JP4675502B2

JP4675502B2 - Liquid storage bag

Info

Publication number: JP4675502B2
Application number: JP2001164096A
Authority: JP
Inventors: 信夫武井; 徹早馬; 剛之山口
Original assignee: TRUMO KABUSHIKI KAISHA
Current assignee: TRUMO KABUSHIKI KAISHA
Priority date: 2001-05-31
Filing date: 2001-05-31
Publication date: 2011-04-27
Anticipated expiration: 2021-05-31
Also published as: JP2002347790A

Description

【０００１】
【発明の属する技術分野】
本発明は、輸液、血液、液状血液成分、腹膜透析液などの液体を収容するための筒状部材を取り付けた液体収容バッグ、および液体収容のバッグへの筒状部材の取り付け方法に関する。本発明による場合は、良好な操作性で、簡単に且つ円滑に筒状部材をバッグ本体に取り付けることができ、しかもそれにより得られる本発明の筒状部材付きのバッグは、筒状部材の取り付け部におけるシール不足に伴う筒状部材両側におけるスリ抜けの発生、バッグ本体材料の極端な薄肉化に伴うピンホールの発生などがなく、筒状部材の取り付け部の液密性および強度に優れている。
【０００２】
【従来の技術】
ブドウ糖輸液、アミノ酸輸液、電解質輸液、脂質輸液などの各種輸液、血液、液状血液成分、腹膜透析液などの液体を収容したバッグでは、バッグからの液体の取り出し、バッグへの他の液体成分の外部からの供給などを行うために、一般に柔軟なバッグ本体に筒状の排出口が取り付けられている。
バッグ本体に筒状の排出口を取り付けるに当たっては、バッグ本体の周縁シール部の一部に、筒状の排出口部材を取り付けるための非シール状の開口部を予め形成しておき、その開口部に筒状の排出口部材を挿入して熱シールによる融着などにより接着する方法が広く採用されている。
この取り付け方法では、バッグ本体の周縁部に設ける排出口部材を取り付けるための非シール状の開口部の内周寸法を、排出口部材の外周寸法とほぼ同じにしておいて、その開口部に排出口部材を挿入して該開口部の内周面に排出口部材を融着させる方法が多く採用されている。
【０００３】
前記方法による場合は、筒状の排出口部材を挿入・接着するための開口部の内周寸法が排出口部材の外周寸法とほぼ同じであることにより、開口部に挿入した排出口部材と開口部の内周面との間に隙間が殆ど生じない。そのため、外部から金型等を当てて排出口部材を開口部の内周面に融着する際に、開口部に無理な応力がかからず、排出口部材の取り付け部分における材料の薄肉化を防止でき、それによってピンホールの発生がなくなり、排出口部材を開口部に液密に取り付けることができ、しかも排出口部材の取り付け部における強度低下などが生じにくい。
【０００４】
しかしながら、前記方法による場合は、バッグ本体の設けた開口部の内周寸法がポート部材の外周寸法とほぼ同じであるために、排出口部材を挿入する際の操作性に劣っており、開口部に挿入しようとする排出口部材との間に位置ずれがあると、排出口部材に開口部の壁面の一部が引っ掛かり、開口部が内側や外側に巻き込まれたり折れたりして、排出口部材の取り付け不良が発生することがある。
しかも、前記方法による場合は、バッグ本体が軟質ポリ塩化ビニルなどのような弾力性、伸縮性、滑り性などに富むものでないと、開口部への排出口部材の挿入が円滑に行われにくい。
しかし、塩化ビニル樹脂は、ハロゲンを含み、焼却時にダイオキシンなどを発生することがあり、環境汚染の問題がある。しかも、軟質ポリ塩化ビニルは、環境ホルモンとして作用する恐れがあることが指摘されている多量のフタル酸系可塑剤を含有しており、近年、塩化ビニル樹脂からの脱却が求められている。
ところが、塩化ビニル樹脂以外の重合体は、医療用バッグに必要とした上記した性質を兼ね備えておらず、医療用バッグに必要な耐熱性および透明性の条件を満足した上で、弾力性、伸縮性および滑り性を兼ね備えていない。
【０００５】
そこで、上記した問題点を解決するために、筒状の排出口部材を挿入するための非シール状の開口部の内周寸法を排出口部材の外周寸法よりもかなり大きくしておく方法、バッグの排出口部材の取り付け部分を有する周縁部全体を非シール状にしておいて排出口部材の取り付けと該周縁部のヒートシールを同時に行う方法などが提案されている（例えば特開昭６１−１４１３６６号公報など）。
これらの方法のうち、前者の方法では開口部の内周寸法が排出口部材の外周寸法よりもかなり大きいことにより、開口部への排出口部材の挿入を簡単に行うことができる。また、後者の方法でも、バッグ本体を形成する上下２枚のシート材料の間の所定位置に排出口部材を簡単に配置することができる。
しかしながら、これらの方法による場合は、外部から金型等を用いて開口部を構成するシート材料に排出口部材を融着させる際に、または上下２枚のシート材料を押圧しながら排出口部材をシート材料に融着すると同時にシート材料の周縁部をヒートシールする際に、例えば、図５の（ａ）および（ｂ）に例示するように、シート部材における金型の１０ａ，１０ｂのエッジ部１０ｃ，１０ｄに接触する部分１４ａ，１４ｂに大きな応力がかかり、シートの薄肉化が著しくなり、場合によってはその部分でピンホールが発生し、排出口部材の取り付け部での液密性が損なわれたり、強度不足などの問題が発生し易い。
【０００６】
【発明が解決しようとする課題】
本発明の目的は、液体収容バッグの周縁に液体を排出したり液体や他の薬剤を導入したりするための筒状部材を取り付けるに当たって、筒状部材を取り付けるための開口部への筒状部材の挿入を良好な操作性で簡単に且つ円滑に行うことができ、しかも筒状部材を取り付けた開口部でのシール不良に伴うスリ抜け、極端な薄肉化に伴うピンホールの発生などのない筒状部材の取り付け方法、および筒状部材を付けた液体収容バッグを提供することである。
さらに、本発明の目的は、液体収容バッグのバッグ本体を、軟質ポリ塩化ビニルのようなハロゲンを含む重合体材料から形成せずに、軟質ポリ塩化ビニルに比べて弾力性、伸縮性、柔軟性には多少劣るが安全性に優れているオレフィン系重合体、ポリエステル系重合体などから形成するか、更には近年広く用いられているスチレン系熱可塑性エラストマー、ポリオレフィン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、ポリアミド系熱可塑性エラストマーなどのハロゲンを含まない熱可塑性エラストマーから形成した場合にも、バッグ本体の周縁部に形成した非シール状の開口部への筒状部材の挿入および接着を良好に行うことのできる筒状部材の取り付け方法、および筒状部材を取り付けた液体収容バッグを提供することである。
【０００７】
【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、液体収容バッグ本体の周縁部に設ける筒状部材を取り付けるための非シール状の開口部の形状を、その内周寸法がバッグ本体の外縁においては筒状部材の外周寸法よりも大きくて且つバッグ本体の外縁から内側に向うにしたがって徐々に小さくなっている漸減部と、該漸減部に連続して設けられた筒状部材の外周寸法にほぼ等しい内周寸法を有する狭小部とを有する形状にすると、開口部の入口（筒状部材の挿入口）部分が大きく開いていることにより、開口部への筒状部材の挿入が極めて容易になること、そして筒状部材が開口部に挿入された後は前記漸減部の傾斜した内周面に案内されて開口部の狭小部までその先端が移動して所定の位置に簡単に配置され得ることを見出した。
さらに、本発明者らは、筒状部材を取り付けるための開口部の形状を前記した特定の形状にすると同時に、筒状部材の先端が、該開口部における前記狭小部と同じ位置にあるかまたは該狭小部よりもバッグ本体内方に突出した状態になるようにして筒状部材を該開口部内に挿入し、その状態で開口部における該狭小部を含む箇所で筒状部材を開口部に接着すると、筒状部材の取り付け部分での極端な薄肉化に伴うピンホールの発生や接着不良に伴う筒状部材のスリ抜けが防止されて、筒状部材の取り付け部に良好な液密性および強度が確保されることを見出した。
また、本発明者らは、筒状部材を取り付けるための開口部を上記した特定の形状として上記した特定の方法で筒状部材を該開口部に取り付ける場合は、バッグ本体が、オレフィン系重合体、ポリエステル系重合体などのような、軟質ポリ塩化ビニルに比べて弾力性、可撓性のやや低い、ハロゲンを含まない重合体材料から形成されている場合であっても、またバッグ本体がハロゲンを含まない熱可塑性エラストマーから形成されている場合であっても、バッグ本体の周縁の一部に形成した非シール状の開口部に筒状部材を極端な薄肉化に伴うピンホールの発生、接着不良に伴う筒状部材のスリ抜けなどを生ずることなく、良好に取り付け得ることを見出し、それらの種々の知見に基づいて本発明を完成した。
【０００８】
すなわち、本発明は、
（１）バッグ本体の周縁シール部の一部に設けられた非シール状に形成された開口部に予め形成された筒状部材を挿入して当該筒状部材を前記開口部に液密に接着してなる筒状部材を有する液体収容バッグであって、前記開口部は、その内周寸法がバッグ本体の外縁においては筒状部材の外周寸法よりも大きくて且つバッグ本体の外縁から内側に向うにしたがって徐々に小さくなっている漸減部と、該漸減部に連続して設けられた筒状部材の外周寸法にほぼ等しい内周寸法を有する狭小部とを有し、前記筒状部材の先端が前記開口部における狭小部と同じ位置にあるかまたは当該狭小部よりもバッグ本体内方に突出しており、当該筒状部材が、前記開口部の狭小部の最も狭い箇所か、或いは前記開口部の狭小部であって且つ当該狭小部の最も狭い箇所よりも外寄りの箇所を熱シール部の下端として、当該開口部に熱シールにより液密に接着されていることを特徴とする液体収容バッグである。
【０００９】
そして、本発明は、
（２）前記開口部のバッグ本体の外縁における内周寸法が筒状部材の外周寸法の１．１〜２．０倍であり、且つ当該開口部における狭小部の内周寸法が筒状部材の外周寸法の０．９８〜１．１倍である前記（１）の液体収容バッグ；
（３）前記非シール状に形成された開口部が、当該前記開口部における狭小部よりバッグ本体内方に位置する部位が、弧状をなしつつ内周寸法が漸次的に拡大されている開口部である前記（１）または（２）の液体収容バッグ；
（４）バッグ本体が、ハロゲンを含まない重合体またはその組成物から形成されている前記（１）〜（３）のいずれかの液体収容バッグ；および、
（５）ハロゲンを含まない重合体が、オレフィン系重合体、ポリエステル系重合体、スチレン系熱可塑性エラストマー、ポリオレフィン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およびポリアミド系熱可塑性エラストマーの１種または２種以上である前記（４）の液体収容バッグ；
を好ましい態様として包含する。
【００１０】
さらに、本発明は、
（６）バッグ本体の周縁シール部の一部に、予め形成された筒状部材を挿入するための非シール状の開口部を設け、当該開口部に前記筒状部材を挿入して熱シールにより液密に接着する液体収容バッグへの筒状部材の取り付け方法であって、非シール状に形成された前記開口部を、その内周寸法がバッグ本体の外縁においては前記筒状部材の外周寸法よりも大きくて且つバッグ本体の外縁から内側に向うにしたがって徐々に小さくなっている漸減部と当該漸減部に連続して設けられた前記筒状部材の外周寸法にほぼ等しい内周寸法を有する狭小部を有する形状とし、当該開口部に前記筒状部材をその先端が当該開口部における狭小部と同じ位置にあるかまたは当該狭小部よりもバッグ本体内方に突出するようにして挿入した後、当該筒状部材を、前記開口部における狭小部の最も狭い箇所か、或いは前記開口部における狭小部であって且つ当該狭小部の最も狭い箇所よりも外寄りの箇所を熱シール部の下端として、当該開口部に熱シールにより液密に接着することを特徴とする液体収容バッグへの筒状部材の取り付け方法である。
【００１１】
そして、本発明は、
（７）前記開口部のバッグ本体の外縁における内周寸法が筒状部材の外周寸法の１．１〜２．０倍であり、且つ当該開口部における狭小部の内周寸法が筒状部材の外周寸法の０．９８〜１．１倍である前記（６）の筒状部材の取り付け方法；
（８）バッグ本体に設けた前記非シール状の開口部が、当該開口部における狭小部よりバッグ本体内方に位置する部位が弧状をなしつつ内周寸法が漸次的に拡大されている開口部である前記（６）または（７）の筒状部材の取り付け方法；
（９）前記バッグ本体が、ハロゲンを含まない重合体またはその組成物から形成されている前記（６）〜（８）のいずれかの筒状部材の取り付け方法；および、
（１０）ハロゲンを含まない重合体が、オレフィン系重合体、ポリエステル系重合体、スチレン系熱可塑性エラストマー、ポリオレフィン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およびポリアミド系熱可塑性エラストマーの１種または２種以上である前記（９）の筒状部材の取り付け方法；
を好ましい態様として包含する。
【００１２】
【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。
本発明の液体収容バッグでは、バッグ本体の周縁のシール部の一部に設けられた非シール状に形成された開口部に、筒状部材が挿入され接着されている。そして、筒状部材を挿入し接着してなる該開口部は、開口部におけるバッグ本体の外縁に位置する部位（開口部への筒状部材の挿入時の入口部分）の内周寸法が筒状部材の外周寸法よりも大きく形成されている。さらに、本発明の液体収容バッグでは、筒状部材を挿入し接着してなる該開口部の内周寸法が、該開口部の漸減部においてバッグ本体の外縁から内側に向うにしたがって徐々に小さくなっている、すなわち開口部の内周面が、その漸減部において内周寸法の大きな入口から開口部の奥（バッグ本体の内側方向）にゆくに従って狭まった傾斜形状を有している。
さらに、本発明の液体収容バッグにおける前記開口部では、前記漸減部に連続して狭小部が設けられており、該狭小部の内周寸法は、筒状部材の外周寸法にほぼ等しくなっている。そして、筒状部材は、その先端が該狭小部と同じ位置にあるかまたは該狭小部よりもバッグ本体内方に突出して状態で、該狭小部を含む箇所、すなわち狭小部の最も狭い箇所か或いは当該狭小部であって且つ当該狭小部の最も狭い箇所よりも外寄りの箇所を熱シール部の下端として、前記開口部に熱シールにより液密に接着されている。
なお、本明細書でいう「開口部の内周寸法」とは、開口部の内周を軸方向と垂直に一回りした長さを言い、また筒状部材の外周寸法とは筒状部材の外周を軸方向と垂直に一回りした長さを言う。
また、前記した特定の筒状部材の取り付け構造を有する本発明の液体収容バッグは、バッグ本体内に液体を収容する前のバッグ（液体収容用のバッグ）、およびバッグ本体内に液体を収容してなるバッグ（液体収容済みのバッグ）の両方を包含する。
【００１３】
本発明の液体収容バッグでは、バッグ内に収容する液体の種類は特に制限されず、例えば、ブドウ糖、アミノ酸、ペプチド、ビタミン類、ミネラルなどの栄養成分、薬効成分、電解質などの１種または２種以上を含有する各種輸液、血液、液状の血液成分、蒸留水などを挙げることができる。
また、液体収容バッグ本体の形状、構造、サイズなども特に制限されず、従来から知られているいずれの形状および構造であってもよい。例えば、本発明における液体収容バッグは、単室型バッグであっても、用事に各室間を連通させて各室内に収容されている成分を混合して用いる多室型バッグであってもいずれでもよい。
また、筒状部材は、バッグ本体の開口部に筒状部材を取り付ける前または取り付けた後にその先端をゴム、エラストマー、その他の栓体でで封止したバッグ本体内の液体の排出口であってもよいし、バッグ本体内に他の薬剤をシリンジなどにより注入するための薬剤導入口であってもよいし、薬剤が封入され用事に液体収容バッグ本体と連通して成分を混合可能な薬剤容器であってもよいし、さらにはそれらの機能を兼ねたものであってもよい。
【００１４】
上記した本発明の液体収容バッグは、図１（液体収容バッグにおける筒状部材の取り付け部分の概略図）により例示するように、液体収容用のバッグ本体（液体を収容する前のバッグ本体）１の周縁シール部２の一部に筒状部材４を挿入するための非シール状の開口部３を設け、該開口部３に筒状の筒状部材４を挿入して開口部３の内周面に接着することによって製造される。その際に、非シール状の開口部３におけるバッグ本体１の外縁に位置する部位（入口）５の内周寸法が筒状部材４の外周寸法よりも大きく設計すると共に、開口部３が、開口部３の内周寸法がバッグ本体１の外縁（開口部３の入口）５から内側（奥）に向うにしたがって徐々に小さくなる傾斜状の形状となっている漸減部６ａと、漸減部６ａに連続して内側へと設けられたその内周寸法が筒状部材４の外周寸法にほぼ等しい狭小部６ｂから構成されるように設計しておくことが必要である［図１の（ａ）］。そして、前記した特定の形状を有する開口部３に、筒状部材４を、その先端４ａが前記開口部３における狭小部６ｂと同じ位置にあるかまたは狭小部６ｂよりもバッグ本体１の内方に突出させた状態（好ましくは３ｍｍ以下の突出距離）で挿入し［図１の（ｂ）］、その状態で狭小部６ｂを含む箇所で筒状部材４を開口部３の内周面に接着する［図１の（ｃ）］。なお、図１の（ｃ）において、８は熱シールによって筒状部材４を開口部３に接着した際の熱シール部を示す。
【００１５】
本発明では、筒状部材４を挿入し接着するための非シール状の開口部３において、その入口５部分の内周寸法を筒状部材４の外周寸法よりも大きく形成してあることにより、開口部３の入口５が大きく開いている。そのため、開口部３への筒状部材４の挿入操作が極めて容易になり、挿入すべき筒状部材４と開口部３との間に多少の位置ずれなどがあっても、筒状部材４を開口部３内に円滑に挿入することができる。しかも、開口部３の内周寸法が、図１に示すように、その漸減部６ａにおいて、開口部３の入口５から奥に向かうにしたがって徐々に狭まった傾斜形状になっているため、開口部３に挿入された筒状部材４は、開口部３の傾斜状で漸減した内周面に案内されて、開口部３の奥の狭小部６ｂまでスムーズに進入し、開口部３内の所定位置に簡単に配置される。
