Sparker Array for Improved Electrohydraulic Lithotripsy (EHL)

描述（由申请人提供）：冲击波碎石（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多尼尔HM3，这是第一个引入美国的碎石机。HM3是一种电液碎石机（EHL），使用单个水下“火花”作为冲击波源。HM3的缺点是电极腐蚀很快，必须在手术过程中更换，并且会产生明显的副作用。该项目是在小型椭球反射器中开发优化的多个火花阵列，这些火花可以持续几个步骤，并且更有效地破碎石头。在放置火花的灵活性上，为在线探头提供了空间，以便在治疗过程中监测结石的位置，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害。具体的项目目标是优化火花阵列，包括使用双脉冲来打破人工和实际肾结石，开发一种在线探针，并进行动物研究以调查副作用并支持IDE。成功的第二阶段将导致原型的开发和临床研究以及随后的商业化。

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 develop optimized arrays several sparkers in small ellipsoidal reflectors that last for several procedures and break stones more effectively. The flexibility in placement of the sparkers allows space for an in-line 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 optimize sparker arrays, including the use of double pulses by breaking both artificial and actual kidney stones, develop an in-line probe and conduct animal studies to investigate side-effects and to support an IDE. A successful Phase II will lead to the development of a prototype and clinical studies and subsequent commercialization. PUBLIC HEALTH RELEVANCE: This research can lead to improved treatment of kidney stones. A successful new lithotripter will have a higher percentage of successes (reducing the number of repeat procedures), less side effects to the patient and will operate for several procedures without having to replace the sparker (which currently is replaced during each procedure).