摘要
Abstract
Objective To propose a repeatable,traceable and acoustically valid method for characterizing intravascular lithotripsy(IVL)balloons based on an automated scanning platform to solve the problem of IVL technique in lacking standardized acoustic characterization methods,and to verify the method proposed.Methods Firstly,an automated scanning platform was constructed,consisting primarily of a motion system and a data acquisition system.The motion system included a customized multi-axis platform(radial r,angular θ and axial z)and a programmable logic controller(PLC),while the data acquisition system integrated an IVL balloons(sound source),medium(a water tank),sensors(three pin-type hydrophones)and recording equipment(an oscilloscope and a host computer).Secondly,high-resolution 3D scans of IVL balloons were performed in a simulated physiological environment at 37 ° C to validate the platform's temporal resolution and to evaluate the repeatability and uncertainty of the measurement method.Finally,the platform was used to scan and quantitatively characterize the near-field sound pressure distribution of IVL balloons.Results The automated scanning platform featured a sampling rate of up to 1 GSa/s and rise time of approximately 3.5 ns,enabling distortion-free capture of sub-microsecond transients in the time domain.The relative standard deviation of the measured peak positive pressure p+was 5.3%on average,with high measurement consistency and stability under multi-point and three-dimensional scanning conditions.The combined standard uncertainty was approximately 9.26%,corresponding to an expanded uncer-tainty of approximately 18.5%,indicating high repeatability and reliability in sound pressure measurements.The sound energy was primarily concentrated around four discrete electrode rings,forming an axial"peak-trough"structure;the peak positive pressure p+monotonically decreased with increasing radial distance r;there's slight angular asymmetry in the sound field.Conclusion The proposed acoustic characterization method of IVL balloons gains high accuracy and excellent stability,enabling precise quantitative characterization of the complex acoustic field of IVL balloons.[Chinese Medical Equipment Journal,2026,47(4):65-72]关键词
血管内冲击波/自动化扫描平台/球囊/声学表征/不确定度评定Key words
intravascular lithotripsy/automated scanning platform/balloon/acoustic characterization/uncertainty evalua-tion分类
医药卫生
