲まれた空間から成る。第３室３１が第３容器３０内の空間により構成される。
【００３９】
図１Ａに示すように、第３容器３０の出口開口３９は円筒形であり、軸線方向に離間して第１栓体３５及び第２栓体３６を収容し、両栓体３５、３６の間に第４室３８を形成する。第４室３８は連通具４０の流入孔４５，流路４３を介し輸液収容室９３に連通されるが、多室薬剤容器１内の薬剤及び外気に対し密封されている。第１栓体３５及び第２栓体３６は、出口開口３９の側壁に対して密封を維持しながら摺動できるようにされる。連通具４０は第１栓体３５及び第２栓体３６に固着され両栓体と一緒に出口開口３９内を軸線方向へ移動可能にされる。連通具４０は、流路４３に連通する流入孔４５を備える。流入孔４５は第１栓体及び第２栓体の間に配置されるように設けられる。図１Ｂに示すように、連通具４０の第１端部４１が第１容器２０の樹脂フィルムを破断する位置へ移動されたとき、連通具の流入孔４５が第３室３１と連通される。
【００４０】
第１容器１０（図１Ａ、図１Ｂでは、袋状容器として示される）内の空間により形成される第１室１１は、第１グループのビタミン剤を含む第１薬剤Ｍ１を収容する。第２容器２０の内壁と第１容器１０の外壁とに囲まれた空間から成る第２室２１は、第２グループのビタミン剤を含む第２薬剤Ｍ２を収容する。第１薬剤Ｍ１及び第２薬剤Ｍ２は、ビタミンＤを含まないものとする。第３容器３０内の空間から成る第３室３１は、ビタミンＤを含む第３薬剤Ｍ３を収容する。第３室３１を囲む第３容器３０の内壁、薄膜３４、連通具４０の外面は、ビタミンＤを吸着しない環状ポリオレフィンにより形成される。
【００４１】
図１Ａは、多室薬剤容器１内の薬剤を使用する前の状態を示し、連通具４０の第１端４１は、薄膜３４付近の第３容器３０内部に位置され、第１栓体３５及び第２栓体３６は、第３容器の円筒形の出口開口３９内に開口の側壁に密封を維持し配置される。連通具の第２端４２は、輸液バッグ９１のシール縁部９２内を伸長し流路４３を輸液バッグの輸液収容室９３へ連通され、多室薬剤容器１と輸液バッグ９１は連通具４０により連結される。第１栓体３５と第２栓体３６の間の出口開口３９の円筒形部分が連通具４０の流入孔４５及び流路４３を介し輸液バッグ９１の輸液収容室９３と連通される。このような多室薬剤容器１の構成により、薬剤の使用に際して、連通具の第２端を輸液バッグ内へ挿入する操作が不要になり、薬剤投与時における操作の複雑性及び負担が減少される。
【００４２】
図１Ｂは、多室薬剤容器１内の薬剤を連通具４０を介し導出中の状態を示す。連通具４０の第１端４１は、薄膜３４を貫通破断し第２室２１と第３室３１を流体連通させ、更に第１容器１０の壁を貫通破断し、第１室１１と第２室２１を流体連通させている。第１栓体３５は第３室３１内に位置され、第１栓体３５と円筒形出口開口３９との間の密封状態は解消され、第２栓体３６と円筒形出口開口３９との間に密封状態が維持されている。連通具の流入孔４５が第３容器３０内の第３室３１と連通され、第３室３１内の薬液が連通具の流路４３を介し輸液バッグの輸液収容室９３へ流出する。第１室及び第２室の薬剤は、連通具の第１端により破断された薄膜３４の破断部分を介し第３室へ流入し、同様に連通具の流路４３を介し輸液バッグの輸液収容室９３へ流出する。連通具４０の第１端は、第２室２１と第３室３１を区分する薄膜３４、及び第１室１１と第２室２１を区分する第１室の壁を破断するために、鋭利にされ得るが、第１室の壁及び薄膜３４を低強度のものとし、丸みのある形状とすることができる。
【００４３】
栄養輸液製剤に通常添加される薬剤の内、ビタミンＤは、比較的柔軟なポリエチレン樹脂材料に吸着される性質を有する。多室薬剤容器の壁材料にビタミンＤが吸着され失われることを避けるため、ビタミンＤを含む薬剤を収容する室、例えば、多室容器１の第３室３１は、それを構成する第３室内壁、即ち第３容器３０の内壁、第1通路２３を遮断する破断可能な薄膜３４の第３室側表面、連通具４０の外表面等をビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。第１室又は第２室にビタミンＤを含む薬剤を収容する場合は、同様に第１室又は第２室を構成する壁面がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００４４】
図２Ａ乃至図２Ｄは、カップ１０から成る第１容器１０を製造する工程を示す図であり、図２Ａは薬剤を充填する前の空のカップの縦断面図、図２Ｂは図２Ａのカップの上面図である。カップ１０は、円筒形又はテーパ付きの側壁１２及び平坦な底壁１４を有し、側壁の上端に開口１３が設けられる。図２Ｃに示すようにカップ１０内のほぼ全体に第１薬剤Ｍ１（例えばビタミンＢ類）を充填する。次に開口１３を樹脂製の薄い壁１６により密封閉鎖する。このカップ１０は、後述する図４Ａ乃至図５Ｃに示すように第２容器２０内へ配置される。薄い壁１６を低強度とすることにより、連通具の第１端を丸みのある安全な形状とすることができる。カップ１０は剛性もしくは準剛性の薄肉の容器としてもよく、比較的硬いビタミン非吸着の環状ポリオレフィンでも容易に成形可能であることから、ビタミンＤを含む第３薬剤Ｍ３を収容してもよい。なお、カップ１０内の第１薬剤は多室薬剤容器１を加熱滅菌する際に同時に滅菌されることから、複数の薬剤容器を個別に滅菌する場合に比べ製造工程が簡素化できる。
【００４５】
図３Ａは変形された薄膜３４を含む第１連通路２３の縦断面図、図３Ｂは図３Ａの上面図である。図３Ａに示す薄膜３４は第１連通路２３内において下方へ凸の円錐形に形成され、且つ図３Ｂに示すように薄膜３４の円錐形部分に十字形の溝又はスリット３７が具備される。薄膜３４に十字形の溝又はスリット３７を設けることにより、連通具の第１端は丸みのある安全な形状とすることができる。
【００４６】
図４Ａは図２Ｃの薬液を充填し薄い壁１６により開口１３を閉じたカップ（第１容器）１０を収容可能な第２容器の縦断面図であり、図４Ｂは図４Ａの第２容器の上面図である。図４Ａ及び図４Ｂに示すように、第２容器２０は、その底壁２５の付近において側壁２４から底壁２５に略平行に容器中央へ向って伸長する４つの弾性指片２６を備える。弾性指片２６は、それぞれの一端が側壁２４により固定され、その他端は、同一円上に配置され、第１容器１０を第２容器２０内に保持可能にされる。
【００４７】
図５Ａ乃至図５Ｃは、第１容器１０及び第２薬液Ｍ２を収容する第２容器２０の充填製造工程を示す縦断面図である。図５Ａに示すように第１容器１０は第２容器２０内へ挿入され、第１容器１０の底壁１４が第２容器２０内の４本の弾性指片２６の間を通り第２容器２０の底壁２５に隣接され、弾性指片２６により第１容器１０が第２容器２０内に係止される。第１容器１０の底壁１４の外径がその側壁１２の外径より大にされることにより、第１容器の底壁１４が弾性指片２６と第２容器の底壁２５の間に確実に保持される。次に図５Ｂに示すように第２容器２０の内部へ第２薬剤Ｍ２（ビタミン１）を充填する。その後、図５Ｃに示すように第２容器２０の開口を薄膜３４により密封することにより、第１容器１０及び第２薬剤Ｍ２を収容する第２容器２０が出来上がる。
【００４８】
図６Ａ及び図６Ｂは、第３薬剤Ｍ３を収容する第３容器３０の充填製造工程を示す縦断面図である。図６Ａに示すように、連通具４０の第１端４１が開口端３２付近の第３容器３０の内部にあるように、連通具４０が配置され、且つ連通具を支持する第１栓体３５が第３容器の円筒形の出口開口３９内に密封係合される。次に図６Ｂに示すように第３容器３０内へ第３薬剤Ｍ３（ビタミン２）を充填する。その後、図６Ｃに示すように、図５Ｃの状態の第２容器２０を上下反転させて図６Ｂの第３容器３０に載せることにより、図６Ｂの第３容器３０の開口端３２に、第２容器２０の薄膜３４により密封された開口端２２を整合させる。開口端２２と開口端３３の間を接着密封することにより第１乃至第３薬剤Ｍ１、Ｍ２、Ｍ３を充填した多室薬剤容器１が出来上がる。連通具４０の第２端４２を輸液バッグ９１の輸液収容室９３へ連通させ固定する工程は、多室薬剤容器１の製造工程の前又は後に行うことが可能である。
【００４９】
使用前の多室薬剤容器１においては、出口開口３９の第１栓体３５と第２栓体３６の間の空間は、連通具４０の流入孔４５、流路４３を介し輸液バッグ９１の輸液収容室９３と流体連通するが、第１栓体３５により多室薬剤容器１の薬剤に対し密封状態にあり、第２栓体３６により外気に対し密封状態にされる。連通具の第２端４２を輸液バッグ９１の輸液収容室９３へ連通させ固定する工程は、多室薬剤容器１の図６Ａ乃至図６Ｃの製造工程の前又は後に行うことができる。連通具の第２端４２は、予め輸液バッグに取り付けられる場合は、丸みのある形状とすることができる。また連通具の丸みのある端により貫通され得る、例えばスリットを設けた注入用栓体を備えた輸液バッグの場合にも丸みのある形状とできる。しかし輸液バッグが刺通可能な栓体を備えている場合は、例えば図７Ａに示すように第２端を鋭利とすることが必要である。
【００５０】
図７Ａ及び図７Ｂは、多室薬剤容器１の部分変形例の概略縦断面図である。図７Ａの多室薬剤容器１は、図６Ｃの多室薬剤容器１において、連通具４０の第２端４２が鋭利な形状を有するものである。多室薬剤容器１を輸液バッグに連結しないで保持する場合、第２端４２は図示しないキャップにより外気に対し密封し、流路４３、第３容器の出口開口３９内等の無菌状態を維持する。図７Ｂの多室薬剤容器１は、図７Ａの多室薬剤容器１において、第１室１１を幾分扁平な球形とすると共に連通具４０の第２端４２を軸線に略直角の平面とし安全性を高めたものである。
【００５１】
【第２実施例】
図８Ａは本発明の第２実施例による多室薬剤容器２の概略斜視図であり、図８Ｂは図８Ａの線Ａ−Ａに沿う断面図である。第２実施例の多室薬剤容器２は、比較的剛性の材料から成る第３容器７０、第３容器内に収容される樹脂フィルムバッグ５０、及び薬剤を注出するための連通具４０を有する。樹脂フィルムバッグ５０は、筒状フィルムの下端及び上端を下縁部５４及び上縁部５６で閉じ、更に両縁部の間において筒状フィルム内を２分するように伸長し配置される第３縁部５５を備える。同じく第３容器７０は、筒状フィルムの下端及び上端を閉じる下縁部７４及び上縁部７６を備える。第３縁部５５により樹脂フィルムバッグ５０内は第１室５１及び第２室６１に仕切られ、それぞれ第１薬剤Ｍ１と第２薬剤Ｍ２が封入される。第３容器７０の内面とバッグ５０の外面に囲まれた空間により成る第３室７１に第３薬剤Ｍ３が収容される。第３容器７０の内面は、１対の剛性の前壁７２及び後壁７３の内面を含む。樹脂フィルムバッグ５０の連通具４０側に位置する下縁部５４は、剥離容易なシール部により形成し、前壁７２と後壁７３の間の距離を減少することによる押し圧力で剥離して第１室５１及び第２室６１を第３室７１へ連通させることができる。
【００５２】
図８Ａの第２実施例による多室薬剤容器２は、図８Ｂに示すように、前壁７２から雄スパイク７５が第３室内へ突出し、後壁７３は雄スパイク７５に係合する雌スパイク７６を具備する。雄スパイク７５は、好ましくは２つの凸部を備え、第１室５１及び第２室６１の下方部分の樹脂フィルムを切断開口するように配置される。雄スパイク７５の２つの凸部の各々がバッグ５０の第１室５１及び第２室６１の樹脂フィルムを確実に切断開口する。雌スパイク７６が雄スパイク７５に対向して第３室７１内に配置され、雄スパイク７５の凸部を受ける構造にされ、第３室７１の壁部分が雄スパイク７５により破断され、薬剤が第３室の壁部分を介して外部へ漏れることを防止する。
【００５３】
