Sparker Array for Improved Electrohydraulic 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。 本计画是开发最佳化的阵列，数个电火花在小的椭球面反射器，持续数个程序，更有效地打破石头。火花器放置的灵活性为在线探头提供了空间，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。 具体项目目标是优化火花阵列，包括使用双脉冲来破碎人造和实际肾结石，开发在线探针并进行动物研究以调查副作用并支持IDE。第二阶段的成功将导致原型和临床研究的开发以及随后的商业化。

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.