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多孔腔镜手术机器人手术器械风险评估及可靠性分析

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多孔腔镜手术机器人是用于开展腹腔微创手术的机器人系统,其中手术器械是与患者身体直接接触的部分,因此其重要度、安全要求极高.同时,因手术器械具有构型复杂、装配工序多等特点,其风险评估和可靠性研究一直是行业内一个难以解决的问题.首先,借助故障模式与影响分析(FMEA)工具,对某款典型手术器械进行了风险分析.其结果表明,机构钢丝-滑轮结构故障发生率较高且危害较大.其次,通过设计钢丝-滑轮结构寿命试验对比分析了不同材质和结构钢丝绳的寿命.试验结果表明,用钨制作的8×19+7×7结构钢丝绳具有最高的使用寿命.然后,通过拟合预紧力与疲劳寿命映射关系,获得钢丝-滑轮机构的疲劳寿命曲线.最后,通过对钨钢丝绳试验结果进行可靠性分析,可求得其疲劳寿命P-S-N曲线图,为钢丝绳使用期限评价和后续风险控制提供了一定的指导.
Risk Assessment and Reliability Analysis of Surgical Instrument of Porous Endoscopic Surgery Robot
Porous endoscopic surgery robot is a robot system used to carry out abdominal minimally invasive surgery,in which the surgical instruments are the parts that directly contact with the patient's body,so their importance and safety requirements are very high.At the same time,surgical instruments have the characteristics of the complex configuration and multiple assembly process,their risk assessment and reliability research has always been a difficult problem to solve in the industry.Firstly,with the help of FMEA tool,the risk analysis of a typical surgical instrument is carried out.The results show that the failure rate of steel wire pulley structure is high and the damage is great.Next through the design of steel wire pulley structure life test,the life of steel wire rope with different materials and structures is analyzed.The test results show that the steel wire rope of 8×19+7×7 structure made of tungsten has the highest service life.Then,the fatigue life curve of the steel-pulley mechanism is obtained by fitting the mapping relationship between the preload force and the fatigue life.Finally,through the reliability analysis of tungsten wire rope test results,the fatigue life P-S-N curve is obtained,which provides certain guidance for the evaluation of wire rope service life and subsequent risk control.

surgical instrumentrisk assessmentreliability analysisFMEAfatigue life

周祁杰、张湘、叶志鹏、王进贤、罗刚银、朱嘉伟、李亚球、李建民、王炳强

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工业和信息化部电子第五研究所,广东 广州 511370

有源医疗器械质量可靠性控制与评价重点实验室,广东 广州 511370

中国科学院苏州生物医学工程技术研究所,江苏 苏州 215163

天津大学机械工程学院,天津 300100

山东威高手术机器人有限公司,山东 威海 264200

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手术器械 风险评估 可靠性分析 故障模式与影响分析 疲劳寿命

广东省药品监督管理局科技创新项目

2021ZDB10

2024

电子产品可靠性与环境试验
工业和信息化部电子第五研究所(中国电子产品可靠性与环境试验研究所) (中国赛宝实验室)

电子产品可靠性与环境试验

影响因子:0.438
ISSN:1672-5468
年,卷(期):2024.42(2)
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