JP6762992B2 - 急性虚血性脳卒中を治療するための方法及びシステム - Google Patents
急性虚血性脳卒中を治療するための方法及びシステム Download PDFInfo
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Description
本出願は以下の同時係属中の米国の仮特許出願の優先権を主張する。(1) 2011年8月5日に出願された米国仮特許出願第61/515,736号、(2) 2011年10月4日に出願された米国仮特許出願第61/543,019号、(3) 2011年10月14日に出願された米国仮特許出願第61/547,597号、(4) 2011年12月22日に出願された米国仮特許出願第61/579,581号。米国仮特許出願の開示は、それらの全体を参照して本明細書に組み込む。
脳血管系への介入(インターベンション)では、特殊なアクセスチャレンジ(アクセスの試み:access challenge)がしばしば成される。最も多くの脳血管インターベンション手技(neurointerventional procedures)は、大腿部から頚動脈又は椎骨動脈へ、そこから目的の脳動脈への経大腿部アクセスを用いる。しかしながら、このアクセス経路はしばしばねじ曲がっており、そして大動脈弓並びに頚動脈血管及び腕頭血管の起点に狭窄プラーク物質を含んでいる可能性があり、手技のアクセス部分(access portion)の間に塞栓合併症のリスクを示している。さらに、脳血管は、通常は、冠血管系又は他の末梢血管系よりもずっと繊細で、穿孔しがちである。近年、介入デバイス(例えばワイヤ、ガイドカテーテル、ステント及びバルーンカテーテルなど)は、神経血管の構造内でより良く機能するように、すっかり小型にされ、より柔軟にされている。しかしながら、デバイスでのアクセスチャレンジであるため、多くの脳血管インターベンション手技は比較的困難か、又は不可能である。「時は脳なり」である急性虚血性脳卒中の場合に、これらの余計な困難性は、重大な臨床的影響を与えるだろう。
急性虚血性脳卒中を治療するための、安全で、迅速で、比較的短く且つ直線的な、脳動脈への経頚部アクセスを可能にする方法及びデバイスを開示する。方法及びデバイスは、閉塞を除去するための遠位カテーテル及びデバイスを含む。方法及びデバイスはまた、遠位の塞栓を最小化するだけでなく、閉塞の除去を容易にする目的で、吸引及び受動的な血流逆転(passive flow reversal)を提供するために含まれている。システムは、脳血管系の具体的な血行力学の要求に対処するために、ユーザーにある程度の血流制御を提供する。開示された方法及びデバイスは、脳の損傷を最小限にするために、手技中に脳のペナンブラ(penumbra)を保護する方法及びデバイスも含んでいる。さらに、開示された方法及びデバイスは、経頚部血腫による壊滅的な被害の可能性(potentially devastating consequences)を回避するために、脳動脈へのアクセスサイトをしっかりと閉鎖する手段を提供する。
総頚動脈内に当該動脈の開口を介して直接導入するのに適した経頚部アクセスシースであって、前記開口は、前記患者の鎖骨の上側で且つ前記患者の総頚動脈が内頚動脈と外頚動脈とに分岐する分岐位置より下側に位置し、内腔を有する経頚部アクセスシースと、
遠位カテーテルが前記経頚部アクセスシースを介して遠位カテーテルを脳動脈に挿入できるように、前記経頚部アクセスシースの前記内腔を通って軸方向に挿入できる寸法及び形状にされた遠位カテーテルであって、内径で規定された内腔を有する前記遠位カテーテルと、
前記経頚部アクセスシースの前記内腔を通って軸方向に挿入できる寸法及び形状にされた細長い内側部材であって、内腔を有する内側部材と、
前記内側部材の内腔を介して前記脳動脈に挿入できるように構成されたガイドワイヤと、を含み、
前記内側部材は、前記遠位カテーテルの内径と前記ガイドワイヤの外径との間の滑らかな移行部(a smooth transition)を形成するように構成された外径を有することを特徴とするシステムを開示している。
総頚動脈内に当該動脈の開口を介して直接導入するのに適した経頚部アクセスシースであって、前記開口は、前記患者の鎖骨の上側で且つ前記患者の総頚動脈が内頚動脈と外頚動脈とに分岐する分岐位置より下側に位置し、内腔を有する経頚部アクセスシースと、
