JP2013542758A - 人体内での流動回復および部材埋込のための装置 - Google Patents
人体内での流動回復および部材埋込のための装置 Download PDFInfo
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- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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Abstract
Description
本願は、閉塞した血管、特に、閉塞した大脳動脈中の少なくとも部分的血流を回復するための方法および装置、ならびに血栓除去および/または血栓溶解のためのそのような装置の用途に関する。本願はまた、人体内の埋込式部材としてのそのような装置の使用に関する。
図1−3を参照すると、血流回復のための、および/または埋込式部材として使用するためのデバイス10は、ガイドワイヤ12と、接続機構14と、自己拡張部材16とを備えることができる。
図10−15を参照すると、前述のように、ガイドワイヤ12および自己拡張部材16を含む、デバイス10は、流動回復デバイスとして使用することができる。例えば、デバイス10は、大頭蓋内血管閉塞のため、虚血性脳卒中を経験した医療患者における血流を回復するために使用することができる。好ましい配列では、デバイス10は、例えば、図10に見られるように、マイクロカテーテル32およびバルーンガイドカテーテル76と併用することができる。デバイス10は、非常に蛇行性であって、小さく、かつ薄い壁血管から、血栓を回収することができる。デバイス10は、内頸動脈、中大脳動脈のM1およびM2区分、前大脳動脈、脳底動脈、および椎骨動脈等、直径、例えば、2.0mmから5.5mmに及ぶ、血管を治療するために使用することができるが、他の範囲、サイズ、および特定の血管もまた、可能である。
例えば、本発明は、以下の項目を提供する。
(項目1)
医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの該遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁は、体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該遠位部分の遠位端は、遠位要素を含むフィラメントをさらに含み、該遠位端の該フィラメントおよび該遠位要素は、該中心の長手方向軸に向かって半径方向内向きに屈曲させられ、
該第1の複数のセルは、フィラメントを含み、該フィラメントは、0.045mmから0.080mmの間のフィラメント厚、および0.040mmから0.090mmの間のフィラメント幅を有し、
該第2の複数のセルは、フィラメントを含み、該フィラメントは、0.040mmから0.075mmの間のフィラメント厚、および0.038mmから0.082mmの間のフィラメント幅を有し、
該第2の複数のセルは、セルを含み、該セルは、3.50mmから5.50mmの間の幅、および2.50mmから4.5mmの間の高さを有し、
該自己拡張部材は、薄膜試験方法を使用して試験されるとき、0.0010N/mm以上の半径方向力測定値、および0.026N/mm以下の恒常的外向き力を有し、2ピン試験方法を使用して試験されるとき、約6から37gf/inの間の半径方向力測定値を有する、デバイス。
(項目2)
前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、項目1に記載の医療デバイス。
(項目3)
前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、項目1に記載の医療デバイス。
(項目4)
前記接続機構は、ステム、ボールおよびキー溝構造、および電解分離可能継手を含む、項目3に記載の医療デバイス。
(項目5)
前記自己拡張部材は、0.010Nから0.700Nの間の範囲に及ぶ駆逐力を有し、該駆逐力は、規定された長さに沿って該自己拡張部材を引張し、滑動が生じる力を記録することによって、完全に展開された自己拡張部材が動脈を模倣するインビトロモデルに沿って軸方向に滑動するようにさせるために必要な力を決定することによって測定される、項目1に記載の医療デバイス。
(項目6)
前記自己拡張部材は、全フィラメント長を有し、該自己拡張部材は、特定の範囲の長さの血栓に係合し、それを除去するように構成され、その結果、該自己拡張部材の該全フィラメント長と該特定の範囲内の血栓長の比率は10対15である、項目1に記載の医療デバイス。
(項目7)
前記自己拡張部材は、255mmの全フィラメント長、12.75の比率を有しており、最大約20mmの長さの範囲に及ぶ血栓に係合し、それを除去するように構成される、項目6に記載の医療デバイス。
(項目8)
前記第2の複数のセルは、フィラメントを含み、該フィラメントは、0.048mmから0.067mmの間の平均厚、および0.053mmから0.067mmの間の平均幅を有する、項目1に記載の医療デバイス。
(項目9)
医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が該体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該遠位部分の遠位端は、複数の遠位要素を含むフィラメントをさらに含み、該遠位端の該フィラメントは、該中心の長手方向軸に向かって半径方向内向きに屈曲させられる、デバイス。
(項目10)
前記遠位要素は、マーカバンドを含む、項目9に記載の医療デバイス。
(項目11)
前記複数の遠位要素は、3から4の遠位要素を含む、項目9に記載の医療デバイス。
