JP2008289927A - 優先断裂式シールを伴う可撓多数コンパートメント医用容器 - Google Patents
優先断裂式シールを伴う可撓多数コンパートメント医用容器 Download PDFInfo
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- JP2008289927A JP2008289927A JP2008227364A JP2008227364A JP2008289927A JP 2008289927 A JP2008289927 A JP 2008289927A JP 2008227364 A JP2008227364 A JP 2008227364A JP 2008227364 A JP2008227364 A JP 2008227364A JP 2008289927 A JP2008289927 A JP 2008289927A
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- Prior art keywords
- seal
- compartment
- container
- drug
- peelable
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
- C08L53/02—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes
Abstract
【解決手段】希釈液と薬剤を一緒に貯蔵及び混合する可撓容器(10)が提供される。本容器は優先剥離式シール(24、26)によって分離された多数のコンパートメント(18、20、22)を組み込んでおり、希釈液と薬剤がそこに保存される。本容器は高酸素及び水分障壁特性を有する熱可塑性材料から構成されており、内容を劣化させることなく容器を長期間保存することができる。剥離式シールは容器の操作によって断裂し、標準IV装置を通じて患者に供給するため内容を混合することができる。本容器は液体の動きまたは乱流の影響を受けやすい単一成分液体薬剤を充填できる。乱流は、まずヘリウムのような低分子量ガスで頭隙を形成し内部ガス頭隙を除去することによって最小化される。
【選択図】図1
Description
容器がこうした材料で満たされている場合、形成されたフィルム・ウェブが乾燥窒素または濾過空気の噴射によって吹かれて開かれ、ある容積を画定し、そこに測定された量の液体が導入される。多くの場合、この容器に収容される液体の量は約100分の1以内に管理されなければならない。容器が液体で満たされた後濾過空気または窒素を容器から排出するのは極めて困難である。空気が充填ポートを通じて排出されるまで、但し何らかの液体が流出する前に、容器壁をゆっくりと圧迫する必要がある。
図2、図3及び図4で示される第1例示実施形態の場合のように、透明高障壁中間積層フィルム(図5の71)は、中間フィルム71の上、すなわち容器の薬剤コンパートメントの上に配置された不透明高障壁アルミニウム箔含有保護フィルム(図2及び図3の55)と組み合わせて提供される。従って、不透明高障壁保護フィルムと組み合わされた透明高障壁中間フィルム71は、薬剤コンパートメントの上に配置される高障壁保護被覆を構成する。以下さらに詳細に説明されるように、高障壁保護被覆には、高水分障壁層、高酸素障壁層、またはこれら両方が含まれる。不透明アルミニウム箔含有保護用フィルム55は、保護が望ましい場合、容器の薬剤コンパートメントへの紫外線及び可視スペクトル光線の透過を防止するために提供される。
完成した容器の使用は容器を製造するために使用されるフィルムとはほぼ無関係である。コンパートメントに分けられた容器10と混合システムは、図1及び図2に示された完全な構成で、健康管理人員、通常病院の薬剤サービス部門によって受け入れられる。ここで図6を参照すると、容器の使用を準備する際、アルミニウム箔含有保護層55のタブ62を把握して容器から保護層を剥離し、液体薬剤を収容する中間コンパートメント20の目視検査を可能にすることで液体薬剤が検査される。薬剤と薬剤コンパートメントが正常な状態であれば、すなわち、隔離式シールが損傷しておらず、正常な投与量の液体薬剤が存在し、その色と清澄度が正常である、等であれば、容器を操作して上部希釈液コンパートメント18の部分で前部及び後部シートを圧縮することで、図17に示されるように溶液が混合される。容器の操作によって発生した流体力による機械的圧力によって、希釈液及び薬剤のコンパートメント間の第1選択剥離式シールが断裂する(断裂した状態が24’で示される)。さらに容器を振る操作によって、希釈液と薬剤の液体とが混合される。完全な混合作用が得られたことの確認は、澄んだ透明な前部シートを通じて混合溶液を視覚的に観察することでなされる。混合作用の完了後、容器の前部及び後部シートを再び圧縮し、シールを断裂する流体圧を容器内に発生させることで、図18に示されるように、薬剤コンパートメントと下部安全確保コンパートメントとの間の第2選択剥離式シールが破れる(断裂した状態が26’で示される)。その後混合溶液は容器から出口ポート30を通じて、標準IV供給セットを使用して投薬される。