特に、本発明の液体収容バッグでは、筒状部材４を取り付けるための開口部３が上記した特定の形状を有していることによって、バッグ本体１がハロゲンを含まない非ポリ塩化ビニル樹脂、特に軟質ポリ塩化ビニルに比べて弾力性や伸縮性が低いオレフィン系重合体、ポリエステル系重合体などから形成されている場合であっても、開口部３への筒状部材４の挿入が円滑に行われる。
【００１６】
さらに、本発明の液体収容バッグでは、狭小部６ｂを含む箇所で筒状部材４が開口部３の内面に接着されているために、開口部３の内周面と挿入された筒状部材４の外周面との間に隙間がないか又は隙間があっても極めて狭くなっているので、筒状部材４の外周が開口部３の内周面と接した状態またはほぼ接した状態で筒状部材４を開口部３の内周面に接着することができる。その結果、接着時に開口部３を形成しているシート材料等が過度に伸ばされて薄肉化してピンホールが発生したり、接着不良に伴う筒状部材４のスリ抜けどのトラブルが防止されて、良好な液密性および機械的強度を保ちながら、筒状部材４が開口部３の内周面に接着されている。
【００１７】
開口部３の漸減部６ａにおける徐々に狭まった傾斜形状は、図１に示すように直線状またはほぼ直線状の形状であってもよいし、或いは図２に示すように開口部２の内側に向かって多少湾曲した形状であってもよい。
【００１８】
開口部３におけるバッグ本体の外縁に位置する部位（すなわち入口）５の内周寸法は、開口部３の奥行き寸法、筒状部材４の長さや材質、バッグ本体１の材質、柔軟性などに応じて調整し得るが、一般的には、筒状部材４の外周寸法の１．１〜２．０倍であることが、筒状部材４の挿入のし易さ、筒状部材４を挿入した後の接着性などの点から好ましく、１．２〜１．８倍であることがより好ましい。
また、開口部３における狭小部（内周寸法の最小部を含む部位）６ｂの内周寸法は、開口部３の内周面への筒状部材４の接着が該内周面の極端な薄肉化に伴うピンホールの発生、接着不良に伴う筒状部材４のスリ抜けなどを発生することなく円滑に行える点から、筒状部材の外周寸法の０．９８〜１．１倍であることが好ましく、１．０〜１．０５倍であることがより好ましい。
さらに、開口部３の入口５から狭小部６ｂまでの距離Ｌは、筒状部材４の全体の長さや直径、筒状部材４およびバッグ本体１の材質などに応じて調整し得るが、一般的には、約５〜３０ｍｍであることが好ましく、１０〜２０ｍｍであることがより好ましい。
【００１９】
筒状部材４については、その外周寸法（外径）、内径、肉厚、長さなどは、液体収容バッグの種類、サイズ、用途、筒状部材４の材質などに応じて適宜選択することができるが、一般的には外径が５〜３０ｍｍ、内径が４〜２９ｍｍ、肉厚が０．１〜２ｍｍ、長さが１０〜１００ｍｍの範囲にあることが好ましい。
【００２０】
本発明の液体収容バッグでは、開口部３における最も内側に位置する部位（筒状部材４の挿入方向からみた開口部３の出口部位）７は、角のある形状でシールされていてもよいが、図１に例示するような角のない弧状形状をなし漸次的に拡大した状態でシールされていることが、バッグ本体１内の液体に過度の圧力がかけられた際にバッグ本体１のシール部２におけるシール破壊が防止されることから好ましい。
【００２１】
開口部３の内周面への筒状部材４の接着は、上記したように、狭小部６ｂを含む含む箇所で行う。その際に、筒状部材４は、狭小部６ｂを含む箇所で接着されているのであれば、狭小部６ｂにおける最も狭い箇所で接着されていても、または狭小部６ｂにおける最も狭い箇所から多少ずれて、やや外寄りの箇所（開口部３の入口側寄りの箇所）で接着されていてもよい。特に、筒状部材４を狭小部６ｂにおける最も狭い箇所よりもやや外寄りの箇所で開口部３の内周面に接着する場合は、バッグ内部で発生する反撥を最も狭い箇所が受けることで、接着部のバッグ内側端部におけるピンホールの発生を効果的に抑制することができるので好ましい。このことは、後述する熱シールによる接着を行った場合に特に顕著である。
【００２２】
開口部３の内周面への筒状部材４の接着は、接着剤や溶剤接着などによって行ってもよいが、熱シール（融着）により行うことが、接着の容易性や操作性、衛生性などの点から好ましい。開口部３を形成しているバッグ本体を構成する材料（シートなど）の内面を少なくとも熱シール性材料から形成しておき、必要に応じて更に筒状部材４の外周面をも熱シール性材料から形成しておくことによって、筒状部材４を開口部３の内周面に良好に熱シールすることができる。
その際に、筒状部材４の深さ方向の熱シール幅ｄおよび横方向の熱シール幅ｗ［図１の（ｃ）を参照］は、開口部３の傾斜角度、筒状部材４の外径、狭小部６ｂの内周寸法などに応じて調整できるが、一般にはｄが２〜２０ｍｍ、ｗが６〜５０ｍｍ程度であることが、開口部３での筒状部材４の融着強度や液密性などの点から好ましい。
【００２３】
開口部３の内周面への筒状部材４の熱シールは、従来から知られている方法と同様にして行うことができる。例えば、図３に例示するように、開口部３に筒状部材４を挿入した状態で、筒状部材４の挿入位置が中心になるようにして開口部３に相当するシート部分３ａ，３ｂおよびその左右のバッグ本体シール部９ａ，９ｂを上下の金型１０ａ，１０ｂで挟んで加圧融着させることにより行うことができる。この際に、筒状部材４の変形や潰れを防止するために、必要に応じて筒状部材４の内部にコアピン（芯金）１１を挿入して融着を行ってもよい。
筒状部材４を開口部３内に熱シール（融着）するための加熱方式は特に制限されず、開口部３を含めてバッグ本体１を構成しているシート材料の材質、筒状部材４の材質などに応じて、例えば、高周波誘電加熱、高周波誘導加熱、超音波加熱、加熱された金型による直接加熱などにより行うことができる。
【００２４】
本発明の液体収容バッグの製造に当たっては、筒状部材を取り付ける周縁部以外の他の周縁部やイージーピール性隔壁のシールは、開口部に筒状部材を挿入して接着する前に予め行っておいてもよいし、または開口部に筒状部材を挿入し接着した後に行ってもよい。バッグ本体の周縁部や必要に応じて設けられるイージーピール性隔壁のシールは、接着剤や溶剤接着などによって行ってもよいが、バッグ本体を形成するシートや中空容器などの少なくとも内面をヒートシール性材料から形成しておき、ヒートシールによって行うことがヒートシールの容易性、生産性、衛生性などの点から好ましい。
【００２５】
本発明の液体収容バッグでは、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いが、ハロゲンを含まない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およびオレフィン系エラストマーのうちの一方または両方との混合物、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、開口部３に挿入した筒状部材４を開口部３の内周面に熱融着により簡単に取り付け得る点、安全性および衛生性に優れている点、透明性などの点から好ましい。
特に、バッグ本体を構成するシートの弾性が低くて該シートの変形によって融着部端部にかかる応力が大きくなってしまうものであるときに、本発明は顕著に機能する。
【００２６】
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。
【００２７】
本発明の液体収容バッグが、多室型バッグである場合は、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オレフィン系エラストマーのうちの一方または両方との混合物、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を簡単に製造することができる。
【００２８】
筒状部材は、変形や潰れの生じにくい重合体材料から形成しておくことが好ましく、そのような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、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、ポリアミドなどを挙げることができる。そのうちでも、筒状部材は、ポリエチレン、ポリプロピレン、ポリエステル、硬質ポリ塩化ビニルから形成されていることが、バッグ本体との融着性、安全性などの点から好ましく、ポリエチレンおよびポリプロピレンのうちの一方または両方から形成されていることがより好ましい。
【００２９】
上記した本発明の筒状部材の取り付け方法を採用する限りは、バッグ本体の製法は特に制限されず、例えば、上記した熱可塑性重合体材料からなるシートを適当な形状および寸法に裁断して２枚重ねて全周縁部および必要に応じてイージーピール性の隔壁部をポート取り付け用の開口部を除いてヒートシールする方法、押出ブロー成形法、射出ブロー成形法などにより有底の筒状成形体を製造し、その開放部分をポート取り付け用の開口部を除いてヒートシールする方法、インフレーション成形法により上下の開放した筒状成形体を製造し、その上部と下部をポート取り付け用の開口部を除いてヒートシールする方法などを挙げることができる。
【００３０】
本発明の液体収容バッグは、従来の液体収容バッグと同様に、必要に応じて、バッグを吊るすための穴、バッグ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。
【００３１】
【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。
【００３２】
《実施例１》
（１）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（筒の内径６７ｍｍ、シート厚み３００μｍ）を偏平にし、底部１２に相当する箇所をヒートシールしてシール部１２を形成し、それと同時に、もう一方の開放端部を筒状部材４を挿入するための開口部３を一部残してヒートシールした後、長さ２９ｃｍに切断して、図４の（ａ）に示すバッグ本体１を形成した。
その際の開口部３の形状および寸法は、バッグ本体の外縁（筒状部材４を挿入するための入口）５の内周寸法を１８ｍｍ、狭小部６ｂの内周寸法を１３．５ｍｍ、該外縁（入口）５と狭小部６ｂとの間の距離Ｌを１５ｍｍ、開口部３の最下部（弧状部）７の曲率半径Ｒを５ｍｍとした。
（２）上記（１）で作製したバッグ本体の開口部３に、ポリプロピレン製の円筒形部材４［外径１５ｍｍ（外周寸法４７ｍｍ）、肉厚１．８ｍｍ、長さ４７ｍｍ］を、その先端部が開口部３の狭小部６ｂよりもバッグ本体内方に突出するようにして挿入した後［図４の（ｂ）］、図３に示した構造を有する加熱金型を用いて、金型温度２００℃、面圧２５ｋｇ／ｃｍ²の条件下で、狭小部６ｂを含む部分（但し狭小部６ｂにおける最も狭い箇所よりも若干外側寄りの箇所）でヒートシール部８の幅ｄおよびｗがそれぞれ８ｍｍおよび３６ｍｍになるようにして、筒状部材４を跨がって筒状部材４のある部分およびその両側でヒートシールして、筒状部材４を開口部３に熱シール（融着）して、筒状部材付きの輸液バッグを作製した［図４の（ｃ）］。
（３）上記（２）の筒状部材４の取り付け操作においては、開口部３の入口５の内周寸法が、筒状部材４の外周寸法よりも大きくて且つ開口部３の内周面が内側に向って徐々に狭くなっていることにより、開口部３への筒状部材４の最初の挿入操作を極めて簡単に且つ円滑に行うことができ、しかも挿入した筒状部材３を開口部３の所定位置まで良好に進入させることができた。
（４）また、上記（２）で得られた筒状部材付きの輸液バッグでは、筒状部材の取り付け部分に極薄化に伴うピンホールが発生しておらず、筒状部材の取り付け部分での液密性および機械的強度が良好に保たれていた。
【００３３】
【発明の効果】
本発明では、液体収容バッグの周縁シール部の一部に設けた筒状部材を取り付けるための非シール状の開口部のバッグ本体の外縁に位置する部位（開口部への筒状部材挿入用の入口）の内周寸法を筒状部材の外周寸法よりも大きく形成してあって開口部の入口が大きく開いていることにより、該開口部への筒状部材の挿入操作が極めて容易になり、挿入すべき筒状部材と開口部との間に多少の位置ずれなどがあっても、筒状部材を開口部内に円滑に挿入することができる。
しかも、本発明では、該開口部の内周寸法がその漸減部においてバッグ本体の外縁から内側に向うにしたがって徐々に小さくなった傾斜形状になっているため、開口部に挿入された筒状部材が開口部における漸減部の傾斜した内周面に案内されて、開口部の奥の狭小部までスムーズに進入し、開口部内の所定位置に簡単に配置される。
そのため、本発明では、バッグ本体を、軟質ポリ塩化ビニルよりもその弾力性や伸縮性が低いがハロゲンを含まず安全性に優れるオレフィン系重合体、ポリエステル系重合体、ポリオレフィン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などから形成した場合にも、開口部への筒状部材の挿入を極めて円滑に行うことができる。
【００３４】
その上、本発明では、筒状部材の先端が開口部における狭小部と同じ位置にあるかまたは狭小部よりもバッグ本体の内方に突出させた状態で筒状部材を上記した特定の形状の開口部に挿入し、その状態で開口部における狭小部を含む箇所で筒状部材を開口部の内周面に接着しているので、挿入された筒状部材の外周面と開口部の内周面との間に隙間がないか又は隙間があっても極めて狭い状態で筒状部材が開口部の内周面に接着されている。そのため、接着時に開口部を形成しているバッグ本体材料が過度に伸ばされて薄肉化に伴うピンホールの発生、接着不良に伴う筒状部材のスリ抜けなどのトラブルが防止されて、筒状部材の取り付け部分の液密性および機械的強度が良好に保たれる。
【図面の簡単な説明】
【図１】本発明のポート取り付け方法の概略を示す図である。
【図２】本発明の液体収容バッグにおけるポート取り付け用開口部の形状の一例を示す図である。
【図３】ポート取り付け用の非シール状の開口部に挿入した筒状部材を該開口部に接着するのに用いる金型の一例を示す図である。
【図４】本明細書の実施例１によるポート付き輸液バッグの製造方法を示す図である。
【図５】従来の液体収容バッグへのポート取り付け方法を示す図である。
【符号の説明】
１バッグ本体
２バッグ本体の周縁のシール部
３非シール状の開口部
４筒状部材
５開口部の最外側に位置する部位（入口）
６ａ開口部における漸減部
６ｂ開口部における狭小部
７開口部における最も内側に位置する部位
８ヒートシール部
９ａバッグ本体シール部
９ｂバッグ本体シール部
１０ａ金型
１０ｂ金型
１０ｃ金型のエッジ部
１０ｄ金型のエッジ部
１１コアピン
１２シール部
１３底部[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a liquid storage bag to which a cylindrical member for storing a liquid such as an infusion solution, blood, a liquid blood component, or a peritoneal dialysis fluid is attached, and a method for attaching the cylindrical member to the liquid storage bag. In the case of the present invention, the tubular member can be easily and smoothly attached to the bag body with good operability, and the obtained bag with the tubular member of the present invention is attached to the tubular member. There is no occurrence of chipping on both sides of the cylindrical member due to insufficient seal at the part, pinholes due to extremely thin bag body material, etc., and excellent liquid tightness and strength of the mounting part of the cylindrical member .
[0002]
[Prior art]
For bags containing fluids such as glucose infusion, amino acid infusion, electrolyte infusion, lipid infusion, blood, liquid blood components, peritoneal dialysis fluid, etc. In general, a cylindrical discharge port is attached to a flexible bag body in order to supply from the bag.
When attaching the cylindrical discharge port to the bag body, a non-seal opening for attaching the cylindrical discharge port member is formed in advance in a part of the peripheral seal portion of the bag body, and the opening A method in which a cylindrical discharge port member is inserted into and bonded by heat sealing or the like is widely used.
