JP5290290B2 - 頚動脈血流の逆流を確立する方法およびシステム - Google Patents
頚動脈血流の逆流を確立する方法およびシステム Download PDFInfo
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- JP5290290B2 JP5290290B2 JP2010517195A JP2010517195A JP5290290B2 JP 5290290 B2 JP5290290 B2 JP 5290290B2 JP 2010517195 A JP2010517195 A JP 2010517195A JP 2010517195 A JP2010517195 A JP 2010517195A JP 5290290 B2 JP5290290 B2 JP 5290290B2
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Description
本出願は、同時係属の米国仮特許出願番号60/950384(2007年7月18日に出願)、および米国仮特許出願番号61/026,308(2008年2月5日に出願)の優先権を主張する。これらの仮特許出願の開示は、その全体を参照して本明細書に組み込む。
頚動脈内への介入手技を行なう間に、血流の逆流を引き起こす方法とシステムは、米国特許US6413235、US6423032、およびUS6837881ならびに印刷された公開公報US2001/0044598、US2002/0087119、およびUS2005/0154349に記載されている。総頚動脈の経頚部アクセスに関する文献刊行物は、Bergeron P.ら、 J. Endovasc Surg. 3, 76-79(1996)、Diethrich E.B.ら、J. Endovasc Surg. 3, 42-62(1996)、Diethrich E.B.ら、J. Endovasc Surg. 3, 182-202(1996)、Criado F.J.ら、Am. J. Surg. 174, 111-114(1997)、およびBergeron P.ら、J. Endovasc Surg. 6, 155-159(1999)を含む。逆流を伴う経頚部アクセスに関する文献は、Stecker M.S.ら、, J. Vase. Interv. Radiol. 2002, 13, 413-417(2002)、Criado E.ら、Ann, Vase. Surg. 2004 Mar., 18(2), 257-61(2004)、Chang D.W.ら、J. Vase. Surg. 2004 May, 39(5), 994-1002、Criado E.ら、J. Vase. Surg. 2004 Jul., 40(l), 92-7(2004)、Criado E.ら、J. Vase. Surg. Sep., 40(3), 476-83 (2004)、Lo C.H., Doblas M., Criado E.、J. Cardiovasc. Surg. (Torino) Jun., 46(3), 229-39(2005)、Pipinos ILら、J. Endovasc. Ther. Aug., 12(4), 446-53(2005)、Lin J.C.ら、Vase. Endovascular Surg. Nov.-Dec., 39(6), 499-503(2005)、Alexandrescu V.ら、J. Endovasc. Ther. Apr., 13(2), 196-204(2006)、Ribo M.ら、Stroke Nov., 37(ll), 2846-9(2006)、Pipinos I.L.ら、Vascular Sep.-Oct., 14(5), 245-55(2006)、およびMatas M.ら、J. Vase. Surg. Jul., 46(l), 49-54(2007)を含む。
