JP4594556B2

JP4594556B2 - Infusion container

Info

Publication number: JP4594556B2
Application number: JP2001196684A
Authority: JP
Inventors: 至坂口; 俊典小澤; 聡千葉
Original assignee: TRUMO KABUSHIKI KAISHA
Current assignee: TRUMO KABUSHIKI KAISHA
Priority date: 2001-06-28
Filing date: 2001-06-28
Publication date: 2010-12-08
Anticipated expiration: 2021-06-28
Also published as: JP2003010286A

Description

【０００１】
【発明の属する技術分野】
本発明は、多室型の輸液用容器に関する。より詳細には、液体を収容したバッグ本体に薬剤を収容した薬剤容器を取り付け、用事に、薬剤容器の底部近傍を破断して、バッグ本体内と薬剤容器内を連通化し、バッグ本体内の液体と薬剤容器内の薬剤とを混合するようにした輸液用容器に関する。
【０００２】
【従来の技術】
患者に輸液を投与するに当たっては、輸液剤中に予め混合しておくことが困難な薬剤（例えば、ビタミン剤、抗生物質など）を、注射器などを用いて輸液剤を収容してある輸液用バッグ内に注入し、輸液用バッグ中で十分に混合した後に、患者に投与することが従来から広く行われている。しかしながら、その場合には、輸液時の操作が繁雑であり、しかも汚染や異物の混入などが生ずる恐れがある。
【０００３】
そこで、上記した問題を解決するために、近年、輸液剤などの液体を収容した輸液用バッグ本体に薬剤を収容した薬剤容器を取り付けておき、輸液を投与する際に薬剤容器を破断して薬剤容器内とバッグ本体内とを連通状態にし、薬剤容器内の薬剤とバッグ本体内の液体をバッグ本体内で混合し、それを患者に投与するようにした多室型の輸液用容器が多く提案されている。
【０００４】
そのような多室型輸液用容器では、薬剤容器の底部近傍に肉薄部やＶ状溝などの脆弱部を設けてそれを破断可能部とし、薬剤容器の底部の外側に前記破断操作を行うための破断操作部を結合しておき、輸液時に該破断操作部を操作して薬剤容器を破断可能部で破断させて薬剤容器内と輸液用バッグ本体内とを連通化する方式が検討されている。その際に、バッグ本体への薬剤容器の取り付け方式として、バッグ本体の周縁シール部に筒状部材を予め取り付けておき、該筒状部材に薬剤容器を挿入して固定する方法が検討されている（例えば特開２０００−１７５９８７号公報、特開２０００−２５４２０８号公報など）。
【０００５】
上記した従来の多室型輸液用容器では、薬剤容器の薬剤充填口の密封および筒状部材と薬剤容器の境界面の密封は、例えば図４に示すように、１個の蓋体またはシール部材を用いて行われている。図４において、１はバッグ本体、２はバッグ本体１の周縁シール部に取り付けられた筒状部材、３は薬剤容器、４ａは蓋体、４ｂは弾性シール部材、５は薬剤容器３における破断可能部、６は破断操作部を示す。
図４の（ａ）は、筒状部材２に挿入された薬剤容器３の薬剤充填口の密封と筒状部材２における薬剤容器３の挿入端部の密封を、１個の蓋体４ａを用いて同時に行っている従来の輸液用容器の例である。また、図４の（ｂ）は、筒状部材２に挿入された薬剤容器３の薬剤充填口の密封と筒状部材２における薬剤容器３の挿入端部の密封を、１個の弾性シール部材４ｂを用いて同時に行っている従来の輸液用容器の例である。
【０００６】
図４の（ａ）および（ｂ）の従来の輸液用容器では、薬剤容器３の薬剤充填口（端部）の密封と筒状部材２の薬剤容器挿入口（端部）の密封を１個の蓋体４ａまたは弾性シール部材４ｂを用いて行っているために、筒状部材２の薬剤容器挿入口と蓋体４ａまたは弾性シール部材４ｂとの境界面Ｃ₁に密封（シール）不良が生じたときにバッグ本体１内に収容されている液体が薬剤容器３の外周面と筒状部材２の内周面との間の境界面Ｄおよび境界面Ｃ₁を経て外部に漏れるというトラブルを生ずることがある。さらには、筒状部材２の薬剤容器挿入口と蓋体４ａまたは弾性シール部材４ｂとの境界面Ｃ₁および薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの境界面Ｃ₂の両方に密封（シール）不良が生じたときにも、薬剤容器３内に収容されている薬剤が該境界面Ｃ₁およびＣ₂を経て外部に漏れたり、バッグ本体１内に収容されている液体が薬剤容器３の外周面と筒状部材２の内周面との間の境界面Ｄおよび境界面Ｃ₁を経て外部に漏れるというトラブルを生ずることがある。そのため、境界面Ｃ₁から外部に液漏れが生じたときに、その液漏れが、筒状部材２の薬剤容器挿入口と蓋体４ａまたは弾性シール部材４ｂとの間の密封不良に起因するのか、薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの間の密封不良に起因するのか、或いは両方の密封不良に起因するのかを判別することが困難であり、液漏れの原因の究明および液漏れ防止のための対策に手間および時間がかかるという欠点がある。
【０００７】
また、図４の（ａ）および（ｂ）の従来の輸液用容器では、筒状部材２の薬剤容器挿入口と蓋体４ａまたは弾性シール部材４ｂとの間の密封が良好に行われていて境界面Ｃ₁から外部に液漏れが生じない場合であっても、薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの間の密封が不良であると、バッグ本体１内に収容されている液体が薬剤容器３の外周面と筒状部材２の内周面との間の境界面Ｄを通り、さらに薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの間の密封不良の境界面（隙間）Ｃ₂を通って、薬剤容器３内に流入するというトラブルを生じやすくなり、輸液用容器の保存時に、バッグ本体１内に収容されている液体と、薬剤容器３内に収容されている薬剤を完全に分離した状態で保存することが困難になる。
【０００８】
さらに、図４の（ａ）および（ｂ）の従来の輸液用容器では、薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの間の密封は、通常、薬剤容器３の薬剤充填口において薬剤容器３の壁厚（肉厚）部分だけで行われるため、薬剤容器３の薬剤充填口と蓋体４ａまたは弾性シール部材４ｂとの間の密封が十分に行われにくいという問題がある。
【０００９】
また、蓋体４ａで密封を行う図４の（ａ）の従来の輸液用容器では、筒状部材２の薬剤容器挿入口と薬剤容器３の薬剤充填口の端部の高さが不揃いであると、密封部分が平面状にならず、蓋体４ａが筒状部材の薬剤容器挿入口と薬剤容器３の薬剤充填口の両方に均一に接着しなくなり（融着せず）、隙間が発生して液漏れや薬剤の漏れを生ずることがある。
【００１０】
【発明が解決しようとする課題】
本発明の目的は、液体を収容したバッグ本体の周縁シール部に筒状部材を取り付け、該筒状部材に破断操作部によって破断可能な薬剤容器を挿入し固定してなる多室型の輸液用容器において、バッグ本体に収容されている液体と薬剤容器に収容されている薬剤が、輸液用容器の保存時に混合するというトラブルの発生しない輸液用容器を提供することである。
そして、本発明の目的は、上記の多室型の輸液用容器において、薬剤容器の薬剤充填口の蓋体による密封、および薬剤容器を挿入・固定してなる筒状部材の薬剤容器挿入口の密封がそれぞれ完全に行われて、液体や薬剤の外部への漏れのない輸液用容器を提供することである。
さらに、本発明の目的は、上記の多室型の輸液用容器において、薬剤容器の薬剤充填口の近傍で万が一液漏れが生じた際に、その液漏れが、薬剤容器の薬剤充填口と蓋体との間の密封不良に起因するのか、または筒状部材の薬剤容器挿入口の密封不良に起因するのかについて漏れの原因を直ちに判別することができて、漏れ防止のための対策を早急に講ずることのできる輸液用容器を提供することである。
【００１１】
【課題を解決するための手段】