In this attachment method, the inner peripheral dimension of the non-seal-like opening for attaching the outlet member provided at the peripheral edge of the bag body is made substantially the same as the outer peripheral dimension of the outlet member, and the outlet is discharged to the opening. Many methods have been adopted in which an outlet member is inserted and a discharge port member is fused to the inner peripheral surface of the opening.
[0003]
In the case of the above method, since the inner peripheral dimension of the opening for inserting and bonding the cylindrical discharge outlet member is substantially the same as the outer peripheral dimension of the discharge outlet member, the outlet member inserted in the opening and the opening There is almost no gap between the inner peripheral surface of the part. For this reason, when the discharge port member is fused to the inner peripheral surface of the opening by applying a mold or the like from the outside, the opening is not subjected to excessive stress, and the material at the mounting portion of the discharge port member is thinned. Therefore, the occurrence of pinholes can be eliminated, the discharge port member can be liquid-tightly attached to the opening, and the strength of the attachment portion of the discharge port member is hardly reduced.
[0004]
However, in the case of the above method, since the inner peripheral dimension of the opening provided in the bag body is substantially the same as the outer peripheral dimension of the port member, the operability when inserting the discharge port member is inferior. If there is a displacement between the outlet member to be inserted into the outlet member, a part of the wall surface of the opening is caught in the outlet member, and the opening is caught or broken inside or outside, so that the outlet member Incorrect mounting may occur.
In addition, in the case of the above-described method, it is difficult to smoothly insert the discharge port member into the opening unless the bag body is rich in elasticity, stretchability, slipperiness, etc., such as soft polyvinyl chloride.
However, vinyl chloride resin contains halogen and may generate dioxins and the like during incineration, resulting in environmental pollution problems. Moreover, soft polyvinyl chloride contains a large amount of phthalic acid plasticizer, which has been pointed out to have the potential of acting as an environmental hormone, and in recent years, it has been demanded to escape from vinyl chloride resin.
However, polymers other than vinyl chloride resin do not have the above-mentioned properties required for medical bags, satisfy the heat resistance and transparency conditions required for medical bags, and have elasticity, expansion and contraction. It does not have both sex and slipperiness.
[0005]
Therefore, in order to solve the above-mentioned problems, a method for making the inner peripheral dimension of the non-sealed opening for inserting the cylindrical discharge port member considerably larger than the outer peripheral dimension of the discharge port member, bag A method has been proposed in which, for example, Japanese Patent Application Laid-Open No. 61-141366 performs the attachment of the discharge port member and the heat sealing of the peripheral portion at the same time by making the entire peripheral portion having the attachment portion of the discharge port member unsealed. Issue gazette).
Among these methods, in the former method, since the inner peripheral dimension of the opening is considerably larger than the outer peripheral dimension of the discharge port member, the discharge port member can be easily inserted into the opening. Even in the latter method, the discharge port member can be easily arranged at a predetermined position between the upper and lower sheet materials forming the bag body.
However, in the case of these methods, when the discharge port member is fused to the sheet material constituting the opening by using a die or the like from the outside, or the discharge port member is pressed while pressing the upper and lower two sheet materials. When heat-sealing the periphery of the sheet material at the same time as fusing to the sheet material, for example, as illustrated in FIGS. 5A and 5B, the edge portions 10c of the molds 10a and 10b of the sheet member , 10d is in contact with the portions 14a and 14b, and the sheet becomes extremely thin. In some cases, pinholes are generated in the portions, and the liquid tightness at the attachment portion of the discharge port member is impaired. Problems such as insufficient strength are likely to occur.
[0006]
[Problems to be solved by the invention]
An object of the present invention is to attach a cylindrical member for discharging a liquid or introducing a liquid or other medicine to the peripheral edge of a liquid containing bag, and a cylindrical member to an opening for attaching the cylindrical member Can be inserted easily and smoothly with good operability, and there is no slip-out due to poor sealing at the opening to which the cylindrical member is attached, or pinholes due to extreme thinning, etc. It is providing the attachment method of a cylindrical member, and the liquid storage bag which attached the cylindrical member.
Furthermore, the object of the present invention is to form the bag body of the liquid storage bag from a polymer material containing a halogen such as soft polyvinyl chloride, and to provide elasticity, stretchability and flexibility compared to soft polyvinyl chloride. Is formed from an olefin polymer or polyester polymer that is slightly inferior but excellent in safety, and is also widely used in recent years. Styrenic thermoplastic elastomers, polyolefin thermoplastic elastomers, polyester thermoplastics Even when formed from a halogen-free thermoplastic elastomer such as an elastomer or a polyamide-based thermoplastic elastomer, the cylindrical member is satisfactorily inserted into and bonded to the non-sealed opening formed at the peripheral edge of the bag body. Provided is a method for attaching a cylindrical member, and a liquid storage bag having the cylindrical member attached thereto. It is.
[0007]
[Means for Solving the Problems]
In order to achieve the above object, the present inventors have made various studies. As a result, the shape of the non-seal-like opening for attaching the cylindrical member provided at the peripheral portion of the liquid containing bag body is such that the inner peripheral dimension is larger than the outer peripheral dimension of the cylindrical member at the outer edge of the bag main body. And a gradually decreasing portion that gradually decreases from the outer edge of the bag body toward the inside, and a narrow portion having an inner peripheral dimension substantially equal to the outer peripheral dimension of the cylindrical member provided continuously to the gradually decreasing part. When the shape is made, the opening of the opening (the insertion port of the tubular member) is wide open, so that the insertion of the tubular member into the opening becomes extremely easy, and the tubular member is inserted into the opening. After being done, it has been found that the tip can be easily arranged at a predetermined position by being guided by the inclined inner peripheral surface of the gradually decreasing portion and moving to the narrow portion of the opening.
Furthermore, the inventors of the present invention have made the shape of the opening for attaching the tubular member to the specific shape described above, and at the same time the tip of the tubular member is at the same position as the narrow portion in the opening or The cylindrical member is inserted into the opening so that it protrudes inward of the bag body from the narrow portion, and the cylindrical member is bonded to the opening at the location including the narrow portion in the opening in that state. This prevents pinholes from being extremely thinned at the mounting part of the cylindrical member and prevents slipping of the cylindrical member due to poor adhesion, resulting in good liquid tightness and strength at the mounting part of the cylindrical member. Has been found to be secured.
