JP2004344442A

JP2004344442A - Multi-chamber receptacle containing drug

Info

Publication number: JP2004344442A
Application number: JP2003145603A
Authority: JP
Inventors: Chiharu Miyajima; 千春宮嶋; Dennai Takeda; 伝内武田; Mitsuharu Fujii; 光春藤井; Hachiro Fukami; 八郎深見
Original assignee: Ajinomoto Pharma Co Ltd
Current assignee: Ajinomoto Pharmaceuticals Co Ltd
Priority date: 2003-05-23
Filing date: 2003-05-23
Publication date: 2004-12-09
Anticipated expiration: 2023-05-23
Also published as: JP4329408B2

Abstract

<P>PROBLEM TO BE SOLVED: To surely mix first medical solution with second medical solution when using a multi-chamber receptacle which is provided with first and second storage chambers separately storing the first and the second medical solution, a releasable isolation means disposed between both the chambers and a port member communicated with the first storage chamber. <P>SOLUTION: This multi-chamber receptacle 10 containing the drug, where the first storage chamber and the second storage chamber are communicated with each other by the release of the isolation means 20, is so formed that the port member 30 communicated with the first storage chamber 11 is provided with a medical solution passage 32 and a control means 36 for opening/closing the passage; and the control means 36 opens the passage 32 and lets the medical solution pass therethrough by the communication of the first storage chamber and the second storage chamber. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

