JP2023030127A - 弁付き導管 - Google Patents
弁付き導管 Download PDFInfo
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- Dispersion Chemistry (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
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Abstract
Description
本出願は、2017年10月31日に出願された米国仮出願第62/579752号の利益を主張して2018年9月12日に出願された米国特許出願第16/129673号明細書に対する優先権の利益を主張するものであり、上記特許出願の内容全体を参照により本明細書に援用する。
2015年10月12日に出願されたW.L.Gore&Associates,Inc.(Armstrong等)の米国特許出願公開第2016/0100939号明細書「Valved Conduit」による弁付き導管(「対照弁」)は縫合により装着された小葉を含み、導管の弁領域に洞がある。本開示の実施形態に基づいて作成されるなどによるもう1つの弁付き導管(「試験弁」)は、非機械的に装着された小葉を含み、内面は径が一定であり、肉眼では妨害物が全く見えず、導管の弁領域には洞がない。図8は、血液への曝露を含む模擬動作条件で、このような対照弁と試験弁の性能を示している。図8に示されるように、対照弁は、試験弁と比較して比較的大きな血栓形成反応を呈している。結果に示されるように、対照弁は、試験弁と比較して著しく大きな血栓形成反応を呈した。このような試験は、本開示の実施形態によって血栓形成の相対的減少が達成されることを示している。
非制限的例として、このような弁付き導管の血栓形成反応を評価する適切な試験方法は、弁付き導管のサンプルを所望時間(例えば、1時間超)動作させるため、実験室で脈動流のある生体外閉鎖血液循環系(例えば、ヘパリン添加ブタ血液)を利用することを含む。弁付き導管のサンプルは、その後、閉鎖血液循環系から取り除かれ、血栓形成の評価及び検証のため切開され得る。
Claims (19)
- 内面と外面とを有する導管と、
該導管内の血栓形成を軽減するように該導管の該内面に配置される内側部分及び該導管の該外面にフィルム層によって非機械的に装着された外側部分を有する少なくとも1つの小葉と、
前記導管及び前記フィルム層の周囲に配置された可撓性フィルムと
を含んでなる弁付き導管。 - 前記少なくとも1つの小葉の前記外側部分が、接着剤、熱接合又は化学的接合によって前記導管の前記外面に付着されている、請求項1に記載の弁付き導管。
- 前記導管は洞を含まない、請求項1又は2に記載の弁付き導管。
- 前記導管は機械的結合を含まない、請求項1~3の何れか一項に記載の弁付き導管。
- 前記少なくとも1つの小葉の前記外側部分が前記導管の前記外面に装着されており、該装着は無縫合である、請求項1~4の何れか一項に記載の弁付き導管。
- 前記少なくとも1つの小葉の前記外側部分が、前記導管の前記外面に接着フィルムの層によって付着されている、請求項1~5の何れか一項に記載の弁付き導管。
- 前記可撓性フィルムは延伸ポリテトラフルオロエチレン(ePTFE)を含み、かつ、前記フィルム層はフッ化エチレンプロピレン(FEP)を含む、請求項1に記載の弁付き導管。
- 前記可撓性フィルムによって前記導管に結合された支持枠を更に備える、請求項1に記載の弁付き導管。
- 前記支持枠はポリエーテルエーテルケトン(PEEK)で形成されている、請求項8に記載の弁付き導管。
- 前記導管の前記外面に、前記少なくとも1つの小葉に隣接して配置された少なくとも1つの放射線不透過性マーカーを更に備える、請求項1~9の何れか一項に記載の弁付き導管。
- 前記導管の前記内面は、径が一定であり、かつ、巨視的な妨害物を含まない、請求項1~10の何れか一項に記載の弁付き導管。
- 前記少なくとも1つの小葉は前記導管内の長さ方向に沿った長手方向位置に配置されており、かつ、前記導管は、前記少なくとも1つの小葉が配置された該長手方向位置と、その隣接する近位部及び遠位部とを通して、径が一定である、請求項1~11の何れか一項に記載の弁付き導管。
- 内面、外面、近位部及び遠位部を有する導管と、
該導管の該内面と該外面との間に開口を有する小葉装着部と、
該導管内での血栓形成を軽減するため、該導管の該内面又は該外面を機械的に改変することなく該導管の該外面にフィルム層によって装着された装着区域を有する少なくとも1つの小葉と、
前記導管及び前記フィルム層の周囲に配置された可撓性フィルムと
を含んでなる弁付き導管。 - 前記少なくとも1つの小葉は3つの小葉を有し、かつ、該3つの小葉は前記導管の内部において間隙によって互いに分離されている、請求項13に記載の弁付き導管。
- 前記導管は、前記導管の前記内面において前記3つの小葉の間に前記間隙を形成するため、前記小葉の各々の前記装着区域で前記小葉を分離する交連間隙を含む、請求項14に記載の弁付き導管。
- 前記装着区域は、前記導管の前記外面に接着剤、熱接合又は化学的接合によって装着される、請求項13~15の何れか一項に記載の弁付き導管。
- 前記装着区域は第1の部分と第2の部分とを含み、該第1の部分は前記導管の前記外面の前記近位部に装着され、該第2の部分は前記導管の前記外面の前記遠位部に装着されている、請求項13~16の何れか一項に記載の弁付き導管。
- 前記小葉装着部は前記導管の一部であり、前記小葉装着部は前記導管の残りの部分よりも密度が高い、請求項13に記載の弁付き導管。
- 前記導管内の血流の方向を示すために、前記導管の前記外面上に方向表示を更に備える、請求項13に記載の弁付き導管。
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US16/129,673 | 2018-09-12 | ||
JP2020524200A JP7202374B2 (ja) | 2017-10-31 | 2018-09-12 | 弁付き導管 |
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2018
- 2018-09-12 CA CA3078607A patent/CA3078607C/en active Active
- 2018-09-12 WO PCT/US2018/050771 patent/WO2019089137A1/en unknown
- 2018-09-12 EP EP18779917.6A patent/EP3703617A1/en active Pending
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US20190125529A1 (en) | 2019-05-02 |
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WO2019089137A1 (en) | 2019-05-09 |
CA3158944A1 (en) | 2019-05-09 |
US11039919B2 (en) | 2021-06-22 |
JP2021501016A (ja) | 2021-01-14 |
US20210322158A1 (en) | 2021-10-21 |
AU2022200147A1 (en) | 2022-02-03 |
EP3703617A1 (en) | 2020-09-09 |
AU2018362080B2 (en) | 2021-09-30 |
CN111818875B (zh) | 2024-05-14 |
CA3078607C (en) | 2022-07-26 |
AU2018362080A1 (en) | 2020-06-11 |
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