JP2006305375A - 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法 - Google Patents
抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法 Download PDFInfo
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Abstract
【解決手段】注入された移植物を製造する方法は、生物、例えばスタフィロコッカス、他のグラム陽性バクテリア、グラム陰性バチルス、カンジダの成長を阻害するのに効果的な濃度の抗菌組成物を形成し、そして抗菌組成物が医学移植物材料に浸透する条件下で医学移植物の少なくとも一部に該抗菌組成物を塗布する工程からなる。抗菌組成物は、抗菌剤を有機溶剤に溶解し、組成物に浸透剤を加え、そしてアルカリ化剤を組成物に加えることにより形成される。抗菌組成物は、組成物を医学移植物に塗布する前に約30℃から約70℃の間の温度に加熱することにより、医学移植物材料の抗菌剤の吸収を高めることが好ましい。注入された移植物を抗菌溶液から取り出した後、注入された移植物を乾燥させ、次に流体で洗浄してミルキングすることにより過剰な顆粒蒸着物を取り除いて、注入された移植物の色を均一にする。
【選択図】なし
Description
1.発明の属する分野
本発明は、医学装置、例えばカテーテルの身体への導入に関し、その材料は、バクテリアおよびカビ生物、例えばスタフィロコッカス、他のグラム陽性バクテリア、グラム陰性バチルスおよびカンジダの成長を阻害するひとつまたは複数の抗菌剤を注入されている。本発明は、身体に導入する医学装置に、ひとつまたは複数の抗菌剤、例えばミノサイクリンおよびリファンピンを注入する方法にも関する。
血管カテーテルを含む身体導入医学装置は、静脈の接近を提供することにより入院患者を管理することにおいて必須となりつつある。これらのカテーテル並びに他の医学装置例えば腹腔カテーテル、心臓血管装置、整形外科移植物および他の補てつ装置からの利益は、しばしば感染合併症により相殺される。これらの感染合併症を引き起こす最も一般的な生物は、スタフィロコッカスエピダミディスおよびスタフィロコッカスアウリウスである。血管カテーテルの場合、これら2つの生物はすべての感染性生物の殆ど70-80%を数え、スタフィロコッカスエピダミディスが最も一般的な生物である。カンジダアービカンスはカビ因子であり、カテーテルの感染の約10-15%を数える。
本発明の目的は、抗菌剤が移植物の露出表面に浸透して移植物の材料を通して注入されている医学移植物および医学移植物のコーティング法を提供することである。
即ち、上記目的の達成において、本発明の一つの側面に従えば、抗菌剤を有機溶剤中に溶解して抗菌組成物に浸透剤を添加することによりバクテリアおよびカビ生物の成長を阻害するのに効果的な濃度の抗菌組成物を形成し;そして、該抗菌組成物が医学移植物の材料に浸透する条件下で医学移植物の少なくとも一部に該抗菌組成物を塗布する工程からなる、非金属医学移植物に抗菌剤を注入させるための方法が提供される。
好ましい態様の記載 本発明で使用される用語「抗菌剤」は、抗生物質、防腐剤、消毒剤および合成モイエティおよびそれらの混合物を意味し、有機溶剤、例えばアルコール、ケトン、エーテル、アルデヒド、アセトニトリル、酢酸、塩化メチレンおよびクロロホルムに溶解性である。
防腐剤および消毒剤の例は、ヘキサクロロフェン、カチオン性ビスイグアニド(即ち、クロルヘキシジン、シクロヘキシジン)ヨードおよびイオドフォア(即ち、ポビドン−ヨード)、パラ−クロロ−メタ−キシレノール、トリクロサン、フラン医療用調製物(即ち、ニトロフラントニン、ニトロフラゾン)、メテナミン、アルデヒド(グルタルアルデヒド、ホルムアルデヒド)およびアルコールである。防腐剤および消毒剤の他の例は、当業者には容易に連想される。
これらの塩は、アルカリ化剤としても医学移植物材料の受容性を高めるための浸透剤としても作用してよい。
基礎的抗菌剤注入法
450mgのNaOHを撹拌しながら透明になるまで45mlのメタノールに溶解し、メタノールmlあたり10mgのNaOH濃度を生じた。溶解は、約45℃の温度にてホットプレート上で撹拌することによりより早く達成される。最終pHは約12.1であったが、有機溶剤中の該pHは極めて再生不可能かもしれないと考察する。
7-frポリウレタン血管カテーテルの比較上の効力
7-frポリウレタン血管カテーテル(2mm直径)に、TDMAC法または本発明の方法の何れかを用いてミノサイクリンおよびリファンピンの混合物をコートした。
ガス滅菌後の7-frポリウレタン
抗生物質注入血管カテーテルの抗菌活性の永続
TDMAC法を用いてミノサイクリンおよびリファンピンをコートされた7-frポリウレタン血管カテーテル(2mmの直径)の抗菌活性は、ガス滅菌またはガンマ照射(2−3メガラッド)により影響されないことは、以前に示された。ここでは、7-frポリウレタン血管カテーテル(2mmの直径)に、本発明の注入法を用いて抗生物質をコートした。カテーテルを、1時間、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。
ガス滅菌後の18-frシリコーン
抗生物質注入尿(フォーリー)カテーテルの抗菌活性の永続
