In this paper an intelligent and remote-controlled artificial anal sphincter based on biological signal feedback mechanism for a novel artificial anal sphincter system ( AASS) was designed and integrated. The peristaltic mechanical medical micropump transported fluid bidirectional with a maximum flow rate of 8. 5 mL/min and built up backpressure up to 170 kPa. The design of the prosthesis reduced the occlusion pressure and allowed low inflation volumes (9 ~ 10.5 mL). The operating pressures between 3.34 and 7. 26 kPa indicated a minor risk of ischemic injury to the bowel. Furthermore, the operation time was estimated at about 2 days with rechargeable battery based on transcutaneous energy transfer technology. The results of in vitro experiments indicated that the system could control the fecal and build the sense of defecation successfully. This AASS is promising in application for the patients with severe anal dysfunction caused by fecal incontinence or colostomy.%设计一款基于生物信号反馈机制的智能化可遥控式人工肛门括约肌系统.所设计的蠕动式微型医用泵在3.3V驱动电压下,最大流量为8.5 mL/min,最大封闭压可达170 kPa.新型括约肌假体在较小注水量(9～10.5 mL)的情况下,可实现对肠壁作用压的均匀分布(3.34～7.26 kPa),符合人体肠道生理结构和安全压力阈值的要求,避免由于局部高压导致的缺血性坏死.人工括约肌系统采用体内充电电池、体外无线经皮能量充电的供电方式,实现系统的完全植入式移植.离体实验结果表明,该系统可以有效地抑制肠道内容物渗漏,成功建立排便感知信号,从而为严重肛门失禁、结肠造口等肛门功能严重缺失的患者提供一种人性化的治疗方案.
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