JP2022037201A - 流出の閉塞を回避するための人工弁 - Google Patents
流出の閉塞を回避するための人工弁 Download PDFInfo
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Abstract
Description
本願は、米国仮特許出願第62/288,987号(2016年1月29日出願)に対する優先権を主張する。
本願明細書は、例えば、以下の項目も提供する。
(項目1)
患者の天然僧帽弁への埋め込みのための人工心臓弁であって、前記心臓弁は、
拡張構成および折り畳まれた構成を有する半径方向に拡張可能なアンカフレームと、
前記アンカフレームに結合されている人工弁と
を備え、
前記人工弁は、複数の人工弁尖を備え、前記複数の人工弁尖の各々は、自由端および固定端を有し、前記固定端は、前記アンカフレームに結合され、前記複数の人工弁尖の前記自由端は、開放構成および閉鎖構成を有し、前記開放構成において、前記自由端は、互いから離れて配置され、それらを通る順行性血流を可能にし、前記閉鎖構成において、前記自由端は、互いに隣接して配置され、それらを通る逆行性血流を実質的に防止し、
前記複数の人工弁尖は、前記天然前尖の幅全体に及ぶようにサイズを決定された人工前尖を備え、
収縮期において、前記人工前尖は、前記左心室流出路から離れるように変位し、障害物のない閉塞されていない流出路を提供する、心臓弁。
(項目2)
前記アンカフレームは、前記天然僧帽弁の前部分に定着するように構成された前定着タブを備えている、項目1に記載の弁。
(項目3)
前記天然僧帽弁の前記前部分は、線維性三角を備えている、項目2に記載の弁。
(項目4)
前記アンカフレームは、前記天然僧帽弁の第2の前部分に定着するように構成された第2の前定着タブを備えている、項目2に記載の弁。
(項目5)
前記アンカフレームは、実質的に平坦な前部分および円筒形の後部分を有するD字形断面を備え、前記平坦な前部分は、前記左心室流出路への前記人工心臓弁の衝突を防止し、前記円筒形の後部分は、前記天然僧帽弁の後部分に係合する、項目1に記載の弁。
(項目6)
前記アンカフレームは、1つ以上の交連柱と、前定着タブとを備え、前記1つ以上の交連柱は、自由端と、前記アンカフレームに結合された反対端とを有し、前記1つ以上の交連柱は、前記複数の人工弁尖に結合され、
前記前定着タブは、前記天然僧帽弁の前部分に定着するように構成されている、項目1に記載の弁。
(項目7)
前記前定着タブと前記1つ以上の交連柱とは、前記アンカフレームが前記折り畳まれた構成であるとき、互いに入れ子にされている、項目6に記載の弁。
(項目8)
前記前定着タブは、前記アンカフレームの円周上の円周位置から生じ、前記1つ以上の交連柱も、前記アンカフレームの前記円周上の前記前定着タブと同じ円周位置から生じる、項目6に記載の弁。
(項目9)
前記前定着タブが前記1つ以上の交連柱から生じているか、または、前記1つ以上の交連柱が前記前定着タブから生じている、項目6に記載の弁。
(項目10)
前記アンカフレームは、前記1つ以上の交連柱から生じている複数の弦状バンパ支柱をさらに備え、前記複数の弦状バンパ支柱は、前記LVOTから離れて天然弁下生体構造を配置するように構成されている、項目9に記載の弁。
(項目11)
前記交連柱は、前記交連柱の自由端に隣接する定着要素をさらに備え、前記定着要素は、送達システムに係合するように構成されている、項目9に記載の弁。
(項目12)
前記アンカフレームは、前記1つ以上の交連柱から生じている複数の叉骨形支柱をさらに備え、前記複数の叉骨形支柱は、隣接する交連柱の間の距離に弓状に架かるように構成され、各叉骨形支柱は、前記叉骨形支柱の自由端に隣接する定着要素を備え、前記定着要素は、送達カテーテルに係合するように構成されている、項目9に記載の弁。
(項目13)
前記複数の叉骨形支柱は、変形可能部材であり、前記送達カテーテルの中へ後退時、前記アンカフレームの半径方向収縮を可能にする、項目12に記載の弁。
(項目14)
前記定着要素は、単一のネジ山付きコネクタ、バックルコネクタ、またはプロングコネクタを備えている、項目12に記載の弁。
(項目15)
患者の天然僧帽弁への埋め込みのための人工心臓弁であって、前記心臓弁は、
