JP2012504995A - 制御放出可能な抗菌剤を備えた医療デバイス - Google Patents
制御放出可能な抗菌剤を備えた医療デバイス Download PDFInfo
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- JP2012504995A JP2012504995A JP2011530496A JP2011530496A JP2012504995A JP 2012504995 A JP2012504995 A JP 2012504995A JP 2011530496 A JP2011530496 A JP 2011530496A JP 2011530496 A JP2011530496 A JP 2011530496A JP 2012504995 A JP2012504995 A JP 2012504995A
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Abstract
Description
以下の詳細な説明において、本発明の好ましい実施態様を記載する。しかし、異なる実施態様の特徴は、実施態様間で交換可能であり、そして特に具体的な記載がなければ異なるやり方を組み合わせてもよいことは理解すべきである。親水性医療デバイスは、多くの異なる目的に、そして種々のタイプの体腔への挿入に使用することができる。しかし、以下の議論は、特に、好ましい使用領域、尿道カテーテルに関するが、本発明は、この特定のタイプのカテーテル又はこの特定のタイプの医療デバイスにさえ制限されることはない。本発明の概念は、いずれか特定のタイプの機器に制限されることなく、さまざまなタイプの医療デバイスを使用することができることは、当業者にとって明白である。
実験のため、一般に商品名メリフレックス(Meliflex)の下で販売されている、材料ポリプロペン(Polypropene)、ポリエテンポリアミド及びスチレン−エタン/ブテン−スチレンコポリマーの組み合わせの基体材料を用いてカテーテルを調製した。
A)抗菌銀コーティングを有するが、親水性コーティングのないカテーテル。
B)A)よりも高い銀濃度の抗菌銀コーティングを有し、かつ親水性コーティングを有するカテーテル。
C)A)とほぼ同じ濃度の抗菌銀コーティングを有し、かつ親水性コーティングを有するカテーテル。特に、A)及びC)によるカテーテルは、カテーテルA)が親水性コーティングを有してない他は、本質的に同一であった。
・銀の浸出量は、群B及びCよりも、親水性コーティングを有しない群Aでより有意に変化している。この効果は、より長い浸出時間についてさらにより顕著である。
・結果的に、親水性コーティングは、抗菌コーティングからの銀イオンの放出をより予測可能及び制御可能にする安定化効果を有すると結論付けることができる。
・浸出した銀の平均量は、コーティング中にほぼ同じ総量の銀を有する群A及びCについてはほぼ同じであった。
・従って、親水性コーティングは、抗菌コーティングからの全体レベルの銀イオンの放出に対して明確な作用を示さないと結論付けることができる。
・銀イオンの放出レベルで見られた変動の低下における大きな改善は、群B及びCについてはほぼ同じであった。同時に、群Bの銀の総量は、群Cと比較して約2倍であった。従って、このポジティブな効果は、抗菌コーティング中の銀イオンの総量に依存しないことは明らかである。
さて、本発明を、種々の実施態様に関連して議論してきた。しかしながら、当業者には当然のことながら、いくつかのさらなる別法が可能である。例えば、微量作用金属を含む多くの他のタイプの抗菌コーティングも、他のタイプの親水性コーティングも、使用することができる。さらに、血管カテーテルなどのような尿道カテーテルとは別のタイプのカテーテルに、又は親水性コーティングを有する別のタイプの医療デバイスに本発明を使用することは可能である。
Claims (15)
- 基体材料、該基体材料の表面の少なくとも一部の上に配置された親水性表面コーティング、及び該基体材料と該親水性表面コーティングとの間に配置された微量作用金属を含む抗菌層を含み、ここで該親水性表面コーティングは、親水性表面コーティングを通して微量作用金属イオンの制御放出を与えるのに十分大きな厚さを有する医療デバイス。
- 基体材料、該基体材料の表面の少なくとも一部の上に配置された親水性表面コーティング、及び該基体材料と該親水性表面コーティングとの間に配置された微量作用金属を含む抗菌層を含み、ここで該親水性表面コーティングは、3μmを超える乾燥時の厚さを有する医療デバイス。
- 親水性表面コーティングは、5μmを超える乾燥時の厚さを有し、そして好ましくは10μmを超える、請求項1又は2に記載の医療デバイス。
- 親水性表面コーティングは、5〜30μmの範囲、そして好ましくは10〜20μmの範囲の乾燥時の厚さを有する、請求項1〜3のいずれか1項に記載の医療デバイス。
- 抗菌層の微量作用金属は、銀、そして好ましくはさらに金及び/又は白金金属のような安定剤を含む、請求項1〜4のいずれか1項に記載の医療デバイス。
- 親水性表面コーティング及び抗菌層は、0.01〜1.0マイクログラム/cm2の範囲、そして好ましくは0.05〜0.5マイクログラム/cm2の範囲、そして最も好ましくは0.10〜0.30マイクログラム/cm2の範囲で微量作用金属の遊離イオンの制御放出を与えるように適合される、請求項1〜5のいずれか1項に記載の医療デバイス。
- 親水性表面コーティングは、湿潤液体で濡らしたときに表面摩擦が有意に低下するポリビニルピロリドン(PVP)のような親水性ポリマーを含む、請求項1〜6のいずれか1項に記載の医療デバイス。