上記した目的を達成すべく本発明者らは種々検討を重ねてきた。その結果、液体を収容した可撓性のバッグ本体に筒状部材を取り付け、該筒状部材に用事に破断可能な薬剤容器を挿入して固定した多室型の輸液用容器において、薬剤容器の薬剤充填口と筒状部材の薬剤容器挿入口の両方の密封に対して１個の蓋体または１個の弾性シール部材で行う上記した従来の方式に代えて、薬剤容器の薬剤充填口の密封と筒状部材の薬剤容器挿入口の密封をそれぞれ特定の方式で個別に行うと、すなわち薬剤容器の薬剤充填口の周囲にフランジを形成して該フランジの上面全周でフランジに蓋体を接着させて薬剤充填口を密封すると共に、筒状部材の薬剤容器挿入口の周囲にもフランジを形成して薬剤容器の薬剤充填口の周囲に形成したフランジの裏面と筒状部材の薬剤容器挿入口の周囲に形成したフランジの上面とを全周にわたって液密に接着させると、薬剤容器の薬剤充填口の密封部と筒状部材の薬剤容器挿入口の密封部とが異なった位置にあることにより、バッグ本体に収容されている液体と薬剤容器に収容されている薬剤が、輸液用容器の保存時に混合することが完全に防止できること、しかも薬剤容器の薬剤充填口と筒状部材の薬剤容器挿入口の密封を完全に行えることを見出した。
さらに、本発明者らは、前記した多室型の輸液用容器では、万が一、薬剤容器の薬剤充填口の近傍で液漏れを生じた際にも、薬剤容器の薬剤充填口の密封部と筒状部材の薬剤容器挿入口の密封部とが異なった位置にあることにより、その液漏れがいずれの密封部の密封不良に起因するのかの判別が容易になり、液漏れ防止のための対策を早急に講じ得ることを見出した。
【００１２】
また、本発明者らは、薬剤容器の薬剤充填口の密封と、筒状部材の薬剤容器挿入口の密封を個別に行う前記した方式を採用するに当たり、薬剤容器の薬剤充填口に被せる蓋体を円板形状にすると共に薬剤容器の薬剤充填口の周囲に形成したフランジの外周に起立部を設けて、蓋体の外径をフランジの外周の起立部に包囲される空間部分の内径と等しいか又は僅かに小さく設計すると、蓋体が薬剤容器の薬剤充填口に形成したフランジに正確に配置されて蓋体による密封がより完全に行えることを見出した。
さらに、本発明者らは、薬剤容器の薬剤充填口に被せた円板形状の蓋体の内面円周上に、蓋体を薬剤容器の薬剤充填口に嵌合するための突条を設けると、蓋体を薬剤容器の薬剤充填口に一層正確に且つ簡単に配置でき、蓋体による薬剤充填口の密封が一層完全に行えることを見出し、それらの知見に基づいて本発明を完成した。
【００１３】
すなわち、本発明は、
（１）液体を収容してなる可撓性のバッグ本体、バッグ本体の周縁シール部に取り付けられた筒状部材、および該筒状部材に挿入され固定された薬剤容器を有し、薬剤容器の底部近傍に用事に薬剤容器を破断して薬剤容器内とバッグ本体内とを連通化するための破断可能部と該破断可能部を破断するための破断操作部を有する輸液用容器であって、薬剤容器は薬剤充填口の周囲にフランジを有し、薬剤容器の薬剤充填口に蓋体が被せられ、該蓋体が薬剤充填口における前記フランジの上面全周でフランジに接着されて薬剤充填口を密封し、さらに前記筒状部材は薬剤容器挿入口の周囲にフランジを有し、薬剤容器の薬剤充填口の周囲におけるフランジの裏面と筒状部材の薬剤容器挿入口の周囲におけるフランジの上面とが全周にわたって液密に接着されていることを特徴とする輸液用容器である。
【００１４】
そして、本発明は、
（２）薬剤容器の薬剤充填口に被せられた蓋体が円板形状であり、薬剤容器の薬剤充填口の周囲におけるフランジが外周に起立部を有し、蓋体の外径が、フランジの外周の起立部に包囲される空間部分の内径と等しいか又は僅かに小さく設計されている前記（１）の輸液用容器；
（３）薬剤容器の薬剤充填口に被せられた蓋体が円板形状であり、該蓋体の内面円周上に、蓋体を薬剤容器の薬剤充填口に嵌合するための突条を有している前記（１）または（２）の輸液用容器；および、
（４）筒状部材、薬剤容器および蓋体が熱可塑性重合体から形成されており、薬剤容器の薬剤充填口におけるフランジへの蓋体の接着および薬剤容器の薬剤充填口の周囲におけるフランジの下面と筒状部材の薬剤容器挿入口の周囲におけるフランジの上面との接着が、ヒートシールによりなされている前記（１）〜（３）のいずれかの輸液用容器；
を好ましい態様として包含する。
【００１５】
【発明の実施の形態】
以下に本発明について詳細に説明する。
本発明の輸液用容器は、可撓性のバッグ本体を有し、該バッグ本体の周縁シール部に筒状部材が取り付けられていて、該筒状部材に薬剤容器が挿入され固定されている。
バッグ本体の材質は特に制限されず、可撓性で且つ液体不透過性の材料からなっていればよく、可撓性の熱可塑性重合体材料から形成されていることが好ましい。バッグ本体を形成するための熱可塑性重合体材料としては、例えば、ポリエチレン、ポリプロピレン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体、架橋型エチレン−酢酸ビニル共重合体などのポリオレフィン類、ポリエチレンテレフタレートやポリブチレンテレフタレートなどのポリエステル、ポリ塩化ビニル、ポリウレタン、ポリアミド、ポリアミド系熱可塑性エラストマー、ポリエステル系熱可塑性エラストマー、スチレン系熱可塑性エラストマー、天然ゴム、イソプレンゴム、ブタジエンゴム、スチレン−ブタジエンゴム、シリコーンゴムなどを挙げることができ、バッグ本体はそれらの１種または２種以上から形成されていることができる。
そのうちでも、バッグ本体は、ポリエチレン、ポリプロピレン、ポリエチレンとポリプロピレンの混合物、ポリプロピレンとスチレン系エラストマー及び／またはオレフィン系エラストマーの混合物、エチレン−酢酸ビニル共重合体などから形成されていることが、バッグ本体の周縁部やイージーピール性隔壁におけるヒートシール性に優れている点、バッグ本体の周縁部にポート部材や薬剤容器を融着により容易に取り付け得る点から好ましい。
【００１６】
バッグ本体は、前記した熱可塑性重合体材料の単層体からなっていても、前記した熱可塑性重合体材料の２以上が積層した多層構造体からなっていても、または前記した熱可塑性重合体材料の１層または２層以上と例えば金属箔、金属蒸着層などの他の層との多層構造体からなっていてもよい。
【００１７】
バッグ本体は、１つの室のみを有していても、または互いに連通可能な隔壁で仕切られた２つ以上の室を有していてもよい。バッグ本体の室には液体が収容されている。バッグ本体に収容する液体の種類は特に制限されず、輸液用容器の用途などに応じて、例えば、生理食塩水、電解質溶液、リンゲル液、高カロリー輸液、ブドウ糖液、注射用水などが収容することができる。バッグ本体が連通可能な隔壁により仕切られた２つ以上の室を有する多室型の場合は、各々の室には通常別の種類の液体を収容しておく。
バッグ本体が、多室型である場合は、バッグ本体をポリプロピレンとスチレン系エラストマーおよび／またはオレフィン系エラストマーの混合物、或いはポリエチレンとポリプロピレンの混合物などのような２種類以上の樹脂の混合物を用いて形成しておくと、前記した混合物からなるシート状材料を上下に重ねて、バッグ本体の周縁部となる部分を高温でヒートシールし、複数の室に区画するための隔壁部分をそれよりも低温でヒートシールすることにより、周縁部が強固にヒートシールされ、隔離部分が外力を加えることによって容易に解除されて連通し得るイージーピール性の多室型バッグ本体を簡単に製造することができる。
【００１８】
本発明の輸液用容器では、バッグ本体が単室型の場合は、その１つの室に、輸液用容器の用途や種類などに応じて、筒状部材を介して１つまたは２つ以上の薬剤容器が取り付けられている。また、バッグ本体が多室型の場合は、輸液用容器の用途や種類などに応じて、１つの室にのみ１つまたは２つ以上の薬剤容器が筒状部材を介して取り付けられていても、または２つ以上の室の各々に１つまたは２つ以上の薬剤容器が筒状部材を介して取り付けられていてもよい。
【００１９】
本発明の輸液用容器では、バッグ本体の周縁シール部に筒状部材が液密に取り付けられていて、該筒状部材に薬剤容器が挿入されて固定されている。そして、薬剤容器の底部が少なくともバッグ本体の内部に位置し、輸液用容器の使用前には、バッグ本体内の液体と薬剤容器内の薬剤とが互いに混合せずに分離状態に保たれ、用事に、薬剤容器の底部近傍にある破断可能部を破断操作部によって破断させたときに、薬剤容器内とバッグ本体とが連通し得るようになっている。バッグ本体への筒状部材の取り付け位置は適宜選択することができる。
【００２０】
限定されるものではないが、本発明の輸液用容器の一例を図１に示す。図１は、略長方形状の単室型のバッグ本体１の周縁シール部に筒状部材２を融着し、筒状部材２に薬剤容器３を挿入して固定した本発明の輸液用容器の一例を示すものである。