【０００１】
【発明の属する技術分野】
本発明は、医療用液体、例えば、静脈投与用輸液剤、液状栄養剤、腹膜透析液等、に配合される複数有効成分を、混合変化を避けるため分離して保持し、投与直前に確実に混合することができる薬剤入り多室容器及び多室容器自体に関する。より詳細には、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液、その他の医療用輸液成分を剥離容易な連通部により区画された複数の収容室に収容する薬液容器において、薬液容器に収容された複数の薬液を使用前に確実に混合することが可能な薬液容器に関する。
【０００２】
【従来の技術】
従来、点滴により人体に供給される輸液成分、例えば、アミノ酸液、ブドウ糖液等は、混合すると変質するため、剥離可能な隔離手段により仕切られた輸液容器、特に輸液バッグ内の複数の個室へそれぞれ収容し、使用時に輸液バッグを外から押圧して隔離手段を剥離させて混合する形式の輸液入り多室容器が知られている。医療現場において、前記形式の輸液入り多室容器を使用して患者に輸液を投与する場合に、医療現場の不慣れ、人手不足等により、薬液の混合操作を完全に行わずに一部の薬液を投与する可能性がある。輸液成分を収容する区画を完全に開通しないまま患者に投与すると、投与目的のとは異なる薬液が患者の身体に供給され患者に悪影響を与えるおそれがある。
【０００３】
輸液成分は本質的に患者へ投与されるものであり、輸液成分の不完全な混合により人体に深刻な影響が生じる可能性は少ない。しかしながら、例えば、糖とアミノ酸を分離収容する形式の高カロリー輸液においては、一方の薬液にカリウムイオンを含むので所定の混合がされない場合、所定値を超える濃度のカリウムイオンが投与され心臓機能に悪影響を与える可能性が存在する。また一方の薬液に葡萄糖を含むので所定の混合がされない場合、所定値を超える濃度の糖液が投与され血管に浸透圧、ｐＨ等に起因する痛みを生じる可能性がある。近年、上記の多室容器に分離収容された薬剤を不完全に混合し投与することを防止するための工夫がされている（例えば、特許文献１参照）。
【０００４】
特許文献１（特開平９−３２７４９８号公報）に開示される医療用容器は、２つ以上の薬剤を混合する腹膜透析液、静注用輸液剤、液状栄養剤において、各薬剤を確実に容易な操作で無菌的に混合できる医療用容器を提供することを目的とする。この医療用容器においては、第１及び第２の薬剤をそれぞれ収容する第１及び第２の分室１１、１２の間に解除可能な第１の閉塞手段４が配置され、薬液排出用の栓体６と第１の分室１１の間に解除可能な第２の閉塞手段３が配置される。第１の分室１１又は第２の分室１２を押圧することにより、最初第１の閉塞手段４が解除され、第１及び第２の薬剤が混合され、さらに強く押圧することにより第２の閉塞手段３が解除され、混合液が栓体６を介して排出される。
【０００５】
また、特許文献２（実用新案登録第３０９０２５６号）は、眼科手術、脳手術等に使用される薬液を収容する多室容器３を開示する。この多室容器３は、開封可能な封止部１５により仕切られた第１収容室９及び第２収容室１１ａを備え、封止部１５は、外部からの力で外れたり、或いは破れることで第１収容室９と第２収容室１１ａが連通される。第２収容室１１ａは、排出用ポート１１の閉鎖された内部空間に設けられる。薬液の使用時に封止部１５が開封され、第１収容室９の薬液及び第２収容室１１ａの薬剤が混合され、排出用ポート１１のゴム栓１３へ導管１６の先端の刺入針１６ａを刺入し、刺入針１６ａ及び導管１６を介し薬液が排出される。
【０００６】
特許文献２の多室容器３において、混合前の薬液が使用されるのを防止するため、第２収容室１１ａの一部が空気で構成される。薬液を投与するため、排出用ポート１１を下側にして容器３を吊り掛けると、第２収容室１１ａの上部に空気の層が形成され、刺入針１６ａの先端の孔１６ｂがこの空気の層の中に位置され、薬液が排出されない。それ故、使用者は、封止部１５が開封されていないことを認識することができる。また、封止部１５が開封されていない場合、刺入針１６ａの先端が充分進入していないときは、第２収容室１１ａ内の薬液が排出されるが、第２収容室１１ａ内の薬液の量が小さいので、使用者は、封止部１５が開封されていないことに気づく。
【０００７】
【特許文献１】特開平９−３２７４９８号公報
【特許文献２】実用新案登録第３０９０２５６号公報
【０００８】
【発明が解決しようとする課題】
特許文献１の医療用容器は、薬液排出用の栓体６と第１の分室１１の間に解除可能な第２の閉塞手段３を設けるので、栓体６と第２の閉塞手段３の間に薬液を収容しない比較的大きな空間が生じる。そのためできるだけ小型にしたい容器の体積を大きくする問題点がある。また、異なる強度の２つの解除可能な閉塞手段を設けることは、多室容器の製造において基本製造ラインの変更を伴い多額の費用と多くの時間を必要とする不利がある。
【０００９】
特許文献２の多室容器３は、第２収容室１１ａが排出用ポート１１の内部空間に設けられるものであるので、第２収容室１１ａの容積を大きくすることができない問題を有する。本発明は、特許文献１、２に見られる多室薬液容器の問題点を解消し、多室薬液容器から混合薬液を投与する場合に混合すべき薬液が確実に混合され投与されるようにすることである。
【００１０】
より詳しくは、本発明の目的は、第１及び第２薬液を分離収容する第１及び第２収容室、両室の間に配置される解除可能な隔離手段、並びに第１収容室に連通するポート部材を備える多室容器の使用に際し、第１及び第２薬液の混合を確実に行うようにすることであり、そのため、複数の収容室に薬液が分離収容され投与時に収容室間の隔離手段を連通される形式の多室薬液容器のポート部材に、連通時の圧力上昇又は連通前後の薬液の密度変化を感知した場合のみ薬液の通過を可能にする手段を配置することである。本発明のその他の目的は、特許請求の範囲及び以下の説明で明瞭にされる。
【００１１】
【課題を解決するための手段】
本発明の複数の薬液を収容するための多室容器は、第１収容室及び第２収容室、両室の間に配置される解除可能な隔離手段、並びに第１収容室に連通するポート部材を備える。ポート部材は薬液の通路及び通路を開閉するための制御部を有する。第１収容室と第２収容室は隔離手段が解除されることにより連通され、両室に収容された薬液を混合させる。制御部は第１収容室と第２収容室が連通されることにより通路を開放し薬液を通過させ患者への投与を可能にする。
【００１２】
本発明の多室容器において、第１収容室、第２収容室及び隔離手段は熱可塑性樹脂フィルムにより形成され、隔離手段は薬液を収容した第１収容室又は第２収容室を押圧することにより解除される。隔離手段は熱可塑性樹脂フィルムに形成された弱シール部である。制御部は隔離手段を解除する圧力又はそれ以上の圧力により通路を開放する可動弁体を具備することができる。また制御部は、薬液を通過させるが可動弁体の第１収容室内への移動を阻止する規制体を有することができる。
【００１３】
本発明の薬剤入り多室容器は、第１薬液を収容する第１収容室及び第２薬液を収容する第２収容室、両室の間に配置される解除可能な隔離手段、並びに第１収容室に連通するポート部材を備える。ポート部材は、薬液の通路及び通路を開閉するための制御部を有し、第１薬液と第２薬液は、隔離手段が解除されることにより混合されて混合薬液を生成し、制御部は、通路を開閉する可動弁を備え、可動弁は第１薬液と第２薬液の混合薬液により通路を開放可能である。
【００１４】
本発明の薬剤入り多室容器において、好ましくは、可動弁は可動弁体及び着座部を含み、可動弁体は第１薬液中にあるとき着座部に着座して通路を閉鎖し、混合薬液中にあるとき着座部から離れて通路を開放する。また、可動弁体は、混合薬液の比重に応じて着座部から離れることができる。好ましくは、可動弁体の比重が１．０４０〜１．０６０である。可動弁体は一体又は別体の浮力調整部材を含むことができる。本発明の薬剤入り多室容器において、ポート部材は更に中空針により刺通可能なゴム栓及び膜体を備え、膜体は水蒸気透過性でありゴム栓を薬液から分離するように配置される。第１薬液が還元糖（ブドウ糖）を含有し、第２薬液がアミノ酸を含有するようにできる。また第１薬液がアミノ酸を含有し、第２薬液が還元糖を含有するようにできる。第１薬液及び第２薬液には、人体に必要な電解質成分やビタミン類を含有させることができる。
【００１５】
【発明の実施の態様】
図１ａは、本発明の第１実施例の薬剤入り多室容器の概略平面図、図１ｂは、図１ａの図Ｂ−Ｂに沿う薬剤入り多室容器の概略断面図である。図１ａ及び図１ｂに示すように、薬剤入り多室容器１０は、薬液Ｍ１収容するための第１収容室１１、薬液Ｍ２を収容するための第２収容室１２、第１収容室１１に連通されるポート部材３０、及び薬液収容室１２に連通されるポート部材４０を含む。図１ａの多室容器１０は、熱可塑性樹脂フィルム１３、１４を左右側縁部１６、１６、上下端縁部１８、１７及び仕切り部２０において接着して製造される。左右側縁部１６、１６及び下端縁部１７、上端縁部１８は、強シールとされ、第１収容室１１と第２収容室１２の間の仕切り部２０は剥離可能な弱シールとされる。
【００１６】
図１ａの多室容器１０において、仕切り部２０の弱シールは、薬液Ｍ１収容した第１収容室１１又は薬液Ｍ２を収容した第２収容室１２を外方から押圧することによる薬液Ｍ１又は薬液Ｍ２の圧力の上昇により剥離される。仕切り部２０が剥離されると第１収容室１１と第２収容室１２が連通され、薬液Ｍ１と薬液Ｍ２を多室容器１０の内部で無菌状態を維持して混合することができる。
【００１７】
多室容器１０の下端縁部１７に薬液を点滴管へ排出するためのポート部材３０が配置される。ポート部材３０は、薬液の通路３２、通路の外方端部を閉じるゴム栓３４、通路３２を開閉するための制御部３６を有する。制御部３６は、第１収容室１１と第２収容室１２が連通され第１薬液及び第２薬液が混合することにより通路３２を開放し薬液を通過させる。制御部３６が薬液を通過させるときゴム栓３４を刺通する図示しない中空針を介し薬液が図示しない点滴管へ排出される。多室容器１０の上端縁部１８に、薬液を投与するため多室容器１０を吊下げるために使用される吊下げ孔２８及びポート部材４０が配置される。多室容器１の吊下げ孔２８は、縁部２３のほぼ中央に配置され、輸液投与の際、多室容器１は、吊下げ孔２８を利用し、所定高さ位置に吊下げられる。ポート部材４０は、第２収容室１２へビタミン類や微量元素を注入するため等に使用され、通路４２及びゴム栓４４を具備する。ポート部材４０は、制御部を具備しない。
【００１８】
図２ａは、本発明の第２実施例の薬剤入り多室容器のポート部材３０の概略縦断面図、図２ｂは、図２ａのポート部材３０の変形例である。図２ａのポート部材３０は、一端３１１及び他端３１２を有する硬質樹脂製の管状部材３１、他端３１２を閉じるゴム栓３４、管状部材３１の内部の通路３２及び制御部３６を備える。管状部材３１は、他端３１２へ向けて幾分拡径されている。ポート部材３０は、更にゴム栓３４を管状部材３１の拡張された他端３１２に固定するための硬質樹脂製の保持部材３３を備える。制御部３６は、管状部材３１の内面に固着され環状弁座３６３を形成する弁座部材３６１、及び環状弁座３６３を閉鎖する弁板３６２から成る。
【００１９】
図２ａのポート部材３０において、弁板３６２は、環状弁座３６３に対し離間可能に固着されて通路３２を閉鎖する構成を有し、薬液を収容した第１収容室又は第２収容室を押圧することにより生じる液圧が隔離手段２０を開放すると共に管状部材３１の一端３１１へ作用することにより、環状弁座３６３から離間し通路３２を開放し薬液の流れを可能にする。弁板３６２を環状弁座３６３から離間するため必要な圧力は隔離手段２０を開放するために必要な圧力と同等又はそれより大きくする。弁板３６２は、通路３２を開放するとき、その全体が環状弁座３６３から離間して中空針の開口を塞ぐこと等が生じないように、部分的に強固な接着部を設ける等により環状弁座３６３に係止される。
【００２０】
図２ａのポート部材３０の環状弁座３６３は、ほぼ管状部材３１の軸線３５に垂直な平面内に配置される。環状弁座３６３と弁板３６２の接触面は、平面又は軸線３５上に回転中心を有する回転曲面とすることができる。弁板３６２は、環状弁座３６３から一旦離間した後は、混合薬液を連続的に排出可能であるように環状弁座３６３を閉鎖しないように構成される。弁板３６２を含む制御部を水蒸気透過性とすることにより、制御部３６とゴム栓３４の間のポート部材３０の内部に水蒸気を存在させ、加熱滅菌時にポート部材３０の内部の加熱不足を防止でき、またゴム栓の成分が薬液に溶出することを防止できる。
【００２１】
図２ｂは、図２ａのポート部材３０の変形例である。図２ｂにおいて図１ａと同様の部材には、同一の符号を付し重複説明を省略する。図２ｂのポート部材３０の制御部３６において、管状部材３１の内面に固着される弁座部材３６１は、環状弁座３６３を形成する弁座部材３６１、及び環状弁座３６３を閉鎖する弁板３６２から成り、環状弁座３６３は、ポート部材３０の軸線３５に対して角度αをなす平面内に配置される。角度αを変化させることにより、第１収容室側の液圧の弁板３６２に作用する面積を適当な値に変えることができる。
【００２２】
図２ｂのポート部材３０において、図２ａのポート部材３０と同様に、弁板３６２は、環状弁座３６３に対し離間可能に固着されて通路３２を閉鎖する構成を有し、薬液を収容した第１収容室又は第２収容室を押圧することにより生じる液圧が管状部材３１の一端３１１へ作用することにより、環状弁座３６３から離間し通路３２を開放し薬液の流れを可能にする。弁板３６２は、通路３２を開放するとき、その全体が環状弁座３６３から離間して中空針の開口を塞ぐこと等が生じないように、部分的に強固な接着部を設ける等により環状弁座３６３に係止される。
【００２３】
図２ａ又は図２ｂのポート部材３０を備える多室容器から混合薬液を投与する場合、もし第１収容室又は第２収容室を押圧することを忘れたり押圧が不十分である等により両室が十分連通されないような場合、即ち両室を連通させるに十分な押圧力が生じない場合には、弁板３６２が環状弁座３６３から剥離されず、薬液が制御部３６を通過しないので、看護士等の関係者が気づくことができる。
【００２４】
図３ａは、本発明の第２実施例の薬剤入り多室容器のポート部材３０の概略縦断面図、図３ｂは、図３ａのポート部材３０に組込まれる規制体３７の概略平面図である。図３ａ及び図３ｂにおいて、図２ａ又は図２ｂと同様の部材には、同一の符号を付し重複説明を省略する。図３ａのポート部材３０において、制御部３６は、管状部材３１の内面に固着される弁座部材３６１と球形弁３６４を有し、弁座部材３６１の中央部に球形弁３６４に係合する球面座３６５が形成される。球形弁３６４が球面座３６５に着座する状態において通路３２が閉鎖されている。図３ａのポート部材３０は、中空針（図示しない）により刺通可能なゴム栓３４を備える。制御部を水蒸気透過性とすることにより、制御部３６とゴム栓３４の間のポート部材３０の内部に水蒸気を存在させ、加熱滅菌時にポート部材３０の内部の加熱不足を防止できる。
【００２５】
図３ｂに示すようにポート部材３０の規制体３７は、多数の通孔３７２を備えるプラスチック製格子３７１からなる。図３ｂに示すポート部材３０は、薬液を使用しないときは、球形弁３６４が第１収容室１１内の第１薬液Ｍ１内にあり、球形弁３６４の比重が第１薬液Ｍ１の比重より大であるため、球形弁３６４が球面座３６５に着座し、通路３５を閉鎖する。薬液を使用するため第１収容室１１内の第１薬液Ｍ１と第２収容室１２内の第２薬液Ｍ２が混合されると両液Ｍ１及びＭ２の混合液の比重は、第１薬液Ｍ１より大きくなり、球形弁３６４を取巻く混合液の比重が球形弁３６４の比重より大きくなり、そのため球形弁３６４が図３ａに実線で示すように球面座３６５から離間し浮上し、通路３２を開放し薬液を通過させる。球面座３６５の上方に規制体３７が配置され、球形弁３６４が第１収容室内へ移動しないようにされる。
【００２６】
図３ａのポート部材３０において、球形弁３６４の比重を適当な値にすることにより、第１薬液Ｍ１及び第２薬液Ｍ２が混合されたときのみ通路３２を開放し薬液の通過が可能とされる。例えば、第１薬液Ｍ１（アミノ酸含有薬液）の比重が１．０３７であり、第１薬液Ｍ１と第２薬液Ｍ２（ブドウ糖及び電解質含有薬液）の混合薬液の比重が１．０５２の場合、球形弁３６４の比重は、１．０３７と１．０５２の間の値、例えば１．０４５とすればよい。球形弁３６４の比重をこのように選定することにより、図３ａのポート部材３０をその軸線３５が上下方向であるように配置するとき、球形弁３６４の周りの薬液が第１薬液Ｍ１及び第２薬液Ｍ２の混合薬液である場合は、混合薬液の比重より小さい比重の球形弁３６４が混合薬液中を上昇し球面座３６５から離間し通路３２が開放されるが、球形弁３６４の周りの薬液が第１薬液Ｍ１である場合は、第１薬液Ｍ１の比重より大きい比重の球形弁３６４は第１薬液Ｍ１中を沈降し球面座３６５に係合し通路３２が閉鎖される。
【００２７】