前記経頚部アクセスシースを介して前記遠位カテーテルを脳動脈に挿入できるように、前記経頚部アクセスシースの前記内腔を通って軸方向に挿入できる寸法及び形状にされた遠位カテーテルであって、前記遠位カテーテルは、第1の内腔と、より小さい第2の内腔とを有し、前記第2の内腔の最遠位部分(distal-most portion)は、前記第1の内腔によって形成された遠位開口を超えて遠位側に突出した伸張部の内側に位置付けられていることを特徴とするシステムを開示している。
総頚動脈内に当該動脈の開口を介して直接導入するのに適した経頚部イントロデューサシースであって、前記開口は、前記患者の鎖骨の上側で且つ前記患者の総頚動脈が内頚動脈と外頚動脈とに分岐する分岐位置より下側に位置し、内腔を有する経頚部イントロデューサシースと、
前記イントロデューサシースに接続された血流ラインであって、前記イントロデューサシースからリターンサイトに血液を流すための経路を提供する血流ラインと、
前記イントロデューサシースの近位領域にあり、失血を防止しながら、前記イントロデューサシースの前記内腔へのアクセスを提供する止血弁と、
ガイドカテーテルの内部を介して脳動脈へのアクセスを提供することができるように、前記止血弁を通って前記イントロデューサシースの前記内腔に挿入できる寸法及び形状にされたガイドカテーテルと、を含むことを特徴とするシステムを開示している。
総頚動脈に切開部を形成する工程と、
前記切開部を通して前記総頚動脈内に経頚部アクセスシースに挿入して、前記シースの遠位端を前記総頚動脈又は内頚動脈内に展開する工程であって、前記アクセスシースは内腔を有している、展開する工程と、
前記アクセスシースの前記内腔に、第1の遠位カテーテルを挿入する工程と、
前記脳動脈の前記第1の遠位カテーテルの遠位端を、前記閉塞に隣接して位置決めする工程と、
前記第1の遠位カテーテルの前記遠位端で前記閉塞を捕獲するために、前記第1の遠位カテーテルを通して吸引する工程と、
前記閉塞を前記アクセスシース内に引き込むために、前記第1の遠位カテーテルの前記遠位端を前記アクセスシース中に引き込む工程と、を含むことを特徴とする方法を開示している。
虚血性脳卒中の治療用の介入デバイスを導入するための、安全で、迅速で、比較的短く且つ直線的な頚動脈及び脳血管系への経頚部アクセスを可能にする方法及びデバイスが、本明細書に記載されている。経頚部アクセスは、血管アクセスポイントから目標の治療サイトまで、距離が短く且つねじ曲がっていない経路を提供し、それにより、例えば経大腿部アプローチと比較して、手技にかかる時間及び困難性を緩和する。さらに、このアクセスルートは、疾患があり、角張っており、又はねじ曲がっている大動脈弓又は総頚動脈組織のナビゲーション(航行:navigation)による塞栓発生のリスクを低減する。
図1に示す動脈アクセスデバイス2010は、別個のイントロデューサシースを使用せずに総頚動脈CCAに直接挿入するように構成されている。この配置では、デバイスが、ガイドワイヤ上を動脈中へと滑らに導入されるように、デバイスの侵入部(entry)又は遠位チップ(遠位側の先端: distal tip)は、先細りにされ、そして先細りにされた拡張器を含んでいる。デバイス2010は、膨張した時に動脈を閉塞するように構成された閉塞バルーン(occlusion balloon)2020を含み得る。代替の実施形態では、動脈アクセスデバイス2010は閉塞バルーンを含んでいない。動脈アクセスデバイスは、さらに、近位アダプターを含んでいる。この近位アダプターは、止血弁を持った近位ポート2015を含んでおり、手技中の失血を防止又は最小にしつつ、デバイスの導入を可能にしている。ある実施形態では、このバルブは、固定シールタイプの受動バルブである。代替の実施形態では、このバルブは、例えばツイ−ボースト弁(Tuohy-Borst valve)又は回転式止血弁(RHV)などの開度調整可能弁(adjustable-opening valve)である。止血弁は近位アダプターと一体にされていてもよく、又はルアー接続(Luer connection)を介してアダプターの近位端に別個に取り付けられてもよい。動脈アクセスデバイス2010は、さらに、受動的又は能動的な逆流手段に接続され得る血流ライン2025(又はシャント)への接続を含んでいてもよい。血流ライン2025は、動脈アクセスデバイスからの血液をシャントするために、動脈アクセスデバイス2010の内腔と通じている内腔を有する。ある実施形態では、血流ライン2025は、動脈アクセスデバイス2010の遠位端と近位端との間の位置で動脈アクセスデバイス2010に取り付けられてそこから伸びているサイドアーム又はYアーム2027である。図1に示されるように、血流ライン2025は、デバイスが動脈アクセスデバイスの近位ポート2015に入る位置よりも遠位側に配置されている。代替の実施形態では、血流ライン2025は、別個に取り付けられたツイ−ボースト弁のYアームに取り付けられている。
