JP2020504651A - 心臓弁輪を再形成するための埋め込み可能な機器および送達システム - Google Patents
心臓弁輪を再形成するための埋め込み可能な機器および送達システム Download PDFInfo
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Abstract
Description
インプラントは、カラー上において、上側頂部および支柱上のカラーの前進を容易にする柔軟部をさらに備えてもよい。
Claims (50)
- 僧帽弁輪を再形成するためのインプラントであって、
近位端と、遠位端と、内部を延びる中央ルーメンとを有する管状フレームであって、近位頂点で接合された、隣接する支柱の第1の対を有する、管状フレームと、
前記近位頂点により支えられ、外側スレッドを有する、回転軸周りに回転するように構成されたシャフトと、
フレームにより支えられ、前記隣接する支柱の第1の対を少なくとも部分的に囲む、前記シャフトの前記外側スレッドと係合した内側スレッドを有するカラーとを備え、
前記回転軸周りの前記シャフトの回転によって、前記カラーが、前記隣接する支柱の第1の対に沿って前進して、前記隣接する支柱の第1の対の間の角度を変化させる、インプラント。 - 前記回転軸周りの前記シャフトの第1の方向の回転によって、前記カラーが、前記遠位端へと前記隣接する支柱の第1の対に沿って前進して、前記隣接する支柱の第1の対の間の前記角度を小さくすることで、前記インプラントを収縮させる、請求項1に記載のインプラント。
- 前記回転軸周りの前記シャフトの前記第1の方向とは反対の第2の方向の回転によって、前記カラーが、前記近位端へと前記隣接する支柱の第1の対に沿って前進して、前記隣接する支柱の第1の対の間の前記角度を大きくすることで、前記インプラントを拡張させ得る、請求項2に記載のインプラント。
- 前記フレームが、更に、前記近位頂点から前記フレームの前記近位端へと延びかつ前記シャフトを少なくとも部分的に保持するように構成された窓部を少なくとも部分的に規定する第1の支持部および第2の支持部を備えた、請求項1に記載のインプラント。
- 前記シャフトの近位端に取り付けられ、ドライバにより回転されて前記シャフトを回転させるように構成されたカップリングをさらに備えた、請求項1に記載のインプラント。
- 前記管状フレームが、中心長手方向軸を規定し、前記隣接する支柱の対が、前記中心長手方向軸に対して半径方向外方に傾斜するように構成された、請求項1に記載のインプラント。
- 前記支柱の隣接する対が、前記隣接する支柱の第1の対の間の前記角度の低減に応答して、中心長手方向軸に対して半径方向外方に傾斜するように構成された、請求項1に記載のインプラント。
- 前記フレームと結合され、前記僧帽弁輪の組織を係合させるように構成されたアンカーをさらに備えた、請求項1に記載のインプラント。
- 前記フレームが、遠位頂点で接合された隣接する支柱の第2の対を備え、
前記アンカーが、前記遠位頂点と結合された、請求項8に記載のインプラント。 - 前記アンカーが、螺旋状アンカーである、請求項8に記載のインプラント。
- 遠位頂点が、前記アンカーを回転可能に受容するように構成された一連の開口を含む、請求項8に記載のインプラント。
- 前記フレームが、遠位頂点で接合された隣接する支柱の第2の対を備え、
遠位頂点が、前記アンカーを回転可能に受容するように構成されたアンカーハウジングを含む、請求項8に記載のインプラント。 - ハウジングが、軸方向に延びる開口を有し、
前記アンカーが、前記ハウジングに対する軸方向位置を維持しつつ前記ハウジング内で回転することによって、心臓弁輪の前記組織を係合させるように構成された、請求項12に記載のインプラント。 - 前記開口が、近位係合構造および遠位チャンバを有し、
前記遠位チャンバの最大幅が、前記近位係合構造の最小幅よりも大きい、請求項13に記載のインプラント。 - 各近位頂点でそれぞれ接合された前記隣接する支柱の複数の第1の対と、
前記各近位頂点によりそれぞれ支えられた複数の前記シャフトと、
各シャフトを係合させるようにそれぞれ構成された複数の前記カラーと
を更に備えた、請求項1に記載のインプラント。 - 隣接する支柱の8つの対、8つの近位頂点、8つのシャフト、および8つのカラーが存在する、請求項15に記載のインプラント。
- 僧帽弁輪を再形成するためのインプラントであって、
近位頂点で接合された、隣接する支柱の第1の対を有する管状フレームと、
前記近位頂点に位置付けられた回転可能なシャフトと、
前記隣接する支柱の第1の対および前記シャフトを少なくとも部分的に囲むカラーとを備え、