本発明において多室容器に収容する薬液は、高カロリー輸液用の糖・電解質・アミノ酸液のみならず、同様の有効成分を含有する末梢静脈投与用輸液、腹膜透析液である場合も、各室へ収容される薬液の比重が異なれば、同様に扱うことができる。即ち、球形弁３６４の比重を第１薬液Ｍ１の比重と混合薬液の比重の中間に選定することにより、混合薬液が生成されたときのみポート部材の制御部が通路を開放するように構成することができる。球形弁３６４の形状は、ポート部材中に生じる薬液の流れが円滑であるように流れ抵抗を考慮したものであることが好ましく、例えば、半球と錐体が組み合わされた形状とすることができる。
【００２８】
球形弁３６４の比重を上記のように選定したポート部材３０を備える多室容器から薬液を患者に投与するとき、多室容器の隔離手段が薬液を収容した第１収容室又は第２収容室を押圧することにより解除され、第１収容室と第２収容室が連通され、両室の第１薬液Ｍ１と第２薬液Ｍ２が混合され、その後、多室容器は吊下げた状態にされ、ポート部材３０の軸線３５が上下方向であるように配置される。またポート部材３０のゴム栓３４を刺通する中空針によりポート部材３０内部の制御部３６の下流部が点滴管と連通される。そして第１薬液Ｍ１と第２薬液Ｍ２が適正に混合され混合薬液が球形弁３６４の周りにある場合は、混合薬液の比重より小さい比重の球形弁３６４が混合薬液中を上昇し球面座３６５から離間し通路３２が開放され混合薬液が点滴管へ流出する。
【００２９】
上記多室容器からの薬液投与の操作において、もし第１収容室又は第２収容室を押圧することを忘れたり不十分である等により両室が十分連通されず、第１薬液Ｍ１と第２薬液Ｍ２が適正に混合されないため、球形弁３６４の周りの薬液が第１薬液Ｍ１である場合は、第１薬液Ｍ１の比重より大きい比重の球形弁３６４は第１薬液Ｍ１中を沈降し球面座３６５に係合し通路３２が閉鎖され、薬液が点滴管へ流出しない。それ故、看護士等の薬液投与の関係者は第１薬液Ｍ１と第２薬液Ｍ２の混合がされていないことに気づく。
【００３０】
また、球形弁３６４は、全体的に球形でない可動弁体とすることができ、フロート部を弁座係合面から離間させた形状、例えば、別体の浮力調整部材を備えるものとすることができる。また、球形弁３６４の周囲の第１薬液Ｍ１が混合薬液の比重より大きい場合は、球形弁３６４が第１薬液Ｍ１により浮上し混合薬液内で沈降するような比重、即ち第１薬液Ｍ１の比重と混合薬液の比重との中間の比重とし、球形弁３６４が浮上状態で球面座３６５に係合し通路３２を閉じ、混合薬液内で球面座３６５から離間し沈降する構成とされる。
【００３１】
本発明の多室容器に収容される薬剤の事例は、経中心静脈栄養療法の開始液や維持液として使用できる高カロリー輸液用の糖・電解質・アミノ酸液にビタミン類を加えた輸液製剤である。好適には、第１収容室に糖・電解質が収容され、第２収容室にアミノ酸類が分離収容される。ビタミン類は、第１収容室及び第２収容室から分離した第３の２以上の薬剤収容室に収容されるか、投与に際し、第２収容室に連通するポート部材のゴム栓を刺通した中空針を介して薬液へ付加される。
【００３２】
本発明の多室容器は、熱可塑性樹脂で構成される。この熱可塑性樹脂は、耐熱性、機械的強度、柔軟性、耐薬品性、とりわけ成形加工性、ガスバリア性、耐屈曲性、透明性、紫外線遮蔽性などについて収容する薬剤や栄養剤に適した樹脂とされる。多室容器２の樹脂フィルム２１、２２は、単層構造あるいは二層以上の積層構造の熱可塑性樹脂フィルムとすることができる。熱可塑性樹脂としては、１種または２種以上のものを混合して用いることができる。また分子鎖に官能基を導入し、変性した熱可塑性樹脂を用いることができる。
【００３３】
可動弁体は、比較的比重の大きいナイロン、ポリスチレン、ＡＢＳ樹脂、ポリ塩化ビニル等と、比重１以下の樹脂であるポリエチレン、ポリプロピレンを適宜組み合わせて所望の比重とすることができる。また、可動弁体は、比重１以下で且つ適切な体積を有する樹脂成形体に医療用ガラスをその内部又は外部へ組み込むなどして比重、浮力を調整することができる。
【００３４】
多室容器１０を形成する熱可塑性樹脂フィルム１３、１４は、例えばポリエチレン、ポリプロピレン、エチレン−α−オレフィン共重合体のごときポリオレフィン、ポリスチレン、ポリカーボネート、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のごときポリエステル、ポリアセタール、ポリアミド、ポリフェニレンエーテル、ポリエーテルサルホン、ポリサルホン、エチレン−酢酸ビニル共重合体、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリフェニレンサルファイド、フッ素樹脂、アクリル樹脂、環状ポリオレフィンなどとすることができる。これらの中でも、ポリエチレン、ポリプロピレン、エチレン−α−オレフィン共重合体、ポリエチレンテレフタレートが好ましい。
【００３５】
薬剤収容室１１、１２は、薬剤の吸着の少ない樹脂で構成することが好ましく、そのような樹脂は、ポリエチレンナフタレート、環状ポリオレフィン、エチレン−テトラフルオロエチレン共重合体、ポリエーテルサルホン及びポリサルホンである。多室容器を形成する樹脂フィルムの表面には、必要に応じて表面処理を施すことができる。このような表面処理法としては、例えばコロナ放電処理、プラズマ処理、火炎処理、スパッタリング処理、溶剤処理、紫外線処理、赤外線処理、オゾン処理、研摩処理などが挙げられる。容器本体を形成するフィルムを積層構造体とする場合は、必要に応じて各層の間にホットメルト接着剤、ポリウレタン接着剤などを使用して各層間の接着強度を向上させることも可能である。
【００３６】
【発明の効果】
第１収容室に収容される第１薬液が糖・電解質であり、第２収容室に収容される第２薬液がアミノ酸である形式の高カロリー輸液においては、第１薬液にカリウムイオンを含む。第１薬液のカリウムイオン濃度を第２薬液により薄めることなく、静脈から投与すると心臓機能に悪影響を与える可能性がある。また第１薬液の高濃度の糖液を薄めることなく投与すると、浸透圧のため血管機能に悪影響を与え、痛みを生じることがある。本発明によれば、第１薬液と第２薬液が確実に混合されるので、これらの問題の発生を防止することができる。
【００３７】
本発明の多室容器は、従来の多室容器においてポート部材を変更することにより製造可能であり、製造ラインの変更が最少であり、製造工数や費用が少ない利点を有する。本発明において制御部、特に弁板又は可動弁体を水蒸気透過性とすることにより、制御部とゴム栓の間のポート部材の内部に水蒸気を存在させ、加熱滅菌時にポート部材の内部の加熱不足を防止できる。また、制御部によりゴム栓を第１収容室内の薬剤から分離するので、ゴム栓の成分が薬液に溶出することを防止することができる。
【図面の簡単な説明】
【図１】図１ａは、本発明の第１実施例の薬剤入り多室容器の概略平面図、図１ｂは、図１ａの線Ｂ−Ｂに沿う薬剤入り多室容器の概略断面図。
【図２】図２ａは、本発明の第２実施例の薬剤入り多室容器のポート部材３０の概略縦断面図、図２ｂは、図２ａのポート部材３０の変形例の概略縦断面図。
【図３】図３ａは、本発明の第２実施例の薬剤入り多室容器のポート部材３０の概略縦断面図、図３ｂは、図３ａのポート部材３０に組込まれる規制体３７の概略平面図である。
【符号の説明】
１０：多室容器、１１：第１収容室、１２：第２収容室、１３、１４：樹脂フィルム、１６：側縁部、１７：下方縁部、１８：上方縁部、２０：仕切り部（隔離手段）、３０、４０：ポート部材、２８：吊り下げ孔、３１：管状部材、３２，４２：通路、３３：保持部材、３４、４４：ゴム栓、３５：軸線、３７：規制体、３６１：弁座部材、３６２：弁板、３６３：環状弁座、３６４：球形弁、３６５：球面座、３７２：通孔、３７１：プラスチック製格子、Ｍ１：第１薬液、Ｍ２：第２薬液。[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention is a medical fluid, for example, intravenous infusion, liquid nutrient, peritoneal dialysis fluid, etc., multiple active ingredients to be separated, in order to avoid mixing changes, to be retained, just before administration The present invention relates to a multi-compartment container containing medicines which can be mixed and the multi-compartment container itself. More specifically, a high-calorie infusion, an amino acid infusion, an electrolyte infusion, a saccharide infusion, and other medical infusion components are stored in a plurality of storage chambers separated by a communication portion that is easily peeled. The present invention also relates to a drug solution container capable of surely mixing a plurality of drug solutions before use.
[0002]
[Prior art]
Conventionally, infusion components supplied to the human body by infusion, for example, amino acid solutions, glucose solutions, etc., are deteriorated when mixed, so that they are respectively separated into a plurality of infusion containers partitioned by a detachable separating means, particularly a plurality of individual chambers in an infusion bag. 2. Description of the Related Art There is known an infusion-containing multi-compartment container of a type in which an infusion bag is housed and the infusion bag is pressed from outside to separate and separate the isolation means during use. At the medical site, when administering an infusion to a patient using an infusion-containing multi-room container of the type described above, some medical solutions may not be completely mixed without completely mixing the medical solutions due to inexperience at the medical site, labor shortage, etc. May be administered. If the patient is administered without completely opening the compartment containing the infusion component, a medical solution different from the purpose of administration may be supplied to the patient's body and adversely affect the patient.
[0003]
The infusion components are essentially administered to the patient and incomplete mixing of the infusion components is unlikely to cause serious effects on the human body. However, for example, in a high-calorie infusion type in which sugar and amino acids are separated and stored, potassium ions having a concentration exceeding a predetermined value are administered when predetermined mixing is not performed because potassium ions are contained in one of the drug solutions, which adversely affects cardiac function. There is a possibility to give. In addition, if one of the liquid medicines contains glucose, and if the predetermined mixing is not performed, a sugar liquid having a concentration exceeding a predetermined value is administered, which may cause pain due to osmotic pressure, pH, and the like in blood vessels. In recent years, measures have been devised to prevent incomplete mixing and administration of the drugs separately housed in the multi-chamber container (for example, see Patent Document 1).
[0004]
The medical container disclosed in Patent Document 1 (Japanese Patent Application Laid-Open No. 9-327498) ensures that each drug can be easily used in a peritoneal dialysate, an intravenous infusion, and a liquid nutrient in which two or more drugs are mixed. An object of the present invention is to provide a medical container that can be mixed aseptically by a simple operation. In this medical container, a releasable first closing means 4 is arranged between first and second compartments 11 and 12 for accommodating first and second drugs, respectively, and a stopper for discharging a drug solution is provided. A releasable second closing means 3 is arranged between 6 and the first compartment 11. By pressing the first compartment 11 or the second compartment 12, the first closing means 4 is first released, the first and second medicines are mixed, and the second closing means is pressed more strongly. 3 is released, and the mixed liquid is discharged through the plug 6.
[0005]
