JP4651280B2 - 血管内人工器具用eptfe被覆材 - Google Patents
血管内人工器具用eptfe被覆材 Download PDFInfo
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- JP4651280B2 JP4651280B2 JP2003530345A JP2003530345A JP4651280B2 JP 4651280 B2 JP4651280 B2 JP 4651280B2 JP 2003530345 A JP2003530345 A JP 2003530345A JP 2003530345 A JP2003530345 A JP 2003530345A JP 4651280 B2 JP4651280 B2 JP 4651280B2
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Description
例1においては、いくつかのePTFE被覆材を製造し、多孔度試験を行った。これらの結果が図11のグラフに示してある。図11におけるT/T、S/T及びT/S/Tは、それぞれ比較例、本発明の実施例1及び実施例2を表す。
図11において、管/管(T/T)は、下記の構造を有する脈管内グラフト(EVG)を表す。
外部層:節間距離20〜30μmのePTFEグラフト
内部層:節間距離40〜60μmのePTFEグラフト
実施例1
シート/管(S/T)は、下記の構造を有する脈管内グラフト(EVG)を表す。
外部層:節間距離5〜10μmのePTFEグラフト/シート
内部層:節間距離40〜60μmのePTFEグラフト
実施例2
管/シート/管(T/S/T)は、下記の構造を有する脈管内グラフト(EVG)を表す。
外部層:節間距離20〜30μmのePTFEグラフト
中間層:節間距離5〜10μmのePTFEグラフト/シート
内部層:節間距離40〜60μmのePTFEグラフト
実施例3
外部層:節間距離20〜30μmのePTFEグラフト
中間層:節間距離5〜10μmのePTFEグラフト
内部層:節間距離40〜60μmのePTFEグラフト
結果は不対t検定により解析し、0.05未満の確率値(P)のみを有意と考えた。
Claims (29)
- 埋込部位に関する1つ以上の生理活性物質の送達を調節するための埋込型の複合器具において、
(a)上記1つ以上の生理活性物質と、
(b)細胞内皮化を促進するのに十分な第1の多孔度を有するePTFEからなり、内腔層である第1層と、
(c)上記第1層の周囲に配置され、通り抜ける上記生理活性物質の送達の調節を可能にする第2の多孔度を有し、ポリマ材料からなる第2層であって、
上記第2層が内部にリザーバーを有し、前記リザーバーはリザーバー壁を有し、及びリザーバー中の生理活性物質がリザーバー壁を通り抜けて、第2層を形成するポリマ材料中に拡散するのに十分な透過性を有する多孔性ポリマ材料で形成されている、第2層と
(d)上記第2層の周囲に配置され、ePTFEからなり、第3の多孔度を有し、上記第1層の半径方向強度を上回る半径方向強度を示す第3層とを有し、
上記第2の多孔度は、上記第1層と上記第3層との間への細胞の侵入を調節する、複合器具。 - 上記リザーバーの内部に上記1つ以上の生理活性物質が埋め込まれていることを特徴とする請求項1記載の複合器具。
- 上記第2層の外側に上記1つ以上の生理活性物質がコーティングされていることを特徴とする請求項1記載の複合器具。
- 該複合器具が管状部材であることを特徴とする請求項1記載の複合器具。
- 上記第2層は、節間距離約5〜約10ミクロンの細孔を有するePTFEからなることを特徴とする請求項1記載の複合器具。
- 上記第2層は、結節/フィブリルの位置関係が約5〜約10ミクロンであることを特徴とする請求項5記載の複合器具。
- 上記第1層が節間距離40ミクロン以上の細孔を有し、
上記第3層が節間距離40ミクロン未満の細孔を有することを特徴とする請求項1記載の複合器具。 - 上記第2層を形成するポリマ材料は、合成ポリマ、天然ポリマ又はそれらの組合せからなるグループから選択されることを特徴とする請求項1記載の複合器具。
- 上記合成ポリマは、ePTFE、ポリウレタン、ポリアクリルアミド、ポリビニルアルコール、ポリリン酸塩エステル、ポリエーテルスルホン、ポリオルトエステル、ポリエステル、シロキサンポリマ、シリコーン、ポリビニルピロリドン、ポリビニルエーテル、ポリカーボネート、ポリアルキレン、ポリアミド、ポリ無水物、酸化ポリエチレン、芳香族ポリビニル、吉草酸ポリヒドロキシ酪酸塩、ポリヒドロキシ酪酸塩−コ−ヒドロキシ吉草酸塩、ポリアクリル酸、並びにそれらの誘導体及び混合物からなるグループから選択されることを特徴とする請求項8記載の複合器具。
