Department of Urology, University of Washington School of Medicine, Seattle, WA.
Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Urology. 2014 Aug;84(2):484-9. doi: 10.1016/j.urology.2014.04.041. Epub 2014 Jun 26.
To provide an update on a research device to ultrasonically reposition kidney stones transcutaneously. This article reports preclinical safety and effectiveness studies, survival data, modifications of the system, and testing in a stone-forming porcine model. These data formed the basis for regulatory approval to test the device in humans.
The ultrasound burst was shortened to 50 ms from previous investigations with 1-s bursts. Focused ultrasound was used to expel 2- to 5-mm calcium oxalate monohydrate stones placed ureteroscopically in 5 pigs. Additionally, de novo stones were imaged and repositioned in a stone-forming porcine model. Acute safety studies were performed targeting 2 kidneys (6 sites) and 3 pancreases (8 sites). Survival studies followed 10 animals for 1 week after simulated treatment. Serum and urine analyses were performed, and tissues were evaluated histologically.
All ureteroscopically implanted stones (6/6) were repositioned out of the kidney in 14 ± 8 minutes with 13 ± 6 bursts. On average, 3 bursts moved a stone more than 4 mm and collectively accounted for the majority of relocation. Stones (3 mm) were detected and repositioned in the 200-kg stone-forming model. No injury was detected in the acute or survival studies.
Ultrasonic propulsion is safe and effective in the porcine model. Stones were expelled from the kidney. De novo stones formed in a large porcine model were repositioned. No adverse effects were identified with the acute studies directly targeting kidney or pancreatic tissue or during the survival studies indicating no evidence of delayed tissue injury.
介绍一种经皮超声碎石复位研究设备的最新进展。本文报告了临床前安全性和有效性研究、生存数据、系统改进以及在结石形成的猪模型中的测试结果。这些数据为该设备在人体中进行测试的监管批准提供了依据。
将超声脉冲从之前的 1 秒缩短至 50 毫秒，然后使用聚焦超声将输尿管镜下放置的 2-5 毫米草酸钙一水合物结石排出。此外，还对新形成的结石进行了成像和重新定位。对 2 个肾脏（6 个部位）和 3 个胰腺（8 个部位）进行了急性安全性研究。对 10 只动物进行了 1 周的模拟治疗后的生存研究。进行了血清和尿液分析，并进行了组织学评估。
所有经输尿管镜植入的结石（6/6）均在 14±8 分钟内通过 13±6 次脉冲重新定位到肾脏以外。平均而言，3 次脉冲使结石移动超过 4 毫米，并且共同导致了大部分重新定位。在 200 公斤的结石形成模型中检测到并重新定位了 3 毫米的结石。在急性或生存研究中均未发现损伤。
超声推进在猪模型中是安全有效的。结石从肾脏中排出。在大型猪模型中形成的新结石被重新定位。直接针对肾脏或胰腺组织的急性研究或生存研究均未发现不良反应，表明没有迟发性组织损伤的证据。