Patent Literature 2 (U.S. Patent No. 3,090,256) discloses a multi-chamber container 3 for containing a drug solution used for ophthalmic surgery, brain surgery, and the like. The multi-chamber container 3 includes a first storage chamber 9 and a second storage chamber 11a separated by an openable sealing portion 15, and the sealing portion 15 is detached or broken by an external force. The 1st accommodation room 9 and the 2nd accommodation room 11a are connected. The second storage chamber 11a is provided in an internal space in which the discharge port 11 is closed. When the chemical is used, the sealing portion 15 is opened, the chemical in the first storage chamber 9 and the medicine in the second storage chamber 11a are mixed, and the puncture needle 16a at the end of the conduit 16 is inserted into the rubber stopper 13 of the discharge port 11. The medical solution is discharged through the insertion needle 16 a and the conduit 16.
[0006]
In the multi-compartment container 3 of Patent Document 2, a part of the second storage chamber 11a is made of air in order to prevent the use of the chemical solution before mixing. When the container 3 is hung with the discharge port 11 on the lower side to administer the liquid medicine, a layer of air is formed above the second storage chamber 11a, and the hole 16b at the tip of the puncture needle 16a is It is located in a layer and does not drain chemicals. Therefore, the user can recognize that the sealing portion 15 has not been opened. In addition, when the sealing portion 15 is not opened, and when the tip of the puncture needle 16a does not enter sufficiently, the liquid medicine in the second storage chamber 11a is discharged, but the liquid medicine in the second storage chamber 11a is discharged. Is small, the user notices that the sealing portion 15 has not been opened.
[0007]
[Patent Document 1] Japanese Patent Application Laid-open No. Hei 9-327498 [Patent Document 2] Japanese Utility Model Registration No. 3090256
[Problems to be solved by the invention]
The medical container disclosed in Patent Literature 1 is provided with the releasable second closing means 3 between the stopper 6 for discharging the chemical solution and the first compartment 11, so that the space between the stopper 6 and the second closing means 3 is provided. Creates a relatively large space that does not contain a chemical solution. Therefore, there is a problem in that the volume of the container to be made as small as possible is increased. Providing two releasable closing means of different strengths also has the disadvantage that the production of a multi-chamber container involves a change in the basic production line, requiring a large amount of money and a lot of time.
[0009]
The multi-chamber container 3 of Patent Document 2 has a problem that the volume of the second storage chamber 11a cannot be increased because the second storage chamber 11a is provided in the internal space of the discharge port 11. The present invention solves the problems of the multi-chamber liquid medicine container shown in Patent Documents 1 and 2, and ensures that the liquid medicines to be mixed when the mixed medicine liquid is administered from the multi-chamber liquid medicine container are mixed and administered. That is.
[0010]
More specifically, an object of the present invention is to communicate with the first and second storage chambers for separately storing the first and second chemical liquids, a releasable isolation means disposed between the two chambers, and the first storage chamber. When a multi-chamber container having a port member is used, the first and second chemicals are surely mixed, and therefore, the chemicals are separately stored in a plurality of storage chambers, and a separation means between the storage chambers at the time of administration is provided. Is arranged in the port member of the multi-chamber liquid medicine container of the type in which the liquid is allowed to pass only when a pressure increase during the communication or a change in the density of the liquid medicine before and after the communication is detected. Other objects of the present invention will be clarified in the claims and the following description.
[0011]
[Means for Solving the Problems]
The multi-chamber container for accommodating a plurality of liquid medicines according to the present invention includes a first accommodating chamber and a second accommodating chamber, a releasable isolation means disposed between both chambers, and a port member communicating with the first accommodating chamber. Is provided. The port member has a passage for the chemical solution and a control unit for opening and closing the passage. The first storage chamber and the second storage chamber are communicated by releasing the isolation means, and mix the chemicals stored in both chambers. The control unit opens the passage by allowing the first storage chamber and the second storage chamber to communicate with each other, allows the medicinal solution to pass therethrough, and enables administration to the patient.
[0012]
In the multi-compartment container according to the present invention, the first storage chamber, the second storage chamber, and the isolation means are formed of a thermoplastic resin film, and the isolation means presses the first storage chamber or the second storage chamber containing the chemical solution. It is released. The isolating means is a weak seal portion formed on the thermoplastic resin film. The control unit may include a movable valve body that opens the passage by a pressure that releases the isolation means or higher. Further, the control unit may include a regulating body that allows the liquid medicine to pass therethrough but prevents the movable valve body from moving into the first storage chamber.
[0013]
The multi-chamber container containing a medicine according to the present invention comprises a first storage chamber for storing a first chemical liquid, a second storage chamber for storing a second chemical liquid, a releasable isolation means disposed between both chambers, and a first storage chamber. A port member communicating with the chamber is provided. The port member has a chemical liquid passage and a control unit for opening and closing the passage, the first chemical liquid and the second chemical liquid are mixed by releasing the isolation means to generate a mixed chemical liquid, and the control unit includes: A movable valve for opening and closing the passage is provided, and the movable valve is capable of opening the passage with a mixed chemical of the first chemical and the second chemical.
[0014]
In the medicine-containing multi-compartment container according to the present invention, preferably, the movable valve includes a movable valve body and a seating part. When the movable valve body is in the first chemical liquid, it is seated on the seating part to close the passage, To release the passageway away from the seat. Further, the movable valve body can be separated from the seating portion according to the specific gravity of the mixed chemical solution. Preferably, the specific gravity of the movable valve body is 1.040 to 1.060. The movable valve body may include an integral or separate buoyancy adjustment member. In the multi-chamber container with a medicine of the present invention, the port member further includes a rubber stopper and a membrane which can be pierced by a hollow needle, and the membrane is arranged so as to be water vapor permeable and separate the rubber stopper from the drug solution. The first chemical solution may contain reducing sugar (glucose), and the second chemical solution may contain amino acids. Further, the first chemical solution may contain an amino acid, and the second chemical solution may contain a reducing sugar. The first chemical solution and the second chemical solution can contain electrolyte components and vitamins necessary for the human body.