筒状部材２は、円筒形であることが、筒状部材２への薬剤容器３の挿入および固定の容易性、強度などの点から好ましい。筒状部材２は、薬剤容器挿入口からもう一方の端部まで内径が同じかまたはほぼ同じであっても、或いは図１に示すように、もう一方の端部に向かって内径が徐々に小さくなったテーパー形状であってもよい。また、薬剤容器３の形状は、筒状部材２の形状に合わせて、有底の円筒形状であることが、筒状部材２への挿入および固定の容易性、強度などの点から好ましい。その際に薬剤容器３は、薬剤充填口から底部まで内径が同じかまたはほぼ同じであっても或いは図１に示すように薬剤容器３の底部に向かって内径が徐々に小さくなったテーパー状であってもよく、筒状部材２の形状に合致させた形状であることが好ましい。
【００２１】
本発明では、薬剤容器３はその薬剤充填口の周囲にフランジ３１を有している。薬剤容器３内に薬剤を収容した後に、薬剤容器３の薬剤充填口に蓋体４を被せ、蓋体４をフランジ３１の上面全周でフランジ３１に接着して薬剤充填口を密封する。
フランジ３１は、図２に例示するように、外周に起立部のない平坦な形状になっていて、それに蓋体４を被せて接着してもよいが、図１に示すように、フランジ３１の外周に起立部３１１を形成しておき、起立部３１１により包囲される空間の内部に起立部３１１の内径と等しいか又は僅かに小さい外径を有する円板形状の蓋体４を配置して接着することが好ましい。起立部３１１を設けることにより、蓋体４をフランジ３１の所定位置に正確に且つ簡単に配置することが可能になり、その状態で蓋体４がフランジ３１に接着されるため、薬剤容器３の薬剤充填口の密封をより完全に行うことができる。しかも、万が一、蓋体４の密封不良が生じた場合に、薬剤容器３内の薬剤の漏れを生ずる位置が、筒状部材２の薬剤容器挿入口の密封不良により生ずる液漏れ（バッグ本体１に収容した液体の漏れ）の位置と大きく隔たっているために、液漏れが、薬剤容器３の薬剤充填口と蓋体４との間の密封不良に起因するのか、または筒状部材２の薬剤容器挿入口の密封不良に起因するのかを容易に判別することができ、液漏れ防止対策を早急に講ずることが可能になる。
さらに、図１に示すように、蓋体４を円板形状にしておき、蓋体４の内面円周上に、蓋体４を薬剤容器３の薬剤充填口に嵌合するための突条４１を形成しておくと、蓋体４がフランジ３１の所定位置に一層確実に且つ容易に配置され、その状態で蓋体４がフランジ３１に接着されるため、薬剤充填口の密封をより完全に且つ簡単に行うことが可能になる。
【００２２】
そして、本発明の輸液用容器では、図１に示すように、筒状部材２はその薬剤容器挿入口の周囲にフランジ２１を有しており、薬剤容器３の薬剤充填口の周囲におけるフランジ３１の裏面と筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１の上面とが全周にわたって液密に接着されている。
【００２３】
上記したように、本発明の輸液用容器では、薬剤容器３の薬剤充填口の密封が、薬剤容器３の薬剤充填口の周囲におけるフランジ３１の上面と蓋体４の下面とが接着した接着面Ａでなされ、一方筒状部材２薬剤容器挿入口の密封が薬剤容器３の薬剤充填口の周囲におけるフランジ３１の下面と筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１の上面とが接着した接着面Ｂによってなされていて、薬剤容器３の薬剤充填口の密封位置と、筒状部材２の薬剤容器挿入口の密封位置が互いに異なっている。
そのため、バッグ本体１内に収容されている液体と薬剤容器３内に収容されている薬剤とが、輸液用容器の保存時などに混合することが防止され、バッグ本体１に収容されている液体と薬剤容器３に収容されている薬剤を互いに完全に分離安定した状態で保存することができる。
また、本発明の輸液用容器では、薬剤容器３の薬剤充填口の密封と、筒状部材２の薬剤容器挿入口の密封が上記した方式で別々に行われているために、それぞれの密封をより確実に行うことができる。
そして、万が一、薬剤容器３の薬剤充填口の近傍で液漏れが生じた場合に、その液漏れが蓋体４の密封不良（薬剤容器３の薬剤充填口の密封不良）に起因するのか、または筒状部材２の先端部（薬剤容器挿入口）の密封不良に起因するのかを容易に判別することができ、液漏れ防止対策を早急に講ずることができる。
【００２４】
薬剤容器３の薬剤充填口の周囲におけるフランジ３１への蓋体４の接着、および薬剤容器３の薬剤充填口の周囲におけるフランジ３１と筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１との間の接着は、融着（ヒートシール）、接着剤による接着、溶剤による接着などのいずれで行ってもよいが、融着により行うことが接着操作の容易性、接着の完全性、衛生性などの点から好ましい。
その場合に、筒状部材２、薬剤容器３および蓋体４のすべてを熱可塑性重合体で作製しておき、筒状部材２、薬剤容器３および蓋体４を構成する熱可塑性重合体の種類などに応じて、高周波誘電加熱、高周波誘導加熱、超音波加熱、熱伝導加熱などの加熱方式を利用して接着することが好ましい。
【００２５】
筒状部材２、薬剤容器３および蓋体４は、硬質の重合体材料から形成しておくことが、バッグ本体１への筒状部材２の取り付け操作、薬剤容器３の薬剤充填口の周囲におけるフランジ３１への蓋体４の接着操作、筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１と薬剤容器３の薬剤充填口の周囲におけるフランジ３１との間の接着操作が容易になる点から好ましい。筒状部材２、薬剤容器３および蓋体４を構成する重合体材料としては、例えば、ポリエチレン、ポリプロピレン、ポリ−１，２−ブタジエン、環状ポリオレフィンなどのポリオレフィン、ポリスチレン、ポリ−（４−メチルペンテン−１）、ポリカーボネート、ＡＢＳ樹脂、ブタジエン−スチレン共重合体、アクリル樹脂、ポリアセタール樹脂、ポリアリレート、ポリアクリロニトリル、ポリサルフォン、ポリエーテルサルフォン、ポリフッ化ビニリデン、アイオノマー、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレートなどのポリエステル、ポリアミドなどを挙げることができ、筒状部材２、薬剤容器３および蓋体４はこれらの重合体の１種または２種以上から形成されていることができる。
【００２６】
上記した重合体材料のうちでも、耐熱性に優れている点からは、筒状部材２、薬剤容器３および蓋体４は、ポリプロピレン、ポリカーボネート、環状ポリオレフィン、ポリエチレンナフタレートから形成されていることが好ましい。
また、安全性が高く、密着性に優れるという点からは、筒状部材２、薬剤容器３および蓋体４は、ポリエチレン、ポリプロピレン、ポリエステル（特にポリエチレンナフタレート）から形成されていることが好ましい。
さらに、酸素、二酸化炭素、水蒸気などのガス透過性が低く、薬剤容器内の薬剤の変質、分解、劣化などを高いレベルで防止できるという点からは、薬剤容器３および蓋体４は、ポリエステル（特にポリエチレンナフタレート）、ポリアクリロニトリル、ポリフッ化ビニリデンから形成されていることが好ましい。
薬剤容器３および蓋体４をポリプロピレンや環状ポリオレフィンなどのような比較的ガス透過性の高い重合体材料から形成する場合は、薬剤容器表面にガスの透過性を減ずる材料の層、例えば、シリカ、アルミナ、酸化チタンなどからなる層を設けておいてもよい。
【００２７】
また、本発明の輸液用容器では、図３に例示するように、薬剤容器３の薬剤充填口に弾性シール部材７を配置し、その上に蓋体４を被せて、蓋体４を薬剤容器３の薬剤充填口の周囲におけるフランジ３１に接着して密封を行ってもよい。
【００２８】
薬剤容器３は、その底部の近傍に破断可能部５を有する。破断可能部５の位置は、薬剤容器３の底部近傍であって、薬剤容器３を該破断可能部５で破断することにより薬剤容器３の底部が薬剤容器本体から分離されて薬剤容器３の底部が開放された状態になり得る位置であればいずれでもよい。一般的には、薬剤容器３の底部から約０．５〜１０ｍｍ程度上の位置であることが、破断の容易性、破断可能部の形成容易性などの点から好ましい。
また、薬剤容器３の底部近傍における破断可能部５の構造は、破断操作部６による操作によって容易に破断可能な構造であればいずれでもよく、例えば、薬剤容器３の底部の近傍の外周に沿ってＶ溝、Ｕ溝、凹溝などを形成しその部分を肉薄の破断可能部５とする方式、或いは薬剤容器３の底部近傍の外周に沿って単に切り込みからなる破断可能部５を設けておく方式などを挙げることができる。