連通具４０は、第３容器７１の下方縁部７４に溶着され支持され、連通具４０の流路４３は、第３容器７０内の第３室７１に連通される。連通具４０の第２端４２は、図８Ａに示すように密封キャップ４８により密封されるか又は図１Ａに示すように輸液バッグの輸液収容室内へ開口される。第３室７１を構成する第３容器７０の内壁及び樹脂フィルムバッグ５０の外面がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。第１室５１及び第２室６１の下方縁部５４を開口するか、又はスパイクにより下方縁部付近の樹脂フィルムを切断開口することにより、第１室５１及び第２室６１内に残留する薬剤を最少にし、大部分の薬剤を連通具４０を介して流出させることができる。
【００５４】
図８Aの下縁部５４が剥離容易なシール部により形成された場合の多室薬剤容器２の薬剤を輸液バッグ内の輸液へ供給する手順は、次の通り。まず、第３容器７０の前璧７２と後壁７３を指で押圧することにより、両璧間の距離を減少させて第３容器７０内に収容された樹脂フィルムバッグ５０を押圧し、弱シールから成るバッグ５０の下縁部５４を剥離開放させ、連通させる。樹脂フィルムバッグ５０の下縁部５４を容易に剥離開放させるため、下縁部５４の接着強度は、調整される。
【００５５】
連通具４０の第２端４２は、輸液バッグの混注用の連結口部を介して輸液収容室へ開口させる。この操作は、多室薬剤容器２を輸液バッグと結合しキットにして提供される場合は不要となる。更に第３容器７０内の容積を変形縮小させ、第３容器内の薬剤を輸液バッグ内へ移送する。第３容器はブロー成形法、インジェクション成形法等各種の樹脂成形法を用いることができる。また、第３容器全体が均質な厚みである必要はなく、押圧力が小さくて変形可能なように一部分を薄肉化することが好ましい。
【００５６】
第３容器７０の前璧７２と後壁７３にスパイクを備えた態様においては、第３容器７０の両璧を押圧し雌雄スパイク７６、７５を係合させることにより、樹脂フィルムバッグ５０に切削開口部をつくることができ、この開口部より充樹脂フィルムバッグ５０に充填された薬剤が第３容器７０内に移送される。第３容器７０の前壁７２及び後壁７３の材質は、雄雌のスパイク７５、７６が噛み合い位置を維持することができるような剛性及び弾性復元力を有するように調整される。連通具４０の第２端４２は、輸液バッグの混注用の連結口部を介して輸液収容室へ開口される。更に第３容器７０の弾性変形能を利用して、第３容器７０を数回押圧して同容器内の薬剤を輸液バッグの輸液収容室へ移送する。
【００５７】
多室薬剤容器２の外殻が剛性の第３容器７０の壁により形成され薬剤の流出によって変形し難い性質を有する場合、多室薬剤容器２から薬剤を円滑に流出させるため、好ましくは連通具４０は、流路４３と平行に置換ガス供給用の換気を具備する。連通具４０の第２端４２は、密封キャップ４８により覆われ、流路４３を周囲雰囲気から密封する。
【００５８】
【第３実施例】
図９は本発明の第３実施例の多室薬剤容器３の概略断面図である。第３実施例の多室薬剤容器３においては、シリンジ（バレル）１３０内に樹脂フィルムバッグ１１０が収容され、シリンジの一端が栓体１４２により閉鎖され、シリンジの他端（排出口）は連通具４０の基端を支持する。樹脂フィルムバッグ１１０は、第１薬剤Ｍ１を収容する第１室１１１及び第２薬剤Ｍ２を収容する第２室１２１を含む。シリンジ１３０の内面、栓体の端面及び樹脂フィルムバッグ１１０の外面等に囲まれるシリンジ１３０の内部空間が第３薬剤Ｍ３を収容する第３室１３１とされる。第１室１１１及び第２室１２１は、樹脂フィルムバッグ１１０が押圧力を受けたとき容易に剥離又は破断する弱結合部１１２、１２２をそれぞれ有する。弱結合部１１２、１２２は、樹脂フィルムバッグ１１０が押圧されると容易に剥離又は破断し、第１薬剤Ｍ１、第２薬剤Ｍ２を、第３室１３１内の第３薬剤Ｍ３に混合させる。連通具４０の基端を支持するシリンジ１３０の排出口付近に多孔板（みざら）１３４が配置され、多孔板１３４の多孔を介しシリンジ１３０内から薬剤が連通具４０の流路４３へ流動可能にされる。多孔板１３４は、樹脂フィルムバッグ１１０を破断開口させるための鋭利な突起１３５を備える。
【００５９】
図９は使用前の多室薬剤容器３を示す。多室薬剤容器３の薬剤を連通具４０を介し図示しない輸液バッグ内の輸液に混合する手順は、次の通り。まず連通具４０から密封キャップ４８を取外し、連通具４０の第２端４２を図示しない輸液バッグの輸液収容室へ開口させる。多室薬剤容器３が輸液バッグと結合されキットとして提供される場合はこの操作は不要である。次にプランジャ１４０に押込み力を加え、栓体１４２をシリンジ１３０内へ押込む。栓体１４２がシリンジ１３０内へ押込まれると、第３薬剤Ｍ３が連通具４０の流路４３及び第２端４２を介し、輸液バッグ内へ移動され輸液に混合される。それと同時に栓体１４２の内方面が樹脂フィルムバッグ１１０を押圧し、その弱結合部１１２、１２２を剥離又は破断し、樹脂フィルムバッグ１１０内から第１薬剤Ｍ１及び第２薬剤Ｍ２を流出させ、第３薬剤Ｍ３と混合する。
【００６０】
多孔板１３４は、多数の孔を有する略円錐形の壁により形成され、円錐形の頂点部１３５が鋭利な形状とされる。樹脂フィルムバッグ１１０は鋭利な頂点部１３５へ向けて押圧されることによりより容易に破断される。多孔板１３４は、多数の孔を通して薬剤を連通具４０の流路４３へ流動させ、樹脂フィルムバッグ１１０が連通具４０の流路４３の入口を塞ぐことを防止する。
【００６１】
第３室１３１に収容される第３薬剤Ｍ３は、ビタミンＤを含むものとすることができる。その場合、第３室１３１の内壁を形成する、シリンジ１３０の内面、栓体の端面及び樹脂フィルムバッグ１１０の外面等は、ビタミンＤを吸着しない比較的硬い樹脂材料で容易に製造する。第３の実施の態様の多室薬剤容器３は、プランジャ１４０の挿入に伴い、薬剤Ｍ１、Ｍ２、Ｍ３を収容する容器内の容積を減少させ得るので、換気ガスを多室薬剤容器内へ導入する必要がない。
【００６２】
【第４実施例】
図１０Ａは本発明の第４実施例の多室薬剤容器４の概略側面図であり、図１０Ｂは図１０Ａの変形例を示す概略側面図である。多室薬剤容器４は、シリンジ（バレル）２３０及び樹脂フィルムバッグ２１０を備える。シリンジ２３０の一端が栓体２３３により閉鎖され、他端は排出口２３４を有する。シリンジ２３０内の空間が第３薬剤Ｍ３を収容する第３室２３１を画成する。樹脂フィルムバッグ２１０は第１薬剤Ｍ１を収容する第１室２１１及び第２薬剤Ｍ２を収容する第２室２２１を画定する。樹脂フィルムバッグ２１０から薬剤を図示しない輸液バッグ内へ案内するための連通具４０が具備される。
【００６３】
樹脂フィルムバッグ２１０は、強固に接着された２つの側縁部２１２及び２つの端縁部２１３を備える。一方の端縁部２１３を通過してシリンジの排出口２３４が配置される。排出口の外面と一方の端縁部２１３の間は気密に接着される。また他方の端縁部２１３を通過して連通具４０が配置される。連通具４０の外面と他方の端縁部２１３の間は気密に接着される。シリンジ２３０の排出口２３４は、図１０Ａの場合、樹脂フィルムバッグ２１０の第１室２１１又は第２室２２１の内部に開口される。図１０Ｂの場合、排出口２３４は、シール部材２３５により密封閉鎖される。シール部材２３５は、シリンジ２３０内へ栓体２３３を挿入するときシリンジ２３０内の液圧の上昇により排出口２３４から離間しシリンジ内の第３室２３１内の第３薬剤Ｍ３が樹脂フィルムバッグ２１０内へ注入される。
【００６４】
第１室２１１と第２室２２１の間に剥離容易な第１弱結合部２１４が設けられ、第１弱結合部２１４は第１室２１１又は第２室２２１へシリンジ内の薬剤が注入されることによる圧力上昇又は樹脂フィルムバッグの外部から与えられる押圧力により剥離され、第１室２１１と第２室２２１を流体連通させる。樹脂フィルムバッグ２１０は、更に第４室２４１を含み、第２室２２１と第４室２４１の間に剥離容易な第２弱結合部２２４が設けられる。第２弱結合部２２４は、第１弱結合部２１４と同様に、第１室２１１又は第２室２２１へシリンジ内の薬剤が注入されることによる圧力上昇又は樹脂フィルムバッグ２１０へ外部から与えられる押圧力により剥離され、第２室２２１と第４室２４１を流体連通させる。第４室は連通具４０の流路に連通される。
【００６５】
図１１Ａ乃至図１１Ｃ並びに図１２Ａ及び図１２Ｂは本発明の第５実施例の多室薬剤容器５の概略断面図である。図１１Ａ及び図１２Ｂは多室薬剤容器５の使用前の状態及び使用後の状態を示す概略側面図であり、図１１Ｂ、図１１Ｃ、図１２Ａは、それぞれ多室薬剤容器５の使用途中の状態を示す概略側面図である。多室薬剤容器５は、第１連通具３６０を備える樹脂フィルムバッグ３１０、及び第２連通具３４０を備えるシリンジ（剛性容器）３３０を含む。樹脂フィルムバッグ３１０内に第１薬剤Ｍ１を収容する第１室３１１及び第２薬剤Ｍ２を収容する第２室３２１が設けられる。第１室３１１と第２室３２１との間に剥離容易な弱結合部３１４が配置される。
【００６６】
シリンジ３３０の一端に栓体３３３が挿入され、他端に第２連通具３４０が連結される。シリンジ３３０円筒形内面、栓体３３３の端壁３３４に囲まれる空間が第３薬剤Ｍ３を収容する第３室２３１を画成する。第１連通具３６０の一端３６２は第２室３２１内に配置される。第１連通具３６０は、逆止弁３６７を備える流路３６４、流路３６４と第２室を連通させる流入口３６１を有する。第１連通具３６０の他端３６５は栓体３３３内に形成された円筒形の第４室３３５内へ伸長され、栓体３６３に固着される。第１連通具３６０の流路３６４の先端開口３６６は、薬剤使用前（図１１Ａ）において密閉空間から成る第４室３３５に連通される。
【００６７】
図１１Ｂは、薬剤を送出するための最初の段階における多室薬剤容器５を示し、第１連通具３６０がシリンジ３３０内へ僅かに移動され第１連通具３６０の先端開口３６６が、第４室３３５の端壁３３４を突き破り、第３室３３１に連通されている。図１１Ｃは、第１室３１１と第２室３２１との間の剥離容易な弱結合部３１４（図１１Ａ）が剥離され、第１室３１１と第２室３２１が連通され、第１薬剤Ｍ１と第２薬剤Ｍ２が混合された状態を示す。
【００６８】
図１２Ａは、栓体３３３をシリンジ３３０から引き出す方向へ移動させ、樹脂フィルムバッグ３１０内の薬剤Ｍ１、Ｍ２が、流入孔３６２、流路３６４、逆止弁３６７及び先端開口３６６を介しシリンジ内の第３室３３１へ移動させる工程を示す。樹脂フィルムバッグ３１０は、薬剤Ｍ１及びＭ２の流出に伴い変形する故に薬剤流出の抵抗を生じない。図１２Ｂは、栓体３３３をシリンジ３３０内へ押し込む方向へ移動させ、栓体３３３によりシリンジ内の薬剤Ｍ１、Ｍ２、Ｍ３を第２連通具３４０を介し輸液バッグ内へ押し出した後の状態を示す。第２連通具３４０は、実施例１の場合と同様に予め輸液バッグに連結するか又は輸液の使用時に輸液バッグに連通させることができる。
【００６９】
図１３Ａは、本発明の第６実施例の多室薬剤容器６を示す概略縦断面図、図１３Ｂは、本発明の第６実施例の変形例の多室薬剤容器６’を示す概略縦断面図、図１４は、第６実施例の多室薬剤容器６、６’に組み合わせて使用可能な連通具４４０の概略縦断面図、図１５Ａは第６実施例の変形例６’に使用される多孔板の平面図、図１５Ｂは、図１５Ａの多孔板の縦断面図である。図１３Ａに示す本発明の第６実施例の多室薬剤容器６は、一端から第１プランジャ４６２が挿入され他端に第１導出路４２４を備える第１シリンジ４２０、一端から第２プランジャ４６３が挿入され他端に第２導出路４３４を備える第２シリンジ４３０、第１プランジャ及び第２プランジャを結合し一緒移動させるプランジャ結合部材４６５、第１導出路４２４及び第２導出路４３４に連通し薬剤を混合し図示しないバッグ内の輸液中へ注入することができる導出フランジ４３８を含む。
【００７０】
