JP7296317B2 - 血管閉塞装置および方法 - Google Patents
血管閉塞装置および方法 Download PDFInfo
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12036—Type of occlusion partial occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
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Description
本出願は、米国特許法第119条(e)の定めにより、2017年2月24日に出願された、米国仮出願第62/463,498号、および2017年5月17日に出願された、米国仮出願第62/507,641号からの優先権を主張する。両方の仮出願の開示は、本明細書での開示と矛盾しない範囲で、本明細書に参照により明示的に組み込まれる。
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Claims (38)
- 身体管腔を閉塞させるための装置であって、
複数の編組フィラメントを含むメッシュ構造であって、前記メッシュ構造は近位端と遠位端との間に延在する縦軸を画定し、前記メッシュ構造の前記フィラメントは、前記近位端で近位ハブ内に、かつ前記遠位端で遠位ハブ内に固定されている、メッシュ構造を備え、
前記メッシュ構造は完全に拡張した弛緩構成から圧縮構成に半径方向に圧縮可能であり、前記管腔内に配備されると、前記圧縮構成から部分的に拡張した、制約構成に弾性的に拡張可能であり、
前記弛緩構成における前記メッシュ構造は、前記縦軸に沿って間隔を置いた複数の半径方向に延出している閉塞領域を含み、前記閉塞領域の各々は、前記メッシュ構造の前記縦軸に対して70°~85°の角度を画定する側面を有し、前記閉塞領域の各々は、頂点を有し、
前記メッシュ構造の前記制約構成において、各半径方向に延出している閉塞領域は各フィラメントに対して前記管腔の2つの半径方向トラバースを画定し、半径方向トラバースの総数は720~2000の間であり、
前記頂点の各々は、前記縦軸に沿った厚さを有し、
前記頂点の組み合わされた厚さは前記半径方向に延出している閉塞領域の最近位のものと前記半径方向に延出している閉塞領域の最遠位のものの間の前記縦軸に沿った前記メッシュ構造の長さの50%よりも小さい、装置。 - 前記メッシュ構造は単層の連続した管状編組構造である、請求項1に記載の装置。
- 各半径方向に延出している閉塞領域は第1の直径を有し、前記第1の直径よりも小さい第2の直径を有する前記メッシュ構造の連結領域によって、最も近い隣接した半径方向に延出している閉塞領域から分離されている、請求項1に記載の装置。
- 前記弛緩構成における前記メッシュ構造は、少なくとも3つの半径方向に延出している閉塞領域を含む、請求項1に記載の装置。
- 前記メッシュ構造は前記縦軸に沿って軸長を画定し、前記閉塞領域は、前記軸長の1センチメートルあたり4~10の間のメッシュ層を提供する、請求項1に記載の装置。
- 前記メッシュ構造が前記制約構成にある場合の前記角度は、前記メッシュ構造が前記弛緩構成にある場合の前記角度よりも小さい、請求項1に記載の装置。
- 前記頂点の各々は、前記閉塞領域の各々がせいぜい2mmの厚さを有する周辺縁を有する、請求項1に記載の装置。
- 前記装置は3~7の間の半径方向に延出している閉塞領域を含む、請求項7に記載の装置。
- 縦軸に沿って近位端と遠位端との間に軸長を画定するメッシュ構造であって、前記メッシュ構造は前記近位端と前記遠位端との間に延在する編組フィラメントメッシュを含み、前記編組フィラメントメッシュは近位ハブ内の前記近位端および遠位ハブ内の前記遠位端で終了している複数の編組フィラメントを含む、メッシュ構造
を備え、
前記メッシュ構造は半径方向に圧縮した構成および半径方向に拡張した弛緩構成を有し、
前記弛緩構成における前記メッシュ構造は、前記縦軸に沿って相互に間隔を置いた、第1の直径を有する複数の半径方向に延出している閉塞領域を有し、各半径方向に延出している閉塞領域は、前記第1の直径よりも小さい第2の直径を有する連結領域により、最も近い隣接した半径方向に延出している閉塞領域から軸方向に分離されており、各半径方向に延出している閉塞領域は、周辺縁で交わる近位側および遠位側を有し、