破断操作部６の形状および構造は、薬剤容器３をその破断可能部５で円滑に破断させ得るものであればいずれでもよい。
【００２９】
本発明の輸液用容器では、薬剤容器３に収容する薬剤の形態は特に制限されず、粉末状、顆粒状、ペレット状などの固形状、液状などのいずれの形態であってもよく、特に本発明の輸液用容器は液状の薬剤を収容した場合の液漏れ防止に有効である。また、薬剤容器３に収容する薬剤の種類も特に制限されず、輸液用容器の用途や使用形態などに応じて、例えば、抗生物質、ビタミン剤（総合ビタミン剤）、各種アミノ酸、ヘパリンなどの抗血栓剤、抗パーキンソン剤、潰瘍治療剤、副腎皮質ホルモン剤、不整脈用剤、抗ウイスル剤、免疫付与剤、抗ガン剤、補正電界質などを挙げることができる。
【００３０】
また、薬剤容器３内は、容器内の薬剤の変質、分解などを防止するために、減圧状態、真空状態、不活性気体で置換した状態にしておいてもよい。
薬剤容器３の容量は特に制限されず、薬剤容器３に収容する薬剤の種類、輸液用容器の用途などに応じて適当な容量を選択し得るが、一般的には１〜５０ｍｌ程度の容量であることが好ましく、２〜１０ｍｌ程度であることがより好ましい。
また、薬剤容器３の内径は、十分な液の流通を確保でき且つ必要以上の大径化を防止する点から、４〜５０ｍｍ程度であることが好ましく、５〜３０ｍｍ程度であることがより好ましい。
薬剤容器３の薬剤充填口の周囲に形成してなるフランジ３１の寸法、フランジ３１の外周に設ける起立部３１１の寸法は、薬剤容器３の薬剤充填口の寸法、薬剤容器３の壁厚、蓋体４の外径、厚さなどに応じて決めることができる。
筒状部材２、そのフランジ２１の寸法は、薬剤容器３、そのフランジ３１の寸法に応じて決めることができる。
【００３１】
本発明の輸液用容器は、従来の輸液用容器と同様に、必要に応じて、輸液用容器を吊るすための穴、輸液用容器の運搬を容易にするための把持部などを有していてもよい。
【００３２】
【実施例】
以下に実施例などにより本発明について具体的に説明するが、本発明は以下の例により何ら限定されない。
【００３３】
《実施例１》
（１）ポリプロピレンを用いて射出成形を行って、図１に示す構造を有する薬剤容器３、すなわち薬剤充填口にフランジ３１を有し、フランジ３１の外周に起立部３１１を有し、底部近傍の外周位置にＶ溝からなる破断可能部５を有し、底部外側に破断操作部６を有する有底の円錐台形の薬剤容器３を成形した。
薬剤容器３における薬剤充填口の内径は１５ｍｍ、フランジ３１の外径は２３．２ｍｍ、フランジ３１および起立部３１１の厚みは約１．２ｍｍ、起立部３１１で包囲される空間部分の内径は２０．８ｍｍ、薬剤容器３の底部の外径は８．５ｍｍ、壁厚は約１ｍｍ、長さ（深さ）は約３５ｍｍ、薬剤容器３の内容量は３．５ｍｌであった。
（２）上記（１）の薬剤容器３内に、液状の薬剤３．３ｍｌを充填した後、図１に示す内周面に突条部４１を有するポリプロピレン製の蓋体４（外径２０．７ｍｍ、厚さ約１．５ｍｍ、突条部４１の高さ約１ｍｍ、幅約１ｍｍ）を薬剤充填口に配置し、薬剤容器３のフランジ３１の上面全周に蓋体４を超音波加熱方式により融着した。
【００３４】
（３）押出成形によって製造したポリプロピレン製筒状シート（筒の折径２１０ｍｍ、シート厚み約３２０μｍ）を筒状のまま長さ約４０ｃｍに切断し、それを偏平にし、図１に示すように、温度約２２０℃で一方の開放端部をヒートシールしてシール部として底部を形成した。それと同時に、もう一方の開放端部を筒状部材２を挿入するための開口部を残して同温度でヒートシールした後、該開口部に、フランジ２１を一端に有するポリプロピレン製の筒状部材２（フランジ２１を有する先端部の内径約１０ｍｍ、肉厚約１ｍｍ、筒状部材の長さ約３５ｍｍ、フランジ２１部分の外径２３．２ｍｍ、フランジ２１の肉厚１．２ｍｍ）を挿入して融着した。
（４）上記（３）で作製したバッグ本体１内に液体約２００〜４００ｍｌをその筒状部材２の取り付け部分から充填した後、該筒状部材２内に、上記（２）で準備した薬剤入り薬剤容器３を挿入した後、薬剤容器３の薬剤充填口の周囲におけるフランジ３１の下面と筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１の上面を超音波加熱方式により融着して、図１に示す輸液用容器を作製した。
【００３５】
（５）上記（４）で得られた輸液用容器は、薬剤容器３の薬剤充填口の蓋体４による密封、薬剤容器３の薬剤充填口の周囲におけるフランジ３１の下面と筒状部材２の薬剤容器挿入口の周囲におけるフランジ２１の上面との間の密封がそれぞれ完全に行われていて、外部への液漏れがなく、しかもバッグ本体１に収容されている液体と薬剤容器３に収容されている薬剤の密封不良に伴う混合のないものであった。また、万が一、外部への液漏れが生じた場合にも、それがどの部分での密封不良により生じたものか容易に判別可能である。
そして、上記（４）で得られた輸液用容器を、バッグ本体１のほぼ外部にある薬剤容器３の本体部分を片方の手の親指と人差し指で掴み、バッグ本体１の内部にある破断操作部６をもう一方の手の親指と人差し指とで掴んで、バッグ本体１の偏平方向に対して直角の方向に折り曲げることにより、薬剤容器３の底部近傍の破断可能部５で容易に破断されて、バッグ本体１内の液体と薬剤容器３内の薬剤が速やかに且つ良好に混合された。
【００３６】
【発明の効果】
本発明の輸液用容器では、薬剤を収容した薬剤容器の薬剤充填口の密封と、薬剤容器を挿入・固定してなる筒状部材の薬剤容器挿入口の密封とが、互いに大きく隔たった位置で個別に行われているため、薬剤容器を取り付けた近傍で、万が一液漏れが生じた場合に、その液漏れが薬剤容器の薬剤充填口の密封不良によるのか、または筒状部材薬剤容器挿入口の密封不良によるのかを簡単に判別でき、それによって液漏れ防止対策を早急に講ずることができる。
本発明の輸液用容器では、薬剤容器の薬剤充填口の密封位置と、筒状部材の薬剤容器挿入口の密封位置が、互いに分離しているので、バッグ本体に収容されている液体と薬剤容器に収容されている薬剤とが、輸液用容器の保存時などに混合することが防止され、バッグ本体に収容されている液体と薬剤容器に収容されている薬剤を互いに完全に分離安定した状態で安定に保存することができる。
さらに、本発明の輸液用容器では、薬剤容器の薬剤充填口の密封と、筒状部材の薬剤容器挿入口の密封が上記した方式で別々に行われているために、それぞれの部分での密封をより確実に行うことができる。
【図面の簡単な説明】
【図１】本発明の輸液用容器の一例を示す図である。
【図２】本発明の輸液用容器における、薬剤容器の薬剤充填口および筒状部材の薬剤容器挿入口における別の密封方式の例を示す部分図である。
【図３】本発明の輸液用容器における、薬剤容器の薬剤充填口および筒状部材の薬剤容器挿入口における別の密封方式の更に別の例を示す部分図である。
【図４】従来の輸液用容器における、薬剤容器の薬剤充填口および筒状部材の薬剤容器挿入口における密封方式を示す図である。
【符号の説明】
１バッグ本体
２筒状部材
２１フランジ
３薬剤容器
３１フランジ
３１１起立部
４蓋体
４１突条部
４ａ蓋体
４ｂ弾性シール部材
５破断可能部
６破断操作部
７弾性シール部材[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a multi-chamber infusion container. More specifically, the medicine container containing the medicine is attached to the bag body containing the liquid, and the vicinity of the bottom of the medicine container is broken, and the inside of the bag body and the medicine container are connected to each other. The present invention relates to an infusion container in which a drug and a drug in a drug container are mixed.
