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金属アレルギーの懸念が少ない脊椎内固定器具の製造販売承認を取得医療機器ニュース

東北大学は、金属アレルギーの主原因となるニッケルを極限まで減らした「いわて発高付加価値コバルト合金:COBARION」を用いた脊椎内固定器具の製造販売承認を取得した。COBARIONを用いた脊椎内固定器具での承認は国内初となる。

» 2017年01月25日 15時00分 公開
[MONOist]
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 東北大学は2017年1月4日、金属アレルギーの主原因となるニッケルを極限まで減らした「いわて発高付加価値コバルト合金:COBARION」を用いた脊椎内固定器具の医療機器製造販売承認を取得したと発表した。

 COBARIONを用いた脊椎内固定器具での承認は、国内初となる。同大学金属材料研究所の千葉晶彦教授、山中謙太助教らの研究グループが開発した。厚生労働省の革新的医療機器創出促進等臨時特例交付金を活用した岩手県革新的医療機器等開発事業として進められたもので、岩手医科大学、センチュリーメディカルも参画。製品に利用するCOBARIONは、エイワが製造した。

 現在、脊椎内固定器具の構成部材の1つである脊椎ロッドには、チタン合金が多く用いられている。しかしチタン合金には、スプリングバックが大きいために操作性の面で課題があった。さらに脊椎固定に用いても、疲労破壊によるロッド破損が発生することもあり、より高強度で破損しにくく、安全に使用できる脊椎ロッドの開発が求められていた。

 研究グループは、これらの課題を解決しようとCOBARIONに着目。COBARIONは、ニッケルを極限まで低減させたことにより金属アレルギーの懸念が少なく、コバルト合金の強さと硬さ、優れた耐食性・耐摩耗性を兼ね備えている。ただし難加工であることから、研究グループは直径5mmほどのロッド形状への加工プロセスを研究。COBARIONRを製造するエイワと協力して試作と評価を重ねることで、強度と曲げ操作性に優れたロッド素材を開発できたとしている。

photo 販売承認された脊椎内固定器具
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