第2シール82の大きな幅寸法は、剥離開放するために第1優先剥離式シール80よりはるかに大きな力を必要とすることが理解されるだろう。さらに、図9から分かるように、液体薬剤コンパートメント20の面積は、希釈液コンパートメント18の液体面積よりかなり小さい。従って、容器は薬剤よりかなり大きな量の液体希釈液を収容することができる。希釈液の量が大きいということの意味は、容器が操作される場合、薬剤が第2剥離式シール82に対して発生する力よりも大きな力を、希釈液が第1剥離式シール80に対して行使するということである。第1剥離式シール80が必要とする作動エネルギーは第2剥離式シール82より低いので、第1シール80が第2剥離式シール82に優先して剥離開放することが理解される。
図9の実施形態とは対照的に、図10の第1優先剥離式シール84は従来の矩形形状を有していない。本発明の原理の実行によれば、第1優先剥離式シール84は正弦曲線または蛇状の形状に形成され、87で示される少なくとも1つの応力ライザが希釈液チャンバ18に突出し、偏位点は希釈液チャンバを操作することによって発生する予想圧力面の方向を向いている。
希釈液コンパートメントの方向を向いた屈曲点を有する応力ライザ87に加えて、図10の第1選択剥離式シール84には、薬剤コンパートメント20の方向を向いた屈曲点を有する2つの追加応力ライザ88及び89が含まれるのが分かる。当業者によく理解される方法で、各応力ライザ屈曲点は剥離開始点を画定し、そこで剥離式シールは、開始点の向きにあるコンパートメントでの圧力事象に応答して剥離開放し始める。動作の際、屈曲点、または開始点の凸状先端エッジは希釈液または液体薬剤の何れかのコンパートメントが圧搾されるとき、その何れかの薬剤の流体圧に対する複合抵抗特性を示す。図10の曲線第1優先剥離式シール84のような非直線障壁に対して発生する圧力面の数学的有限要素分析が示すところによれば、ΔPによる力は、屈曲点が圧力面の方向に延びる、応力ライザの最大屈曲の領域に集中する。ΔPによるこの集中された力は、屈曲点で優先的にシールの断裂を開始しようとする。さらに、こうしたシールは、シールが均一な直線の構成である場合より、低いわずかな操作圧力で剥離プロセスを開始しようとする。
本発明の原理の実行によって提供される容器と優先剥離式シールの追加実施形態とが図12に半概略形態で例示される。図12に例示される容器の実施形態は図11の実施形態と本質的に同じ優先剥離式シールの構造および配置を備えているが、優先剥離式シールと出口ポート30との間に配置された追加剥離式シール、すなわち安全シールを備えている。図12および図11の実施形態の間の優先剥離式シールの構造および配置が相似しているため、開始点等を含む優先剥離式シールは同一の参照符号で特定される。しかし、出口範囲(図11の22)はここでは、一般に矩形の形状で容器にわたり、両側で永久周辺シール16と重なり合う安全シール100によって二分されている。安全シール100は出口範囲(図11の22)を、安全シール100と第2優先剥離式シール92との間に配置された圧力チャンバ102と、安全シール100と出口ポート30との間に配置された出口チャンバ104とにさらに分割する。
理論にしばられることなく、シールの剥離性は、時間、圧力及び温度を、後部シートの中間及び外部層より低い溶融温度を有する、容器の前部及び後部シートの内部層の間の境界を溶解する程度に制限することで達成されると考えられる。溶解ゾーンの内部層の構造変化の深さが制限され、それによって剥離する性質がシールに付与される一方、容器の正常な取扱時の破損を防止する十分な強度が提供される。好適には、本発明の容器の作動力は、極端な取扱い条件で容器の完全性を提供する一方で、全てのユーザにとって作動が容易であるように厳しく管理される。作動労力または力は、各シールの形状、幅Wまたはその機能(第1優先剥離式シール、第2優先剥離式シール、または安全シール)によって必然的に変化するが、好適には個々のシールに関して±6.89Pa(±1ポンド/平方インチ(psi))程度まで均一な破裂圧力を特徴とする。
特に液体の動きや乱流の影響を受けやすい乳剤、リポソーム等の複合貯蔵及び投与に適した医用容器の追加実施形態が図13に例示される。一般に110で示される容器は表面的には前に説明した実施形態と同様であるが、この容器は活性成分、好適には液体を収容する単一コンパートメント112を備えていることが注目される。成分コンパートメント112は、容器にわたり、容器を構成する前部及び後部シートを結合する永久周辺シール16と重なり合う一般に直線の矩形剥離式シール116によって空の出口コンパートメント114から分離される。出口ポート30は容器の一端に提供され、出口コンパートメント114と流通する。動作の際、容器112を圧搾して操作すると、成分コンパートメント112内に剥離式シール116を断裂する流体圧力が発生し、投与のために出口ポート30を通じて液体成分が利用できるようにする。
当業者が理解するように、充填処理終了時の頭隙調整工程は一定の量のヘリウム・ガスを容器の成分コンパートメントに導入し、容器内の初期頭隙を画定する。ここで図13を参照すると、ヘリウムの噴射によって画定された初期頭隙はVi で示され、成分コンパートメントに提供される初期頭隙容積を表す。
18、20、22 コンパートメント
24、26 優先剥離式シール
