Noninvasive, non-ionizing localization and clearance of kidney stones

无创、非电离定位和清除肾结石

• 批准号: 8153391
• 负责人: MICHAEL R BAILEY
• 金额: $ 57.97万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153391
• 关键词: Accounting; Acoustics; American; Animal Model; Awareness; Calculi; Clinical; Clinical Trials; Clinical Trials Design; Complex; Conduct Clinical Trials; Data; Detection; Devices; Disease; Engineering; Ensure; Excision; Exposure to; Family suidae; Focused Ultrasound Therapy; Goals; Gold; Health Care Costs; Human; Image; Imagery; Injury; Investigation; Ionizing radiation; Kidney; Kidney Calculi; Lead; Lithotripsy; Location; Measurement; Measures; Mechanics; Methodology; Methods; Office Visits; Operative Surgical Procedures; Output; Patients; Physiologic pulse; Population; Procedures; Publications; Publishing; Renal pelvis; Residual state; Resources; Roentgen Rays; Safety; Shock; Software Design; Surgical Management; System; Technology; Testing; Therapeutic; Time; Treatment Cost; Ultrasonography; United States Food and Drug Administration; Ureteroscopy; Urologist; X-Ray Computed Tomography; acoustic imaging; base; cost; design; effective therapy; follow-up; human subject; imaging modality; improved; innovation; meetings; new technology; prototype; success

DESCRIPTION (provided by applicant): Ten percent of the U.S. population will develop kidney stones. Three million Americans seek treatment each year, and total treatment cost is over $2B. Initial success rates range from ~70% to greater than 90% depending on the type of treatment performed, but stones will recur in half the patients within 5 years. Follow- up surgical management of stones is complex and individualized but expends significant resources, creates additional discomfort and can expose the patient to X-rays many times. Small stone fragments in the renal pelvis have a good chance of passing naturally, but fragments located in the lower calyces are more likely to remain and become problematic. We have developed a handheld pulsed-ultrasound device to non-invasively expel stone fragments (or small stones) from the kidney. We have also developed a unique ultrasound imaging method to dramatically enhance the visualization of kidney stones, which provides a safe alternative to the ionizing radiation of plane X-ray and computerized tomography (CT). A prototype device has been engineered from a commercially available diagnostic ultrasound imager and probe. Preliminary results in animal models show we can localize and safely repositioning stones from the lower calyx to the ureteropelvic juncture (UPJ) in less than 5 minutes, a procedure that could easily be completed during an office visit. The objective of this proposal using human subjects is to assess the ability of this device to reposition stone fragments. We will first measure, imaging accuracy of enhanced ultrasound localization compared to CT as the gold standard. In partnership with a regulatory consultant, we will prepare an application to the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to test the therapeutic strategy of repositioning stones in human subjects. The long-term goal is to provide urologists with a new non-invasive surgical option to clear stone fragments and small stones from the kidney. This device would be used to clear residual fragments remaining after shock wave lithotripsy (or invasive stone removal such as ureteroscopy), and could be a means to prophylactically expel small stones from the kidney before they become symptomatic. This stone repositioning device and its complementary stone imaging methodology have the potential to deliver safer, more effective treatments and significantly lower healthcare costs. PUBLIC HEALTH RELEVANCE: The proposal is to transition technology to detect and reposition kidney stones with ultrasound to facilitate stone clearance. As such kidney stone patients who account for 10% of the US population might be spared ionizing radiation of stone detection by x-ray computerized tomography and spared surgery or lithotripsy for initial or follow-on treatment.

描述（由申请人提供）：美国百分之十的人口将发展肾结石。每年有300万美国人寻求治疗，总治疗费用超过$ 2B。根据所进行的治疗类型，初始成功率的范围从〜70％到90％以上，但在5年内，一半的患者会复发一半。对石头的手术管理进行后续管理是复杂且个性化的，但会花费大量资源，造成额外的不适感，并可能使患者多次暴露于X射线。肾脏骨盆中的小石材碎片有很大的机会自然传递，但是位于下部钙的碎片更有可能保留并变得有问题。我们已经开发了一种手持式脉冲脉冲式设备，以从肾脏中非侵入地排出石材碎片（或小石头）。我们还开发了一种独特的超声成像方法，可以显着增强肾结石的可视化，这为平面X射线和计算机层析成像（CT）的电离辐射提供了安全的替代方法。原型设备已通过市售的诊断超声影像仪和探针进行了设计。动物模型的初步结果表明，我们可以在不到5分钟的时间内将石头定位并安全地将石头从下部花萼重新定位到输尿管纤维通知口（UPJ），这一过程可以在办公室访问期间很容易完成。使用人类受试者的该提案的目的是评估该设备重新放置石材碎片的能力。我们将首先测量与CT作为黄金标准相比，增强超声定位的成像精度。与监管顾问合作，我们将为美国食品药品监督管理局（FDA）的申请做准备，以进行研究设备豁免（IDE），以测试重新定位人类受试者石头的治疗策略。长期目标是为泌尿科医生提供一种新的非侵入性外科手术选择，以清除肾脏中的石材碎片和小石头。该设备将用于清除冲击波碎石术（或侵入性石材去除（例如输尿管镜））之后剩余的残留碎片，并且可能是预防性在肾脏中预防小石头的一种手段。这种石材重新定位装置及其互补的石材成像方法有可能提供更安全，更有效的治疗方法，并显着降低医疗保健成本。 公共卫生相关性：该提案是过渡技术，以超声检测和重新放置肾结石，以促进石材间隙。因此，占美国人群10％的肾结石患者可能会通过X射线计算机断层扫描和避免手术或岩石疗法来免除石材检测的电离辐射，以进行初始或后续治疗。