JP6900556B2 - 形状記憶ポリマ容器閉塞デバイス - Google Patents
形状記憶ポリマ容器閉塞デバイス Download PDFInfo
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- JP6900556B2 JP6900556B2 JP2020104156A JP2020104156A JP6900556B2 JP 6900556 B2 JP6900556 B2 JP 6900556B2 JP 2020104156 A JP2020104156 A JP 2020104156A JP 2020104156 A JP2020104156 A JP 2020104156A JP 6900556 B2 JP6900556 B2 JP 6900556B2
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- A61B2017/00898—Material properties expandable upon contact with fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
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- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Filling Or Discharging Of Gas Storage Vessels (AREA)
Description
この発明は、国立保健研究所並びに生物医学撮像及び生物工学研究所によって授与されたR01EB000462の下での政府支援によって行われた。政府は本発明に一定の権利を有する。
本出願は、その内容を参照として本明細書に援用する2015年9月4日に出願された「Shape Memory Polymer Vessel Occlusion Device」という名称の米国仮特許出願第62,214,767号に対する優先権を主張する。
SMPフォームの様々なバージョンが製造されている。例えば、1つのバージョンは、100%ヘキサメチレンジイソシアネート(HDI)を含有し、他のバージョンは、ポリウレタン反応におけるイソシアネートモノマのためのHDIとトリメチルヘキサメチレンジイソシアネート(2,2,4−及び2,4,4−混合物)(TMHDI)の混合物を含有する。疎水性のより少ない100%HDIフォームは、外部加熱を必要とせずにインビボ(in vivo)でのVODの即時自己作動を可能にするよう血管移植のために特別に作られた。フォームは、血液中の水分に晒された後に体温で作動し、それは材料の転移温度の降下を引き起こす。両方のフォームを同じ方法で網状化し且つ化学的に後処理した。それらの異なる疎水性は別として、これらの2つのフォームは、極めて類似の機械的特性及び形状記憶特性を共有する。発泡プロセス(foaming process)の間、材料は容器の側壁によって拘束され(constrained)、それが上昇するに応じて上方から拘束解除される(unconstrained)。これらの条件及びそれらの超低密度の故に、フォームは、異方性形態構造(anisotropic morphology)を有することがある。
Freeze Dryer(Labconco, Kansas City, MO)で24時間凍結乾燥させる前に、−20℃の冷凍庫内で12時間冷凍した。
直径10mmの生検パンチを用いて一軸及び三軸網状化SMPフォームサンプルを20〜30mmの長さの円筒状サンプルに切断した。97℃でSC250ステントクリンパ(Machine Solutions Inc., Flagstaff, AZ)を用いて直径1mmまで径方向圧縮することによってサンプルを予備調整し、加熱してそれらの元の形状に膨張させた。次に、SMPフォームシリンダを化学的にエッチングし、すすぎ、且つ洗浄した。サンプルを真空中で乾燥させ、乾燥剤を備える気密容器内に貯蔵した。先の細いはさみを用いて円筒状のサンプルを8mmの直径に切断し、レーザブレードを用いて10mmの長さに切断した。次に、97℃でステントクリンパを用いて、サンプルを径方向に約1mmの最小直径まで圧縮し、圧縮下で冷却して圧縮形状を維持し、インビボで移植するまで乾燥剤を備える気密容器内に保存した。
