JP2021090836A - 経皮的心臓弁置換のための複数の支持アームを有する心臓弁プロテーゼ及び方法 - Google Patents
経皮的心臓弁置換のための複数の支持アームを有する心臓弁プロテーゼ及び方法 Download PDFInfo
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Abstract
Description
人工心臓弁装置の送達及び埋め込みのための選択されたシステム及び方法
上述の、かつ図4A〜図10Dに例示される心臓弁プロテーゼ及び送達システム構成部品の特徴は、本発明に従って構成された追加の実施形態を形成するように修正され得る。例えば、単一の主支持アーム又は弁尖捕捉アームのみを示す、上述の、かつ図4A〜図8Cに例示される心臓弁プロテーゼはまた、例えば、後尖組織を捕捉するために、かつ/又は埋め込み後のプロテーゼの移動に更に抵抗するために、弁支持体から延在する追加の弁尖捕捉アームを含むことができる。患者の心臓弁を修復又は置換するための心臓弁プロテーゼの送達及び展開のための上述の様々な方法ステップはまた、本発明の追加の実施形態を形成するように置き換えることができる。例えば、上述の方法ステップは所与の順序で提示されるが、代替の実施形態は異なる順序でステップを実施してもよい。本明細書に記載の様々な実施形態はまた、更なる実施形態を提供するために組み合わされてもよい。
Claims (20)
- 圧縮送達構成と、心臓内の展開のための拡張展開構成とを有する、弁プロテーゼであって、
内部に人工弁構成部品を保持するための管状部分であって、第1の端部及び第2の端部を有する、管状部分と、
前記弁プロテーゼが前記拡張構成にあるときに、前記管状部分の前記第1の端部から半径方向に延在する流入部分と、
第1の長さを有する、前記管状部分の前記第2の端部から延在する主支持アームと、
前記管状部分の前記第2の端部から延在する補助支持アームの第1の組であって、前記補助支持アームの第1の組の各々が、第2の長さを有する、補助支持アームの第1の組と、
前記管状部分の前記第2の端部から延在する補助支持アームの第2の組であって、前記補助支持アームの第2の組の各々が、前記第2の長さ未満である第3の長さを有する、補助支持アームの第2の組と、を有するフレームを備え、
前記主支持アームの前記第1の長さが、前記補助支持アームの第1及び第2の組の前記補助支持アームのそれぞれ前記第2及び第3の長さよりも長い、弁プロテーゼ。 - 前記主支持アーム、前記補助支持アームの第1の組、及び前記補助支持アームの第2の組が、前記フレームの前記管状部分の前記第2の端部の円周の周囲で離間している、請求項1に記載の弁プロテーゼ。
- 前記補助支持アームの第2の組のうちの少なくとも1つが、前記主支持アームと正反対になるように位置付けられている、請求項2に記載の弁プロテーゼ。
- 前記補助支持アームの第1の組のうちの1つが、前記主支持アームの各側に円周方向に位置付けられている、請求項3に記載の弁プロテーゼ。
- 前記拡張構成において、前記主支持アーム、前記補助支持アームの第1の組、及び前記補助支持アームの第2の組が、前記フレームの前記管状部分の前記第1の端部に向かって屈曲する、請求項1に記載の弁プロテーゼ。
- 前記拡張構成において、前記補助支持アームの第1及び第2の組の前記補助支持アームの各端部分が、前記フレームの前記管状部分に対して実質的に同じ長手方向の位置又は高さで配置される、請求項5に記載の弁プロテーゼ。
- 前記拡張構成において、前記補助支持アームの第1及び第2の組の前記補助支持アームの各端部分が、それらの間に前記心臓の組織を挟むために前記流入部分と接触する、請求項6に記載の弁プロテーゼ。
- 前記拡張構成において、
第1の角度が、前記主支持アームと前記フレームの前記管状部分との間に画定され、
第2の角度が、前記補助支持アームの第1の組の各補助支持アームと前記フレームの前記管状部分との間に画定され、
第3の角度が、前記補助支持アームの第2の組の各補助支持アームと前記フレームの前記管状部分との間に画定され、
前記第1、第2、及び第3の角度が等しくない、請求項5に記載の弁プロテーゼ。 - 前記第1の角度が前記第2の角度よりも大きく、前記第2の角度が前記第3の角度よりも大きい、請求項8に記載の弁プロテーゼ。
- 前記フレームの前記管状部分内に固定された人工弁と、
前記管状部分、前記流入部分、及び少なくとも前記主支持アームの端部分、並びに前記補助支持アームの第1及び第2の組の前記補助支持アームの各々の端部分の部分のうちの1つ以上を被覆するために、前記フレームに固定された密封材料と、を更に備える、請求項1に記載の弁プロテーゼ。 - 前記弁プロテーゼが前記拡張構成にあるときに、前記補助支持アームの第1及び第2の組の前記補助支持アームの各々の湾曲部分間で被覆及び延在するために、前記フレームの前記第2の端部の外周の一部分の周囲に配置された、緩衝ストリップを更に備える、請求項10に記載の弁プロテーゼ。
- 圧縮送達構成と、心臓内の展開のための拡張展開構成とを有する、弁プロテーゼであって、
第1の端部及び第2の端部を有する弁支持体と、
前記弁プロテーゼが前記拡張構成にあるときに、前記弁支持体の前記第1の端部から半径方向に延在する流入部分と、