第１シリンジ４２０内に可動仕切部材４１４により分けられた第１室４１１及び第２室４２１が画成される。第２シリンジ４３０内に第３室４３１が画成される。第１シリンジ４２０の内壁に凹所４２６が形成され、第１プランジャ４６２が第１シリンジ４２０内へ挿入され可動仕切部材４１４が内壁の凹所４２６に一致すると第１室４１１と第２室４２１が流体連通され、第１室４１１及び第２室４２１内の薬剤Ｍ１、Ｍ２が第１導出路４３４及び導出フランジ４３８を介して輸液バッグ（図示しない）内へ導出され、、また第２プランジャ４６３が第２シリンジ４３０内へ挿入されることにより第２シリンジ４３０内の薬液Ｍ３が第２導出路４３４を介して輸液バッグ内へ導出される。導出フランジ４３８と輸液バッグ（図示しない）の間に図１４に示す連通具４４０を用いることができる。図１３Ａに示す本発明の第６実施例の多室薬剤容器６において、第３室４３１を構成する第２シリンジ４３０の内壁がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００７１】
図１３Ｂは、本発明の第６実施例の変形例の多室薬剤容器６’を示す概略縦断面図である。多室薬剤容器６’は、一端から第１プランジャ４６２が挿入され他端に第１導出路４２４を備える第１シリンジ４２０、一端から第２プランジャ４６３が挿入され他端に第２導出路４３４を備える第２シリンジ４３０、第１プランジャ４６２及び第２プランジャ４６３を一緒に移動するよう結合するプランジャ結合部材４６５、第１導出路４２４及び第２導出路４３４に連通し薬剤を輸液バッグ内の輸液中へ注入することができる導出フランジ４３８を含む。導出フランジ４３８の出口は、密封キャップ４４で覆われるか又は輸液バッグ内に配置される。
【００７２】
図１３Ｂの第６実施例の変形例の多室薬剤容器６’において、第１シリンジ４２０の内部空間は弱結合部４１４を有する樹脂フィルムバッグ４１０から成る第１室４１１を含み且つ第２室４２１を画成する。第２シリンジ４３０内に第３室４３１が画定される。第１導出路４２４の入口付近に多孔板４２８が配置され、第１プランジャ４６２が第１シリンジ４２０に挿入されると樹脂フィルムバッグから成る第１室４１１のフィルムが破られ第１室４１１内の第１薬剤Ｍ１が第２室４２１内の第２薬剤Ｍ２と共に第１導出路４２４及び導出フランジ４３８（並びに図１４の連通具４４０）を介し導出される。第１プランジャ４６２の挿入と同時に第２プランジャ４６３が第２シリンジ４３０へ挿入され、第３室４３１内の第３薬剤Ｍ３が第２導出路４３４及び導出フランジ４３８（並びに図１４連通具４４０）を介し導出される。第３室４３１を構成する第２シリンジ４３０の内壁がビタミンＤに対し非吸着性の環状ポリオレフィンにより形成される。
【００７３】
図１４は第６実施例の多室薬剤容器６、６’と組み合わせて使用される連通具４４０の概略縦断面図である。連通具４４０は、バレル４００の導出フランジ４３８に嵌合する基部４４１、並びに第１導出路４２４及び第２導出路４３４に連通される２つの流路４４７、４４８を有する。２つの流路４４７、４４８は、第１及び台２導出路４２４、４３４との接続部は、いわゆる中空管の端部を切り口が鋭くなるように傾斜面にて切断された「竹の子針」の形状が好適である。
【００７４】
図１５Ａは第６実施例の変形例６’に使用される多孔板４２８の平面図、図１５Ｂは、図１５Ａの多孔板４２８の縦断面図である。この多孔板４２８は、図９の多室薬剤容器３の多孔板１３４と同様に樹脂フィルムバッグ４１０が第１導出路４２４の入口を塞ぐことを防止する。また好適には多孔板１３４と同様に、多孔板４２８は円錐形状を有し、中央付近に鋭利な突部４２７を備える。
【００７５】
【発明の効果】
本発明の多室薬剤容器は、高カロリー輸液用糖・電解質・アミノ酸液に混合し投与することが必要なビタミンＢ₂他のビタミン剤、及び鉄供給源他の複数の微量元素を含有する微量元素製剤を複数の室へ分離収容することにより、それらの薬剤の品質劣化、析出物生成を効果的に防止することができる。特に、同一容器内に充填すると温度、光、還元物質、酸素などが関与し短時間に生成するビタミンＢ₂と微量元素製剤に含まれる鉄供給源由来の析出物を効果的に防止することができる。
【００７６】
本発明の多室薬剤容器は、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液その他の薬液収容する輸液バッグ内へ患者に必要な少量の薬液を混注する作業を、安全に且つ容易に行うことができ、また混注すべき異種の薬液間の品質劣化の原因となる相互作用を排除し、隔壁手段で隔離された複数の室に薬液を選択的に分離収容することが可能な薬液容器を提供するものである。
【００７７】
本発明多室薬剤容器は、３種以上の薬剤、特に総合ビタミンを外気に晒すことなく容器内に別々に保管し使用時に簡単な操作により混合することが可能な多室薬剤容器を提供し、ビタミンＤを収容する室の内壁をビタミンＤに対し非吸着性の比較的に硬質の樹脂、例えば環状ポリオレフィンにより製造することによりビタミンＤが容器に吸着されることを防止することができる。
【００７８】
本発明の多室薬剤容器は、少量の複数の薬剤を袋状容器に収容した多量の薬液（輸液）中へ比較的容易に無菌状態を保持し誤作動なく混合することを可能にする。本発明は、またそのような多室薬剤容器においてビタミンＤに対し非吸着性を有する樹脂から成る室を含む構造を確実に提供することができる。
【００７９】
本発明の多室薬剤容器は、容器の外部から人手により力を加えることにより複数の室の間を容易に液体連通状態にすることができ、それらに収容された薬剤を簡易に誤りなく混合可能な構造を提供する。更に本発明の多室薬剤容器は、収容された複数の少量の薬剤を容器内で無菌状態を保持したまま混合可能であり、混合された薬剤を輸液バッグへ注入することが可能である。また、多室薬剤容器において、単一の操作により順次に複数の少量の薬剤を輸液バッグへ注入するか又は単一の操作により複数の少量の薬剤を混合し輸液バッグへ注入することができる。
【図面の簡単な説明】
【図１】図１Ａ−図６Ｃは、本発明の第１実施例の多室薬剤容器１を概略的に示す図であり、図１Ａは、本発明の第１実施例の多室薬剤容器の縦断面図、図１Ｂは、薬剤混合時の多室薬剤容器の縦断面図。
【図２】図２Ａ−２Ｄは、多室薬剤容器１の第１室の充填製造工程をそれぞれ示す縦断面図。
【図３】図３Ａは、薄膜の変形例の断面図、図３Ｂは、図３Ａの薄膜の平面図。
【図４】図４Ａは第２容器の縦断面図、図４Ｂは、図４Ａの第２容器の内部平面図。
【図５】図５Ａ−５Ｃは、第２室の充填製造工程を示す縦断面図。
【図６】図６Ａ−６Ｃは、第３室の充填製造工程を示す縦断面図。
【図７】図７Ａ及び図７Ｂは、多室薬剤容器１の部分変形例の概略縦断面図。
【図８】図８Ａは本発明の第２実施例による多室薬剤容器２の概略側面図であり、図８Ｂは図８Ａの線Ａ−Ａに沿う断面図。
【図９】図９は本発明の第３実施例の多室薬剤容器３の概略断面図。
【図１０】図１０Ａは本発明の第４実施例の多室薬剤容器４の概略側面図であり、図１０Ｂは図１０Ａの変形例を示す概略側面図。
【図１１】図１１Ａ乃至図１１Ｃ本発明の第５実施例の多室薬剤容器５の概略側面図であり、図１１Ａは多室薬剤容器５の使用前の状態、図１１Ｂ及び図１１Ｃは使用するため多室薬剤容器５の操作を開始した段階を示す概略側面図。
【図１２】図１２Ａ本発明の多室薬剤容器５の操作の更なる段階を示す概略側面図。図１２Ｂは多室薬剤容器５の使用後の概略側面図。
【図１３】図１３Ａは、本発明の第６実施例の多室薬剤容器６を示す概略縦断面図、図１３Ｂは、本発明の第６実施例の変形例の多室薬剤容器６‘を示す概略縦断面図。
【図１４】図１４は第６実施例に使用される連通具の概略縦断面図。
【図１５】図１５Ａは第６実施例の変形例６’に使用される多孔板の平面図、図１５Ｂは、図１５Ａの多孔板の縦断面図である。
【符号の説明】
１〜６：多室薬剤容器、１０：第１容器、１１：第１室、１６：薄い壁、２０：第２容器、２１：第２室、２２：開口端、２３：第１通路、２４：側壁、２６：弾性指片、３０：第３容器、３１：第３室、３２：開口端、３４：薄膜、３５：第１栓体、３６：第２栓体、３７：スリット、３８：第４室、３９：出口開口、４０：連通具、４１：第１端、４２：第２端、４３：流路、４５：流入口、４８：密封キャップ、５０：５１：第１室、樹脂フィルムバック、６１：第２室、７０：第３容器、７１：第３室、７２：前壁、７３：後壁、７５：雄スパイク、７６：雌スパイク、９１：輸液バッグ、９２：シール縁部、９３：輸液収容室、１１０：樹脂フィルムバッグ、１１１：第１室、１１２：弱結合部、１２１：第２室、１２２：弱結合部、１３０：シリンジ、１３１：第３室、１３４：多孔板、１４２：栓体、２１０：樹脂フィルムバッグ、２１１：第１室、２１２：側縁部、２１３：端縁部、２２１：第２室、２２４：第２弱結合部、２３０：シリンジ（バレル）、２３１：第３室、２３２：プランジャ、２３３：栓体、２３４：排出口、２４１：第４室、３１０：樹脂フィルムバッグ、３１１：第１室、３１２：側縁部、２１３：端縁部、３１４：弱結合部、３２１：第２室、３３０：シリンジ、３３１：第３室、３３３：栓体、３３４：端壁、３３５：第４室、３４０：第２連通具、３４４：密封キャップ、３６０：第１連通具、３６１：流入口、３６２：一端、３６３：栓体、３６４：流路、３６５：他端、３６６：先端開口、３６７：逆止弁、３６８：突起、４１１：第１室、４２１：第２室、４２４：第１導出路、４２８：多孔板、４３０：第２シリンジ、４３１：第３室、４３４：第２導出路、４４０：連通具、４６２：第１プランジャ、４６３：第２プランジャ、４６５：プランジャ結合部材、Ｍ１、Ｍ２、Ｍ３：薬剤。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a multi-chamber drug container having a first chamber, a second chamber, and a third chamber for separately storing at least a first drug, a second drug, and a third drug for mixing with an infusion solution, respectively. . In particular, the present invention separates and stores infusions, ie, vitamins and other multiple drugs that are blended in medical fluids such as infusion preparations for intravenous administration, liquid nutrients, peritoneal dialysis fluid, etc. The present invention relates to a multi-chamber drug container capable of easily mixing a plurality of drugs immediately before.
[0002]
[Prior art]
Conventionally, infusion components supplied to the human body by infusion, for example, amino acid solution, glucose solution, etc., are altered when mixed, so each of the infusion containers separated by a detachable isolating means, especially into a plurality of individual chambers in the infusion bag, respectively. It has been devised to accommodate and separate the mixing means by pressing the infusion bag from the outside during use (see, for example, Patent Document 1).
