JP2006525089A - 抗菌層を備える医療用デバイス - Google Patents
抗菌層を備える医療用デバイス Download PDFInfo
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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Abstract
Description
(発明の分野)
本発明は、医療用デバイスに関し、そしてより具体的には、医療用デバイスに抗菌機能を付与する方法、ならびにそのシステムおよび装置に関する。
換気器に関連する肺炎は、重大に罹患している患者における死因であり得る。気管に関連する肺炎(VAP)の約250,000の症例が、毎年報告されている。VAPに関連する死亡率は、年間約23,000の患者である(Engelmann,J.ら:Ventilator−Associated Pneumonia,Seminars in Infection Control,第1巻、第2号、2001)。
第一の実施形態において、医療用デバイスは、流体のための導管を備え、この導管は、外側表面を有する壁を備え、この壁は、疎水性ポリマーを含み、この外側表面上に、外側層が配置されており、この外側層は、第一の量の親水性ポリマーを含み、この親水性ポリマーの内部には、実質的に、抗菌化合物が分散されており、この抗菌化合物は、所定の量の金属が内部に実質的に分散した、所定の量のリンベースのガラスを含み、そしてこの壁および外側層は、押出し成形によって形成される。
医療用デバイスとは、生存身体の周りで使用され得るか、またはその内部に挿入され得るデバイスである。1つのこのようなデバイスは、ET管のような管であり得る。ET管が、以下の実施例において使用され得るが、本発明は、ET管に限定されない。本発明は、種々の実施形態において、他の型の医療用デバイス(例えば、管、カテーテル、ステント、供給管、呼吸回路、静脈内管、呼吸管、回路、ならびに関連する気道付属物(例えば、コネクタ、アダプタ、フィルタ、加湿器、ネブライザ、およびプロテーゼ))に、同様に適用され得る。
Claims (24)
- 医療用デバイスであって、以下:
流体のための導管であって、該導管は、外側表面を有する壁を備え、該壁は、疎水性ポリマーを含む、導管;
該外側表面上に配置された外側層であって、該外側層は、内部に実質的に分散されている抗菌化合物を有する、第一の量の親水性ポリマーを含む、外側層;
を備え、
該抗菌化合物は、内部に実質的に分散された所定の量の金属を有する、所定の量のリンベースのガラスを含み、そして
該壁および該外側層が、押出成型によって形成されている、
医療用デバイス。 - 前記金属が:
銅、
金、
銀粉末、
実質的に元素の銀、
銀イオン、
酸化銀、および
これらの組み合わせ、
からなる群より選択される、請求項1に記載の医療用デバイス。 - 前記壁が、
内側表面;
該内側表面上に配置された内側層であって、該内側層は、内部に実質的に分散された前記抗菌化合物を有する、第二の量の前記親水性ポリマーを含む、内側層、
をさらに備え;そして
該内側層が、押出成型によって形成されている、
請求項1に記載の医療用デバイス。 - 前記内側層の厚さが、約0.002mm〜2.5mmの範囲内である、請求項3に記載の医療用デバイス。
- 前記外側層の厚さが、約0.002mm〜2.5mmの範囲内である、請求項1に記載の医療用デバイス。
- 内部に実質的に分散された前記抗菌化合物を有する、第三の量の前記親水性ポリマーが、前記壁内に実質的に分散されている、請求項1に記載の医療用デバイス。
- カフをさらに備え、該カフは、前記医療用デバイスの周りに配置されたカフ外側表面、該カフ外側表面上に配置されたカフ外側層を有し、該カフ外側層は、内部に実質的に分散された前記抗菌化合物を有する、第四の量の前記親水性ポリマーを含み;
該カフ外側層が、押出成型によって形成されている、
請求項1に記載の医療用デバイス。 - 前記親水性ポリマーが、ポリウレタンを含む、請求項1に記載の医療用デバイス。
- 前記親水性ポリマーが、医療等級の親水性熱可塑性ポリウレタンを含む、請求項1に記載の医療用デバイス。
- 前記金属が、前記抗菌化合物から放出可能である、請求項1に記載の医療用デバイス。
- 前記金属が、約0.01μg/cm2/日までの溶離速度で放出される、請求項10に記載の医療用デバイス。
- 前記金属が、約0.01μg/cm2/日と約1.0μg/cm2/日との間の溶離速度で放出される、請求項10に記載の医療用デバイス。
- 前記金属が、約0.4μg/cm2/日の溶離速度で放出される、請求項10に記載の医療用デバイス。
- 前記所定の量のリンベースのガラスが、前記抗菌化合物の重量の約0.1〜50%を構成する、請求項1に記載の医療用デバイス。
- 前記疎水性ポリマーが:
PVC、
PE、
PU、
PDMS、
ポリエステル、
シリコーン、および
ゴム、
からなる群より選択される材料を含む、請求項1に記載の医療用デバイス。 - 前記医療用デバイスが、気管内チューブを備える、請求項1に記載の医療用デバイス。
- 前記医療用デバイスが:
カテーテル、
ステント、
栄養管、
呼吸回路、
静脈内管、
回路、
補助気道、
コネクタ、
アダプタ、
フィルタ、
加湿器、
ネブライザ、および
プロテーゼ、