前記弁支持体の前記第2の端部から延在する主支持アームと、
前記弁支持体の前記第2の端部から延在する複数の長い補助支持アームと、
前記弁支持体の前記第2の端部から延在する複数の短い補助支持アームであって、前記主支持アームが、前記複数の長い補助支持アーム及び短い補助支持アームよりも長い、複数の短い補助支持アームと、を有するフレームを備え、
前記拡張構成において、前記主支持アーム、前記複数の長い補助支持アーム、及び前記複数の短い補助支持アームが、前記弁支持体の前記第1の端部に向かって屈曲し、
前記拡張構成において、前記複数の長い補助支持アームの各々及び前記複数の短い補助支持アームの各々が、実質的に同じ展開高さを有する、弁プロテーゼ。 - 前記拡張構成において、前記長い補助支持アーム及び短い補助支持アームの前記端部分が、展開時にそれらの間に前記心臓の弁輪組織を挟むために前記流入部分と接触する、請求項12に記載の弁プロテーゼ。
- 前記主支持アーム並びに前記複数の長い補助支持アーム及び短い補助支持アームが、前記弁支持体の前記第2の端部の円周の周囲で離間している、請求項12に記載の弁プロテーゼ。
- 前記主支持アーム及び前記複数の長い補助支持アームが、前記弁プロテーゼが心臓内で前記拡張構成にあるときに、天然僧帽弁の前尖と係合するために前記第2の端部の前記円周の周囲に配置され、前記複数の短い補助支持アームが、前記弁プロテーゼが心臓内で前記拡張構成にあるときに、天然僧帽弁の後尖と係合するために前記第2の端部の前記円周の周囲に配置される、請求項14に記載の弁プロテーゼ。
- 治療部位への送達のための圧縮構成と、心臓内の展開のための拡張構成とを有する、弁プロテーゼを展開する方法であって、
前記心臓の左心房への経心房アクセスを提供することと、
前記経心房アクセスを介して、内部に前記圧縮構成で前記弁プロテーゼを有する送達カテーテルの遠位部分を、前記左心房内へと前進させることであって、前記弁プロテーゼが、主支持アーム及び複数の補助支持アームを有するフレームを含む、前進させることと、 前記主支持アーム及び前記複数の補助支持アームの各々が、前記送達カテーテルの前記遠位部分から延在するにつれて屈曲展開状態をとるように、前記弁プロテーゼの前記主支持アーム及び前記複数の補助支持アームを前記左心房内で展開することと、
前記屈曲展開状態の前記主支持アーム及び前記複数の補助支持アームが弁輪を通して前記心臓の左心室内へと押されるまで、前記送達カテーテルの前記遠位部分を前記心臓の天然僧帽弁の前記弁輪に向かって前進させることと、
前記主支持アーム及び前記複数の補助支持アームの各々が前記天然僧帽弁の前尖及び後尖の少なくとも一部分と係合するまで、前記送達カテーテルを近位に後退させることと、 前記天然僧帽弁を置換するために、前記弁プロテーゼの残りの部分を前記送達カテーテルから展開することと、を含む、方法。 - 前記送達カテーテルの前記遠位部分を前記天然僧帽弁の弁輪に向かって前進させる前記ステップを実施する前に、前記弁プロテーゼの前記主支持アームを、前記天然僧帽弁の前記前尖のA2セグメントと方向を合わせること、を更に含む、請求項16に記載の方法。
- 前記送達カテーテルを近位に後退させる前記ステップ中に、前記複数の補助支持アームが前記前尖の残りのセグメント及び前記後尖のセグメントと係合する前に、前記弁プロテーゼの前記主支持アームが、前記A2セグメントにおいて前記前尖と係合し、それを捕捉するように構成されている、請求項17に記載の方法。
- 前記送達カテーテルを近位に後退させる前記ステップ中に、前記複数の補助支持アームの前記端部分が、前記弁輪に対して押し付けられ、前記力が、前記弁プロテーゼの残りの部分を展開する前記ステップが実施されている間に前記弁輪に対して維持される、請求項16に記載の方法。
- 前記弁プロテーゼの残りの部分を展開する前記ステップが、前記弁輪の下側に対して作用する前記複数の補助支持アームと反対に、前記左心房の底部に対して作用するために前記左心房内で前記弁プロテーゼの前記フレームの入口区分を解放し、それにより、前記弁プロテーゼを前記天然僧帽弁内で固定することを含む、請求項19に記載の方法。
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2017
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US10321992B2 (en) | 2019-06-18 |
US20210068950A1 (en) | 2021-03-11 |
JP2019506937A (ja) | 2019-03-14 |
WO2017136275A1 (en) | 2017-08-10 |
CN112998910A (zh) | 2021-06-22 |
CN108601653B (zh) | 2021-02-02 |
JP7248726B2 (ja) | 2023-03-29 |
US20190254818A1 (en) | 2019-08-22 |
US11278397B2 (en) | 2022-03-22 |
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