JP2022132342A - 心耳の閉塞のためのデバイスおよび方法 - Google Patents
心耳の閉塞のためのデバイスおよび方法 Download PDFInfo
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Abstract
Description
本願は、2015年5月14日出願の仮特許出願第62/161,742号明細書(参照によりそのすべてを本明細書中に取り込む)の優先権を主張する。
(態様)
(態様1)
体内の脈管、付属器官、および開口中に配置するためのデバイスであって、
近位末端、遠位末端、および縦軸を有する単一の自己拡張フレームであって、予め組み込まれた平面形状および(i)前記近位末端に配置されたセンターフレーム部分および(ii)前記センターフレーム部分から延びる複数の細長部材を有する面部分、および胴部分を含む、単一の自己拡張フレームと、
前記単一の自己拡張フレームに取り付けられた膜と、
を含む、デバイスであって、
前記複数の細長部材は、前記縦軸に直交する平面において実質的にたわむかまたは曲がるように構成され、および前記単一の自己拡張フレームの前記胴部分に掛けられた圧縮力に応答して、前記面部分の縦の動作を軽減する、デバイス。
(態様2)
前記センターフレーム部分が内周および外周を有する穴であり、および前記複数の細長部材が前記センターフレーム部分の外周から放射状に外に延びている、態様1に記載のデバイス。
(態様3)
前記センターフレーム部分が、前記センターフレーム部分の前記内周の周りに配置された複数の弧をさらに含む、態様2に記載のデバイス。
(態様4)
前記複数の細長部材の前記縦軸に対する厚さが前記センターフレーム部分の前記縦軸に対する厚さとほぼ等しい、態様1~3のいずれか一項に記載のデバイス。
(態様5)
前記センターフレーム部分および前記複数の細長部材が前記縦軸に実質的に直交する第1の平面内に配置されている、態様1~4のいずれか一項に記載のデバイス。
(態様6)
前記膜がそこを通る流体の通路および血栓の通路を妨げるように構成されている閉塞性材料を含む、態様1~5のいずれか一項に記載のデバイス。
(態様7)
前記膜が接着剤を使用して前記フレームに取り付けられている、態様6に記載のデバイス。
(態様8)
前記膜が血栓の通路を妨げながら、そこを通る流体の通路を部分的に可能にするように構成された半閉塞性材料を含む態様1~5のいずれか一項に記載のデバイス。
(態様9)
前記半閉塞性材料が、延伸ポリテトラフルオロエチレン(ePTFE)を含む、態様8に記載のデバイス。
(態様10)
前記単一の自己拡張フレームが、前記複数の細長部材と前記胴部分との間に配置された移行部分をさらに含み、および前記移行部分が前記胴部分に向かって前記複数の細長部材を移行させる湾曲を含む、態様1~9のいずれか一項に記載のデバイス。
(態様11)
前記単一の自己拡張フレームが切断された管でできており、および前記センターフレーム部分が前記切断された管から扁平になっている、態様1~10のいずれか一項に記載のデバイス。
(態様12)
前記単一の自己拡張フレームが平面シートでできている、態様1~10のいずれか一項に記載のデバイス。
(態様13)
前記複数の細長部材が、第1の曲線部、第2の曲線部、および第3の曲線部、前記第1の曲線部と前記第2の曲線部との間の第1の変曲点、および前記第2の曲線部と前記第3の曲線部との間の第2の変曲点を含む、態様1~12のいずれか一項に記載のデバイス。
(態様14)
前記第1の曲線部および前記第3の曲線部が第1の方向の湾曲を含み、前記第2の曲線部が、第2の方向の湾曲を含み、および前記第1の方向が前記第2の方向と反対の方向である、態様13に記載のデバイス。
(態様15)
前記面部分および前記胴部分は、前記圧縮力のない第1の形状および前記胴部分に掛けられた前記圧縮力に応答した第2の形状を含み、および前記面部分が前記第1の形状および前記第2の形状のそれぞれにおいてほぼ均一な表面を含む、態様1~14のいずれか一項に記載のデバイス。
(態様16)
前記面部分が前記近位末端に対して前記面部分から外側への突起のない表面を含む、態様1~15のいずれか一項に記載のデバイス。
(態様17)
前記センターフレーム部分が前記デバイスの送達のための付着点を提供するように構成されている、態様1~16のいずれか一項に記載のデバイス。
(態様18)
