Sparker Array for Improved Electro-Hydraulic Lithotripsy (EHL)

描述（由申请人提供）：冲击波碎石术（SWL）是大多数肾结石患者的一线治疗。SWL的黄金标准仍然被认为是Dornier HM 3，这是第一台引入美国的碎石机。HM 3是一种电液碎石机（EHL），使用单个水下“火花”作为冲击波源。HM 3的缺点是电极腐蚀很快，必须在手术过程中更换，并导致严重的副作用。 这个项目是为了证明，一个小的椭球反射器阵列的几个火花可以打破石头，而不必停止一个程序。阵列中的每个火花器中的相对低的电流减少了腐蚀，这可以允许火花器阵列操作用于多次治疗。火花器放置的灵活性为在线超声探头提供了空间，以在治疗期间监测结石位置，这将导致更少的压力脉冲错过结石并减少对周围组织的损伤。 项目的具体目标是开发一种电火花阵列，并通过在不更换电极的情况下破碎人造石头来证明其功效。一个成功的第一阶段将导致第二阶段开发一个原型，并证明改善临床结果的潜力。 公共卫生相关性：这项研究可以改善肾结石的治疗。一台成功的新碎石机将有更高的成功率（减少重复手术的次数）和更少的副作用。

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.