A Continuum Over Tube with Variable Stiffness for Transrectal Notes

IF 0.8 4区 医学 Q4 ENGINEERING, BIOMEDICAL Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-04-14 DOI:10.1115/1.4054343
Jinhua Li, Lan Zhang, Yuan Xing, R. Liu
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Abstract

Background: The continuum over tube applied to natural orifice transluminal endoscopic surgery (NOTES) should be flexible during insertion and provide sufficient stiffness upon arrival at the lesion. In order to satisfy these two properties, a variable stiffness continuum over tube was proposed. Method: The over tube realizes stiffness variation through the heating and cooling of filling materials. Polyethylene glycol, cocoa butter and gallium metal are selected as filling materials. Several experiments were designed to test its rigid and response characteristic and suitable material was selected. The risk management test was carried out, and the frequency and risk level of the risk point was recorded. Results: According to experimental data, the polyethylene glycol and gallium shows better variable stiffness performance, with the 20 times stiffness variation range, and polyethylene glycol was selected as suitable materials for its low cost and non-toxic characteristic. The average heating time and cooling time of polyethylene glycol-filled over tube are 52.3s and 36s respectively. Moreover, three kinds of high frequency risk points including smoke, thread ejection and uneven distribution of the material were found, and corresponding design improvement and use principle are proposed. Conclusion: The proposed continuum over tube can satisfy the requirement of colorectal NOTES, and the safety of the instrument can be improved by controlling high frequency risk points with relevant methods.
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用于经直肠票据的变刚度管上连续体
背景:应用于自然孔腔内窥镜手术(NOTES)的连续管在插入过程中应具有灵活性,并在到达病变处时提供足够的硬度。为了满足这两个性质,提出了一种管上变刚度连续体。方法:外套管通过对填充材料的加热和冷却来实现刚度的变化。填充材料选用聚乙二醇、可可脂和金属镓。设计了几个实验来测试其刚性和响应特性,并选择了合适的材料。进行了风险管理测试,并记录了风险点的频率和风险水平。结果:根据实验数据,聚乙二醇和镓表现出更好的变刚度性能,刚度变化范围为20倍,聚乙二醇因其低成本和无毒特性而被选为合适的材料。管内填充聚乙二醇的平均加热时间和冷却时间分别为52.3s和36s。此外,还发现了冒烟、螺纹弹出和材料分布不均匀三种高频危险点,并提出了相应的设计改进和使用原则。结论:所提出的连续管可以满足结直肠NOTES的要求,通过相关方法控制高频危险点可以提高仪器的安全性。
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来源期刊
CiteScore
1.80
自引率
11.10%
发文量
56
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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