JP2017517338A - 血管からの急性閉塞物の除去のための装置 - Google Patents
血管からの急性閉塞物の除去のための装置 Download PDFInfo
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Abstract
Description
1つの実施形態において、流れ制限部は、係合された構成と係合解除された構成との間で駆動可能である。カテーテルは、流れ制限部を選択的に係合および/または係合解除するアクチュエータを備え得る。
1つの場合において、カテーテルの遠位端が、凝血塊の受容のための開口部を備える。開口部が拡張性先端によって画定されてもよい。
1つの場合において、開口部が拡張された構成と後退された構成とを有する。カテーテルは、拡張された構成と後退された構成との間の開口部の移動を制御するための制御部材を備えてもよい。
別の態様において、本発明は、血管内の凝血塊を吸引するためのカテーテルであって、遠位端および近位端と、遠位区分および近位区分と、遠位端の近位で延び、遠位区分の近位端における移送口において終端する内腔と、を備え、カテーテルの遠位端が凝血塊の受容のための開口部を備えた、カテーテルを提供する。開口部が拡張性先端によって画定されてもよい。1つの場合において、カテーテルは、移送口の遠位のカテーテルの外側表面に配置された流れ制限部を有する。
第1のカテーテルおよび第2のカテーテルを備え、
第1のカテーテルが、近位端と、遠位端と、近位端と遠位端との間で延びる内腔と、を備え、第1のカテーテルの内腔が、近位区分と遠位区分とをさらに備え、
第2のカテーテルが遠位端および近位端と、遠位区分および近位区分と、内腔と、を備え、内腔が、遠位端の近位で延び、遠位区分の近位端における移送口において終端し、
第1のカテーテルが、内腔を通した吸引を容易にするように構成され、
移送口が、第1のカテーテルの近位内腔において吸引を第2のカテーテルの遠位区分の内腔へと送るように構成され、第2のカテーテルの遠位端が第2のカテーテルの内腔の少なくとも一部へと凝血塊を受容するように構成されたシステムである。
1つの場合において、第2のカテーテルの遠位端が凝血塊の受容のための開口部を備える。開口部は拡張性先端によって画定されてもよい。
1つの場合において、第1のカテーテルは案内カテーテルである。第2のカテーテルは中間カテーテルであってもよい。
案内カテーテルおよび中間カテーテルを提供するステップであって、中間カテーテルが遠位開口部を有し、案内カテーテルの内腔内で進むことができるように構成された、ステップと、
閉塞部の近位の第1の血管内へと案内カテーテルを挿入するステップと、
案内カテーテルの内腔を通して中間カテーテルの先端が案内カテーテルの遠位において閉塞部に隣接した第2の血管内へと延びるまで中間カテーテルを進めるステップと、
案内カテーテルの近位端に対して吸引を適用するステップと、を備え、
中間カテーテルが、中間カテーテルの開口部内へと凝血塊を吸引するために中間カテーテルの遠位内腔を通して吸引を方向付けるように構成された、方法である。
1つの実施形態において、方法は、中間カテーテルの外側表面と案内カテーテルの内側表面との間で流れを制限するステップを備える。
第1の吸引カテーテルおよび第2の吸引カテーテルを提供するステップであって、第2の吸引カテーテルが第1の吸引カテーテルの遠位で延び、第1の吸引カテーテルの遠位端の近位の移動内腔をさらに備えるステップと、
第1のカテーテルを閉塞部の近位の第1の血管内へと挿入するステップと、
第1のカテーテルの内腔を通して第2のカテーテルの先端が第1のカテーテルの遠位において第2の血管内へと延び、閉塞部と実質的に対向するまで第2のカテーテルを進めるステップと、
第2のカテーテルの遠位内腔内へと凝血塊を進めるように第1のカテーテルの近位内腔を通して吸引するステップと、を備えた方法を提供する。
方法は、吸引前または吸引後に、マイクロカテーテルを閉塞部へ輸送し、マイクロカテーテルから凝血塊収集装置を展開するステップを備えてもよい。1つの場合において、方法は、吸引前に、移送口の近位の位置へとマイクロカテーテルを後退させるステップを備える。