前記周辺縁の各々は、前記縦軸に沿った厚さを有し、前記周辺縁の組み合わされた厚さは、前記半径方向に延出している閉塞領域の最近位のものと前記半径方向に延出している閉塞領域の最遠位のものの間の前記縦軸に沿った前記メッシュ構造の長さの50%よりも小さく、
前記閉塞領域は前記軸長の1センチメートルあたり4~10の間のメッシュ層を提供する、
身体管腔を閉塞させるための装置。 - 前記メッシュ構造は単層の連続した編組構造である、請求項9に記載の装置。
- 前記弛緩構成における前記メッシュ構造は、少なくとも3つの半径方向に延出している閉塞領域を含む、請求項9に記載の装置。
- 前記近位側および前記遠位側の少なくとも1つは、前記弛緩構成において前記縦軸に対して70°~85°の間の角度を画定する、請求項9に記載の装置。
- 前記メッシュ構造は前記身体管腔内で部分的に拡張した制約構成をとり、それにより、前記制約構成において、各半径方向に延出している閉塞領域は、各フィラメントに対して前記管腔の2つの半径方向トラバースを画定し、半径方向トラバースの総数は720~2000の間である、請求項9に記載の装置。
- 前記メッシュ構造は前記身体管腔内で部分的に拡張した制約構成をとり、前記角度は、前記メッシュ構造が前記制約構成にある場合、前記メッシュ構造が前記弛緩構成にある場合の前記角度よりも小さい、請求項12に記載の装置。
- 前記周辺縁の各々は、せいぜい2mmの厚さを有する、請求項9に記載の装置。
- 前記装置は3~7の間の半径方向に延出している閉塞領域を含み、それにより前記装置は、前記軸長の1センチメートルあたり2~4の間の周辺縁を含む、請求項15に記載の装置。
- 腔内壁によって画定される身体管腔を閉塞させるための装置であって、前記装置は、
近位端と遠位端との間に縦軸を有するメッシュ構造であって、前記メッシュ構造は前記近位端と前記遠位端との間に延在する編組フィラメント状メッシュを含み、前記メッシュは複数の編組フィラメントを含み、その各々は近位ハブ内の前記近位端および遠位ハブ内の前記遠位端で終了する、メッシュ構造
を備え、
前記メッシュ構造は半径方向に圧縮した構成および弛緩構成を有し、
前記半径方向に圧縮した構成における前記メッシュ構造は、前記身体管腔内の標的部位への送達のために0.7mmを超えない外径を有し、
前記弛緩構成における前記メッシュ構造は複数の半径方向に延出している閉塞領域を有し、各半径方向に延出している閉塞領域は、周辺縁で交わる近位側および遠位側を有し、前記近位側および前記遠位側の少なくとも1つは、前記弛緩構成における場合、前記メッシュ構造の前記縦軸に対して第1の角度を成し、前記メッシュ構造が前記周辺縁と前記腔内壁との間の接触によって半径方向に制約される場合、第2の角度は前記第1の角度より小さく、
前記周辺縁の各々は、前記縦軸に沿った厚さを有し、前記周辺縁の組み合わされた厚さは、前記半径方向に延出している閉塞領域の最近位のものと前記半径方向に延出している閉塞領域の最遠位のものの間の前記縦軸に沿った前記メッシュ構造の長さの50%よりも小さい、装置。 - 前記メッシュ構造は単層の連続した編組構造である、請求項17に記載の装置。
- 前記弛緩構成における前記メッシュ構造は、少なくとも3つの半径方向に延出している閉塞領域を含む、請求項17に記載の装置。
- 前記第1の角度は70°~85°の間であり、前記第2の角度は70°未満である、請求項17に記載の装置。
- 前記メッシュ構造は前記身体管腔内にある場合に部分的に拡張した制約構成をとり、それにより、前記制約構成において、各半径方向に延出している閉塞領域は、各フィラメントに対して前記管腔の2つの半径方向トラバースを画定し、半径方向トラバースの総数は720~2000の間である、請求項17に記載の装置。
- 前記メッシュ構造は前記縦軸に沿って軸長を画定し、前記閉塞領域は、前記軸長の1センチメートルあたり4~10の間のメッシュ層を提供する、請求項17に記載の装置。
- 前記閉塞領域の各々の前記周辺縁はせいぜい2mmの厚さを有する、請求項17に記載の装置。
- 前記装置は前記縦軸に沿った軸長を有し、前記装置は3~7の間の半径方向に延出している閉塞領域を含み、それにより前記装置は、前記軸長の1センチメートルあたり3~7の間の周辺縁を含む、請求項23に記載の装置。
