JP5366155B2 - 血栓症を低減するためにホスホリルコリンアクリレートポリマーの上塗層を備え、機械特性が改善された埋め込み型医療デバイス - Google Patents
血栓症を低減するためにホスホリルコリンアクリレートポリマーの上塗層を備え、機械特性が改善された埋め込み型医療デバイス Download PDFInfo
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- JP5366155B2 JP5366155B2 JP2010508476A JP2010508476A JP5366155B2 JP 5366155 B2 JP5366155 B2 JP 5366155B2 JP 2010508476 A JP2010508476 A JP 2010508476A JP 2010508476 A JP2010508476 A JP 2010508476A JP 5366155 B2 JP5366155 B2 JP 5366155B2
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Description
本発明は、有機化学、高分子科学、材料科学、及び医療デバイスの分野に関する。詳細には、本発明は、脈管疾患を治療するためのホスホリルコリンアクリレートポリマー上塗層を備えた医療デバイスに関する。
経皮的経管冠動脈形成術(PTCA)は、心疾患を治療するための一般的な手術である。PTCAに関連した問題には、バルーンが収縮した後に脈管を潰して閉塞させることがある内膜フラップや断裂動脈内層の発生がある。さらに、手術から数カ月経過すると、動脈の血栓症及び再狭窄が起きて、別の脈管形成術や外科バイパス手術が必要になることもある。動脈内層が潰れることによる動脈の部分的又は完全な閉塞を軽減させて、血栓症及び再狭窄が発生する可能性を低減させるために、ステントを内腔に埋め込んで脈管の開存性を維持する。
したがって、一態様では、本発明は、
デバイス本体と、
このデバイス本体の上に設けられた任意選択の下塗層と、
このデバイス本体又は下塗層(選択された場合)の上に設けられた、1つ又は複数の治療薬を含む薬物保持層と、
この薬物保持層の上に最外層として設けられた、ホスホリルコリンアクリレートポリマーを含む上塗層と
を備えた埋め込み型医療デバイスに関する。
(式中、mは0.005〜0.90、nは0.10〜0.995、m+n=1、xは65〜6960、R1及びR2は、水素及びメチルからなる群から独立に選択され、炭化水素基は、不飽和又は飽和の分枝鎖又は直鎖C1〜C16脂肪族部分、脂環式部分、又は芳香族部分からなる群から選択される)
治療を必要とする患者の脈管に、
デバイス本体と、
このデバイス本体の上に設けられた任意選択の下塗層と、
このデバイス本体又は下塗層(選択された場合)の上に設けられた、1つ又は複数の治療薬を含む薬物保持層と、
この薬物保持層の上に最外層として設けられた、ホスホリルコリンアクリレートポリマーを含む上塗層と
を備えた埋め込み型医療デバイスを配置するステップ
を含む方法である。
(式中、mは0.005〜0.90、nは0.10〜0.995、m+n=1、xは65〜6960、R1及びR2は、水素及びメチルからなる群から独立に選択され、炭化水素基は、不飽和又は飽和の分枝鎖又は直鎖C1〜C16脂肪族部分、脂環式部分、又は芳香族部分からなる群から選択される)
本明細書における単数形の使用は、特段の記載がない限り複数形を含み、逆もまた同様である。すなわち、「ある(a)」及び「その(the)」は、これらの語が修飾するあらゆる1つ又は複数の語を指す。例えば、「ある治療薬」は、1つの治療薬及び2つの治療薬なども含む。同様に、「その層」は、1つの層、2つの層又はそれ以上の層を指すことができ、「そのポリマー」は、1つのポリマー又は複数のポリマーを指すことができる。さらに、限定するものではないが、「層」及び「ポリマー」などの語は、特段の記載がある場合又は意図しないことが文脈から明らかな場合を除き、複数の層又はポリマーはもちろん、1つの層又はポリマーも指す。
[[−Y−]n/[−Z−]m]x
この式は、規則的な交互コポリマー、ランダムコポリマー、又はブロックコポリマーを指し、現在は、ランダムコポリマーが好ましい。本明細書で用いる英字「n」及び「m」は、構成単位YとZのモル比を意味し、n+m=1である。英字「x」は、配列の重複数、すなわちポリマーのカッコ外の範囲における上記式の反復数を意味する。
Claims (8)
- デバイス本体と、
前記デバイス本体の上に設けられた任意選択の下塗層と、
前記デバイス本体又は前記下塗層(選択された場合)の上に設けられた、1つ又は複数の治療薬を含む薬物保持層と、
前記薬物保持層の上に最外層として設けられた、ホスホリルコリンアクリレートポリマーを含む上塗層と