拡張構成および折り畳まれた構成と、上流端および下流端とを有する半径方向に拡張可能なアンカフレームであって、前記半径方向に拡張可能なアンカフレームは、自由端と前記下流端に隣接して前記アンカフレームに結合された反対端とを有する1つ以上の交連柱と、前記下流端に隣接して前記アンカフレームに結合された前定着タブとを備え、前記前定着タブは、前記天然僧帽弁の前部分に定着するように構成され、前記前定着タブと前記1つ以上の交連柱とは、前記アンカフレームが前記折り畳まれた構成であるとき、互いに入れ子にされている、アンカフレームと、
前記アンカフレームに結合されている人工弁と
を備え、
前記人工弁は、1つ以上の人工弁尖を備え、前記1つ以上の人工弁尖の各々は、自由端および固定端を有し、前記固定端は、前記アンカフレームに結合されており、
前記1つ以上の交連柱は、前記1つ以上の人工弁尖に結合されている、心臓弁。
(項目16)
前記1つ以上の人工弁尖の前記自由端は、開放構成および閉鎖構成を有し、前記開放構成において、前記自由端は、互いから離れて配置され、それらを通る順行性血流を可能にし、前記閉鎖構成において、前記自由端は、互いに隣接して配置され、それらを通る逆行性血流を実質的に防止し、前記1つ以上の人工弁尖は、2つの天然線維性三角の間の天然前弁尖の幅に及ぶようにサイズを決定された人工前尖を備え、収縮期において、前記人工前尖は、前記左心室流出路から離れるように変位し、障害物のない閉塞されていない流出路を提供する、項目15に記載の弁。
(項目17)
前記天然僧帽弁の前記前部分は、線維性三角を備えている、項目15に記載の弁。
(項目18)
前記アンカフレームは、前記天然僧帽弁の第2の前部分に定着するように構成された第2の前定着タブを備えている、項目15に記載の弁。
(項目19)
前記アンカフレームは、実質的に平坦な前部分および円筒形の後部分を有するD字形断面を備え、前記平坦な前部分は、前記左心室流出路への前記人工心臓弁の衝突を防止し、前記円筒形部分は、前記天然僧帽弁の後部分に係合する、項目15に記載の弁。
(項目20)
前記前定着タブは、前記アンカフレームの円周上の円周位置から生じ、前記1つ以上の交連柱も、前記アンカフレームの前記円周上の前記前定着タブと同じ円周位置から生じる、項目15に記載の弁。
(項目21)
前記前定着タブが前記1つ以上の交連柱から生じているか、または、前記1つ以上の交連柱が前記前定着タブから生じている、項目15に記載の弁。
(項目22)
患者の心臓内の天然僧帽弁を治療する方法であって、前記方法は、
天然前弁尖の幅に及ぶ人工前尖を有する人工僧帽弁を提供することと、
前記天然僧帽弁の中に前記人工僧帽弁を定着させることと、
収縮期中、前記左心室流出路から離れるように収縮期における前記人工前尖を変位させ、それによって、閉塞されていない流出路を作成することと
を含む、方法。
(項目23)
定着させることは、前記人工弁の前部分上に配置された前定着タブを前記天然僧帽弁の前部分に定着させることを含む、項目22に記載の方法。
(項目24)
前記天然僧帽弁の前記前部分は、線維性三角を備えている、項目23に記載の方法。
(項目25)
折り畳まれた構成から拡張構成に前記人工僧帽弁を半径方向に拡張することを含み、前記人工僧帽弁を半径方向に拡張することは、1つ以上の交連柱内で入れ子にされた位置から離れるように1つ以上の前定着タブを拡張することを含む、項目22に記載の方法。
(項目26)
折り畳まれた構成から拡張構成に前記人工僧帽弁を半径方向に拡張することを含み、半径方向に拡張することは、1つ以上の交連柱内で入れ子にされた位置から離れるように1つ以上の後定着タブを拡張することを含む、項目22に記載の方法。
(項目27)
前記人工僧帽弁を定着させることは、第1の方向へ送達システム上のアクチュエータ機構を作動させることであって、前記第1の方向へ前記アクチュエータ機構を作動させることは、前記人工僧帽弁から離れるようにシースカテーテルを移動させ、拘束を除去し、それによって、前記人工僧帽弁が拡張することを可能にすることを含む、ことと、前記第1の方向と反対の第2の方向へ前記アクチュエータ機構を作動させることと
を含み、
前記第2の方向へ前記アクチュエータ機構を作動させることは、前記人工僧帽弁に向かってシースカテーテルを移動させ、拘束を提供し、それによって、前記人工僧帽弁が強制的に圧縮されるようにすることを含む、項目22に記載の方法。
(項目28)