- 親水性ポリマーは、ポリビニル化合物、ポリラクタム、特にポリビニルピロリドンなど、多糖類、特にヘパリン、デキストラン、キサンタンガム、誘導体化多糖類、ヒドロキシプロピルセルロース、メチルセルロース、ポリウレタン、ポリアクリレート、ポリヒドロキシアクリレート、ポリメタクリレート、ポリアクリルアミド、ポリアルキレンオキシド、特にポリエチレンオキシド、ポリビニルアルコール、ポリアミド、ポリアクリル酸、上述ポリマーのコポリマー、ビニル化合物とアクリレート又は無水物とのコポリマー、ビニルピロリドンとヒドロキシエチルメチルアクリレートとのコポリマー、ポリビニルピロリドンのカチオン性コポリマー、及びポリメチルビニルエーテルとマレイン酸無水物とのコポリマーの少なくとも1つである、請求項1〜7のいずれか1項に記載の医療デバイス。
- 医療デバイスは、カテーテル、そして好ましくは尿道カテーテルである、請求項1〜8のいずれか1項に記載の医療デバイス。
- 親水性表面コーティングは、浸透圧を高める化合物をさらに含む、請求項1〜9のいずれか1項に記載の医療デバイス。
- 基体材料を備え;
該基体材料の表面の少なくとも一部の上に抗菌層を配置し;そして
該抗菌層の上面上に親水性表面コーティングを配置する:工程を含み、
ここで、該親水性表面コーティングは、親水性表面コーティングを通して微量作用金属イオンを制御放出するのに十分大きな厚さを有する、微量作用金属を含む抗菌層からの微量作用金属イオンの制御可能な放出を得る方法。 - 基体材料を備え;
該基体材料の表面の少なくとも一部の上に抗菌層を配置し;そして
該抗菌層の上面上に親水性表面コーティングを配置する:工程を含み、
ここで、該親水性表面コーティングは3μmを超える乾燥時の厚さを有する、
微量作用金属を含む抗菌層から微量作用金属イオンの制御可能な放出を得る方法。 - 親水性コーティングは、ポリ尿素ネットワークを形成し、それによって該ポリ尿素ネットワークは、基体中の活性水素基に共有結合を形成する、請求項11又は12に記載の方法。
- 基体材料をコーティングする工程は、基体の表面に、最初にイソシアネート化合物0.05〜40%(質量/体積)を含む溶液、そしてその後、ポリビニルピロリドン0.5〜50%(質量/体積)を含む溶液を順に塗布し、そして高温で硬化するサブ工程を含む、請求項13に記載の方法。
- 親水性コーティングは、照射によって基体に架橋される、請求項11又は12に記載の方法。
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- 2008-10-14 EP EP08166578.8A patent/EP2177238B1/en not_active Not-in-force
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2009
- 2009-10-09 CN CN2009801398653A patent/CN102176928A/zh active Pending
- 2009-10-09 WO PCT/EP2009/063188 patent/WO2010043565A1/en active Application Filing
- 2009-10-09 CA CA2736932A patent/CA2736932C/en not_active Expired - Fee Related
- 2009-10-09 US US12/576,358 patent/US20100086580A1/en not_active Abandoned
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS58193767A (ja) * | 1982-04-22 | 1983-11-11 | アストラ・メデイテツク・アクチエボラ−グ | 親水性コ−テイングの製法 |
JP2004529208A (ja) * | 1999-11-05 | 2004-09-24 | スィー.アール. バード インコーポレイテッド | 活性物質を含有するシランコポリマー組成物 |
WO2006002628A1 (en) * | 2004-06-30 | 2006-01-12 | Coloplast A/S | A hydrophilic, water-swellable, cross-linked matrix having incorporated therein an anti-microbial polymer |
WO2007011287A1 (en) * | 2005-07-18 | 2007-01-25 | Astra Tech Ab | Urinary catheter |
Also Published As
Publication number | Publication date |
---|---|
JP5685539B2 (ja) | 2015-03-18 |
BRPI0920314B1 (pt) | 2018-07-17 |
US20100086580A1 (en) | 2010-04-08 |
AU2009305471A1 (en) | 2010-04-22 |
BRPI0920314A2 (pt) | 2016-02-23 |
EP2177238A1 (en) | 2010-04-21 |
AU2009305471B2 (en) | 2013-11-14 |
EP2177238B1 (en) | 2016-11-09 |
CA2736932A1 (en) | 2010-04-22 |
WO2010043565A1 (en) | 2010-04-22 |
CN102176928A (zh) | 2011-09-07 |
CA2736932C (en) | 2017-03-07 |
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