Design, Improvement and Evaluation of a Novel in Situ Implanted Bionic Artificial Anal Sphincter

IF 0.8 4区医学 Q4 ENGINEERING, BIOMEDICAL

Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-07-15 DOI:10.1115/1.4055001

Lichao Wang, G. Yan, Ding Han, Dasheng Liu, Fangfang Hua, Tong Wu

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Abstract

Artificial anal sphincter has gradually become an emerging means of treating anal incontinence. However, most of the systems cannot be implanted in the human body for a long time due to insufficient reliability. Therefore, this paper has designed and improved a novel bionic artificial anal sphincter (BAAS). In order to make it work reliably for a long time, we first optimized and improved key parts to increase their strength. Given the humid working environment in the body, we optimized the design of the waterproof pressure sensor and carried out experimental research on the sealing of the circuit board and the overall sealing. When evaluating the improved system, I used simulation to analyze the structural strength and motion characteristics of the BAAS and used underwater experiments to simulate the human environment to evaluate the waterproofness of the system. The results showed that the strength of the key joint increased by 49.4%, the average clamping time and opening time of the prosthesis were 14.5s and 13.4s, respectively, and the angular velocity of the pendulum rod approaching the intestine was about 4.5°/s, which was in line with the normal defecation process of the human body. The performance is stable and reliable in the 20-day underwater body fluid simulation experiment. BAAS basically meets the application needs of long-term implantation in the treatment of fecal incontinence.

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一种新型原位植入仿生人工肛门括约肌的设计、改进与评价

人工肛门括约肌已逐渐成为治疗肛门失禁的一种新兴手段。然而，由于可靠性不足，大多数系统无法长期植入人体。因此，本文设计并改进了一种新型的仿生人工肛门括约肌（BAAS）。为了使其长期可靠工作，我们首先对关键部件进行了优化和改进，以增加其强度。考虑到体内潮湿的工作环境，我们对防水压力传感器进行了优化设计，并对电路板的密封和整体密封进行了实验研究。在评估改进后的系统时，我使用模拟来分析BAAS的结构强度和运动特性，并使用水下实验来模拟人类环境来评估系统的防水性。结果显示，关键关节的强度增加了49.4%，假体的平均夹紧时间和打开时间分别为14.5s和13.4s，摆杆接近肠道的角速度约为4.5°/s，符合人体正常排便过程。在为期20天的水下体液模拟实验中，该性能稳定可靠。BAAS基本满足了长期植入治疗大便失禁的应用需求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Medical Devices-Transactions of the Asme ENGINEERING, BIOMEDICAL-

CiteScore

1.80

自引率

11.10%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.

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