Improving the practicality and safety of artificial corneas: Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis
Improving the practicality and safety of artificial corneas: Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis
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DOI：
10.1016/j.jtos.2018.04.002
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发表时间：
2018-07-01
期刊：
影响因子：
6.4
通讯作者：
Dohlman, Claes H.
中科院分区：
文献类型：
--
作者：
Gonzalez-Andrades, Miguel;Sharifi, Roholah;Dohlman, Claes H.
目的：为了使Boston人工角膜（B-KPro）及其载体角膜移植物更容易获得、运输和储存，以及更便宜、外科医生更容易植入和对患者更安全，建议由专业技术人员预组装B-KPro-移植物组合，然后用伽马射线辐照（GI）灭菌，允许在室温下长期储存。对于这是可能的，它必须表明，B-KPro本身（不仅是移植物）仍然不受伤害的辐射。方法：聚甲基丙烯酸甲酯（PMMA）光盘和B-KPros提交环氧乙烷灭菌或不同剂量的GI。评价细胞生物相容性、机械强度和光学质量。将B-KPro组装到角膜移植物上，然后进行γ射线照射的可行性也进行了评估。光学评价显示所有组的透明度都很高。紫外线吸光度高的GI治疗组。通过纳米压痕进行的机械评价显示，GI后PMMA盘没有变化。弯曲试验显示了类似的机械性能。从技术上讲，预组装和GI的B-KPro没有发现任何问题。结论：使用GI的B-KPro灭菌对设备没有不利影响。将B-KPro预组装到供体角膜上，然后进行伽马灭菌，是一种有效且安全的手术。(C)2018爱思唯尔公司All rights reserved.
Purpose: To make the Boston keratoprosthesis (B-KPro), together with its carrier corneal graft, more easily procured, transported and stored, as well as less expensive, easier for the surgeon to implant and safer for the patient, it is proposed that the B-KPro-graft combination be pre-assembled by an expert technician, followed by sterilization with gamma ray irradiation (GI) allowing long-term storage at room temperature. For this to be possible, it must be shown that the B-KPro itself (not only the graft) remains unharmed by the irradiation.Methods: Polymethyl methacrylate (PMMA) discs and B-KPros were submitted to either ethylene oxide sterilization or different doses of GI. Cell biocompatibility, mechanical strength and optical quality were evaluated. The feasibility of assembling the B-KPro to a corneal graft, and gamma-radiate afterwards, was also assessed.Results: There were no differences in cell biocompatibility between the samples. The optical evaluation showed high levels of transparency for all the groups. The absorbance of ultraviolet was higher for the groups treated with GI. The mechanical evaluation by nanoindentation showed no alterations of the PMMA discs after GI. The flexure test revealed a similar mechanical behavior. Technically, pre-assembly and GI of the B-KPro revealed no problems.Conclusions: Sterilization of B-KPro using GI has no detrimental influence on the device. The pre-assembly of B-KPro to a donor cornea, followed by gamma sterilization, emerges as an efficient and safe procedure. (C) 2018 Elsevier Inc. All rights reserved.