Moreover, when attaching the cylindrical member to the opening by the specific method described above, the present invention has the olefin polymer as an opening for attaching the cylindrical member as the specific shape described above. Even if the bag body is made of a polymer material that is slightly less elastic and flexible than soft polyvinyl chloride, such as a polyester polymer, and does not contain halogen, Even if it is formed from a thermoplastic elastomer that does not contain a pinhole due to extreme thinning of the cylindrical member in the non-sealed opening formed at a part of the periphery of the bag body, adhesion The present inventors have found that the tubular member can be satisfactorily attached without causing a slip-out of the cylindrical member due to a defect, and the present invention has been completed based on these various findings.
[0008]
That is, the present invention
(1) In an opening formed in a non-seal shape provided in a part of the peripheral seal portion of the bag body Preformed Insert the tubular member Concerned The cylindrical member In the opening A liquid storage bag having a cylindrical member formed by liquid-tight bonding, wherein the opening has an inner peripheral dimension larger than an outer peripheral dimension of the cylindrical member at an outer edge of the bag main body, and an outer edge of the bag main body. A gradually decreasing portion that gradually decreases from the inside toward the inside, and a narrow portion having an inner peripheral dimension substantially equal to the outer peripheral dimension of the cylindrical member provided continuously to the gradually decreasing part, Said The tip of the cylindrical member is at the same position as the narrow portion in the opening, or Concerned It protrudes inward of the bag body from the narrow part, The cylindrical member is Narrow part of opening The narrowest part of the opening or the narrow part of the opening and the outer part of the narrow part is the lower end of the heat seal part, and the opening is liquid-tight by heat sealing. A liquid storage bag that is bonded.
[0009]
And this invention,
( 2 ) The inner peripheral dimension of the outer edge of the bag body of the opening is 1.1 to 2.0 times the outer peripheral dimension of the tubular member, and Concerned The inner peripheral dimension of the narrow part in the opening is 0.98 to 1.1 times the outer peripheral dimension of the tubular member ( 1 ) Liquid storage bag;
( 3 ) The opening formed in the non-seal shape is The portion located inside the bag body from the narrow portion in the opening has an arc shape while forming an arc shape. Gradually Next enlarged opening Is (1) Or (2) Liquid storage bag;
( 4 (1) to (1), wherein the bag body is formed of a halogen-free polymer or a composition thereof. 3 ) Any liquid containing bag; and
( 5 ) Polymers containing no halogen are olefin polymers, polyester polymers, styrene thermoplastic elastomers, polyolefin thermoplastic elastomers, polyester thermoplastic elastomers. and Polyamide thermoplastic elastomer One or more of The above ( 4 ) Liquid storage bag;
Is included as a preferred embodiment.
[0010]
Furthermore, the present invention provides
( 6 ) In part of the peripheral seal part of the bag body, Preformed Provide a non-seal opening for inserting the tubular member, Concerned In the opening Said Insert the tubular member Heat seal A method of attaching a cylindrical member to a liquid storage bag that is liquid-tightly bonded, Non Formed into a seal Said At the outer edge of the bag body, the inner circumference of the opening Said A gradually decreasing portion that is larger than the outer peripheral dimension of the tubular member and gradually decreases from the outer edge of the bag body toward the inside; Concerned Provided continuously in the taper part Said A shape having a narrow portion having an inner peripheral dimension substantially equal to the outer peripheral dimension of the cylindrical member, Concerned In the opening Said The tip of the cylindrical member Concerned In the same position as the narrow part of the opening or Concerned After inserting so as to protrude inward of the bag body from the narrow part, The cylindrical member is Narrow part at opening The narrowest part of the opening, or the narrow part of the opening and the outer part of the narrow part of the narrow part, the lower end of the heat seal part, In the opening Liquid tight with heat seal It is the attachment method of the cylindrical member to the liquid storage bag characterized by adhering.
[0011]
And this invention,
( 7 ) The inner peripheral dimension of the opening at the outer edge of the bag body is 1.1 to 2.0 times the outer peripheral dimension of the tubular member, and Concerned The inner peripheral dimension of the narrow part in the opening is 0.98 to 1.1 times the outer peripheral dimension of the tubular member ( 6 ) Method of attaching the cylindrical member;
( 8 ) The non-sealing opening provided in the bag body is The inner circumferential dimension of the part located inside the bag body from the narrow part in the opening is arcuate. Gradually Next enlarged opening Is Said ( 6) or (7) tubular member Mounting method;
( 9 The bag body is formed of a halogen-free polymer or a composition thereof ( 6) to (8) A method of attaching any of the cylindrical members; and
( 10 The polymer containing no halogen is an olefin polymer, polyester polymer, styrene thermoplastic elastomer, polyolefin thermoplastic elastomer, polyester thermoplastic elastomer or polyamide thermoplastic elastomer. One or more of The above ( 9 ) Method of attaching the cylindrical member;
The It is included as a preferred embodiment.
[0012]
DETAILED DESCRIPTION OF THE INVENTION
The present invention is described in detail below.
In the liquid storage bag of the present invention, a cylindrical member is inserted and bonded to an opening formed in a non-seal shape provided in a part of the seal portion at the periphery of the bag body. The opening formed by inserting and adhering the cylindrical member has a cylindrical inner peripheral dimension of a portion (inlet portion when the cylindrical member is inserted into the opening) located at the outer edge of the bag body in the opening. It is formed larger than the outer peripheral dimension of the member. Furthermore, in the liquid storage bag of the present invention, the inner peripheral dimension of the opening formed by inserting and bonding the cylindrical member gradually decreases from the outer edge of the bag body toward the inside at the gradually decreasing portion of the opening. That is, the inner peripheral surface of the opening has an inclined shape that narrows from the entrance having a large inner peripheral dimension toward the back of the opening (inward of the bag body) in the gradually decreasing portion.
Further, in the opening portion in the liquid storage bag of the present invention, a narrow portion is provided continuously to the gradually decreasing portion, and the inner peripheral dimension of the narrow portion is substantially equal to the outer peripheral dimension of the cylindrical member. . And, the cylindrical member is located at the same position as the narrow portion or a portion including the narrow portion in a state of projecting inward of the bag body from the narrow portion, That is, the narrowest part of the narrow part or the narrow part and a part outside the narrowest part of the narrow part is defined as a lower end of the heat seal part, and the opening is liquid-tight by heat sealing. It is glued.
