JP2005517490A - ポリマー性カバリングおよび生体活性コーティングを有する複合ステント - Google Patents
ポリマー性カバリングおよび生体活性コーティングを有する複合ステント Download PDFInfo
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Abstract
Description
本発明は、デバイス上にポリマー性カバリングを有し、そしてデバイスおよびこのポリマー性カバリング上に生体活性コーティングを有する複合膨張可能デバイス、送達装置、ならびに方法に関する。
伏在静脈移植片は、これまで、心臓中の閉塞した動脈血管をバイパスするために使用されてきた。これらは動脈組織ではなく静脈組織であるので、これらは、異なる特徴を有し、一般的に、動脈血管として長期に良好に機能しない。伏在バイパス静脈は、より筋肉性が低く、一般的に、極めてもろく、そしてコンプライアントである。これらの伏在静脈移植片が、年齢と共に疾患にかかる場合、コンシステンシー(consistency)がチーズまたはバターのようであり、非常に展性のある狭窄閉塞性沈着物が、形成され、これは、ステント移植物が後に続く場合でさえ、介入性カテーテル手順を用いて効果的に処置され得ない。狭窄を形成するプラーク材料は、ステントを通って滲み出る傾向があり、ステントおよび伏在静脈移植片によって流路を再閉塞する。他の脈管性閉塞物(例えば、大腿血管および膝窩血管および頸動脈ならびにネイティブな冠状動脈における)はまた、閉塞を罹患する。これらの多くの場合において、プラークは、ステントが血管中に展開される場合、ステントを通って増殖する。従って、このような状況において、永久の治療的軽減を提供するための、新規かつ改善されたデバイスおよび方法に対する大きな必要性が、存在する。
一般的に、その上に実質的に不浸透性のポリマー性カバリングを有し、このデバイスおよびカバリングの上に生体活性コーティングを有する、複合膨張可能デバイス、ならびに血管中の閉塞または部分閉塞を処置するために使用され得る複合膨張可能デバイス、特に伏在静脈移植片を使用する方法を提供することは、本発明の課題である。1つの実施形態において、ポリマー性カバリングは、不浸透性である。別の実施形態において、ポリマー性カバリングは、多孔性である。
一般的に、本発明を組込む複合膨張可能デバイスは、血液を保持する血管への送達のためであり、第1および第2の端部を有する膨張可能支持体を備える。不浸透性または多孔性ポリマー性スリーブは、支持体フレーム上に延長し、支持体フレームの第1および第2の端部を曝露されたままにし得る。生体活性コーティングは、ポリマー性スリーブの内部表面および外部表面の1つまたは両方に提供され、内皮細胞増殖を増大するためのフレームは、ポリマー性スリーブおよびフレームの血液接触表面上に提供される。
本発明の支持体において提供される配列
Claims (22)
- 血液を運ぶ脈管に送達するための複合膨張可能デバイスであって、第1および第2の端部を有する膨張可能支持フレーム、該支持フレーム上を延び、内側表面および外側表面を有するポリマースリーブ、ならびに該ポリマースリーブの内側表面および外側表面のうちの少なくとも1つに配置されそして取り付けられた、該ポリマースリーブにおける内皮細胞増殖を促進するためのコーティング、を備える、デバイス。
- 前記ポリマースリーブが、多孔性である、請求項1に記載のデバイス。
- 前記ポリマースリーブが、不浸透性である、請求項1に記載のデバイス。
- 前記内側表面および外側表面の両方が、前記コーティングで被覆されている、請求項1に記載のデバイス。
- 前記第1および第2の端部が露出され、前記スリーブを含まない、請求項1に記載のデバイス。
- 前記膨張可能支持フレームおよびポリマースリーブが、円筒形である、請求項1に記載のデバイス。
- 前記膨張可能支持フレームおよびポリマースリーブが、テーパー状である、請求項1に記載のデバイス。
- 前記膨張可能支持フレームが、該フレームの膨張の間にその長さを維持するように構築されている、請求項1に記載のデバイス。
- 請求項1に記載のデバイスであって、前記コーティングが、前記内側表面または外側表面を、高周波エネルギーを使用するガス状プラズマクリーニングプロセスを用いて処理し、該内側表面または外側表面をアブレーションし、該内側表面または外側表面を官能化し、そして官能基を有するプラズマ沈着層を生成し、そして該プラズマ沈着層を、湿式化学処理において多官能性リンカー/スペーサーに供し、該リンカー/スペーサーと該プラズマ沈着層の官能基との間に共有結合を形成し、細胞接着ペプチドを基板の該内側表面または外側表面に共有結合することによって、調製される、デバイス。
- 前記コーティングが、細胞接着ペプチドである、請求項1に記載のデバイス。
- 前記細胞接着ペプチドが、配列番号1として表されるアミノ酸配列を有する、請求項10に記載のデバイス。
- 請求項1に記載のデバイスであって、前記膨張可能支持フレームが、
複数の軸方向に整列されたベルト
第1および第2の端部;および
連結手段、
を含み、該ベルトの各々が、第1端部および第2端部を有する複数の円周上で間隔の空いた支材、および折り畳み可能リンクを含み、該リンクは、該支材の第1端部および第2端部に固定され、該連結手段は、該ベルトと該第1端部および第2端部とを軸に沿って延びるように連続的に連結し、そして該デバイスの長さを維持しつつ、該ベルトと該端部との間の軸方向の屈曲を可能にする、デバイス。 - 前記連結手段が、少なくとも1つの支材および複数のS字型リンクを含む、請求項12に記載のデバイス。
- 前記連結手段が、単一の支材、ならびに第1および第2のS字型リンクを含み、これら全てが120°離れている、請求項12に記載のデバイス。
- 隣接するベルト間の前記連結手段が、互いに対して角度をつけてオフセットされている、請求項12に記載のデバイス。
