人造肛门括约肌经皮无线供能系统安全性及相容性分析

doi:10.16183/j.cnki.jsjtu.2020.196

上海交通大学学报 ›› 2021, Vol. 55 ›› Issue (9): 1151-1157.doi: 10.16183/j.cnki.jsjtu.2020.196

所属专题：《上海交通大学学报》2021年12期专题汇总专辑；《上海交通大学学报》2021年“机械工程”专题

人造肛门括约肌经皮无线供能系统安全性及相容性分析

杨辰, 颜国正(), 周泽润, 华芳芳

医疗机器人研究院, 上海 200240

收稿日期:2020-06-30 出版日期:2021-09-28 发布日期:2021-10-08
通讯作者: 颜国正 E-mail:gzhyan@sjtu.edu.cn
作者简介:杨辰(1998-),男,江西省宜春市人,硕士生,主要从事经皮无线供能系统研究.
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

YANG Chen, YAN Guozheng(), ZHOU Zerun, HUA Fangfang

Institute of Medical Robotics, Shanghai Jiao Tong University, Shanghai 200240, China

Received:2020-06-30 Online:2021-09-28 Published:2021-10-08
Contact: YAN Guozheng E-mail:gzhyan@sjtu.edu.cn

摘要/Abstract

摘要：

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.

关键词: 人造肛门括约肌, 生物相容性, 生物安全性

Abstract:

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

中图分类号:

TH772

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.

YANG Chen, YAN Guozheng, ZHOU Zerun, HUA Fangfang. Biocompatibility and Biosafety Analysis of Transcutaneous Energy Transfer System of Artificial Anal Sphincter[J]. Journal of Shanghai Jiao Tong University, 2021, 55(9): 1151-1157.

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参考文献 18

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线圈参数	发射/接收线圈参数取值
外径/mm	48
内径/mm	16
层数	1
线径/mm	0.9
等效电感/μH	105.02
匝数	16
等效电阻/Ω	1.475

发布者	频率范围	全身SAR(W/kg)	头部与躯干局部SAR(W/kg)	四肢局部SAR(W/kg)
ICNIRP	100 kHz~10 MHz	0.40	10	20
ANSI	100 kHz~3 GHz	0.40	10	20
中华人民共和国环境保护局	100 kHz~300 GHz	0.10(职业照射) 0.02(公众照射)

组别	白细胞数×10^-9/ L^-1	红细胞数×10^-9/ L^-1	血小板数×10^-9/ L^-1	红细胞比容	血红蛋白浓度/ (g·L^-1)	平均红细胞体积/fL	平均红细胞血红蛋白/pg	平均红细胞血红蛋白浓度/ (g·L^-1)
实验前1号猪	24.11	7.72	569	0.48	141	61.1	17.7	307
1号猪	15.43	7.62	367	0.46	142	61.2	18.6	305
实验前2号猪	22.94	7.71	608	0.49	141	62.5	18.2	309
2号猪	13.20	7.64	475	0.49	140	61.7	19.0	308
健康巴马猪参数范围	23.65±0.95	7.70±0.09	599.30±26.1	0.48±0.01	139.3±2	55.60±3.16	16.88±0.9	303.8±8.04

人造肛门括约肌经皮无线供能系统安全性及相容性分析

Biocompatibility and Biosafety Analysis of Transcutaneous Energy Transfer System of Artificial Anal Sphincter

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