本発明の注入法を用いて、18-frシリコーン尿(フォーリー)カテーテル(4mmの直径)に抗生物質をコートした。カテーテルを、1時間、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。カテーテルを乾燥し、洗浄し、ミルキングして(milked)次に再び乾燥し、そしてエンテロコッカスフェーカリス、エシェリヒアコリ、シュードモナスエルギノーサおよびカンジダに対する効力を測定した。次に、カテーテルを酸化エチレンでガス滅菌に供して効力を再び測定した。表7は、ガス滅菌前および後のこれら生物に対するコートされたカテーテルの効力を示す。結果は、ガス滅菌が、本発明の方法により塗布された抗菌剤の効力に顕著に影響しないことを示す。
抗生物質注入血管グラフトの効力
ゴルテックス(Gortex)、ダクロン(Dacron)またはゲルシール(Gelseal)で作られた血管グラフトに、本発明の注入法を利用して抗菌剤をコートした。カテーテルを、1時間、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。次に、グラフトをスタフィロコッカスエピダミディスの培養液に暴露して抗菌剤注入グラフトの効力を試験した。表8は、ミノサイクリン、リファンピン、有機溶剤およびNaOHの上記混合物を注入させたグラフトが、スタフィロコッカスエピダミディスに対して最初に効果的な抗菌作用を示すことを示す。
抗生物質注入尿カテーテルの効力
本発明の注入法を利用して、16-frポリエチレン尿カテーテル(恥骨上に挿入された膀胱カテーテル)に抗菌剤混合物を塗布した。カテーテルを、1時間、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり15mgミノサイクリンおよび30mgリファンピン並びにメタノールmlあたり10mgのNaOHを含む抗菌剤溶液に浸した。
7-frポリウレタン血管カテーテルの抗菌効力に対する
注入溶液中のNaOHおよび抗生物質の濃度変更の作用
抗菌溶液中のNaOHおよび抗生物質の濃度を変更して、様々なコーティングを7-frポリウレタン血管カテーテルに塗布した。第1のカテーテルは、コーティング処理に暴露しなかった。第2のカテーテルは、酢酸ブチル、メタノールおよびNaOHを含むが抗菌剤を含まない溶液に浸した。第3のカテーテルは、酢酸ブチルおよびメタノールを含みNaOHまたは抗菌剤を含まない溶液に浸した。第4のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり15mgミノサイクリンおよび30mgリファンピンを含みNaOHを含まない抗菌剤溶液に浸した。第5のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり15mgミノサイクリンおよび30mgリファンピン並びにメタノールmlあたり10mgのNaOHを含む抗菌剤溶液に浸した。第6のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。第7のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり40mgミノサイクリンおよび80mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。表10は、スタフィロコッカスエピダミディス、シュードモナスエルギノーサおよびカンジダアービカンスに対する、様々な溶液をコートされた各々のカテーテルの抗菌効力を示す。表10は、注入されたカテーテルの材料に結合したミノサイクリンおよびリファンピンのレベルも示す。
18-frシリコーン尿(フォーリー)カテーテルの抗菌効力に対する
注入溶液中のNaOHおよび抗生物質の濃度変更の作用
抗菌溶液中のNaOHおよび抗生物質の濃度を変更して、様々なコーティングを18-frシリコーン尿(フォーリー)カテーテルに塗布した。第1のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり15mgミノサイクリンおよび30mgリファンピン並びにメタノールmlあたり10mgのNaOHを含む抗菌剤溶液に浸した。第2のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。
注入溶液中での7-frポリウレタン血管浸潤時間の変更の抗菌効力への作用
7-frポリウレタン血管カテーテルを2つの異なる抗菌溶液中に異なる時間で浸した。第1群のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり10mgミノサイクリンおよび30mgリファンピンを含み、NaOHを含むまない溶液に浸した。第2群のカテーテルは、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含む抗菌剤溶液に浸した。各群のカテーテルは、以下の表12に示すとおり、15、30、60及び120分間溶液に浸して効果的な抗菌コーティングを提供するのに必要な最適な期間を測定した。
ナフシリンまたはエリスロマイシンを含む抗菌溶液を注入した
7-frポリウレタン血管カテーテルの効力
7-frポリウレタン血管カテーテルに、NaOHを含まない有機溶剤(酢酸ブチル:メタノール=50:50)の混合物中の10mg/mlの濃度のナフシリンでコートした。7-frポリウレタン血管カテーテルは、NaOHを含まない有機溶剤(酢酸ブチル:メタノール=50:50)の混合物中の10mg/mlの濃度のエリスロマイシンでもコートした。スタフィロコッカスアウリウスに対する阻害ゾーンは表13に示され、ナフシリンおよびエリスロマイシンを注入したカテーテルの効力を示す(即ち、Z.I.>10mm)。
