JP7046924B2 - 血管から閉塞性血塊を除去するための血塊回収装置 - Google Patents
血管から閉塞性血塊を除去するための血塊回収装置 Download PDFInfo
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Description
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
外側細長本体は、血塊受容空間を画定するように、展開構成における内側本体の径方向範囲よりも大きい径方向範囲まで拡張可能である、血塊回収装置が提供される。
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
外側細長本体は、血塊受容空間を画定するように、展開構成における内側本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、血塊係合領域は、血塊と係合すると、血塊を血塊受容開口部に向かって、かつ外側細長本体と内側細長本体との間の受容空間内に付勢するように適合されている、血塊回収装置も提供する。
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
外側細長本体は、血塊受容空間を画定するように、展開構成における内側本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
外側細長本体は遠位端部分を備え、
内側細長本体は、本体部分と遠位部分とを備え、遠位部分は、展開構成において、外側細長本体に向かって、本体部分よりも大きい範囲で延在し、
内側細長部材の遠位部分と外側細長本体の遠位端部分は、共に三次元保護構造体を画定して、装置から血塊又は血塊断片が遠位に脱出するのを実質的に防止する、血塊回収装置が提供される。
本発明による血塊回収装置を血塊を横切って送達することと、
血塊の少なくとも一部が血塊受容空間内に長手方向に付勢されるように、血塊回収装置を拡張することと、
拡張された展開構成における内側本体を通る血液の流れを可能にするために、血塊の内側本体内への移動を阻止することと、を含む、方法、を提供する。
近位端と遠位端との間に延在するシャフトと、
シャフトに連結された拡張可能な本体であって、拡張可能な本体は、隣接する血塊スキャフォールドセグメント間に複数の血塊入口開口部を形成する空隙によって分離された4つの長手方向に離間した血塊スキャフォールドセグメントを備え、各血塊スキャフォールドセグメントは、複数の閉鎖セルを含み、複数の血塊スキャフォールドセグメントのそれぞれの少なくとも1つの閉鎖セルは、隣接する閉鎖セルへの接続を含まない遠位頂点で終端する、装置、を提供する。
第1のモノリシック構造は、第2のモノリシック構造を実質的に封入するように構成されており、
第1のモノリシック構造は、近位部分と、中間部分と、遠位部分と、を含み、遠位部分は閉鎖遠位端を備えており、
血塊係合要素の遠位端は閉鎖遠位端を備え、当該閉鎖遠位端は、血塊断片を捕捉するように、かつ/又は血塊断片の遠位移動を防止するように構成されており、
拡張部は、血塊断片の移動を防止するように構成されており、
第1のモノリシック構造の遠位端は閉鎖遠位端を備え、当該閉鎖遠位端は表面を画定し、表面は血塊断片バリア表面として構成されており、
血塊断片バリア表面は、相互接続されたストラットの網状組織を含んでおり、
血塊係合要素の遠位部分は、血塊移動に対する三次元バリアを提供するように構成されており、
装置は、細長いコネクタ要素を更に備え、当該細長いコネクタ要素は、近位端と遠位端とを含み、近位端は第2のモノリシック構造に接続されており、遠位端は第1のモノリシック構造に接続されており、
細長いコネクタ要素はばね要素を含み、当該ばね要素は第2のモノリシック構造と一体であり、
第1のモノリシック構造及び第2のモノリシック構造は、それらの遠位端で接続されており、
第1のモノリシック構造及び第2のモノリシック構造は、それらの遠位端で接続されておらず、及び/又は
第1のモノリシック構造及び第2のモノリシック構造の近位部分は、細長部材の遠位端に接続されている、ことを含む。
容積パターンは、少なくとも部分的に円錐形状の容積パターンを含んでおり、
容積パターンは、少なくとも部分的に円筒形の容積パターンを含んでおり、
容積パターンは、少なくとも1つの複数の相互接続されたストラットを含んでおり、容積パターンは、少なくとも2つの複数の相互接続されたストラットを含んでおり、容積パターンは、第1の軸の周りに配置された第1の複数のストラットと、第2の軸の周りに配置された第2の複数のストラットと、を備えており、
第1の軸の位置は、第2の軸の位置に対して移動可能であり、
第1の軸及び第2の軸は中心線を含み、使用中に当該中心線が直線及び/又は湾曲した中心線を含んでもよく、
中心線は互いに対して偏向可能であり、
容積パターンは、末端部を含んでおり、
末端部は、当該複数のストラットのうちの少なくともいくつかのための末端接合部を含んでおり、