前記回転可能なシャフトの回転によって、前記カラーが、前記隣接する支柱の第1の対に沿って前進して、前記隣接する支柱の第1の対の間の角度を小さくすることで、前記インプラントを収縮させる、インプラント。 - フレームと結合され、前記僧帽弁輪の組織を係合させるように構成されたアンカーを更に備えた、請求項17に記載のインプラント。
- 前記回転可能なシャフトを軸方向に拘束する窓部を前記近位頂点に更に備えた、請求項17に記載のインプラント。
- 僧帽弁輪を再形成する方法であって、
僧帽弁輪に隣接してインプラントを位置決めすることであって、前記インプラントが、支柱の対を有する管状フレームと、フレームにより支えられた回転可能なシャフトと、前記回転可能なシャフトと係合しかつ前記支柱の対を少なくとも部分的に囲む平行移動可能なカラーと、前記フレームと結合されたアンカーとを備えたことと、
前記アンカーを前記僧帽弁輪の組織に固定することと、
前記シャフトを回転させて、前記支柱の第1の対に沿って前記カラーを平行移動させることと、
前記カラーの平行移動によって、前記支柱の第1の対の間の角度を小さくすることと
を含む、方法。 - 心臓弁輪を再形成するためのインプラントであって、
近位端と、遠位端と、内部を延びる中央ルーメンとを有する管状フレームと、
フレームの前記遠位端と結合された、近位部、遠位部、および軸方向に内部を延びる開口を有するハウジングと、
前記ハウジングの前記開口に受容され、遠位方向に前進して、前記ハウジングに対する軸方向位置を維持しつつ前記ハウジング内で回転することによって、前記心臓弁輪の組織を係合させるように構成されたアンカーと
を備えた、インプラント。 - 前記ハウジングが、更に、
前記近位部における内側スレッド部と、
前記遠位部におけるチャンバとを備え、
前記アンカーが、前記ハウジングの前記遠位部に対する軸方向位置を維持しつつ前記ハウジングの前記遠位部において前記チャンバ内で回転するように構成された、請求項21に記載のインプラント。 - 前記アンカーが、更に、
ドライバにより係合されて前記アンカーを回転させるように構成されたカップリングを有する円筒状の近位ヘッドと、
遠位方向に延びる近位ヘッドと結合され、前記組織を係合させるように構成された遠位螺旋状部と
を備えた、請求項21に記載のインプラント。 - 僧帽弁輪を再形成するためのインプラント用のアンカーアセンブリであって、
近位部、遠位部、および軸方向に内部を延びる開口を有するハウジングと、
前記ハウジングの前記開口に受容され、遠位方向に前進して、前記ハウジングに対する軸方向位置を維持しつつ前記ハウジング内で回転することにより、心臓弁輪の組織を係合させるように構成されたアンカーと
を備えた、アンカーアセンブリ。 - 前記開口が、近位係合構造および遠位チャンバを有し、
前記遠位チャンバの最大幅が、前記近位係合構造の最小幅よりも大きく、
前記アンカーが、前記遠位チャンバに対する軸方向位置を維持しつつ前記遠位チャンバ内で回転するように構成された、請求項24に記載のアンカーアセンブリ。 - 近位係合構造が、螺旋状溝を含む、請求項24に記載のアンカーアセンブリ。
- アンカーとアンカーハウジングとを備えたインプラントを心臓弁輪に固定する方法であって、
i)ハウジング内で前記アンカーを回転させることと、ii)前記心臓弁輪の組織内へと遠位方向かつ軸方向に前記アンカーを前進させることと、iii)ハウジングに対する前記アンカーの軸方向位置を維持することと、を同時に行う、方法。 - 僧帽弁輪を再形成するためのインプラントであって、
近位端と、遠位端と、内部を延びる中央ルーメンとを有し、頂点で接合された隣接する支柱の対を備えた管状フレームを備え、
前記支柱の隣接する対が、前記隣接する支柱の対の間の角度変化に応答して、中心長手方向軸に対して半径方向外方に傾斜するように構成された、インプラント。 - 心臓弁輪を再形成するためのインプラント用のカップリングであって、
凹面により近位側方突起と結合された遠位基部を備え、
前記凹面が、前記遠位基部と前記近位側方突起との間に開口を規定し、
前記開口が、前記カップリングを回転させるための回転可能なドライバを受容するように構成された、カップリング。 - 心臓弁輪を再形成するためのインプラント用の拘束装置であって、前記インプラントが、頂点で接合されて両者間に角度を規定する隣接する支柱の対を備えた拘束装置において、
軸方向に延びる本体と、
前記本体を通って軸方向に延びる中心開口と、
前記中心開口の内側面上の内部係合構造とを備え、
前記頂点で前記隣接する支柱の対を少なくとも部分的に囲むとともに、アクチュエータの作動で前記拘束装置が前記隣接する支柱の対に沿って前進し、両者間の前記角度を変化させるように、前記内部係合構造を前記アクチュエータと係合させるように構成された、拘束装置。 - 前記中心開口の両側で前記本体を通って軸方向に延びかつ前記インプラントの各支持部を受容するように構成された第1および第2のチャネルを更に備えた、請求項30に記載の拘束装置。
