JP2022133393A - 急速吸引血栓摘出システムおよび方法 - Google Patents
急速吸引血栓摘出システムおよび方法 Download PDFInfo
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- JP2022133393A JP2022133393A JP2022108520A JP2022108520A JP2022133393A JP 2022133393 A JP2022133393 A JP 2022133393A JP 2022108520 A JP2022108520 A JP 2022108520A JP 2022108520 A JP2022108520 A JP 2022108520A JP 2022133393 A JP2022133393 A JP 2022133393A
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Abstract
Description
本願は、2015年2月4日に出願された米国仮出願第62/111,481号、および2015年4月3日に出願された米国仮出願第62/142,637号に基づく優先権を主張するものであり、出典明示により、それぞれの開示内容は、すべて本明細書に組み入れられる。
本実施態様では、ユーザーは、手順に対して適切な長さ、形状、および機械的特徴を有するいくつかの利用可能なシースから選択することができ、本開示に記載された手順の工程を実施することができる。取り外し可能な近位部材280は、吸引ライン230と洗浄ライン236をそれぞれ終端させるバルブコネクタ232と238とともに、Y字アームコネクタ226、吸引ライン230、近位延長部240、近位止血弁234および洗浄ライン236を含むことができる。コネクタ285は、シース220の近位コネクタ226に接続することができる。図6に示す一実施態様では、コネクタ285は、シース10を通り、近位部280に入る流れ抵抗を最小限にするように構成されている。例えば、標準的なオスメスのルアー接続に代えて、コネクタ285は、管腔と、シースによくみられる標準メス型ルアーコネクタ62に合う面とを有するアダプター60、そのアダプター60とシースメス型ルアー62との間をシールするシール部材64、および回転ナット66とを含み、該回転ナットは、シール64が圧縮されると、流体、空気真空および圧力に対してシールすることができるように、メス型ルアー62のネジ部分と係合し、アダプター60とルアー62とを一体となるように接続している。再び図5に戻ると、近位部材280がシース10に接続された場合に、シース10との流体接続を近位部が選択的に開放または閉鎖できるように、近位部材280はY字アームコネクタ226上にバルブ242を含んでもよい。シース吸引ライン230を吸引源に接続するコネクタ232についても、同様のタイプの接続を行うことができる。
スパイン付きカテーテル320を所望の部位に移動させるのを補助するために、テーパー付き拡張器340に代えてマイクロカテーテル400を用いることができる。よって、その近位端に、スパイン330をマイクロカテーテル400に係止する手段を含んでもよく、それにより、2つの要素(スパイン付きカテーテルおよびマイクロカテーテル400)を、ガイドワイヤに沿って単一のユニットとして前進させることができる。いくつかの例では、マイクロカテーテル400は、カテーテル320の前方を前進させて、カテーテル320が前進する時のサポートをさせ、あるいは閉塞を横断させ、閉塞に遠位の血管造影を行う。この場合、マイクロカテーテル400の長さを、スパイン付きカテーテルよりも約10~20cm長くすることができる。マイクロカテーテル400は、回収可能なステントデバイス500を閉塞に送達するために使用することもできる。この場合、マイクロカテーテル400は、回収可能なステントデバイス500の送達に適した内径、例えば、0.021インチと0.027インチの範囲と、PTFEのインナーライナーとを有することができる。マイクロカテーテル400は、移動時に吸引カテーテル320の遠位端を超えて延在できるように、スパイン付きカテーテル320の全長よりも少なくとも約5~10cm、あるいは約5~20cm長くしてもよい。