(項目12)
前記遠位要素は、フック状構成を有し、該フック状構成は、血栓保定を補助するように構成される、項目9に記載の医療デバイス。
(項目13)
前記遠位端のフィラメントは、約10度から30度の間の角度で、半径方向内向きに屈曲させられる、項目9に記載の医療デバイス。
(項目14)
医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する、略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該第1の複数のセルは、フィラメントを含み、該フィラメントは、0.045mmから0.080mmの間のフィラメント厚、および0.040mmから0.090mmの間のフィラメント幅を有し、
該第2の複数のセルは、フィラメントを含み、該フィラメントは、0.040mmから0.075mmの間のフィラメント厚、および0.038mmから0.082mmの間のフィラメント幅を有する、デバイス。
(項目15)
前記第2の複数のセルは、セルを含み、該セルは、3.50mmから5.50mmの間の幅、および2.50mmから4.5mmの間の高さを有する、項目14に記載の医療デバイス。
(項目16)
前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、項目14に記載の医療デバイス。
(項目17)
前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、項目14に記載の医療デバイス。
(項目18)
前記接続機構は、ステムとボールとキー溝との構造、および電解分離可能継手を含む、項目17に記載の医療デバイス。
(項目19)
医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は少なくとも1つの半径方向に複数の層を有し、
該自己拡張部材は、薄膜試験方法を使用して試験されるとき、0.0010N/mm以上の半径方向力測定値、および0.026N/mm以下の恒常的外向きの力を有し、2ピン試験方法を使用して試験されるとき、約6から37gf/inの間の半径方向力測定値を有する、デバイス。
(項目20)
前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、項目19に記載の医療デバイス。
(項目21)
前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、項目19に記載の医療デバイス。
(項目22)
前記接続機構は、ステム、ボールおよびキー溝構造、および電解分離可能継手を含む、項目21に記載の医療デバイス。
Claims (22)
- 医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの該遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁は、体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該遠位部分の遠位端は、遠位要素を含むフィラメントをさらに含み、該遠位端の該フィラメントおよび該遠位要素は、該中心の長手方向軸に向かって半径方向内向きに屈曲させられ、
該第1の複数のセルは、フィラメントを含み、該フィラメントは、0.045mmから0.080mmの間のフィラメント厚、および0.040mmから0.090mmの間のフィラメント幅を有し、
該第2の複数のセルは、フィラメントを含み、該フィラメントは、0.040mmから0.075mmの間のフィラメント厚、および0.038mmから0.082mmの間のフィラメント幅を有し、
該第2の複数のセルは、セルを含み、該セルは、3.50mmから5.50mmの間の幅、および2.50mmから4.5mmの間の高さを有し、
該自己拡張部材は、薄膜試験方法を使用して試験されるとき、0.0010N/mm以上の半径方向力測定値、および0.026N/mm以下の恒常的外向き力を有し、2ピン試験方法を使用して試験されるとき、約6から37gf/inの間の半径方向力測定値を有する、デバイス。 - 前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、請求項1に記載の医療デバイス。
- 前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、請求項1に記載の医療デバイス。
- 前記接続機構は、ステム、ボールおよびキー溝構造、および電解分離可能継手を含む、請求項3に記載の医療デバイス。
- 前記自己拡張部材は、0.010Nから0.700Nの間の範囲に及ぶ駆逐力を有し、該駆逐力は、規定された長さに沿って該自己拡張部材を引張し、滑動が生じる力を記録することによって、完全に展開された自己拡張部材が動脈を模倣するインビトロモデルに沿って軸方向に滑動するようにさせるために必要な力を決定することによって測定される、請求項1に記載の医療デバイス。
- 前記自己拡張部材は、全フィラメント長を有し、該自己拡張部材は、特定の範囲の長さの血栓に係合し、それを除去するように構成され、その結果、該自己拡張部材の該全フィラメント長と該特定の範囲内の血栓長の比率は10対15である、請求項1に記載の医療デバイス。
- 前記自己拡張部材は、255mmの全フィラメント長、12.75の比率を有しており、最大約20mmの長さの範囲に及ぶ血栓に係合し、それを除去するように構成される、請求項6に記載の医療デバイス。
- 前記第2の複数のセルは、フィラメントを含み、該フィラメントは、0.048mmから0.067mmの間の平均厚、および0.053mmから0.067mmの間の平均幅を有する、請求項1に記載の医療デバイス。