[0003]
[Patent Literature]
JP 62-176451 A
JP-A-8-182739
Japanese National Patent Publication No. 8-509631
[0004]
In addition, when infusion is administered to a patient by intravenous drip, depending on the patient's pathology, a small amount of various medicinal solutions such as amino acid solution and glucose solution, for example, trace mineral (trace element), vitamin, analgesic, fat infusion, antibiotics It is necessary to mix substances, minerals, cardiotonics, etc. Usually, a work (mixed injection) for mixing a small amount of liquid medicine with an infusion preparation is performed in a clean booth in a hospital, and the liquid medicine to be mixed is injected into the infusion liquid in an infusion bag using a syringe. In this case, it is performed carefully so as not to cause bacterial infection of the drug solution. These mixed injection operations are complicated, and it is desired that mixed injection can be performed with a simple operation.
[0005]
Japanese Patent Laid-Open No. 10-24088 discloses a drug-filled container set for the purpose of providing an infusion container in which a drug-filled vial or the like is simply connected with few parts in a state where sterility is guaranteed. This drug enclosure container set is a resin container and has a plurality of chambers, and at least a part of a separating strip portion between the chambers is formed by a peel seal portion or a weak seal portion that can be opened from the outside. A chemical solution is stored in the chamber, a filling container is connected to the second chamber, the filling container stores the drug mixed with the chemical solution, and a lid or a film body that closes the opening of the filling container presses from the outside of the second chamber. Thus, it can be pushed into the filling container, and the second chamber and the filling container are communicated with each other by pushing the lid or film into the filling container. The plastic container sterilized by high-pressure steam and the vial containing the drug are connected in a sterile, dust-free chamber, and then only the second chamber is sterilized by electron irradiation, and the outer surface of the filled container once exposed to the outside in the second chamber And sterilized together.
[0006]
Medical solutions such as injections, infusions for intravenous administration, dialysis solutions, eye drops, ophthalmic perfusates, and organ preservation solutions are stored in a sterile state, so they are almost liquid-tight in a thermoplastic resin container or glass container. Filled and sterilized or sterilized. One product form of medical solutions is a kit product. The kit product is a combination of a drug and a medical device or two or more drugs as a single administration system, and is intended to reduce the burden at the time of dispensing in a medical institution, prevent bacterial contamination, and prevent foreign substances from being mixed. Examples of kit products are prefilled disposable injections (prefilled syringe products), two-chamber mixed-type infusions called double bags, such as “PN Twin” (trade name) manufactured by Ajinomoto Pharma. The kit product has advantages such as prevention of errors during dispensing and quick response in an emergency.
[0007]
Double bags and pre-filled syringes are sold with a container divided into two chambers, but there is a drawback that cannot be applied when adding additional drugs or nutrients. In order to solve this problem, a medical container having three chambers has been proposed in, for example, Japanese Patent Publication No. 2000-501324. In the invention of this publication, the flexible bag is partitioned by a peelable seal, and a chamber for storing the third medicine is provided. However, when a multi-compartment room is provided, an extremely careful opening operation is required to ensure communication between all the compartments and mixing of the components, and there is a problem in quick response in an emergency. Moreover, when it is administered to a patient with a section that is not opened, a solution different from the administrable liquid property being supplied, leading to the occurrence of side effects.
[0008]
Japanese Unexamined Patent Publication No. 2000-87350 discloses a multi-chamber infusion container in which a first container for storing a liquid medicine and a second container for storing a solid medicine are integrated. The multi-chamber infusion container includes a partition member between the first container and the second container. The partition member includes a hollow portion that connects the adjacent first and second containers so as to communicate with each other, and the hollow portion. A lid for sealing one end of the unit. The lid is connected to the main body of the partition member via the thin wall portion, and is opened by deforming the partition member. This multi-chamber infusion container has a disadvantage that a small amount of a plurality of drugs cannot be separated and stored.
[0009]
In some cases, medical solutions such as infusions are used in combination with antibiotics or vitamins depending on the pathology of the patient being administered. In addition, storage stability can be expected to be improved by separating and storing various active ingredients in multiple chambers. However, providing multiple compartments or compartments for the container complicates the manufacturing process of the container, and can be used during use. There is a problem that convenience of the service is reduced.
[0010]
A nutritional infusion preparation containing glucose or the like needs to be mixed with 13 essential vitamins when administered. Vitamin D in the total vitamins has the property of being adsorbed to a relatively flexible resin film, and in order to avoid adsorption, the container that holds and holds vitamin D may be made of a relatively rigid cyclic polyolefin. is necessary. However, when the resin film bag is made of a cyclic polyolefin, it is difficult to form a welded portion, particularly an easily peelable adhesive portion. Conventionally, vitamin D is contained in a container separate from other vitamins, and it is necessary to separately mix it with the infusion solution at the time of administration of the infusion solution. Typically, a combination of two vitamins consisting of vitamin D contained in one syringe and other vitamins contained in another syringe is manipulated and injected into the infusion solution. The injection is complete.
[0011]
[Problems to be solved by the invention]
In a chemical container that can be mixed and mixed with an infusion preparation with a small amount of various chemical solutions, it is necessary to prevent the chemical solutions from becoming contaminated or promoting decomposition by mixing. In particular, vitamin agents are not only accelerated in quality deterioration by light and temperature, but may contain insoluble precipitates or fine particles or may be decomposed when mixed with trace elements.
[0012]
High-calorie infusion sugar, electrolytes and amino acid solutions include vitamin B₂There are many examples of co-injecting other vitamin preparations and trace element preparations containing iron sources and other trace elements. A chemical solution containing a vitamin preparation and a trace element preparation deteriorates in a short period of time.₂And the precipitate derived from the iron supply source contained in the trace element preparation. Factors such as temperature, light, reducing substances, and oxygen are involved in the formation of this precipitate, but since it is generated in a very short time, it is difficult to fill the same container.
[0013]
It is an object of the present invention to be able to safely and easily perform the work of co-injecting a small amount of liquid medicine necessary for a patient into an infusion bag containing high-calorie infusion, amino acid infusion, electrolyte infusion, saccharide infusion, or other medicinal liquid. To do. The present invention also eliminates an interaction that causes quality deterioration between different types of chemical solutions to be mixed, and a chemical solution container capable of selectively separating and storing chemical solutions in a plurality of chambers separated by a partition means. The purpose is to provide.
[0014]
The object of the present invention is a multi-chamber drug capable of being stored separately in a container without being exposed to the open air and mixed by a simple operation at the time of use, especially three or more kinds of drugs that are in increasing need. Is to provide a container. In particular, the present invention has a structure that prevents vitamin D from being adsorbed in a container by manufacturing the inner wall of a chamber containing vitamin D with a relatively hard resin that is non-adsorbable with respect to vitamin D, such as cyclic polyolefin. Is to provide a multi-chamber drug container. Another object of the present invention is to provide a drug kit product that accommodates a relatively large amount of drug solution in a bag-shaped container and a relatively small amount of a plurality of drugs in a set of multi-chamber drug containers. Another object of the present invention is to provide a structure that does not require an easily peelable seal portion in a container made of a resin that is non-adsorbable to vitamin D in the multi-chamber drug container.
[0015]
Still another object of the present invention is to provide a drug in a multi-chamber drug container that can be easily brought into liquid communication between a plurality of chambers by manually applying force from the outside of the container. It is to provide a structure that can be easily mixed without error. Still another object of the present invention is to allow a plurality of small amounts of drugs contained in a multi-chamber container to be mixed while maintaining aseptic conditions in the container, and to allow the mixed drugs to be injected into an infusion bag. It is to provide a chamber drug container. Still another object of the present invention is to inject a plurality of small amounts of drugs into an infusion bag sequentially by a single operation in a multi-chamber drug container or to mix a plurality of small amounts of drugs by a single operation. Is to be able to inject. Other objects and advantages of the present invention will become apparent in the drawings and the following description.
[0016]
[Means for Solving the Problems]
The multi-chamber drug container of the present invention includes a first chamber, a second chamber, and a third chamber that separately store a first drug, a second drug, and a third drug, and includes a first drug, a second chamber, and a second chamber. The structure in which the drug and the third drug can be mixed into the infusion solution in the infusion bag with or without mixing. According to the first aspect of the present invention, the multi-chamber drug container includes a second container having an open end, a first container made of a partially resin film disposed in the second container, and an open end of the second container. A third container having an open end and an outlet opening to be coupled; a first communication path capable of communicating the second container and the internal space of the third container; a breakable thin film blocking the first communication path; and a first end; A communication device having a second end and a flow path and capable of dispensing a drug at the time of administration is included. The first chamber is composed of the space in the first container, the second chamber is composed of the space surrounded by the inner wall of the second container and the outer wall of the first container, and the third chamber is composed of the space in the third container. By moving the first end of the communication tool into the first passage, the thin film and the resin film of the first container are broken by the first end of the communication tool, and the medicines in the first chamber and the second chamber are in the first communication. It enters the third chamber through the passage, and is mixed into the infusion solution from the third chamber through the flow path of the communication tool.
[0017]
  In the multi-chamber drug container of the first aspect of the present invention, preferably, the third chamber is configured.3rd containerThe inner wall is made of a relatively hard resin that is non-adsorbable with respect to vitamin D, such as cyclic polyolefin.
  Further, the communication tool is provided at the outlet opening of the third container.While maintaining the sealing of the third containerIt is supported by the first and second plugs slidably inserted, and has an inlet for the flow path between the first and second plugs, and the first end of the communication tool is in the first passage. The inlet of the flow path is communicated with the third chamber.
  The first container and the second container are rigid containers, and it is difficult for the medicine to flow out unless the gas that replaces the medicine flows in. Therefore, the communication device allows the gas in the infusion bag to flow in parallel with the medicine lead-out path. A gas passage leading to the first or second container is provided.
  The first and second plugs may be formed so as to be spaced apart from each other in the axial direction of the communication tool and move together with the communication tool.
The outlet opening of the third container may be formed in a cylindrical shape.
[0018]
According to the second aspect of the present invention, the first chamber, the second chamber, and the third chamber for separately storing the first drug, the second drug, and the third drug for mixing with the infusion solution are provided. The multi-chamber drug container includes a first container having a pair of front and rear walls, a resin film bag accommodated between the front wall and the rear wall in the first container, and a communication device for allowing the drug to flow out. Have A 1st chamber and a 2nd chamber consist of the space in a resin film bag, and a 3rd chamber is formed by the inner surface of a 1st container, and the outer surface of the said resin film bag. The first container can be deformed to change the distance between the pair of front and rear walls. The front wall of the first container supports a male spike having two protrusions extending toward the resin film bag, and the first container is elastically deformed to allow a distance between the pair of rigid front and rear walls. When it is decreased, the wall of the resin film bag is broken by the male spike, and the first drug, the second drug, and the third drug are mixed, and can flow out through the flow path of the communication tool.
[0019]
A female spike is disposed on the rear wall opposite the male spike to prevent the male spike from damaging the rear wall. In the multi-chamber drug container of the second aspect of the present invention, the inner wall of the first container and the outer surface of the resin film bag constituting the third chamber are preferably made of a resin that is non-adsorbable with respect to vitamin D.
[0020]
According to the third aspect of the present invention, the first chamber, the second chamber, and the third chamber for separately storing the first drug, the second drug, and the third drug for mixing with the infusion solution are provided. The multi-chamber drug container includes a syringe having one end into which a plunger plug is inserted, a resin film bag inserted into a space in the syringe, and a communication device having a flow path. The communication tool is fixed to the other end of the syringe, and a perforated plate is disposed in the syringe adjacent to the communication tool. The first chamber and the second chamber are formed in the resin film bag, and an easily peelable seal is formed in at least a part of the edge adjacent to the first chamber and the second chamber of the resin film bag. The third chamber consists of a space between the outer surface of the resin bag and the inner surface of the syringe. By inserting a plunger plug into the syringe, the third medicine flows out through the flow path of the communication tool and the resin film. The bag is broken and the first drug and the second drug in the first chamber and the second chamber flow out through the flow path of the communication tool.
[0021]
In the multi-chamber drug container of the third aspect of the present invention, preferably, the perforated plate has a conical shape, and the upper part has a sharp convex portion, thereby forming the first chamber and the second chamber. And the first drug, the second drug, and the third drug are mixed. Since the perforated plate stops the resin film bag, the flow path of the communication tool is not clogged. Further, the inner wall of the syringe constituting the third chamber and the outer surface of the resin film bag are formed of a resin that is non-adsorbable with respect to vitamin D.
[0022]
According to the fourth aspect of the present invention, the first chamber, the second chamber, and the third chamber for separately storing the first drug, the second drug, and the third drug for mixing in the infusion, respectively. The multi-chamber drug container includes a syringe having a plunger inserted from one end thereof and a discharge path provided at the other end to define a third chamber, a resin film bag defining the first chamber and the second chamber, and infusion of the drug from the resin film bag A communication tool for guiding the bag into the bag is included. The syringe lead-out path is disposed inside the first chamber or the second chamber and is hermetically closed by the seal member. When the plunger is inserted into the syringe, the seal member is separated from the lead-out path due to an increase in the hydraulic pressure in the syringe. The drug inside is injected into the resin film bag. A first weakly bonded portion that is easily peeled is provided between the first chamber and the second chamber.