これは、注射器286を介してカテーテルを生理食塩水または造影剤で洗浄する場合に、ユーザーにフィードバックを提供する。
Claims (95)
- アクセスシースを介する、神経血管内の管腔内医療処置の促進のための血管内アクセスシステムであって
可撓性の遠位管腔部であって、前記管腔部の近位端の近位開口部と前記管腔部の遠位端の遠位開口部との間に延在する管腔を画定する内径を有する、該可撓性の遠位管腔部と、
前記管腔部の少なくとも近位端に結合され、そこから近位方向に延在する剛性のスパインと、を含む吸引カテーテルまたは支持カテーテル、および
前記管腔部の管腔内に受け入れ可能に寸法決めされた可撓性の遠位拡張器部と、前記遠位拡張器部から近位方向に延在する剛性の拡張器スパインとを有する拡張器、を含む、該血管内アクセスシステム。 - 使用時には、前記拡張器スパインは、カテーテルのスパインと並んで整列している、請求項1記載のシステム。
- 前記遠位拡張器部は、テーパー状の遠位先端を有する、請求項1または2に記載のシステム。
- 前記拡張器は、前記拡張器の遠位先端が前記管腔部の前記遠位開口部から突出することができる長さを少なくとも有する、請求項1~3のいずれかに記載のシステム。
- 前記拡張器は、その長さの少なくとも一部に沿って概ね管状である、請求項1~4のいずれかに記載のシステム。
- 前記カテーテルスパインの近位端は、前記アクセスシースを通ってカテーテルを移動させるために、ユーザーが把持できるように構成された把持機構を含む、請求項1~5のいずれかに記載のシステム。
- 前記拡張器スパインの近位端は、前記把持機能で係止できるように構成されたタブを前記カテーテルスパイン上に有することを特徴とする請求項6に記載のシステム。
- 前記カテーテルと前記拡張器は、前記アクセスシースを通って、単一のユニットとして前進できる、係止構成にある、請求項7記載のシステム。
- 前記把持機構と前記拡張器タブは、係止構成では、前記拡張器タブが前記把持機構に係合し、非係止構成では、前記拡張器が前記把持機構と非係合となるように、前記把持機構と前記拡張器タブが取り外し可能に結合されている、請求項7または8に記載のシステム。
- 前記拡張器タブが、前記拡張器に固定されている、請求項7~9のいずれかに記載のシステム。
- 前記拡張器タブは、前記拡張器と前記カテーテルとの間の異なる相対位置に対応できるように、前記拡張器上で摺動可能である、請求項7~9のいずれかに記載のシステム。
- 前記遠位拡張器部は、1つ以上の戻り止めを外面上に含むことができ、該戻り止めは、拡張器部がその中を延在する管腔部の内面上の、対応するように賦形された表面特徴に係止されるように構成されている、請求項1~11のいずれかに記載のシステム。
- 前記拡張器スパインと前記カテーテルスパインは、同様の硬さとキンク抵抗を有する、請求項1~12のいずれかに記載のシステム。
- 前記拡張器は、前記遠位先端の遠位端および/または近位端に視覚マーカーを有する、請求項1~13のいずれかに記載のシステム。
- 前記拡張器の遠位端領域は、より可撓性であり、前記拡張器の近位端領域の方向に向かって硬くなる、請求項1~14のいずれかに記載のシステム。
- 前記カテーテルスパインと前記拡張器スパインは、アクセスシースの管腔を通って前記管腔部が双方向に摺動して移動できるとともに、処置部位に到達させるために前記管腔部を脳血管内に移動できるように構成されている、請求項1~15のいずれかに記載のシステム。
- アクセスシースを介する、神経血管内の管腔内医療処置の促進のための血管内アクセスシステムであって
シース本体を含むアクセスシースであって、前記シース本体が、前記シース本体の近位端と遠位端との間の管腔を画定する内径と、前記シース本体の遠位端領域の近傍の前記管腔からの少なくとも1つの開口部とを有する、該アクセスシースと、
可撓性の遠位管腔部であって、前記アクセスシースの前記管腔を通って挿入できるように寸法決めされた外径と、前記管腔部の近位端の近位開口部と前記管腔部の遠位端の遠位開口部との間に延在する管腔を画定する内径と、前記遠位開口部と前記近位開口部との間の長さ、とを有する該可撓性の遠位管腔部と、前記管腔部の前記近位端に少なくとも結合し、そこから近位方向に延在する剛性のスパインと、を含む、吸引カテーテルまたは支持カテーテルと、を含み、