- 医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が該体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該遠位部分の遠位端は、複数の遠位要素を含むフィラメントをさらに含み、該遠位端の該フィラメントは、該中心の長手方向軸に向かって半径方向内向きに屈曲させられる、デバイス。 - 前記遠位要素は、マーカバンドを含む、請求項9に記載の医療デバイス。
- 前記複数の遠位要素は、3から4の遠位要素を含む、請求項9に記載の医療デバイス。
- 前記遠位要素は、フック状構成を有し、該フック状構成は、血栓保定を補助するように構成される、請求項9に記載の医療デバイス。
- 前記遠位端のフィラメントは、約10度から30度の間の角度で、半径方向内向きに屈曲させられる、請求項9に記載の医療デバイス。
- 医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する、略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は、少なくとも1つの半径方向に複数の層を有し、
該第1の複数のセルは、フィラメントを含み、該フィラメントは、0.045mmから0.080mmの間のフィラメント厚、および0.040mmから0.090mmの間のフィラメント幅を有し、
該第2の複数のセルは、フィラメントを含み、該フィラメントは、0.040mmから0.075mmの間のフィラメント厚、および0.038mmから0.082mmの間のフィラメント幅を有する、デバイス。 - 前記第2の複数のセルは、セルを含み、該セルは、3.50mmから5.50mmの間の幅、および2.50mmから4.5mmの間の高さを有する、請求項14に記載の医療デバイス。
- 前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、請求項14に記載の医療デバイス。
- 前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、請求項14に記載の医療デバイス。
- 前記接続機構は、ステムとボールとキー溝との構造、および電解分離可能継手を含む、請求項17に記載の医療デバイス。
- 医療デバイスであって、
該デバイスは、
近位端および遠位端を有するガイドワイヤと、
接続機構と、
該接続機構を介して該ガイドワイヤの遠位端に取着される自己拡張部材であって、該自己拡張部材は、メッシュ構成を有する、自己拡張部材と
を含み、
該自己拡張部材は、
第1の複数のセルを有する近位部分であって、該近位部分は、その長さの長手方向部分に沿ってテーパ状である、近位部分と、
第2の複数のセルを有する遠位部分であって、該遠位部分は、中心の長手方向軸を有する略管状の構成を形成する、遠位部分と、
該遠位部分の長手方向軸に沿う継目であって、該継目は、2つの縁を形成し、該2つの縁は、該自己拡張部材に沿って略長手方向に延在する、継目と
を含み、
該自己拡張部材は、マイクロカテーテル内への挿入のための、略コイル状の管状構成を有する体積縮小形態に修正されることができ、該遠位部分の縁が体積縮小コイル状構成にオーバーラップされて、該体積縮小コイル状構成において、該自己拡張部材は少なくとも1つの半径方向に複数の層を有し、
該自己拡張部材は、薄膜試験方法を使用して試験されるとき、0.0010N/mm以上の半径方向力測定値、および0.026N/mm以下の恒常的外向きの力を有し、2ピン試験方法を使用して試験されるとき、約6から37gf/inの間の半径方向力測定値を有する、デバイス。 - 前記接続機構は、前記ガイドワイヤと自己拡張部材との間に界面または点を含む、請求項19に記載の医療デバイス。
- 前記接続機構は、前記自己拡張部材を前記ガイドワイヤから取り外すための取外し可能機構を含む、請求項19に記載の医療デバイス。
- 前記接続機構は、ステム、ボールおよびキー溝構造、および電解分離可能継手を含む、請求項21に記載の医療デバイス。
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US9039749B2 (en) | 2015-05-26 |
US20120083868A1 (en) | 2012-04-05 |
US20150297375A1 (en) | 2015-10-22 |
JP6346221B2 (ja) | 2018-06-20 |
EP2621375B1 (en) | 2020-11-04 |
JP2014193379A (ja) | 2014-10-09 |
US20200000613A1 (en) | 2020-01-02 |
EP2621375A1 (en) | 2013-08-07 |
CN103153214A (zh) | 2013-06-12 |
CN103153214B (zh) | 2016-06-15 |
JP5615979B2 (ja) | 2014-10-29 |
KR101484868B1 (ko) | 2015-01-20 |
JP2016172048A (ja) | 2016-09-29 |
KR20130076868A (ko) | 2013-07-08 |
JP6042372B2 (ja) | 2016-12-14 |
WO2012044757A1 (en) | 2012-04-05 |
BR112013007860A2 (pt) | 2016-06-21 |
US10426644B2 (en) | 2019-10-01 |
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