Chmal-Fudali Edyta, Basińska Daria, Kucharska-Jastrząbek Agnieszka, Struszczyk Marcin H, Muzalewska Małgorzata, Wyleżoł Marek, Wątrobiński Marcin, Andrzejewski Jacek, Tarzyńska Nina, Gzyra-Jagieła Karolina
Institute of Security Technologies "MORATEX", 3 M. Sklodowskiej-Curie Str., 90-505 Lodz, Poland.
Department of Fundamentals of Machinery Design, Faculty of Mechanical Engineering, Silesian University of Technology, Konarskiego 18a Str., 44-100 Gliwice, Poland.
Materials (Basel). 2023 Sep 4;16(17):6070. doi: 10.3390/ma16176070.
Biodegradable craniofacial and cranial implants are a new aspect in terms of reducing potential complications, especially in the long term after surgery. They are also an important contribution in the field of surgical reconstructions for children, for whom it is important to restore natural bone in a relatively short time, due to the continuous growth of bones. The aim of this study was to verify the impact of the technology on biodegradability and to estimate the risk of inappropriate implant resorption time, which is an important aspect necessary to select prototypes of implants for in vivo testing. Prototypes of implants were made using two technologies: 3D printing using a PLDLA: poly(L-co-D,L lactide) (PLDLA) filament containing hydroxyapatite nanoparticles, and injection using PLDLA. After the radiation sterilization process, they were subjected to in vitro degradation under accelerated conditions. As part of this study, the in vitro degradation of newly developed biodegradable implant technologies was assessed in accordance with the guidelines of European standards. It was found that the implant manufacturing process had a significant impact on the degradation time under simulated conditions in various media. Implants made using the injection technique were characterized by lower susceptibility to degradation media compared to the 3D-printed implant under accelerated conditions.
可生物降解的颅面和颅骨植入物在减少潜在并发症方面是一个新的领域,尤其是在手术后的长期阶段。它们在儿童外科重建领域也做出了重要贡献,由于骨骼持续生长,对儿童来说,在相对较短的时间内恢复天然骨骼非常重要。本研究的目的是验证该技术对生物降解性的影响,并估计植入物吸收时间不当的风险,这是选择用于体内测试的植入物原型所必需的一个重要方面。植入物原型采用两种技术制作:使用含有羟基磷灰石纳米颗粒的聚(L-共-D,L-丙交酯)(PLDLA)长丝进行3D打印,以及使用PLDLA进行注塑。经过辐射灭菌处理后,它们在加速条件下进行体外降解。作为本研究的一部分,根据欧洲标准指南评估了新开发的可生物降解植入技术的体外降解情况。结果发现,在各种介质中的模拟条件下,植入物制造工艺对降解时间有显著影响。在加速条件下,与3D打印的植入物相比,采用注塑技术制造的植入物对降解介质的敏感性较低。