様々なポリマー抗生物質注入尿カテーテルの効力
尿(膀胱)カテーテルを1時間、有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり25mgミノサイクリンおよび40mgリファンピン並びにメタノールmlあたり5mgのNaOHを含むコーティング溶液に浸した。結果は以下のとおりであった。
カテーテル エンテロコッカスに対する阻害ゾーン(m.m.)
ヘキサクロロフェンを含む抗菌溶液を注入された
7-frポリウレタン血管カテーテルの効力
7-frポリウレタン血管カテーテルに、NaOHを含まない有機溶剤の混合物(メタノールプラス酢酸ブチル、15:85体積比)のmlあたり10mg/mlの濃度のヘキサクロロフェンをコートした。スタフィロコッカスアウリウスおよびエンテロコッカスフェーカリスに対する阻害ゾーンは、それぞれ11および12mlであった。結果は、防腐剤並びに抗生物質、およびその混合物は、非金属医学装置例えばカテーテルの材料の注入において効果的に使用可能であることを示す。
Claims (1)
- 有機溶剤中に抗菌剤を溶解して、該組成物に浸透剤を加えることにより、バクテリアおよびカビ生物の成長を阻害するのに効果的な濃度の抗菌組成物を形成し;
組成物にアルカリ化剤を加え;そして 抗菌組成物が医学移植物の材料に浸透する条件下で医学移植物の少なくとも一部に抗菌組成物を塗布する工程からなる、抗菌剤を非金属医学移植物に注入する方法。
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US08/427,379 US5624704A (en) | 1995-04-24 | 1995-04-24 | Antimicrobial impregnated catheters and other medical implants and method for impregnating catheters and other medical implants with an antimicrobial agent |
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JP8532708A Division JPH11504241A (ja) | 1995-04-24 | 1996-04-22 | 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法 |
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JP8532708A Ceased JPH11504241A (ja) | 1995-04-24 | 1996-04-22 | 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法 |
JP2006178045A Expired - Lifetime JP4630238B2 (ja) | 1995-04-24 | 2006-06-28 | 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法 |
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US (2) | US5624704A (ja) |
EP (1) | EP0830107B1 (ja) |
JP (2) | JPH11504241A (ja) |
AU (1) | AU705163B2 (ja) |
CA (1) | CA2219342C (ja) |
DE (1) | DE69633177T2 (ja) |
ES (1) | ES2248809T3 (ja) |
WO (1) | WO1996033670A1 (ja) |
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Also Published As
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EP0830107A1 (en) | 1998-03-25 |
AU705163B2 (en) | 1999-05-20 |
DE69633177T2 (de) | 2005-08-11 |
DE69633177D1 (de) | 2004-09-23 |
EP0830107A4 (en) | 2000-10-25 |
US5902283A (en) | 1999-05-11 |
JPH11504241A (ja) | 1999-04-20 |
EP0830107B1 (en) | 2004-08-18 |
US5624704A (en) | 1997-04-29 |
ES2248809T3 (es) | 2006-03-16 |
JP4630238B2 (ja) | 2011-02-09 |
CA2219342A1 (en) | 1996-10-31 |
AU5575696A (en) | 1996-11-18 |
CA2219342C (en) | 2010-10-26 |
WO1996033670A1 (en) | 1996-10-31 |
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