李中华 马宇立* 侯淑玲
上海三友医疗器械股份有限公司
摘要(Abstract):
本文研究开发了一种碳纤维/PEEK(聚醚醚酮)复合材料脊柱重建系统,用于脊柱肿瘤切除后的稳定性重建。该系统具有射线透明性,可避免术后放疗和病灶复查受阻;同时其弹性模量与人体骨组织接近,可有效降低应力遮挡效应和椎体塌陷风险。项目攻克了碳纤维与PEEK界面结合强度不足、复合材料各向异性、手术工具适配性及生物力学测试等技术难点,开发了碳纤维复合材料内固定、螺旋撑开式PEEK人工椎体及专用手术工具系统。经生物力学和生物相容性测试,系统性能不劣于传统钛合金重建系统,为 脊柱肿瘤患者提供了更安全、有效的治疗方式。
关键词(KeyWords):
脊柱肿瘤;射线透明性;生物力学性能;生物相容性
参考文献(References):
[1]Ofir U ,Yoram F ,Gil L , et al.A Novel Spine Fixation System Made Entirely of Carbon-Fiber-Reinforced PEEK Composite: An In Vitro Mechanical Evaluation. [J].Advances in orthopedics,2020,20204796136.
[2]Adler D ,Akbar M ,Spicher A ,et al.Biomechanical Study of a Novel, Expandable, Non-Metallic and Radiolucent CF/PEEK Vertebral Body Replacement (VBR)[J].Materials,2019,12 (17):2732-2732.
[3]Francis H S ,Alessandro G ,Darren F L ,et al.Integrated Custom Composite Polyetheretherketone/Carbon fiber (PEEK/CF) Vertebral Body Replacement(VBR)in the treatment of Bone Tumors of the Spine: A Preliminary Report From a Multicenter Study [J].Spine,2021,
[4]Stefano B ,Giuseppe T ,Lu M ,et al.Carbon-fiber-reinforced PEEK fixation system in the treatment ofspine tumors: a preliminary report. [J].European spine journal : official publication of the European Spine Society,the European Spinal Deformity Society,and theEuropean Section of the Cervical SpineResearch Society,2018,27(4):874-881.
[5]中国合格评定国家认可委员会(CNAS). (n.d.). https://www.cnas.org.cn. (访问日期:2025.04.01)