[0023]
In the multi-chamber drug container according to the fourth aspect of the present invention, the first weakly bonded portion has a pressure increase due to the drug in the syringe being injected into the first chamber or the second chamber of the resin film bag or the resin film bag. It is peeled off by a pressing force applied from the outside. Preferably, the resin film bag further includes a fourth chamber, and a second weakly bonded portion that is easily peeled is provided between the second chamber and the fourth chamber, and the fourth chamber communicates with the flow path of the communication tool.
[0024]
According to the fifth aspect of the present invention, the first chamber, the second chamber, and the third chamber for separately storing the first drug, the second drug, and the third drug for mixing with the infusion solution are provided. The multi-chamber drug container includes a resin film bag including a first communication tool and a rigid container including a second communication tool. The first chamber and the second chamber are formed in the resin film bag. An easily peelable seal is disposed between the two chambers, and the third chamber is formed by a space in the rigid container. The first communication device can communicate the first chamber or the second chamber with the third chamber, and the first communication device can inject a drug from the third chamber into the infusion solution in the bag.
[0025]
In the multi-chamber drug container according to the fifth aspect of the present invention, preferably, the inner wall of the rigid container constituting the third chamber is formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0026]
According to the sixth aspect of the present invention, the first chamber, the second chamber, and the third chamber for separately storing the first drug, the second drug, and the third drug for mixing in the infusion, respectively. The multi-chamber drug container has a first syringe with a first plunger inserted from one end and a first outlet path at the other end, a second syringe with a second plunger inserted from one end and a second outlet path at the other end, A plunger coupling member that couples the first plunger and the second plunger to move together, and a communication device that communicates with the first outlet passage and the second outlet passage to mix and inject the medicine into the infusion in the bag. A first chamber and a second chamber divided by a movable partition member are defined in the first syringe, and a third chamber is formed in the second syringe.
[0027]
When a recess is formed in the inner wall of the first syringe, the first plunger is inserted and the movable partition member coincides with the recess in the inner wall, the first chamber and the second chamber are in fluid communication, and the medicine in the first chamber and the second chamber Is led out into the infusion bag through the first lead-out path. According to the 5th form of this invention, the chemical | medical solution in a 2nd plunger is guide | induced into an infusion bag via a 2nd lead-out path by inserting a 2nd plunger in a 2nd syringe.
[0028]
In the multi-chamber drug container according to the sixth aspect of the present invention, preferably, the inner wall of the second syringe constituting the third chamber is formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0029]
A multi-chamber having a first chamber, a second chamber, and a third chamber for separately storing a first drug, a second drug, and a third drug for mixing with the infusion solution of the sixth aspect of the present invention The drug container (deformation) includes a first syringe with a first plunger inserted from one end and a first outlet path at the other end, a second syringe with a second plunger inserted from one end and a second outlet path at the other end, A plunger coupling member that couples the first plunger and the second plunger to move together, and a communication device that communicates with the first lead-out path and the second lead-out path and that can inject a drug into the infusion in the infusion bag.
[0030]
According to the sixth aspect of the present invention, the internal space of the first syringe includes the first chamber made of the resin film bag and defines the second chamber, the third chamber is defined in the second syringe, A perforated plate is disposed in the vicinity of one lead-out path. When the first plunger is inserted into the first syringe, the film of the resin film bag is broken and the medicine in the first chamber is led out together with the medicine in the second chamber through the first lead-out path, and at the same time, the second plunger is put into the second syringe. The medicine in the second chamber is inserted and led out through the second lead-out path. Preferably, the inner wall of the second syringe constituting the third chamber is formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0031]
The multi-chamber drug container of the present invention can be manufactured from a thermoplastic resin such as polyethylene, polypropylene, poly-4-methylpentene, and cyclic polyolefin. In addition, it is preferable to form a multilayer film in which a cyclic polyolefin and polyethylene are laminated in two or three layers by a T-die extruder, an inflation molding machine or a blow molding machine and use it as a drug container. Further, in place of polyethylene, a multilayer film of polypropylene or a resin having a mixed composition of polyethylene and polypropylene may be formed. The multi-chamber drug container of the present invention is preferably enclosed in an oxygen poorly permeable outer bag made of a colored light-shielding film or an aluminum laminate film together with an oxygen scavenger to form a final product.
[0032]
Vitamin A, B as vitamin preparations to be mixed in the infusion bag₁, B₆, B₁₂, C, D, E, K, pantothenic acid, biotin, nicotinic acid and folic acid, 13 essential vitamins. Each of the 13 types of vitamins has an optimum pH when adjusted to a chemical solution, and when mixed in the same chemical solution, the composition may change between vitamins, so it is separated into appropriate groups and filled in each chamber. It is preferable to do. In addition, the amount of the chemical solution containing vitamins is preferably 1 to 5 ml, but each chamber is filled with an inert gas such as nitrogen gas and carbon dioxide gas together with the chemical solution to adjust the capacity of the chemical solution container with good operability. Is preferred. If the capacity of the chemical container of the chemical container is too small, such as 5 ml or less, the mixed injection operation becomes difficult, and if the capacity is 200 ml or more, it is difficult to mix with one hand and the cost of the container material is undesirably high.
[0033]
Trace minerals (trace elements) are suitable as the drug separated and accommodated in the drug container of the present invention together with the vitamin drug. Examples of the iron supply source blended in the chemical solution containing a trace element include iron sulfate, ferrous chloride, ferric chloride, and iron gluconate. Examples of the zinc supply source include zinc sulfate, zinc chloride, zinc gluconate, zinc lactate, and zinc acetate. Examples of the manganese supply source include manganese sulfate, and examples of the copper supply source include copper sulfate. Regarding preferable combinations of the respective sources of the trace element preparation, ferric chloride (hexahydrate), manganese chloride (tetrahydrate), zinc sulfate (seven) described in Table 1 of Japanese Patent Application No. 2001-54370 are used. Hydrate), copper sulfate (pentahydrate) and potassium iodide are preferably contained. The trace element-containing preparation described in Japanese Patent Application No. 2000-394260 is suitably used as a chemical solution because it does not contain manganese as a trace element preparation mixed for patients with hepatic dysfunction. A trace element preparation containing selenium disclosed in JP-A-2000-178181 can also be accommodated in the multi-chamber drug container of the present invention.
[0034]
The multi-chamber drug container of the present invention is suitably filled and accommodated with a multivitamin and a trace element preparation, but in addition, can also contain various drugs marketed as injection solutions. Inorganic salt preparation that can change the infusion composition according to the patient's condition, amino acid preparation for injection containing arginine and glutamine that can increase the dosage of arginine and glutamine, peptide preparation for injection, soybean oil, etc. Anticoagulants such as fat blended injections and heparin sodium injections can also be accommodated. In particular, when high-calorie infusion is performed, the multi-chamber drug container of the present invention containing an antiemetic and a digestive agent in addition to vitamins and trace elements is preferably used.
[0035]
Vitamin C blended as a vitamin preparation may be vitamin C itself, or a derivative or salt thereof. Specific examples include vitamin C (ascorbic acid), sodium ascorbate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbic acid phosphate magnesium salt, and the like. As vitamin B1, any conventionally used one can be used. For example, thiamine may be used, and derivatives thereof, specifically, prosultiamine, actiamine, thiamine disulfide, fullsultiamine and the like. Or a salt thereof such as thiamine hydrochloride, thiamine nitrate and the like. As vitamin B1, any conventionally used one can be used. For example, thiamine may be used, and derivatives thereof, specifically, prosultiamine, actiamine, thiamine disulfide, fullsultiamine and the like. Or a salt thereof such as thiamine hydrochloride, thiamine nitrate and the like.
[0036]
Vitamin A, vitamin D, vitamin E and vitamin K may be per se or may be used in the form of their derivatives. Specifically, vitamin A and its derivatives include vitamin A₁(Retinol), vitamin A₂(3-dehydroretinol), vitamin A_Three(Subvitamin A), retinene (vitamin A aldehyde), vitamin A acid, retinol palmitate, retinol acetate and the like can be mentioned. Vitamin D and its derivatives are vitamin D₂(Ergocalciferol), vitamin D_Three(Cholecalciferol), vitamin D_Four, Provitamin D₂(Ergosterin), provitamin D_Three(Dehydrocholesterin) and the like. Examples of vitamin E and derivatives thereof include α-tocopherol, tocopherol acetate, β-tocopherol, γ-tocopherol, and δ-tocopherol. Vitamin K and its derivatives include vitamin K1 (phylloquinone, phytonadione), vitamin K₂(Farnoquinone), vitamin K_Three(Menadione), vitamin K_Four, Vitamin K_Five, Vitamin K₆, Vitamin K₇Etc.
[0037]
BEST MODE FOR CARRYING OUT THE INVENTION
1A to 6C are views schematically showing a multi-chamber drug container according to a first embodiment of the present invention. FIG. 1A is a longitudinal sectional view of a multi-chamber drug container according to the first embodiment of the present invention, and FIG. 1B is a longitudinal cross-sectional view of the multi-chamber drug container at the time of drug mixture extraction. 2A-2D are longitudinal sectional views of the first chamber showing the filling and manufacturing process, FIG. 3A is a sectional view of a modification of the thin film, FIG. 3B is a plan view of the thin film of FIG. 3A, and FIG. 4B is an internal plan view of the second container of FIG. 4A, FIGS. 5A-5C are vertical cross-sectional views of the second chamber showing the filling manufacturing process, and FIGS. 6A-6C are diagrams showing the filling manufacturing process. It is a longitudinal cross-sectional view of 3 chambers. Throughout the drawings, similar members are denoted by the same reference numerals, and description thereof is omitted.
[0038]
[First embodiment]
A multi-chamber drug container 1 of the first embodiment of the present invention shown in FIGS. 1A to 6C is a second container 20 having an open end 22 and a first container made of a partially resin film disposed in the second container 20. 10, a third container 30 having an open end 32 coupled to the open end 22 of the second container 20 and an outlet opening 39, a first passage 23 capable of communicating the internal space of the second container 20 and the third container 30, a first 1 includes a breakable thin film 34 that blocks the passage 23, and a communication device 40. The communication device 40 has a first end 41, a second end 42 opposite to the first end, an inflow hole 45, and a flow path 43, and allows the medicine in the multi-chamber drug container 1 to flow through the inflow hole 45 and the flow path 43. Via the second end 42, it is configured to be able to inject into the infusion chamber 93 in the infusion bag 91. The first chamber 11 is configured by the space in the first container 10. The second chamber 21 is composed of a space surrounded by the inner wall of the second container 20 and the outer wall of the first container 10. The third chamber 31 is constituted by a space in the third container 30.
[0039]
As shown in FIG. 1A, the outlet opening 39 of the third container 30 has a cylindrical shape, and is spaced apart in the axial direction to accommodate the first plug body 35 and the second plug body 36, and between the plug bodies 35, 36. A fourth chamber 38 is formed. The fourth chamber 38 communicates with the infusion solution storage chamber 93 through the inflow hole 45 and the flow path 43 of the communication device 40, but is sealed against the drug and the outside air in the multi-chamber drug container 1. The first plug body 35 and the second plug body 36 can slide with respect to the side wall of the outlet opening 39 while maintaining a hermetic seal. The communication tool 40 is fixed to the first plug body 35 and the second plug body 36 and is movable in the axial direction in the outlet opening 39 together with both plug bodies. The communication tool 40 includes an inflow hole 45 that communicates with the flow path 43. The inflow hole 45 is provided so as to be disposed between the first plug body and the second plug body. As shown in FIG. 1B, when the first end 41 of the communication tool 40 is moved to a position where the resin film of the first container 20 is broken, the inflow hole 45 of the communication tool is communicated with the third chamber 31.
[0040]
A first chamber 11 formed by a space in the first container 10 (shown as a bag-like container in FIGS. 1A and 1B) contains a first drug M1 containing a first group of vitamin drugs. The second chamber 21, which is a space surrounded by the inner wall of the second container 20 and the outer wall of the first container 10, stores the second drug M <b> 2 containing the second group of vitamin drugs. It is assumed that the first drug M1 and the second drug M2 do not contain vitamin D. The third chamber 31 formed of the space in the third container 30 accommodates the third medicine M3 containing vitamin D. The inner wall of the third container 30 surrounding the third chamber 31, the thin film 34, and the outer surface of the communication device 40 are formed of cyclic polyolefin that does not absorb vitamin D.