Claims (17)
- 可撓容器の作動方法において、
(a)流体圧を前記可撓容器に加え、前記可撓容器は、
(1)可撓後部シートと、
(2)共通周辺エッジに沿って前記後部シートに密封された可撓前部シートと、
(3)第1製品を収容する第1コンパートメントを形成するため前記前部シート及び前記後部シートを分離式に接合する第1優先剥離式シールと、
(4)第2製品を収容する第2コンパートメントを形成するため前記前部及び後部シートを分離式に接合する第2優先剥離式シールと、を備えており、
さらに、
(b)それぞれ異なった断裂特性を伴って前記第1及び第2優先剥離式シールを構成することにより、前記流体圧が前記第1コンパートメントまたは前記第2コンパートメントのどちらに発生したかとは無関係に、前記第1優先剥離式シールを前記第2優先剥離式シールの前に断裂させる、作動方法。 - 前記第1及び第2優先剥離式シールがほぼ矩形の形状であって、前記容器の前記共通周辺エッジの2つの側面の間に延びる、請求項1に記載の作動方法。
- 前記第1及び第2優先剥離式シールが各々シール幅を特徴とし、前記第1優先剥離式シールの前記シール幅が前記第2優先剥離式シールのシール幅より小さい、請求項1に記載の作動方法。
- 前記第2優先剥離式シールが、前記第2コンパートメントが出口コンパートメントと前記第1コンパートメントとの中間にあるような前記出口コンパートメントを形成するため、前記共通周辺エッジの2つの側面の間に延びる、請求項3に記載の作動方法。
- 前記第2製品が液体の薬剤である、請求項4に記載の作動方法。
- 前記第1優先剥離式シールが前記共通周辺エッジの前記2つの側面にわたり複合曲線として形成され、前記第2優先剥離式シールが前記共通周辺エッジの前記2つの側面にわたりほぼ矩形の形状である、請求項1に記載の作動方法。
- 前記第1及び第2優先剥離式シールが各々幅寸法を特徴とし、前記第1優先剥離式シールの前記幅寸法が前記第2優先剥離式シールの前記幅寸法よりかなり小さいようにした、請求項6に記載の作動方法。
- 前記第1優先剥離式シールの前記複合曲線が、前記第1コンパートメントの方向を向いた凸状外形を有する屈曲点を画定する、請求項7に記載の作動方法。
- 前記第1優先剥離式シールの前記複合曲線がさらに、前記第2コンパートメントの方向を向いた凸状外形を有する少なくとも一つの第2の屈曲点を備える、請求項8に記載の作動方法。
- 前記第1優先剥離式シールが、流体圧の発生元であるコンパートメントの方向を向いた屈曲点で優先的に断裂を開始する、請求項9に記載の作動方法。
- 少なくとも二つのコンパートメントを備えた貯蔵用可撓容器の形成方法において、
可撓後部シートを形成し、
共通周辺エッジに沿って前記後部シートに密封された可撓前部シートを形成し、
第1コンパートメントを形成するため前記前部シート及び前記後部シートを分離式に接合する第1優先剥離式シールを生成し、
第2コンパートメントを形成するため前記前部及び後部シートを分離式に接合する第2優先剥離式シールを生成し、
前記第1優先剥離式シールが、前記容器を操作することによって発生する第1流体圧に応答して断裂し、前記第2優先剥離式シールが、前記容器を操作することによって発生する第2流体圧に応答して断裂し、
前記第1流体圧が前記第1コンパートメントまたは前記第2コンパートメントのどちらに発生したかとは無関係に、前記第1優先剥離式シールを断裂させる第1流体圧が前記第2優先剥離式シールを断裂させる第2流体圧よりも小さいようなシール幅を前記第1優先剥離式シールが備えるようにした、形成方法。 - 前記第1及び第2優先剥離式シールがほぼ矩形の形状であって、前記容器の前記共通周辺エッジの2つの側面の間に延びる、請求項11に記載の形成方法。
- 前記第1及び第2優先剥離式シールが各々シール幅を特徴とし、前記第1優先剥離式シールの前記シール幅が前記第2優先剥離式シールのシール幅より小さいようにした、請求項11に記載の形成方法。
- 前記第2優先剥離式シールが、前記第2コンパートメントが出口コンパートメントと前記第1コンパートメントとの中間にあるような前記出口コンパートメントを形成するため、前記共通周辺エッジの2つの側面の間に延びる、請求項11に記載の形成方法。
- 前記第1優先剥離式シールが前記共通周辺エッジの前記2つの側面にわたり複合曲線として形成され、前記第2優先剥離式シールが前記共通周辺エッジの前記2つの側面にわたりほぼ矩形の形状である、請求項11に記載の形成方法。
- 前記第1及び第2優先剥離式シールが各々幅寸法を特徴とし、前記第1優先剥離式シールの前記幅寸法が前記第2優先剥離式シールの前記幅寸法よりかなり小さいようにした、請求項11に記載の形成方法。
- さらに、前記第1コンパートメント内に第1製品を含むと共に、前記第2コンパートメント内に第2製品を含むようにした請求項11に記載の形成方法。
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1997
- 1997-11-12 US US08/967,687 patent/US5928213A/en not_active Expired - Lifetime
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1998