Yアームを備えた近位アダプターを含んでいてもよい。血流ライン2045は、遠位カテーテル2030の内腔と通じている内腔を有する。近位アダプターは、さらに、ガイドワイヤ、マイクロカテーテル又は他のカテーテルの挿入用の近位止血弁2035を含んでいる。ある実施形態では、近位アダプターは、遠位カテーテル2030に、取り外せないように取り付けられている。別の実施態様では、近位アダプターは、Yアームを備えた別個のツイ−ボースト弁を取着可能なメスのルアーコネクタ(Luer connector)である。
動脈アクセスデバイス2010及び遠位カテーテル2030のいずれか一方又は両方は、デバイス上の血流ライン2025、2045(図1)を介して、受動的又は能動的な吸引源に接続されてもよい。吸引のモードはデバイスごとに異なってもよい。
すなわち、各デバイス3205は、血流ライン2025の一部を包含するチャンバーを包含しているハウジング3215を含む。ポンプデバイス3205a、3205bは、各ポンプデバイス3205が拡張可能な部分3210を備えた血流ライン2025を有するように、血流ライン2025と平行に接続される。一対のポンプデバイス3205a、3205bは、ポンプシステム3305を通して比較的連続流の状態を形成するために、拡張状態(expanded state)と引込み状態(retracted state)とを交互にされてもよい。ポンプ3205a、3205bが、ポンプシステム3305を通して総合的には中断のない血流を駆動するように、例えば、ポンプ3205bが引込み状態にされているときに、ポンプデバイス3205aが拡張状態にされてもよい。
開示されたデバイスシステムのいずれかと共に使用するための血栓回収デバイスの典型的な実施形態は、例えば上述のデバイスであって経頚部的に設置するように構成されたものである。具体的には、血栓回収デバイスは、それが伸びて、脳閉塞にアクセスし横断するのに十分な長さの動脈アクセスデバイス2010又は遠位カテーテル2030から出ることができるような作業長を有している。より具体的には、作業長が80〜120cmの血栓回収デバイスである。
ある実施形態では、システムは、血栓性閉塞よりも遠位側の脳血管系及び虚血の脳組織を、例えば、動脈アクセスデバイス2010を通して血栓症閉塞10よりも遠位側のサイトに送達された灌流カテーテルを介して灌流する手段を含んでいてもよい。灌流カテーテルは、所望の位置に灌流溶液を送達するのに適している。灌流溶液は、例えば、受動的な逆流回路3500の血流ラインから又は別の動脈からの自家動脈血、酸素処理された溶液、又は他の神経保護剤を含んでいてもよい。さらに、灌流溶液は、脳組織を冷却するために低体温にされていても、虚血期間中の脳の外傷を最小限にすることが示さている別の戦略であってもよい。灌流カテーテルは、血栓溶解療法に準ずる動脈内の血栓溶解剤のボーラス投与(bolus)を送達するために使用されてもよい。典型的に、血栓溶解療法は、ボーラス投与を送達した後、閉塞を取り除くのに1〜2時間かかるだろう。機械的な血栓回収はまた、遮断された動脈を首尾よく再開通するのに1〜2時間かかるだろう。虚血性領域の遠位側の灌流は、脳卒中の治療手技中の脳外傷のレベルを最小限にし得る。遠位側の灌流手段の実施形態を以下に記述する。
いずれかのタイプの閉鎖要素は、自動閉鎖要素(self-closing element)、縫合糸ベースの閉鎖要素(suture-based closing element)、静水圧封止要素(hydrostatic seal element)を含め、手技の最後に動脈アクセスデバイス2010又はイントロデューサシース2110(手技的なシース)を引き抜く前に、総頚動脈壁の貫通部に又はその周囲に展開してもよい。米国特許第20100042118号、発明の名称「縫合糸送達装置("Suture Delivery Device")」及び米国特許第20100228269号、発明の名称「血管閉鎖クリップ装置("Vessel Closure Clip Device")」には、典型的な閉鎖装置及び方法が記載されており、その全体を参照して本明細書に組み込む。
