JP2009519068A - 医療用投薬容器のための液体輸送デバイス - Google Patents
医療用投薬容器のための液体輸送デバイス Download PDFInfo
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Abstract
Description
a)内側空間を形成し、生理学的に受容可能なガスを含む医療用投薬容器と、
b)液体を容器に搬送し、かつ液体を容器から搬送するために容器に接続される液体搬送デバイスとを備え、
前記デバイスは、第1および第2の導管を有し、
第1の導管および第2の導管は、前記デバイスが容器に接続されたとき、内側空間と外側大気との間の流体接触を可能にし、
前記デバイスが容器に接続されて、液体フローが容器に出入りするとき、液体フローが第1の導管を介して流れ、第2の導管が容器と外側大気との間のガスフローを可能にし、
前記デバイスが容器に接続されて、定常状態条件下にあるとき、容器に含まれるガスの全体量の20%容量比未満のガスが、定常状態条件下で6時間にわたって外側大気と置換され、
第2の導管は、容器と外側大気との間のガスフローを遮断する手段を実質的に有さないことを特徴とする製薬キット。
150個のバイアル瓶(それぞれの内容量が約11cm3)に、室温大気圧下でSF6ガスを充填し、ゴム製ストッパで封止する。
3つのバイアル瓶を50グループに分割し、以下に示す液体搬送デバイスを用いて、バイアル瓶のストッパのそれぞれに孔を開ける。
デバイスD1は(ドイツのMelsungenにあるB. Braun Melsungen AG)から市販されているミニスパイク(Mini-spike、登録商標)の投薬ピンDP-1000である。
このデバイスは、図2に示すデバイスに対応し、管状シート部202において樹脂が欠落して、ガス導管201を構成する。すなわち管状シート部202は、長さが17mm、直径が1.10mmの(スパイク軸に平行な)第1の部分と、長さが11mmで、直径が4.25mmの(スパイク軸から半径方向外側に延びる)第2の部分とを有してなる、全体の長さが28mmで、平均直径が2.3mmのガス流路を有する。
デバイスD2:直径が0.17mm、長さが2.5cm
デバイスD3:直径が0.17mm、長さが5.0cm
デバイスD4:直径が0.17mm、長さが10cm
デバイスD5:直径が0.28mm、長さが2.5cm
デバイスD6:直径が0.28mm、長さが5.0cm
デバイスD7:直径が0.28mm、長さが10cm
デバイスD8:直径が0.58mm、長さが2.5cm
デバイスD9:直径が0.58mm、長さが5.5cm
デバイスD10:直径が0.58mm、長さが10cm
実施例1の液体搬送デバイス(D2-D10)を用いて、液体注入時のバイアル瓶内の圧力変化を測定するために、以下の装置を用いた。
較正差動圧力トランスデューサ(米国のレイクウッドにあるCOBE社から市販されたCOBE(登録商標)圧力センサ、品番:#041-500-5003)を20G11/2ニードルに取り付けた後、ゴム製ストッパに穿孔することによりバイアル瓶に挿入する。2mlの生理食塩水を充填したシリンジを実施例1のデバイスの液体導管に取り付けた後、実施例1で説明したようにバイアル瓶内に挿入する。シリンジプランジャを一定速度で移動させて、全体容量2mlの液体を実質的に同一の注入速度(2ml/秒)でバイアル瓶に注入する。図10〜図12は、異なる搬送デバイスD2〜D10を用いたときの、時間の関数としてバイアル瓶内の圧力変化を示すものである。これらの図面から明らかなように、直径が小さく、長い導管を有するデバイスほど、内部圧力は過剰に高くなる。
6個のバイアル瓶(内容量が約11cm3)に、室温でほぼ大気圧下でSF6ガスを充填し、ゴム製ストッパで封止する。
3つのバイアル瓶からなる2つのグループに分割し、以下に示す液体搬送デバイスを用いて、それぞれのバイアル瓶のストッパに孔を開ける。
デバイスD1は上述のとおりである。
デバイスD11:図2に示すデバイスに基づき、デバイスD1のガス導管の半径方向外側に延びる部分に、直径が0.17mmで、長さが0.5mmのガス導管を形成することによりデバイスD1を変形したものである。
実施例2で行った動作手順を実施例3の排気管を有するデバイスに対して実施する。図15は、時間の関数としてバイアル瓶内の圧力変化を示すものである。
12個のバイアル瓶(内容量が約11cm3)に、室温でほぼ大気圧下でC4F10ガスを充填し、ゴム製ストッパで封止する。
