JP2005538814A - 医薬品を投与するための医療装置 - Google Patents
医薬品を投与するための医療装置 Download PDFInfo
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Abstract
Description
拡張されたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、最大限膨脹して、その全長が、酢酸エチル1ml当たり18.8mgのパクリタキセル、+1%薬剤用オリーブオイルの中に1分間浸漬され、その後、乾燥され、パクリタキセル含有量が39μgになる(エタノール、HPLCで抽出された後)。
折り曲げられたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、その全長が、酢酸エチル1ml当たり18.8mgのパクリタキセル、+1%薬剤用オリーブオイルの中に1分間、折り曲げられた状態に浸漬され、その後、乾燥され、パクリタキセル含有量が69μgになる。
折り曲げられたバルーンカテーテルを、酢酸エチル溶液の中におけるパクリタキセルでコーティングすること
a)ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、その全長が、酢酸エチル1ml当たり16.6mgのパクリタキセルの中に1分間、折り曲げられた状態に浸漬され、その後、4時間乾燥され、パクリタキセル含有量が54μgになる。
b)同じ処置であるが、溶液A(=3.33mlの酢酸エチル+100.0mgのパクリタキセル)の中に5秒間、2回浸漬され、その後、それぞれの浸漬の後に1時間の乾燥時間があり、パクリタキセル含有量が126μgになる。
c)同じ処置であるが、同じ溶液の中に5秒間、4回浸漬され、その後、それぞれの浸漬の後に1時間の乾燥時間があり、パクリタキセル含有量が158μgになる。
バルーンカテーテルを、アセトンの中におけるパクリタキセルでコーティングすること
9.0mlのアセトンの中に350mgのパクリタキセルが溶解され、ドイツ、オーベルプファーフェンホーフェン/ミュンヘンのBMT社(BMT,Oberpfaffenhofen/Munich,Germany)によって作られ、製品名がジョーカーライト(Joker Lite)であり、バルーン寸法が2.5mm×20mmであるバルーンカテーテルは、最大限膨脹して、その全長が、1分間浸漬されて取り出される。溶媒は室温で12時間乾燥される。その後、バルーンは膨脹して、普通はPTFEでコーティングされたツールを用いて折り曲げられる。場合によっては、バルーンの表面に適切な寸法のステントを圧着することができ、バルーンにおけるパクリタキセル含有量が29μgになる。
バルーンカテーテルを、アセトンの中におけるパクリタキセルでコーティングすること
a)BMT社によって作られ、製品名がアレグロ(Allegro)であり、バルーン寸法が2.5mm×20mmである折り曲げられたバルーンカテーテルは、0.15mlのエタノール+4.5μlのウルトラビスト300(ドイツ、ベルリンのSchering AG社によって作られたX線造影剤)+1.35mlのアセトン+0.8mgのスーダンレッド+30.0mgのパクリタキセルからなる混合物の中に浸漬される。
b)飽和された水性マンニット溶液が、ウルトラビスト300の代わりに用いられる。
c)飽和された水性サリチル酸ナトリウム溶液(pH7.5)が、ウルトラビスト300の代わりに用いられる。
d)5mgのアセチルサリチル酸が、(5a)によって完全な溶液に添加される。
e)5mgのグリセリンが、(5a)によって完全な溶液に添加される。
血流の中への活性物質の溶着
BMT社によって作られ、製品名がアレグロ(Allegro)であり、バルーン寸法が2.5mm×20mmである12個のバルーンカテーテルが用いられた。6個のグループのカテーテルにおける折り曲げられたバルーン部分は、(0.15mlのエタノール+4.5μlのウルトラビスト300+1.35mlのアセトン+0.8mgのスーダンレッド+30.0mgのパクリタキセル)の中に5回、あるいは(1.5mlの酢酸エチル+0.8mgのスーダンレッド+31.0mgのパクリタキセル)の中に5回、浸漬されたが、その第1回目は、それぞれ1分間の浸漬で3時間の乾燥であり、その後の4回は、それぞれ1時間の間隔を置いた5秒間の浸漬である。次いで、それぞれのグループにおける折り曲げられた3個のバルーンは、パクリタキセルの含有量を測定するために、50mlの人の血液中において37℃で5分間、おだやかに動かされて除去された。血液中でカテーテルを動かすと、血液中で動かされなかった3個の対照カテーテルに比べて、平均値(コーティング法についてn=3)が減少する。
アセトン:12%
酢酸エチル:10%
豚の冠状動脈の中での血管形成およびステント移植の後における再狭窄抑制の試験
BMT社によって作られ、寸法が3.5mm×20mmあるいは3.0mm×20mmであるジョーカーライト型の折り曲げられたバルーンカテーテルは、
溶液A)3.33mlの酢酸エチル(EA)+100.0mgのパクリタキセル
の中にあるいは、
溶液B)0.45mlのエタノール+100μlのウルトラビスト370+4.5mlのアセトン(ac)+150.0mgのパクリタキセル
の中に1分間浸漬され、次いで室温で一晩にわたって乾燥された。翌日に、あと一回(低投与量=Lのとき)あるいはあと4回(高投与量=Hのとき)の浸漬処理が、1時間の間隔を置いてちょうど5秒間、それぞれ行われた。
