A Novel Protection Device for Shock Wave Lithotripter

描述(由申请人提供)： 冲击波碎石术(SWL)于20世纪80年代初由德国多尼尔医疗系统首次成功引入临床治疗。现在，它已成为尿石症疾病的治疗手段。然而，SWL也会引起急性肾损伤，如出血、血肿、水肿和肾脏增大。虽然大多数患者经过治疗后恢复良好，但也有一些患者亚组患慢性损伤的风险要高得多。这些患者包括有孤立肾脏、既有高血压的患者，尤其是儿科和老年患者。目前商业化的碎石机都没有配备任何保护患者碎石安全的装置。这项提议的目的是将一项新技术商业化，开发出一种产品，在不影响结石粉碎能力的情况下，显著减少冲击波引起的组织损伤。具体地说，我们的目标是1)开发一种创新的技术来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保护装置原型，3)从肾破裂和结石粉碎的倾向来评估保护装置的性能，4)测试各种修改边缘波的方法在碎石机领域中的可行性，如波形反转、阻断和散射等，以及5)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，包括声场测绘、空化活动评估、气泡空化的高速成像以及结石破碎和血管破裂的体模研究。还将进行标准的质量保证测试，对冲击波引起的气泡空化的抑制效果的稳定性，以及石块的一致性。这项研究将对尿路结石患者和碎石器制造商的临床管理产生重大影响和重大裨益。

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.