Benchtop and Initial Clinical Evaluation of the ShockPulse Stone Eliminator in Percutaneous Nephrolithotomy

Benchtop and Initial Clinical Evaluation of the ShockPulse Stone Eliminator in Percutaneous Nephrolithotomy
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DOI:
10.1089/end.2016.0664
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发表时间:
2017-02-01
影响因子:
2.7
通讯作者:
Lange, Dirk
Lange, Dirk
中科院分区:
医学3区
文献类型:
--
作者:
Chew, Ben H.;Matteliano, Andre A.;Lange, Dirk

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目的:对新型ShockPulse (TM)体内碎石机进行标准化台架测试,对比三种市售碎石机系统,以确定性能的差异和细微差别。材料和方法:使用硬(ultra -30)和软(巴黎石膏)的石模,在标准化的实验台上,对ShockPulse体内碎石机与us -2 (TM)、CyberWand (TM)和EMS LithoClast (TM)进行测试。使用体外肾脏模型记录将结石样本破碎成可回收大小的碎片所需的时间。还记录了完全粉碎和疏散石样所需的时间。使用免提装置确定每个装置在不同施加压力下的功效,该装置用于施加1.0磅,1.5磅和2.0磅的固定力。结果:对于硬石和软石,所有系统中产生可回收碎片所需的时间相似(p=0.585)。ShockPulse在完全破碎和疏散石头样本方面明显快于us -2和LithoClast (p=0.046),而CyberWand在这项任务中明显慢于所有三种系统(p=0.001)。当固定的力作用在一个大的石头幻影上时,ShockPulse和CyberWand的速度明显快于us -2和LithoClast
Purpose: Standardized bench testing of the new ShockPulse (TM) intracorporeal lithotripter was performed against three commercially available lithotripsy systems to determine differences and nuances in performance.Materials and Methods: The ShockPulse intracorporeal lithotripter was tested against the LUS-2 (TM), CyberWand (TM), and EMS LithoClast (TM) in a standardized bench setting using hard (Ultracal-30) and soft (plaster of Paris) stone phantoms. An in vitro kidney model was used to record the time needed to fragment stone samples into retrievable-sized pieces. The time needed to fully comminute and evacuate stone samples was also recorded. The efficacy of each device at various applied pressures was determined using a hands-free apparatus, which was used to apply 1.0, 1.5, and 2.0 pounds of fixed force.Results: For hard and soft stones, the time needed to create retrievable fragments was similar among all systems (p=0.585). The ShockPulse was significantly faster than the LUS-2 and LithoClast at fully fragmenting and evacuating stone samples (p=0.046), while the CyberWand was significantly slower than all three systems at this task (p=0.001). When fixed forces were applied to a large stone phantom, the ShockPulse and CyberWand were significantly faster than the LUS-2 and LithoClast (p