A design strategy for long-term stability of porous PEEK implants by regulation of porous structure and in vivo mechanical stimulation  

一种联合机械刺激调控促进多孔PEEK植入物骨整合的结构设计策略

作　　者：Yingjie Liu Ling Wang Jie Zhang Shuguang Liu Jibao Zheng Jianfeng Kang Enchun Dong Changning Sun Ruhan A Chaozong Liu Chuncheng Yang Dichen Li 刘颖洁;王玲;张婕;刘曙光;郑纪豹;康建峰;董恩纯;孙畅宁;阿茹罕;刘朝宗;杨春成;李涤尘(西安交通大学机械工程学院,精密微纳制造技术全国重点实验室,西安市710049;西安交通大学国家药品监督管理局医用增材制造器械研究与评价重点实验室,西安市710049;南方医科大学口腔医院,广州市510280;中南大学湘雅口腔医学院,口腔颌面外科,长沙市410000;佛山大学机电工程与自动化学院,佛山市528225;国家药品监督管理局医疗器械技术审评中心,北京市100076;伦敦大学学院骨科与肌肉骨骼科学研究所,英国皇家国立骨科医院,英国伦敦市,HA74LP;陕西聚高增材智造科技发展有限公司,西安市714026)

机构地区：[1]State Key Laboratory for Manufacturing Systems Engineering,School of Mechanical Engineering,Xi’an Jiaotong University,Xi’an 710049,China [2]National Medical Products Administration(NMPA)Key Laboratory for Research and Evaluation of Additive Manufacturing Medical Devices,Xi’an Jiaotong University,Xi’an 710049,China [3]Stomatological Hospital of Southern Medical University,Guangzhou 510280,China RESEARCH ARTICLE [4]Department of Oral and Maxillofacial Surgery,Center of Stomatology,Xiangya Hospital,Central South University,Changsha 410000,China [5]School of Mechatronic Engineering and Automation,Foshan University,Foshan 528225,China [6]Center for Medical Device Evaluation of NMPA,Beijing 100076,China [7]Institute of Orthopaedic&Musculoskeletal Science,University College London,Royal National Orthopaedic Hospital,Stanmore HA74LP,UK [8]Shaanxi Jugao-AM Technology Co.,Ltd.,Xi’an 714026,China

出　　处：《Bio-Design and Manufacturing》2025年第2期275-287,I0004,共14页生物设计与制造(英文)

基　　金：supported by the National Key R&D Program of China(No.2023YFB4603500);the Program for Innovation Team of Shaanxi Province(No.2023-CX-TD-17);the Fundamental Research Funds for the Central Universities;the Shaanxi Province Qinchuangyuan“Scientist+Engineer”Team Construction Project(No.2022KXJ-106).

摘　　要：The bioinert nature of polyether ether ketone(PEEK)material limits the widespread clinical application of PEEK implants.Although the porous structure is considered to improve osseointegration of PEEK implants,it is hardly used due to its mechanical properties.This study investigated the combined influence of the porous structure and in vivo mechanical stimulation on implantation safety and bone growth based on finite element analysis of the biomechanical behavior of the implantation system.The combined control of pore size and screw preloads allows the porous PEEK implant to achieve good osseointegration while maintaining a relatively high safety level.A pore size of 600μm and a preload of 0.05 N·m are the optimal combination for the long-term stability of the implant,with which the safety factor of the implant is>2,and the predicted percentage of effective bone growth area of the bone-implant interface reaches 97%.For further clinical application,PEEK implants were fabricated with fused filament fabrication(FFF)three-dimensional(3D)printing,and clinical outcomes demonstrated better bone repair efficacy and long-term stability of porous PEEK implants compared to solid PEEK implants.Moreover,good osteointegration performance of 3D-printed porous PEEK implants was observed,with an average bone volume fraction>40%three months after implantation.In conclusion,3D-printed porous PEEK implants have great potential for clinical application,with validated implantation safety and good osseointegration.聚醚醚酮(PEEK)材料的生物惰性限制了其在临床上的广泛应用。虽然多孔结构能改善PEEK植入物的骨整合能力,但其同时降低了植入物的机械性能,从而阻碍了其临床应用。本研究基于对植入物生物力学行为的有限元分析,研究了多孔结构和在体机械刺激对植入安全性和界面骨生长状态的综合影响。通过对孔隙大小和螺钉预紧力的联合调控,使多孔PEEK植入物在实现良好骨整合的同时保持相对较高的安全性能。600μm的孔径和0.05 N·m的螺钉预紧力是保证植入物长期稳定性的最佳组合;在该参数下,植入物的安全系数大于2,骨-植入物界面的预测有效骨生长面积百分比达到97%。本研究使用熔丝制造(FFF)3D打印技术制作了PEEK植入物,并进行了临床运用。临床结果表明,与实心PEEK植入物相比,多孔PEEK植入物具有更优的骨修复效果和长期稳定性。3D打印多孔PEEK植入物的骨整合性能良好,植入后3个月的平均骨体积分数>40%。综上,3D打印多孔PEEK植入物的植入安全性和骨整合性能得到了验证,其具备巨大的临床应用潜力。

关 键 词：Porous polyether ether ketone(PEEK)implant OSTEOINTEGRATION Interface biomechanics Maxillofacial implants Finite element analyses Fused filament fabrication(FFF)3D printing 

分 类 号：TQ3[化学工程]