1つの態様において、本発明は凝血塊受容装置を提供する。1つの場合において、装置は、高速交換特徴を含み得るカテーテルである。1つの実施形態において、装置は、流れ停止部を備えた自己拡張する吸引カテーテルを提供する。
カテーテルは、大きな近位内腔を利用した案内部を通して吸引が適用され得るように、案内カテーテルの内側内腔に対して近位シールを提供する。
(完全にそれを取り除くというよりはむしろ)ちょうど出口の近位におけるマイクロカテーテルの後退は、大きな吸引利点を生じさせる。
たとえば、中間カテーテル7および凝血塊受容部2を配置しつつ、凝血塊受容部2、中間カテーテル7および案内部11を通して凝血塊1および機械的血栓除去装置15を患者から引き出すと好適となり得る。これは、除去され得るいかなる凝血塊粒子も逃げるのを防ぐために医師が血管内に保護シールを保持するのを可能とし、さらに完全に血管をきれいにするため、付加的な通過が必要とされる場合において、マイクロカテーテルおよび血栓除去装置によって目的の場所に戻る迅速かつ容易なアクセスの手段を維持するのを可能とする。
図3は、外側の膜カバー27を備えたステントのような自己拡張するフレーム25を備える凝血塊受容部の遠位端の1つの実施形態を示す。近位シャフト21は、近位の入口開口部20においてフレームおよび膜に対して結合される。拡張区分の近位端24は、遠位端23が拡張して血管壁に並置するように構成される一方で、それが通って輸送されるカテーテルの壁にそっと並置するように構成され、内部受容空間内への大きな開口部22を形成する。フレーム構造25は、1つの実施形態において管材または板材からレーザーカットされたニチノール構造であり、別の実施形態において、ニチノールまたはステンレス鋼から巻かれまたは織り込まれたワイヤー構造であり、あるいは、ステントまたはスネアの構成において通常使用されるような他のこうした生体適合性の良い金属材料である。膜27は、フレーム25の内側で折りたたまれて覆われた縁部26を備えてもよい。
案内ワイヤーおよびマイクロカテーテル109は、次いで凝血塊110を横切って進められる。案内ワイヤーは、取り除かれ得るものであり、ステント回収装置100のような凝血塊回収装置が導入される。
1つの実施形態において拡張性先端112は、長手方向のサポートを提供するように高弾性高分子130と共に共押出し成形された柔軟拡張性高分子131のような、異なる特性を備えた材料の共押出し成形物(co-extrusion)から形成され得る。完全に拡張性のリング132は、図14に示されるように次いでこの先端に対して結合され得る。先端112は、図15および図24に示されるように1または複数の金属ワイヤーサポート133を含んでもよい。図18に示されるように、別の実施形態において、先端は、回収または吸引の間の凝血塊との接触面積を増すようなスカイブ形状(skived profile)を有する。先端は、図16および図17に示されるように装置100および凝血塊110が先端へと後退したときにそれが分離して形状変化するのを可能とするような穴134または穿孔137を備えて形成されてもよい。これらの特徴は、図16、図17、図18、図21および図25に示されるように異なるデュロメータの材料を含む先端構成と結合され得る。これらの実施形態において、先端材料143、136、146、151、164は、より低いデュロメータを有し、支持材料135、144、145、150、165より拡張性がある。これらの支持材料は、管材の壁内に組み込まれてもよく、内側または外側表面上にあってもよい。それらは、凝血塊またはステントリーバー装置の回収の間または案内カテーテルまたはアクセスカテーテルを通した挿入の間に生じるような、つぶれ、または圧縮荷重で座屈するのを防ぐため、拡張性材料に対して長手方向のサポートを提供するようにスプライン、コイル、ストリップ、「U」形または他の構成に形成されてもよい。図19は、先端において複数の穴139が格子またはフレームワークを生成する別の実施形態を示す。図20に示されるように凝血塊における把持を向上させるため、単一のまたは複数の突出部または「歯」141が、遠位先端において内側表面142に対して適用されてもよい。
300 取り外し可能なハブ
301 マイクロカテーテルシャフト
302 マイクロカテーテルハブから延びるひずみレリーフ要素
303 内部接続部(詳細は図42/図43参照)
304 分離されたマイクロカテーテルシャフトの端部
