人造肛门括约肌经皮无线供能系统安全性及相容性分析
收稿日期: 2020-06-30
网络出版日期: 2021-10-08
基金资助
国家自然科学基金项目(61673271);国家自然科学基金项目(81971767);上海市科研项目(19441910600);上海市科研项目(19441913800);上海市科研项目(19142203800);上海交通大学医疗机器人研究院项目(IMR2018KY05)
Biocompatibility and Biosafety Analysis of Transcutaneous Energy Transfer System of Artificial Anal Sphincter
Received date: 2020-06-30
Online published: 2021-10-08
通过仿真与实验相结合,对人造肛门括约肌经皮无线供能系统的生物安全性问题及植入后的生物相容性问题进行研究.生物安全性研究基于生物电磁辐射量仿真及供能时的温升情况.生物相容性研究基于活体实验中供能系统周围组织切片染色实验结果.生物安全性研究结果表明,经皮无线供能系统在谐振频率为110 kHz,发射端输出功率为10 W的实验环境下,生物电磁安全性优异,局部比吸收率远低于国际人体电磁安全标准;且经过30 min的快速充电,系统温升仅为2.81 ℃,低于温升阈值4.8 ℃,具有较好的温控安全性.无线供能系统的切片染色实验结果表明,采用聚醚醚酮外壳能够显著减少免疫排斥,提升系统的生物相容性.
杨辰, 颜国正, 周泽润, 华芳芳 . 人造肛门括约肌经皮无线供能系统安全性及相容性分析[J]. 上海交通大学学报, 2021 , 55(9) : 1151 -1157 . DOI: 10.16183/j.cnki.jsjtu.2020.196
The biosafety and biocompatibility after implantation of the transcutaneous energy transfer system of artificial anal sphincter is verified by combining simulation and experiment in this paper. The biosafety study is based on the simulation of bioelectromagnetic radiation experiment and the thermal rise during the charging period while the biocompatibility study is based on the coloration experiment of the tissue around the energy supply system during the in vivo experiment. The results of biosafety indicate that the transcutaneous energy transfer system performs excellently in bioelectromagnetic safety in the experimental environment with a resonance frequency of 110 kHz and an output power of 10 W. In addition, the local specific absorption rate is far below the international human electromagnetic safety standard. After 30 minutes of fast charging, the system temperature increases by 2.81 ℃, which is lower than the temperature threshold of 4.8 ℃, demonstrating the outstanding biothermal safety of the system. The section staining experiment of the wireless energy supply system indicates that the poly-ether-ether-ketone (PEEK) shell can significantly reduce immune rejection and improve the biocompatibility of the system.
Key words： artificial anal sphincter; biocompatibility; biosafety
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