[0002]
[Prior art]
When administering an infusion to a patient, an infusion bag containing an infusion using a syringe or the like that is difficult to mix in advance in the infusion (eg vitamins, antibiotics, etc.) It has been widely practiced to administer it to a patient after it has been injected into the infusion bag and thoroughly mixed in an infusion bag. However, in that case, the operation at the time of infusion is complicated, and there is a possibility that contamination or contamination of foreign matters may occur.
[0003]
Therefore, in order to solve the above-described problem, in recent years, a medicine container containing a medicine is attached to an infusion bag body containing a liquid such as an infusion medicine, and the medicine container is broken when administering the infusion. Many multi-chamber infusion containers have been proposed in which the container and the bag body are in communication, the drug in the drug container and the liquid in the bag body are mixed in the bag body, and then administered to the patient. Has been.
[0004]
In such a multi-chamber infusion container, a weak part such as a thin part or a V-shaped groove is provided near the bottom of the drug container to make it a breakable part, and the breaking operation is performed outside the bottom of the drug container. A method of connecting the inside of the medicine container and the inside of the infusion bag body by connecting the breaking operation part of the medicine and operating the breaking operation part at the time of infusion to break the medicine container at the breakable part has been studied. . At that time, as a method of attaching the drug container to the bag body, a method in which a cylindrical member is attached in advance to the peripheral seal portion of the bag body, and the drug container is inserted and fixed to the cylindrical member has been studied. (For example, Unexamined-Japanese-Patent No. 2000-175987, Unexamined-Japanese-Patent No. 2000-254208, etc.).
[0005]
In the conventional multi-chamber type infusion container described above, sealing of the medicine filling port of the medicine container and sealing of the boundary surface between the cylindrical member and the medicine container are carried out by, for example, one lid or sealing member as shown in FIG. It is done using. In FIG. 4, 1 is a bag body, 2 is a cylindrical member attached to the peripheral seal portion of the bag body 1, 3 is a drug container, 4a is a lid, 4b is an elastic seal member, and 5 is breakable in the drug container 3. Reference numeral 6 denotes a breaking operation part.
FIG. 4A shows the sealing of the medicine filling port of the medicine container 3 inserted into the cylindrical member 2 and the sealing of the insertion end of the medicine container 3 in the cylindrical member 2 using one lid 4a. It is an example of the conventional container for infusion performed simultaneously. FIG. 4B shows a single elastic seal member for sealing the medicine filling port of the medicine container 3 inserted in the cylindrical member 2 and sealing the insertion end of the medicine container 3 in the cylindrical member 2. It is an example of the conventional container for infusion currently performed simultaneously using 4b.
[0006]
In the conventional infusion container of FIGS. 4A and 4B, one seal of the drug filling port (end) of the drug container 3 and one seal of the drug container insertion port (end) of the cylindrical member 2 are provided. Since the lid 4a or the elastic seal member 4b is used, the boundary surface C between the medicine container insertion port of the cylindrical member 2 and the lid 4a or the elastic seal member 4b is used. ₁ When a sealing failure occurs in the bag, the liquid stored in the bag main body 1 is a boundary surface D and a boundary surface C between the outer peripheral surface of the drug container 3 and the inner peripheral surface of the cylindrical member 2. ₁ May cause troubles such as leaking outside. Further, the boundary surface C between the medicine container insertion port of the cylindrical member 2 and the lid 4a or the elastic seal member 4b. ₁ And a boundary surface C between the medicine filling port of the medicine container 3 and the lid 4a or the elastic seal member 4b. ₂ Even when a sealing failure occurs in both of the medicines, the medicine contained in the medicine container 3 remains in the boundary surface C. ₁ And C ₂ The boundary surface D and the boundary surface C between the outer peripheral surface of the drug container 3 and the inner peripheral surface of the cylindrical member 2 are leaked to the outside through the ₁ May cause troubles such as leaking outside. Therefore, the boundary surface C ₁ When the liquid leaks from the outside to the outside, the liquid leak is caused by poor sealing between the medicine container insertion port of the cylindrical member 2 and the lid 4a or the elastic seal member 4b, or the medicine in the medicine container 3 It is difficult to determine whether it is caused by poor sealing between the filling port and the lid 4a or the elastic seal member 4b, or both, and the cause of the liquid leakage and the prevention of liquid leakage There is a drawback that it takes time and effort to take measures.
[0007]
4 (a) and 4 (b), the sealing between the drug container insertion port of the cylindrical member 2 and the lid 4a or the elastic seal member 4b is well performed. Interface C ₁ Even if liquid leakage does not occur from the outside, if the sealing between the drug filling port of the drug container 3 and the lid 4a or the elastic seal member 4b is poor, it is accommodated in the bag body 1. The liquid passes through the boundary surface D between the outer peripheral surface of the drug container 3 and the inner peripheral surface of the cylindrical member 2, and further, the sealing failure between the drug filling port of the drug container 3 and the lid 4a or the elastic seal member 4b. Boundary surface (gap) C ₂ It is easy to cause a trouble of flowing into the medicine container 3 through the liquid, and when storing the infusion container, the liquid contained in the bag body 1 and the medicine contained in the medicine container 3 are completely removed. It becomes difficult to store in a separated state.
[0008]
Furthermore, in the conventional infusion container shown in FIGS. 4A and 4B, the seal between the drug filling port of the drug container 3 and the lid 4a or the elastic seal member 4b is usually the drug in the drug container 3. Since it is performed only at the wall thickness (thickness) portion of the medicine container 3 at the filling port, there is a problem that the sealing between the medicine filling port of the medicine container 3 and the lid 4a or the elastic seal member 4b is not sufficiently performed. is there.
[0009]
Further, in the conventional infusion container of FIG. 4A in which sealing is performed with the lid 4a, the heights of the end portions of the drug container insertion port of the cylindrical member 2 and the drug filling port of the drug container 3 are uneven. Then, the sealed portion is not flat, and the lid 4a does not adhere evenly to both the medicine container insertion port of the cylindrical member and the medicine filling port of the medicine container 3 (not fused), and a gap is generated. Liquid leakage or drug leakage may occur.
[0010]
[Problems to be solved by the invention]
An object of the present invention is a multi-chamber type infusion solution in which a cylindrical member is attached to a peripheral seal portion of a bag body containing liquid, and a drug container that can be broken by a breaking operation portion is inserted and fixed to the cylindrical member. An object of the present invention is to provide an infusion container that does not cause a trouble that the liquid contained in the bag body and the medicine contained in the medicine container are mixed when the infusion container is stored.
An object of the present invention is to seal the medicine container filling port of the medicine container with the lid of the medicine container in the above-described multi-chamber infusion container, and to insert the medicine container into the cylindrical container container insertion / fixation port. It is to provide an infusion container that is completely sealed and does not leak liquid or medicine to the outside.
Furthermore, an object of the present invention is to provide a multi-chamber type infusion container as described above, in the unlikely event that a liquid leak occurs near the drug filling port of the drug container, the liquid leakage is It is possible to immediately determine the cause of leakage as to whether it is caused by poor sealing with the body or due to poor sealing of the medicine container insertion port of the cylindrical member, and promptly take measures to prevent leakage It is to provide an infusion container that can be taken.
[0011]
[Means for Solving the Problems]
In order to achieve the above object, the present inventors have made various studies. As a result, in a multi-chamber infusion container in which a cylindrical member is attached to a flexible bag body containing liquid and a drug container that can be appropriately broken is inserted and fixed to the cylindrical member, Instead of the above-described conventional method for sealing both the medicine filling port and the medicine container insertion port of the cylindrical member with one lid or one elastic seal member, sealing the medicine filling port of the medicine container And sealing the cylindrical container medicine container insertion port individually in a specific manner, that is, forming a flange around the medicine filling port of the medicine container and bonding the lid to the flange all around the upper surface of the flange In addition to sealing the medicine filling port, a flange is also formed around the medicine container insertion port of the cylindrical member, and the back surface of the flange formed around the medicine filling port of the medicine container and the medicine container insertion port of the cylindrical member And the top surface of the flange formed around When liquid-tightly bonded around the entire circumference, the liquid contained in the bag body is different because the sealing part of the drug filling port of the drug container and the sealing part of the drug container insertion port of the cylindrical member are located at different positions. It has been found that the medicine contained in the medicine container can be completely prevented from mixing during storage of the infusion container, and that the medicine filling opening of the medicine container and the medicine container insertion opening of the cylindrical member can be completely sealed. It was.