- 上記天然ポリマは、フィブリン、エラスチン、セルロース、コラーゲン、ゼラチン、ビトロネクチン、フィブロネクチン、ラミニン、再構成基底膜基質、デンプン、デキストラン、アルギン酸塩、ヒアルロン酸、ポリラクト酸、ポリグリコール酸、ポリペプチド、グリコサミノグリカン、並びにそれらの誘導体及び混合物からなるグループから選択されることを特徴とする請求項8記載の複合器具。
- 上記天然ポリマ及び上記合成ポリマは、生体安定性又は生体吸収性ポリマであることを特徴とする請求項8記載の複合器具。
- 埋込部位に関する1つ以上の生理活性物質の送達を調節するための埋込型の複合器具において、
節間距離が40ミクロン以上の細孔を有するePTFEからなり、内腔層である第1層と、
上記第1層の周囲に配置され、ePTFEからなる第2層と、
上記第2層の周囲に配置され、節間距離が40ミクロン未満の細孔を有するePTFEからなる第3層とを有し、
上記第2層は、節間距離が約5〜約10ミクロンであり、且つ結節/フィブリルの位置関係が約5〜約10ミクロンである細孔を有し、該第2層を通り抜ける天然又は合成生理活性物質の送達の調節を可能にし、上記第2層が内部にリザーバーを有し、前記リザーバーはリザーバー壁を有し、及びリザーバー中の生理活性物質がリザーバー壁を通り抜けて、第2層を形成するePTFE中に拡散するのに十分な透過性を有する多孔性ポリマ材料で形成されている、
ことを特徴とする複合器具。 - 埋込部位に関する1つ以上の生理活性物質の送達を調節するための埋込型の複合器具において、
節間距離が40ミクロン未満の細孔を有するePTFEからなり、内腔層である第1層と、
上記第1層の周囲に配置され、ePTFEからなる第2層と、
上記第2層の周囲に配置され、節間距離が40ミクロン以上の細孔を有するePTFEからなる第3層とを有し、
上記第2層は、節間距離が約5〜約10ミクロンであり、且つ結節/フィブリルの位置関係が約5〜約10ミクロンである細孔を有し、該第2層を通り抜ける天然又は合成生理活性物質の送達の調節を可能にし、
上記第2層が内部にリザーバーを有し、前記リザーバーはリザーバー壁を有し、及びリザーバー中の生理活性物質がリザーバー壁を通り抜けて、第2層を形成するePTFE中に拡散するのに十分な透過性を有する多孔性ポリマ材料で形成されている、
ことを特徴とする複合器具。 - 上記第1層と上記第2層との間に埋込型補綴ステントをさらに有することを特徴とする請求項1、請求項12又は請求項13のいずれか1項に記載の複合器具。
- 上記第2層と上記第3層との間に埋込型補綴ステントをさらに有することを特徴とする請求項1、請求項12又は請求項13のいずれか1項に記載の複合器具。
- 上記1つ以上の生理活性物質は、成長因子、抗凝血物質、狭窄抑制物質、抗血栓物質、抗生物質、抗腫瘍物質、抗増殖物質、成長ホルモン、抗ウイルス物質、抗血管形成物質、血管形成物質、抗有糸分裂物質、抗炎症物質、細胞周期調節物質、遺伝物質、コレステロール降下物質、血管拡張物質、内因性血管作用機序を阻害する物質、ホルモン、それらの同族体、誘導体、断片、薬用塩、及びそれらの組合せからなるグループから選択されることを特徴とする請求項8、請求項12又は請求項13のいずれか1項に記載の複合器具。
- 埋込部位に関する1つ以上の生理活性物質の送達を調節するための埋込型の複合器具を製造する方法において、
第1の多孔度を有するePTFE材料からなり、内腔層である第1層を準備するステップと、
第2の多孔度を有し、天然又は合成ポリマ材料からなる第2層を上記第1層の周囲に配置するステップと、
第3の多孔度を有し、ePTFE材料からなる第3層を上記第2層の周囲に配置するステップとを有し、
上記第2層は、該第2層を通り抜ける上記1つ以上の生理活性物質の送達の調節を可能にし、上記第2層が内部にリザーバーを有し、前記リザーバーはリザーバー壁を有し、及びリザーバー中の生理活性物質がリザーバー壁を通り抜けて、第2層を形成するポリマ材料中に拡散するのに十分な透過性を有する多孔性ポリマ材料で形成されている、
することを特徴とする複合器具の製造方法。 - さらに埋込型補綴ステントを上記第1層と上記第2層との間に挿入することを特徴とする請求項17記載の複合器具の製造方法。
