文章摘要
郭佳乐,许建霞,刘斌,付步芳,李岩.3D打印骨科钛合金医疗器械的性能研究进展[J].中国药事,2021,35(4):471-478
3D打印骨科钛合金医疗器械的性能研究进展
Research Progress of 3D-printed Orthopedic Titanium Alloy Medical Devices
  
DOI:10.16153/j.1002-7777.2021.04.016
中文关键词: 3D打印  骨科  钛合金  医疗器械  生物学性能
英文关键词: 3D printing  orthopedic  titanium alloy  medical devices  biological property
基金项目:国家重点研发项目(编号 2018YFC 1106700)
作者单位
郭佳乐 中国食品药品检定研究院,北京 100050 北京航空航天大学材料科学与工程学院,北京 100191 
许建霞 中国食品药品检定研究院,北京 100050 
刘斌 国家药品监督管理局医疗器械技术审评中心,北京 100081 
付步芳 中国食品药品检定研究院,北京 100050 
李岩 北京航空航天大学材料科学与工程学院,北京 100191 
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中文摘要:
      在骨缺损治疗中通常使用生物相容性和机械性能较好的钛合金骨科医疗器械进行替换,但是传统的加工制造工艺不能满足对复杂外形医疗器械的加工要求。近年来流行的3D打印技术具有传统材料制造技术不具有的优点,其性能优良的生物医用材料结合先进的材料制造技术,在骨科医疗器械领域具有很大的发展潜力。在计算机软件的帮助下,可以按照患者的需求制造特殊外形和结构的骨科医疗器械,从而实现个性化医疗。近几年出现了很多3D打印的骨科植入物,都表现出了优良的生物学性能。但是也存在一些问题,例如钛合金材料在力学性能上不能很好地匹配人骨,产生“应力屏蔽”现象,研究者们通过3D打印制造多孔结构的钛合金来降低钛合金人体植入物的弹性模量,也有研究者通过3D打印制造低模量的新型β型钛合金,这两种途径都有效地减小了应力屏蔽现象。此外,3D打印制造的钛合金零件往往会产生空隙和未熔化的粉末缺陷,从而导致表面光滑度下降和金属离子过度析出,影响骨科植入物的生物安全性。研究者们通过对3D打印钛合金骨科植入物进行表面处理,提高了生物安全性。通过创新三维结构和改进钛合金材料的成分使骨科钛合金医疗器械的力学性能得到了较好的优化,通过一些表面处理技术提高了3D打印钛合金骨科医疗器械的表面质量,进一步提高了其生物安全性和有效性。因此近年来出现了很多临床上使用3D打印钛合金骨科医疗器械修复骨缺损的案例,取得了良好的效果。在未来, 3D打印技术将成为定制化骨科医疗器械的主流制造方法,会有更多的3D打印新工艺和新材料出现。本文主要就3D打印骨科钛合金医疗器械产品的研究进展做出简要评述。
英文摘要:
      In the treatment of bone defects, titanium alloy orthopedic medical devices with good biocompatibility and mechanical properties are commonly used for replacement, but the traditional manufacturing process cannot meet the processing requirements for medical devices with complex shapes. In recent years,the popular 3D printing technology has the advantages that traditional material manufacturing technology does not have. Biomedical materials with excellent performance combined with advanced material manufacturing technology have great potential for development in the field of orthopedic medical devices. With the help of computer software, orthopedic medical devices with special shapes and structures could be manufactured meeting to the needs of patients to achieve personalized medicine. In recent years, there have been many 3D printed orthopedic titanium alloy materials, mainly used in orthopedic implants, which have shown excellent biological properties. However, there are also some problems, such as the titanium alloy material not matching the human bone well in terms of mechanical properties, resulting in a ‘stress shielding’ phenomenon. The researchers have made a porous titanium alloy by 3D printing to reduce the modulus of the titanium alloy human implant for modulus. Some researchers have also made new modulus β-type titanium alloys with low modulus through 3D printing. Both of these approaches have effectively reduced the stress shielding phenomenon. In addition, 3D printed titanium alloy parts often have voids and unmelted powder defects, resulting in reduced surface smoothness and excessive precipitation of metal ions, reducing the biological safety of orthopedic implants. Researchers have performed surface treatment on 3D printed titanium alloy orthopedic implants, which has improved the biological safety. By innovating the 3D structure and improving the composition of titanium alloy materials, the mechanical properties of orthopedic titanium alloy medical devices have been better optimized. Some surface treatment technologies have improved the surface quality of 3D printed titanium alloy orthopedic medical devices, and further improved their biological safety and effectiveness. Therefore, many clinical cases of using 3D printed titanium orthopedic medical devices to repair bone defects have emerged in recent years, with good results. In the future, 3D printing technology will become the mainstream manufacturing method for customized orthopedic medical devices, and more new 3D printing processes and materials will emerge. This article mainly reviews the research progress of 3D printed orthopedic titanium alloy medical device products.
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