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

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.

Keywords

• artificial anal sphincter
• biocompatibility
• biosafety