Janssen Karmon M, Brand Timothy C, Cunitz Bryan W, Wang Yak-Nam, Simon Julianna C, Starr Frank, Liggitt H Denny, Thiel Jeff, Sorensen Mathew D, Harper Jonathan D, Bailey Michael R, Dunmire Barbrina
1 Department of Urology, Madigan Army Medical Center , Tacoma, Washington.
2 Applied Physics Laboratory, Center for Industrial and Medical Ultrasound, University of Washington , Seattle, Washington.
J Endourol. 2017 Aug;31(8):793-799. doi: 10.1089/end.2017.0167. Epub 2017 Jun 26.
In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration.
Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones.
Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm "skin-to-stone" depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies.
A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.
在超声推进的首次人体试验中，受试者排出了用C5 - 2探头重新定位的残留结石碎片集合。在此，比较了C5 - 2探头与产生更长聚焦束和脉冲持续时间的定制（SC - 50）探头在移动多个碎片方面的有效性和安全性。
有效性通过从由模拟组织材料块中30毫米深、充满水的孔组成的肾盏模型中排出的结石数量来量化。每个探头置于模型下方以逆重力移动结石。对三个不同目标施加持续时间为50毫秒或3秒的单次推进脉冲：两种不同尺寸（1 - 2毫米和2 - 3毫米）的10个碎片以及一块4×7毫米的人体结石。安全性研究包括暴露于10分钟脉冲持续时间极端剂量下的猪肾，包括为期7天的存活研究以及对手术植入结石的急性研究。
尽管在临床试验中取得成功，但C5 - 2探头较短的聚焦束和最长50毫秒的脉冲持续时间能移动结石，但未从模型30毫米深的肾盏中排出任何结石。在相同50毫秒脉冲持续时间下，SC - 50探头的结果类似。与C5 - 2探头相比，SC - 50探头可用的更长（3秒）脉冲在4.5厘米和9.5厘米“皮肤至结石”深度均排出了所有结石，且探头发热更低。在动物研究中使用的10分钟脉冲持续时间内，在肾脏或周围组织中未观察到异常行为、尿液化学、血清化学或组织学发现。
更长的聚焦束和脉冲持续时间在广泛的临床相关穿透深度范围内改善了结石和多个结石碎片从模型中的排出，且在动物研究中未造成肾损伤。
