JP2020524032A - 前方に指向される衝撃波を生成するためのデバイスおよび方法 - Google Patents
前方に指向される衝撃波を生成するためのデバイスおよび方法 Download PDFInfo
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Abstract
Description
本願は、2017年6月19日に出願された仮出願第62/521,994号の優先権を主張し、その開示全体が参照によって本明細書に援用される。
本開示は、概して、衝撃波の生成に関し、より具体的には、血管または泌尿器構造内での衝撃波の生成に関する。
本発明は、血管内の石灰化病変、または尿管内の腎臓結石等の他の管内の閉塞を処置することに関する。この課題に対処するための1つの一般的なアプローチは、バルーン血管形成術である。本タイプの手技では、バルーンを担持するカテーテルが、バルーンが閉塞と整合されるまで、ガイドワイヤに沿って血管系の中に前進させられる。バルーンは、次いで、閉塞を低減または破壊するような様式で加圧される。高圧まで膨張させられると、血管形成バルーンは、それらが拡張する特定の最大直径を有し得る。概して、求心性病変下の管内の開口部は、典型的には、はるかに小さくなる。圧力が血流のための通路を開放するために増加されるにつれて、バルーンは、(これが破壊されて開放される前に)石灰化病変内の開口部のサイズまで限局される。圧力が蓄積するにつれて、膨大な量のエネルギーが、石灰化病変が破壊しまたは割れるまでバルーン内に貯蔵される。そのエネルギーが、次いで、解放され、バルーンのその最大寸法までの急速な膨張をもたらし、管壁に応力印加し、管壁を傷つけ得る。
管内のプラークまたは閉塞の処置のための衝撃波デバイスおよび方法が、本明細書に記載される。管は、患者の血管系内の血管または患者の泌尿器系内の尿管を含み得る。衝撃波デバイスの一実施例は、外側被覆と、ガイドワイヤ管腔を形成する内側部材とを含む。外側被覆および内側部材は、本デバイスの遠位端において接続され、外側被覆と内側部材との間の容積が、伝導性流体で充填可能である。第1の伝導性ワイヤおよび第2の伝導性ワイヤが、外側被覆と内側部材との間の容積内で、本デバイスの長さに沿って延在し、本デバイスの遠位端に近接して終了する。第1および第2のワイヤの長さは、絶縁され、第1および第2のワイヤの端部は、絶縁されていない。伝導性エミッタバンドが、第1および第2のワイヤの端部の周囲を囲み、第1のワイヤの端部とエミッタバンドとの間に第1のスパーク間隙を形成し、第2のワイヤの端部とエミッタバンドとの間に第2のスパーク間隙を形成する。容積が伝導性流体で充填され、高電圧パルスが第1および第2のワイヤを横断して印加されると、第1および第2の衝撃波が、第1および第2のスパーク間隙から開始される。
慢性完全閉塞(CTO)または周辺カルシウム等の血管疾患を処置するために、または尿管内の結石または腎臓結石等の尿路疾患を処置するために、実質的に前方方向に伝搬する衝撃波を生成するためのデバイス、システム、および方法が、本明細書に説明される。本開示によると、衝撃波デバイスは、外側被覆と、ガイドワイヤ管腔を形成する内側部材とを含む。外側被覆および内側部材は、本デバイスの遠位端において接続される。第1の伝導性ワイヤおよび第2の伝導性ワイヤが、外側被覆と内側部材との間の容積内で、本デバイスの長さに沿って延在し、本デバイスの遠位端に近接して終了する。伝導性エミッタバンドが、第1および第2のワイヤの端部の周囲を囲み、第1のワイヤの端部とエミッタバンドとの間に第1のスパーク間隙を形成し、第2のワイヤの端部とエミッタバンドとの間に第2のスパーク間隙を形成する。
Claims (17)
- 衝撃波デバイスであって、
外側被覆と、
内側部材であって、前記外側被覆および内側部材が、前記デバイスの遠位端に接続され、前記外側被覆と前記内側部材との間の容積が、伝導性流体で充填可能である、内側部材と、