前記胴部分が第1の先細りになっている部分および第2の先細りになっている部分を含み、前記第1の先細りになっている部分が第1の割合で周囲が減少し、前記第2の先細りになっている部分が第2の割合で周囲が減少し、および前記第1の割合が前記第2の割合より小さい、態様1~17のいずれか一項に記載のデバイス。
(態様19)
前記胴部分が複数のアンカーをさらに含み、および前記複数のアンカーのそれぞれがアンカー部分およびアームを含む、態様1~18のいずれか一項に記載のデバイス。
(態様20)
前記複数のアンカーが第1の群のアンカーおよび第2の群のアンカーを含み、前記第1の群のアンカーのアームが第1の長さを含み、前記第2の群のアンカーのアームが第2の長さを含み、および前記第2の長さが前記第1の長さより大きく、ならびに、
前記第1の群のアンカーのアンカー部分が前記遠位末端に対して第1の高さで配置されており、前記第2の群のアンカーのアンカー部分が前記遠位末端に対して第2の高さで配置されており、および前記第1の高さが前記第2の高さより大きい、態様19に記載のデバイス。
(態様21)
細長い形状および配置された形状を有する体内の脈管、付属器官、および開口中に配置するためのデバイスであって、前記デバイスが、
近位末端および遠位末端を有するニチノールの切断された管フレームであって、
前記近位末端に配置されおよびセンターフレーム部分の周囲に配置された複数の弧を含むセンターフレーム部分ならびに前記センターフレーム部分から延びる複数の細長部材を有する面部分と、
胴部分と、を含む、フレームと、
前記ニチノールの切断された管フレームに取り付けられた膜と、
を含み、
前記センターフレーム部分および前記複数の細長部材が実質的に均一な表面を形成し、および前記センターフレーム部分が前記デバイスのための送達システムのための付着点を提供するように構成されている、デバイス。
(態様22)
前記センターフレーム部分が前記複数の細長部材の厚さにほぼ等しい厚さを含む、態様21に記載のデバイス。
(態様23)
前記面部分が前記面部分の外部への突起のない表面を含む、態様21または22に記載のデバイス。
(態様24)
前記ニチノールの切断された管フレームがハブなしの面部分を含む、態様21~23のいずれか一項に記載のデバイス。
(態様25)
前記胴部分が複数のアンカーをさらに含み、および前記複数のアンカーのそれぞれがアンカー部分およびアームを含む、態様21~24のいずれか一項に記載のデバイス。
(態様26)
前記ニチノールの切断された管フレームが縦軸を含み、および前記複数の細長部材が縦軸に直交する平面において実質的にたわむかまたは曲がるように構成され、および前記ニチノールの切断された管フレームの前記胴部分に掛けられた圧縮力に応答し、前記面部分の縦の動作を軽減する、態様21~25のいずれか一項に記載のデバイス。
(態様27)
前記複数の細長部材が第1の曲線部、第2の曲線部、および第3の曲線部、前記第1の曲線部と前記第2の曲線部との間の第1の変曲点、および前記第2の曲線部と前記第3の曲線部との間の第2の変曲点を含む、態様21~26のいずれか一項に記載のデバイス。
(態様28)
前記細長い形状と前記配置された形状との間で移行する際に前記センターフレーム部分の周囲に分配するように構成された前記センターフレーム部分の周囲に前記複数の弧が配置されている、態様21~27のいずれか一項に記載のデバイス。
(態様29)
患者の左心耳の治療で栓形成を減らす方法であって、
前記左心耳の小孔を通して経カテーテル集成体を配置することと、
前記経カテーテル集成体からデバイスを配置することであって、前記デバイスが近位末端、遠位末端、および縦軸を有する単一の自己拡張フレームを含み、前記単一の自己拡張フレームが、前記近位末端に配置されたセンターフレーム部分および前記センターフレーム部分から延びる複数の細長部材を有する面部分と、前記面部分に実質的に直交して配置された胴部分と、前記単一の自己拡張フレームに取り付けられた膜と、を含み、前記面部分および前記膜が前記デバイスの閉塞面を画定することと、
前記左心耳からの1種または2種以上の力を吸収することあって、それによって前記縦軸に直交する平面中の前記複数の細長部材を曲げて、それに応答して面部分の縦の動作を軽減することと、
を含む、方法。
(態様30)
前記左心耳から1種または2種以上の力を吸収することが実質的に平面閉塞面を維持することによって血栓形成を軽減することを含む、態様29に記載の方法。