305 中間カテーテルの交換のための伸張可能なシャフト
306 マイクロカテーテルハブにおけるめねじ
307 マイクロカテーテル接続部
308 Oリングシール
309 マイクロカテーテル接続部におけるおねじ
310 結合部
311 出血を防ぐための閉止された端部
312 結合部
313a 伸張ワイヤー
313b 伸張ワイヤーハウジング
314 マイクロカテーテルのためのコア補強部として機能するレーザーカットハイポチューブ
315 マイクロカテーテルの除去の間に把持されかつ引かれ/ねじられるような硬い近位シャフト
316 成形されたカテーテルハブ内へと組み込まれたマイクロカテーテルを凹部内へと拘束する圧縮可能なOリング
317 取り外し可能なハブ
318 伸張チューブ
319 ばねクリップ、たとえばステンレス鋼またはニチノール
320 射出成形されたハブ
D1 おおよそ内径0.533mm(0.021インチ)
D2 おおよそ外径0.737mm(0.029インチ)
D3 おおよそ外径0.991mm(0.039インチ)
D4 おおよそ外径1.143mm(0.045インチ)。
図47は、先端からの距離と横剛性のグラフである。
内腔Aは、類似の径の内腔が装置を回収するために、かつ、凝血塊をせん断させるために使用され得る。内腔Aの遠位端は、内腔Bの遠位先端と同一平面またはそこから凹部となり得る。
より小さい内腔Aは、内腔を通したマイクロカテーテルの案内を容易とするための内径を有してもよい。マイクロカテーテルは、次いで標準的手順により、この内腔を通し、凝血塊に亘り挿入され得る。ステントリーバー装置は、凝血塊に亘り次いで展開され得る。ステントリーバーおよび凝血塊のカテーテル内への回収は、吸引カテーテル内において凝血塊をステントリーバーでせん断させる。この構成は、凝血塊がステントリーバー装置の支柱において詰まり、吸引内腔を遮断するのを防ぐ。より大きい径の内腔は、おおよそ1.473mm(0.058インチ)の径を有してもよく、装置がより小さい径の内腔内へと回収されるときに凝血塊を吸引するためそれに適用される吸引を有してもよい。
Claims (49)
- 血管からの凝血塊の回収を支援するためのカテーテルであって、遠位端および近位端と、遠位区分および近位区分と、前記遠位端の近位で延び、前記遠位区分の前記近位端における移送口において終端する内腔と、前記移送口の遠位における前記カテーテルの外側表面に置かれた流れ制限部と、を備えるカテーテル。
- 前記流れ制限部が、係合された構成と係合解除された構成との間で駆動可能である、請求項1に記載のカテーテル。
- 前記流れ制限部を選択的に係合および/または係合解除するアクチュエータを備える、請求項2に記載のカテーテル。
- 前記流れ制限部がフレームワークと前記フレームワークに結合された膜とを備え、前記フレームワークが前記アクチュエータによって拡張された構成と後退された構成との間で可動な、請求項2または3に記載のカテーテル。
- 前記遠位区分の前記近位端の遠位の近位流れ制限部と前記近位流れ制限部から遠位に離間された遠位流れ制限部とを備えた、請求項1から4のいずれか一項に記載のカテーテル。
- 前記カテーテルの前記遠位端が、凝血塊の受容のための開口部を備えた、請求項1から5のいずれか一項に記載のカテーテル。
- 前記開口部が拡張性先端によって画定される、請求項6に記載のカテーテル。
- 前記遠位区分が前記遠位開口部に隣接したヒンジを含む、請求項6または7に記載のカテーテル。
- 前記ヒンジが横可撓性を有するように構成された前記遠位区分の領域によって画定される、請求項8に記載のカテーテル。
- 前記開口部が拡張された構成と後退された構成とを有する、請求項6から9のいずれか一項に記載のカテーテル。
- 前記拡張された構成と前記後退された構成との間の前記開口部の移動を制御するための制御部材を備えた、請求項10に記載のカテーテル。
- 前記開口部が複数の区分を備え、前記制御部材が少なくとも前記区分のいくつかを動かすように構成された、請求項11に記載のカテーテル。
- 前記制御部材が引き出し線を備える、請求項12に記載のカテーテル。
- 血管内の凝血塊を吸引するためのカテーテルであって、遠位端および近位端と、遠位区分および近位区分と、前記遠位端の近位で延び、前記遠位区分の前記近位端における移送口において終端する内腔と、を備え、前記カテーテルの前記遠位端が凝血塊の受容のための開口部を備えた、カテーテル。