[0015]
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Fig. 1a is a schematic plan view of a multi-chamber container with medicine according to the first embodiment of the present invention, and Fig. 1b is a schematic cross-sectional view of the multi-chamber container with medicine along Fig. BB of Fig. 1a. As shown in FIGS. 1A and 1B, the medicine-containing multi-chamber container 10 communicates with a first storage chamber 11 for storing a liquid medicine M1, a second storage chamber 12 for storing a liquid medicine M2, and a first storage chamber 11. And a port member 40 communicated with the chemical solution storage chamber 12. The multi-chamber container 10 of FIG. 1A is manufactured by bonding thermoplastic resin films 13 and 14 at left and right side edges 16 and 16, upper and lower edges 18 and 17 and a partition 20. The left and right edges 16, 16 and the lower edge 17 and the upper edge 18 are strong seals, and the partition 20 between the first storage chamber 11 and the second storage chamber 12 is a peelable weak seal. .
[0016]
In the multi-compartment container 10 of FIG. 1A, the weak seal of the partition portion 20 is formed by pressing the first storage chamber 11 containing the chemical liquid M1 or the second storage chamber 12 containing the chemical liquid M2 from the outside. Peeled off due to an increase in pressure of When the partition part 20 is peeled off, the first storage chamber 11 and the second storage chamber 12 are communicated with each other, so that the liquid medicine M1 and the liquid medicine M2 can be mixed while maintaining the aseptic state inside the multi-chamber container 10.
[0017]
At the lower edge 17 of the multi-chamber container 10, a port member 30 for discharging the liquid medicine to the drip tube is arranged. The port member 30 has a chemical solution passage 32, a rubber stopper 34 for closing an outer end of the passage, and a control unit 36 for opening and closing the passage 32. The control unit 36 opens the passage 32 by allowing the first storage chamber 11 and the second storage chamber 12 to communicate with each other and mixing the first chemical liquid and the second chemical liquid, thereby allowing the chemical liquid to pass therethrough. When the control unit 36 allows the liquid medicine to pass, the liquid medicine is discharged to a drip tube (not shown) through a hollow needle (not shown) penetrating the rubber stopper 34. At the upper edge 18 of the multi-chamber container 10, a hanging hole 28 and a port member 40 used for hanging the multi-chamber container 10 to administer the liquid medicine are arranged. The hanging hole 28 of the multi-compartment container 1 is arranged substantially at the center of the edge 23, and the multi-compartment container 1 is hung at a predetermined height position using the hanging hole 28 at the time of infusion administration. The port member 40 is used for, for example, injecting vitamins and trace elements into the second storage chamber 12, and includes a passage 42 and a rubber stopper 44. The port member 40 has no control unit.
[0018]
FIG. 2A is a schematic longitudinal sectional view of the port member 30 of the medicine-containing multi-compartment container according to the second embodiment of the present invention, and FIG. 2B is a modified example of the port member 30 of FIG. 2A. 2a includes a tubular member 31 made of a hard resin having one end 311 and the other end 312, a rubber stopper 34 closing the other end 312, a passage 32 inside the tubular member 31, and a control unit 36. The tubular member 31 is somewhat enlarged in diameter toward the other end 312. The port member 30 further includes a holding member 33 made of a hard resin for fixing the rubber stopper 34 to the expanded other end 312 of the tubular member 31. The control unit 36 includes a valve seat member 361 fixed to the inner surface of the tubular member 31 to form an annular valve seat 363, and a valve plate 362 for closing the annular valve seat 363.
[0019]
In the port member 30 of FIG. 2A, the valve plate 362 is configured to be fixed to the annular valve seat 363 so as to be able to be separated and close the passage 32, and presses the first storage chamber or the second storage chamber that stores the chemical solution. Then, the hydraulic pressure generated by this operation opens the isolation means 20 and acts on one end 311 of the tubular member 31 to separate the passage 32 from the annular valve seat 363 to allow the flow of the chemical liquid. The pressure required to separate the valve plate 362 from the annular valve seat 363 is equal to or greater than the pressure required to open the isolation means 20. When the passage 32 is opened, the valve plate 362 is partially provided with a strong adhesive portion so as to prevent the whole thereof from being separated from the annular valve seat 363 and closing the opening of the hollow needle. The seat 363 is locked.
[0020]
The annular valve seat 363 of the port member 30 of FIG. 2 a is arranged substantially in a plane perpendicular to the axis 35 of the tubular member 31. The contact surface between the annular valve seat 363 and the valve plate 362 can be a flat surface or a rotating curved surface having a center of rotation on the axis 35. After the valve plate 362 is once separated from the annular valve seat 363, the valve plate 362 is configured not to close the annular valve seat 363 so that the mixed chemical solution can be continuously discharged. By making the control unit including the valve plate 362 water vapor permeable, water vapor is present inside the port member 30 between the control unit 36 and the rubber stopper 34, thereby preventing insufficient heating inside the port member 30 during heat sterilization. In addition, the components of the rubber stopper can be prevented from being eluted into the chemical solution.
[0021]
FIG. 2b is a modification of the port member 30 of FIG. 2a. In FIG. 2B, the same members as those in FIG. 1A are denoted by the same reference numerals, and redundant description will be omitted. In the control unit 36 of the port member 30 in FIG. 2B, the valve seat member 361 fixed to the inner surface of the tubular member 31 includes a valve seat member 361 forming an annular valve seat 363 and a valve plate 362 closing the annular valve seat 363. And the annular valve seat 363 is disposed in a plane that forms an angle α with the axis 35 of the port member 30. By changing the angle α, the area acting on the valve plate 362 of the hydraulic pressure on the first storage chamber side can be changed to an appropriate value.
[0022]
In the port member 30 of FIG. 2B, similarly to the port member 30 of FIG. 2A, the valve plate 362 is configured to be fixed to the annular valve seat 363 so as to be separable and closes the passage 32, and contains the chemical liquid. The hydraulic pressure generated by pressing the first storage chamber or the second storage chamber acts on one end 311 of the tubular member 31 to separate the passage 32 from the annular valve seat 363 to allow the flow of the chemical solution. When the passage 32 is opened, the valve plate 362 is partially provided with a strong adhesive portion so as to prevent the whole thereof from being separated from the annular valve seat 363 and closing the opening of the hollow needle. The seat 363 is locked.