図1Aは、逆流システム100の第1の実施態様を示しており、このシステムは、脳血管(特に内頚動脈)への塞栓の放出を制限または防止するために、頚動脈分岐部の領域内における逆流血液循環(retrograde or reverse flow blood circulation)を確立し駆動するのに適している。システム100は、頚動脈と相互に作用して、頚動脈から、例えば内頚静脈(あるいは、別の大静脈や、代わりの実施態様における外部レセプタクルなどの別のリターンサイト)などの静脈リターンサイトに逆流を提供する。逆流システム100は、動脈アクセスデバイス110と、静脈リターンデバイス115と、動脈アクセスデバイス110から静脈リターンデバイス115までの逆流通路を提供するシャント120と、を含んでいる。血流制御アセンブリ125はシャント120と相互に作用する。以下により詳細に記述するように、血流制御アセンブリ125は、総頚動脈から内頚静脈までの逆流を調節しおよび/またはモニタするのに適している。血流制御アセンブリ125は、シャント120、内部の血流パスおよび外部の血流パスのいずれか一方あるいは両方を介して血流パスと相互に作用する。より詳細に下に記述されるように、動脈アクセスデバイス110は少なくとも部分的に、総頚動脈CCAに挿入され、静脈リターンデバイス115は少なくとも部分的に、内頚静脈IJVなどの静脈リターンサイトに挿入される。動脈アクセスデバイス110および静脈リターンデバイス115は、結合位置127a、127bにおいて、シャント120と結合される。総頚動脈を通る血流が遮断される場合、内頚動脈と静脈系との間の自然な圧力勾配によって、血液は、脳血管から内頚動脈とシャント120とを通って静脈系まで、逆方向RG(図2A)に流れる。血流制御アセンブリ125は、逆流する血流を調整し(modulate)、増大させ(augment)、支援し(assist)、モニタし(monitor)、および/または別の方法で調節する(regulate)。
・脳の側副血行路(Collateral Brain Circulation)
ウィリス輪CWは、脳の主たる動脈吻合の主要部であり、脳に供給する全ての主な動脈、すなわち2本の内頚動脈(ICA)と椎骨脳底動脈系(vertebral basilar system)とが接続する。血液は、ウィリス輪から、前大脳動脈、中大脳動脈および後大脳動脈によって脳まで運ばれる。動脈間のこの連絡は、脳を通る側副血行路(collateral circulation)を形成することができる。代わりのルートを通る血流を形成することができるので、脳に血液を提供する血管の1つ以上が遮断状態(blockage)の場合には、安全機構を提供する。動脈系のどこかが遮断状態にあったとしても(例えば、本願明細書に記述されるように内頚動脈(ICA)が結紮されたときでも)、脳は、ほとんどの場合、適切な血液供給を受け続けることができる。ウィリス輪を通る血流は、血液の枯渇した側(deprived side)に血液を再分配する多数の経路によって、適切な脳血流を保証する。
図5は、患者の頚部中の関連する血管の拡大図を示す。総頚動脈CCAは、分岐部Bで、内頚動脈ICAおよび外頚動脈ECAに分岐する。分岐部は、ほぼ第4頚椎のレベルに位置する。図5は分岐部Bに生成されたプラークPを示す。
先に述べたように、逆流システム100は、動脈アクセスデバイス110と、静脈リターンデバイス115と、動脈アクセスデバイス110から静脈リターンデバイス115への逆流のための通路を提供するシャント120と、を含んでいる。システムはまた、血流制御アセンブリ125を含んでおり、それはシャント120と相互に作用して、シャント120を介して逆流する血流を調節しおよび/またはモニタする。逆流システム100の構成要素の典型的な実施態様を、ここに記述する。
図6Aは、動脈アクセスデバイス110の典型的な実施態様を示しており、遠位シース605、近位伸張部610、血流ライン615、アダプターまたはYコネクター620、および止血バルブ625を含む。遠位シース605は、開いた外科的切開、あるいは、例えばセルジンガー法を用いて確立された経皮的穿刺のいずれかによる総頚動脈の壁部への切開または穿刺を通して導入するのに適している。シースの長さは5〜15cmの範囲にすることができ、通常は10cm〜12cmである。内径は、典型的には7Fr(フレンチ:1Fr=0.33mm)〜10Frの範囲にあり、通常は8Frである。特に、シースが経頚部アプローチを介して、鎖骨より上側だが頚動脈の分岐部より下側に導入される場合、シース605は、よじれ(kinking)と曲がり(backling)に抵抗するためのフープ強度(hoop strength)を保持しつつ、非常に柔軟であるのが望ましい。このように、遠位シース605は、組み紐(braid)、螺旋状のリボン(helical ribbon)、螺旋状のケーブル(helical wire)などによって、周囲から強化されてもよい。代わりの実施態様では、遠位シースは、例えば鼠径部内の大腿動脈への経皮的穿刺を介して、大動脈弓AAを上がって目標となる総頚動脈CCAへと導入するのに適している。
