介入式心室辅助装置可靠性试验方法学研究

Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device

介入式心室辅助装置在临床应用前要对其进行体外可靠性试验。目前尚没有适用于介入式心室辅助装置的可靠性测试装置和方法。该研究从试验可靠性角度出发,结合介入式心室辅助装置的结构和功能特点,对介入式心室辅助装置的试验测试装置、临床工况、失效模式与效应分析和评价模型进行多角度研究。通过该研究形成了一套针对介入式心室辅助装置的工程化解决方案,对于规范介入式心室辅助装置可靠性评价具有借鉴意义。

Prior to clinical application,reliability of percutaneous ventricular assist devices(pVAD)requires to be tested systematically.Currently,there's a lack of dedicated reliability testing equipment and methodologies for pVAD.Considering the structural and functional aspects of percutaneous ventricular assist devices,this study conducts research on pVAD reliability test engineering.Test setups,clinical conditions,failure modes,effects analysis,and evaluation models have been investigated.A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed.This study offers valuable insights into standardizing their reliability evaluation in clinical settings.