JP7015609B2 - 心臓弁膜置換システムおよびその方法 - Google Patents
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Description
Claims (21)
- 心臓の心周期中に心臓弁を通る血流を調整するために開放形態と閉鎖位置との間を動く生来の前尖および後尖を有する、病的な心臓弁の処置のための人工心臓弁であって、該人工心臓弁は、
圧縮位置から拡張された動作位置へと選択的に拡張可能な半月形のステントであって、該ステントは、上部のフレア状の部分および下部の心室部分を有し、上部のフレア状の部分は、病的な心臓弁の生来の弁輪の後部に重なるように広がり、下部の心室部分の少なくとも一部は、上部のフレア状の部分から伸長して心臓の心室の部屋に入り、下部の心室部分の少なくとも一部は、少なくとも1つの生来の弁尖の部分に接して位置づけられ、動作位置への拡張で少なくとも1つの生来の弁尖を血流から変位させるように構成される、ステントと、
ステントの内側表面に据え付けられた少なくとも1つの人工弁尖であって、少なくとも1つの人工弁尖は遊離端、2つの交連付着領域、付着端、接合領域、腹部領域、および遊離端から伸長し、かつステントの下部の心室部分に直接連結された少なくとも1つの突起構造を含み、ここで、動作位置において少なくとも1つの人工弁尖とステントの接合部が、3次元の弁尖-ステント付着曲線を形成するように、少なくとも1つの人工弁尖はステントに据え付けられる、人工弁尖と、
を含む、人工心臓弁。 - 心臓の心周期中に心臓弁を通る血流を調整するために開放形態と閉鎖位置との間を動く生来の前尖および後尖を有する、病的な心臓弁の処置のための人工心臓弁であって、該人工心臓弁は、
圧縮位置から拡張された動作位置へと選択的に拡張可能な半月形のステントであって、該ステントは、上部のフレア状の部分および下部の心室部分を有し、ここで、上部のフレア状の部分は、病的な心臓弁の生来の弁輪の後部に重なるように構成され、下部の心室部分の少なくとも一部は、上部のフレア状の部分から伸長して心臓の心室の部屋に入り、下部の心室部分の少なくとも一部は、少なくとも1つの生来の弁尖の部分に接して位置づけられ、動作位置への拡張で少なくとも1つの生来の弁尖を血流から変位させるように構成される、ステントと、
ステントの内側表面に据え付けられる中央の人工弁尖と、
中央の人工弁尖のいずれかの側にあるステントの内側表面に据え付けられる、側面交連弁尖と、
を含み、
ここで、中央の人工弁尖は遊離端、2つの交連付着領域、付着端、接合領域、腹部領域、および遊離端から伸長し、かつステントの下部の心室部分に直接連結するように構成された少なくとも1つの突起構造を含み、ここで、弁膜が閉鎖位置にある時、中央の人工弁尖と側面交連弁尖が生来の弁尖に接合して、弁膜を通って血液が逆流するのを防ぐように、中央の人工弁尖は心周期の全体にわたって可動性を有するように構成され、ここで、動作位置において中央の人工弁尖とステントの接合部が3次元の弁尖-ステント付着曲線を形成するように、中央の人工弁尖はステントに据え付けられる、
人工心臓弁。 - 各側面交連弁尖は突起構造を有していない、請求項2に記載の人工心臓弁。
- 少なくとも1つの突起構造は鼓形である、請求項1-3のいずれか1つに記載の人工心臓弁。
- 心臓の心周期中に心臓弁を通る血流を調整するために開放形態と閉鎖位置との間を動く生来の前尖および後尖を有する、病的な心臓弁の処置のための人工心臓弁であって、該人工心臓弁は、
圧縮位置から拡張された動作位置へと選択的に拡張可能な半月形のステントであって、該ステントは、上部のフレア状の部分および下部の心室部分を有し、ここで、上部のフレア状の部分は、病的な心臓弁の生来の弁輪の後部に重なるように構成され、下部の心室部分の少なくとも一部は、上部のフレア状の部分から伸長して心臓の心室の部屋に入り、下部の心室部分の少なくとも一部は、少なくとも1つの生来の弁尖の部分に接して位置づけられ、動作位置への拡張で少なくとも1つの生来の弁尖を血流から変位させるように構成される、ステントと、