3つのバイアル瓶からなる4つのグループに分割し、以下に示す液体搬送デバイスを用いて、それぞれのバイアル瓶のストッパに孔を開ける。デバイスD1、デバイスD5、デバイスD6、デバイスD7。
分析的動作手順は実施例1で説明したものと同じである。ガス置換の度合いについて180分間測定される。
下記の表2は、実験結果を示すものであり、搬送デバイスの排気設計を変更することにより、通常の通気孔を有するデバイスに対して、空気のバイアル瓶への侵入を実質的に抑制できることを示すものである。
Claims (27)
- 薬剤を調製するための製薬キットであって、
a)内側空間を形成し、生理学的に受容可能なガスを含む医療用投薬容器(402)と、
b)液体を容器に搬送し、かつ液体を容器から搬送するために容器に接続される液体搬送デバイス(401)とを備え、
前記デバイスは、第1の導管(103,303)と、第2の導管(104,201,304)とを有し、
第1の導管および第2の導管は、前記デバイスが容器に接続されたとき、内側空間と外側大気との間の流体接触を可能にし、
前記デバイスが容器に接続されて、液体フローが容器に出入りするとき、液体フローが第1の導管を介して流れ、第2の導管が容器と外側大気との間のガスフローを可能にし、
前記デバイスが容器に接続されて、定常状態条件下にあるとき、容器に含まれるガスの全体量の20%容量比未満のガスが、6時間にわたって外側大気と置換され、
第2の導管は、容器と外側大気との間のガスフローを遮断する手段を実質的に有さないことを特徴とする製薬キット。 - 請求項1に記載の製薬キットであって、
容器が乾燥堆積物の形態を有するガス充填微小胞の懸濁液の前駆物質を含むことを特徴とする製薬キット。 - 請求項1に記載の製薬キットであって、
10%容量比未満のガスが置換されることを特徴とする製薬キット。 - 請求項1に記載の製薬キットであって、
5%容量比未満のガスが置換されることを特徴とする製薬キット。 - 請求項1〜4のいずれか1に記載の製薬キットであって、
前記デバイスが容器に接続されて、液体フローが容器に出入りするとき、容器の内側空間と外側大気との間の圧力差が約300ミリバール未満であることを特徴とする製薬キット。 - 請求項5に記載の製薬キットであって、
圧力差が約200ミリバール未満であることを特徴とする製薬キット。 - 請求項5に記載の製薬キットであって、
圧力差が約100ミリバール未満であることを特徴とする製薬キット。 - 請求項1〜7のいずれか1に記載の製薬キットであって、
第2の導管は、液体抽出の際、バイアル瓶の内容物が微生物による汚染から保護するためのフィルタ手段ことを特徴とする製薬キット。 - 請求項8に記載の製薬キットであって、
フィルタ手段は、疎水性フィルタを有することを特徴とする製薬キット。 - 請求項1〜9のいずれか1に記載の製薬キットであって、
第1の導管は、搬送すべき液体を含む外部デバイスに搬送デバイスを接続するための接続手段を有することを特徴とする製薬キット。 - 請求項1〜10のいずれか1に記載の製薬キットであって、
搬送デバイスの第2の導管は0.7mm未満の直径を有することを特徴とする製薬キット。 - 請求項11に記載の製薬キットであって、
前記直径は0.5mm未満であることを特徴とする製薬キット。 - 請求項11に記載の製薬キットであって、
前記直径は0.4mm未満であることを特徴とする製薬キット。 - 請求項1〜10のいずれか1に記載の製薬キットであって、
搬送デバイスの第2の導管は約2.5mm〜約400mmの長さを有することを特徴とする製薬キット。 - 請求項14に記載の製薬キットであって、
搬送デバイスの第2の導管は約5mm〜約250mmの長さを有することを特徴とする製薬キット。 - 請求項14に記載の製薬キットであって、
搬送デバイスの第2の導管は約10mm〜約150mmの長さを有することを特徴とする製薬キット。 - 請求項1〜16のいずれか1に記載の製薬キットであって、
搬送デバイスの第2の導管が長さ(l)および直径(d)を有するとき、比(l/d)が25〜600の範囲にあることを特徴とする製薬キット。 - 請求項17に記載の製薬キットであって、
前記比(l/d)が50〜500の範囲にあることを特徴とする製薬キット。 - 請求項17に記載の製薬キットであって、
前記比(l/d)が150〜400の範囲にあることを特徴とする製薬キット。 - 請求項1〜19のいずれか1に記載の製薬キットであって、
第1の導管は、流体注入器が取り外されたとき、第1の導管を閉じるためのシャッタ手段を有することを特徴とする製薬キット。 - 請求項20に記載の製薬キットであって、
前記接続手段はルアコネクタであることを特徴とする製薬キット。 - 請求項20に記載の製薬キットであって、