前記第1の方向へ前記アクチュエータ機構を作動させることは、定着カテーテルから離れるようにベルカテーテルを移動させ、拘束を除去し、それによって、交連アンカが解放されることを可能にすることをさらに含み、前記交連アンカは、前記人工僧帽弁のフレームを前記送達システムに係合する定着要素を備え、前記第2の方向へ前記アクチュエータ機構を作動させることは、前記定着カテーテルに向かって前記ベルカテーテルを移動させ、前記交連アンカを捕捉または制限する拘束を提供することを含む、項目27に記載の方法。
(項目29)
前記拘束を提供することは、前記交連アンカの上で制限要素を解放可能にスライドさせることを含む、項目28に記載の方法。
(項目30)
前記アクチュエータ機構を作動させることは、前記定着カテーテルの上でシースカテーテルを移動させ、それによって、拘束を加えることを含み、前記拘束を加えることは、交連アンカが圧縮されることを可能にすることを含み、前記交連アンカは、前記人工僧帽弁の前記フレームを前記送達システムに係合する可撓性定着要素を備えている、項目27に記載の方法。
(項目31)
患者の心臓内の天然僧帽弁を治療する方法であって、前記方法は、
上流端および下流端を有する半径方向に拡張可能なアンカフレームに結合された人工僧帽弁を提供することであって、前記半径方向に拡張可能なアンカフレームは、自由端と前記下流端に隣接して前記アンカフレームに結合された反対端とを有する1つ以上の交連柱と、前記下流端に隣接して前記アンカフレームに結合された前定着タブとを備えている、ことと、
折り畳まれた構成から拡張構成に前記半径方向に拡張可能なアンカフレームを拡張することと、
前記天然僧帽弁の中に前記人工僧帽弁を定着させることであって、前記前定着タブは、前記天然僧帽弁の前部分に定着する、ことと、
前記1つ以上の交連柱内で入れ子にされた位置から離れるように前記前定着タブを半径方向に拡張することと
を含む、方法。
(項目32)
前記天然僧帽弁の前記前部分は、線維性三角を備えている、項目31に記載の方法。
(項目33)
前記アンカフレームを半径方向に拡張することは、前記前定着タブ内で入れ子にされた位置から離れるように1つ以上の前記1つ以上の交連柱を拡張することを含む、項目31に記載の方法。
(項目34)
前記人工僧帽弁は、人工前尖を備え、前記方法は、
2つの天然線維性三角の間の天然前弁尖の幅に及ぶことと、
左心室流出路から離れるように前記人工前尖を変位させることと、
前記人工前尖の前記変位によって閉塞されていない流出路を作成することと
を含む、項目31に記載の方法。
(項目35)
補綴具を標的治療領域に送達するための送達システムであって、前記システムは、
近位端、遠位端、およびそれらの間に延びている管腔を有する内側ガイドワイヤカテーテルであって、前記管腔は、ガイドワイヤをスライド可能に受け取るようにサイズを決定されている、内側ガイドワイヤカテーテルと、
前記ガイドワイヤカテーテルに結合された可撓性拡張先端であって、前記拡張先端は、テーパ状かつ可撓性の自己拡張縁を有する、拡張先端と、
前記内側ガイドワイヤカテーテルを覆ってスライド可能に配置されたシースカテーテルであって、前記シースカテーテルは、近位端および遠位端を有する、シースカテーテルと、
前記シースカテーテルの前記近位端に動作可能に結合されたアクチュエータ機構と
を備え、
第1の方向への前記アクチュエータ機構の作動は、前記拡張器先端から離れるように前記シースカテーテルを移動させ、それによって、前記補綴具から拘束を除去し、前記補綴具が拡張することを可能にし、
前記第1の方向と反対の第2の方向への前記アクチュエータ機構の作動は、前記拡張器先端と係合するように前記シースカテーテルを移動させ、それによって、その中に前記補綴具を封入する、システム。
(項目36)
前記ガイドワイヤカテーテルを覆って固定して配置された静止定着カテーテルをさらに備え、前記定着カテーテルは、前記定着カテーテルの遠位端に隣接し、前記補綴具に係合するように構成されているアンカ要素を有する、項目35に記載のシステム。
(項目37)
前記定着カテーテルを覆ってスライド可能に配置されたベルカテーテルをさらに備え、前記ベルカテーテルは、前記ベルカテーテルの遠位端に隣接して配置されたベル要素を有し、前記ベル要素は、前記アンカカテーテルと係合するように前記補綴具を拘束する、項目36に記載のシステム。
(項目38)
前記定着カテーテルは、前記定着カテーテルの前記遠位端に隣接する可撓性プロング型アンカ要素を有し、前記アンカ要素は、前記補綴具に係合するように構成されている、項目36に記載のシステム。
