JP2010523805A5 - - Google Patents

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Publication number
JP2010523805A5
JP2010523805A5 JP2010503206A JP2010503206A JP2010523805A5 JP 2010523805 A5 JP2010523805 A5 JP 2010523805A5 JP 2010503206 A JP2010503206 A JP 2010503206A JP 2010503206 A JP2010503206 A JP 2010503206A JP 2010523805 A5 JP2010523805 A5 JP 2010523805A5
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JP
Japan
Prior art keywords
blend
solidified
solidified blend
uhmwpe
antioxidant
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Pending
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JP2010503206A
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English (en)
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JP2010523805A (ja
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Priority claimed from PCT/US2008/059909 external-priority patent/WO2008124825A2/en
Publication of JP2010523805A publication Critical patent/JP2010523805A/ja
Publication of JP2010523805A5 publication Critical patent/JP2010523805A5/ja
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Claims (24)

  1. 医療用途での使用のためのUHMWPEを処理する方法であり、その方法は次の段階を含む:UHMWPEを酸化防止剤と一緒にして酸化防止剤0.01〜3.0wt%を有するブレンドを形成すること;ブレンドを固化するように処理すること、ここで固化されたブレンドは融点を有する;固化されたブレンドの融点未満の予熱温度に、固化されたブレンドを予熱すること;ならびに固化されたブレンドの融点未満の温度に、固化されたブレンドを維持する間に、固化されたブレンドに照射すること。
  2. UHMWPEを酸化防止剤と一緒にする段階が、酸化防止剤0.01〜3.0wt%を有する実施的に均一なUHMWPEブレンドを形成することを含む請求項1に記載の方法。
  3. UHMWPEを酸化防止剤と一緒にする段階が、溶媒ブレンド、高せん断混合、精密コーティング、流動床、噴霧、エマルション重合、静電沈殿、粒子の濡れまたは被覆およびマスターバッチブレンドの少なくとも1つにより、UHMWPE粉末をトコフェロールと混合することをさらに含む請求項1に記載の方法。
  4. UHMWPEを酸化防止剤と一緒にする段階が、高せん断混合により、UHMWPE粉末をトコフェロールと混合することをさらに含む請求項1に記載の方法。
  5. UHMWPEを、トコフェロール、ビタミンC、リコピン、蜂蜜、フェノール性酸化防止剤、アミン酸化防止剤、ハイドロキノン、ベータカロチン、アスコルビン酸、CoQエンザイムおよびそれらの誘導体から選ばれる酸化防止剤と一緒にする請求項1に記載の方法。
  6. UHMWPEをd、l-α-トコフェロールと一緒にする請求項1に記載の方法。
  7. ブレンドを固化するように処理することが、圧縮成形、ネットシェイプ成形、射出成形、押出し、モノブロック成形、繊維、溶融紡糸、ブロー成形、溶液紡糸、熱間等方加圧、高圧結晶化および薄膜の少なくとも1つにより行われる請求項1に記載の方法。
  8. ブレンドを固化するように処理することが、圧縮成形によりブレンドを多孔質基板中に少なくとも部分的に伸長させて行われる請求項1に記載の方法。
  9. 基板が、骨代用材、細胞受容材、組織受容材、骨伝導性材および骨誘導材の少なくとも1つとして有用な、高度に多孔質の生体適合性材料である請求項8に記載の方法。
  10. 基板が、骨代用材、細胞受容材、組織受容材、骨伝導性材および骨誘導材の少なくとも1つとして有用な、高度に多孔質の生体適合性材料であり、少なくとも55%の気孔率を有する請求項8に記載の方法。
  11. ブレンドを固化するように処理することが、肉眼でみて機械的に組み合わせる特徴を持つ基板上の粗面化した表面にブレンドを圧縮成形することにより行われる請求項1に記載の方法。
  12. 固化されたブレンドの融点が示差熱量測定法で測定される請求項1に記載の方法。
  13. 固化されたブレンドを実質的に60℃〜130℃の予熱温度に予熱する請求項1に記載の方法。
  14. 固化されたブレンドを機械加工して医療用製品を形成することをさらに含む請求項1に記載の方法。
  15. 固化されたブレンドにより受けられる合計架橋照射線量を同定すること;
    固化されたブレンドにより受けられる最大の個別照射線量を同定するが、固化されたブレンドを固化されたブレンドの融点未満に維持すること;ならびに
    固化されたブレンドを照射する段階が、最大の個別照射線量に等しいか、少ない、第1の照射線量で固化されたブレンドを照射することを含む;
    をさらに含む請求項1に記載の方法。
  16. 最大の個別照射線量に等しいか、少ない、少なくとも1つの続く照射線量で固化されたブレンドをさらに照射することを含む請求項15に記載の方法。
  17. 固化されたブレンドを照射することが、電子ビーム照射、ガンマ照射およびX線照射の少なくとも1つで、固化されたブレンドを照射する請求項15に記載の方法。
  18. 合計架橋照射線量が実質的に50kGy〜1000kGyである請求項15に記載の方法。
  19. 合計架橋照射線量が実質的に100kGy〜250kGyである請求項15に記載の方法。
  20. 第1の照射の後に、固化されたブレンドの温度を予熱温度に平衡にすること;ならびに合計架橋照射線量および第1の照射線量および固化されたブレンドのための最大の個別照射線量の間の差異の小さい方に等しいか、少ない、第2の照射線量で固化されたブレンドを照射すること、をさらに含む請求項15に記載の方法。
  21. ガスプラズマ殺菌、エチレンオキシド殺菌、ガンマ線殺菌、電離放射線殺菌、オートクレーブ処理および超臨界流体法の少なくとも1つによりUHMWPEブレンドを殺菌することをさらに含む請求項1に記載の方法。
  22. 照射段階後に、固化されたブレンドを熱処理することをさらに含む請求項1に記載の方法。
  23. 照射段階前に、固化されたブレンドの少なくとも1部分をシールドすることをさらに含む請求項1に記載の方法。
  24. 請求項1〜23のいずれか1項に記載の方法により製造された生成物。
JP2010503206A 2007-04-10 2008-04-10 医療機器用途のための、酸化防止剤で安定化された架橋超高分子量ポリエチレン Pending JP2010523805A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92273807P 2007-04-10 2007-04-10
PCT/US2008/059909 WO2008124825A2 (en) 2007-04-10 2008-04-10 An antioxidant stabilized crosslinked ultra-high molecular weight polyethylene for medical device applications

Publications (2)

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JP2010523805A JP2010523805A (ja) 2010-07-15
JP2010523805A5 true JP2010523805A5 (ja) 2011-05-26

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JP2010503206A Pending JP2010523805A (ja) 2007-04-10 2008-04-10 医療機器用途のための、酸化防止剤で安定化された架橋超高分子量ポリエチレン

Country Status (8)

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US (6) US20080319137A1 (ja)
EP (4) EP2578248B1 (ja)
JP (1) JP2010523805A (ja)
AT (1) ATE544476T1 (ja)
AU (1) AU2008236996B2 (ja)
CA (1) CA2678459C (ja)
ES (2) ES2378721T3 (ja)
WO (1) WO2008124825A2 (ja)

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