Non-invasive Promotion of Clearance of Kidney Stones and Fragments

无创促进肾结石和碎片的清除

• 批准号: 9144610
• 负责人: Oren Levy
• 金额: $ 73.69万
• 依托单位: SONOMOTION, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9144610
• 关键词: Acoustics; Affect; American; Animal Model; Clinical Trials; Custom; Data; Development; Devices; Diagnostic; Documentation; Economic Burden; Effectiveness; Emergency department visit; Event; FDA approved; Family suidae; Focus Groups; Guidelines; Health; Heating; Human; Image; In Vitro; Individual; Intervention; Kidney; Kidney Calculi; Laser Lithotripsy; Lead; Lithotripsy; Marketing; Measurement; Medical; Methods; Monitor; Movement; Operative Surgical Procedures; Outcome; Pain; Patient observation; Phase; Physiologic pulse; Procedures; Production; Radiation; Recurrence; Research; Residual state; Retreatment; Safety; Shipping; Ships; Shock; Skin; Surface; System; Technology; Testing; Time; Ultrasonics; Ultrasonography; Ureter; Urologic Diseases; Urologist; Urology; Width; base; cost; design; effectiveness clinical trial; imaging system; improved; in vivo; interest; meetings; minimally invasive; new technology; phantom model; prototype; tool; urolithiasis; urologic; usability

 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.

 描述（由适用提供）：肾结石以每年的成本为10B美元，影响11名美国人中有1个，这两个数字都在悄然攀登。注意等待是石材管理的首选方法，但是没有任何方法可以预测石头何时会通过或石头是否会通过。通常建议一旦石头超过5毫米，通常建议干预，通常涉及将石头分解成较小的碎片，然后预计会自行通过。多项研究表明，这些残留碎片通常不会自行传递，并导致高达50％的症状石事件，而在每年执行的70万手术中，有20％的继发性手术。一种可以促进石材碎片通道的非侵入性工具将显着改善肾结石的管理。技术：超声推进是一种非侵入性工具，可以使用声学辐射力在收集空间中移动石头。该技术使用现有的商业诊断探针，因此可以通过成像实时监控石材机芯。该技术有可能在办公环境中通过小石头和碎片的通过，在岩石疗法后立即提高无石率，并通过移动一块堵塞输尿管来挽救疼痛。初步数据：可行性试验的研究结果显示了该技术 为了在15个受试者中有14名重新定位的人类中的人类安全和有效，并且有30个石材碎片，占6个后腹膜后受试者中的4个。具体目的：这是一个快速的轨道提案，将使用第1阶段来测试技术进步，该技术将在第2阶段中形成最终设计规范，以在第2阶段的商业原型开发中形成。第1阶段目标1扩展了我们技术的能力，增强了旨在一次移动一块石材的推动脉冲，以便集体移动一群小石头碎片。自定义幻影模型将用于量化相对于现有窄光束系统的推广光束推动效率的提高。结果将提高操作员清除腹部后术中发现的许多小残留片段的能力 短时间。第2阶段包括集成成像，该成像跟踪石材独有的声音签名并组装焦点组，以提高系统的可用性，将技术移植到FDA批准的，OEM，完整的，完整的泌尿外识超声系统上，并执行用于用于调查设备的应用所需的安全性和有效性测试。该提案的结果将是一个可以有效治疗腹膜后的石材碎片的临床试验，商业上可行的超声推进和成像系统。