JP2022500194A - バルーンカプセル封入および等容性の吸引血栓除去カテーテルならびにその方法 - Google Patents
バルーンカプセル封入および等容性の吸引血栓除去カテーテルならびにその方法 Download PDFInfo
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- JP2022500194A JP2022500194A JP2021516901A JP2021516901A JP2022500194A JP 2022500194 A JP2022500194 A JP 2022500194A JP 2021516901 A JP2021516901 A JP 2021516901A JP 2021516901 A JP2021516901 A JP 2021516901A JP 2022500194 A JP2022500194 A JP 2022500194A
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Abstract
Description
本開示は、血栓を除去するためのカテーテルシステムを提供する。いくつかの実施形態では、カテーテルシステムは、PEの治療に使用され得る。一態様では、カテーテルシステムは、近位端、注入セグメント、および遠位端を有する内側カテーテルを含み得る。内側カテーテルは、注入セグメントに沿った少なくとも1つの注入窓および遠位端に遠位カプセル封入バルーンを含み得る。カテーテルシステムはまた、近位端および遠位端を有する外側シースを含み得る。外側シースは、遠位端に近位カプセル封入バルーンを含み得る。外側シースは、内側カテーテルの少なくとも一部を取り囲む。いくつかの態様では、カテーテルシステムは、血栓を撹拌することのできる撹拌機をさらに含む。
本開示は、以下に説明する図面と併せ、以下の詳細な説明を参照することによって理解することができる。説明を明確にするために、様々な図面におけるある要素は、一定の縮尺で描かれていない場合があることに留意されたい。
いくつかの例では、カテーテルシステムは、内側カテーテル、外側シース、および/または撹拌機を含む。内側カテーテルは、近位端、注入セグメント、および遠位端を有する。内側カテーテルは、注入セグメントに沿った少なくとも1つの注入窓および遠位端に遠位カプセル封入バルーンをさらに有する。外側シースは、近位端および遠位端を有する。外側シースは、遠位端に、近位カプセル封入バルーンをさらに含む。いくつかの例では、外側シースは、内側カテーテルの少なくとも部分を取り囲み、かつ遠位カプセル封入バルーンと近位カプセル封入バルーンは注入セグメントに沿った距離で分離されている。
カテーテルシステム100は、内側カテーテル101を含む。内側カテーテルは、近位端、注入セグメント、および遠位端を有する。一実施形態では、内側カテーテルは、少なくとも3つの管腔、注入セグメントに沿って少なくとも1つの注入窓、および内側カテーテルの遠位端にある遠位カプセル封入バルーンを含む。内側カテーテルは、その近位端に、注入ポート、バルーン膨張ポート、およびガイドワイヤアクセスポートを含むマニホールドをさらに含み得、各ポートは、内側カテーテルの少なくともそこにある管腔の1つに流体接続されている。
カテーテルシステム100は、図7に見られるように、近位カプセル封入バルーン108を備えた外側シース106をさらに含む。外側シースは、近位端および遠位端を有する。一実施形態では、外側シースは、外側シースの近位端から遠位端まで延びる、少なくとも3つの管腔と、遠位端に近位カプセル封入バルーン108とを含む。外側シースは、その近位端に、吸引ポート121、バルーン膨張ポート123、およびデバイスアクセスポート125を、各ポートが外側シースの少なくともそこにある管腔の1つに流体接続されるように備えた、マニホールド118をさらに含む。外側シースは、構造的安定性を確保するための一貫した壁の厚さと、外側シースの長さに沿って乗る「レール」内のバルーンのためのより大きな管腔とを備えた、おおよそ「パワーシンボル」設計を有する場合がある。
カテーテルシステムは、血栓を撹拌または細切するように動作可能な撹拌機を使用して局所的な機械的血栓溶解を提供し得る。細切(Morcellation)は、血栓を局所的に断片化するために使用され得る。撹拌機は、カテーテルシステムが患者から取り外されるときに、吸引管腔を通して吸引されるか、または近位と遠位のカプセル封入バルーンの間に含まれることを可能にするために、大きな血栓を機械的に分解することに用いられ得る。
本明細書で提供されるのは、カテーテルシステムを使用する治療方法である。一実施形態では、カテーテルシステムは、PEを治療するために使用される。例えば、カテーテルシステムは、大腿静脈カニューレまたは内頸静脈カニューレから進められ得る。カテーテルシステムは、次に、カプセル封入バルーンを膨らませ、血栓を撹拌し、等容性の吸引および流体の回復の使用により血栓を除去することに展開され得る。
実施例1:プロトタイプの吸引血栓除去効率の予備比較分析
バルーンカプセル収容の血管内血栓除去カテーテルシステム(本明細書ではハイドラ(Hydra)と呼ばれる)を、以下の実施例の方法を使用して試験した。カスタムモーフィングポリエチレンテレフタレート(PET)バルーンが開発された。ベンチトップIVC管腔血栓モデルは、Hydraカテーテルとインディゴ(登録商標)ペナンブラ(Penumbra)カテーテルの初期比較テスト用に開発された。5cm3の亜急性血栓は、ハイドラ(Hydra)カテーテルとインディゴ(登録商標)ペナンブラ(Penumbra)カテーテルを使用して70kPAの負の吸引を行って捉えられた。1分間の間に、ハイドラカテーテルは血栓をより効率的に除去することができた(p<0.01;図15)。
図12A〜12Fに示すように、撹拌機と撹拌機フィンのいくつかの設計をテストするために、撹拌機の縦軸に対して5、10、15、および30度で変化させた。撹拌機の各バリエーションは、他の全ての変数を一定に保った状態で、フローシミュレーションを用いて分析された。撹拌機の前面によって加えられる力は決定され、各フィン角度設計のCdを計算するために、使用される。図16Aは、様々なフィン角度オフセットについて計算された抗力係数の結果を提供する。図16Bは、様々なフィン角度オフセットについて計算された加えられた力の結果を提供する。一般に、抗力係数と加えられる力は、5度の剛毛(bristle)オフセット角度で最大であった。5度オフセット撹拌機のベンチトップ試験は、図16Cに見られるように、撹拌機の血餅への単一の通過による血餅の抗力と保持を示した。
