Non-invasive Promotion of Clearance of Kidney Stones and Fragments

 描述（由申请人提供）：肾结石影响11个美国人中的1个，每年花费100亿美元，这两个数字都在稳步攀升。观察等待是结石管理的首选方法，但没有办法预测结石何时会通过或是否会通过。一旦结石超过5 mm，通常建议进行干预，通常涉及将结石破碎成较小的碎片，然后预计这些碎片会自行通过。多项研究表明，在每年进行的700，000例手术中，这些残留碎片通常不会自行排出，并导致高达50%的症状性结石事件和20%的二次手术。一种能够促进结石碎片通过的非侵入性工具将显著改善肾结石的治疗。技术：超声波推进是一种非侵入性工具，利用声辐射力在收集空间内移动结石。该技术使用现有的商业诊断探头，因此可以通过成像实时监测结石移动。该技术有可能在办公室环境中帮助小结石和碎片通过，在碎石术后立即提高结石清除率，并通过移动阻塞输尿管的结石来缓解疼痛。初步数据：可行性试验的调查结果显示， 在15名受试者中有14名患者的结石重新定位以及6名碎石术后受试者中有4名患者排出了总计30块结石碎片的情况下，对人体安全有效。具体目标：这是一个快速通道提案，将利用第1阶段测试技术进步，并根据这些技术进步形成最终设计规范，用于第2阶段的商业原型开发。第1阶段目标1扩展了我们的技术能力，增强了旨在一次移动一块石头的推动脉冲，以便共同移动一簇小石头碎片。自定义体模模型将用于量化相对于现有窄光束系统的加宽光束的推进效率的改善。该结果将提高操作者清除碎石术后受试者中发现的许多小残留碎片的能力， 很短的时间第2阶段包括整合成像，跟踪结石特有的声学特征，并组建一个焦点小组，以提高系统的可用性，将该技术移植到FDA批准的OEM完整泌尿系统超声系统上，并执行申请研究器械豁免所需的安全性和有效性测试。该提案的结果将是一个临床试验准备就绪，商业上可行的超声推进和成像系统，可以有效地治疗碎石后结石碎片。

 DESCRIPTION (provided by applicant): Kidney stones affect 1 in 11 Americans at an annual cost of $10B, with both numbers steadily climbing. Watchful waiting is the preferred approach to stone management, but there are no means to predict when the stone will pass or if the stone will pass. Intervention is typically recommended once a stone is over 5 mm and usually involves breaking the stone into smaller fragments, which are then expected to pass on their own. Multiple studies have shown that these residual fragments often do not pass on their own and lead to symptomatic stone events in up to 50%, and secondary surgery in 20%, of the 700,000 procedures performed yearly. A non-invasive tool that could facilitate stone fragment passage would significantly improve the management of kidney stones. Technology: Ultrasonic propulsion is a non-invasive tool to move stones within the collecting space using acoustic radiation force. The technology uses an existing commercial diagnostic probe so the stone movement can be monitored in real-time with imaging. The technology has the potential to aid in the passage of small stones and fragments in an office setting, improve stone free rates immediately following lithotripsy procedures, and relieve pain by moving a stone blocking the ureter. Preliminary Data: Investigational results from a feasibility trial has shown the technology to be safe and effective in humans with stone repositioning in 14 of 15 subjects and an aggregate 30 stone fragments passed by 4 of 6 post-lithotripsy subjects. Specific Aims: This is a Fast Track proposal that will use Phase 1 to test technical advances from which final design specifications will be formed for commercial prototype development in Phase 2. Phase 1 Aim 1 expands the capabilities of our technology, augmenting the Push pulse designed to move one stone at a time in order to collectively move a cluster of small stone fragments. A custom phantom model will be used to quantify improvement in the Push efficiency of a broadened beam relative to that of the existing narrow-beam system. The outcome will improve an operator's ability to clear the many small residual fragments found in post-lithotripsy subjects in a short timeframe. Phase 2 includes integrating imaging that tracks an acoustic signature unique to stones and assembling a focus group all to improve the usability of the system, porting the technology onto an FDA-approved, OEM, complete, urological ultrasound system, and performing the safety and effectiveness tests necessary for application for an investigational device exemption. The outcome of this proposal will be a clinical trial-ready, commercially viable ultrasonic propulsion and imaging system that can effectively treat post-lithotripsy stone fragments.