バイアル瓶の内容物は、生理学的に受容なガスと接触した、乾燥堆積物の形態を有するガス充填微小胞の懸濁液の前駆物質を含むことを特徴とする製薬キット。 - 請求項1〜22のいずれか1に記載の製薬キットであって、
生理食塩水が事前に充填されたシリンジをさらに有することを特徴とする製薬キット。 - 請求項1〜23のいずれか1に記載の製薬キットであって、
生理学的に受容なガスは、診断上および/または治療上有効な薬剤であることを特徴とする製薬キット。 - ガスを含む容器に液体を搬送し、かつ容器から液体を抽出するための液体搬送デバイス(401)であって、
液体が流れるように構成された第1の導管(103,303)と、
ガスが流れるように構成された第2の導管(104,201,304)と備え、
第2の導管が長さ(l)および直径(d)を有するとき、比(l/d)が25〜600の範囲にあることを特徴とする液体搬送デバイス。 - 請求項25に記載の液体搬送デバイスであって、
前記比(l/d)が50〜500の範囲にあることを特徴とする液体搬送デバイス。 - 請求項25に記載の液体搬送デバイスであって、
前記比(l/d)が150〜400の範囲にあることを特徴とする液体搬送デバイス。
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EP20050112319 EP1797919A1 (en) | 2005-12-16 | 2005-12-16 | Liquid transfer device for medical dispensing containers |
EP05112319.8 | 2005-12-16 | ||
PCT/EP2006/069336 WO2007068633A1 (en) | 2005-12-16 | 2006-12-05 | Liquid transfer device for medical dispensing containers |
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JP2009519068A true JP2009519068A (ja) | 2009-05-14 |
JP5010613B2 JP5010613B2 (ja) | 2012-08-29 |
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EP (2) | EP1797919A1 (ja) |
JP (1) | JP5010613B2 (ja) |
KR (1) | KR101345589B1 (ja) |
CN (1) | CN101330936B (ja) |
AU (1) | AU2006326148B2 (ja) |
CA (1) | CA2629252C (ja) |
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JP2021016678A (ja) * | 2019-07-23 | 2021-02-15 | 株式会社ジェイ・エム・エス | バイアルアダプタ |
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JP5010613B2 (ja) | 2012-08-29 |
CA2629252A1 (en) | 2007-06-21 |
CN101330936B (zh) | 2011-06-08 |
EP1797919A1 (en) | 2007-06-20 |
AU2006326148B2 (en) | 2013-01-17 |
KR101345589B1 (ko) | 2013-12-31 |
WO2007068633A1 (en) | 2007-06-21 |
CN101330936A (zh) | 2008-12-24 |
AU2006326148A1 (en) | 2007-06-21 |
CA2629252C (en) | 2014-04-22 |
EP1960020A1 (en) | 2008-08-27 |
US9238103B2 (en) | 2016-01-19 |
US20090159485A1 (en) | 2009-06-25 |
ES2406945T3 (es) | 2013-06-10 |
KR20080090396A (ko) | 2008-10-08 |
EP1960020B1 (en) | 2013-02-13 |
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