Furthermore, the present inventors, in the case of the above-described multi-chamber type infusion container, should have a liquid leakage in the vicinity of the drug filling port of the drug container, and the sealing portion and the cylinder of the drug filling port of the drug container. Since the sealing part of the drug container insertion port of the shaped member is located at a different position, it becomes easy to determine which sealing part is caused by poor sealing and take measures to prevent liquid leakage I found out that I could do it as soon as possible.
[0012]
In addition, the present inventors, when adopting the above-described method for individually sealing the drug filling port of the drug container and sealing the drug container insertion port of the cylindrical member, covers the drug filling port of the drug container. Is formed in a disc shape and an upright portion is provided on the outer periphery of the flange formed around the drug filling port of the drug container, and the outer diameter of the lid is equal to the inner diameter of the space portion surrounded by the upright portion of the outer periphery of the flange However, it has been found that if the lid is designed to be slightly smaller, the lid can be accurately placed on the flange formed in the drug filling port of the drug container and the lid can be sealed more completely.
Furthermore, the present inventors provide a protrusion for fitting the lid to the drug filling port of the drug container on the inner circumference of the disc-shaped lid that covers the drug filling port of the drug container. The present inventors have found that the lid can be placed more accurately and easily in the medicine filling port of the medicine container, and that the medicine filling port can be more completely sealed by the lid, and the present invention has been completed based on these findings.
[0013]
That is, the present invention
(1) A flexible bag body containing liquid, a cylindrical member attached to a peripheral seal portion of the bag body, and a drug container inserted and fixed in the cylindrical member, A container for infusion having a breakable part for breaking the drug container in the vicinity of the bottom and communicating the inside of the drug container and the bag body, and a breaking operation part for breaking the breakable part, The medicine container has a flange around the medicine filling port, the medicine filling port of the medicine container is covered with a lid, and the lid is adhered to the flange all around the upper surface of the flange in the medicine filling port. The cylindrical member further has a flange around the drug container insertion port, and a rear surface of the flange around the drug filling port of the drug container and an upper surface of the flange around the drug container insertion port of the cylindrical member. Is liquid-tight over the entire circumference It is the container for infusions characterized by being adhere | attached on.
[0014]
And this invention,
(2) The lid over the drug filling port of the drug container has a disc shape, the flange around the drug filling port of the drug container has an upright portion on the outer periphery, and the outer diameter of the lid is The infusion container according to (1), which is designed to be equal to or slightly smaller than the inner diameter of the space portion surrounded by the upright portion on the outer periphery;
(3) The lid placed on the drug filling port of the drug container has a disc shape, and a protrusion for fitting the lid to the drug filling port of the drug container is provided on the inner circumference of the lid. The infusion container according to (1) or (2), and
(4) The cylindrical member, the drug container, and the lid are formed of a thermoplastic polymer, and the lid is bonded to the flange at the drug filling port of the drug container and the lower surface of the flange around the drug filling port of the drug container And the infusion container according to any one of the above (1) to (3), wherein adhesion between the cylindrical member and the upper surface of the flange around the medicine container insertion port is performed by heat sealing;
Is included as a preferred embodiment.
[0015]
DETAILED DESCRIPTION OF THE INVENTION
The present invention is described in detail below.
The infusion container of the present invention has a flexible bag body, a cylindrical member is attached to the peripheral seal portion of the bag body, and a drug container is inserted and fixed to the cylindrical member.
The material of the bag body is not particularly limited as long as it is made of a flexible and liquid-impermeable material, and is preferably made of a flexible thermoplastic polymer material. Examples of the thermoplastic polymer material for forming the bag body include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer, Polyester such as polyethylene terephthalate and polybutylene terephthalate, polyvinyl chloride, polyurethane, polyamide, polyamide thermoplastic elastomer, polyester thermoplastic elastomer, styrene thermoplastic elastomer, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, A silicone rubber etc. can be mentioned, The bag main body can be formed from those 1 type, or 2 or more types.
Among them, the bag body is formed of polyethylene, polypropylene, a mixture of polyethylene and polypropylene, a mixture of polypropylene and styrene elastomer and / or olefin elastomer, ethylene-vinyl acetate copolymer, etc. It is preferable from the viewpoint that the heat sealability in the peripheral edge portion and the easy-peeling partition wall is excellent, and the port member and the drug container can be easily attached to the peripheral edge portion of the bag body by fusion.
[0016]
The bag body may be composed of a single layer of the above-described thermoplastic polymer material, a multilayer structure in which two or more of the above-mentioned thermoplastic polymer materials are laminated, or the above-mentioned thermoplastic polymer. You may consist of the multilayer structure of one layer or two or more layers of material, and other layers, such as metal foil and a metal vapor deposition layer, for example.
[0017]
The bag body may have only one chamber, or may have two or more chambers separated by a partition wall that can communicate with each other. The bag body chamber contains liquid. The type of liquid stored in the bag body is not particularly limited, and may be stored, for example, physiological saline, electrolyte solution, Ringer's solution, high-calorie infusion, glucose solution, water for injection, etc., depending on the use of the container for infusion. it can. In the case of a multi-chamber type having two or more chambers partitioned by a partition wall through which the bag body can communicate, each chamber usually stores another type of liquid.
When the bag body is a multi-chamber type, the bag body is formed using a mixture of two or more kinds of resins such as a mixture of polypropylene and styrene elastomer and / or olefin elastomer, or a mixture of polyethylene and polypropylene. In this case, the sheet-like material made of the above mixture is stacked one above the other, the peripheral portion of the bag body is heat-sealed at a high temperature, and the partition portion for partitioning into a plurality of chambers is formed at a lower temperature than that. By heat-sealing, it is possible to easily manufacture an easy-peeled multi-chamber bag body that is firmly heat-sealed at the peripheral edge and can be easily released and communicated with the isolated portion by applying external force.
[0018]
In the infusion container of the present invention, when the bag body is of a single chamber type, one or two or more medicines are provided in the one chamber via a cylindrical member depending on the use or type of the infusion container. A container is attached. Further, when the bag body is a multi-chamber type, one or more drug containers may be attached to only one chamber via a cylindrical member depending on the use or type of the infusion container. Alternatively, one or more drug containers may be attached to each of the two or more chambers via a cylindrical member.
[0019]
In the infusion container of the present invention, a cylindrical member is liquid-tightly attached to the peripheral seal portion of the bag body, and a drug container is inserted and fixed to the cylindrical member. The bottom of the medicine container is located at least inside the bag body, and before using the infusion container, the liquid in the bag body and the medicine in the medicine container are kept in a separated state without being mixed with each other. In addition, when the breakable portion in the vicinity of the bottom of the medicine container is broken by the breaking operation section, the inside of the medicine container and the bag body can communicate with each other. The attachment position of the cylindrical member to the bag body can be selected as appropriate.
[0020]
Although not limited, an example of the infusion container of the present invention is shown in FIG. FIG. 1 shows an infusion container according to the present invention in which a cylindrical member 2 is fused to a peripheral seal portion of a substantially rectangular single-chamber bag body 1 and a drug container 3 is inserted and fixed to the cylindrical member 2. An example is shown.
The cylindrical member 2 is preferably cylindrical in view of ease of insertion and fixation of the drug container 3 to the cylindrical member 2 and strength. Even if the cylindrical member 2 has the same or substantially the same inner diameter from the drug container insertion port to the other end, or as shown in FIG. 1, the inner diameter gradually decreases toward the other end. It may be a tapered shape. Further, the shape of the drug container 3 is preferably a bottomed cylindrical shape in accordance with the shape of the cylindrical member 2 from the viewpoints of ease of insertion and fixation into the cylindrical member 2, strength, and the like. At this time, the drug container 3 has a tapered shape in which the inner diameter is the same or substantially the same from the drug filling port to the bottom, or the inner diameter gradually decreases toward the bottom of the drug container 3 as shown in FIG. It may be, and it is preferable that it is a shape matched with the shape of the cylindrical member 2.
[0021]
In the present invention, the medicine container 3 has a flange 31 around the medicine filling port. After the medicine is stored in the medicine container 3, the lid 4 is put on the medicine filling port of the medicine container 3, and the lid 4 is adhered to the flange 31 around the upper surface of the flange 31 to seal the medicine filling port.