- 1998-10-01 AU AU96747/98A patent/AU746490B2/en not_active Expired
- 1998-10-01 CA CA002309167A patent/CA2309167C/en not_active Expired - Lifetime
- 1998-10-01 AT AT98950789T patent/ATE491427T1/de not_active IP Right Cessation
- 1998-10-01 DE DE69842051T patent/DE69842051D1/de not_active Expired - Lifetime
- 1998-10-01 CA CA 2588610 patent/CA2588610C/en not_active Expired - Lifetime
- 1998-10-01 WO PCT/US1998/020510 patent/WO1999024086A1/en active IP Right Grant
- 1998-10-01 ES ES98950789T patent/ES2354801T3/es not_active Expired - Lifetime
- 1998-10-01 ES ES10007867T patent/ES2424919T3/es not_active Expired - Lifetime
- 1998-10-01 JP JP2000520171A patent/JP2001522655A/ja not_active Withdrawn
- 1998-10-01 KR KR10-2000-7005106A patent/KR100524357B1/ko not_active IP Right Cessation
- 1998-10-01 EP EP20100007867 patent/EP2238963B1/en not_active Expired - Lifetime
- 1998-10-01 EP EP98950789A patent/EP1034006B1/en not_active Expired - Lifetime
- 1998-12-07 US US09/206,449 patent/US6117123A/en not_active Expired - Lifetime
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2001
- 2001-01-05 HK HK01100117.7A patent/HK1029293A1/xx not_active IP Right Cessation
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- 2008-09-04 JP JP2008227364A patent/JP4473329B2/ja not_active Expired - Lifetime
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Also Published As
Publication number | Publication date |
---|---|
DE69842051D1 (de) | 2011-01-27 |
JP5175323B2 (ja) | 2013-04-03 |
EP1034006A4 (en) | 2004-07-28 |
CA2309167C (en) | 2007-08-21 |
EP2238963B1 (en) | 2013-06-05 |
US5928213A (en) | 1999-07-27 |
EP1034006B1 (en) | 2010-12-15 |
ES2354801T3 (es) | 2011-03-18 |
ES2424919T3 (es) | 2013-10-09 |
WO1999024086A1 (en) | 1999-05-20 |
JP2011026012A (ja) | 2011-02-10 |
CA2588610A1 (en) | 1999-05-20 |
ATE491427T1 (de) | 2011-01-15 |
AU9674798A (en) | 1999-05-31 |
CA2588610C (en) | 2010-07-20 |
HK1029293A1 (en) | 2001-03-30 |
US6117123A (en) | 2000-09-12 |
KR20010031996A (ko) | 2001-04-16 |
AU746490B2 (en) | 2002-05-02 |
EP2238963A1 (en) | 2010-10-13 |
JP2001522655A (ja) | 2001-11-20 |
EP1034006A1 (en) | 2000-09-13 |
CA2309167A1 (en) | 1999-05-20 |
KR100524357B1 (ko) | 2005-10-26 |
JP4473329B2 (ja) | 2010-06-02 |
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