(項目39)
前記シースカテーテルは、前記定着カテーテルを覆ってスライド可能に配置され、前記シースカテーテルの前記遠位端の前進は、前記補綴具と係合するように前記可撓性プロング型アンカ要素を折り畳む、項目38に記載のシステム。
(項目40)
前記定着カテーテルを覆って固定して配置された静止ベルカテーテルをさらに備え、前記ベルカテーテルは、前記ベルカテーテルの遠位端に隣接して配置されたベル要素を有し、前記ベル要素は、前記アンカカテーテルから前記補綴具を解放する、項目36に記載のシステム。
(項目41)
前記ガイドワイヤカテーテルを覆って回転可能に配置されたベルカテーテルをさらに備え、前記ベルカテーテルは、前記ベルカテーテルの遠位端に隣接して配置された内部ネジ山付きベル要素を有し、前記ネジ山付きベル要素は、係合するように前記補綴具を拘束する、項目35に記載のシステム。
(項目42)
前記ベルカテーテルの近位端に動作可能に結合された第2のアクチュエータ機構をさらに備え、第1の方向への前記第2のアクチュエータ機構の作動は、前記補綴具を前記ベルカテーテルに結合し、前記補綴具のための拘束を提供し、前記第1の方向と反対の第2の方向への前記第2のアクチュエータ機構の作動は、前記ベルカテーテルから前記補綴具を分断し、前記補綴具から前記拘束を除去する、項目41に記載のシステム。
(項目43)
前記ガイドワイヤカテーテルを覆って回転可能に配置された回転トルクカテーテルをさらに備え、前記トルクカテーテルは、前記トルクカテーテルの遠位端に隣接し、トルクを伝達するように構成された駆動歯車要素を有する、項目35に記載のシステム。
(項目44)
前記トルクカテーテルに隣接して回転可能に配置された複数の回転ネジ山コネクタカテーテルをさらに備え、前記ネジ山コネクタカテーテルの各々は、各ネジ山コネクタカテーテルの遠位端に隣接する被駆動歯車要素と、各ネジ山コネクタカテーテルの前記遠位端に隣接するネジ山付きソケットとを有し、前記被駆動歯車要素は、前記駆動歯車要素と絡み合い、トルクを受け取るようにサイズを決定され、前記ネジ山付きソケットは、前記補綴具を拘束し、係合するように構成されている、項目43に記載のシステム。
(項目45)
前記トルクカテーテルの近位端に動作可能に結合された第2のアクチュエータ機構をさらに備え、第1の方向への前記第2のアクチュエータ機構の作動は、前記補綴具を前記ネジ山コネクタカテーテルに結合し、前記第1の方向と反対の第2の方向への前記第2のアクチュエータ機構の作動は、前記ネジ山コネクタカテーテルから前記補綴具を分断する、項目44に記載のシステム。
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2017
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- 2017-01-27 CN CN201780021798.XA patent/CN108882981B/zh active Active
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US20220257370A1 (en) | 2022-08-18 |
JP7006940B2 (ja) | 2022-01-24 |
US11357622B2 (en) | 2022-06-14 |
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EP4183372A1 (en) | 2023-05-24 |
CA3007670A1 (en) | 2017-08-03 |
EP3407835A4 (en) | 2019-06-26 |
US10433952B2 (en) | 2019-10-08 |
CN108882981B (zh) | 2021-08-10 |
CN113633435A (zh) | 2021-11-12 |
DE112017000541T5 (de) | 2018-10-18 |
EP3407835A1 (en) | 2018-12-05 |
WO2017127939A1 (en) | 2017-08-03 |
JP2019503246A (ja) | 2019-02-07 |
US20190388219A1 (en) | 2019-12-26 |
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