血管拡張およびステント移植の後におけるカテーテルの活性物質含有量
ステントの移植および動物からの除去の後に、長さがほぼ3cmの例8から一片のバルーンが、バルーンカテーテルとは切り離されて、1.5mlのエタノールの中に置かれた。パクリタキセル含有量がHPLCを用いて測定された。入手可能なすべてのコーティングされたバルーンおよび選択された非コーティングのバルーンが試験された。
冠状動脈
3.0×20mm、コーティング
高Ac 38±4μg(n=4)
低Ac 22±5μg(n=2)
高EEE 41μg (n=1)
3.5×20mm、コーティング
高Ac 37±10μg(n=8)
低Ac 26±6μg(n=8)
高EEE 53±9μg(n=9)
非コーティング(大きさおよび血管区域とは無関係) 0.9±1.0μg(n=7)
アセトンにプロブコールが1ml当たり100mgの濃度で添加され、この溶液が、前記の例において説明されたバルーンカテーテルをコーティングするために用いられる。
ラパマイシンが、ジエチルエーテルの中に10mg/mlの濃度で溶解される。カテーテルのバルーン区域が、先の例において説明されたようにコーティングされる。コーティング溶液から取り出した後に、バルーンは水平位置に置かれ、引き続いてそれらの長手軸の周りに回転される。
エポチロンBが、酢酸エチルに2mg/mlの濃度で添加され、この溶液が、前記の例において説明されたバルーンカテーテルをコーティングするために用いられる。
Claims (30)
- 病変した組織あるいは器官部分の選択療法のための医薬品を投与する医療装置であって、
親油性であり、ほとんど水不溶性であり、かつ任意の種類の組織に結合する医薬品が、活性成分が即時に投与される圧力下で、病変組織と少なくとも短時間接触する装置の表面に付着し、活性成分のキャリアが、少なくとも1つのバルーンカテーテル(12)であることと、前記バルーンカテーテル(12)が、バルーン(14)から突出するかあるいはバルーン(14)の表面に位置する、狭窄を切り開くための少なくとも1つの装置(24)を備えることを特徴とする、医療装置。 - 狭窄を切り開くための装置(24)が、バルーン(14)の長手軸に対して平行に配置された少なくとも1つのワイヤ状装置(16)であることを特徴とする、請求項1に記載の装置。
- 装置(24)が、少なくとも2つのワイヤ状装置(16)から構成されていると共に、格子状構造体を形成しており、該構造体の長手軸が、バルーン(14)の長手軸に対して平行にすなわち軸平行に配置されることを特徴とする、請求項2に記載の装置。
- ワイヤ状装置が、金属、合金、あるいはプラスチックからなることを特徴とする、請求項2または3に記載の装置。
- 合金が、形状記憶合金であることを特徴とする、請求項4に記載の装置。
- 狭窄を切り開くための装置が、少なくとも1つのブレード状装置からなることを特徴とする、請求項1に記載の装置。
- 狭窄を切り開くための装置が、バルーン(14)から突出するかあるいはバルーン(14)の表面に位置する少なくとも1つの突起部からなることを特徴とする、請求項1に記載の装置。
- ブレード状装置あるいは突起部が、金属、合金、あるいはプラスチックからなることを特徴とする、請求項6または7に記載の装置。
- バルーンカテーテル(12)が、ステント、カテーテルおよび/またはカテーテルの部品、針、および案内用のワイヤ、ならびにステントと共に使うことを目的とすることを特徴とする、請求項1から8のいずれか一項に記載の装置。
- 予備成形された長手折曲部を有するバルーンが、薬剤コーティングのために使われることと、バルーンの再び折り曲がる傾向が、膨張によって失われないことを特徴とする、請求項1から9のいずれか一項に記載の装置。
- バルーンが、きわめて平滑な材料からなり、該きわめて平滑な材料に、バルーンを折り曲げるために必要な力を損なうことなく大部分が耐えるために、薬剤が充分良好に付着することを特徴とする、請求項1から9のいずれか一項に記載の装置。
- 活性物質の低粘度溶液の中にバルーンを完全に折り曲げた状態で浸漬することによってコーティングされたバルーンが、使われることを特徴とする、請求項1から9のいずれか一項に記載の装置。
- 折曲部によって覆われた部位だけが、塗布された後に乾燥した薬剤物質で被覆されることを特徴とする、請求項1から12のいずれか一項に記載の装置。
- 親油性薬剤が、細胞増殖過程あるいは炎症性過程の抑制剤、または酸化防止剤であることを特徴とする、請求項1に記載の装置。
- 用いられる薬剤が、パクリタキセルおよび他のタキサン類、ラパマイシンおよび関連物質、タクロリスマスおよび関連物質、コルチコイド、性ホルモンおよび関連物質、スタチン、エポチロン、プロブコール、プロスタサイクリン、血管形成の誘発物質などであることを特徴とする、請求項14に記載の装置。
- 親油性薬剤が、それぞれの生成物の表面に乾燥固体物質としてあるいは油として存在することを特徴とする、請求項14または15に記載の装置。
- 有効量の薬剤が、活性成分の水への溶解度が低いにもかかわらず迅速に溶解する、粒径が0.1μm未満から5μmの範囲にある無定形構造を含むことを特徴とする、請求項16に記載の装置。
- 親油性薬剤が、装置への良好な付着を達成しかつ組織による吸収を改善するために、易水溶性基質物質の中に埋め込まれることを特徴とする、請求項1に記載の装置。
- 基質物質が、分子量が5,000D未満である低分子量親水性物質からなることを特徴とする、請求項18に記載の装置。