単軸網状化フォームの平均閉塞時間は90±11秒を有し、三軸網状化フォームの平均閉塞時間は128±77秒を有した。平均して、単軸網状化フォームは、三軸網状化フォームよりも速い閉塞を誘発した。この結果は予期されていない。何故ならば、血液流は、網状化のより少ないフォームによってより多く妨げられる可能性が高く、流れの停滞及び表面積の増大に起因するより迅速な凝固を潜在的にもたらすからである。三軸フォームが単軸フォームに対して示す閉塞時間の大きな相違の故に、閉塞時間に対する網状化の程度の影響は依然として調査されている。
Claims (17)
- 近位端と、遠位端とを有する、外側導管と、
近位端と、遠位端とを有する、形状記憶ポリマ(SMP)フォームであって、SMPフォームがその転移温度を超えて加熱されるときに、SMPフォームの二次形状からSMPフォームの一次形状に移行する、SMPフォームと、
(a)(i)前記SMPフォームの前記近位端から前記SMPフォームの前記遠位端まで延び、前記SMPフォームによって概ね覆われる、第1の部分と、(a)(ii)前記SMPフォームの前記遠位端から遠位に延び、前記SMPフォームによって覆われない、第2の部分とを含む、金属背骨とを含み、
(b)(i)前記SMPフォーム及び前記金属背骨は、両方とも、前記外側導管の前記遠位端に隣接する前記外側導管内に含められ、(b)(ii)前記金属背骨の前記第2の部分は、前記金属背骨の前記第2の部分の巻かれていない二次形状から前記金属背骨の前記第2の部分の巻かれている一次形状に移行し、(b)(iii)前記金属背骨の前記第2の部分は、前記金属背骨の前記第2の部分の前記二次形状にあり、前記SMPフォームの前記遠位端と前記外側導管の前記遠位端との間に配置され、
前記SMPフォーム及び前記金属背骨の前記第2の部分は、前記SMPフォームが前記外側導管の前記遠位端から展開する前に、前記金属背骨の前記第2の部分が前記外側導管の前記遠位端から展開するように、互いに対して並びに前記外側導管に対して方向付けられ、
前記金属背骨は、白金、パラジウム、タングステン、イリジウム、又はそれらの組み合わせのうちの少なくとも1つを含む、
システム。 - 前記金属背骨は、通路を含む、請求項1に記載のシステム。
- 前記金属背骨は、コイルを含む、請求項2に記載のシステム。
- 前記金属背骨は、第3の部分を含み、該第3の部分は、前記SMPフォームの前記近位端から近位に延び、前記SMPフォームによって覆われない、請求項3に記載のシステム。
- 前記金属背骨は、前記外側導管の内径の少なくとも50%である外径を含む、請求項4に記載のシステム。
- 前記SMPフォームは、径方向に圧縮される、請求項5に記載のシステム。
- 前記SMPフォームを前記金属背骨に取り付けるニートポリマを含む、請求項6に記載のシステム。
- 前記ニートポリマは、SMPを含む、請求項7に記載のシステム。
- 前記SMPフォームは、N,N,N’,N’−テトラキス(2−ヒドロキシプロピル)エチレンジアミン(HPED)、トリエタノールアミン(TEA)、及びヘキサメチレンジイソシアネート(HDI)を含む、ポリウレタンSMPフォームである、請求項8に記載のシステム。
- 前記SMPフォームは、N,N,N’,N’−テトラキス(2−ヒドロキシプロピル)エチレンジアミン(HPED)、トリエタノールアミン(TEA)、及びヘキサメチレンジイソシアネート(HDI)の反応生成物である、ポリウレタンSMPフォームである、請求項8に記載のシステム。
- ガイドワイヤ又はプッシャー機構のうちの少なくとも1つと、
前記ガイドワイヤ又は前記プッシャー機構のうちの前記少なくとも1つから前記SMPフォーム及び前記金属背骨を解放する解放機構とを含み、
該解放機構は、電解解放機構、機械的解放機構、又はそれらの組み合わせのうちの少なくとも1つを含む、
請求項9又は10に記載のシステム。 - 前記転移温度は、摂氏37度よりも大きい、請求項11に記載のシステム。
- 末梢閉塞デバイスを含み、該末梢閉塞デバイスは、前記SMPフォームと、前記金属背骨とを含む、請求項12に記載のシステム。
- 前記外側導管は、導入シースを含む、請求項8に記載のシステム。
- 前記コイルは、ワイヤを含む、請求項3に記載のシステム。
- 前記ワイヤは、ステンレス鋼、ニチノール、鋼合金、ポリプロピレン、ポリテトラフルオロエチレン、ナイロン、又はそれらの組み合わせを含む、請求項15に記載のシステム。
- 前記金属背骨の前記第1の部分は、前記金属背骨の前記第1の部分の前記巻かれていない二次形状から前記金属背骨の前記第1の部分の前記巻かれている一次形状に移行する、請求項3に記載のシステム。
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