[0041]
FIG. 1A shows a state before the medicine in the multi-chamber medicine container 1 is used, and the first end 41 of the communication device 40 is located inside the third container 30 near the thin film 34, and the first plug body 35 and The second plug 36 is disposed within the cylindrical outlet opening 39 of the third container, maintaining a hermetic seal on the side wall of the opening. The second end 42 of the communication tool extends in the seal edge portion 92 of the infusion bag 91 and communicates the flow path 43 to the infusion bag storage chamber 93. The multi-chamber drug container 1 and the infusion bag 91 are connected by the communication tool 40. Connected. The cylindrical portion of the outlet opening 39 between the first plug body 35 and the second plug body 36 communicates with the infusion chamber 93 of the infusion bag 91 through the inflow hole 45 and the flow path 43 of the communication tool 40. Such a configuration of the multi-chamber drug container 1 eliminates the need to insert the second end of the communicating device into the infusion bag when using the drug, and reduces the complexity and burden of the operation during drug administration. .
[0042]
FIG. 1B shows a state in which the medicine in the multi-chamber medicine container 1 is being led out through the communication tool 40. The first end 41 of the communication tool 40 penetrates and breaks the thin film 34 to fluidly communicate the second chamber 21 and the third chamber 31, and further breaks the wall of the first container 10 to penetrate the first chamber 11 and the second chamber. 21 is in fluid communication. The first plug body 35 is located in the third chamber 31, and the sealed state between the first plug body 35 and the cylindrical outlet opening 39 is canceled, and the second plug body 36 and the cylindrical outlet opening 39 are not connected. The sealed state is maintained. The inflow hole 45 of the communication tool communicates with the third chamber 31 in the third container 30, and the chemical solution in the third chamber 31 flows out to the infusion solution storage chamber 93 of the infusion bag via the flow path 43 of the communication tool. The medicines in the first chamber and the second chamber flow into the third chamber through the fractured portion of the thin film 34 broken by the first end of the communication device, and similarly, the infusion bag accommodates the infusion solution through the flow channel 43 of the communication device. It flows out into the chamber 93. The first end of the communication tool 40 is sharp to break the thin film 34 that separates the second chamber 21 and the third chamber 31 and the wall of the first chamber that separates the first chamber 11 and the second chamber 21. However, the walls of the first chamber and the thin film 34 can be of low strength and rounded.
[0043]
Of the drugs usually added to nutritional infusion preparations, vitamin D has the property of being adsorbed on a relatively soft polyethylene resin material. In order to prevent vitamin D from being adsorbed and lost to the wall material of the multi-chamber drug container, the chamber containing the drug containing vitamin D, for example, the third chamber 31 of the multi-chamber container 1 is a third chamber constituting the chamber. The wall, that is, the inner wall of the third container 30, the third chamber side surface of the breakable thin film 34 that blocks the first passage 23, the outer surface of the communication device 40, etc. are formed of cyclic polyolefin that is non-adsorbable to vitamin D The When a medicine containing vitamin D is accommodated in the first chamber or the second chamber, the wall surface constituting the first chamber or the second chamber is similarly formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0044]
2A to 2D are views showing a process of manufacturing the first container 10 composed of the cup 10. FIG. 2A is a longitudinal sectional view of an empty cup before filling the medicine, and FIG. 2B is a view of the cup of FIG. 2A. It is a top view. The cup 10 has a cylindrical or tapered side wall 12 and a flat bottom wall 14 with an opening 13 at the upper end of the side wall. As shown in FIG. 2C, the first drug M1 (for example, vitamin B) is filled almost entirely in the cup 10. Next, the opening 13 is hermetically closed by a thin wall 16 made of resin. The cup 10 is disposed in the second container 20 as shown in FIGS. 4A to 5C described later. By making the thin wall 16 low in strength, the first end of the communication tool can be formed into a rounded safe shape. The cup 10 may be a rigid or quasi-rigid thin-walled container, and since it can be easily molded from a relatively hard non-adsorbing cyclic polyolefin, it may contain a third drug M3 containing vitamin D. In addition, since the 1st chemical | medical agent in the cup 10 is sterilized simultaneously when heat-sterilizing the multi-chamber pharmaceutical container 1, a manufacturing process can be simplified compared with the case where a several chemical | medical agent container is sterilized separately.
[0045]
3A is a longitudinal sectional view of the first communication passage 23 including the deformed thin film 34, and FIG. 3B is a top view of FIG. 3A. The thin film 34 shown in FIG. 3A is formed in a conical shape projecting downward in the first communication path 23, and a cross-shaped groove or slit 37 is provided in the conical portion of the thin film 34 as shown in FIG. 3B. By providing a cross-shaped groove or slit 37 in the thin film 34, the first end of the communication tool can be made into a safe shape with a roundness.
[0046]
4A is a longitudinal sectional view of a second container that can accommodate a cup (first container) 10 filled with the chemical solution of FIG. 2C and whose opening 13 is closed by a thin wall 16, and FIG. 4B is a view of the second container of FIG. 4A. It is a top view. As shown in FIGS. 4A and 4B, the second container 20 includes four elastic finger pieces 26 extending from the side wall 24 toward the center of the container substantially in parallel with the bottom wall 25 in the vicinity of the bottom wall 25. One end of each elastic finger piece 26 is fixed by the side wall 24, and the other end is arranged on the same circle so that the first container 10 can be held in the second container 20.
[0047]
FIG. 5A to FIG. 5C are vertical cross-sectional views showing a filling and manufacturing process of the second container 20 that contains the first container 10 and the second chemical liquid M2. As shown in FIG. 5A, the first container 10 is inserted into the second container 20, and the bottom wall 14 of the first container 10 passes between the four elastic finger pieces 26 in the second container 20. The first container 10 is locked in the second container 20 by the elastic finger piece 26. By making the outer diameter of the bottom wall 14 of the first container 10 larger than the outer diameter of the side wall 12, the bottom wall 14 of the first container is surely secured between the elastic finger piece 26 and the bottom wall 25 of the second container. Retained. Next, as shown in FIG. 5B, the second drug M2 (vitamin 1) is filled into the second container 20. Thereafter, as shown in FIG. 5C, the opening of the second container 20 is sealed with the thin film 34, whereby the second container 20 containing the first container 10 and the second medicine M2 is completed.
[0048]
6A and 6B are longitudinal cross-sectional views illustrating a filling and manufacturing process of the third container 30 that contains the third medicine M3. As shown in FIG. 6A, the first plug body 35 is arranged such that the communication tool 40 is disposed and supports the communication tool so that the first end 41 of the communication tool 40 is inside the third container 30 near the opening end 32. Are sealingly engaged in the cylindrical outlet opening 39 of the third container. Next, as shown in FIG. 6B, the third drug M3 (vitamin 2) is filled into the third container 30. Thereafter, as shown in FIG. 6C, the second container 20 in the state of FIG. 5C is turned upside down and placed on the third container 30 of FIG. 6B, so that the second end 20 of the third container 30 of FIG. The open end 22 sealed by the thin film 34 of the container 20 is aligned. By bonding and sealing between the open end 22 and the open end 33, the multi-chamber drug container 1 filled with the first to third drugs M1, M2, and M3 is completed. The step of communicating and fixing the second end 42 of the communication device 40 to the infusion storage chamber 93 of the infusion bag 91 can be performed before or after the manufacturing process of the multi-chamber drug container 1.
[0049]
In the multi-chamber drug container 1 before use, the space between the first plug body 35 and the second plug body 36 of the outlet opening 39 is an infusion solution of the infusion bag 91 through the inflow hole 45 and the flow path 43 of the communication device 40. Although in fluid communication with the storage chamber 93, the first plug body 35 is sealed with respect to the drug in the multi-chamber drug container 1, and the second plug body 36 is sealed with respect to the outside air. The step of communicating and fixing the second end 42 of the communication tool to the infusion storage chamber 93 of the infusion bag 91 can be performed before or after the manufacturing process of the multi-chamber drug container 1 of FIGS. 6A to 6C. The second end 42 of the communication tool can be rounded when attached to the infusion bag in advance. Also, in the case of an infusion bag that can be penetrated by the rounded end of the communicating tool, for example, an infusion bag provided with a slit, a rounded shape can be obtained. However, when the infusion bag is provided with a piercable stopper, it is necessary to sharpen the second end as shown in FIG. 7A, for example.
[0050]
7A and 7B are schematic longitudinal sectional views of a partial modification of the multi-chamber drug container 1. The multi-chamber drug container 1 of FIG. 7A is a multi-chamber drug container 1 of FIG. 6C in which the second end 42 of the communication tool 40 has a sharp shape. When the multi-chamber drug container 1 is held without being connected to the infusion bag, the second end 42 is sealed against the outside air by a cap (not shown) to maintain aseptic conditions such as the flow path 43 and the outlet opening 39 of the third container. . The multi-chamber drug container 1 shown in FIG. 7B is the same as the multi-chamber drug container 1 shown in FIG. 7A. The first chamber 11 has a slightly flat spherical shape, and the second end 42 of the communication device 40 is a plane substantially perpendicular to the axis. It is the one that has improved the nature.
[0051]
[Second embodiment]
FIG. 8A is a schematic perspective view of the multi-chamber drug container 2 according to the second embodiment of the present invention, and FIG. 8B is a cross-sectional view taken along line AA of FIG. 8A. The multi-chamber drug container 2 of the second embodiment has a third container 70 made of a relatively rigid material, a resin film bag 50 accommodated in the third container, and a communication device 40 for dispensing the drug. . The resin film bag 50 has a lower end and an upper end that are closed by a lower edge portion 54 and an upper edge portion 56, and is extended and arranged so as to divide the inside of the cylindrical film into two portions between both edge portions. An edge 55 is provided. Similarly, the third container 70 includes a lower edge portion 74 and an upper edge portion 76 that close the lower end and the upper end of the tubular film. The inside of the resin film bag 50 is partitioned into a first chamber 51 and a second chamber 61 by the third edge 55, and the first drug M1 and the second drug M2 are sealed therein, respectively. The third medicine M3 is accommodated in a third chamber 71 formed by a space surrounded by the inner surface of the third container 70 and the outer surface of the bag 50. The inner surface of the third container 70 includes an inner surface of a pair of rigid front wall 72 and rear wall 73. The lower edge portion 54 located on the communication device 40 side of the resin film bag 50 is formed by an easily peelable seal portion, and is peeled off by a pressing force by reducing the distance between the front wall 72 and the rear wall 73. The first chamber 51 and the second chamber 61 can communicate with the third chamber 71.
[0052]
In the multi-chamber drug container 2 according to the second embodiment of FIG. 8A, as shown in FIG. 8B, the male spike 75 protrudes from the front wall 72 into the third chamber, and the rear wall 73 engages with the male spike 75. It comprises. The male spike 75 preferably has two convex portions and is disposed so as to cut and open the resin films in the lower portions of the first chamber 51 and the second chamber 61. Each of the two convex portions of the male spike 75 reliably cuts and opens the resin film in the first chamber 51 and the second chamber 61 of the bag 50. A female spike 76 is disposed in the third chamber 71 so as to face the male spike 75, and is configured to receive the convex portion of the male spike 75. The wall portion of the third chamber 71 is broken by the male spike 75, and the medicine is Prevent leakage to the outside through the wall of the three chambers.
[0053]
The communication tool 40 is welded and supported at the lower edge 74 of the third container 71, and the flow path 43 of the communication tool 40 is communicated with the third chamber 71 in the third container 70. The second end 42 of the communication device 40 is sealed by a sealing cap 48 as shown in FIG. 8A, or is opened into the infusion chamber of the infusion bag as shown in FIG. 1A. The inner wall of the third container 70 constituting the third chamber 71 and the outer surface of the resin film bag 50 are formed of cyclic polyolefin that is non-adsorbable with respect to vitamin D. The medicine remaining in the first chamber 51 and the second chamber 61 by opening the lower edge 54 of the first chamber 51 and the second chamber 61 or cutting and opening the resin film in the vicinity of the lower edge with a spike. And most of the medicine can flow out through the communication device 40.
[0054]
The procedure for supplying the drug in the multi-chamber drug container 2 to the infusion in the infusion bag when the lower edge 54 of FIG. 8A is formed by an easily peelable seal is as follows. First, by pressing the front wall 72 and the rear wall 73 of the third container 70 with a finger, the distance between the both walls is reduced to press the resin film bag 50 accommodated in the third container 70, and a weak seal is obtained. The lower edge portion 54 of the bag 50 is peeled open and communicated. In order to easily peel and open the lower edge portion 54 of the resin film bag 50, the adhesive strength of the lower edge portion 54 is adjusted.