- 心臓弁輪を再形成するためのインプラント用の回転可能なシャフトであって、前記インプラントが、頂点で接合されて両者間に角度を規定する隣接する支柱の対を備えた回転可能なシャフトにおいて、
外側面と、その外側面に沿って外部スレッドを有する細長本体と、
凹面により近位側方突起と結合された遠位基部を有する近位カップリングであって、前記凹面が、前記遠位基部と前記近位側方突起との間に開口を規定し、前記開口が、前記シャフトを回転させるための回転可能なドライバを受容するように構成された、近位カップリングと
を備えた、回転可能なシャフト。 - 心臓弁輪を再形成するためのインプラントを再位置決めする方法であって、前記インプラントが、シャフト、カラー、支柱の対、およびアンカーを備えた方法において、
前記シャフトを第1の方向に回転させることと、
前記支柱の対に沿って近位方向に前記カラーを平行移動させることと、
前記支柱の対の間の角度を大きくすることと、
前記心臓弁輪の組織の第1の位置から前記アンカーを外すことと、
前記心臓弁輪の前記組織の第2の位置と前記アンカーを係合させることと、
前記シャフトを第2の方向に回転させることと、
前記支柱の対に沿って遠位方向に前記カラーを平行移動させることと、
前記支柱の対の間の前記角度を小さくすることと
を含む、方法。 - 前記第1の位置から前記アンカーを外すことが、前記アンカーを第3の方向に回転させることを含み、
前記第2の位置と前記アンカーを係合させることが、前記アンカーを第4の方向に回転させることを含む、請求項33に記載の方法。 - 患者の心臓弁輪に固定されたインプラントを回収する方法であって、前記インプラントが、シャフト、カラー、支柱の対、およびアンカーを備えた方法において、
前記シャフトを第1の方向に回転させることと、
前記支柱の対に沿って近位方向に前記カラーを平行移動させることと、
前記支柱の対の間の角度を大きくすることと、
前記心臓弁輪の組織から前記アンカーを外すことと、
前記シャフトを第2の方向に回転させることと、
前記支柱の対に沿って遠位方向に前記カラーを平行移動させることと、
前記支柱の対の間の前記角度を小さくすることと、
前記インプラントを送達カテーテルに受容することと、
前記インプラントを前記患者から取り除くことと
を含む、方法。 - 心臓弁を囲む弁輪の埋め込み後動的収縮用のインプラントであって、
近位端と、遠位端と、内部を延びる中央ルーメンと、頂点で接合されて両者間に角度を有する隣接する支柱の少なくとも1つの対とを備えたインプラント本体と、
前記心臓弁を囲む組織に埋め込まれるように構成された前記インプラント本体上の複数の組織アンカーと、
前記隣接する支柱の対を少なくとも部分的に囲み、前記頂点から離れる方向に前記隣接する支柱の対に沿って移動して、前記隣接する支柱の対の間の前記角度を小さくすることにより、第1の直径から第2のより小さな直径へと、第2の直径の場合の前記弁輪が加える移動に対する抵抗によって少なくとも1つの支柱が最初に弾性偏向した状態で、前記インプラント本体に前記弁輪を収縮させ得る可動拘束装置とを備え、
埋め込み後、前記弁輪が加える移動に対する抵抗を前記支柱の弾性張力が緩めて前記抵抗に打ち勝った場合に、前記第2の直径から第3のより小さな直径へと収縮するように構成された、インプラント。 - 弾性張力が、可動拘束装置と組織アンカーとの間で前記支柱に蓄えられた、請求項1に記載の埋め込み後動的収縮用のインプラント。
- 心臓弁を囲む弁輪の埋め込み後動的収縮の方法であって、
第1の直径を有する僧帽弁輪を囲む心房の壁にインプラントを固定するステップと、
前記インプラントを調整カテーテルで能動的に調整して、前記第1の直径から第2のより小さな直径へと前記弁輪を小さくするステップと、
前記調整カテーテルを取り除くステップと、
前記インプラントに蓄えられたポテンシャルエネルギーに応答して、カテーテルを取り除いた後に、第2の直径より小さな第3の直径へと前記直径を小さくし続けるステップと
を含む、方法。 - 前記第2の直径が、およそ27mm以下であり、
前記第3の直径が、前記第2の直径より少なくとも1mm小さい、請求項38に記載の方法。 - 前記第2の直径が、およそ27mm以下であり、
前記第3の直径が、前記第2の直径より少なくとも2mm小さい、請求項39に記載の方法。 - 前記インプラントが、埋め込み後、前記調整カテーテルを取り除く前記ステップ後のおよそ30日以内に、前記第2の直径から第3のより小さな直径へと収縮するように構成された、請求項38に記載の方法。
- 前記第2の直径から前記第3の直径への前記弁輪の縮小に応答して、僧帽弁尖接合が少なくともおよそ25%増加する、請求項38に記載の方法。