[0023]
When the mixed drug solution is administered from the multi-chamber container provided with the port member 30 of FIG. 2A or FIG. 2B, if both chambers are forgotten to press the first storage chamber or the second storage chamber or the pressure is insufficient, the two chambers may be used. If the communication is not sufficient, that is, if there is not enough pressing force to allow the two chambers to communicate with each other, the valve plate 362 is not peeled off from the annular valve seat 363, and the chemical does not pass through the control unit 36. Etc. can be noticed.
[0024]
FIG. 3A is a schematic vertical sectional view of the port member 30 of the medicine-containing multi-compartment container according to the second embodiment of the present invention, and FIG. 3B is a schematic plan view of a regulating body 37 incorporated in the port member 30 of FIG. In FIGS. 3A and 3B, the same members as those in FIGS. 2A and 2B are denoted by the same reference numerals, and redundant description will be omitted. In the port member 30 of FIG. 3A, the control unit 36 has a valve seat member 361 and a spherical valve 364 fixed to the inner surface of the tubular member 31, and a spherical surface engaged with the spherical valve 364 at the center of the valve seat member 361. A seat 365 is formed. The passage 32 is closed when the spherical valve 364 is seated on the spherical seat 365. The port member 30 of FIG. 3a includes a rubber stopper 34 that can be pierced by a hollow needle (not shown). By making the control unit water vapor permeable, water vapor can be present inside the port member 30 between the control unit 36 and the rubber plug 34, thereby preventing insufficient heating inside the port member 30 during heat sterilization.
[0025]
As shown in FIG. 3B, the regulating body 37 of the port member 30 includes a plastic lattice 371 having a large number of through holes 372. In the port member 30 shown in FIG. 3B, when the chemical is not used, the spherical valve 364 is in the first chemical M1 in the first storage chamber 11, and the specific gravity of the spherical valve 364 is larger than the specific gravity of the first chemical M1. Therefore, the spherical valve 364 sits on the spherical seat 365 and closes the passage 35. When the first chemical liquid M1 in the first storage chamber 11 and the second chemical liquid M2 in the second storage chamber 12 are mixed to use the chemical liquid, the specific gravity of the mixed liquid of the two liquids M1 and M2 is higher than that of the first chemical liquid M1. As a result, the specific gravity of the mixture surrounding the spherical valve 364 becomes greater than the specific gravity of the spherical valve 364, so that the spherical valve 364 floats away from the spherical seat 365 as shown by a solid line in FIG. Through. The regulating body 37 is disposed above the spherical seat 365 so that the spherical valve 364 does not move into the first storage chamber.
[0026]
In the port member 30 of FIG. 3A, by setting the specific gravity of the spherical valve 364 to an appropriate value, the passage 32 is opened only when the first chemical liquid M1 and the second chemical liquid M2 are mixed, and the chemical liquid can pass therethrough. . For example, when the specific gravity of the first chemical solution M1 (chemical solution containing amino acid) is 1.037 and the specific gravity of the mixed chemical solution of the first chemical solution M1 and the second chemical solution M2 (chemical solution containing glucose and electrolyte) is 1.052, the spherical valve The specific gravity of 364 may be a value between 1.037 and 1.052, for example, 1.045. By selecting the specific gravity of the spherical valve 364 in this manner, when the port member 30 of FIG. 3A is arranged so that its axis 35 is in the up-down direction, the chemical around the spherical valve 364 becomes the first chemical M1 and the second chemical. In the case of the mixed chemical liquid of the chemical liquid M2, the spherical valve 364 having a specific gravity smaller than the specific gravity of the mixed chemical liquid rises in the mixed chemical liquid, is separated from the spherical seat 365, and the passage 32 is opened, but the chemical liquid around the spherical valve 364 is discharged. In the case of the first chemical liquid M1, the spherical valve 364 having a specific gravity larger than the specific gravity of the first chemical liquid M1 sinks in the first chemical liquid M1, engages with the spherical seat 365, and the passage 32 is closed.
[0027]
In the present invention, the drug solution contained in the multi-compartment container is not only a sugar / electrolyte / amino acid solution for high-calorie infusion, but also a peripheral intravenous infusion containing the same active ingredient, and a peritoneal dialysis solution. If the specific gravity of the chemical solution stored in the container is different, the same treatment can be performed. That is, by selecting the specific gravity of the spherical valve 364 to be intermediate between the specific gravity of the first chemical liquid M1 and the specific gravity of the mixed chemical liquid, the control unit of the port member opens the passage only when the mixed chemical liquid is generated. Can be. The shape of the spherical valve 364 preferably takes into account flow resistance so that the flow of the chemical solution generated in the port member is smooth. For example, the shape can be a shape in which a hemisphere and a cone are combined.
[0028]
When administering a drug solution to a patient from the multi-chamber container having the port member 30 in which the specific gravity of the spherical valve 364 is selected as described above, the isolation means of the multi-chamber container sets the first storage chamber or the second storage chamber containing the drug solution. It is released by being pressed, the first storage chamber and the second storage chamber are communicated, the first chemical solution M1 and the second chemical solution M2 of both chambers are mixed, and then the multi-chamber container is suspended and the port The member 30 is arranged so that the axis 35 of the member 30 is in the vertical direction. The downstream portion of the control unit 36 inside the port member 30 communicates with the drip tube by a hollow needle penetrating the rubber stopper 34 of the port member 30. When the first chemical solution M1 and the second chemical solution M2 are properly mixed and the mixed chemical solution is located around the spherical valve 364, the spherical valve 364 having a specific gravity smaller than the specific gravity of the mixed chemical solution rises in the mixed chemical solution and moves from the spherical seat 365. The separated passage 32 is opened, and the mixed drug solution flows out to the drip tube.
[0029]
In the operation of administering the drug solution from the multi-chamber container, if the first chamber or the second chamber is forgotten to be pressed or is insufficient, the two chambers are not sufficiently communicated with each other. When the chemical solution around the spherical valve 364 is the first chemical solution M1 because the chemical solution M2 is not properly mixed, the spherical valve 364 having a specific gravity larger than the specific gravity of the first chemical solution M1 sinks in the first chemical solution M1 and the spherical seat 316 The passage 32 is closed by engaging with 365, and the liquid medicine does not flow into the drip tube. Therefore, a person related to the liquid medicine administration such as a nurse notices that the first liquid medicine M1 and the second liquid medicine M2 are not mixed.
