Focused ultrasound to displace renal calculi: threshold for tissue injury
Yak-Nam Wang1, Julianna C Simon1, Bryan W Cunitz1
1Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, 1013 NE 40th Street, Seattle, WA 98105, USA.
Background:
The global prevalence and incidence of renal calculi is reported to be increasing. Of the patients that undergo surgical intervention, nearly half experience symptomatic complications associated with stone fragments that are not passed and require follow-up surgical intervention. In a clinical simulation using a clinical prototype, ultrasonic propulsion was proven effective at repositioning kidney stones in pigs. The use of ultrasound to reposition smaller stones or stone fragments to a location that facilitates spontaneous clearance could therefore improve stone-free rates. The goal of this study was to determine an injury threshold under which stones could be safely repositioned.
Methods:
Kidneys of 28 domestic swine were treated with exposures that ranged in duty cycle from 0%-100% and spatial peak pulse average intensities up to 30 kW/cm(2) for a total duration of 10 min. The kidneys were processed for morphological analysis and evaluated for injury by experts blinded to the exposure conditions.
Results:
At a duty cycle of 3.3%, a spatial peak intensity threshold of 16,620 W/cm(2) was needed before a statistically significant portion of the samples showed injury. This is nearly seven times the 2,400-W/cm(2) maximum output of the clinical prototype used to move the stones effectively in pigs.
Conclusions:
The data obtained from this study show that exposure of kidneys to ultrasonic propulsion for displacing renal calculi is well below the threshold for tissue injury.
Insights
Ultrasonic propulsion effectively repositions kidney stones, with safety thresholds significantly exceeding therapeutic levels. This technology offers a promising approach to improve stone-free rates and reduce complications from renal calculi.
Area of Science:
- Biomedical Engineering
- Nephrology
- Medical Ultrasound
Background:
- Increasing global incidence of renal calculi (kidney stones).
- High rates of complications and re-intervention after surgical stone removal.
- Previous studies demonstrated ultrasonic propulsion's efficacy in repositioning kidney stones in pigs.
Purpose of the Study:
- To determine the tissue injury threshold for ultrasonic propulsion used in kidney stone repositioning.
- To establish safety parameters for using ultrasound to facilitate spontaneous clearance of renal calculi.
Main Methods:
- Exposure of 28 swine kidneys to varying duty cycles (0%-100%) and intensities (up to 30 kW/cm²).
- Morphological analysis of kidney tissues by blinded experts to assess injury.
- Evaluation of injury thresholds at specific duty cycles and spatial peak pulse average intensities.
Main Results:
- A statistically significant injury threshold was observed at a spatial peak intensity of 16,620 W/cm² with a 3.3% duty cycle.
- This threshold is approximately seven times higher than the maximum output of the clinical prototype used for stone repositioning.
- No significant tissue injury was observed at therapeutic levels of ultrasonic propulsion.
Conclusions:
- Ultrasonic propulsion for displacing renal calculi is safe and operates well below the identified tissue injury threshold.
- The findings support the potential of ultrasound to improve stone-free rates and reduce complications associated with kidney stones.
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