前記外側被覆と前記内側部材との間の前記容積内で前記デバイスの長さに沿って延在し、前記デバイスの遠位端に近接して終了する、第1の伝導性ワイヤおよび第2の伝導性ワイヤであって、前記第1および第2のワイヤの長さは、絶縁され、前記第1および第2のワイヤの遠位端近傍で前記第1および第2のワイヤのそれぞれにおいて非絶縁部分が存在する、第1の伝導性ワイヤおよび第2の伝導性ワイヤと、
前記第1および第2のワイヤの端部の周囲を囲む伝導性エミッタバンドであって、前記伝導性エミッタバンドは、前記第1のワイヤの端部と前記エミッタバンドとの間に第1のスパーク間隙を形成し、前記第2のワイヤの端部と前記エミッタバンドとの間に第2のスパーク間隙を形成し、前記容積が前記伝導性流体で充填され、高電圧パルスが前記第1および第2のワイヤを横断して印加されると、第1および第2の衝撃波が、前記第1および第2のスパーク間隙から開始される、伝導性エミッタバンドと
を備える、デバイス。 - 前記第1および第2のワイヤの端部に近接する領域において前記内側部材の周囲を囲む絶縁シースをさらに備える、請求項1に記載のデバイス。
- 前記外側被覆は、血管形成バルーンを備える、請求項1に記載のデバイス。
- 前記エミッタバンドは、前記デバイスの遠位端に第1および第2のワイヤの端部よりも近接して延在する円筒管である、請求項1に記載のデバイス。
- 前記デバイスの近位端に接続され、伝導性流体を前記外側被覆と前記内側部材との間の前記容積に提供するように構成されている流体ポンプと、
前記デバイスの遠位端に近接した入口を有し、前記外側被覆と前記内側部材との間の前記容積から前記伝導性流体を除去するように構成されている流体帰還ラインと
をさらに備え、前記流体ポンプおよび流体帰還ラインは、圧力下で、前記外側被覆と前記内側部材との間の前記容積内で前記伝導性流体を循環させるように構成されている、請求項1に記載のデバイス。 - 前記流体帰還ラインの出口に圧力リリーフ弁をさらに備える、請求項5に記載のデバイス。
- 前記外側被覆と前記内側部材との間の前記容積内で、前記デバイスの長さに沿って延在し、前記デバイスの遠位端に近接して終了する、第3の伝導性ワイヤおよび第4の伝導性ワイヤであって、前記第3および第4のワイヤの長さは、絶縁され、前記第3および第4のワイヤの遠位端近傍で前記第3および第4のワイヤのそれぞれにおいて非絶縁部分が存在する、第3の伝導性ワイヤおよび第4の伝導性ワイヤ
をさらに備え、前記伝導性エミッタバンドは、前記第3および第4のワイヤの端部の周囲を囲み、前記第3のワイヤの端部と前記エミッタバンドとの間に第3のスパーク間隙を形成し、前記第4のワイヤの端部と前記エミッタバンドとの間に第4のスパーク間隙を形成し、前記容積が前記伝導性流体で充填され、第2の高電圧パルスが前記第3および第4のワイヤを横断して印加されると、第3および第4の衝撃波が、前記第3および第4のスパーク間隙から開始される、請求項1に記載のデバイス。 - 前記伝導性流体は、生理食塩水、または、生理食塩水および造影剤の組み合わせを含む、請求項1に記載のデバイス。
- 前記デバイスの中間場所に配置され、前記中間場所から第3の衝撃波を開始させるように構成されている1つまたは複数の二次エミッタバンドをさらに備える、請求項1に記載のデバイス。
- 前記内側部材は、ガイドワイヤ管腔を含む、請求項1に記載のデバイス。
- 血管プラークを処置するための方法であって、
衝撃波デバイスを患者の血管系の中に導入することであって、前記衝撃波デバイスは、
外側被覆と、
内側部材であって、前記外側被覆および内側部材は、前記デバイスの遠位端に接続され、前記外側被覆と前記内側部材との間の容積は、伝導性流体で充填される、内側部材と、
前記外側被覆と前記内側部材との間の前記容積内で前記デバイスの長さに沿って延在し、前記デバイスの遠位端に近接して終了する、第1の伝導性ワイヤおよび第2の伝導性ワイヤであって、前記第1および第2のワイヤの長さは、絶縁され、前記第1および第2のワイヤの遠位端近傍で前記第1および第2のワイヤのそれぞれにおいて非絶縁部分が存在する、第1の伝導性ワイヤおよび第2の伝導性ワイヤと、