- 親油性薬剤が、粒子に吸収されるか、あるいは低分子量基質を有する装置の表面に塗布されることを特徴とする、請求項1に記載の装置。
- 表面が、装置のすべり特性のような特定の性質に影響を及ぼすか、あるいは血液凝固の減少に影響を及ぼす物質で追加コーティングされることを特徴とする、請求項1に記載の装置。
- 溶液、懸濁液、あるいはエマルジョン媒体の中における親油性薬剤および補助薬が、浸漬、散布、噴霧処理あるいは容積計量器を用いて塗布され、一方、表面にゆるく付着する過剰な媒体および過剰な物質が、除去されることを特徴とする、請求項1から21のいずれか1つに記載の装置の製造方法。
- コーティング処理が、同じかあるいは異なる溶液、懸濁液、またはエマルジョン媒体および/または補助薬を用いて、活性物質含有量の再現可能な増加のために繰り返し行われることを特徴とする、請求項22に記載の方法。
- 溶液、懸濁液、およびエマルジョン媒体として、エタノール、イソプロパノール、酢酸エチル、ジエチルエーテル、アセトン、ジメチルスルホキシド、ジメチルホルムアミド、グリセリン、水、あるいはこれらの混合物が用いられることを特徴とする、請求項23に記載の方法。
- 滅菌の前あるいは後に、コーティングされる利用のための準備が整っているか、あるいは圧着ステントを有し折り曲げられたバルーンが、活性成分のキャリアとして使われることを特徴とする、請求項22から24のいずれか一項に記載の方法。
- バルーンが、折り曲げられていない状態でそれぞれの親油性薬剤によりコーティングされることと、バルーンが、特に潤滑性のある、場合によっては生体適合性のあるすべり物質で濡らされたツールで折り曲げられることを特徴とする、請求項25に記載の方法。
- バルーンカテーテルに連結されたステントが、コーティング処理の前かあるいは後に組み付けられることを特徴とする、請求項22に記載の方法。
- 装置が、完全にコーティングされた後に、エチレンオキシドを用いて滅菌されることを特徴とする、請求項22に記載の方法。
- 血管疾患あるいは血行障害の治療のための、請求項1から28のいずれか一項によって構成され製造された医療装置の使用方法。
- 体内に開放通路を作り出すための、請求項1から28のいずれか一項によって構成され製造された医療装置の使用方法。
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- 2003-08-26 SI SI200331213T patent/SI1539266T1/sl unknown
- 2003-08-26 CN CNB038242745A patent/CN100349624C/zh not_active Expired - Lifetime
- 2003-08-26 US US10/528,577 patent/US8257305B2/en active Active
- 2003-08-26 EP EP14199392.3A patent/EP2857049B1/de not_active Revoked
- 2003-08-26 RU RU2005111752A patent/RU2316358C2/ru active
- 2003-08-26 DK DK03750300T patent/DK1539266T3/da active
- 2003-08-26 ES ES14199403.8T patent/ES2620496T3/es not_active Expired - Lifetime
- 2003-08-26 ES ES14199392.3T patent/ES2616521T3/es not_active Expired - Lifetime
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JP2010536513A (ja) * | 2007-08-29 | 2010-12-02 | インヴァテック テクノロジー センター ジーエムビーエイチ | 膨張制御バルーンカテーテル |
JP2009240783A (ja) * | 2008-03-31 | 2009-10-22 | Cordis Corp | 治療薬の液体調合物を用いる局所送達および/または所与の領域に亘る送達のための装置 |
JP2012514510A (ja) * | 2009-01-09 | 2012-06-28 | インバテック テクノロジー センター ゲゼルシャフト ミット ベシュレンクテル ハフツング | 薬剤溶出医療デバイス |
JP2011245308A (ja) * | 2010-05-28 | 2011-12-08 | Cordis Corp | ラパマイシン被覆された拡張可能な装置 |
JP2013066727A (ja) * | 2012-10-30 | 2013-04-18 | Japan Stent Technology Co Ltd | ステントの製造方法 |
JP2015195962A (ja) * | 2014-04-01 | 2015-11-09 | テルモ株式会社 | バルーンコーティング方法 |
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JP7072504B2 (ja) | 2015-10-30 | 2022-06-02 | アコテック サイエンティフィック カンパニー リミテッド | 動静脈シャントの薬剤コーティングバルーンカテーテル |
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