前記剛性のスパインは、処置部位に到達させるために前記管腔部を脳血管内に移動させるために、前記アクセスシースの管腔を通って前記管腔部が双方向に摺動して移動し、少なくとも1つの開口部から出ることができるように構成され、および
処置部位に到達させるために、脳血管の中に前記管腔部の前記遠位端を延在させると、前記管腔部の外径の部分が、前記アクセスシースの内径をシールする、該血管内アクセスシステム。 - 前記管腔部と前記シース本体は、同心状に配置され、前記管腔部の前記管腔と前記シース本体の前記管腔は、前記管腔部の前記遠位端から前記シース本体の前記近位端まで連続する吸引管腔を形成する、請求項17記載のシステム。
- 前記連続する吸引管腔は、前記管腔部の前記遠位開口部から流体とデブリを吸引することに使用できる、請求項18記載のシステム。
- 前記連続する吸引管腔は、前記管腔部の前記遠位開口部を通って物質を送達することに使用できる、請求項18または19に記載のシステム。
- 前記連続する吸引管腔は、前記管腔部の前記管腔が前記シース本体の前記管腔の中に入り込む、逓増する直径部を形成する、請求項17~20のいずれかに記載のシステム。
- 前記管腔部の前記管腔は、前記シース本体の前記管腔よりも短い、請求項17~21のいずれかに記載のシステム。
- 前記管腔部と前記シース本体は、前記管腔部が、前記シース本体の少なくとも1つの開口部を超えて遠位方向へ延在する時、重なり領域を形成する、請求項17~22のいずれかに記載のシステム。
- 前記管腔部の外径は、前記重なり領域によりシールが形成されるように、前記シース本体の前記管腔の内径に近付いている、請求項23記載のシステム。
- 前記シールは、最高25水銀柱インチ(inHg)または最高28水銀柱インチ(inHg)の真空に対してシールすることができるように構成されている、請求項24に記載のシステム。
- 前記重なり領域内の前記シールは、最大300mmHgの圧力に対してシールが可能なように構成されている。請求項24に記載のシステム。
- 前記シールは、前記管腔部の近位端の遠位方向であって、前記シース本体の少なくとも1つの開口部の近位方向に位置している、請求項24~26のいずれかに記載のシステム。
- 前記管腔部の外面上に位置するシール要素をさらに含む、請求項24~27のいずれかに記載のシステム。
- 前記シール要素は、前記重なり領域に、逓増した直径部または突出特徴部を含む、請求項28に記載のシステム。
- 前記シール要素は、1つ以上の外部リッジ特徴部を含む、請求項28に記載のシステム。
- 前記管腔部が前記シース本体の前記管腔内に挿入される時、前記1つ以上の外部リッジ特徴部は、圧縮可能である、請求項30に記載のシステム。
- 前記シール要素は、前記のシース本体管腔の内面に対して付勢する1つ以上の傾斜面を有する、請求項28に記載のシステム。
- 前記シール要素は、シールするために作業する、1つ以上の拡張部材を含む、請求項28に記載のシステム。
- 前記シース本体は、頚動脈への挿入に適した外径を有する、請求項17~33のいずれかに記載のシステム。
- 前記シース本体の外径は、5Frと7Frの間である、請求項34に記載のシステム。
- 前記シース本体は、経大腿動脈アプローチで、前記シース本体の遠位端を内頸動脈の錐体部に配置するのに適した、前記近位端と前記遠位端との間の長さを有する、請求項17~35のいずれかに記載のシステム。
- 前記シース本体の長さは、80cmと105cmの間である、請求項36に記載のシステム。
- 前記管腔部の長さは、10cmと25cmの間である、請求項17~37のいずれかに記載のシステム。
- 前記カテーテルを前記シース本体の中に後退させる時に、前記管腔部の重なり領域と前記シース本体の内径との間にシールが残るように、前記管腔部の長さが前記シース本体の長さより短い、請求項17~38のいずれかに記載のシステム。
- 前記スパインは、前記シース本体の全長よりも長い、請求項17~39のいずれかに記載のシステム。
- 前記管腔部は、内側潤滑性ライナー、補強層、および外側ジャケット層を含む3層以上を含む、請求項17~40のいずれかに記載のシステム。
- 前記外側ジャケット層は、遠位管腔部の長さに沿って可撓性を変化させるために、異なるデュロメータ硬度、組成、および/または厚さを有する、ポリマーの個別部分から構成されている、請求項41に記載のシステム。