を備えた埋め込み型医療デバイスであって、
前記ホスホリルコリンアクリレートポリマーは、ポリ(2−(メタクリロイルオキシエチル)−2−(トリメチルアンモニウムエチル)−リン酸,分子内塩)−co−(n−ドデシルメタクリレート)−co−(ヒドロキシプロピルメタクリレート)−co−(3−(トリメトキシシリル)プロピルメタクリレート)を含み、
前記薬物保持層は、以下の式を有するアクリレート又はメタクリレートポリマーを含む、埋め込み型医療デバイス
- ステントである請求項1に記載の埋め込み型医療デバイス。
- (2−(メタクリロイルオキシエチル)−2−(トリメチルアンモニウムエチル)−リン酸,分子内塩)と(n−ドデシルメタクリレート)と(ヒドロキシプロピルメタクリレート)と(3−(トリメトキシシリル)プロピルメタクリレート)との構成単位の比(wt/wt)は概ね28.8:50.7:15.3:5.3からである請求項1に記載の埋め込み型医療デバイス。
- 前記ホスホリルコリンアクリレートポリマーは実質的に非晶質である請求項1に記載の埋め込み型医療デバイス。
- 前記アクリレート又はメタクリレートポリマーは、約20,000〜約600,000ダルトンの平均分子量を有する請求項1に記載の埋め込み型医療デバイス。
- 前記アクリレート又はメタクリレートポリマーは、ポリ(ブチルメタクリレート)を含む請求項1に記載の埋め込み型医療デバイス。
- 少なくとも1つの前記治療薬が、増殖抑制剤、抗炎症剤、抗新生物薬、抗有糸分裂剤、抗血小板剤、抗凝固剤、抗フィブリン剤、抗トロンビン薬、細胞増殖抑制剤、抗生物質、抗アレルギー剤及び酸化防止剤からなる群から選択される、請求項1〜6のいずれか一項に記載の埋め込み型医療デバイス。
- 少なくとも1つの前記治療薬が、アクチノマイシンD、タキソール、ドセタキセル、パクリタキセル、ラパマイシン、バイオリムス、ペルフェニドン、エベロリムス、40−O−(3−ヒドロキシプロピル)ラパマイシン、40−O−[2−(2−ヒドロキシ)エトキシ]エチル−ラパマイシン、40−O−テトラゾリルラパマイシン、40−epi−(N1−テトラゾリル)−ラパマイシン、及びこれらの組合せからなる群から選択される増殖抑制剤である、請求項1〜6のいずれか一項に記載の埋め込み型医療デバイス。
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US11/803,651 US20080286332A1 (en) | 2007-05-14 | 2007-05-14 | Implantable medical devices with a topcoat layer of phosphoryl choline acrylate polymer for reduced thrombosis, and improved mechanical properties |
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-
2007
- 2007-05-14 US US11/803,651 patent/US20080286332A1/en not_active Abandoned
-
2008
- 2008-04-11 EP EP08745670.3A patent/EP2162159B1/en not_active Not-in-force
- 2008-04-11 WO PCT/US2008/060110 patent/WO2008144130A2/en active Application Filing
- 2008-04-11 JP JP2010508476A patent/JP5366155B2/ja not_active Expired - Fee Related
-
2012
- 2012-08-29 US US13/597,600 patent/US9180225B2/en not_active Expired - Fee Related
Also Published As
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US20080286332A1 (en) | 2008-11-20 |
WO2008144130A3 (en) | 2009-10-29 |
EP2162159B1 (en) | 2016-08-31 |
JP2010527262A (ja) | 2010-08-12 |
EP2162159A2 (en) | 2010-03-17 |
WO2008144130A2 (en) | 2008-11-27 |
US9180225B2 (en) | 2015-11-10 |
US20120330405A1 (en) | 2012-12-27 |
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