As illustrated in FIG. 2, the flange 31 has a flat shape without an upstanding portion on the outer periphery, and may be covered with a lid 4, but as shown in FIG. 1, An upright portion 311 is formed on the outer periphery, and a disc-shaped lid body 4 having an outer diameter that is equal to or slightly smaller than the inner diameter of the upright portion 311 is disposed inside the space surrounded by the upright portion 311 and bonded. It is preferable to do. By providing the standing portion 311, the lid body 4 can be accurately and easily disposed at a predetermined position of the flange 31, and the lid body 4 is adhered to the flange 31 in this state. The drug filling port can be more completely sealed. Moreover, in the unlikely event that the lid 4 is poorly sealed, the position where the medicine leaks in the medicine container 3 is leaked due to poor sealing of the medicine container insertion port of the cylindrical member 2 (in the bag body 1). The liquid leakage is caused by a sealing failure between the medicine filling port of the medicine container 3 and the lid body 4 or the medicine container of the cylindrical member 2. It is possible to easily determine whether it is caused by a sealing failure of the insertion port, and it is possible to immediately take measures to prevent liquid leakage.
Further, as shown in FIG. 1, the lid body 4 is formed in a disc shape, and a protrusion 41 for fitting the lid body 4 to the medicine filling port of the medicine container 3 on the inner circumference of the lid body 4. When the lid 4 is formed, the lid 4 is more reliably and easily disposed at a predetermined position of the flange 31. In this state, the lid 4 is bonded to the flange 31, so that the medicine filling port is more completely sealed. And it becomes possible to carry out easily.
[0022]
In the infusion container of the present invention, as shown in FIG. 1, the cylindrical member 2 has a flange 21 around the medicine container insertion port, and a flange 31 around the medicine filling port of the medicine container 3. And the upper surface of the flange 21 around the medicine container insertion port of the cylindrical member 2 are liquid-tightly bonded over the entire circumference.
[0023]
As described above, in the infusion container of the present invention, the drug filling port of the drug container 3 is sealed by the adhesive surface where the upper surface of the flange 31 and the lower surface of the lid 4 are bonded around the drug filling port of the drug container 3. On the other hand, sealing of the cylindrical member 2 drug container insertion port is performed by bonding the lower surface of the flange 31 around the drug filling port of the drug container 3 and the upper surface of the flange 21 around the drug container insertion port of the cylindrical member 2. The sealing position of the drug filling port of the drug container 3 and the sealing position of the drug container insertion port of the cylindrical member 2 are different from each other.
Therefore, the liquid contained in the bag body 1 is prevented from being mixed with the liquid contained in the bag body 1 and the medicine contained in the drug container 3 when the infusion container is stored. And the medicine stored in the medicine container 3 can be stored in a state of being completely separated and stable from each other.
Further, in the infusion container of the present invention, the sealing of the drug filling port of the drug container 3 and the sealing of the drug container insertion port of the cylindrical member 2 are performed separately by the above-described method. This can be done more reliably.
In the unlikely event that a liquid leak occurs in the vicinity of the drug filling port of the drug container 3, the liquid leak is caused by a poor sealing of the lid body 4 (a poor sealing of the drug filling port of the drug container 3), or It is possible to easily determine whether it is caused by poor sealing of the distal end portion (drug container insertion port) of the cylindrical member 2, and it is possible to immediately take measures to prevent liquid leakage.
[0024]
Adhesion of the lid 4 to the flange 31 around the medicine filling port of the medicine container 3, and flange 31 around the medicine filling port of the medicine container 3 and the flange 21 around the medicine container insertion opening of the cylindrical member 2 Adhesion between them may be performed by any one of fusion (heat sealing), adhesion by an adhesive, adhesion by a solvent, etc., but it is easy to perform an adhesion operation, adhesion completeness, hygiene, etc. by fusion. From the point of view, it is preferable.
In that case, all of the cylindrical member 2, the drug container 3 and the lid 4 are made of a thermoplastic polymer, and the kind of the thermoplastic polymer constituting the cylindrical member 2, the drug container 3 and the lid 4. It is preferable to bond using a heating method such as high-frequency dielectric heating, high-frequency induction heating, ultrasonic heating, or heat conduction heating.
[0025]
The cylindrical member 2, the drug container 3, and the lid 4 may be formed of a hard polymer material so that the cylindrical member 2 can be attached to the bag body 1 around the drug filling port of the drug container 3. From the point that the bonding operation of the lid 4 to the flange 31 and the bonding operation between the flange 21 around the medicine container insertion port of the cylindrical member 2 and the flange 31 around the medicine filling port of the medicine container 3 are facilitated. preferable. Examples of the polymer material constituting the cylindrical member 2, the drug container 3, and the lid body 4 include polyolefins such as polyethylene, polypropylene, poly-1,2-butadiene, and cyclic polyolefin, polystyrene, and poly- (4-methylpentene). -1), polycarbonate, ABS resin, butadiene-styrene copolymer, acrylic resin, polyacetal resin, polyarylate, polyacrylonitrile, polysulfone, polyethersulfone, polyvinylidene fluoride, ionomer, polyethylene terephthalate, polybutylene terephthalate, polyethylene Examples thereof include polyester such as phthalate, polyamide, and the like, and the cylindrical member 2, the drug container 3, and the lid 4 can be formed of one or more of these polymers.
[0026]
Among the polymer materials described above, from the viewpoint of excellent heat resistance, the cylindrical member 2, the drug container 3, and the lid 4 are made of polypropylene, polycarbonate, cyclic polyolefin, and polyethylene naphthalate. preferable.
Moreover, it is preferable that the cylindrical member 2, the chemical | medical agent container 3, and the cover body 4 are formed from polyethylene, a polypropylene, and polyester (especially polyethylene naphthalate) from the point of being safe and excellent in adhesiveness.
Furthermore, from the viewpoint that the gas permeability of oxygen, carbon dioxide, water vapor, etc. is low and the alteration, decomposition, degradation, etc. of the drug in the drug container can be prevented at a high level, the drug container 3 and the lid 4 are made of polyester ( In particular, it is preferably formed from polyethylene naphthalate), polyacrylonitrile, or polyvinylidene fluoride.
When the drug container 3 and the lid body 4 are formed of a polymer material having a relatively high gas permeability such as polypropylene or cyclic polyolefin, a layer of a material that reduces the gas permeability on the drug container surface, for example, silica, A layer made of alumina, titanium oxide, or the like may be provided.
[0027]
Further, in the infusion container of the present invention, as illustrated in FIG. 3, an elastic seal member 7 is disposed at the medicine filling port of the medicine container 3, and the lid body 4 is covered thereon, and the lid body 4 is placed on the medicine container. 3 may be adhered and sealed to the flange 31 around the medicine filling port.
[0028]
The medicine container 3 has a breakable portion 5 in the vicinity of the bottom thereof. The position of the breakable portion 5 is in the vicinity of the bottom of the drug container 3, and the bottom of the drug container 3 is separated from the drug container main body by breaking the drug container 3 with the breakable portion 5. Any position can be used as long as the position can be opened. In general, the position approximately 0.5 to 10 mm above the bottom of the drug container 3 is preferable from the viewpoints of easy breakage, easy formation of breakable parts, and the like.
Further, the breakable portion 5 in the vicinity of the bottom of the drug container 3 may have any structure as long as it can be easily broken by an operation by the breaking operation portion 6, for example, along the outer periphery in the vicinity of the bottom of the drug container 3. A method of forming a V-groove, U-groove, concave groove, etc. and making the portion a thin breakable portion 5 or a breakable portion 5 simply formed by cutting along the outer periphery in the vicinity of the bottom of the drug container 3 is provided. A method etc. can be mentioned.
The shape and structure of the breaking operation part 6 may be any as long as the drug container 3 can be smoothly broken by the breakable part 5.
[0029]
In the infusion container of the present invention, the form of the medicine accommodated in the medicine container 3 is not particularly limited, and may be any form such as powder, granules, pellets, and other solid forms, liquid forms, etc. The infusion container of the invention is effective for preventing liquid leakage when a liquid medicine is accommodated. In addition, the type of drug stored in the drug container 3 is not particularly limited, and, for example, antibiotics, vitamin drugs (general vitamin drugs), various amino acids, heparin, and the like depending on the use and usage form of the infusion container. Examples include thrombotic agents, anti-Parkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, anti-viral agents, immunizing agents, anti-cancer agents, and corrected electrolytes.