- 前記遠位管腔部は、大脳動脈の中へ移動できるよう寸法決めされている、請求項17~42のいずれかに記載のシステム。
- 前記遠位管腔部の内径は、0.040インチと0.088インチの間である、請求項17~43のいずれかに記載のシステム。
- 前記管腔部の外径は前記シース本体の内径に近付くことで、前記シース本体を通ってカテーテルが移動をすることを可能にしながら、重なり領域にシール領域を形成する、請求項17~44に記載のシステム。
- 前記管腔部が前記シース本体をシールする場所の近傍で、前記管腔部の最遠位端が前記管腔部のより近位領域と比べてより小さな外径を有するように、前記カテーテルは前記遠位開口部に向かうテーパー形状を有する、請求項17~45のいずれかに記載のシステム。
- 前記シース本体の前記遠位端領域は、閉塞要素を含む、請求項17~46のいずれかに記載のシステム。
- 前記シース本体の前記遠位端領域は、拡張遠位先端を含む、請求項17~47のいずれかに記載のシステム。
- 前記管腔からの少なくとも1つの開口部は、前記シース本体の遠位先端から離れて位置する側方開口部を有する、請求項17~48のいずれかに記載のシステム。
- 前記シース本体の遠位先端は、前記カテーテルを前記シース本体の管腔の長手方向軸から遠ざけて、前記少なくとも1つの開口部を通って外に出られるような角度に向けるように構成された傾斜特徴部を含む、請求項17~49のいずれかに記載のシステム。
- 前記スパインは、前記シース本体の全長よりも長い、請求項17~50のいずれかに記載のシステム。
- 前記スパインは、0.014インチ~0.018インチの外側寸法を有する、請求項17~51のいずれかに記載のシステム。
- 前記スパインは、それを通って延在するガイドワイヤ通路を有するハイポチューブである、請求項17~52に記載のシステム。
- 前記スパインは、厚さが0.010インチ~0.025インチの外側寸法を有するリボンである、請求項17~53のいずれかに記載のシステム。
- 前記リボンは、少なくとも円弧の一部に沿って湾曲している、請求項54記載のシステム。
- 前記スパインは、前記アクセスシースの長手方向軸の周りを前記管腔部が回転するように構成されている、請求項17~55のいずれかに記載のシステム。
- 前記スパインは、前記管腔部に偏心的に結合され、前記スパインは、前記管腔部から前記シース本体の前記近位端の外側に向けて近位に延在している、請求項17~56のいずれかに記載のシステム。
- 前記管腔部の前記近位端は、角度付きカットを有する、請求項17~57のいずれかに記載のシステム。
- 前記角度付きカットは、ほぼ平坦または湾曲している、請求項58に記載のシステム。
- 前記シース本体は、前記シース本体の前記遠位端領域に1つ以上の視覚マーカーを有する、請求項17~59のいずれかに記載のシステム。
- 前記遠位管腔部は、前記管腔部の遠位端領域、前記管腔部の近位端領域、またはその両方に1つ以上の視覚マーカーを有する請求項17~60のいずれかに記載のシステム。
- 前記シース本体上の1つ以上の視覚マーカーと前記管腔部上の1つ以上の視覚マーカーは、視覚的に区別可能である、請求項60または61に記載のシステム。
- 前記スパインは、1つ以上の視覚マーカーを有する、請求項60~62のいずれかに記載のシステム。
- 前記スパインの前記1つ以上の視覚マーカーは、前記遠位管腔部と前記シース本体との間の重なりを示す、請求項63記載のシステム。
- 前記スパインの前記視覚マーカーを前記アクセスシースの一部と整列させる時、前記カテーテルと前記シース本体との間のシールを形成するのに必要な最小限の重なり長さを有する最遠位位置に前記カテーテルが位置するように、前記スパインの前記1つ以上の視覚マーカーは配置される、請求項63または64に記載のシステム。
- さらに拡張器を含み、該拡張器は、遠位先端を有するとともに前記カテーテルの前記管腔部内に受け入れ可能に寸法決めされた、可撓性の遠位拡張部を含む、請求項17~65のいずれかに記載のシステム。
- 前記拡張器は、その長さの少なくとも一部に沿った管状要素である、請求項66に記載のシステム。
- 前記拡張器は、ユーザーにより成形が可能なように構成された、可鍛性材料で形成された固体ロッドである、請求項66に記載のシステム。