- 前記移送口の遠位の前記カテーテルの前記外側表面に置かれた流れ制限部を有する、請求項13に記載のカテーテル。
- 前記開口部が拡張性先端によって画定された、請求項15に記載のカテーテル。
- 前記遠位区分が前記遠位開口部に隣接したヒンジを含む、請求項15または16に記載のカテーテル。
- 前記ヒンジが横可撓性を有するように構成された前記遠位区分の領域によって画定される、請求項17に記載のカテーテル。
- 前記開口部が拡張された構成と後退された構成とを有する、請求項15から18のいずれか一項に記載のカテーテル。
- 前記拡張された構成と前記後退された構成との間の前記開口部の前記移動を制御するための制御部材を備えた、請求項19に記載のカテーテル。
- 前記開口部が複数の区分を備え、前記制御部材が少なくとも前記区分のいくつかを動かすように構成された、請求項20に記載のカテーテル。
- 前記制御部材が引き出し線を備えた、請求項21に記載のカテーテル。
- 前記カテーテルが凝血塊を吸引するための吸引カテーテルである、請求項1から22のいずれか一項に記載のカテーテル。
- 血管内の閉塞部を治療するためのシステムであって、前記システムは、
第1のカテーテルおよび第2のカテーテルと、を備え、
前記第1のカテーテルが、近位端と、遠位端と、前記近位端と前記遠位端との間で延びる内腔と、を備え、前記第1のカテーテルの前記内腔が、近位区分と遠位区分とをさらに備え、
前記第2のカテーテルが遠位端および近位端と、遠位区分および近位区分と、内腔と、を備え、前記内腔が、前記遠位端の近位で延び、前記遠位区分の前記近位端における移送口において終端し、
前記第1のカテーテルが、前記内腔を通した吸引を容易にするように構成され、
前記移送口が、前記第1のカテーテルの前記近位内腔において吸引を前記第2のカテーテルの前記遠位区分の前記内腔へと送るように構成され、前記第2のカテーテルの前記遠位端が前記第2のカテーテルの前記内腔の少なくとも一部へと凝血塊を受容するように構成された、システム。 - 前記第2のカテーテルが請求項1から23のいずれか一項に記載のカテーテルである、請求項24に記載のシステム。
- 前記第1のカテーテルと前記移送口の遠位の前記第2のカテーテルの前記遠位区分との間の流れ制限部をさらに備える、請求項24に記載のシステム。
- 前記流れ制限部が、前記第1のカテーテルの前記内側表面に置かれた、請求項26に記載のシステム。
- 前記流れ制限部が前記第2のカテーテルの前記外側表面に置かれた、請求項26または27に記載のシステム。
- 前記第2のカテーテルの前記遠位区分の前記近位端の遠位の近位流れ制限部と、前記近位の流れ制限部から遠位に離間された遠位流れ制限部と、を備えた、請求項26から28のいずれか一項に記載のシステム。
- 前記第2のカテーテルの前記遠位端が凝血塊の受容のための開口部を備えた、請求項24から29のいずれか一項に記載のシステム。
- 前記開口部が拡張性先端によって画定された、請求項30に記載のシステム。
- 前記移送口が高速交換開口部を備えた、請求項24から31のいずれか一項に記載のシステム。
- 前記第1のカテーテルが案内カテーテルである、請求項24から32のいずれか一項に記載のシステム。
- 前記第2のカテーテルが中間カテーテルである、請求項24から33のいずれか一項に記載のシステム。
- 前記第1のカテーテルおよび前記第2のカテーテルを通して進められるように適合されたマイクロカテーテルをさらに備えた、請求項24から34のいずれか一項に記載のシステム。
- 前記マイクロカテーテルからの輸送のための凝血塊係合装置をさらに備えた、請求項35に記載のシステム。
- 前記案内カテーテルは、それを通って吸引が適用される近位の回転止血弁において取り付けられた、請求項33に記載のシステム。
- 前記マイクロカテーテルの近位端および前記吸引カテーテルの近位端が、近位の回転止血弁の分離した分岐部内に設置可能な、請求項35または36に記載のシステム。
- 血管から凝血塊を取り除くための方法であって、
案内カテーテルおよび中間カテーテルを提供するステップであって、前記中間カテーテルが遠位開口部を有し、前記案内カテーテルの内腔内で進むことができるように構成された、ステップと、
