A Novel Protection Device for Shock Wave Lithotripter

描述（由申请人提供）： 冲击波碎石术（Shock Wave Lithotripsy，SWL）于20世纪80年代初由德国的Dornier Medical System成功地引入临床。目前已成为治疗泌尿系结石病的主要手段。然而，SWL也可引起急性肾损伤，如出血、血肿、水肿和肾肿大。虽然大多数患者在治疗后恢复良好，但也有一些亚组的患者患慢性损伤的风险要高得多。这些患者包括孤立肾患者、既存高血压患者，特别是儿童和老年患者。目前市售的碎石机均未配备任何保护装置，以保证患者在碎石过程中的安全。该提案的目的是将一项新技术商业化为一种开发产品，用于显著减少冲击波引起的组织损伤，而不影响结石粉碎能力。具体而言，我们的目标是1）开发一种创新技术，以减少边缘波对气泡空化的贡献，2）开发一种基于新型原位边缘波抑制技术的原型保护装置，3）评估保护装置在肾破裂和结石粉碎倾向方面的性能，4）验证波形反转、阻断、散射等多种方法对碎石机场边缘波修正的可行性。优化保护装置的设计和使用。将对整个碎石机系统进行全面的物理表征，包括声场绘图、空化活动评估、气泡空化高速成像以及结石破碎和血管破裂的体模研究。还将进行标准质量保证试验，即对冲击波诱导气泡空化的抑制效果的稳定性、结石碎片的一致性。这项研究将产生全球性的影响，并对尿路结石患者和碎石机制造商的临床管理产生重大效益。

DESCRIPTION (provided by applicant): The shock wave lithotripsy (SWL) was first introduced successfully in clinical treatment in the earlier 1980s by Dornier Medical System in Germany. Now it has become the modality for urolithiasis diseases. However, SWL also causes acute renal injury, such as hemorrhage, hematoma, edema and enlargement of kidney. Although most patients recover well following treatment, there are subgroups of patients who are at much higher risk for chronic injury. These include patients with solitary kidneys, preexisting hypertension and, in particular, pediatric and elderly patients. Now none of the currently commercial lithotripters has been instrumented with any protection device for patient's safety in lithotripsy. The objective of this proposal is to commercialize a novel technology into a developed product for significant reduction of shock wave induced tissue injury without compromising stone comminution ability. Specifically, our aims are 1) to develop an innovative technique to reduce the contribution of edge wave to bubble cavitation, 2) to develop a prototype protection device based on the novel in situ edge wave suppression technique, 3) to evaluate the performance of the protection device in terms of the propensity of renal rupture and stone comminution, 4) to test the feasibility of diverse methods on modifying edge wave in lithotripter field, such as waveform inverting, blocking and scattering etc., and 5) to optimize the design and usage of protection device. A comprehensive physical characterization of the complete lithotripter system will be carried out, including acoustic field mapping, assessment of cavitation activities, high-speed imaging on bubble cavitation and phantom studies of stone fragmentation and vessel rupture. Standard quality assurance test, stability of suppression effect on shock wave induced bubble cavitation, consistency in stone fragments, will also be performed. This study would generate worldwide impact and significant benefit to the clinical management of patients suffering urolithiasis and the lithotripter manufacturers.