この出願は、2019年5月3日に出願された米国仮出願第62/842,975号、および2018年9月26日に出願された米国仮出願第62/736,890号に優先権を主張し、その内容は参照により本明細書に完全に組み込まれる。
Claims (20)
- 血管から血栓を除去するためのカテーテルシステムであって、
近位端、注入セグメント、および遠位端を有する内側カテーテルであって、
前記注入セグメントに沿った少なくとも1つの注入窓、および
前記遠位端に遠位カプセル封入バルーンを含む内側カテーテルと、
近位端および遠位端を有する外側シースであって、
該遠位端に近位カプセル封入バルーンを含む外側シースと、を含み、
前記外側シースは、前記内側カテーテルの少なくとも一部を取り囲み、かつ
前記遠位カプセル封入バルーンと前記近位カプセル封入バルーンは、前記注入セグメントに沿った距離で離れている、カテーテルシステム。 - 前記遠位カプセル封入バルーンおよび前記近位カプセル封入バルーンは、様々な血管サイズに対応し、かつ、血管へのダメージまたは損傷を最小限に抑えるように動作可能な、コンプライアントバルーンである、請求項1に記載のカテーテルシステム。
- 前記遠位カプセル封入バルーンと前記近位カプセル封入バルーンの間の距離は調整可能である、請求項1に記載のカテーテルシステム。
- 前記遠位カプセル封入バルーンと前記近位カプセル封入バルーンの間の距離が血栓溶解治療領域を形成し、除去される前記血栓が前記血栓溶解治療領域内に含まれる、請求項1に記載のカテーテルシステム。
- 注入セグメントが血栓溶解治療領域内にある、請求項4に記載のカテーテルシステム。
- 前記内側カテーテルは、血栓溶解治療領域に流体を注入するように動作可能であり、かつ前記外側シースは、血栓溶解治療領域から流体を除去するための吸引を提供するように動作可能である、請求項5に記載のカテーテルシステム。
- 前記内側カテーテルおよび前記外側シースは、血栓溶解治療領域内の流体の等容性の吸引および回復を提供するように動作可能である、請求項6に記載のカテーテルシステム。
- 前記内側カテーテルは、前記内側カテーテルの前記近位端から前記遠位端まで延びる少なくとも3つの管腔をさらに含む、請求項1に記載のカテーテルシステム。
- 前記内側カテーテルは、膨張管腔、ガイドワイヤ管腔、および注入管腔を含み、前記注入セグメントに沿った少なくとも1つの注入窓は、流体の注入を可能にするために注入管腔に接続される、請求項8に記載のカテーテルシステム。
- 前記内側カテーテルは、その近位端に、注入ポート、バルーン膨張ポート、およびガイドワイヤアクセスポートを含むマニホールドをさらに含み、各ポートは、内側カテーテルの少なくとも3つの管腔のうちの1つと流体接続されている、請求項9に記載のカテーテルシステム。
- 前記外側シースは、前記外側シースの近位端から遠位端まで延びる少なくとも3つの管腔をさらに含む、請求項1に記載のカテーテルシステム。
- 前記外側シースは、膨張管腔、吸引管腔、およびカテーテル管腔を含み、前記内側カテーテルは、前記外側シースのカテーテル管腔内に配置される、請求項11に記載のカテーテルシステム。
- 前記外側シースは、その近位端に、吸引ポート、バルーン膨張ポート、およびデバイスアクセスポートを含むマニホールドをさらに含み、
各ポートは、外側シースの少なくともそこの管腔の1つに流体接続されている、請求項12に記載のカテーテルシステム。 - 前記カテーテル管腔が前記吸引管腔と同心である、請求項12に記載のカテーテルシステム。
- 血栓を撹拌するように動作可能な撹拌機をさらに含む、請求項1に記載のカテーテルシステム。
- 前記外側シースが前記撹拌機を取り囲む、請求項15に記載のカテーテルシステム。
- 前記撹拌機は、前記外側シースにレールで取り付けられ、前記外側シースの遠位端から突出するように構成され、および/または、前記撹拌機は、前記外側シースのカテーテル管腔にわたって前進および後退するように動作可能である、請求項15に記載のカテーテルシステム。
- 前記撹拌機は、前記血管の壁に触れることなく使用されるように動作可能である、請求項15に記載のカテーテルシステム。
- 前記撹拌機は、前記血管への剪断応力を低減するように動作可能なピッチ角で複数の突起またはブラシを含む、請求項15に記載のカテーテルシステム。
- 前記複数の突起は、前記攪拌機の長さに沿ってらせん状に分布している、請求項19に記載のカテーテルシステム。
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EP3856054B1 (en) | 2018-09-26 | 2024-02-14 | Washington University | Balloon encapsulation and isovolumetric suction thrombectomy catheter |
AU2021343489A1 (en) * | 2020-09-18 | 2023-05-04 | East End Medical, Llc | Percutaneous retrograde therapy for pulmonary embolism |
US20220249813A1 (en) * | 2021-02-05 | 2022-08-11 | Devaraj Pyne | Detachable balloon embolization device and methods |
WO2023044446A1 (en) | 2021-09-17 | 2023-03-23 | Caeli Vascular, Inc. | Aspiration devices for treatment of thrombosis including expandable distal ends and systems and methods thereof |
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