As used herein, the “inner peripheral dimension of the opening” refers to the length of the inner periphery of the opening that is one round perpendicular to the axial direction, and the outer peripheral dimension of the cylindrical member is the length of the cylindrical member. This is the length of the outer circumference that goes around perpendicular to the axial direction.
In addition, the liquid storage bag of the present invention having the above-described specific cylindrical member mounting structure stores the liquid in the bag body before storing the liquid (bag for storing liquid) and the bag body. And a bag containing liquid (a bag containing liquid).
[0013]
In the liquid storage bag of the present invention, the type of liquid stored in the bag is not particularly limited, and for example, one or two types of nutrient components such as glucose, amino acids, peptides, vitamins, minerals, medicinal components, electrolytes, etc. Examples include various infusions containing the above, blood, liquid blood components, and distilled water.
Further, the shape, structure, size and the like of the liquid storage bag main body are not particularly limited, and may be any shape and structure conventionally known. For example, the liquid storage bag according to the present invention may be a single-chamber bag or a multi-chamber bag that is used by mixing the components housed in each room for communication between the rooms. But you can.
Further, the cylindrical member is a liquid discharge port in the bag body whose front end is sealed with rubber, elastomer, or other plug body before or after the cylindrical member is attached to the opening of the bag body. Alternatively, it may be a drug introduction port for injecting another drug into the bag main body with a syringe or the like, or a drug container in which the drug is sealed and can communicate with the liquid storage bag main body and mix components. It may also be one that also has these functions.
[0014]
The liquid storage bag of the present invention described above has a liquid storage bag main body (bag main body before storing liquid) 1 as illustrated in FIG. 1 (schematic diagram of an attachment portion of a cylindrical member in the liquid storage bag). A non-seal-like opening 3 for inserting the tubular member 4 is provided in a part of the peripheral seal portion 2 of the outer periphery, and the tubular tubular member 4 is inserted into the opening 3 so that the inner periphery of the opening 3 is inserted. Manufactured by bonding to a surface. At that time, the inner peripheral dimension of the portion (inlet) 5 located at the outer edge of the bag body 1 in the non-sealed opening 3 is designed to be larger than the outer peripheral dimension of the cylindrical member 4, and the opening 3 is opened. The gradually decreasing portion 6a has an inclined shape that gradually decreases from the outer edge of the bag body 1 (inlet of the opening 3) 5 toward the inside (back), and the gradually decreasing portion 6a. It is necessary to design so that the inner peripheral dimension continuously provided inward is composed of a narrow portion 6b substantially equal to the outer peripheral dimension of the cylindrical member 4 [(a) of FIG. 1]. . Then, the cylindrical member 4 is inserted into the opening 3 having the specific shape as described above, the tip 4a of the opening 4 is located at the same position as the narrow portion 6b in the opening 3, or the inner side of the bag body 1 than the narrow portion 6b. And inserted in a protruding state (preferably a protruding distance of 3 mm or less) [FIG. 1 (b)], and in this state, the tubular member 4 is bonded to the inner peripheral surface of the opening 3 at a location including the narrow portion 6b. [FIG. 1 (c)]. In FIG. 1C, reference numeral 8 denotes a heat seal portion when the cylindrical member 4 is bonded to the opening 3 by heat seal.
[0015]
In the present invention, in the non-sealing opening 3 for inserting and bonding the cylindrical member 4, the inner peripheral dimension of the inlet 5 portion is formed larger than the outer peripheral dimension of the cylindrical member 4, The entrance 5 of the opening 3 is wide open. Therefore, the operation of inserting the cylindrical member 4 into the opening 3 becomes extremely easy, and the cylindrical member 4 can be moved even if there is a slight misalignment between the cylindrical member 4 to be inserted and the opening 3. It can be smoothly inserted into the opening 3. In addition, as shown in FIG. 1, the inner circumferential dimension of the opening 3 has an inclined shape that gradually narrows from the inlet 5 of the opening 3 toward the back in the gradually decreasing portion 6 a. The cylindrical member 4 inserted into the guide 3 is guided to the inner peripheral surface gradually reduced in an inclined shape of the opening 3, smoothly enters the narrow portion 6 b at the back of the opening 3, and reaches a predetermined position in the opening 3. Easy to arrange.
In particular, in the liquid storage bag of the present invention, the opening 3 for attaching the tubular member 4 has the above-described specific shape, so that the bag body 1 is a non-polyvinyl chloride resin containing no halogen, particularly The cylindrical member 4 can be smoothly inserted into the opening 3 even when it is formed of an olefin polymer or a polyester polymer that is less elastic and stretchable than soft polyvinyl chloride. Is called.
[0016]
Furthermore, in the liquid storage bag of the present invention, since the cylindrical member 4 is bonded to the inner surface of the opening 3 at a location including the narrow portion 6b, the cylindrical member 4 inserted into the inner peripheral surface of the opening 3 is used. Since there is no gap between the outer peripheral surface of the cylindrical member 4 or the gap is very narrow even if there is a gap, the cylindrical member 4 is in a state of being in contact with or substantially in contact with the inner peripheral surface of the opening 3. The member 4 can be bonded to the inner peripheral surface of the opening 3. As a result, the sheet material or the like forming the opening 3 at the time of bonding is excessively stretched and thinned to generate pinholes, or troubles such as slipping of the cylindrical member 4 due to poor bonding are prevented. The cylindrical member 4 is bonded to the inner peripheral surface of the opening 3 while maintaining good liquid tightness and mechanical strength.
[0017]
The gradually narrowed inclined shape in the gradually decreasing portion 6a of the opening 3 may be a linear shape or a substantially linear shape as shown in FIG. 1, or inside the opening 2 as shown in FIG. The shape may be slightly curved.
[0018]
The inner peripheral dimension of the portion (that is, the inlet) 5 located at the outer edge of the bag body in the opening 3 depends on the depth dimension of the opening 3, the length and material of the tubular member 4, the material of the bag body 1, the flexibility, and the like. However, it is generally 1.1 to 2.0 times the outer peripheral dimension of the cylindrical member 4, the ease of insertion of the cylindrical member 4, the cylindrical member 4 is inserted. It is preferable from the point of subsequent adhesiveness, and more preferably 1.2 to 1.8 times.
Further, the inner peripheral dimension of the narrow portion (the part including the minimum inner peripheral dimension) 6b in the opening 3 is such that the cylindrical member 4 is bonded to the inner peripheral surface of the opening 3 so that the inner peripheral surface is extremely thin. It is 0.98 to 1.1 times the outer circumferential dimension of the cylindrical member from the viewpoint that it can be smoothly performed without generating pinholes due to the formation of, and without slipping of the cylindrical member 4 due to poor adhesion. Preferably, it is 1.0 to 1.05 times.