ステントの内側表面に据え付けられる突起のある人工弁尖であって、ここで、突起のある人工弁尖は、遊離端、2つの交連付着領域、付着端、接合領域、腹部領域、および遊離端から伸長し、かつステントの下部の心室部分に直接連結された少なくとも1つの鼓形の突起構造を含み、ここで、弁膜が閉鎖位置にある時、突起のある人工弁尖が生来の弁尖に接合して、弁膜を通って血液が逆流するのを防ぐように、突起のある人工弁尖は心周期の全体にわたって可動性を有するように構成され、ここで、動作位置において突起のある人工弁尖とステントの接合部が3次元の弁尖-ステント付着曲線を形成するように、突起のある人工弁尖はステントに据え付けられる、人工弁尖と、
上部のフレア状の部分を通って伸長する複数の開口部と、
生来の弁輪内に固着させられ、複数の開口部を介して、上部のフレア状の部分を生来の弁輪に対して固着するように構成される、複数のアンカーと、
を含む、
人工心臓弁。 - 各アンカーは、人工心臓弁を生来の弁輪内に導き、かつ人工心臓弁をアンカーに固定するように構成された細長いテザー部をさらに含むことを特徴とする、請求項5に記載の人工心臓弁。
- 人工心臓弁は、
(1)3次元の弁尖-ステント付着曲線は3つの谷で構成され、
(2)少なくとも1つの鼓形の突起構造は5.0~15.0mmの長さを有し、および
(3)少なくとも1つの鼓形の突起構造の先端は約20°の角度である、
ことからなる群から選択される少なくとも1つの特徴を含むことを特徴とする、請求項1-6のいずれか1つに記載の人工心臓弁。 - ステントは放射状に折り畳み可能および拡張可能であることを特徴とする、請求項1-7のいずれか1つに記載の人工心臓弁。
- 上部のフレア状の部分の少なくとも一部、および下部の心室部分の少なくとも一部は、動作位置へと拡張可能であることを特徴とする、請求項1-8のいずれか1つに記載の人工心臓弁。
- 下部の心室部分は円周の長さに沿って異なる高さを有することを特徴とする、請求項1-9のいずれか1つに記載の人工心臓弁。
- 各人工弁尖は可撓性であり、および開放形態と閉鎖位置との間を動くように構成されることを特徴とする、請求項1-10のいずれか1つに記載の人工心臓弁。
- 少なくとも1つの突起構造は、遊離端から伸長し、かつステントの下部の心室部分に連結された複数の突起構造を含むことを特徴とする、請求項1-11のいずれか1つに記載の人工心臓弁。
- 少なくとも1つの突起構造は、少なくとも1つの人工弁尖の腹部領域に連結されることを特徴とする、請求項1-11のいずれか1つに記載の人工心臓弁。
- 少なくとも1つの突起構造は弁尖の遊離端に連結されることを特徴とする、請求項1-11のいずれか1つに記載の人工心臓弁。
- 上部のフレア状の部分は、上部のフレア状の部分を通って伸長する複数の開口部を画定することを特徴とする、請求項1-14のいずれか1つに記載の人工心臓弁。
- 弁膜は複数のアンカーをさらに含むことを特徴とする、請求項1-15のいずれか1つに記載の人工心臓弁。
- 各アンカーの近位部は、テザーの取り付けのために構成されたスロットを画定することを特徴とする、請求項16に記載の人工心臓弁。
- 各アンカーは、アンカーに人工心臓弁を配置かつ固定するように構成された細長いテザー部をさらに含むことを特徴とする、請求項16に記載の人工心臓弁。
- ステントの内側表面および/または外側表面の少なくとも一部に連結されたスカートをさらに含むことを特徴とする、請求項1-18のいずれか1つに記載の人工心臓弁。
- 少なくとも1つの人工弁尖の付着端は、スカートを介してステントに取り付けられ、および少なくとも1つの突起構造はスカートを介してステントに取り付けられることを特徴とする、請求項19に記載の人工心臓弁。
- 人工心臓弁の展開に続いて、複数のロック部材を同時に展開するように構成されたデリバリーシステムをさらに含むことを特徴とする、請求項1-20のいずれか1つに記載の人工心臓弁。
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