JP6401781B2 - 一体型流量調整による経血管的腫瘍塞栓形成の装置及び方法 - Google Patents
一体型流量調整による経血管的腫瘍塞栓形成の装置及び方法 Download PDFInfo
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Description
本出願は、2013年5月8日に出願された米国特許出願第61/821,058号、2013年12月12日に出願された同第61/915,425号、及び2013年12月17日に出願された同第61/917,131号の利益を主張するものであり、これらのそれぞれは参照によって全内容が本明細書に組み込まれている。
本明細書中において言及される全ての刊行物及び特許出願は、それぞれ個々の刊行物又は特許出願が参照により具体的且つ個別に示されて組み込まれる場合と同程度に、参照により本明細書に組み込まれる。
或いは、円形又は楕円形を含み、これに限定されない標準的なバルーンを修正することによって近位から遠位への流路を実現してよい。バルーンを修正する一方法は、円周に沿って揃えられた長手方向のひだを形成して、バルーンの近位端からバルーンの遠位端に延びるV字形の流路を形成することである。そのような修正されたバルーンにシース又はフィルムをかぶせることにより、同時係属中の出願第61/917,131号に記述されているような長手方向流路及び一方向弁が得られる。
〔付記1〕
近位端、遠位端、及びバルーン膨張用管腔を有するカテーテルボディと、
前記カテーテルボディの前記遠位端に取り付け可能な膨張可能バルーンであって、前記バルーンは、内部容積を少なくとも部分的に画定する内面を有し、前記バルーンは、前記バルーンを膨らませる為に前記内部容積が前記カテーテルボディの前記膨張用管腔と流体連通することが可能であるように構成されており、前記バルーンは近位面及び遠位面を有する、前記バルーンと、を備えるカテーテルアセンブリであって、
前記バルーンには前記バルーンを貫通して延びる流路が設けられており、前記流路は、前記バルーンの前記近位面と前記バルーンの前記遠位面とを流体連通させるように構成されている、
カテーテルアセンブリ。
〔付記2〕
前記カテーテルボディの前記遠位端を越えて延びる遠位先端区間を備える、付記1に記載のカテーテルアセンブリ。
〔付記3〕
前記バルーンは、前記流路を通る流体流に作用するように構成された弁を備える、付記1に記載のカテーテルアセンブリ。
〔付記4〕
前記弁は、前記流路の遠位端に配置されている、付記3に記載のカテーテルアセンブリ。
〔付記5〕
前記弁は、前記流路内に配置されている、付記3に記載のカテーテルアセンブリ。
〔付記6〕
前記弁は、遠位方向の流れを可能にし、近位方向の流れを制限するように構成されている、付記3に記載のカテーテルアセンブリ。
〔付記7〕
身体内の標的部位に治療用薬剤を送達する装置であって、
近位端、遠位端、第1の軸方向管腔、及び第2の軸方向管腔を有するカテーテルボディであって、前記第1の軸方向管腔は、前記カテーテルボディの前記近位端から前記カテーテルボディの前記遠位端に延びて、前記近位端と前記遠位端とを流体連通させており、前記第2の軸方向管腔は、前記カテーテルボディの前記近位端から前記カテーテルボディ上のより遠位の場所まで延びている、前記カテーテルボディと、
前記カテーテルボディの前記遠位端の近くに半径方向に配置されたバルーンであって、前記バルーンは、近位バルーン面と、遠位バルーン面と、半径方向に拘束された形態と、半径方向に広がった形態と、を有しており、前記バルーンは、前記第2の軸方向管腔と流体連通しており、前記近位バルーン面から前記遠位バルーン面に延びる少なくとも1つの流路を有することによって、前記近位バルーン面と前記遠位バルーン面とを流体連通させている、前記バルーンと、
前記バルーンの外面の上に配置されたバルーンシースであって、前記シースには近位側と遠位側とがあり、前記近位側は、前記バルーン流路の近位端と一直線上にある開口を有しており、前記シースの前記遠位側は前記バルーン流路の遠位端の上に延びており、前記シースの前記遠位側は、遠位方向の流体圧力が、前記近位側の前記開口を通して、前記バルーン流路を通して、前記シースの前記遠位側の近位面に対してかけられると、遠位方向に偏ることによって、流体が前記バルーン流路を通り抜けて、前記バルーン及び前記バルーンシースより遠位にある血管区画に入ることを可能にすることができ、前記シースの前記遠位側は又、前記シースの前記遠位側に圧力がかけられると、前記遠位バルーン面に向かって近位方向に偏ることによって、前記バルーン流路内の近位方向の流れを阻止することもできる、前記シースと、
を備える装置。
〔付記8〕