次に図9を参照すると、静脈リターンデバイス115は、遠位シース910および血流ライン915を含むことができ、システムの使用中は、シャント120に接続されてシャント120の脚部を形成する。遠位シース910は、切開または穿刺を通して静脈リターン場所(頚静脈または大腿静脈など)に導入するのに適している。遠位シース910および血流ライン915は永久に取り付けることができ、あるいは、図9に示すように、従来のluer嵌合を用いて取り付けることができる。任意で、図10に示すように、シース910はYコネクター1005によって血流ライン915に結合することができる。Yコネクター1005は、拡張器1015の挿入を可能にする止血バルブ1010を含むことができ、内頚静脈あるいは他の静脈への静脈リターンデバイスの導入を容易にする。動脈アクセス拡張器645と同様に、静脈拡張器1015はガイドワイヤー用の中央の管腔を含んでおり、それにより、静脈シースと拡張器との組合せをガイドワイヤー上に設置できる。任意で、静脈シース910は、近位端または遠位端に栓1025を備えた洗い流しライン1020を含むことができる。
シャント120は、動脈アクセスカテーテル110と静脈リターンカテーテル115との間の流体の連絡を提供してそれらの間で逆流する血流の経路を提供する単一チューブまたは複数の接続チューブから形成することができる。図1Aに示すように、シャント120は、その一端で、(コネクター127aを介して)動脈アクセスデバイス110の血流ライン615に接続し、他端で、(コネクター127bを介して)静脈リターンカテーテル115の血流ライン915に接続する。
血流制御アセンブリ125は、シャント120と相互に作用して、総頚動脈から、例えば内頚静脈などの静脈リターンサイトへの、あるいは外部レセプタクル130への逆流速度を調節および/またはモニタする。これに関して、ユーザーは、血流制御アセンブリ125により、現存のシステムより高い最大血流速度を達成することができ、また、逆流する血流速度を選択的に調節、設定、あるいは調整することができる。以下に全て記載するように、様々な機構を利用して、逆流速度を調節することができる。以下に記載するように、ユーザーは、血流制御アセンブリ125により、様々な処置法に適したやり方で逆流する血流を構成することができる。
コントローラ1130は、逆流の状態に関して、ユーザーに視覚的および/または音声的な信号を提供する1つ以上のインジケータ(表示部)を含むことができる。音声表示は、ユーザーに対して血流コントローラ1130の視覚的チェックを要求せずに、血流状態をユーザーに思い出させるのに有利である。インジケータは、スピーカー1150および/またはライト1155、あるいはユーザーに逆流の状態を伝えるための他の手段を含むことができる。コントローラ1130は、システムの1つ以上のセンサと通じて、インジケータの作動を制御することができる。あるいは、インジケータの作動は、血流制御アクチュエーター1165の1つを動かすユーザーに直接結び付けることができる。インジケータは、スピーカーまたはライトでなくてもよい。インジケータは、視覚的に逆流の状態を示す単なるボタンまたはスイッチにすることができる。例えば、ある状態(例えば、押されたまたは下がった状態)のボタンは、逆流が高い状態にあることを視覚的に表示していてもよい。あるいは、特定のラベルを付けた血流状態を指しているしているスイッチまたはダイヤルが、逆流がラベルを付けた状態にあることを、視覚的に表示していてもよい。
