JP2021532851A - 吸引カテーテルを用いた血栓除去のための吸引式血栓除去システムおよび方法 - Google Patents
吸引カテーテルを用いた血栓除去のための吸引式血栓除去システムおよび方法 Download PDFInfo
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Abstract
Description
(1)「高真空」が絶対圧力ゼロに近づく、圧力の絶対レベル。これは、「絶対圧」と呼ばれる真空の測定方法である。完全な真空はゼロであり、大気圧は標準的な雰囲気下(760mmHg)で維持される水銀カラムの高さを測定することによって示される。したがって、値が低いほど、周囲の大気圧に対して真空のレベルが高くなることを示している。
(2)大気圧に対する相対的な圧力。標準的な大気圧に対する圧力を測定するこの手段は、「ゲージ圧」と呼ばれる。(大気圧を下回る)真空領域の圧力を測定する最も一般的な方法は、1つの大気がゼロ(標準的な大気圧)となり、可能な限り最大の真空のレベルが「29.92インチの水銀」として表示されるように較正されたゲージを使用することである。一般的な機械式の真空ゲージはこのように動作するため、この使用法は一般的になっている。
・ 状態1:正常な吸引が行われている。真空チャネル3は、閉塞していない。コントローラ100は、真空ポンプ80と真空チャネル3とが接続されている静止状態にある。
・ 移行A−閉塞:血栓4は、真空チャネル3の遠位端を閉塞する。詰まり解除コントローラ10は、真空チャネル3を閉塞し、コントローラ10の遠位側にある真空流を停止するように作動される。
・ 状態2:真空チャネル3内の流れが停止している。
・ 移行B−詰まり解除:コントローラ10は、計量された容積のカラムシフトのために真空チャネル3内に逆流を引き起こすように作動を継続する。
・ 状態3:フローの反転が停止する。
・ 移行C−戻りカラムシフト:コントローラ10は、真空ポンプ80と真空チャネル3とを再接続することにより、カラムを戻して血栓4をカテーテル先端に加速するように、反転される。
・ 状態1に戻り、繰り返し:正常な吸引が行われる。
・ 状態1:正常な吸引が行われている。真空チャネル3は、閉塞していない。コントローラ100は、真空ポンプ80と真空チャネル3とが接続されている静止状態にある。真空ブースタ100はコック状態にある。血栓トラップ200は、ブリードパージが行われていない状態で動作している。
・ 移行A−閉塞:血栓4は、真空チャネル3の遠位端を閉塞する。詰まり解除コントローラ10は、真空チャネル3を閉塞し、コントローラ10の遠位側にある真空流を停止するように作動される。
・ 状態2:真空チャネル3内の流れが停止している。
・ 移行B−詰まり解除:コントローラ10は、計量された容積のカラムシフトのために真空チャネル3内に逆流を引き起こすように作動を継続する。
・ 状態3:フロー反転が停止する。
・ 移行C−真空ブースト:真空ブースタ100は、公称方向の流れを再び開始し、カテーテル先端への血栓4の吸引を促進するために作動される。その少し前、同時に、またはその直後に、コントローラ10は、真空チャネル3を開放し、ポンプ80の真空を流体の流れのために再始動させ、血栓4を血栓トラップ200内に吸引する。同時にまたはその後、血栓トラップ200の制御されたパージまたは自動パージが生じて、血栓4の検査が可能になる。
・ 状態1に戻り、繰り返し:真空ブースタ100とセルフパージトラップ200が作動されなくなる。正常な吸引が行われる。
・ 状態1:正常な吸引が行われている。真空チャネル3は、閉塞していない。容積変更コントローラ300は、真空ポンプ80と真空チャネル3とが接続されている静止状態にある。
・ 移行A−閉塞:血栓4は、真空チャネル3の遠位端を閉塞する。コントローラ300は、真空チャネル3を閉塞し、コントローラ300の遠位側にある真空流を停止するように作動される(差し込まれる)。
・ 状態2:真空チャネル3内の流れが停止している。
・ 移行B−詰まり解除:コントローラ300は、定量的なカラムシフトのために、真空チャネル3で逆流を引き起こすためにプランジを継続する。
・ 状態3:フロー反転が停止する。
・ 移行C−戻りカラムシフト:コントローラ300は、真空ポンプ80と真空チャネル3とを再接続することにより、カラムを戻して血栓4をカテーテル先端に加速するように、反転される。