- 前記第2の直径から前記第3の直径への前記弁輪の縮小に応答して、僧帽弁尖接合が少なくともおよそ50%増加する、請求項42に記載の方法。
- 前記直径が、前記調整カテーテルを取り除く前記ステップ後の少なくともおよそ5日間にわたって小さくなり続ける、請求項38に記載の方法。
- 前記直径が、前記調整カテーテルを取り除く前記ステップ後の少なくともおよそ10日間にわたって小さくなり続ける、請求項44に記載の方法。
- 僧帽弁輪動的収縮機器の埋め込み後に僧帽弁尖接合を増加させる方法であって、
第1の直径を有する僧帽弁輪を囲む心房の壁にインプラントを固定するステップと、
前記インプラントを調整カテーテルで能動的に調整して、前記第1の直径から第2の、より小さな直径へと弁輪を小さくするステップと、
前記調整カテーテルを取り除くステップとを含み、
カテーテルを取り除く前記ステップの後、動的インプラントが、第2の直径に対応する接合から、弁尖接合を少なくともおよそ25%増加させる、方法。 - 前記カテーテルを取り除く前記ステップの後、前記動的インプラントが、前記第2の直径に対応する接合から、弁尖接合を少なくともおよそ50%増加させる、請求項46に記載の僧帽弁尖接合を増加させる方法。
- 前記カテーテルを取り除く前記ステップの後、前記動的インプラントが、弁尖接合を少なくともおよそ2mm増加させる、請求項46に記載の僧帽弁尖接合を増加させる方法。
- 前記カテーテルを取り除く前記ステップの後、前記動的インプラントが、弁尖接合を少なくともおよそ4mm増加させる、請求項46に記載の僧帽弁尖接合を増加させる方法。
- 僧帽弁輪をリモデリングする方法であって、
僧帽弁輪に隣接してインプラントを位置決めすることであって、前記インプラントが、支柱の対を有する管状フレームと、フレームにより支えられた回転可能なシャフトと、前記回転可能なシャフトと係合しかつ前記支柱の対を少なくとも部分的に囲む平行移動可能なカラーと、前記フレームと結合されたアンカーとを備えたことと、
前記アンカーを前記僧帽弁輪の組織に固定することと、
前記シャフトを回転させて、前記支柱の第1の対に沿って前記カラーを平行移動させることと、
前記カラーの平行移動によって、前記支柱の第1の対の間の角度を小さくすることと、
24時間より長い期間にわたって、第1の縮小幅へと心臓弁輪の幅を収縮させることと、
前記期間の後、前記第1の縮小幅よりも小さな第2の縮小幅へと前記心臓弁輪の前記幅をさらに収縮させることと
を含む、方法。
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- 2018-02-09 CN CN201880011000.8A patent/CN110381887B/zh active Active
- 2018-02-09 EP EP18750618.3A patent/EP3579789A4/en active Pending
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US9180005B1 (en) * | 2014-07-17 | 2015-11-10 | Millipede, Inc. | Adjustable endolumenal mitral valve ring |
US20160235526A1 (en) * | 2015-02-13 | 2016-08-18 | Millipede, Inc. | Valve replacement using rotational anchors |
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Publication number | Publication date |
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CN110381887B (zh) | 2022-03-29 |
WO2018148584A1 (en) | 2018-08-16 |
JP6788746B2 (ja) | 2020-11-25 |
US10548731B2 (en) | 2020-02-04 |
EP3579789A1 (en) | 2019-12-18 |
US20200146825A1 (en) | 2020-05-14 |
US20180228610A1 (en) | 2018-08-16 |
CN110381887A (zh) | 2019-10-25 |
WO2018148584A4 (en) | 2018-10-04 |
US11432927B2 (en) | 2022-09-06 |
EP3579789A4 (en) | 2020-09-30 |
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