末端部は、当該複数のストラットが終端及び/又は接続される接続点を含んでおり、
容積パターンは、第1の複数のストラットと、第2の複数のストラットと、を備えており、
第2の複数のストラットは、第1の複数のストラットによって少なくとも部分的に包囲されており、
第2の複数のストラットは、第1の複数のストラットを取り囲んでおり、
第1の複数のストラットは、第1の軸の周りに配置され、第2の複数のストラットは、第2の軸の周りに配置され、当該第1及び第2の軸は実質的に平行であり、
第1の複数のストラットは、第1の軸の周りに配置され、第2の複数のストラットは、第2の軸の周りに配置され、当該第1及び第2の軸は実質的に平行であり、
第1の複数のストラットは円錐形状を備えており、
第2の複数のストラットは、球形、平坦にされた球形、円筒形、又はスピンドルトーラス形状を備えている、ことを含む。
第1の管状構造体及び第2の管状構造体は、相互接続されたストラットのモノリシック構造を含んでおり、
第1の管状構造体及び第2の管状構造体は、長手方向に延在する構造体を含んでおり、
第1の管状構造体及び第2の管状構造体の両方は、折り畳まれた送達構成と拡張された展開構成とを含み、第1の管状構造体は、拡張された構成及び折り畳まれた構成の両方において、第2の管状構造体を少なくとも部分的に取り囲んでおり、
第1の管状構造体及び第2の管状構造体の一方又は両方は、第1の管状構造体及び第2の管状構造体の一方又は両方を細長部材の遠位端に接続するための近位カラーを備えており、
少なくとも1つの近位カラーは部分カラーを備えており、並びに/あるいは
少なくとも1つの近位カラーはハイポチューブから切断され、細長部材の遠位端の少なくとも一部分を取り囲んでいる、ことを含む。
第1のコネクタはカラーを備え、
第2コネクタはカラー又は部分カラーを備え、並びに/あるいは
細長部材は、第1のコネクタ及び/又は第2のコネクタの遠位移動を防止するように構成された遠位安全停止部を備える、ことを含む。
当該第1及び第2の管腔構造体の遠位端は、三次元の血塊断片移動バリアを形成するように構成されており、
当該第2の管腔構造体の遠位端は、当該複数のストラットへの接線が当該第2の管腔構造体の軸に実質的に平行である変曲領域を更に備えており、
当該第2の管腔構造体の遠位端は、当該複数のストラットが当該第2の管腔構造体の軸線上に収束する収束領域を更に備えており、
当該第2の管腔構造体の遠位端は、当該複数のストラットが終端する第2の遠位接合部を更に備えており、
当該第1の管腔構造体の遠位端は、当該複数のストラットが終端する第1の遠位接合部を更に備えており、
第1の遠位接合部は第2の遠位接合部の遠位にあり、並びに/あるいは
第1の遠位接合部は、コネクタ要素によって第2の遠位接合部に接続されている、ことを含む。
拡張領域の直径は、拡張状態における中間部分の直径よりも大きく、
血塊係合要素は、モノリシック構造で接続された複数のストラットを備えており、
拡張領域は、分岐領域と収束領域と、を含んでおり、
拡張領域は、分岐領域と収束領域との間に変曲点を含んでおり、
拡張領域は中間部分と一体であり、
拡張領域は、拡張領域を中間部分に接続する複数のストラットを含む遷移部分を備えており、
拡張領域は、テーパ状の遠位端を備えており、
装置は、拡張領域の遠位端に接続された細長部材を含んでおり、及び/又は
拡張状態では、管腔構造は、血塊を通る流れ内腔を画定するように構成されている、ことを含む。
血塊捕捉構造体は、複数のストラットと、フィルタに構成された少なくとも1つの繊維と、を含んでおり、
拡張状態において、血塊捕捉構造体の少なくとも一部の直径は、血管の直径と類似しており、
拡張状態において、血塊捕捉構造体の少なくとも一部分の直径は、第2の管腔構造体の直径よりも大きく、及び/又は
拡張状態において、血塊捕捉構造体の少なくとも一部分の直径は、第1の管腔構造体の直径と類似している、ことを含む。
第1の拡張可能部材の遠位部分は血塊捕捉構造体を備えており、
第2の拡張可能部材の遠位部分は血塊捕捉構造体を備えており、
血塊捕捉構造体は複数のストラットを含んでおり、
血塊捕捉構造体は、複数のストラットと、フィルタに構成された少なくとも1つの繊維と、を含んでおり、
第1の拡張可能部材の近位端は、細長いシャフトの遠位部分に接続されており、
第1の拡張可能部材の近位端は、第2の拡張可能部材に接続されており、
第2の拡張可能部材の近位端は、細長いシャフトの遠位部分に接続されており、
第1の拡張可能部材の遠位端は、第2の拡張可能部材の遠位端に接続されておらず、
第1の拡張可能部材の遠位端は、第2の拡張可能部材の遠位端に接続されており、
自由に拡張された状態における第2の拡張可能部材の本体部分は、自由に拡張された状態における第1の拡張可能部材の本体部分の直径の50%未満であり、
自由に拡張された状態における第2の拡張可能部材の本体部分は、自由に拡張された状態における第1の拡張可能部材の本体部分の直径の40%未満であり、
