JP2018512247A - 多要素生体吸収性血管内ステント - Google Patents
多要素生体吸収性血管内ステント Download PDFInfo
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- JP2018512247A JP2018512247A JP2017564763A JP2017564763A JP2018512247A JP 2018512247 A JP2018512247 A JP 2018512247A JP 2017564763 A JP2017564763 A JP 2017564763A JP 2017564763 A JP2017564763 A JP 2017564763A JP 2018512247 A JP2018512247 A JP 2018512247A
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Abstract
Description
本出願は、2015年3月3日出願の「MULTI−ELEMENT BIORESORBABLE INTRAVASCULAR STENT」という名称の米国仮特許出願第62/127370号明細書の利益及び優先権を主張し、この特許出願の全開示内容は、参照により本明細書に組み入れられる。
Claims (27)
- 血管を通る血流を維持又は促進するために前記血管内に配置される装置において、複数のステント要素が互いに接触することなく多要素ステントとして前記血管内に移植されるように構成された複数のバルーン拡張型生体吸収性血管ステント要素を含み;
前記ステント要素が第1のセットのクローズドセル及び第2のセットのクローズドセルを含み、前記第1のセットのクローズドセルが前記第2のセットのクローズドセルと異なる形状又は大きさを有し;
前記第1のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第2のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第1のセットのクローズドセルと前記第2のセットのクローズドセルとが円周方向にオフセットされ、前記第1のセットのクローズドセル及び前記第2のセットのクローズドセルが、螺旋状に整合された交互パターンを有することを特徴とする装置。 - 請求項1に記載の装置において、前記第1のセットのクローズドセルが、第1の開口寸法を有するより大きいセルであり、及び前記第2のセットのクローズドセルが、前記第1の開口寸法よりも小さい第2の開口寸法を有するより小さいセルであり;
前記より大きいクローズドセルのそれぞれが少なくとも1つのより幅広のストラット及び少なくとも1つのより細いストラットによって形成され、前記より幅広のストラットが第1の幅を有し、及び前記より細いストラットが前記第1の幅よりも狭い第2の幅を有し;
前記より幅広のストラットが、長手方向に整合された隣接するより大きいクローズドセル間にあり、前記より細いストラットが、円周方向に整合された隣接するより大きいクローズドセル間にあることを特徴とする装置。 - 請求項2に記載の装置において、前記より大きいクローズドセルのそれぞれが少なくとも1つの中間幅ストラットによって更に形成され、前記中間幅ストラットが、前記第1の幅よりも狭く且つ前記第2の幅よりも広い第3の幅を有し;
前記中間幅ストラットが、螺旋状に整合された隣接するより大きいクローズドセルとより小さいクローズドセルとの間にあることを特徴とする装置。 - 請求項1に記載の装置において、第1のセットのクローズドセルが第1の小葉形状を有し、及び前記第2のセットのクローズドセルが第2の小葉形状を有することを特徴とする装置。
- 請求項4に記載の装置において、前記第1のセットのクローズドセルのうちの前記セルのそれぞれが、長手方向に整合された小葉及び円周方向に整合された小葉を含み;前記長手方向に整合された小葉が前記円周方向に整合された小葉よりも大きいことを特徴とする装置。
- 請求項5に記載の装置において、長手方向に整合された隣接する小葉が長手方向連結ストラットによって連結され、及び円周方向に整合された隣接する小葉が円周方向連結ストラットによって連結されていることを特徴とする装置。
- 請求項1に記載の装置において、前記第1のセットのクローズドセルがラチェットセルであり、及び前記第2のセットのクローズドセルが非ラチェットセルであることを特徴とする装置。
- 請求項7に記載の装置において、前記ラチェットセルのそれぞれが、長手方向に整合されたラチェットストラットを含み;前記ラチェットストラットの一部にある歯が、キャビティ内を移動し且つ爪に係合するように構成されていることを特徴とする装置。
- 請求項1に記載の装置において、前記第1のセットのクローズドセルが双安定性セルであり、及び前記第2のセットのクローズドセルが非双安定性セルであり、前記双安定性セルが、双安定性ばねバンド構成を有する円周方向に整合された双安定性ストラットを含むことを特徴とする装置。
- 請求項9に記載の装置において、前記双安定性ストラットが、凹状湾曲が長手方向に向いた凹凸形状を有することを特徴とする装置。
