基于自动化扫描平台的血管内冲击波球囊声学表征方法及验证OA
Acoustic characterization method and validation of intravascular shock wave balloons based on automated scanning platform
目的:针对血管内冲击波(intravascular lithotripsy,IVL)技术缺乏标准化声学表征方法的现状,基于自动化扫描平台,提出可重复、可溯源且符合声学特性的IVL球囊声学表征方法,并对提出的方法进行验证.方法:首先,搭建主要由运动系统及采集系统组成的自动化扫描平台,其中,运动系统包含定制的多轴平台(径向r、角向θ、轴向z)与可编程逻辑控制器(programmable logic controller,PLC),采集系统集成了IVL球囊(声源)、介质(水箱)、传感器(3支针式水听器)与记录设备(示波器及上位机).其次,在37℃的模拟生理环境中对IVL球囊进行高分辨率三维扫描,验证该平台的时间分辨率,并对测量方法的重复性与不确定度进行评定.最后,利用该平台对IVL球囊的近场声压分布进行扫描及定量表征.结果:自动化扫描平台的采样率高达1 GSa/s,上升时间约为3.5 ns,在时间域上能够无失真地捕捉亚微秒级瞬态特征.测得的峰值正压p+相对标准偏差的平均值为5.3%,在多点、三维扫描条件下保持了较好的测量一致性与稳定性.最终合成标准不确定度约为9.26%,对应扩展不确定度约为18.5%,在声压测量中的可重复性与可靠性较高.声能量主要集中在4个离散的电极环周围,形成轴向的"峰-谷"结构;峰值正压p+均随径向距离r的增大而单调衰减;声场在角向上存在轻微的非对称性.结论:提出的IVL球囊声学表征方法精度高、稳定性好,能够实现对IVL球囊复杂声场的精确定量表征.
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]
陆凌峰;周雪
上海市医疗器械检验研究院,上海 201318上海市医疗器械检验研究院,上海 201318
医药卫生
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
intravascular lithotripsyautomated scanning platformballoonacoustic characterizationuncertainty evalua-tion
《医疗卫生装备》 2026 (4)
65-72,8
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