Furthermore, the distance L from the inlet 5 of the opening 3 to the narrow portion 6b can be adjusted according to the overall length and diameter of the tubular member 4, the material of the tubular member 4 and the bag body 1, etc. Is preferably about 5 to 30 mm, more preferably 10 to 20 mm.
[0019]
About the cylindrical member 4, the outer periphery dimension (outer diameter), an internal diameter, thickness, length, etc. can be suitably selected according to the kind of liquid storage bag, a size, a use, the material of the cylindrical member 4, etc. In general, however, the outer diameter is preferably 5 to 30 mm, the inner diameter is 4 to 29 mm, the wall thickness is 0.1 to 2 mm, and the length is preferably 10 to 100 mm.
[0020]
In the liquid storage bag of the present invention, the innermost portion of the opening 3 (the exit portion of the opening 3 viewed from the insertion direction of the tubular member 4) 7 may be sealed with a corner shape. An arc shape without a corner as illustrated in FIG. Gradually The liquid in the bag body 1 is sealed in the next enlarged state. Excessive It is preferable because the seal breakage in the seal portion 2 of the bag main body 1 is prevented when the pressure is applied.
[0021]
Adhesion of the cylindrical member 4 to the inner peripheral surface of the opening 3 is performed at a location including the narrow portion 6b as described above. At this time, if the cylindrical member 4 is bonded at a location including the narrow portion 6b, the cylindrical member 4 is slightly deviated from the narrowest portion of the narrow portion 6b even if it is bonded at the narrowest portion of the narrow portion 6b. In addition, it may be bonded at a slightly outside location (location near the entrance side of the opening 3). In particular, when the cylindrical member 4 is adhered to the inner peripheral surface of the opening 3 at a position slightly outside the narrowest portion in the narrow portion 6b, the narrowest portion receives the repulsion generated inside the bag, Since the generation | occurrence | production of the pinhole in the bag inner side edge part of an adhesion part can be suppressed effectively, it is preferable. This is particularly noticeable when adhesion by heat sealing described later is performed.
[0022]
Bonding of the cylindrical member 4 to the inner peripheral surface of the opening 3 may be performed by adhesive or solvent bonding, but is performed by heat sealing (fusion) to facilitate adhesion, operability, and hygiene. It is preferable from the viewpoint of sex. The inner surface of the material (sheet or the like) constituting the bag body forming the opening 3 is formed from at least a heat-sealable material, and if necessary, the outer peripheral surface of the tubular member 4 is also heat-sealable. In this way, the cylindrical member 4 can be heat-sealed well to the inner peripheral surface of the opening 3.
At this time, the heat seal width d in the depth direction and the heat seal width w in the lateral direction of the tubular member 4 (see FIG. 1C) are the inclination angle of the opening 3 and the outside of the tubular member 4. Although it can be adjusted according to the diameter, the inner peripheral size of the narrow portion 6b, etc., generally, d is about 2 to 20 mm, and w is about 6 to 50 mm. It is preferable in terms of liquid tightness.
[0023]
The heat sealing of the cylindrical member 4 to the inner peripheral surface of the opening 3 can be performed in the same manner as conventionally known methods. For example, as illustrated in FIG. 3, in a state where the cylindrical member 4 is inserted into the opening 3, the sheet portions 3 a and 3 b corresponding to the opening 3 with the insertion position of the cylindrical member 4 being the center, and This can be done by sandwiching the left and right bag body seal portions 9a, 9b between the upper and lower molds 10a, 10b and pressurizing them. At this time, in order to prevent the tubular member 4 from being deformed or crushed, a core pin (core metal) 11 may be inserted into the tubular member 4 as necessary to perform fusion.
The heating method for heat-sealing (fusing) the cylindrical member 4 in the opening 3 is not particularly limited, and the material of the sheet material that forms the bag body 1 including the opening 3, the cylindrical member 4. Depending on the material, for example, high-frequency dielectric heating, high-frequency induction heating, ultrasonic heating, direct heating with a heated mold, or the like can be performed.
[0024]
In manufacturing the liquid storage bag of the present invention, the peripheral edge other than the peripheral edge to which the cylindrical member is attached and the seal of the easy peelable partition are performed in advance before the cylindrical member is inserted and bonded to the opening. Alternatively, it may be performed after the cylindrical member is inserted and bonded to the opening. Sealing of the peripheral part of the bag body and the easy peelable partition provided as necessary may be done by adhesive or solvent bonding, but at least the inner surface of the sheet or hollow container forming the bag body is heat-sealable It is preferable that the material is formed from a material and is heat-sealed from the viewpoints of heat-sealability, productivity, hygiene, and the like.
[0025]
In the liquid storage bag of the present invention, the material of the bag body is not particularly limited, and may be made of a flexible and liquid-impermeable material. However, the flexible thermoplastic polymer material does not contain halogen. It is preferable that it is formed from. 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, polyurethane, polyamide, polyamide thermoplastic elastomer, polyester thermoplastic elastomer, styrene thermoplastic elastomer, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, etc. The bag body can be formed from one or more of them.
Among them, the bag body is made of polyethylene, polypropylene, a mixture of polyethylene and polypropylene, polypropylene and , Styrene elastomer and Olefin elastomer With one or both of The cylindrical member 4 inserted into the opening 3 is that it is excellent in heat sealability in the peripheral part of the bag body or in the easy-peeling partition wall. It is preferable from the viewpoints that it can be easily attached to the inner peripheral surface of the opening 3 by thermal fusion, is excellent in safety and hygiene, and is transparent.
In particular, the present invention functions remarkably when the elasticity of the sheet constituting the bag body is low and the stress applied to the end portion of the fused portion increases due to deformation of the sheet.
[0026]
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.
[0027]
When the liquid storage bag of the present invention is a multi-chamber bag, the bag body is made of polypropylene. , Styrene elastomer and Olefin elastomer With one or both of Or a mixture of two or more kinds of resins such as a mixture of polyethylene and polypropylene, the sheet material made of the above mixture is stacked up and down to form the peripheral portion of the bag body. By heat-sealing the part at a high temperature and heat-sealing the partition part for partitioning into multiple chambers at a lower temperature, the peripheral part is firmly heat-sealed and the isolated part is easily released by applying external force Thus, an easy peel multi-chamber bag that can be communicated with each other can be easily manufactured.
[0028]