- 血管管腔を構成する管腔内壁を有する血管を塞栓させるための移植装置であって、該装置は、
前記移植装置が血管の血管管腔中の標的部位に位置決めされるときに、(a)圧縮送達状態から(b)拡張配備位置に半径方向に拡張するように構成されたメッシュ構造を含み、
送達状態において、前記メッシュ構造は、円筒形形状を有し、
拡張状態において、
前記メッシュ構造は、複数の半径方向に延びる領域を含み、
前記半径方向に延びる領域は、多孔性であり、前記移植装置および前記血管管腔を通る血流を遮るように構成されており、
前記半径方向に延びる領域の個々の領域は、前記血管管腔の管腔内壁に係合するように構成された頂点を含み、
前記頂点の各々は、前記移植装置の縦軸に沿った厚さを有し、
前記頂点の組み合わされた厚さは、前記半径方向に延出している閉塞領域の最近位のものと前記半径方向に延出している閉塞領域の最遠位のものの間の前記縦軸に沿った前記メッシュ構造の長さの50%よりも小さい、装置。 - 前記メッシュ構造は、カテーテルを通して前記標的部位に送達されるように構成されている、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記頂点の各々の厚さは、1mmよりも小さい、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記頂点の各々は、0.10mm~0.40mmの間にある縁半径を有する、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記メッシュ構造は、複数のコア部を含み、前記コア部の個々のコア部は、隣接した対の前記半径方向に延びる部分の間にあり、前記コア部は、円筒形形状を有する、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記コア部の個々のコア部は、0.25mm~3mmの間の直径を有し、前記半径方向に延びる個々の部分は、2mm~12mmの間の直径を有する、請求項29に記載の装置
- 前記メッシュ構造が拡張状態にあるときに、前記頂点の組み合わされた厚さは、前記半径方向に延出している領域の最近位のものと前記半径方向に延出している領域の最遠位のものの間の前記移植装置の縦軸に沿った前記メッシュ構造の長さの25%よりも小さい、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、隣接した対の前記頂点の間の距離は、0.7mm~4.5mmの間にある、請求項25に記載の装置。
- 前記メッシュ構造の近位部分に結合された取付け固定具をさらに含み、前記取付け固定具は、前記標的部位に前記メッシュ構造を送達するためのプッシャ要素に着脱可能に連結されるように構成されている、請求項25に記載の装置。
- 前記メッシュ構造は、該メッシュ構造が配備状態に部分的に拡張されるように、該メッシュ構造の配備状態において前記血管によって制約されており、前記メッシュ構造は、該メッシュ構造が前記血管によって制約されないときに、該メッシュ構造の弛緩状態に半径方向に拡張されるようにさらに構成されている、請求項25に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記半径方向に延びる領域の個々の領域は、前記移植装置の縦軸に対する第1の角度を構成し、
前記メッシュ構造が、部分的に拡張した配備状態にあるときに、前記半径方向に延びる領域の個々の領域は、前記第1の角度よりも小さい前記移植装置の縦軸に対する第2の角度を構成する、請求項34に記載の装置。 - 前記第2の角度は、20°~60°の間にある、請求項35に記載の装置。
- 前記半径方向に延びる領域の個々の領域は、前記移植装置の縦軸と垂直に延びる平面に沿った円形の横断面形状を有する、請求項35に記載の装置。
- 前記メッシュ構造が拡張状態にあるときに、前記半径方向に延びる領域の個々の領域は、(a)前記頂点を通って、かつ、(b)前記移植装置の縦軸と垂直に延びる平面のまわりで対称的である、請求項35に記載の装置。
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