- 前記端部が、正弦曲線状である、請求項15に記載のデバイス。
- 前記端部によって保持される放射線透過性マーカーをさらに含む、請求項12に記載のデバイス。
- 請求項1に記載のデバイスであって、前記スリーブが、折り畳み部を備え、該デバイスが、該デバイスの展開の間に前記フレームから前記スリーブが外れるのを防ぐために、ラベルを該スリーブに取り付けるための手段をさらに備える、デバイス。
- ある長さおよびある内径を有する膨張可能デバイスのための送達装置であって、
シャフト;
該シャフトに取り付けられたバルーン;および
放射線透過性マーカー、
を含み、
該シャフトは、該バルーンを膨らませそして縮ませるための管腔をその中に有し、該バルーンは、近位部分、遠位部分および中間部分を有して形成され、該中間部分は、該膨張可能デバイスを収容するための長さを有し、該放射線透過性マーカーは、該バルーンの近位部分および遠位部分内に保持され、かつ該マーカーが該バルーンの中間部位に取り付けられた場合に、該膨張可能デバイスを該中間部分に取り付けるために、該膨張可能デバイスの内径より大きな直径を有し、該膨張装置の展開の間に該膨張可能デバイスが外れるのを防ぐようにサイズ決めされ、該バルーンの近位端および遠位端は、これらが該中間部分に配置された場合、該秒長可能デバイスのサイズより大きいサイズを有し、該装置を用いる該膨張デバイスの展開の間、該膨張可能デバイスの不慮の外れを防止するようにサイズ決めされている、
送達装置。 - 複数の複合膨張可能デバイスを展開する方法であって、該複合膨張可能デバイスは、対向する近位端部および遠位端部を有する膨張可能フレーム、ならびに該フレーム上を延びるポリマースリーブを含み、該方法は、遠位端部上に膨張可能バルーンを有するバルーン送達カテーテルを使用し、
該方法は、
第1の複合膨張可能デバイスを該バルーンに取り付ける工程、該バルーン送達カテーテルを使用して、該デバイスを脈管中の所望の部位に送達する工程、該脈管中で、該バルーンを膨らませて、該デバイスを膨張させる工程、該バルーンを縮め、該バルーンを該脈管から取り出す工程、バルーン送達カテーテルを使用して、第2の複合膨張可能デバイスを該部位まで送達し、すでに適所に配置された該第1の複合デバイスの該近位端部において、さらなる複合膨張可能デバイスの遠位端部を、該端部を互いに噛みあわせることによってドッキングする工程、該バルーンを膨張させて、該第2の複合膨張可能デバイスを膨張させ、すでに適所に配置された該複合膨張可能デバイスの近位端部内で、該遠位端部を膨張させて、ドッキングを完了する工程、該バルーンを縮める工程、および該バルーン送達カテーテルを該脈管から取り出す工程、を包含する、方法。 - 前記第1のデバイスが、テーパー状デバイスである、請求項20に記載の方法。
- 血液を保有する脈管中に送達するためのデバイスであって、内側表面および外側表面を有するポリマースリーブ、ならびに該ポリマースリーブ上での内皮細胞増殖を促進するために、該ポリマースリーブの該内側表面および外側表面の少なくとも1つに配置されそしてこれに取り付けられたコーティング、を含む、デバイス。
Applications Claiming Priority (1)
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PCT/US2001/049635 WO2003070125A1 (en) | 2001-12-21 | 2001-12-21 | Composite stent with polymeric covering and bioactive coating |
Publications (1)
Publication Number | Publication Date |
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JP2005517490A true JP2005517490A (ja) | 2005-06-16 |
Family
ID=27752542
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JP2003569087A Pending JP2005517490A (ja) | 2001-12-21 | 2001-12-21 | ポリマー性カバリングおよび生体活性コーティングを有する複合ステント |
Country Status (6)
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US (2) | US20060034883A1 (ja) |
EP (1) | EP1467678A1 (ja) |
JP (1) | JP2005517490A (ja) |
AU (1) | AU2002241676B2 (ja) |
CA (1) | CA2470824A1 (ja) |
WO (1) | WO2003070125A1 (ja) |
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2008
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US20090062899A1 (en) | 2009-03-05 |
EP1467678A1 (en) | 2004-10-20 |
AU2002241676B2 (en) | 2008-10-23 |
US20060034883A1 (en) | 2006-02-16 |
CA2470824A1 (en) | 2003-08-28 |
WO2003070125A1 (en) | 2003-08-28 |
AU2002241676A1 (en) | 2003-09-09 |
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