The cylindrical member is preferably formed from a polymer material that is not easily deformed or crushed. Examples of such a polymer material include polyolefins such as polyethylene, polypropylene, poly 1,2-butadiene, polystyrene, Examples include poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polyacetal resin, polyarylate, polyacrylonitrile, polyethylene terephthalate, polybutylene terephthalate, and polyamide. Among them, the cylindrical member is preferably formed of polyethylene, polypropylene, polyester, or hard polyvinyl chloride from the viewpoint of fusion with the bag body, safety, and the like. and polypropylene One or both of More preferably, it is formed from.
[0029]
As long as the above-described method for attaching the tubular member of the present invention is adopted, the manufacturing method of the bag body is not particularly limited. For example, the sheet made of the thermoplastic polymer material described above is cut into an appropriate shape and size. A cylindrical molded body with a bottom by stacking all the peripheral edges and, if necessary, heat-sealing the easy-peeling partition walls excluding the port mounting opening, extrusion blow molding, injection blow molding, etc. A heat-sealed method of removing the opening except for the opening for attaching the port, and a cylindrical molded body that is open at the top and bottom by the inflation molding method. Examples of the method include heat sealing and the like.
[0030]
Similarly to the conventional liquid storage bag, the liquid storage bag of the present invention may have a hole for hanging the bag, a gripping part for facilitating transport of the bag, and the like as necessary.
[0031]
【Example】
EXAMPLES The present invention will be specifically described below with reference to examples and the like, but the present invention is not limited to the following examples.
[0032]
Example 1
(1) A polypropylene cylindrical sheet manufactured by extrusion molding (inner diameter 67 mm, sheet thickness 300 μm) is flattened, and a portion corresponding to the bottom 12 is heat-sealed to form a seal portion 12. After the heat-sealing of the open end portion, leaving a part of the opening 3 for inserting the tubular member 4, it was cut to a length of 29 cm to form the bag body 1 shown in FIG.
The shape and size of the opening 3 at that time are as follows: the inner peripheral size of the outer edge (inlet for inserting the tubular member 4) 5 of the bag body is 18 mm, the inner peripheral size of the narrow portion 6b is 13.5 mm, The distance L between the (inlet) 5 and the narrow portion 6b was 15 mm, and the curvature radius R of the lowermost portion (arc-shaped portion) 7 of the opening 3 was 5 mm.
(2) Polypropylene cylindrical member 4 [outer diameter 15 mm (outer dimension 47 mm), wall thickness 1.8 mm, length 47 mm] is inserted into the opening 3 of the bag body produced in (1) above. Is inserted so as to protrude inward of the bag body from the narrow portion 6b of the opening 3 [FIG. 4 (b)], and the mold temperature is determined using the heating mold having the structure shown in FIG. 200 ° C, surface pressure 25kg / cm ² Under the conditions, the width d and w of the heat seal portion 8 are 8 mm and 36 mm, respectively, in the portion including the narrow portion 6b (however, a portion slightly outside the narrowest portion in the narrow portion 6b). The cylindrical member 4 is heat-sealed across the cylindrical member 4 and on both sides thereof, and the cylindrical member 4 is heat-sealed (fused) to the opening 3 to provide an infusion bag with the cylindrical member. It produced [(c) of FIG. 4].
(3) In the mounting operation of the cylindrical member 4 of (2) above, the inner peripheral dimension of the inlet 5 of the opening 3 is larger than the outer peripheral dimension of the cylindrical member 4 and the inner peripheral surface of the opening 3 is By gradually narrowing inward, the first insertion operation of the cylindrical member 4 into the opening 3 can be performed very easily and smoothly, and the inserted cylindrical member 3 can be inserted into the opening 3. It was possible to make good entry to a predetermined position.
(4) Moreover, in the infusion bag with a cylindrical member obtained in the above (2), pinholes associated with ultrathinning are not generated in the mounting portion of the cylindrical member, and the cylindrical member mounting portion The liquid-tightness and mechanical strength of were kept good.
[0033]
【The invention's effect】
In the present invention, a portion (on the outer side of the bag body for inserting the cylindrical member into the opening) of the non-sealed opening for attaching the cylindrical member provided on a part of the peripheral seal portion of the liquid storage bag. The inner peripheral dimension of the inlet) is formed to be larger than the outer peripheral dimension of the cylindrical member, and the opening of the opening is greatly opened, so that the operation of inserting the cylindrical member into the opening becomes extremely easy. Even if there is a slight misalignment between the cylindrical member to be inserted and the opening, the cylindrical member can be smoothly inserted into the opening.
Moreover, in the present invention, since the inner circumferential dimension of the opening is an inclined shape that gradually decreases from the outer edge of the bag body toward the inside at the gradually decreasing portion, the cylindrical member inserted into the opening Is guided to the inclined inner peripheral surface of the gradually decreasing portion in the opening, smoothly enters the narrow portion at the back of the opening, and is easily disposed at a predetermined position in the opening.
Therefore, in the present invention, the bag body is made of an olefin polymer, a polyester polymer, a polyolefin thermoplastic elastomer, a styrene, which is less elastic and stretchable than soft polyvinyl chloride but does not contain halogen and is excellent in safety. Even when formed from a thermoplastic elastomer or the like, the cylindrical member can be inserted into the opening very smoothly.
[0034]
In addition, in the present invention, the cylindrical member has the above-described specific shape with the tip of the cylindrical member located at the same position as the narrow portion of the opening or protruding inward of the bag body from the narrow portion. Since the cylindrical member is bonded to the inner peripheral surface of the opening at the location including the narrow portion in the opening in that state, the outer peripheral surface of the inserted cylindrical member and the inner periphery of the opening Even if there is no gap between the surfaces, or there is a gap, the cylindrical member is adhered to the inner peripheral surface of the opening in a very narrow state. Therefore, troubles such as generation of pinholes accompanying thinning due to excessive thinning of the bag body material forming the opening at the time of bonding and slipping of the cylindrical member due to poor adhesion are prevented, and the cylindrical member The liquid-tightness and mechanical strength of the mounting portion of the are kept good.
[Brief description of the drawings]
FIG. 1 is a diagram showing an outline of a port mounting method according to the present invention.
FIG. 2 is a diagram showing an example of the shape of a port attachment opening in the liquid storage bag of the present invention.
FIG. 3 is a view showing an example of a mold used for bonding a cylindrical member inserted into a non-sealing opening for port attachment to the opening.
FIG. 4 is a diagram showing a method for manufacturing an infusion bag with a port according to Example 1 of the present specification.
FIG. 5 is a diagram illustrating a method of attaching a port to a conventional liquid storage bag.
[Explanation of symbols]
1 Bag body
2 Perimeter seal of bag body
3 Unsealed opening
4 Tubular member
5 Site located at the outermost side of the opening (inlet)
6a Gradually decreasing part at the opening
6b Narrow part at the opening
7 The innermost part of the opening
8 Heat seal part
9a Bag body seal
9b Bag body seal
10a Mold
10b Mold
10c Edge of mold
10d Mold edge
11 Core pins
12 Sealing part
13 Bottom