自由に拡張された状態における第2の拡張可能部材の本体部分は、自由に拡張された状態における第1の拡張可能部材の本体部分の直径の30%未満であり、及び/又は
自由に拡張された状態における第2の拡張可能部材の本体部分は、自由に拡張された状態における第1の拡張可能部材の本体部分の直径の20%未満である、ことを含む。
拡張可能な本体は、内側拡張可能部材と外側拡張可能部材とを備えており、
内側拡張可能部材の拡張直径は、外側拡張可能部材の拡張直径よりも小さく、
内側拡張可能部材の少なくとも一部分は、外側拡張可能部材の少なくとも一部の内部に延在しており、
内側拡張可能部材の少なくとも一部分は、外側拡張可能部材の近位に延在しており、
拡張可能な本体の遠位部分は血塊捕捉構造体を備えており、血塊捕捉構造体は、内側拡張可能部材に接続されており、
血塊捕捉構造体は、外側拡張可能部材に接続されており、及び/又は使用中に細長いシャフトは患者の外側に延在する、ことを含む。
(1) 血管から閉塞性血塊を除去するための血塊回収装置であって、
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
前記内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
前記外側細長本体は、血塊受容空間を画定するように、前記展開構成における前記内側本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
前記外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、前記血塊係合領域は、血塊と係合すると、血塊を前記血塊受容開口部に向かって、かつ前記外側細長本体と前記内側細長本体との間の前記受容空間内に付勢するように適合されており、
前記装置の前記径方向力プロファイルは、前記装置の前記長さに沿って変化する、装置。
(2) 前記装置の遠位端における前記径方向力は、前記装置の中央部分における前記径方向力よりも小さい、実施態様1に記載の装置。
(3) 前記装置の遠位端における前記径方向力は、前記装置の中央部分及び近位部分の前記径方向力よりも小さい、実施態様1に記載の装置。
(4) 前記装置は複数のセグメントを含み、1つのセグメントの前記径方向力は、少なくとも1つの他のセグメントの前記径方向力とは異なる、実施態様1に記載の装置。
(5) 前記セグメント間の径方向力の差は、20%未満又は10%未満である、実施態様4に記載の装置。
(7) 前記径方向力は、前記装置の前記長さに沿って近位から遠位に向かって減少する、実施態様4又は5に記載の装置。
(8) 中間セグメントの前記径方向力は、前記遠位セグメントの前記径方向力よりも大きい、実施態様4又は5に記載の装置。
(9) 中間セグメントの前記径方向力は、前記近位セグメント及び前記遠位セグメントの前記径方向力よりも大きい、実施態様4又は5に記載の装置。
(10) 前記外側本体は複数のセグメントを含む、実施態様1に記載の装置。
(12) 前記浮遊セル又は小葉状部は、隣接する遠位セグメントに接続されていない遠位頂点を備える、実施態様11に記載の装置。
(13) 前記第2の径方向力は、前記第1の径方向力よりも20%~80%又は40%~60%小さい、実施態様11又は12に記載の装置。
(14) 前記外側本体の前記セグメントの前記血塊入口開口部は、前記装置の前記長さに沿って異なる、実施態様10~13のいずれかに記載の装置。
(15) 前記装置の近位領域内の血塊入口開口部は、前記装置の遠位領域内の血塊入口開口部よりも小さい、実施態様14に記載の装置。
(17) 前記装置の中央部分の前記血塊入口開口部は、前記装置のより近位及び/又はより遠位の領域内の前記血塊入口開口部よりも大きい、実施態様14に記載の装置。
(18) 前記装置の前記長さに沿って前記血塊入口開口部のサイズの勾配が存在する、実施態様14に記載の装置。
(19) 前記勾配は近位から遠位に向かって増加する、実施態様18に記載の装置。
(20) 前記勾配は近位から遠位に向かって減少する、実施態様18に記載の装置。
(22) 前記内側細長本体の前記テーパは、前記外側本体の前記血塊入口開口部の前記勾配と反対である、実施態様21に記載の装置。
(23) 前記外側細長部材は、ストラット及びクラウンによって形成されたフレームワークを含み、近位放射線不透過性マーカーは、近位クラウンに近位に隣接するストラットの遠位端に位置している、実施態様1~22のいずれかに記載の装置。
(24) 前記血塊受容開口部の前記面積は、0.5mm2~4.0mm2である、実施態様1~23のいずれかに記載の装置。
(25) 前記血塊受容開口部の前記面積は、1.0mm2~3.0mm2である、実施態様24に記載の装置。
(27) 前記内側細長本体の前記拡張直径は、0.75mm~1.75mmである、実施態様1~26のいずれかに記載の装置。
(28) 前記内側細長本体の前記直径は、前記内側細長本体の前記長さに沿って変化する、実施態様1~25のいずれかに記載の装置。
(29) 前記内側細長本体は、近位直径からより小さい遠位直径までテーパ状になっている、実施態様28に記載の装置。