Claims (30)
- 体内の脈管、付属器官、および開口中に配置するためのデバイスであって、
近位末端、遠位末端、および縦軸を有する単一の自己拡張フレームであって、予め組み込まれた平面形状および(i)前記近位末端に配置されたセンターフレーム部分および(ii)前記センターフレーム部分から延びる複数の細長部材を有する面部分、および胴部分を含む、単一の自己拡張フレームと、
前記単一の自己拡張フレームに取り付けられた膜と、
を含む、デバイスであって、
前記複数の細長部材は、前記縦軸に直交する平面において実質的にたわむかまたは曲がるように構成され、および前記単一の自己拡張フレームの前記胴部分に掛けられた圧縮力に応答して、前記面部分の縦の動作を軽減する、デバイス。 - 前記センターフレーム部分が内周および外周を有する穴であり、および前記複数の細長部材が前記センターフレーム部分の外周から放射状に外に延びている、請求項1に記載のデバイス。
- 前記センターフレーム部分が、前記センターフレーム部分の前記内周の周りに配置された複数の弧をさらに含む、請求項2に記載のデバイス。
- 前記複数の細長部材の前記縦軸に対する厚さが前記センターフレーム部分の前記縦軸に対する厚さとほぼ等しい、請求項1~3のいずれか一項に記載のデバイス。
- 前記センターフレーム部分および前記複数の細長部材が前記縦軸に実質的に直交する第1の平面内に配置されている、請求項1~4のいずれか一項に記載のデバイス。
- 前記膜がそこを通る流体の通路および血栓の通路を妨げるように構成されている閉塞性材料を含む、請求項1~5のいずれか一項に記載のデバイス。
- 前記膜が接着剤を使用して前記フレームに取り付けられている、請求項6に記載のデバイス。
- 前記膜が血栓の通路を妨げながら、そこを通る流体の通路を部分的に可能にするように構成された半閉塞性材料を含む請求項1~5のいずれか一項に記載のデバイス。
- 前記半閉塞性材料が、延伸ポリテトラフルオロエチレン(ePTFE)を含む、請求項8に記載のデバイス。
- 前記単一の自己拡張フレームが、前記複数の細長部材と前記胴部分との間に配置された移行部分をさらに含み、および前記移行部分が前記胴部分に向かって前記複数の細長部材を移行させる湾曲を含む、請求項1~9のいずれか一項に記載のデバイス。
- 前記単一の自己拡張フレームが切断された管でできており、および前記センターフレーム部分が前記切断された管から扁平になっている、請求項1~10のいずれか一項に記載のデバイス。
- 前記単一の自己拡張フレームが平面シートでできている、請求項1~10のいずれか一項に記載のデバイス。
- 前記複数の細長部材が、第1の曲線部、第2の曲線部、および第3の曲線部、前記第1の曲線部と前記第2の曲線部との間の第1の変曲点、および前記第2の曲線部と前記第3の曲線部との間の第2の変曲点を含む、請求項1~12のいずれか一項に記載のデバイス。
- 前記第1の曲線部および前記第3の曲線部が第1の方向の湾曲を含み、前記第2の曲線部が、第2の方向の湾曲を含み、および前記第1の方向が前記第2の方向と反対の方向である、請求項13に記載のデバイス。
- 前記面部分および前記胴部分は、前記圧縮力のない第1の形状および前記胴部分に掛けられた前記圧縮力に応答した第2の形状を含み、および前記面部分が前記第1の形状および前記第2の形状のそれぞれにおいてほぼ均一な表面を含む、請求項1~14のいずれか一項に記載のデバイス。
- 前記面部分が前記近位末端に対して前記面部分から外側への突起のない表面を含む、請求項1~15のいずれか一項に記載のデバイス。
- 前記センターフレーム部分が前記デバイスの送達のための付着点を提供するように構成されている、請求項1~16のいずれか一項に記載のデバイス。
- 前記胴部分が第1の先細りになっている部分および第2の先細りになっている部分を含み、前記第1の先細りになっている部分が第1の割合で周囲が減少し、前記第2の先細りになっている部分が第2の割合で周囲が減少し、および前記第1の割合が前記第2の割合より小さい、請求項1~17のいずれか一項に記載のデバイス。
- 前記胴部分が複数のアンカーをさらに含み、および前記複数のアンカーのそれぞれがアンカー部分およびアームを含む、請求項1~18のいずれか一項に記載のデバイス。