前記シースの前記遠位側と前記遠位バルーン面との間の境界面が一方向弁を形成している、付記7に記載の装置。
〔付記9〕
前記カテーテルボディの前記遠位端から長手方向にカテーテル延長部が配置されている、付記7に記載の装置。
〔付記10〕
直径が前記カテーテルボディの直径より小さい、付記9に記載のカテーテル延長部。
〔付記11〕
前記バルーン及び前記バルーンシースは、前記カテーテル延長部上に配置されている、付記9に記載の装置。
〔付記12〕
前記カテーテル延長部の、前記バルーン及び前記バルーンシースより遠位の場所にノーズピースが適合されている、付記9に記載の装置。
〔付記13〕
前記バルーン及び前記バルーンシースは、前記カテーテルボディの前記遠位端と前記ノーズピースの近位端との間にあるポケットの中に配置されている、付記12に記載の装置。
〔付記14〕
前記半径方向に拘束されたバルーン及び前記バルーンシースの外径が、前記カテーテルボディの外径以下である、付記9に記載の装置。
〔付記15〕
腫瘍に塞栓を形成する方法であって、
カテーテルボディ及び一部閉塞構造を含む装置を身体内の標的腫瘍部位まで進めるステップと、
前記一部閉塞構造を通過する順行性血流を可能にするステップであって、前記可能にされる順行性血流は、前記一部閉塞構造が配置されなかったとしたら通常存在するであろう血流より少ない、前記可能にするステップと、
前記装置から塞栓物質を注入して、前記順行性血流が前記塞栓物質を前記腫瘍標的の血管系内まで搬送することを可能にするステップと、
前記一部閉塞構造より遠位にある血管空間におけるリアルタイム圧力測定値を監視するステップと、
前記圧力測定値の前記監視に基づいて処置エンドポイントを通知するステップと、
前記身体から前記装置を引き抜くステップと、
を含む方法。
〔付記16〕
前記可能にされる順行性血流は、前記一部閉塞構造が配置されなかったとしたら通常存在するであろう血流の約1%から約25%の範囲内にある、付記15に記載の方法。
〔付記17〕
前記処置エンドポイントの前記通知は、前記一部閉塞構造より遠位にある前記血管空間における圧力が所定圧力に達したときに行われる、付記15に記載の方法。
〔付記18〕
前記所定圧力は、非閉塞時の収縮期圧に対する所定のパーセンテージである、付記17に記載の方法。
〔付記19〕
前記所定のパーセンテージは約100%である、付記17に記載の方法。
Claims (13)
- 近位端、遠位端、及びバルーン膨張用管腔を有するカテーテルボディと、
前記カテーテルボディの前記遠位端に取り付け可能な膨張可能バルーンであって、前記バルーンは、内部容積を少なくとも部分的に画定する内面を有し、前記バルーンは、前記バルーンを膨らませる為に前記内部容積が前記カテーテルボディの前記膨張用管腔と流体連通することが可能であるように構成されており、前記バルーンは近位面及び遠位面を有する、前記バルーンと、を備えるカテーテルアセンブリであって、
前記バルーンには前記バルーンを貫通して延びる流路が設けられており、前記流路は、前記バルーンの前記近位面と前記バルーンの前記遠位面とを流体連通させるように構成されており、
前記バルーンは、前記流路を通る流体流に作用するように構成された弁を備え、
前記バルーンの外面の上に配置されたバルーンシースであって、前記シースには近位側と遠位側とがあり、前記近位側は、前記バルーン流路の近位端と一直線上にある開口を有しており、前記シースの前記遠位側は前記バルーン流路の遠位端の上に延びており、前記シースの前記遠位側は、遠位方向の流体圧力が、前記近位側の前記開口を通して、前記バルーン流路を通して、前記シースの前記遠位側の近位面に対してかけられると、遠位方向に偏ることによって、流体が前記バルーン流路を通り抜けて、前記バルーン及び前記バルーンシースより遠位にある血管区画に入ることを可能にすることができ、前記シースの前記遠位側は又、前記シースの前記遠位側に圧力がかけられると、前記遠位バルーン面に向かって近位方向に偏ることによって、前記バルーン流路内の近位方向の流れを阻止することもできる、前記シース、を備える、カテーテルアセンブリ。 - 前記バルーンの前記遠位面から離れた領域における流体圧力を検知するように構成された圧力センサを備える、請求項1に記載のカテーテルアセンブリ。
- 前記弁は、前記流路の遠位端に配置されている、請求項1に記載のカテーテルアセンブリ。
- 前記弁は、前記流路内に配置されている、請求項1に記載のカテーテルアセンブリ。
- 前記弁は、遠位方向の流れを可能にし、近位方向の流れを制限するように構成されている、請求項1に記載のカテーテルアセンブリ。
- 前記シースの前記遠位側と前記遠位バルーン面との間の境界面が一方向弁を形成している、請求項1に記載のカテーテルアセンブリ。