Claims

The opening formed in the non-seal-like provided in a part of the peripheral seal portion of the bag body, by bonding the cylindrical member by inserting the tubular member which is preformed in a liquid-tight manner to the opening In the liquid storage bag having a cylindrical member, the inner peripheral dimension of the opening is larger than the outer peripheral dimension of the cylindrical member at the outer edge of the bag main body, and as it goes inward from the outer edge of the bag main body. and decreasing portions which gradually decreases, and a narrow portion having an inner peripheral dimension substantially equal to the outer peripheral dimension of the tubular member provided continuously to the tapering portion, the distal end of the tubular member is the opening It protrudes bag body side than or the narrow portion at the same position as the narrow part of the section, the cylindrical member, or the narrowest point of the narrow portion of the opening, or the narrow portion of the opening And the narrowest part of the narrow part Liquid storage bags a portion of the outboard as the lower end of the heat sealed portion, characterized in that it is bonded to the liquid-tight by thermal sealing to the opening than at.

The inner peripheral dimension of the outer edge of the bag body of the opening is 1.1 to 2.0 times the outer peripheral dimension of the tubular member, and the inner peripheral dimension of the narrow portion of the opening portion of the outer peripheral dimension of the tubular member The liquid storage bag according to claim 1 , which is 0.98 to 1.1 times.

The opening formed in the non-seal shape, site located bag body side from the narrow portion of the said opening is the opening where the inner peripheral dimensions while an arc shape is enlarged gradually following manner The liquid storage bag according to claim 1 or 2 .

The liquid storage bag according to any one of claims 1 to 3 , wherein the bag body is formed of a polymer containing no halogen or a composition thereof.

Polymers containing no halogen, olefinic polymers, polyester polymers, is a styrene-based thermoplastic elastomer, polyolefin thermoplastic elastomer, one polyester-based thermoplastic elastomer and polyamide thermoplastic elastomer or two or more The liquid storage bag according to claim 4 .

Some of the peripheral seal portion of the bag body is provided with a non-seal-shaped opening for inserting a tubular member which is preformed in a liquid tight manner by inserting the tubular member into the opening by heat sealing large a method of mounting the tubular member into the liquid storage bag to adhere, the opening formed in the non-seal-like, than the outer peripheral dimension of the tubular member at the outer edge of the inner peripheral dimension bag body and has a narrow portion having an inner peripheral dimension substantially equal to the outer peripheral dimension of the tubular member provided continuously to the decreasing portion and the tapering portion which is gradually reduced in accordance with direction from the outer edge of the bag body inside Te a shape, after the leading end of the tubular member to the opening portion is inserted so as to protrude into the bag body side than or the narrow portion at the same position as the narrow portion of the opening, the cylindrical The part in front Or the narrowest point of the narrow portion at the opening, or as the lower end of the heat seal portion of the portion of the outboard than the narrowest point of and the narrow section a narrow portion of the opening, by thermal sealing to the opening A method for attaching a cylindrical member to a liquid storage bag, wherein the cylindrical member is adhered in a liquid-tight manner.

The inner peripheral dimension of the outer edge of the bag body of the opening is 1.1 to 2.0 times the outer peripheral dimension of the tubular member, and the inner peripheral dimension of the narrow portion of the opening portion of the outer peripheral dimension of the tubular member The attachment method of the cylindrical member according to claim 6 which is 0.98 to 1.1 times.

Wherein provided on the bag body unsealed shaped opening is the opening site located bag body side from the narrow portion of the opening portion inner peripheral dimensions while an arc shape is enlarged gradually following manner The attachment method of the cylindrical member of Claim 6 or 7 .

The attachment method of the cylindrical member of any one of Claims 6-8 in which the said bag main body is formed from the polymer or its composition which does not contain a halogen.

Polymers containing no halogen, olefinic polymers, polyester polymers, is a styrene-based thermoplastic elastomer, polyolefin thermoplastic elastomer, one polyester-based thermoplastic elastomer and polyamide thermoplastic elastomer or two or more The attachment method of the cylindrical member of Claim 9 .