JP2013505082A - ステント付き経カテーテル補綴心臓弁搬送システムおよび方法 - Google Patents
ステント付き経カテーテル補綴心臓弁搬送システムおよび方法 Download PDFInfo
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Images
Classifications
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Abstract
【選択図】図11B
Description
本願は、2009年9月21日に出願された、「Stented Transcatheter Prosthetic Heart Valve Delivery System and Method」という名称の米国仮特許出願第61/244,344号(代理人整理番号M190.347.101/P0035222.00)の米国特許法35 U.S.C §119(e)(1)に基づく優先権を主張し、その出願内容全体が参照により本明細書に組み込まれる。
Claims (19)
- ステント付き補綴心臓弁を経皮的に配置するための搬送器具であって、
遠位先端、近位端、およびステント付き補綴心臓弁と選択的に係合するように構成された連結構造を提供する中間部を画定する内側シャフト組立体と、
前記シャフトの少なくとも前記中間部を摺動自在に受け入れるようなサイズにされたルーメンを形成し、遠位領域で終了するシースと、
前記シースとは別に形成された管状搬送カプセルであって、前記シースの前記遠位領域に取り付けられた近位帯と、遠位端を終了する遠位帯と、を画定し、前記遠位帯が通常状態と拡がり状態との間で移行するように構成され、前記遠位端の直径が前記通常状態よりも前記拡がり状態で大きく、前記カプセルが自然に前記通常状態を取るように構成された形状記憶構成部品を含む、管状搬送カプセルと、を備え、
前記器具が、ステント付き補綴心臓弁を前記搬送カプセルの内部に摺動自在に受け入れるように構成され、前記ステント付き補綴心臓弁の一部が前記カプセルの遠位で露出されて半径方向に拡張する可逆的一部展開手順を実行するように操作可能であり、その後に、前記カプセルが前記ステント付き補綴心臓弁に対して遠位に進み、それによって、前記遠位帯が前記拡がり状態に移行して、折り畳む力を前記ステント付き補綴心臓弁に加え、前記ステント付き補綴心臓弁を半径方向に折り畳むようにする、搬送器具。 - 前記カプセルがレーザーカット管を含む、請求項1に記載の器具。
- 前記カプセルがポリマー被包する前記レーザーカット管をさらに含む、請求項2に記載の器具。
- 前記レーザーカット管がNitinolで形成されている、請求項2に記載の器具。
- 前記カプセルが前記近位帯と前記遠位帯との間に第1中間帯をさらに画定し、前記中間帯が少なくとも前記遠位帯と比較して高められた半径方向屈曲性を有する、請求項2に記載の器具。
- 前記レーザーカット管が、複数の概ね長手方向に延在し、前記遠位帯に沿って格子状構造を形成する相互連結された主スプラインと、概ね円周方向に延在し、前記中間帯に沿って相互連結された複数の部分を画定する、請求項5に記載の器具。
- 前記遠位帯が、前記遠位端の反対側で、前記中間帯の遠位に配置された基部を形成し、さらに、前記遠位帯の前記主スプラインが前記基部から延出し、前記収縮状態と前記拡がり状態との間で移行する時に前記基部に対して旋回する、請求項6に記載の器具。
- 前記レーザーカット管が、前記遠位端で、前記主スプラインの隣接するものが円周方向に相互連結する波状の筋交いをさらに画定する、請求項7に記載の器具。
- 前記レーザーカット管が、前記円周部の隣接するものを長手方向に相互連結する、前記中間帯に沿った少なくとも1つの縦スパインをさらに画定する、請求項6に記載の器具。
- 前記シースが、少なくとも1つの縦シーススパインを保持するポリマー管を含み、さらに、前記管の前記少なくとも1つの縦スパインが、少なくとも1つの縦搬送シーススパインに沿って長手方向に位置合わせされた、請求項9に記載の器具。
- 前記中間帯が、2つの円周方向に反対側の縦スパインを含む、請求項9に記載の器具。
- 前記カプセルが、前記遠位帯と前記第1中間帯との間に第2中間帯をさらに画定し、前記第2中間帯が折り畳み状態と拡張状態との間で移行するように構成され、前記第2中間帯の直径が、前記折り畳み状態より前記拡張状態での方が大きい、請求項5に記載の器具。
- 前記カプセルの前記形状記憶構成部品が、自然に前記折り畳み状態を取るように構成されている、請求項12に記載の器具。
- 前記遠位帯が第1管状部によって形成され、前記中間帯が第2管状部によって形成され、さらに、前記第1および第2管状部が別々に形成されて、材料、壁の厚さ、および直径から成るグループから選択される少なくとも1つの特性に関して異なる、請求項5に記載の器具。