[0055]
The second end 42 of the communication tool 40 is opened to the infusion solution storage chamber via a joint port for infusion of the infusion bag. This operation is not necessary when the multi-chamber drug container 2 is provided as a kit by being combined with an infusion bag. Further, the volume in the third container 70 is deformed and reduced, and the medicine in the third container is transferred into the infusion bag. Various resin molding methods, such as a blow molding method and an injection molding method, can be used for the third container. In addition, it is not necessary that the entire third container has a uniform thickness, and it is preferable that a part of the third container is thinned so that the pressing force is small and the deformation is possible.
[0056]
In the aspect in which the front wall 72 and the rear wall 73 of the third container 70 are provided with spikes, the resin film bag 50 has a cutting opening by pressing both walls of the third container 70 and engaging the male and female spikes 76 and 75. The medicine filled in the chargeable resin film bag 50 is transferred into the third container 70 from this opening. The material of the front wall 72 and the rear wall 73 of the third container 70 is adjusted so that the male and female spikes 75 and 76 have rigidity and elastic restoring force that can maintain the meshing position. The second end 42 of the communication device 40 is opened to the infusion storage chamber through a joint port for mixed injection of the infusion bag. Furthermore, using the elastic deformability of the third container 70, the third container 70 is pressed several times to transfer the medicine in the container to the infusion chamber of the infusion bag.
[0057]
In the case where the outer shell of the multi-chamber drug container 2 is formed by the wall of the rigid third container 70 and has a property that is difficult to be deformed by the outflow of the drug, the drug is preferably flowed out smoothly from the multi-chamber drug container 2. 40 includes ventilation for supplying replacement gas in parallel with the flow path 43. The second end 42 of the communication device 40 is covered with a sealing cap 48 and seals the flow path 43 from the ambient atmosphere.
[0058]
[Third embodiment]
FIG. 9 is a schematic sectional view of the multi-chamber drug container 3 according to the third embodiment of the present invention. In the multi-chamber drug container 3 of the third embodiment, a resin film bag 110 is accommodated in a syringe (barrel) 130, one end of the syringe is closed by a stopper 142, and the other end (discharge port) of the syringe is a communication tool. 40 base ends are supported. The resin film bag 110 includes a first chamber 111 that stores the first drug M1 and a second chamber 121 that stores the second drug M2. The inner space of the syringe 130 surrounded by the inner surface of the syringe 130, the end surface of the stopper, the outer surface of the resin film bag 110, and the like serves as the third chamber 131 that houses the third medicine M3. The first chamber 111 and the second chamber 121 have weak coupling portions 112 and 122 that easily peel or break when the resin film bag 110 receives a pressing force, respectively. When the resin film bag 110 is pressed, the weak coupling portions 112 and 122 easily peel or break, and mix the first drug M1 and the second drug M2 with the third drug M3 in the third chamber 131. A porous plate 134 is disposed near the discharge port of the syringe 130 that supports the proximal end of the communication device 40, and the drug can flow from the inside of the syringe 130 to the flow path 43 of the communication device 40 through the pores of the porous plate 134. To be. The perforated plate 134 includes sharp protrusions 135 for opening the resin film bag 110 in a broken opening.
[0059]
FIG. 9 shows the multi-chamber drug container 3 before use. The procedure for mixing the drug in the multi-chamber drug container 3 with the infusion solution in the infusion bag (not shown) via the communication device 40 is as follows. First, the sealing cap 48 is removed from the communication tool 40, and the second end 42 of the communication tool 40 is opened to an infusion storage chamber of an infusion bag (not shown). This operation is not necessary when the multi-chamber drug container 3 is combined with an infusion bag and provided as a kit. Next, a pushing force is applied to the plunger 140 to push the plug 142 into the syringe 130. When the plug 142 is pushed into the syringe 130, the third medicine M3 is moved into the infusion bag via the flow path 43 and the second end 42 of the communication device 40 and mixed with the infusion solution. At the same time, the inner surface of the plug 142 presses the resin film bag 110, peels or breaks the weakly bonded portions 112 and 122, and causes the first drug M1 and the second drug M2 to flow out from the resin film bag 110. Mix with 3 drugs M3.
[0060]
The perforated plate 134 is formed by a substantially conical wall having a large number of holes, and a conical apex portion 135 has a sharp shape. The resin film bag 110 is more easily broken by being pressed toward the sharp apex 135. The perforated plate 134 allows the drug to flow into the flow path 43 of the communication tool 40 through a large number of holes, and prevents the resin film bag 110 from blocking the inlet of the flow path 43 of the communication tool 40.
[0061]
The third medicine M3 accommodated in the third chamber 131 may contain vitamin D. In that case, the inner surface of the syringe 130, the end surface of the stopper, the outer surface of the resin film bag 110, and the like that form the inner wall of the third chamber 131 are easily manufactured from a relatively hard resin material that does not adsorb vitamin D. The multi-chamber drug container 3 according to the third embodiment can reduce the volume in the container that accommodates the drugs M1, M2, and M3 as the plunger 140 is inserted, so that ventilation gas is introduced into the multi-chamber drug container. There is no need to do.
[0062]
[Fourth embodiment]
FIG. 10A is a schematic side view of the multi-chamber drug container 4 of the fourth embodiment of the present invention, and FIG. 10B is a schematic side view showing a modification of FIG. 10A. The multi-chamber drug container 4 includes a syringe (barrel) 230 and a resin film bag 210. One end of the syringe 230 is closed by a plug 233, and the other end has a discharge port 234. A space in the syringe 230 defines a third chamber 231 in which the third medicine M3 is accommodated. The resin film bag 210 defines a first chamber 211 that contains the first medicine M1 and a second chamber 221 that contains the second medicine M2. A communication device 40 is provided for guiding the drug from the resin film bag 210 into an infusion bag (not shown).
[0063]
The resin film bag 210 includes two side edges 212 and two end edges 213 that are firmly bonded. A syringe outlet 234 is disposed through one end edge 213. The outer surface of the discharge port and one end edge 213 are bonded in an airtight manner. Further, the communication tool 40 is disposed through the other end edge 213. The outer surface of the communication tool 40 and the other end edge 213 are bonded in an airtight manner. In the case of FIG. 10A, the discharge port 234 of the syringe 230 is opened inside the first chamber 211 or the second chamber 221 of the resin film bag 210. In the case of FIG. 10B, the discharge port 234 is hermetically closed by the seal member 235. When the plug 233 is inserted into the syringe 230, the seal member 235 is separated from the discharge port 234 due to an increase in the hydraulic pressure in the syringe 230, and the third medicine M3 in the third chamber 231 in the syringe is in the resin film bag 210. Injected into.
[0064]
A first weak coupling portion 214 that is easily peeled is provided between the first chamber 211 and the second chamber 221, and the medicine in the syringe is injected into the first chamber 211 or the second chamber 221 in the first weak coupling portion 214. The first chamber 211 and the second chamber 221 are brought into fluid communication by being peeled off due to a pressure increase caused by this or a pressing force applied from the outside of the resin film bag. The resin film bag 210 further includes a fourth chamber 241, and a second weak coupling portion 224 that is easily peeled is provided between the second chamber 221 and the fourth chamber 241. Similar to the first weak coupling portion 214, the second weak coupling portion 224 is given a pressure increase due to the injection of the medicine in the syringe into the first chamber 211 or the second chamber 221, or is given to the resin film bag 210 from the outside. The second chamber 221 and the fourth chamber 241 are in fluid communication with each other by the pressing force. The fourth chamber communicates with the flow path of the communication tool 40.
[0065]
11A to 11C and FIGS. 12A and 12B are schematic sectional views of the multi-chamber drug container 5 of the fifth embodiment of the present invention. 11A and 12B are schematic side views showing a state before and after use of the multi-chamber drug container 5, and FIGS. 11B, 11C, and 12A are states during use of the multi-chamber drug container 5, respectively. It is a schematic side view which shows. The multi-chamber drug container 5 includes a resin film bag 310 including the first communication tool 360 and a syringe (rigid container) 330 including the second communication tool 340. A first chamber 311 for accommodating the first drug M1 and a second chamber 321 for accommodating the second drug M2 are provided in the resin film bag 310. A weakly coupled portion 314 that is easily peeled is disposed between the first chamber 311 and the second chamber 321.
[0066]
The stopper 333 is inserted into one end of the syringe 330 and the second communication tool 340 is connected to the other end. A space surrounded by the cylindrical inner surface of the syringe 330 and the end wall 334 of the stopper 333 defines a third chamber 231 in which the third medicine M3 is accommodated. One end 362 of the first communication tool 360 is disposed in the second chamber 321. The first communication device 360 includes a flow channel 364 including a check valve 367 and an inflow port 361 that communicates the flow channel 364 with the second chamber. The other end 365 of the first communication device 360 extends into a cylindrical fourth chamber 335 formed in the plug 333 and is fixed to the plug 363. The tip opening 366 of the flow path 364 of the first communication tool 360 is communicated with the fourth chamber 335 formed of a sealed space before using the medicine (FIG. 11A).
[0067]
FIG. 11B shows the multi-chamber drug container 5 in the first stage for delivering the drug, where the first communicating device 360 is slightly moved into the syringe 330 and the first opening 360 of the first communicating device 360 is in the fourth chamber. 335 penetrates the end wall 334 and communicates with the third chamber 331. FIG. 11C shows that the weakly coupling portion 314 (FIG. 11A) that is easily peeled between the first chamber 311 and the second chamber 321 is peeled off, the first chamber 311 and the second chamber 321 are communicated, and the first medicine M1 is connected. The state with which 2nd chemical | medical agent M2 was mixed is shown.
[0068]
12A, the stopper 333 is moved in the direction of pulling out from the syringe 330, and the medicines M1 and M2 in the resin film bag 310 pass through the inflow hole 362, the flow path 364, the check valve 367, and the tip opening 366. The process of moving to the 3rd chamber 331 is shown. Since the resin film bag 310 is deformed with the outflow of the medicines M1 and M2, no resistance to the outflow of the medicine occurs. FIG. 12B shows the state after the stopper 333 has been moved in the direction of pushing into the syringe 330 and the medicine M1, M2, M3 in the syringe has been pushed out by the stopper 333 into the infusion bag through the second communication device 340. . The second communication tool 340 can be connected to the infusion bag in advance as in the case of Example 1, or can be connected to the infusion bag when the infusion solution is used.
[0069]
FIG. 13A is a schematic longitudinal sectional view showing a multi-chamber drug container 6 of the sixth embodiment of the present invention, and FIG. 13B is a schematic longitudinal cross-sectional view showing a multi-chamber drug container 6 ′ of a modification of the sixth embodiment of the present invention. FIGS. 14 and 14 are schematic longitudinal sectional views of a communication device 440 that can be used in combination with the multi-chamber drug containers 6 and 6 ′ of the sixth embodiment, and FIG. 15A is used for a modification 6 ′ of the sixth embodiment. FIG. 15B is a plan view of the porous plate, and FIG. 15B is a longitudinal sectional view of the porous plate of FIG. 15A. The multi-chamber drug container 6 of the sixth embodiment of the present invention shown in FIG. 13A has a first syringe 420 with a first plunger 462 inserted from one end and a first outlet 424 at the other end, and a second plunger 463 from one end. The second syringe 430 having the second outlet 434 inserted at the other end, the plunger connecting member 465 for connecting and moving the first plunger and the second plunger together, the first outlet 424 and the second outlet 434 communicating with the medicine And a lead-out flange 438 that can be mixed and injected into an infusion in a bag (not shown).
[0070]
A first chamber 411 and a second chamber 421 separated by the movable partition member 414 are defined in the first syringe 420. A third chamber 431 is defined in the second syringe 430. When the recess 426 is formed in the inner wall of the first syringe 420, the first plunger 462 is inserted into the first syringe 420, and the movable partition member 414 coincides with the recess 426 in the inner wall, the first chamber 411 and the second chamber 421 are formed. The fluids are communicated so that the medicines M1 and M2 in the first chamber 411 and the second chamber 421 are led out into an infusion bag (not shown) through the first lead-out path 434 and the lead-out flange 438, and the second plunger 463 is By being inserted into the second syringe 430, the drug solution M3 in the second syringe 430 is led out into the infusion bag via the second lead-out path 434. A communication tool 440 shown in FIG. 14 can be used between the outlet flange 438 and an infusion bag (not shown). In the multi-chamber drug container 6 of the sixth embodiment of the present invention shown in FIG. 13A, the inner wall of the second syringe 430 constituting the third chamber 431 is formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0071]
FIG. 13B is a schematic longitudinal sectional view showing a multi-chamber drug container 6 'according to a modification of the sixth embodiment of the present invention. The multi-chamber drug container 6 ′ has a first syringe 420 with a first plunger 462 inserted from one end and a first outlet 424 at the other end, a second plunger 463 inserted from one end and a second outlet 434 at the other end. A second syringe 430, a plunger coupling member 465 for coupling the first plunger 462 and the second plunger 463 to move together, the first outlet path 424 and the second outlet path 434 communicated with each other during the infusion in the infusion bag. A lead-out flange 438 that can be injected. The outlet of the outlet flange 438 is covered with a sealing cap 44 or placed in the infusion bag.