- さらに埋込型補綴ステントを上記第2層と上記第3層との間に挿入することを特徴とする請求項17記載の複合器具の製造方法。
- 上記第2層は、節間距離が約5〜約10ミクロンである細孔を有するePTFEからなることを特徴とする請求項17記載の複合器具の製造方法。
- 上記第2層は、結節/フィブリルの位置関係が約5〜約10ミクロンであることを特徴とする請求項20記載の複合器具の製造方法。
- 上記第3層は、上記第1層の半径方向強度を上回る半径方向強度を示すことを特徴とする請求項17記載の複合器具の製造方法。
- 上記ePTFEからなる第1層は、節間距離が40ミクロン以上の細孔を有し、
上記ePTFEからなる第3層は、節間距離が40ミクロン未満の細孔を有することを特徴とする請求項22記載の複合器具の製造方法。 - 上記第1層は、上記第3層の半径方向強度を上回る半径方向強度を示すことを特徴とする請求項17記載の複合器具の製造方法。
- 上記ePTFEからなる第1層は、節間距離が40ミクロン未満の細孔を有し、
上記ePTFEからなる第3層は、節間距離が40ミクロン以上の細孔を有することを特徴とする請求項24記載の複合器具の製造方法。 - 前記合成ポリマは、ePTFE、ポリウレタン、ポリアクリルアミド、ポリビニルアルコール、ポリリン酸塩エステル、ポリエーテルスルホン、ポリオルトエステル、ポリエステル、シロキサンポリマ、シリコーン、ポリビニルピロリドン、ポリビニルエーテル、ポリカーボネート、ポリアルキレン、ポリアミド、ポリ無水物、酸化ポリエチレン、芳香族ポリビニル、吉草酸ポリヒドロキシ酪酸塩、ポリヒドロキシ酪酸塩-コ-ヒドロキシ吉草酸塩、ポリアクリル酸、並びにそれらの誘導体及び混合物からなるグループから選択されることを特徴とする請求項17記載の複合器具の製造方法。
- 上記天然ポリマは、フィブリン、エラスチン、セルロース、コラーゲン、ゼラチン、ビトロネクチン、フィブロネクチン、ラミニン、再構成基底膜基質、デンプン、デキストラン、アルギン酸塩、ヒアルロン酸、ポリラクト酸、ポリグリコール酸、ポリペプチド、グリコサミノグリカン、並びにそれらの誘導体及び混合物からなるグループから選択されることを特徴とする請求項17記載の複合器具の製造方法。
- 上記天然ポリマ及び上記合成ポリマは、生体安定性ポリマ又は生体吸収性ポリマであることを特徴とする請求項17記載の複合器具の製造方法。
- 上記1つ以上の生理活性物質は、増殖因子、抗凝血物質、狭窄抑制物質、抗血栓物質、抗生物質、抗腫瘍物質、抗増殖物質、成長ホルモン、抗ウイルス物質、抗血管形成物質、血管形成物質、抗有糸分裂物質、抗炎症物質、細胞周期調節物質、遺伝物質、コレステロール降下物質、血管拡張物質、内因性血管作用機序を阻害する物質、ホルモン、それらの同族体、誘導体、断片、薬用塩、及びそれらの組合せからなるグループから選択されることを特徴とする請求項17記載の複合器具の製造方法。
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US09/962,062 US6827737B2 (en) | 2001-09-25 | 2001-09-25 | EPTFE covering for endovascular prostheses and method of manufacture |
PCT/US2002/022596 WO2003026713A1 (en) | 2001-09-25 | 2002-07-16 | Eptfe covering for endovascular prostheses |
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EP1925270B1 (en) | 2012-05-02 |
EP1429816A1 (en) | 2004-06-23 |
WO2003026713A1 (en) | 2003-04-03 |
CA2465704A1 (en) | 2003-04-03 |
EP1925270A2 (en) | 2008-05-28 |
CA2465704C (en) | 2010-11-09 |
US20030060871A1 (en) | 2003-03-27 |
JP2005503240A (ja) | 2005-02-03 |
EP1925270A3 (en) | 2008-06-04 |
US6827737B2 (en) | 2004-12-07 |
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