[0030]
Further, the inside of the medicine container 3 may be in a reduced pressure state, a vacuum state, or a state in which it is replaced with an inert gas in order to prevent alteration or decomposition of the medicine in the container.
The capacity of the medicine container 3 is not particularly limited, and an appropriate capacity can be selected according to the kind of medicine accommodated in the medicine container 3, the use of the infusion container, etc. Generally, the capacity is about 1 to 50 ml. It is preferable that it is about 2 to 10 ml.
In addition, the inner diameter of the drug container 3 is preferably about 4 to 50 mm, more preferably about 5 to 30 mm, from the viewpoint of ensuring a sufficient liquid flow and preventing an unnecessarily large diameter. .
The dimensions of the flange 31 formed around the medicine filling port of the medicine container 3 and the dimensions of the upright portion 311 provided on the outer periphery of the flange 31 are the dimensions of the medicine filling port of the medicine container 3, the wall thickness of the medicine container 3, and the lid. It can be determined according to the outer diameter and thickness of the body 4.
The dimensions of the cylindrical member 2 and its flange 21 can be determined according to the dimensions of the drug container 3 and its flange 31.
[0031]
The infusion container of the present invention has a hole for suspending the infusion container, a gripping part for facilitating transport of the infusion container, etc., as necessary, like the conventional infusion container. Also good.
[0032]
【Example】
Hereinafter, the present invention will be specifically described with reference to examples and the like, but the present invention is not limited to the following examples.
[0033]
Example 1
(1) Injection molding is performed using polypropylene, and the drug container 3 having the structure shown in FIG. 1, that is, the drug filling port has the flange 31, the flange 31 has an upright part 311, and the vicinity of the bottom part A bottomed truncated cone-shaped drug container 3 having a breakable portion 5 formed of a V-groove at the outer peripheral position and a break operation portion 6 outside the bottom was formed.
The inner diameter of the medicine filling port in the medicine container 3 is 15 mm, the outer diameter of the flange 31 is 23.2 mm, the thickness of the flange 31 and the upright part 311 is about 1.2 mm, and the inner diameter of the space part surrounded by the upright part 311 is 20. The outer diameter of the bottom of the drug container 3 was 8.5 mm, the wall thickness was approximately 1 mm, the length (depth) was approximately 35 mm, and the drug container 3 had an internal volume of 3.5 ml.
(2) After filling 3.3 ml of the liquid medicine into the medicine container 3 of (1) above, the lid 4 made of polypropylene (outer diameter 20. 7 mm, thickness about 1.5 mm, height of protrusion 41 about 1 mm, width about 1 mm) is placed in the medicine filling port, and lid 4 is ultrasonically heated on the entire upper surface of flange 31 of medicine container 3. Fused.
[0034]
(3) Polypropylene cylindrical sheet (cylinder folding diameter 210 mm, sheet thickness about 320 μm) produced by extrusion molding is cut into a length of about 40 cm while still in a cylindrical shape, and is flattened, as shown in FIG. One open end portion was heat-sealed at a temperature of about 220 ° C. to form a bottom portion as a seal portion. At the same time, the other open end portion is heat-sealed at the same temperature leaving an opening for inserting the tubular member 2, and then the polypropylene tubular member 2 having a flange 21 at one end in the opening. (The inner diameter of the tip having the flange 21 is about 10 mm, the thickness is about 1 mm, the length of the cylindrical member is about 35 mm, the flange 21 has an outer diameter of 23.2 mm, and the flange 21 has a thickness of 1.2 mm). I wore it.
(4) After filling about 200 to 400 ml of liquid into the bag body 1 produced in the above (3) from the attachment part of the cylindrical member 2, the drug prepared in the above (2) in the cylindrical member 2 After inserting the containing drug container 3, the lower surface of the flange 31 around the drug filling port of the drug container 3 and the upper surface of the flange 21 around the drug container insertion port of the cylindrical member 2 are fused by an ultrasonic heating method. The infusion container shown in FIG. 1 was produced.
[0035]
(5) The infusion container obtained in the above (4) is sealed by the lid 4 of the medicine filling port of the medicine container 3, the lower surface of the flange 31 around the medicine filling port of the medicine container 3, and the cylindrical member 2 Sealing between the upper surface of the flange 21 around the medicine container insertion port is completely performed, there is no liquid leakage to the outside, and the liquid contained in the bag body 1 and the medicine container 3 are accommodated. The drug was not mixed due to poor sealing. Also, in the unlikely event that liquid leaks to the outside, it is possible to easily determine at which part it is caused by poor sealing.
Then, the infusion container obtained in (4) above is grasped with the thumb and index finger of one hand of the drug container 3 substantially outside the bag body 1, and the breaking operation part inside the bag body 1 6 is grasped with the thumb and forefinger of the other hand and bent in a direction perpendicular to the flat direction of the bag body 1 to be easily broken at the breakable portion 5 in the vicinity of the bottom of the drug container 3, The liquid in the bag body 1 and the drug in the drug container 3 were mixed quickly and satisfactorily.
[0036]
【The invention's effect】
In the infusion container of the present invention, the sealing of the medicine filling port of the medicine container containing the medicine and the sealing of the medicine container insertion port of the cylindrical member formed by inserting and fixing the medicine container are at a position far from each other. Since it is performed individually, in the unlikely event that a liquid leak occurs in the vicinity where the drug container is attached, the liquid leak may be due to poor sealing of the drug filling port of the drug container, or the cylindrical member drug container insertion port It is possible to easily determine whether it is due to a sealing failure, and thereby it is possible to immediately take measures to prevent liquid leakage.
In the infusion container of the present invention, since the sealing position of the drug filling port of the drug container and the sealing position of the drug container insertion port of the cylindrical member are separated from each other, the liquid contained in the bag body and the drug container The medicine contained in the container is prevented from mixing during storage of the infusion container, etc., and the liquid contained in the bag body and the medicine contained in the medicine container are completely separated and stabilized from each other. It can be stored stably.
Further, in the infusion container of the present invention, the drug filling port of the drug container and the drug container insertion port of the cylindrical member are separately sealed by the above-described method, so that the respective parts are sealed. Can be performed more reliably.
[Brief description of the drawings]
FIG. 1 shows an example of an infusion container according to the present invention.
FIG. 2 is a partial view showing another example of the sealing method in the drug filling port of the drug container and the drug container insertion port of the cylindrical member in the infusion container of the present invention.
FIG. 3 is a partial view showing still another example of another sealing method in the medicine filling port of the medicine container and the medicine container insertion port of the cylindrical member in the infusion container of the present invention.
FIG. 4 is a view showing a sealing method in a drug filling port of a drug container and a drug container insertion port of a cylindrical member in a conventional infusion container.
[Explanation of symbols]
1 Bag body
2 Tubular member
21 Flange
3 drug containers
31 Flange
311 Standing part
4 lid
41 ridge
4a Lid
4b Elastic seal member
5 Breakable parts
6 Breaking operation part
7 Elastic seal member

Claims

A flexible bag body containing liquid, a cylindrical member attached to a peripheral seal portion of the bag body, and a drug container inserted and fixed in the cylindrical member, and near the bottom of the drug container An infusion container having a breakable part for breaking the drug container for communication and allowing the inside of the drug container and the bag body to communicate with each other, and a breaking operation part for breaking the breakable part, There is a flange around the medicine filling port, and a lid is put on the medicine filling port of the medicine container, and the lid is bonded to the flange all around the upper surface of the flange in the medicine filling port to seal the medicine filling port. Further, the cylindrical member has a flange around the medicine container insertion port, and the back surface of the flange around the medicine filling port of the medicine container and the upper surface of the flange around the medicine container insertion port of the cylindrical member are all around. Adhering liquid tightly over Fluid vessel, characterized in that is.

The lid that covers the drug filling port of the drug container has a disk shape, the flange around the drug filling port of the drug container has an upright portion on the outer periphery, and the outer diameter of the lid body stands on the outer periphery of the flange The infusion container according to claim 1, wherein the infusion container is designed to be equal to or slightly smaller than an inner diameter of a space portion surrounded by the portion.

The lid placed on the drug filling port of the drug container has a disc shape, and has a protrusion for fitting the lid to the drug filling port of the drug container on the inner circumference of the lid. The infusion container according to claim 1 or 2.

The cylindrical member, the drug container, and the lid are formed of a thermoplastic polymer, and the lid is bonded to the flange at the drug filling port of the drug container and the lower surface of the flange and the cylinder around the drug filling port of the drug container The infusion container according to any one of claims 1 to 3, wherein the member is bonded to the upper surface of the flange around the medicine container insertion port by heat sealing.