Sparker Array for Improved Electro-Hydraulic Lithotripsy (EHL)

说明(申请人提供)：冲击波碎石术(SWL)是大多数肾结石患者的一线治疗方法。SWL的黄金标准仍然被认为是Dornier HM3，这是第一个引入美国的碎石机。HM3是一种电液压碎石机(EHL)，它使用单一的水下“火花”作为冲击波来源。HM3的缺点是电极腐蚀快，必须在操作过程中更换，并会产生显著的副作用。这个项目是为了证明，在小椭球反射器中的几个火花阵列可以在不必停止程序的情况下打破石头。阵列中每个火花块中的相对较低的电流减少了侵蚀，这可以允许火花块阵列操作用于多个治疗。电火花的灵活放置为在线超声探头提供了空间，以便在治疗期间监测结石的位置，这将导致更少的压力脉冲遗漏结石，并减少对周围组织的损害。该项目的具体目标是开发一种火花阵列，并通过在不必更换电极的情况下打破人造石头来展示其功效。成功的第一阶段将导致第二阶段，以开发原型并展示改善临床结果的潜力。 公共卫生相关性：这项研究可以改进肾结石的治疗。成功的新碎石机既有更高的成功率(减少重复手术的次数)，又对患者的副作用较少。

DESCRIPTION (provided by applicant): Shock wave lithotripsy (SWL) is the first line treatment for the majority of patients with kidney stones. The gold standard in SWL is still considered to be the Dornier HM3, which was the first lithotripter introduced into the US. The HM3 is an electrohydraulic lithotripter (EHL) that uses a single underwater "sparker" as a shock wave source. The HM3 has the drawback that the electrodes erode quickly and must be replaced in the middle of a procedure, and causes significant side effects. This project is to demonstrate that an array of several sparkers in small ellipsoidal reflectors can break stones without having to stop a procedure. The relatively low electrical current in each sparker in the array reduces the erosion, which may allow the sparker array to operate for multiple treatments. The flexibility in placement of the sparkers allows space for an in-line ultrasound probe to monitor stone location during treatment, which will result in fewer pressure pulses missing the stone and reduce damage to surrounding tissue. The specific project objectives are to develop a sparker array and demonstrate its efficacy by breaking artificial stones without having to replace electrodes. A successful Phase I will lead to a Phase II to develop a prototype and demonstrate the potential for improved clinical outcomes. PUBLIC HEALTH RELEVANCE: This research can lead to improved treatment of kidney stones. A successful new lithotripter will have both a higher percentage of successes (reducing the number of repeat procedures) and less side effects to the patient.