[0030]
Further, the spherical valve 364 may be a movable valve body that is not entirely spherical, and may have a shape in which the float portion is separated from the valve seat engagement surface, for example, may include a separate buoyancy adjusting member. it can. When the first chemical liquid M1 around the spherical valve 364 is larger than the specific gravity of the mixed chemical, the specific gravity is such that the spherical valve 364 floats with the first chemical M1 and sinks in the mixed chemical, that is, the specific gravity of the first chemical M1. The spherical valve 364 is engaged with the spherical seat 365 in a floating state, closes the passage 32, and separates from the spherical seat 365 in the mixed chemical solution to settle.
[0031]
An example of a drug housed in the multi-compartment container of the present invention is an infusion preparation obtained by adding vitamins to a sugar / electrolyte / amino acid solution for high calorie infusion which can be used as a starting solution or a maintenance solution for central parenteral nutrition therapy. . Preferably, the sugar and electrolyte are stored in the first storage chamber, and the amino acids are separated and stored in the second storage chamber. The vitamins are stored in third or more drug storage rooms separated from the first storage room and the second storage room, or pierced through a rubber stopper of a port member communicating with the second storage room upon administration. It is added to the drug solution via the hollow needle.
[0032]
The multi-chamber container of the present invention is made of a thermoplastic resin. This thermoplastic resin is suitable for chemicals and nutrients to be contained in heat resistance, mechanical strength, flexibility, chemical resistance, especially moldability, gas barrier properties, flex resistance, transparency, ultraviolet shielding properties, etc. It is said. The resin films 21 and 22 of the multi-chamber container 2 can be a thermoplastic resin film having a single-layer structure or a laminated structure of two or more layers. As the thermoplastic resin, one kind or a mixture of two or more kinds can be used. In addition, a thermoplastic resin modified by introducing a functional group into a molecular chain can be used.
[0033]
The movable valve body can be made to have a desired specific gravity by appropriately combining nylon, polystyrene, ABS resin, polyvinyl chloride, or the like having a relatively large specific gravity, and polyethylene or polypropylene having a specific gravity of 1 or less. In addition, the specific gravity and buoyancy of the movable valve body can be adjusted by incorporating medical glass into or out of a resin molded body having a specific gravity of 1 or less and having an appropriate volume.
[0034]
The thermoplastic resin films 13 and 14 forming the multi-compartment container 10 are made of, for example, polyethylene, polypropylene, polyolefin such as ethylene-α-olefin copolymer, polystyrene, polycarbonate, polyester such as polyethylene terephthalate or polybutylene terephthalate, polyacetal, or polyamide. , Polyphenylene ether, polyether sulfone, polysulfone, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyvinylidene chloride, polyphenylene sulfide, fluororesin, acrylic resin, cyclic polyolefin and the like. Among them, polyethylene, polypropylene, ethylene-α-olefin copolymer and polyethylene terephthalate are preferred.
[0035]
The medicine chambers 11 and 12 are preferably made of a resin that absorbs a small amount of a medicine, and such a resin is made of polyethylene naphthalate, cyclic polyolefin, ethylene-tetrafluoroethylene copolymer, polyether sulfone, and polysulfone. is there. The surface of the resin film forming the multi-chamber container can be subjected to a surface treatment as necessary. Examples of such surface treatment methods include corona discharge treatment, plasma treatment, flame treatment, sputtering treatment, solvent treatment, ultraviolet treatment, infrared treatment, ozone treatment, and polishing treatment. When the film forming the container body is a laminated structure, the adhesive strength between the layers can be improved by using a hot melt adhesive, a polyurethane adhesive or the like between the layers as necessary.
[0036]
【The invention's effect】
In a high-calorie infusion in which the first drug solution stored in the first storage chamber is a sugar / electrolyte and the second drug solution stored in the second storage chamber is an amino acid, the first drug solution contains potassium ions. Intravenous administration without diluting the potassium ion concentration of the first drug solution with the second drug solution may adversely affect cardiac function. In addition, if a high-concentration sugar solution of the first drug solution is administered without diluting, osmotic pressure may adversely affect vascular function and cause pain. According to the present invention, since the first chemical solution and the second chemical solution are surely mixed, the occurrence of these problems can be prevented.
[0037]
The multi-compartment container of the present invention can be manufactured by changing the port member in the conventional multi-compartment container, has the advantage that the change of the production line is minimal, and the number of manufacturing steps and costs are small. In the present invention, by making the control unit, particularly the valve plate or the movable valve element, water vapor permeable, water vapor is present inside the port member between the control unit and the rubber stopper, and insufficient heating inside the port member during heat sterilization. Can be prevented. Further, since the rubber stopper is separated from the medicine in the first storage chamber by the control unit, it is possible to prevent the components of the rubber stopper from being eluted into the drug solution.
[Brief description of the drawings]
FIG. 1a is a schematic plan view of a multi-chamber container with medicine of a first embodiment of the present invention, and FIG. 1b is a schematic cross-sectional view of the multi-chamber container with medicine along line BB in FIG. 1a.
FIG. 2A is a schematic vertical sectional view of a port member 30 of a multi-chamber container with medicine according to a second embodiment of the present invention, and FIG. 2B is a schematic vertical sectional view of a modified example of the port member 30 of FIG. 2A.
3A is a schematic longitudinal sectional view of a port member 30 of a multi-chamber container with medicine according to a second embodiment of the present invention, and FIG. 3B is a schematic plan view of a regulating body 37 incorporated in the port member 30 of FIG. 3A. FIG.
[Explanation of symbols]
10: multi-chamber container, 11: first storage chamber, 12: second storage chamber, 13, 14: resin film, 16: side edge, 17: lower edge, 18: upper edge, 20: partition ( Isolation means), 30, 40: port member, 28: hanging hole, 31: tubular member, 32, 42: passage, 33: holding member, 34, 44: rubber stopper, 35: axis, 37: regulating body, 361 : Valve seat member, 362: valve plate, 363: annular valve seat, 364: spherical valve, 365: spherical seat, 372: through hole, 371: plastic lattice, M1: first chemical liquid, M2: second chemical liquid.

