新型人工肛门括约肌系统及初步动物实验研究

New artificial anal sphincter system and preliminary animal experiment

目的研究可用于治疗肛门失禁的植入式人工肛门括约肌系统（artificial anal sphincter system，AASS）。方法系统由体内执行、体外控制和经皮能量传输3个模块构成，体内外通过无线模式通信。当体内直肠壁上压力超出阈值后，向体外发送排便报警信号，患者通过体外控制模块控制体内执行模块打开或关闭直肠，采用经皮能量传输模块为体内电池充电。通过1例猪的动物实验，评估在活体环境下系统各模块的可靠性和稳定性。15d后将动物解剖，观察组织变化并进行体内的腹泻实验和血供实验。结果植入体内后，体外控制模块可实时控制体内执行模块的各项操作，通过经皮能量传输充电3h，在体内可持续工作24h。拟腹泻状态下，对肠壁施加7．16kPa的压力（正常肛肠静息压为6．26～9．47kPa），能有效抑制肠道内容物渗漏。结论AASS可以模拟正常人体肛门括约肌功能，为严重肛门失禁的患者提供了一种新的治疗方法。

Objective To develop a new implantable artificial anal sphincter system （AASS） for the treatment of fecal incontinence. Methods The system was composed of internal execution prosthesis, external control module and wireless transcutaneous energy transmission system （ TETS）. Wireless communication was used for the data transmission between the internal and external. Once the rectal pressure exceeded the threshold ,an alarm signal was sent to the external to remind the patient for defecation. Patients controlled the internal execution prosthesis to open or close the rectum through the external control module and the internal execution module was charged through TETS. The system was implanted into a pig to evaluate the stability of each part. After 15 days the pig was dissected to observe the changes and the diarrhea and rectum blood experiments were conducted in vivo. Results External control module achieved the real-time control of internal execution prosthesis. The internal execution module could sustainably work 24 h after charging 3 h through TETS. Diarrhea experiment showed that when the pressure of 7.16 kPa was applied on the intestinal wall （normal anorectal resting pressure ：6.26-9.47 kPa） ,the prosthesis could effectively suppress the leakage of intestinal contents. Conclusions AASS could simulate the function of normal sphincter, as a new solution for patients with severe fecal incontinence.