Department of Instrument Science and Engineering, Shanghai Jiao Tong University, Shanghai, China.
Artif Organs. 2020 Jul;44(7):E300-E312. doi: 10.1111/aor.13645. Epub 2020 Feb 20.
While fecal incontinence (FI) is not fatal, it can dramatically decrease the patient's quality of life. An artificial anal sphincter (AAS) is an implantable device that treats FI by replacing a diseased or damaged anal sphincter, thus allowing the patient's continence to be maintained. Here, we report a novel implantable puborectalis-like artificial anal sphincter (PAAS) that replicates rectal perception and has a low risk of ischemia necrosis. Using the pressure sensors embedded in the PAAS, the relationship between the mass of feces and the pressure was determined, and a feces mass estimation model was developed based on in vitro studies. Rectal perception is provided through the real-time monitoring of rectal feces, and the feeling of defecation is quantified based on a comparison between the feces mass and a preset threshold mass. In vivo studies were performed for validation, and the accuracy of the model was determined to be as high as 90%. The performance of the PAAS in the real-time monitoring of rectal feces and its in vivo biocompatibility were also evaluated. The device should further the functionality of existing AAS systems while improving their biosafety and thus expand the applicability of implantable AAS systems in the treatment of FI.
虽然粪便失禁 (FI) 不会致命，但它会显著降低患者的生活质量。人工肛门括约肌 (AAS) 是一种可植入装置，通过替代患病或受损的肛门括约肌来治疗 FI，从而维持患者的节制能力。在这里，我们报告了一种新型可植入的耻骨直肠肌样人工肛门括约肌 (PAAS)，它可以复制直肠感知，并且缺血坏死的风险较低。通过在 PAAS 中嵌入的压力传感器，确定了粪便质量与压力之间的关系，并基于体外研究开发了一种粪便质量估计模型。通过实时监测直肠粪便来提供直肠感知，并根据粪便质量与预设阈值质量的比较来量化排便感。进行了体内研究以验证，模型的准确性高达 90%。还评估了 PAAS 在直肠粪便实时监测中的性能及其体内生物相容性。该设备应在提高现有 AAS 系统生物安全性的同时提高其功能，从而扩大可植入 AAS 系统在 FI 治疗中的适用性。