前記第1および第2のワイヤの端部の周囲を囲む伝導性エミッタバンドであって、前記第1のワイヤの端部と前記エミッタバンドとの間に第1のスパーク間隙を形成し、前記第2のワイヤの端部と前記エミッタバンドとの間に第2のスパーク間隙を形成する伝導性エミッタバンドと
を備える、ことと、
前記衝撃波デバイスの遠位端が第1の処置領域に面するように、前記血管系内に前記衝撃波デバイスを前進させることと、
前記第1および第2のワイヤを横断して高電圧パルスを印加し、前記第1および第2のスパーク間隙から第1および第2の衝撃波を開始させることと
を含む、方法。 - 前記外側被覆は、血管形成バルーンを備え、前記方法はさらに、
前記印加するステップの後に、前記血管形成バルーンが前記第1の処置領域と整合されるように、さらに前記血管内に前記衝撃波デバイスを前進させることと、
前記血管形成バルーンを膨張させることと
を含む、請求項11に記載の方法。 - 前記外側被覆は、血管形成バルーンを備え、前記方法はさらに、
前記印加するステップの後に、前記血管形成バルーンが第2の処置領域と整合されるように、さらに前記血管内に前記衝撃波デバイスを前進させることと、
前記血管形成バルーンを膨張させることと
を含む、請求項11に記載の方法。 - 前記衝撃波デバイスはさらに、前記デバイスの中間場所に配置されている1つまたは複数の二次エミッタバンドを備え、前記方法はさらに、
前記印加するステップの後に、前記1つまたは複数の二次エミッタバンドの中間場所が前記第1の処置領域と整合されるように、さらに前記血管内に前記衝撃波デバイスを前進させることと、
前記1つまたは複数の二次エミッタバンドから第3の衝撃波を開始させることと
を含む、請求項11に記載の方法。 - 前記衝撃波デバイスはさらに、前記デバイスの中間場所に配置されている1つまたは複数の二次エミッタバンドを備え、前記方法はさらに、
前記印加するステップの後に、前記1つまたは複数の二次エミッタバンドの中間場所が第2の処置領域と整合されるように、さらに前記血管内に前記衝撃波デバイスを前進させることと、
前記1つまたは複数の二次エミッタバンドから第3の衝撃波を開始させることと
を含む、請求項11に記載の方法。 - 管は、患者の血管系の血管または患者の泌尿器系の尿管である、請求項11に記載の方法。
- 第1の処置領域は、慢性完全閉塞(CTO)、周辺カルシウム、または腎臓結石を含む、請求項11に記載の方法。
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CN116531055A (zh) | 2023-08-04 |
US11950793B2 (en) | 2024-04-09 |
US10966737B2 (en) | 2021-04-06 |
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EP3641672B1 (en) | 2021-09-22 |
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JP2022106828A (ja) | 2022-07-20 |
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EP3960099B1 (en) | 2023-08-30 |
JP7364735B2 (ja) | 2023-10-18 |
ES2896873T3 (es) | 2022-02-28 |
JP7142035B2 (ja) | 2022-09-26 |
CN110785137B (zh) | 2023-05-30 |
WO2018236551A1 (en) | 2018-12-27 |
CN110785137A (zh) | 2020-02-11 |
EP3641672A1 (en) | 2020-04-29 |
US11602363B2 (en) | 2023-03-14 |
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