からなる群より選択される、請求項1に記載の医療用デバイス。 - 前記抗菌化合物が:
二酸化炭素濃度の指示薬、
気管支拡張薬、
抗炎症性薬剤、および
局所麻酔薬、
からなる群より選択される薬剤をさらに含有する、請求項1に記載の医療用デバイス。 - 請求項1に記載の医療用デバイスを作製する方法であって:
疎水性ポリマーを提供する工程;
該疎水性ポリマーを押出成型して、壁を形成する工程;
内部に実質的に分散した所定の量の金属を有する、所定の量のリンベースのガラスを含む、抗菌化合物を生成する工程;
該抗菌化合物と親水性ポリマーとを混合する工程;および
内部に実質的に分散した該抗菌化合物を有する該親水性ポリマーを、該壁の外側表面を覆って押出成型する工程、
を包含する、方法。 - 内部に実質的に分散した前記抗菌化合物を有する前記親水性ポリマーの層を、前記壁の内側表面を覆って押出成型する工程をさらに包含する、請求項19に記載の医療用デバイスを作製する方法。
- 前記導管の端部にカフを形成する工程をさらに包含する、請求項19に記載の医療用デバイスを作製する方法。
- 医療用デバイスを作製するためのシステムであって、以下:
疎水性ポリマーを提供するための手段;
該疎水性ポリマーを押出成型して壁を形成するための手段;
内部に実質的に分散された所定の量の金属を有する、所定の量のリンベースのガラスを含む抗菌化合物を生成するための手段;
該抗菌化合物と親水性ポリマーとを混合するための手段;および
内部に実質的に分散された該抗菌化合物を有する該親水性ポリマーの層を、該壁の外側表面を覆って押出成型するための手段、
を備える、システム。 - 医療用デバイスであって、以下:
流体のための導管であって、該導管は、外側表面を有する壁を備え、該壁は、疎水性ポリマーを含む、導管;
該外側表面上に配置された外側層であって、該外側層は、内部に実質的に分散された抗菌化合物を有する、第一の量の親水性ポリマーを含む、外側層、
を備え;
該抗菌化合物が、内部に実質的に分散された所定の量の金属を有する、所定の量のリンベースのガラスを含み;そして
該壁および該外側層が、成型によって形成されている、
医療用デバイス。 - 前記成型が:
オーバーモールディング、
インサートモールディング、
吹込成型、
積層吹込成型、
射出成型、および
圧縮成型、
からなる群より選択される、請求項23に記載の医療用デバイス。
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US10/425,030 US20040220534A1 (en) | 2003-04-29 | 2003-04-29 | Medical device with antimicrobial layer |
PCT/US2004/013196 WO2004096330A2 (en) | 2003-04-29 | 2004-04-29 | Medical device with antimicrobial layer |
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JP2006525089A true JP2006525089A (ja) | 2006-11-09 |
JP2006525089A5 JP2006525089A5 (ja) | 2007-11-15 |
Family
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US (4) | US20040220534A1 (ja) |
EP (1) | EP1617890B1 (ja) |
JP (1) | JP2006525089A (ja) |
AT (1) | ATE472343T1 (ja) |
AU (1) | AU2004234001B2 (ja) |
CA (1) | CA2523857A1 (ja) |
DE (1) | DE602004027899D1 (ja) |
WO (1) | WO2004096330A2 (ja) |
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Also Published As
Publication number | Publication date |
---|---|
DE602004027899D1 (de) | 2010-08-12 |
EP1617890B1 (en) | 2010-06-30 |
US20110067703A1 (en) | 2011-03-24 |
US20040220534A1 (en) | 2004-11-04 |
WO2004096330A2 (en) | 2004-11-11 |
AU2004234001B2 (en) | 2010-08-12 |
ATE472343T1 (de) | 2010-07-15 |
AU2004234001A1 (en) | 2004-11-11 |
EP1617890A2 (en) | 2006-01-25 |
US20060118122A1 (en) | 2006-06-08 |
WO2004096330A3 (en) | 2005-01-06 |
CA2523857A1 (en) | 2004-11-11 |
US20060118121A1 (en) | 2006-06-08 |
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