Noninvasive, non-ionizing localization and clearance of kidney stones

描述（由申请人提供）：10%的美国人口将患肾结石。每年有300万美国人寻求治疗，总治疗费用超过20亿美元。初始成功率范围从约70%到大于90%，取决于所进行的治疗类型，但结石会在5年内复发。结石的后续手术管理是复杂的和个性化的，但消耗大量资源，产生额外的不适，并可能使患者多次暴露于X射线。肾盂中的小结石碎片有很好的机会自然通过，但位于下肾盏的碎片更有可能残留并成为问题。我们开发了一种手持式脉冲超声设备，可以无创地从肾脏排出结石碎片（或小结石）。我们还开发了一种独特的超声成像方法，以显着提高肾结石的可视化，这提供了一个安全的替代电离辐射的平面X射线和计算机断层扫描（CT）。一个原型设备已经从市售的诊断超声成像仪和探头工程。动物模型的初步结果表明，我们可以在不到5分钟的时间内将结石从下肾盏定位并安全地重新定位到肾盂输尿管交界处（UPJ），这是一个可以在诊所就诊时轻松完成的过程。本提案使用人类受试者的目的是评估该器械重新定位结石碎片的能力。我们将首先测量增强超声定位的成像准确性，并将其与CT作为金标准进行比较。我们将与监管顾问合作，准备向美国食品药品监督管理局（FDA）申请研究器械豁免（IDE），以测试在人类受试者中重新定位结石的治疗策略。长期目标是为泌尿科医生提供一种新的非侵入性手术选择，以清除肾脏中的结石碎片和小结石。该装置将用于清除冲击波碎石术（或侵入性结石清除术，如输尿管镜检查）后残留的残余碎片，并可在出现症状前将小结石从肾脏中排出。这种结石复位装置及其补充结石成像方法有可能提供更安全，更有效的治疗，并显着降低医疗成本。 公共卫生相关性：该提案旨在过渡技术，通过超声检测和重新定位肾结石，以促进结石清除。因此，占美国人口10%的肾结石患者可以通过X射线计算机断层扫描避免结石检测的电离辐射，并避免手术或碎石术进行初始或后续治疗。

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.