Claims

A multi-chamber container comprising a first storage chamber and a second storage chamber, releasable isolation means disposed between the two chambers, and a port member communicating with the first storage chamber,
The port member has a control unit for opening and closing the passage of the chemical solution and the passage,
The first storage chamber and the second storage chamber are communicated by releasing the isolation means,
The multi-chamber container, wherein the control unit opens the passage and allows the chemical solution to pass through by communicating the first storage chamber and the second storage chamber.

2. The method according to claim 1, wherein the first storage chamber, the second storage chamber, and the isolation unit are formed of a thermoplastic resin film, and the isolation unit is released by pressing the first storage chamber or the second storage chamber that stores the liquid medicine. Multi-chamber container.

3. The multi-compartment container according to claim 2, wherein said isolation means is a weak seal portion formed on a thermoplastic resin film.

The multi-chamber container according to any one of claims 1 to 3, wherein the control unit includes a movable valve body that opens a passage by a pressure that releases the isolation means or a pressure higher than the pressure.

The multi-chamber container according to claim 4, wherein the control unit includes an annular valve seat, the movable valve body is a valve plate fixed to the annular valve seat, and the valve plate is water vapor permeable.

The multi-chamber container according to any one of claims 1 to 3, wherein the control unit includes a movable valve body that opens a passage according to a change in specific gravity of the contacting chemical solution.

7. The multi-chamber container according to claim 6, wherein the control unit has a regulating body that allows the liquid medicine to pass therethrough but prevents the movable valve body from moving into the first storage chamber.

A medicine containing a first accommodating chamber for accommodating the first medicinal liquid, a second accommodating chamber for accommodating the second medicinal liquid, a releasable isolating means disposed between the two chambers, and a port member communicating with the first accommodating chamber. A multi-chamber container,
The port member has a control unit for opening and closing the passage of the chemical solution and the passage,
The first chemical liquid and the second chemical liquid are mixed by releasing the isolation means to generate a mixed chemical liquid,
The control section is a medicine-containing multi-chamber container capable of opening a passage by mixing the first chemical liquid and the second chemical liquid.

9. The method according to claim 8, wherein the first storage chamber, the second storage chamber, and the isolation means are formed of a thermoplastic resin film, and the isolation means is released by pressing the first storage chamber or the second storage chamber containing the chemical. Multi-chamber container with medicine.

The medicine-containing multi-chamber container according to claim 8 or 9, wherein the control unit includes a movable valve body that opens a passage by a pressure for releasing the isolation means or a pressure higher than the pressure.

The drug-containing multi-chamber container according to claim 10, wherein the control unit includes an annular valve seat, the movable valve body is a valve plate fixed to the annular valve seat, and the valve plate is water vapor permeable.

The medicine-containing multi-chamber container according to claim 8 or 9, wherein the control unit includes a movable valve body and a seating part, and the movable valve body is separated from the seating part according to the specific gravity of the mixed chemical liquid.

13. The multi-chamber container with a drug according to claim 12, wherein the movable valve element is seated on a seating portion to close the passage when the movable valve body is in the first chemical solution, and opens away from the seating portion when the movable valve body is in the mixed chemical solution.

14. The medicine-containing multi-compartment container according to claim 12, wherein the specific gravity of the movable valve body is 1.040 to 1.060.

The drug-containing multi-compartment container according to any one of claims 12 to 14, wherein the movable valve body includes an integral or separate buoyancy adjusting member.

The drug-containing multi-chamber container according to any one of claims 8 to 15, wherein the first chemical solution contains a reducing sugar, and the second chemical solution contains an amino acid.

The drug-containing multi-chamber container according to any one of claims 8 to 15, wherein the first drug solution contains an amino acid, and the second drug solution contains a reducing sugar.