为了促进基于光固化 3D打印模具注塑工艺成型的个性化聚醚醚酮(poly-ether-ether-ketone,PEEK)植入物的临床应用,首先对PEEK下颌骨植入物与骨骼的装配安全性进行了评估,然后采用体外细胞毒性实验对PEEK原材料和PEEK注塑成型植入物材料进行生物相容性表征,最后采用该工艺方案制造出个性化PEEK全颞下颌关节,并联合数字化正颌外科技术成功治疗了一例严重"半侧颜面短小综合征"患者.研究结果表明,PEEK下颌骨植入物的设计厚度应不小于 2 mm;该工艺方案所使用的PEEK原材料对细胞无毒害作用,而且在整个工艺过程中没有引入新的有毒物质;一次手术实现了颞下颌关节重建、下颌骨缺损修复和偏颌畸形的精确矫正,手术效果好、手术安全、患者满意度高.因此,采用 3D打印树脂模具个性化注塑成型PEEK下颌骨植入物是治疗重度"半侧颜面短小综合征"的有效方法,本研究为个性化PEEK植入物在临床的广泛应用奠定了基础.
In order to promote the clinical application of personalized poly-ether-ether-ketone(PEEK)implant formed by 3D printing technology of stereolithography and injection molding process,the assembly safety between PEEK mandibular implant and bone was evaluated,and then the biocompatibility characterization of PEEK raw material and PEEK injection molded implant material were tested by in vitro cytotoxicity test.Finally,personalized PEEK total temporomandibular joint prostheses were manufactured by using injection molding with 3D printed resin mold,and a patient with severe hemifacial shortness syndrome was successfully treated in combination with digital orthognathic surgery.The results show that,the de-sign thickness of PEEK mandibular implant should not be less than 2 mm;the PEEK raw material used in the process has no toxic effect on cells,and no new toxic substances is introduced in the whole process;one operation realizes the reconstruc-tion of temporomandibular joint,the repair of mandibular defect and the accurate correction of partial jaw deformity;the op-eration has good effect,operation safety and high patient satisfaction.Therefore,personalized PEEK mandibular implant in-jected with 3D printed resin mold is an effective method for the treatment of severe hemifacial shortness syndrome,this study lays a foundation for the wider clinic application of personalized PEEK implants.