[0072]
In the multi-chamber drug container 6 ′ of the modified example of the sixth embodiment of FIG. 13B, the internal space of the first syringe 420 includes a first chamber 411 composed of a resin film bag 410 having a weak coupling portion 414 and a second chamber 421. Is defined. A third chamber 431 is defined in the second syringe 430. A porous plate 428 is disposed in the vicinity of the inlet of the first lead-out path 424, and when the first plunger 462 is inserted into the first syringe 420, the film in the first chamber 411 made of a resin film bag is broken and the film in the first chamber 411 is broken. The first medicine M1 is led out together with the second medicine M2 in the second chamber 421 through the first lead-out path 424 and the lead-out flange 438 (and the communication tool 440 in FIG. 14). Simultaneously with the insertion of the first plunger 462, the second plunger 463 is inserted into the second syringe 430, and the third medicine M3 in the third chamber 431 passes through the second outlet path 434 and the outlet flange 438 (and the communication tool 440 in FIG. 14). Derived through. The inner wall of the second syringe 430 constituting the third chamber 431 is formed of a cyclic polyolefin that is non-adsorbable with respect to vitamin D.
[0073]
FIG. 14 is a schematic longitudinal sectional view of a communication device 440 used in combination with the multi-chamber drug container 6, 6 'of the sixth embodiment. The communication tool 440 includes a base portion 441 that fits into the outlet flange 438 of the barrel 400, and two flow paths 447 and 448 that communicate with the first outlet path 424 and the second outlet path 434. The two flow paths 447, 448 are connected to the first and base 2 lead-out paths 424, 434, and the “bamboo needle” is cut at an inclined surface so that the end of the so-called hollow tube is sharpened. The shape is preferred.
[0074]
FIG. 15A is a plan view of the porous plate 428 used in the modified example 6 'of the sixth embodiment, and FIG. 15B is a longitudinal sectional view of the porous plate 428 of FIG. 15A. This perforated plate 428 prevents the resin film bag 410 from blocking the inlet of the first outlet passage 424, like the perforated plate 134 of the multi-chamber drug container 3 of FIG. Also preferably, like the porous plate 134, the porous plate 428 has a conical shape and is provided with a sharp protrusion 427 near the center.
[0075]
【The invention's effect】
The multi-chamber drug container of the present invention is vitamin B which needs to be mixed and administered in a high calorie infusion sugar / electrolyte / amino acid solution₂It is possible to effectively prevent the deterioration of quality of these drugs and the formation of precipitates by separating and containing trace element preparations containing other vitamins and iron sources and other trace elements in multiple chambers. it can. In particular, vitamin B is produced in a short time due to the involvement of temperature, light, reducing substances, oxygen, etc. when filled in the same container.₂And the deposit derived from the iron supply source contained in the trace element preparation can be effectively prevented.
[0076]
The multi-chamber drug container of the present invention performs a safe and easy operation of injecting a small amount of drug solution necessary for a patient into an infusion bag containing high-calorie infusion solution, amino acid infusion solution, electrolyte infusion solution, saccharide infusion solution and other medicinal solution. Provided with a chemical container capable of selectively separating and accommodating chemical liquids in a plurality of chambers separated by a partition means, eliminating the interaction that causes quality degradation between different chemical liquids to be mixed To do.
[0077]
The multi-chamber drug container of the present invention provides a multi-chamber drug container that can be stored in a container separately without exposing three or more kinds of drugs, particularly multivitamins to the outside air, and can be mixed by a simple operation during use. By manufacturing the inner wall of the chamber containing vitamin D with a relatively hard resin that is non-adsorbable with respect to vitamin D, such as cyclic polyolefin, vitamin D can be prevented from being adsorbed to the container.
[0078]
The multi-chamber drug container of the present invention allows a relatively small amount of a plurality of drugs to be maintained in a sterilized state and mixed without malfunction into a large amount of drug solution (infusion solution) contained in a bag-like container. The present invention can also reliably provide a structure including a chamber made of a resin that is non-adsorbable with respect to vitamin D in such a multi-chamber drug container.
[0079]
The multi-chamber drug container of the present invention can be easily brought into liquid communication between a plurality of chambers by manually applying force from the outside of the container, and can easily mix the drugs contained in them without error. Provide a good structure. Furthermore, the multi-chamber drug container of the present invention can mix a plurality of small quantities of stored medicines while maintaining sterility in the container, and can inject the mixed drugs into an infusion bag. Further, in a multi-chamber drug container, a plurality of small amounts of drugs can be sequentially injected into an infusion bag by a single operation, or a plurality of small amounts of drugs can be mixed and injected into an infusion bag by a single operation.
[Brief description of the drawings]
1A to 6C are views schematically showing a multi-chamber drug container 1 of a first embodiment of the present invention, and FIG. 1A is a diagram of a multi-chamber drug container of a first embodiment of the present invention. FIG. 1B is a longitudinal sectional view of a multi-chamber drug container during drug mixing.
FIGS. 2A to 2D are longitudinal sectional views showing respective filling and manufacturing steps of the first chamber of the multi-chamber drug container 1. FIGS.
3A is a cross-sectional view of a modification of the thin film, and FIG. 3B is a plan view of the thin film of FIG. 3A.
4A is a longitudinal sectional view of a second container, and FIG. 4B is an internal plan view of the second container of FIG. 4A.
FIGS. 5A-5C are longitudinal sectional views showing a filling and manufacturing process of the second chamber. FIGS.
6A-6C are longitudinal sectional views showing a filling and manufacturing process of the third chamber. FIG.
7A and 7B are schematic longitudinal sectional views of a partial modification of the multi-chamber drug container 1. FIG.
8A is a schematic side view of a multi-chamber drug container 2 according to a second embodiment of the present invention, and FIG. 8B is a cross-sectional view taken along line AA in FIG. 8A.
FIG. 9 is a schematic sectional view of a multi-chamber drug container 3 according to a third embodiment of the present invention.
10A is a schematic side view of a multi-chamber drug container 4 according to a fourth embodiment of the present invention, and FIG. 10B is a schematic side view showing a modification of FIG. 10A.
11A to 11C are schematic side views of a multi-chamber drug container 5 according to a fifth embodiment of the present invention. FIG. 11A is a state before the multi-chamber drug container 5 is used, and FIGS. 11B and 11C are used. The schematic side view which shows the step which started operation of the multi-chamber medicine container 5 in order to do.
FIG. 12A is a schematic side view showing a further stage of operation of the multi-chamber drug container 5 of the present invention. FIG. 12B is a schematic side view of the multi-chamber drug container 5 after use.
13A is a schematic longitudinal sectional view showing a multi-chamber drug container 6 according to a sixth embodiment of the present invention, and FIG. 13B shows a multi-chamber drug container 6 ′ according to a modification of the sixth embodiment of the present invention. The schematic longitudinal cross-sectional view shown.
FIG. 14 is a schematic longitudinal sectional view of a communication tool used in a sixth embodiment.
15A is a plan view of a porous plate used in Modification 6 'of the sixth embodiment, and FIG. 15B is a longitudinal sectional view of the porous plate of FIG. 15A.
[Explanation of symbols]
1-6: Multi-chamber drug container, 10: First container, 11: First chamber, 16: Thin wall, 20: Second container, 21: Second chamber, 22: Open end, 23: First passage, 24 : Side wall, 26: elastic finger, 30: third container, 31: third chamber, 32: open end, 34: thin film, 35: first plug, 36: second plug, 37: slit, 38: Fourth chamber, 39: outlet opening, 40: communication tool, 41: first end, 42: second end, 43: flow path, 45: inflow port, 48: sealing cap, 50: 51: first chamber, resin Film back, 61: second chamber, 70: third container, 71: third chamber, 72: front wall, 73: rear wall, 75: male spike, 76: female spike, 91: infusion bag, 92: seal edge Part, 93: infusion storage chamber, 110: resin film bag, 111: first chamber, 112: weakly coupled portion, 121: second chamber, 122: weakly coupled , 130: syringe, 131: third chamber, 134: perforated plate, 142: stopper, 210: resin film bag, 211: first chamber, 212: side edge, 213: edge, 221: second chamber 224: second weak coupling portion, 230: syringe (barrel), 231: third chamber, 232: plunger, 233: stopper, 234: discharge port, 241: fourth chamber, 310: resin film bag, 311: First chamber, 312: Side edge portion, 213: End edge portion, 314: Weak coupling portion, 321: Second chamber, 330: Syringe, 331: Third chamber, 333: Plug body, 334: End wall, 335: Fourth chamber, 340: second communication device, 344: sealing cap, 360: first communication device, 361: inlet, 362: one end, 363: stopper, 364: flow path, 365: other end, 366: tip Opening, 367: check valve, 368: protrusion, 41 : First chamber, 421: second chamber, 424: first outlet path, 428: perforated plate, 430: second syringe, 431: third chamber, 434: second outlet path, 440: communication tool, 462: first 1 plunger, 463: second plunger, 465: plunger coupling member, M1, M2, M3: drug.

Claims

輸液に混合するための第１の薬剤、第２の薬剤及び第３の薬剤を分離してそれぞれ収容する第１室、第２室及び第３室を有する多室薬剤容器であって、
開口端を有する第２容器（２０）、第２容器内に配置される一部樹脂フィルムからなる第１容器（１０）、第２容器の開口端と結合される開口端及び出口開口を有する第３容器（３０）、第２容器と第３容器の内部空間を連通可能な第１連通路（２３）、第１連通路を遮断する破断可能な薄膜、並びに第１端（４１）、第２端（４２）及び流路（４３）を有する連通具（４０）を含み、
第１室は第１容器内の空間から成り、第２室は第２容器の内壁と前記第１容器の外壁とに囲まれた空間から成り、第３室は第３容器内の空間からなり、
連通具を移動させることにより前記薄膜及び第１容器の樹脂フィルムを連通具の第１端により破断し連通具の流路を介し各室の薬剤を流出させることが可能であり、
前記連通具は、第３容器の出口開口に、第３容器の密封を維持しつつ摺動可能に挿入される第１及び第２の栓体（３５、３６）により支持され、
前記第１及び第２の栓体は、前記連通具の軸方向に離間して形成され、前記連通具とともに移動可能であり、
前記連通具は流路の入口（４５）を第１及び第２の栓体の間に備え、
連通具の第１端部が第１容器の樹脂フィルムを破断する位置へ移動されたとき連通具の入口（４５）が第３室に連通される多室薬剤容器。A multi-chamber drug container having a first chamber, a second chamber, and a third chamber for separately storing a first drug, a second drug, and a third drug for mixing with an infusion solution,
A second container (20) having an open end, a first container (10) made of a partially resin film disposed in the second container, an open end coupled to the open end of the second container, and a second container having an outlet opening Three containers (30), a first communication path (23) capable of communicating with the internal space of the second container and the third container, a breakable thin film blocking the first communication path, a first end (41), a second A communication device (40) having an end (42) and a flow path (43);
The first chamber is composed of the space in the first container, the second chamber is composed of the space surrounded by the inner wall of the second container and the outer wall of the first container, and the third chamber is composed of the space in the third container. ,
By moving the communication tool, it is possible to break the resin film of the thin film and the first container at the first end of the communication tool, and allow the medicine in each chamber to flow out through the flow path of the communication tool,
The communication tool is supported by first and second plug bodies (35, 36) inserted slidably into the outlet opening of the third container while maintaining the sealing of the third container ,
The first and second plugs are formed apart from each other in the axial direction of the communication tool, and are movable together with the communication tool,
The communication device comprises a flow path inlet (45) between the first and second plugs,
A multi-chamber drug container in which the inlet (45) of the communication tool communicates with the third chamber when the first end of the communication tool is moved to a position where the resin film of the first container is broken .

前記第３容器の出口開口は、円筒形に形成されていることを特徴とする請求項１の多室薬剤容器。The multi-chamber drug container according to claim 1, wherein the outlet opening of the third container is formed in a cylindrical shape .

前記第３室を構成する第３容器の内壁がビタミンＤに対し非吸着性の樹脂により形成される請求項１又は２の多室薬剤容器。The multi-chamber drug container according to claim 1 or 2, wherein an inner wall of the third container constituting the third chamber is formed of a resin that is non-adsorbable with respect to vitamin D.