(30) 前記内側細長本体は概ね円錐形の形状のものである、実施態様28又は29に記載の装置。
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
前記内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
前記外側細長本体は、血塊受容空間を画定するように、前記展開構成における前記内側本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
前記外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、前記血塊係合領域は、血塊と係合すると、血塊を前記血塊受容開口部に向かって、かつ前記外側細長本体と前記内側細長本体との間の前記受容空間内に付勢するように適合されており、
前記外側細長部材は、ストラット及びクラウンによって形成されたフレームワークを含み、近位放射線不透過性マーカーは、近位クラウンに近位に隣接するストラットの遠位端に位置している、装置。
(32) 前記外側拡張可能部材は、管内にスロットを切断することによって形成されている、実施態様1~31のいずれかに記載の装置。
(33) 前記外側拡張可能部材は、形状記憶材料のレーザー切断されたスロット付き管である、実施態様1~32のいずれかに記載の装置。
Claims (19)
- 血管から閉塞性血塊を除去するための血塊回収装置であって、
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
前記内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
前記外側細長本体は、血塊受容空間を画定するように、前記展開構成における前記内側細長本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
前記外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、前記血塊係合領域は、血塊と係合すると、血塊を前記血塊受容開口部に向かって、かつ前記外側細長本体と前記内側細長本体との間の前記受容空間内に付勢するように適合されており、
前記装置の径方向力プロファイルは、前記装置の前記長さに沿って変化し、
前記外側細長本体は複数のセグメントを含み、セグメントは、第1の径方向力を有する閉鎖セルの近位リングを含み、これに、前記第1の径方向力よりも小さい第2の径方向力を有する少なくとも1つの浮遊セル又は小葉状部が接続されている、装置。 - 前記装置の遠位端における径方向力は、前記装置の中央部分における径方向力よりも小さい、請求項1に記載の装置。
- 前記装置の遠位端における径方向力は、前記装置の中央部分及び近位部分の径方向力よりも小さい、請求項1に記載の装置。
- 前記装置は複数のセグメントを含み、1つのセグメントの径方向力は、少なくとも1つの他のセグメントの径方向力とは異なる、請求項1に記載の装置。
- 前記セグメント間の径方向力の差は、20%未満である、請求項4に記載の装置。
- 前記径方向力は、前記装置の前記長さに沿って近位から遠位に向かって増加する、請求項4に記載の装置。
- 前記径方向力は、前記装置の前記長さに沿って近位から遠位に向かって減少する、請求項4に記載の装置。
- 中間セグメントの前記径方向力は、遠位セグメントの前記径方向力よりも大きい、請求項4に記載の装置。
- 中間セグメントの前記径方向力は、近位セグメント及び遠位セグメントの前記径方向力よりも大きい、請求項4に記載の装置。
- 前記浮遊セル又は小葉状部は、隣接する遠位セグメントに接続されていない遠位頂点を備える、請求項1に記載の装置。
- 前記第2の径方向力は、前記第1の径方向力よりも20%~80%小さい、請求項1に記載の装置。
- 前記外側本体の前記血塊受容開口部は、前記装置の前記長さに沿って異なり、前記装置の近位領域内の血塊受容開口部は、前記装置の遠位領域内の血塊受容開口部よりも小さい、請求項1に記載の装置。
- 前記外側本体の前記血塊受容開口部は、前記装置の前記長さに沿って異なり、前記装置の中央部分の前記血塊受容開口部は、前記装置のより近位及び/又はより遠位の領域内の前記血塊受容開口部よりも小さい、請求項1に記載の装置。
- 前記外側本体の前記血塊受容開口部は、前記装置の前記長さに沿って異なり、前記装置の中央部分の前記血塊受容開口部は、前記装置のより近位及び/又はより遠位の領域内の前記血塊受容開口部よりも大きい、請求項1に記載の装置。
- 前記装置の前記長さに沿って前記血塊受容開口部のサイズの勾配が存在し、前記勾配は近位から遠位に向かって増加する、請求項12に記載の装置。
- 前記装置の前記長さに沿って前記血塊受容開口部のサイズの勾配が存在し、前記勾配は近位から遠位に向かって減少する、請求項12に記載の装置。
- 血管から閉塞性血塊を除去するための血塊回収装置であって、