- 前記カテーテルボディの前記遠位端から長手方向にカテーテル延長部が配置されている、請求項1に記載のカテーテルアセンブリ。
- 前記カテーテル延長部の直径が前記カテーテルボディの直径より小さい、請求項7に記載のカテーテルアセンブリ。
- 前記バルーン及び前記バルーンシースは、前記カテーテル延長部上に配置されている、請求項7に記載のカテーテルアセンブリ。
- 前記カテーテル延長部の、前記バルーン及び前記バルーンシースより遠位の場所にノーズピースが適合されている、請求項7に記載のカテーテルアセンブリ。
- 前記バルーン及び前記バルーンシースは、前記カテーテルボディの前記遠位端と前記ノーズピースの近位端との間にあるポケットの中に配置されている、請求項10に記載のカテーテルアセンブリ。
- 半径方向に拘束された前記バルーン及び前記バルーンシースの外径が、前記カテーテルボディの外径以下である、請求項7に記載のカテーテルアセンブリ。
- 前記カテーテルボディは、塞栓剤を塞栓剤送達管腔を介して前記バルーンの前記遠位面から離れた領域に供給するための塞栓剤送達装置に連通可能に構成された前記塞栓剤送達管腔を備え、前記カテーテルアセンブリは、前記圧力センサからの信号に応じて前記塞栓剤送達装置を非アクティブ化することが可能なコントローラに接続可能である、請求項2に記載のカテーテルアセンブリ。
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2014
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- 2014-05-08 CN CN201480035529.5A patent/CN105530986A/zh active Pending
- 2014-05-08 EP EP14794561.2A patent/EP2994188A4/en not_active Withdrawn
- 2014-05-08 JP JP2016513090A patent/JP6401781B2/ja active Active
- 2014-05-08 US US14/273,445 patent/US9205226B2/en active Active
- 2014-06-27 US US14/318,210 patent/US9174020B2/en active Active
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2015
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2016
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2018
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- 2018-11-20 US US16/196,398 patent/US11123482B2/en active Active
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HK1219909A1 (zh) | 2017-04-21 |
JP2016517778A (ja) | 2016-06-20 |
US10130762B2 (en) | 2018-11-20 |
WO2014182959A3 (en) | 2015-03-05 |
US9174020B2 (en) | 2015-11-03 |
EP2994188A4 (en) | 2017-03-29 |
CN105530986A (zh) | 2016-04-27 |
WO2014182959A9 (en) | 2015-01-15 |
EP2994188A2 (en) | 2016-03-16 |
WO2014182959A2 (en) | 2014-11-13 |
JP2021183243A (ja) | 2021-12-02 |
US20140371709A1 (en) | 2014-12-18 |
US20140364835A1 (en) | 2014-12-11 |
US20190083705A1 (en) | 2019-03-21 |
US20160158439A1 (en) | 2016-06-09 |
JP2018187506A (ja) | 2018-11-29 |
US9205226B2 (en) | 2015-12-08 |
US11123482B2 (en) | 2021-09-21 |
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