- ステント付き補綴心臓弁を移植位置に配置するための方法であって、
搬送器具が、
内側シャフトと、
ルーメンおよび遠位領域を形成するシースと、
前記遠位領域に取り付けられて、前記遠位領域から延出する近位帯と、前記近位帯の反対側にある遠位帯と、を有する管状搬送カプセルとを備え、
ステント付き補綴心臓弁が前記内側シャフトに連結されて、前記搬送器具が前記ステント付き補綴心臓弁を折り畳み配置で保持するように、前記搬送カプセルの内部に摺動自在に受け入れられる、
前記ステント付き補綴心臓弁を前記搬送器具に取り外し可能に装着することと、
前記ステント付き補綴心臓弁を前記折り畳み配置で身体の内腔を通って、前記搬送器具で前記移植位置まで搬送することと、
前記ステント付き補綴心臓弁の遠位部が前記カプセルの遠位で露出されるよう、前記搬送カプセルを前記ステント付き補綴心臓弁に対して近位にある程度引っ込めることであって、前記遠位部が拡張配置に向けて自己拡張し、前記ステント付き補綴心臓弁の少なくとも近位部が少なくとも前記搬送カプセルの内部に前記折り畳み配置で保持されている、前記搬送カプセルを前記ステント付き補綴心臓弁に対して近位に部分的に引っ込めることと、
前記ステント付き補綴心臓弁の位置を前記移植位置と比較して評価することと、
前記評価が、前記ステント付き補綴心臓弁が正しく位置付けられていないことを示している場合に、前記シースおよび前記カプセルを前記ステント付き補綴心臓弁に対して遠位に進めて、前記遠位帯が、遠位への移動に伴って前記ステント付き補綴心臓弁の周囲で円周方向に広がりながら、同時に前記ステント付き補綴心臓弁の接触領域に折り畳む力を加えて、前記接触領域を前記折り畳み配置に移行させることと、
前記ステント付き補綴心臓弁が前記内側シャフトから展開されるように、前記搬送カプセルを前記ステント付き補綴心臓弁から完全に近位に引っ込めることと
を含む方法。 - 前記搬送カプセルを前記ステント付き補綴心臓弁に対してある程度引っ込める前記ステップが、前記搬送器具のアクチュエータを第1方向に作動させることを含み、
前記シースおよび前記搬送カプセルを遠位に進める前記ステップが、前記アクチュエータを前記第1方向と反対の第2方向に作動させることを含む、
請求項15に記載の方法。 - 前記シースおよび前記搬送カプセルを遠位に進める前記ステップが、前記遠位帯を前記補綴心臓弁の遠位に配置することを含み、さらに、前記遠位帯が拡がり状態から通常状態に自己遷移する、請求項15に記載の方法。
- 前記シースおよび前記搬送カプセルを遠位に進める前記ステップに続いて、前記方法が、前記搬送カプセルを、前記遠位帯を前記通常状態にして、前記移植位置に対して再配置することをさらに含む、請求項15に記載の方法。
- ステント付き補綴心臓弁を経皮的に配置するための搬送器具であって、
遠位先端、近位端、およびステント付き補綴心臓弁と選択的に係合するように構成された連結構造を提供する中間部を画定する内側シャフト組立体と、
前記シャフトの少なくとも前記中間部を摺動自在に受け入れるようなサイズのルーメンを形成し、遠位領域で終了するシースと、
前記シースの前記遠位領域とは別に形成され、前記遠位領域に取り付けられていて、
遠位広がり可能帯および中間屈曲性帯を画定するように切り込まれた管と、
前記管を包み、シリコンポリマーと混合された熱可塑性ポリエーテルウレタンを含むポリマー被包とを含む搬送カプセルと、
を含む器具。
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Also Published As
Publication number | Publication date |
---|---|
WO2011035327A1 (en) | 2011-03-24 |
AU2010295291A1 (en) | 2012-04-05 |
US20110098804A1 (en) | 2011-04-28 |
CN102548508B (zh) | 2015-06-03 |
JP5685256B2 (ja) | 2015-03-18 |
HK1170651A1 (en) | 2013-03-08 |
US8974524B2 (en) | 2015-03-10 |
US20140046435A1 (en) | 2014-02-13 |
AU2010295291B2 (en) | 2013-10-24 |
EP2480167A1 (en) | 2012-08-01 |
EP2480167B1 (en) | 2017-08-16 |
US8562673B2 (en) | 2013-10-22 |
CN102548508A (zh) | 2012-07-04 |
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