- 血管を通る血流を維持又は促進するために前記血管内に配置される装置において、複数のステント要素が互いに接触することなく多要素ステントとして前記血管内に移植されるように構成された複数のバルーン拡張型生体吸収性血管ステント要素を含み;
前記ステント要素が、凸状リッジと凹状溝とが交互している波形円筒構成を有することを特徴とする装置。 - 請求項11に記載の装置において、前記ステント要素が中実壁を有することを特徴とする装置。
- 請求項11に記載の装置において、前記ステント要素が、セルパターンを備えた非中実壁を有することを特徴とする装置。
- 血管を通る血流を維持又は促進するために前記血管内に配置される装置において、複数のステント要素が互いに接触することなく多要素ステントとして前記血管内に移植されるように構成された複数のバルーン拡張型生体吸収性血管ステント要素を含み;
前記ステント要素が、2つのより大きいセルと、より小さいセルのセットとの交互配列を含み;前記2つのより大きいセルが、前記2つのより大きいセル間のピボットストラットによって形成されていることを特徴とする装置。 - 請求項14に記載の装置において、前記ピボットストラットが、より剛性の低い状態からより剛性の高い状態に旋回するように構成されていることを特徴とする装置。
- 多要素生体吸収性血管ステントを製造する方法において、
付加的製造プロセスを用いて、バルーン拡張型及び非自己拡張型である前記生体吸収性血管ステントの長さを生体吸収性材料から形成するステップであって、ステント要素が、第1のセットのクローズドセル及び前記第1のセットのクローズドセルと異なる形状又は大きさを有する第2のセットのクローズドセルを含み、前記第1のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第2のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第1のセットのクローズドセルと前記第2のセットのクローズドセルとが円周方向にオフセットされ、前記第1のセットのクローズドセル及び前記第2のセットのクローズドセルが、螺旋状に整合された交互パターンを有する、ステップと;
前記生体吸収性血管ステントの前記長さを切断して、前記ステントの複数のステント要素を形成するステップと
を含むことを特徴とする方法。 - 請求項16に記載の方法において、前記付加的製造プロセスがマイクロ−ステレオリソグラフィーを含むことを特徴とする方法。
- 請求項16に記載の方法において、前記付加的製造プロセスが3D印刷を含むことを特徴とする方法。
- 請求項16に記載の方法において、前記生体吸収性材料が、ポリ(L−乳酸)(PLLA)、ポリグリコール酸(PGA)、及びポリ(ヨウ化デスアミノチロシル−チロシンエチルエステル)カーボネートからなる群から選択されることを特徴とする方法。
- 請求項19に記載の方法において、コーティングを前記生体吸収性材料に塗布するステップを更に含むことを特徴とする方法。
- 請求項20に記載の方法において、前記コーティングがポリ−D,L−ラクチド(PDLLA)を含むことを特徴とする方法。
- 請求項16に記載の方法において、薬物を前記ステントに塗布するステップを更に含むことを特徴とする方法。
- 請求項22に記載の方法において、前記薬物が、エベロリムス及び他の抗増殖剤からなる群から選択されることを特徴とする方法。
- 血管を通る血流を維持又は促進するための方法において、
バルーンカテーテルを前記血管内に前進させるステップと;
前記バルーンカテーテル上のバルーンを膨張させて、前記バルーン上に配置された複数の生体吸収性血管ステント要素を拡張させて前記血管の内壁に接触させるステップであって、前記ステント要素が、第1のセットのクローズドセル及び前記第1のセットのクローズドセルと異なる形状又は大きさを有する第2のセットのクローズドセルを含み、前記第1のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第2のセットのクローズドセルが、長手方向に整合された繰り返しパターン及び円周方向に整合された繰り返しパターンを有し、前記第1のセットのクローズドセルと前記第2のセットのクローズドセルとが円周方向にオフセットされ、前記第1のセットのクローズドセル及び前記第2のセットのクローズドセルが、螺旋状に整合された交互パターンを有する、ステップと;
前記バルーンを収縮させると同時に、前記血管ステント要素を前記血管内の所定の位置に残置するステップと;
前記バルーンカテーテルを前記血管から抜去するステップと
を含むことを特徴とする方法。 - 請求項24に記載の方法において、前記血管が末梢血管を含むことを特徴とする方法。
- 請求項24に記載の方法において、前記ステント要素を拡張させるステップが、少なくとも4つのステント要素を拡張させるステップを含むことを特徴とする方法。
- 請求項24に記載の方法において、前記ステント要素が前記バルーンに沿って互いに離間され、前記ステント要素を拡張させるステップが、前記ステント要素を離間された構成で前記血管の前記内壁に送達するステップを含むことを特徴とする方法。
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