閉塞部の近位の第1の血管内へと前記案内カテーテルを挿入するステップと、
前記案内カテーテルの前記内腔を通して前記中間カテーテルの前記先端が前記案内カテーテルの遠位において前記閉塞部に隣接した第2の血管内へと延びるまで前記中間カテーテルを進めるステップと、
前記案内カテーテルの前記近位端に対して吸引を適用するステップと、を備え、
前記中間カテーテルが、前記中間カテーテルの前記開口部内へと前記凝血塊を吸引するために前記中間カテーテルの前記遠位内腔を通して前記吸引を方向付けるように構成された、方法。 - 前記吸引カテーテルが遠位端と、近位端と、遠位区分と、近位区分と、前記遠位端の近位で延び、前記遠位区分の前記近位端における移送口において終端する内腔と、を備えた、請求項39に記載の方法。
- 前記中間カテーテルの前記外側表面と前記案内カテーテルの前記内側表面との間で流れを制限するステップを備えた、請求項39または40に記載の方法。
- 吸引前または吸引後に、前記閉塞部へマイクロカテーテルを輸送し、前記マイクロカテーテルから凝血塊収集装置を展開するステップを備えた、請求項39から41のいずれか一項に記載の方法。
- 前記マイクロカテーテルを前記凝血塊へと進めるステップと、凝血塊収集装置を前記マイクロカテーテルから展開するステップと、前記吸引カテーテルの遠位区分の前記近位端において移送口の近位の位置へと前記マイクロカテーテルを後退させるステップと、を備えた、請求項42に記載の方法。
- 血管から閉塞部を取り除く方法であって、
第1の吸引カテーテルおよび第2の吸引カテーテルを提供するステップであって、前記第2の吸引カテーテルが前記第1の吸引カテーテルの遠位で延び、前記第1の吸引カテーテルの前記遠位端の近位の移送内腔をさらに備えるステップと、
前記第1のカテーテルを前記閉塞部の近位の第1の血管内へと挿入するステップと、
前記第1のカテーテルの前記内腔を通して前記第2のカテーテルの前記先端が前記第1のカテーテルの遠位において第2の血管内へと延び、前記閉塞部と実質的に対向するまで前記第2のカテーテルを進めるステップと、
前記第2のカテーテルの前記遠位内腔内へと前記凝血塊を押し進めるように前記第1のカテーテルの前記近位内腔を通して吸引するステップと、を備えた、方法。 - 前記第2のカテーテルの前記外側表面と前記第1のカテーテルの前記内側表面との間で流れを制限するステップを備えた、請求項44に記載の方法。
- 吸引前または吸引後に、マイクロカテーテルを前記閉塞部へ輸送し、前記マイクロカテーテルから凝血塊収集装置を展開するステップを備えた、請求項44または45に記載の方法。
- 吸引前に、前記移送口の近位の位置へと前記マイクロカテーテルを後退させるステップを備えた、請求項46に記載の方法。
- 前記第1の吸引カテーテルが案内カテーテルである、請求項44から47のいずれか一項に記載の方法。
- 前記第2の吸引カテーテルが中間カテーテルである、請求項44から48のいずれか一項に記載の方法。
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EP3154452A1 (en) | 2017-04-19 |
US20190328411A1 (en) | 2019-10-31 |
US20160256180A1 (en) | 2016-09-08 |
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US20150359547A1 (en) | 2015-12-17 |
JP6900440B2 (ja) | 2021-07-07 |
JP6595513B2 (ja) | 2019-10-23 |
US20230200830A1 (en) | 2023-06-29 |
US10441301B2 (en) | 2019-10-15 |
WO2015189354A1 (en) | 2015-12-17 |
JP2020014873A (ja) | 2020-01-30 |
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US11446045B2 (en) | 2022-09-20 |
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