図1に図示されているように、動脈アクセスデバイス2010は、患者の総頚動脈CCAへ経頚部的に直接導入される。これは経皮的穿刺又は直接的な切開によって行うことができる。穿刺の場合、最初の動脈穿刺を正確に行うために超音波画像診断を使用することができる。動脈アクセスデバイス2010は、遠位チップが総頚動脈、又は内頚動脈ICAの近位側若しくは遠位側の頸部、錐体部若しくは海綿静脈洞部に位置決めされるように、血管系に通される。着脱可能な近位側伸張部は、蛍光透視下で、ユーザーの手が放射線による被ばくなしに、動脈アクセスデバイス2010を設置するために使用されてもよい。2010年7月12日に出願された米国特許出願第12/834,869号には、着脱可能な近位側伸張部の典型的な実施形態について記載されており、参照して本明細書に組み込む。
Claims (17)
- 患者の脳血管内の治療部位で医療処置を実行するためのデバイスのシステムであって、
内径と遠位端を有するカテーテル内腔を備えたカテーテルと、
前記カテーテル内腔にスライド可能に寸法と形状を付与された内側部材であって、単一の内腔を規定するとともに、遠位部分と最遠位端を有する前記内側部材と、を備え、
前記遠位部分は、第1の外径を有し、前記第1の外径は遠位方向に減少し前記第1の外径より小さい第2の外径に移行し、
前進構成において前記内側部材が前記カテーテルに対して同軸的に配置される時、前記内側部材が前記カテーテル内腔を通って延在し、かつ前記遠位部分が前記カテーテルの遠位端へと遠位方向に配置されることで、前記カテーテルの前記遠位端で、前記第2の外径から前記カテーテル内腔の内径へと円滑に移行できるように、前記第1の外径の寸法が決められており、および
前記システムは、前記内側部材の前記単一の内腔の中に配置され、前記遠位部分の遠位開口から延出する、ガイドワイヤをさらに含み、デバイスの前記同軸システムが、前記前進構成に配置される時、前記遠位部分は、ガイドワイヤの可撓性と前記カテーテルの前記遠位端の可撓性との間に、可撓性の滑らかな移行をもたらすものであり、
前記システムは十分に可撓性であり、前記前進構成で同軸的に配置された時、前記システムは、内頸動脈の錐体部分へと遠位方向に一体的に前進できるように構成されている、前記システム。 - 前記カテーテル内腔の内径は、0.89mmから1.52mm、あるいは1.78mmから2.41mmの間である、請求項1に記載のシステム。
- 前記ガイドワイヤの外径は、0.36mmから0.46mmである、請求項1に記載のシステム。
- 前記内側部材の前記単一の内腔の内径は、0.51mmから0.61mmである、請求項2に記載のシステム。
- 前記第1の外径は、前記カテーテルの遠位端の内径に実質的に相当する、請求項1に記載のシステム。
- 前記内側部材は、前記遠位部分の近位にある材料よりも柔らかい、前記遠位部分の材料から構成されている、請求項1に記載のシステム。
- 前記カテーテルは、可撓性の遠位内腔部分と、前記可撓性の遠位内腔部分の近位端の近くの取付点から近位方向に延在する近位テザー要素とをさらに備え、前記近位テザー要素は、前記患者の体外へと近位方向に延在している、請求項1に記載のシステム。
- 前記取付点における前記近位テザー要素の外径は、前記取付点における前記遠位内腔部分の外径よりも小さい、請求項7に記載のシステム。
- 前記近位テザー要素は、固体であるか、あるいは内腔を有する、請求項7に記載のシステム。
- 頸動脈に導入できるように寸法と形状を付与された伸張体を含む動脈アクセスデバイスをさらに備え、前記伸張体は内腔と遠位端を規定する、請求項6に記載のシステム。
- 前記可撓性の遠位内腔部分の長さは、前記動脈アクセスデバイスの挿入できる長さよりも短い、請求項10に記載のシステム。
- 前記動脈アクセスデバイスの近位端領域上に配置された止血バルブをさらに備え、
必要に応じて、負圧デバイスが前記止血バルブ上の吸引口に結合され、前記負圧デバイスはポンプを含む、請求項10に記載のシステム。 - 前記ポンプは、前記カテーテルの内腔を通って吸引力を加えるように構成されている、請求項12に記載のシステム。
- 前記遠位部分の前記第2の外径は、前記内側部材の最遠位端にある、請求項1に記載のシステム。
- 前記遠位部分の可撓性は、前記内側部材の前記第2の外径から、近位方向に減少する、請求項1に記載のシステム。
- 前記遠位部分は端から端まで、前記カテーテルの遠位端よりも大きな可撓性を有する、請求項14に記載のシステム。
- 前記内側部材の遠位部分は、前記第1の外径から前記第2の外径まで、遠位方向に先細となる、請求項16に記載のシステム。
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JP7437800B2 (ja) | 2024-02-26 |
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