− 状態1に戻り、繰り返し:正常な吸引が行われる。
・ 真空弁620が閉鎖され、
・ 所定の時間が経過した後に通気弁650が開放され、
・ 所定の時間が経過した後に通気弁650が閉鎖され、
・ 所定の時間が経過した後に真空弁620が開放され、且つ
・ 所定の時間が経過した後にこのシーケンスが繰り返される。
Claims (20)
- 血栓除去システムであって、
遠位端を有し、近位部分および遠位部分を有する流体カラムで満たされた管腔を画定するカテーテルと、
制御可能な真空弁と、
前記真空弁に流体的に接続された真空源と、
通気液入口を有する制御可能な通気弁と、
通気液を含み、前記通気液入口において前記通気液を保持するように前記通気弁に流体的に接続された通気液源と、
前記カテーテル、前記真空弁および前記通気弁に接続されたマニホールドであって、
・ 前記真空弁を介して前記管腔内の流体カラムの近位部分と前記真空源とを流体的に接続し、
・ 前記通気弁を介して前記管腔内の流体カラムの近位部分と前記通気液源とを流体的に接続する、
マニホールドと、
前記真空弁および前記通気弁に接続されたコントローラであって、前記コントローラは、前記真空弁と前記通気弁とを選択的に開閉するように構成されており、これにより、
・ 前記真空弁の開放に応答して前記真空源と前記管腔内の流体カラムとが流体的に接続され、
・ 前記通気弁の開放に応答して前記通気液源と前記管腔内の流体カラムとが流体的に接続される、
コントローラと、
を備え、
前記コントローラは、前記真空弁と前記通気弁とを周期的に開閉するように構成されており、これにより、
・ 前記遠位端における真空のレベルを変化させ、
・ 各サイクルの間に、前記遠位端から外への前記遠位部分の前方流を防止することができる、
システム。 - 前記コントローラは、前記真空弁が閉鎖され且つ前記通気弁が閉鎖されている二重閉鎖状態を含む繰り返しサイクルで、前記真空弁と前記通気弁とを周期的に開閉するように構成される、請求項1に記載のシステム。
- 前記二重閉鎖状態の時間は、30ms以下である、請求項2に記載のシステム。
- 前記コントローラは、前記真空弁が閉鎖され且つ前記通気弁が開放されている通気のみの状態を含む繰り返しサイクルで、前記真空弁と前記通気弁とを周期的に開閉するように構成される、請求項1に記載のシステム。
- 前記通気のみの状態の時間は、50ms以下である、請求項4に記載のシステム。
- 前記コントローラは、
・ 前記真空弁が開放され且つ前記通気弁が閉鎖されている真空のみの状態と、
・ 前記真空弁が閉鎖され且つ前記通気弁が閉鎖されている第1の二重閉鎖状態と、
・ 前記真空弁が閉鎖され且つ前記通気弁が開放されている通気のみの状態と、
・ 前記真空弁が閉鎖され且つ前記通気弁が閉鎖されている第2の二重閉鎖状態と、
を含む繰り返しサイクルで、前記真空弁と前記通気弁とを選択的に開閉するように構成される、請求項1に記載のシステム。 - 前記通気弁の開放と前記通気弁の閉鎖との間の時間は、約10ms〜約50msの範囲である、請求項6に記載のシステム。
- 前記サイクルの周期は、約6Hz〜約16Hzの範囲である、請求項6に記載のシステム。
- 前記サイクルの周期は、約8Hz〜12Hzの範囲である、請求項6に記載のシステム。
- 前記遠位端における真空のレベルの変化は、約15inHgよりも大きく、約50ms以下である、請求項1に記載のシステム。
- 前記遠位端における真空のレベルの変化は、約20inHgよりも大きく、約30ms以下である、請求項1に記載のシステム。
- 前記遠位端における真空のレベルの変化は、約25inHgよりも大きく、約20ms以下である、請求項1に記載のシステム。
- 前記管腔は、約0.038”〜約0.106”の範囲の内径を有し、
前記コントローラは、2〜16Hzの範囲の周波数で前記真空弁と前記通気弁とを周期的に開閉するように構成される、
請求項1に記載のシステム。 - 前記管腔は、約0.068”〜約0.088”の範囲の内径を有し、
前記コントローラは、2〜16Hzの範囲の周波数で前記真空弁と前記通気弁とを周期的に開閉するように構成される、
