Non-invasive Promotion of Clearance of Kidney Stones and Fragments

 描述(由申请人提供)：肾结石影响每11个美国人中就有一个，每年的成本为100亿美元，而且这两个数字都在稳步上升。谨慎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毫米，通常建议进行干预，通常包括将结石粉碎成更小的碎片，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转移，并导致高达50%的症状性结石事件，以及20%的二次手术。一种可以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：超声波推进是一种利用声辐射力在收集空间内移动石头的非侵入性工具。这项技术使用了现有的商业诊断探头，因此可以通过成像实时监控结石的移动。这项技术有可能帮助办公室环境中的小结石和碎片通过，在碎石手术后立即提高结石排净率，并通过移动结石阻塞输尿管来缓解疼痛。初步数据：可行性试验的调查结果表明，这项技术 在人类中安全有效，15名患者中有14名患者进行了结石复位，6名碎石患者中有4名患者总共排出了30块结石碎片。具体目标：这是一个快速通道提案，将使用第一阶段来测试技术进步，在第二阶段将形成最终的设计规范，用于商业原型开发。第一阶段目标1扩展了我们技术的能力，增强了推力脉冲，设计为一次移动一块石头，以便集体移动一簇小石头碎片。一个定制的体模模型将被用来量化加宽光束相对于现有窄光束系统的推动效率的提高。结果将提高操作员清除碎石后患者体内发现的许多微小残留物的能力 一个很短的时间框架。第二阶段包括整合追踪石头特有声学特征的成像技术，组建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完整的泌尿系超声系统上，并执行申请研究设备豁免所需的安全和有效性测试。这项提议的结果将是一种临床试验就绪、商业上可行的超声波推进和成像系统，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.