コントローラ1130は、ユーザーが押し(press)、切り替え(switch)、操作し(manipulate)、あるいは動かす(actuate)ことのできる1つ以上のアクチュエーターを含んで、逆流する血流速度を調節および/または血流速度をモニタすることができる。例えば、コントローラ1130は、コントローラが逆流の態様を選択的に変更するためにユーザーが動かすことのできる血流制御アクチュエーター1165(例えば、1つ以上のボタン、ノブ、ダイヤル、スイッチなど)を含むことができる。例えば、図示された実施態様では、血流制御アクチュエーター1165は、システム100に特定の逆流状態を達成させるコントローラ1130に各々が対応している様々な別個の位置に回転させることのできるノブである。
それらの状態は、例えば、(a)オフ(OFF)状態、(b)低流(LO-FLOW)状態、(c)高流(HI-FLOW)状態、および(d)吸引(ASPIRATE)状態を含んでいる。前述の状態は単なる例示であり、異なる状態や、状態の組合せも利用できると認識されるべきである。コントローラ1130は、センサ、バルブ、可変抵抗成分および/またはポンプを含むシステムの1つ以上の構成要素と相互に作用することにより、様々な逆流状態を達成する。コントローラ1130はまた、ユーザーがコントローラ1130を積極的に動かす必要のないように、逆流速度を調節しおよび/または血流速度をモニタする電気回路およびソフトウェアを含むこともできると認識されるべきである。
上述のように、血流制御アセンブリ125は、1つ以上のセンサを含むか、あるいは1つ以上のセンサと相互に作用することができ、それは、システム100と連絡しており、および/または患者の組織と連絡している。センサの各々は、物理的な刺激(例えば、熱、光、音、圧力、磁気、運動などを含む)に応答するのに適していてもよく、また、計測または表示用に、あるいはコントローラ1130の操作用に得られた信号を伝えるのに適してもよい。ある実施態様では、血流センサ1135はシャント120と相互に作用して、シャント120を通る血流の状況(例えば、血流の流速または容積流量など)を検知する。血流センサ1135は、血流の容積流量または流速の値を直接表示するディスプレイに、直接連結することができる。あるいは、血流センサ1135は、表示用の容積流量あるいは流速のデータをコントローラ1130に入力することができる。
システム100は、様々な様態で逆流を調節するのに適している。ポンプ1110、バルブ1115、シリンジ1120および/または可変抵抗成分1125の組合せを、ユーザーが手動制御するか、あるいはコントローラ1130を介して自動制御して、逆流速度を調節することができる。このように、システム100は、能動的な血流構成要素(例えば、ポンプ、シリンジなど)を制御すること、血流の制限(restriction)を低減すること、吸引源(あらかじめ設定されたバキュロックシリンジ、バキュティナ、吸気装置など)に切り替えること、またはそれらの組合せを含む様々な様態で、逆流を調節することができる。
図21A〜21Eを参照すると、本願で開示された方法の異なる段階における頚動脈分岐部を通る血流が記載されている。最初は、図21Aに示すように、動脈アクセスデバイス110の遠位シース605が総頚動脈CCAに導入される。上述のように、総頚動脈CCAへのエントリーは、経頚部アプローチあるいは経大腿部アプローチであろう。動脈アクセスデバイス110のシース605が総頚動脈CCAに導入された後、図21Aに示すように、血流は順行性の方向AGで継続し、血流は、総頚動脈から内頚動脈ICAおよび外頚動脈ECAの両方に入るだろう。
Claims (20)
- 頚動脈へのアクセスおよび処置に使用されるシステムであって、
総頚動脈に導入して前記総頚動脈からの血流を受容するのに適した動脈アクセスデバイスと、
前記動脈アクセスデバイスに対して流体流通的に接続されたシャントであって、前記動脈アクセスデバイスからリターンサイトに流れる血液の経路を提供するシャントと、
前記シャントに連結され、前記シャントを通る血流を少なくとも第1の血流状態と少なくとも第2の血流状態との間で調節するのに適した血流制御アセンブリであって、前記シャントを通る前記血流と相互に作用する1つ以上の構成要素を含んでいる血流制御アセンブリと、
を含み、
前記第1の血流状態と前記第2の血流状態が、受動的血流状態、能動的血流状態、吸引状態、及びオフ状態を含む群から選ばれ、
