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

doi:10.16183/j.cnki.jsjtu.2020.196

Abstract

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

CLC Number:

TH772

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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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