- 前記拡張器は、前記拡張部から近位方向に延在する、剛性の拡張器スパインである、請求項66に記載のシステム。
- 前記拡張器スパインは、同軸である、請求項69記載のシステム。
- 前記同軸拡張器スパインは、それを通って延在する管腔を有する、請求項70記載のシステム。
- 前記拡張器スパインは偏心している、請求項69に記載のシステム。
- 使用時には、前記拡張器スパインは、前記カテーテルの前記スパインと並んで整列している、請求項69~72に記載のシステム。
- 前記遠位先端はテーパー状である、請求項66~73のいずれかに記載のシステム。
- 前記拡張器は、前記遠位先端が前記管腔部の前記遠位開口部から突出するように、前記カテーテルと少なくとも同じ長さを有する、請求項74記載のシステム。
- 前記スパインの近位端は、前記アクセスシースを通ってカテーテルを移動させるために、ユーザが把持できるように構成された把持機構を含む、請求項69~75のいずれかに記載のシステム。
- 前記拡張器スパインの近位端は、前記把持機能で係止できるように構成されたタブを前記カテーテルスパイン上に有する、請求項76に記載のシステム。
- 前記カテーテルと前記拡張器は、前記シース本体を通って、単一のユニットとして前進できる、係止構成にある、請求項77記載のシステム。
- 前記把持機構と前記拡張器タブは、係止構成では、前記拡張器タブが前記把持機構に係合し、非係止構成では、前記拡張器が前記把持機構と非係合となるように、前記把持機構と前記拡張器タブが取り外し可能に結合されている、請求項77または78に記載のシステム。
- 前記拡張器タブが、前記拡張器に固定されている、請求項77~79のいずれかに記載のシステム。
- 前記拡張器タブは、前記拡張器と前記カテーテルとの間の異なる相対位置に対応できるように、前記拡張器上で摺動可能である、請求項77~79のいずれかに記載のシステム。
- 前記遠位拡張器部は、1つ以上の戻り止めを外面上に含むことができ、該戻り止めは、拡張器部がその中を延在する管腔部の内面上の、対応するように賦形された表面特徴に係止されるように構成されている、請求項66~81のいずれかに記載のシステム。
- 前記拡張器スパインと前記カテーテルスパインは、同様の硬さとキンク抵抗を有する、請求項69~82のいずれかに記載のシステム。
- 前記拡張器は、前記遠位先端の遠位端および/または近位端に視覚マーカーを有する、請求項66~83のいずれかに記載のシステム。
- 前記拡張器の遠位端領域は、より可撓性であり、前記拡張器の前記近位端領域の方向に向かって硬くなる、請求項66~84のいずれかに記載のシステム。
- 前記アクセスシースは、前記シース本体の前記近位端を近位止血弁に接続するコネクタをさらに含む、請求項17~85のいずれかに記載のシステム。
- 前記近位止血弁は、前記カテーテルをその上の凝血塊を除去することなく取り外すことができる十分な大きさに寸法決めされた調整可能な開口部を有する、請求項86に記載のシステム。
- 前記アクセスシースとともに使用する時には、前記カテーテルの剛性スパインは、前記アクセスシースの管腔を通って前記管腔部から、前記アクセスシースの前記近位止血弁の外へと近位方向に延在する、請求項86または87に記載のシステム。
- 前記コネクタは、前記シース本体の前記近位端の吸引ラインへの接続を提供する、請求項86~88のいずれかに記載のシステム。
- 前記コネクタは、大口径の管腔を有し、大口径の吸引ラインに接続する、請求項86~89のいずれかに記載のシステム。
- 前記吸引ラインは、吸引源に接続する、請求項89又は90に記載のシステム。
- 前記吸引源は能動吸引源である、請求項91のシステム。
- 前記吸引ラインは、前方点滴または洗浄ラインに接続する、請求項89~92のいずれかに記載のシステム。
- 前記アクセスシースは近位拡張部をさらに含み、前記カテーテルの前記遠位管腔部は、前記シース本体の管腔から引き出される時、前記近位拡張部の中に留まる、請求項17~93のいずれかに記載のシステム。
- 前記管腔部の内径は、前記管腔部を通して介入デバイスを配置することが可能なように寸法決めされる、請求項17~94のいずれかに記載のシステム。
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