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
前記内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
前記外側細長本体は、血塊受容空間を画定するように、前記展開構成における前記内側細長本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
前記外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、前記血塊係合領域は、血塊と係合すると、血塊を前記血塊受容開口部に向かって、かつ前記外側細長本体と前記内側細長本体との間の前記受容空間内に付勢するように適合されており、
前記装置の径方向力プロファイルは、前記装置の前記長さに沿って変化し、
前記装置の前記長さに沿って前記血塊受容開口部のサイズの勾配が存在し、前記内側細長本体はテーパ状であり、前記内側細長本体の前記テーパは、前記外側細長本体の前記血塊受容開口部の前記勾配と反対である、装置。 - 前記外側細長本体は、ストラット及びクラウンによって形成されたフレームワークを含み、近位放射線不透過性マーカーは、近位クラウンに近位に隣接するストラットの遠位端に位置している、請求項1に記載の装置。
- 血管から閉塞性血塊を除去するための血塊回収装置であって、
折り畳まれた送達構成と拡張された展開構成とを有する内側細長本体と、
前記内側細長本体を少なくとも部分的に覆う外側細長本体と、を備え、
前記外側細長本体は、血塊受容空間を画定するように、前記展開構成における前記内側細長本体の径方向範囲よりも大きい径方向範囲まで拡張可能であり、
前記外側細長本体は、複数の血塊受容開口部と複数の血塊係合領域とを備え、前記血塊係合領域は、血塊と係合すると、血塊を前記血塊受容開口部に向かって、かつ前記外側細長本体と前記内側細長本体との間の前記受容空間内に付勢するように適合されており、
前記外側細長本体は、ストラット及びクラウンによって形成されたフレームワークを含み、近位放射線不透過性マーカーは、近位クラウンに近位に隣接するストラットの遠位端に位置し、
前記外側細長本体は複数のセグメントを含み、セグメントは、第1の径方向力を有する閉鎖セルの近位リングを含み、これに、前記第1の径方向力よりも小さい第2の径方向力を有する少なくとも1つの浮遊セル又は小葉状部が接続されている、装置。
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JP2014511223A (ja) | 2011-02-04 | 2014-05-15 | コンセントリック メディカル,インク. | 脈管・体内導管を治療するデバイスおよび方法 |
WO2012120490A2 (en) | 2011-03-09 | 2012-09-13 | Neuravi Limited | A clot retrieval device for removing occlusive clot from a blood vessel |
JP2016513505A (ja) | 2013-03-14 | 2016-05-16 | ニューラヴィ・リミテッド | 血管から閉塞血餅を除去するための血餅回収デバイス |
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EP3854322C0 (en) | 2024-01-17 |
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ES2867599T3 (es) | 2021-10-20 |
KR102494176B1 (ko) | 2023-02-02 |
BR112019004484A2 (pt) | 2019-05-28 |
IL265151A (en) | 2019-05-30 |
EP3854322B1 (en) | 2024-01-17 |
CO2019002678A2 (es) | 2019-06-11 |
CA3035706A1 (en) | 2018-03-15 |
AU2017324233A1 (en) | 2019-04-04 |
JP2019526365A (ja) | 2019-09-19 |
CN109906058B (zh) | 2022-06-07 |
US11147572B2 (en) | 2021-10-19 |
EP3509509A2 (en) | 2019-07-17 |
EP3509509B1 (en) | 2021-03-31 |
WO2018046408A3 (en) | 2018-05-11 |
US20200305900A1 (en) | 2020-10-01 |
EP3854322A1 (en) | 2021-07-28 |
RU2019110141A (ru) | 2020-10-08 |
CN109906058A (zh) | 2019-06-18 |
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