請求項1に記載のシステム。 - 前記コントローラは、繰り返しサイクルで、前記真空弁と前記通気弁とを周期的に開閉するように、および前記通気弁のタイミングを調整して、各周期の間に、前記遠位端から外への前記遠位部分の前方流を防止するように構成される、請求項1に記載のシステム。
- 前記コントローラは、前記遠位端における圧力のレベルを生理的圧力よりも低いレベルで保持するように、前記真空弁と前記通気弁とを周期的に開閉するように構成される、請求項1に記載のシステム。
- シャフトをさらに備え、前記シャフトには、前記真空弁と前記通気弁とが共に取り付けられる、請求項1に記載のシステム。
- 血栓除去システムであって、
遠位端を有し、近位部分および遠位部分を有する流体カラムで満たされた管腔を画定するカテーテルと、
制御可能な真空弁と、
前記真空弁に流体的に接続された真空源と、
通気液入口を有する制御可能な通気弁と、
通気液を含み、前記通気液入口において前記通気液を保持するように前記通気弁に流体的に接続された通気液源と、
前記カテーテル、前記真空弁および前記通気弁に接続されたマニホールドであって、
・ 前記真空弁を介して前記管腔内の流体カラムの近位部分と前記真空源とを流体的に接続し、
・ 前記通気弁を介して前記管腔内の流体カラムの近位部分と前記通気液源とを流体的に接続する、
マニホールドと、
前記真空弁および前記通気弁に接続されたコントローラであって、前記コントローラは、前記真空弁と前記通気弁とを選択的に開閉するように構成されており、これにより、
・ 前記真空弁の開放に応答して前記真空源と前記管腔内の流体カラムとが流体的に接続され、
・ 前記通気弁の開放に応答して前記通気液源と前記管腔内の流体カラムとが流体的に接続される、
コントローラと、
を備え、
前記コントローラは、前記真空弁が閉鎖され且つ前記通気弁が閉鎖されている二重閉鎖状態を含む繰り返しサイクルで、前記真空弁と前記通気弁とを周期的に開閉するように構成されており、これにより、
・ 前記遠位端における真空のレベルを変化させ、
・ 各サイクルの間に、前記遠位端から外への前記遠位部分の前方流を防止することができ、
前記二重閉鎖状態の時間は、約30ms以下である、
システム。 - 血栓除去システムであって、
遠位端を有し、近位部分および遠位部分を有する流体カラムで満たされた管腔を画定するカテーテルと、
真空源と、
通気液源と、
真空・通気制御システムと、
を備え、
前記真空・通気制御システムは、前記真空源と前記通気液源とを周期的に接続または切断するように構成されており、これにより、
・ 前記遠位端における真空のレベルを変化させ、
・ 前方流を実質的に防止することができる、
システム。 - 血栓除去システムであって、
遠位端を有し、近位部分および遠位部分を有する流体カラムで満たされた管腔を画定するカテーテルと、
真空源と、
通気液源と、
真空・通気制御システムと、
を備え、
前記真空・通気制御システムは、
・ 前記真空源からの真空、
・ 前記通気液源からの通気液、および
・ 前記真空または前記通気液のいずれでもないもの、
のうちの少なくとも1つと前記近位部分とを周期的に流体的に接続するように構成され、
これにより、前記遠位端における真空のレベルを変化させ、前方流を実質的に防止することができる、
システム。
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CN112996548A (zh) | 2021-06-18 |
US20240000468A1 (en) | 2024-01-04 |
US20230338047A1 (en) | 2023-10-26 |
CA3105402A1 (en) | 2020-01-23 |
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EP3823686A4 (en) | 2022-03-30 |
US11547426B2 (en) | 2023-01-10 |
EP3823686A1 (en) | 2021-05-26 |
US20200297362A1 (en) | 2020-09-24 |
US11406402B2 (en) | 2022-08-09 |
US20200022712A1 (en) | 2020-01-23 |
US11918240B2 (en) | 2024-03-05 |
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