前記受動的血流状態は、低速の血流速度と高速の血流速度とを含み、
前記血流制御アセンブリは、前記シャントを通る血流の抵抗を調節するのに適した血流抵抗成分を含んでおり、
前記血流抵抗成分は、前記シャントの2つ以上の並列な血流パスと、1つ以上の前記血流パスを通して血流を選択的に方向付けるために、1つ以上の前記血流パスを開閉するバルブとを含み、
前記並列な血流パスは、メインの血流パスと、前記メインの血流パスよりも高い血流抵抗を有している第2の血流パスとを含むことを特徴とするシステム。 - 前記第1の血流状態は低速の血流速度であり、前記第2の血流状態は高速の血流速度であることを特徴とする請求項1に記載のシステム。
- 前記血流制御アセンブリは、前記血流制御アセンブリの前記1つ以上の構成要素を制御するコントローラを含んでいることを特徴とする請求項1に記載のシステム。
- 前記コントローラは、血流状態を変化させるためにユーザーが操作可能な少なくとも1つのアクチュエーターを含んでいることを特徴とする請求項3に記載のシステム。
- 前記コントローラは複数のアクチュエーターを含むことを特徴とする請求項4に記載のシステム。
- 前記複数のアクチュエーターは、前記血流状態を第1の血液速度から第2の速度まで変化するためにユーザーが操作可能なアクチュエーターを含む請求項5に記載のシステム。
- 前記複数のアクチュエーターは、血流速度が0に向かうように前記血流状態を動かすアクチュエーターを含んでいることを特徴とする請求項5に記載のシステム。
- 前記血流制御アセンブリは前記血流状態を示すインジケータを含んでいることを特徴とする請求項1に記載のシステム。
- 前記血流制御アセンブリは、前記シャントを通る血流が存在しないときに信号を出力することを特徴とする請求項1に記載のシステム。
- 前記血流制御アセンブリは、前記シャントを通る血流のレベルを示すためのディスプレイを含んでいることを特徴とする請求項1に記載のシステム。
- 前記血流制御アセンブリの前記1つ以上の構成要素は、前記シャントを通る前記血流の状況を検知する血流センサを含んでいることを特徴とする請求項1に記載のシステム。
- 血流を流出するのに適した静脈リターンデバイスをさらに含み、
前記静脈リターンデバイスは、静脈に挿入するのに適しており、
前記シャントは、前記血液が前記シャントを通って前記総頚動脈から前記静脈に流れるように、前記動脈アクセスデバイスを前記静脈リターンデバイスに対して流体流通的に接続することを特徴とする請求項1に記載のシステム。 - 前記動脈アクセスデバイスは、前記総頚動脈に入る遠位シース部と、前記シャントに接続している血流ラインとを含むことを特徴とする請求項1に記載のシステム。
- 前記動脈アクセスデバイスは、前記総頚動脈に入る遠位シース部を含み、
前記遠位シース部は、前記総頚動脈への導入を容易にするための縮径された遠位領域と、全体的な血流抵抗を減少するために大きい管腔直径を有する近位領域とを有していることを特徴とする請求項1に記載のシステム。 - 前記動脈アクセスデバイスは、前記総頚動脈に入る遠位シースと、前記総頚動脈を閉塞するのに適した拡張可能な閉塞部材とを含むことを特徴とする請求項1に記載のシステム。
- 前記第2の血流パスは、前記メインの血流パスよりも長いことを特徴とする請求項1に記載のシステム。
- 前記第2の血流パスは、前記メインの血流パスよりも小径であることを特徴とする請求項1に記載のシステム。
- 前記バルブは、前記シャントを通る前記血流を第2の前記血流パスに完全に迂回させそれにより血流抵抗を増加して前記シャントを通る血流速度を減少するように、前記シャントの前記メインの血流パスを通る血流を遮断するように構成されていることを特徴とする請求項1に記載のシステム。
- 前記シャントに結合されたフィルターをさらに含み、前記フィルターは、前記シャントを通る血流をろ過することを特徴とする請求項1に記載のシステム。
- 前記シャントに結合された一方向弁をさらに含み、前記一方向弁は、前記シャントを通って動脈アクセスデバイスに向かう方向の血流を防ぐことを特徴とする請求項1に記載のシステム。
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