- 前記複数のアンカーが第1の群のアンカーおよび第2の群のアンカーを含み、前記第1の群のアンカーのアームが第1の長さを含み、前記第2の群のアンカーのアームが第2の長さを含み、および前記第2の長さが前記第1の長さより大きく、ならびに、
前記第1の群のアンカーのアンカー部分が前記遠位末端に対して第1の高さで配置されており、前記第2の群のアンカーのアンカー部分が前記遠位末端に対して第2の高さで配置されており、および前記第1の高さが前記第2の高さより大きい、請求項19に記載のデバイス。 - 細長い形状および配置された形状を有する体内の脈管、付属器官、および開口中に配置するためのデバイスであって、前記デバイスが、
近位末端および遠位末端を有するニチノールの切断された管フレームであって、
前記近位末端に配置されおよびセンターフレーム部分の周囲に配置された複数の弧を含むセンターフレーム部分ならびに前記センターフレーム部分から延びる複数の細長部材を有する面部分と、
胴部分と、を含む、フレームと、
前記ニチノールの切断された管フレームに取り付けられた膜と、
を含み、
前記センターフレーム部分および前記複数の細長部材が実質的に均一な表面を形成し、および前記センターフレーム部分が前記デバイスのための送達システムのための付着点を提供するように構成されている、デバイス。 - 前記センターフレーム部分が前記複数の細長部材の厚さにほぼ等しい厚さを含む、請求項21に記載のデバイス。
- 前記面部分が前記面部分の外部への突起のない表面を含む、請求項21または22に記載のデバイス。
- 前記ニチノールの切断された管フレームがハブなしの面部分を含む、請求項21~23のいずれか一項に記載のデバイス。
- 前記胴部分が複数のアンカーをさらに含み、および前記複数のアンカーのそれぞれがアンカー部分およびアームを含む、請求項21~24のいずれか一項に記載のデバイス。
- 前記ニチノールの切断された管フレームが縦軸を含み、および前記複数の細長部材が縦軸に直交する平面において実質的にたわむかまたは曲がるように構成され、および前記ニチノールの切断された管フレームの前記胴部分に掛けられた圧縮力に応答し、前記面部分の縦の動作を軽減する、請求項21~25のいずれか一項に記載のデバイス。
- 前記複数の細長部材が第1の曲線部、第2の曲線部、および第3の曲線部、前記第1の曲線部と前記第2の曲線部との間の第1の変曲点、および前記第2の曲線部と前記第3の曲線部との間の第2の変曲点を含む、請求項21~26のいずれか一項に記載のデバイス。
- 前記細長い形状と前記配置された形状との間で移行する際に前記センターフレーム部分の周囲に分配するように構成された前記センターフレーム部分の周囲に前記複数の弧が配置されている、請求項21~27のいずれか一項に記載のデバイス。
- 患者の左心耳の治療で栓形成を減らす方法であって、
前記左心耳の小孔を通して経カテーテル集成体を配置することと、
前記経カテーテル集成体からデバイスを配置することであって、前記デバイスが近位末端、遠位末端、および縦軸を有する単一の自己拡張フレームを含み、前記単一の自己拡張フレームが、前記近位末端に配置されたセンターフレーム部分および前記センターフレーム部分から延びる複数の細長部材を有する面部分と、前記面部分に実質的に直交して配置された胴部分と、前記単一の自己拡張フレームに取り付けられた膜と、を含み、前記面部分および前記膜が前記デバイスの閉塞面を画定することと、
前記左心耳からの1種または2種以上の力を吸収することあって、それによって前記縦軸に直交する平面中の前記複数の細長部材を曲げて、それに応答して面部分の縦の動作を軽減することと、
を含む、方法。 - 前記左心耳から1種または2種以上の力を吸収することが実質的に平面閉塞面を維持することによって血栓形成を軽減することを含む、請求項29に記載の方法。
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WO2016183495A2 (en) | 2016-11-17 |
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AU2016260549B2 (en) | 2021-05-13 |
JP2020006219A (ja) | 2020-01-16 |
JP2018515246A (ja) | 2018-06-14 |
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