利用金属3D打印制造个性化骨盆髋臼接骨板及其性能研究

The reduction and fixation of pelvic and acetabular fractures has been a major issue in orthopedics，due to special anatomical positions and irregular structures. The accurate reduction and rigid fixation is the nodus of treatment in pelvic and acetabular fractures. Based on the previous study of dozens of cases, we collected the imaging data of the pelvises and morphologically compared the bilateral pelvises. The feasibility of the plate was definitely designed by the bilateral pelvic mirror principle. And then we planned in vitro experiment using 3D printing technique which could fabricate the characteristics of complex structural parts. According to the three-dimensional visualization of the pelvis, the customized plate was designed by SolidWorks.The finite element analysis was used to mimic the post-implantation load, collect the data of stress distribution and motion analysis, and analyze and improve the biomechanical properties of the plate. Then the precise and customized titanium alloy plate was printed by the metal 3D printing technology. The anastomosis between the customized plate and the pelvis was determined through the simulated surgery in cadaver. And the biocompatibility test, the implantation experiment of the animal and the biomechanical test and verification of the customized plate were compared with the traditional plate in order to apply for the three types of medical equipment business license. Thus, the clinical application of customized plate could optimize the treatment of pelvic and acetabular fractures, ultimately achieving precise and customized surgery.

骨盆髋臼骨折因其特殊的解剖位置、不规则的形态结构，精准复位固定一直是骨科的重大难题。本研究在前期应用3D打印模型辅助手术数十例的基础上，收集骨盆影像学资料，对双侧骨盆进行形态学比对，明确通过健侧骨盆镜像原理设计接骨板的可行性，再利用3D打印可制造复杂结构部件的特点，通过CT数据转化骨盆三维模型，再根据骨盆髋臼的三维结构，利用Solidworks设计出与模型最吻合的个性化接骨板。通过有限元分析技术模拟植入后载荷，收集应力分布、运动分析等数据，分析并改进接骨板的生物力学性能，再通过金属3D打印技术，打印出精准的、个性化的钛合金接骨板，通过尸体模拟手术确定个性化接骨板与骨盆的吻合度，再对接骨板进行生物相容性实验、动物体内植入实验及个性化接骨板的生物力学检测与验证并与传统工艺制作的接骨板进行对比，以期申请三类医疗器械许可证，应用于临床，优化骨盆髋臼骨折的治疗，最终真正实现个性化、精准化手术。

骨盆髋臼骨折因其特殊的解剖位置、不规则的形态结构，精准复位固定一直是骨科的重大难题。本研究在前期应用3D打印模型辅助手术数十例的基础上，收集骨盆影像学资料，对双侧骨盆进行形态学比对，明确通过健侧骨盆镜像原理设计接骨板的可行性，再利用3D打印可制造复杂结构部件的特点，通过CT数据转化骨盆三维模型，再根据骨盆髋臼的三维结构，利用Solidworks设计出与模型最吻合的个性化接骨板。通过有限元分析技术模拟植入后载荷，收集应力分布、运动分析等数据，分析并改进接骨板的生物力学性能，再通过金属3D打印技术，打印出精准的、个性化的钛合金接骨板，通过尸体模拟手术确定个性化接骨板与骨盆的吻合度，再对接骨板进行生物相容性实验、动物体内植入实验及个性化接骨板的生物力学检测与验证并与传统工艺制作的接骨板进行对比，以期申请三类医疗器械许可证，应用于临床，优化骨盆髋臼骨折的治疗，最终真正实现个性化、精准化手术。.通过体外试验验证金属 3D打印钛合金接骨板的浸提液对细胞并无明显的毒性作用。通过体内试验，金属 3D打印钛合金接骨板在全身毒性试验、致敏试验及动物肌肉植入试验中均表现出良好的生物相容性。本研究成功完成试验并得到预期的结果：金属 3D打印钛合金接骨板具有优越的生物相容性。这一结果及发现能为金属 3D打印个性化髋臼翼状接骨板在临床中的应用提供伦理基础及安全保证，其具有成为解决累及四方体的髋臼骨折无理想内固定物这一难题的巨大潜力，为个性化髋臼翼状接骨板的应用推广提供了可靠的依据，具有十分广阔的前景。.通过生物力学实验数据结果，新型翼形钢板能有效固定髋臼骨折，在生物力学上优于传统固定方式。单一翼型接骨板固定髋臼骨折具有足够的稳定性，使用 3D打印个性化翼型接骨板治疗髋臼骨折完全可靠。