Center for Devices and Radiological Health, US Food and Drug Administration, Building 62, 10902 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
J Acoust Soc Am. 2010 Jan;127(1):549-59. doi: 10.1121/1.3257547.
Experiments and computations were performed to study factors affecting thermal safety when high-intensity focused ultrasound (HIFU) beams are normally incident (i.e., beam axis normal to the interface) upon a bone/soft-tissue interface. In particular, the temperature rise and thermal dose were determined as a function of separation between the beam focus and the interface. Under conditions representative of clinical HIFU procedures, it was found that the thermal dose at the bone surface can exceed the threshold for necrosis even when the beam focus is more than 4 cm from the bone. Experiments showed that reflection of the HIFU beam from the bone back into the transducer introduced temperature fluctuations of as much as +/-15% and may be an important consideration for safety analyses at sufficiently high acoustic power. The applicability of linear propagation models in predicting thermal dose near the interface was also addressed. Linear models, while underpredicting thermal dose at the focus, provided a conservative (slight overprediction) estimate of thermal dose at the bone surface. Finally, temperature rise due to absorption of shear waves generated by the HIFU beam in the bone was computed. Modeling shear-wave propagation in the thermal analysis showed that the predicted temperature rise off axis was as much as 30% higher when absorption of shear waves is included, indicating that enhanced heating due to shear-wave absorption is potentially important, even for normally incident HIFU beams.
进行了实验和计算,以研究当高强度聚焦超声(HIFU)光束垂直入射(即,光束轴垂直于界面)于骨/软组织界面时影响热安全性的因素。特别是,确定了温度升高和热剂量作为光束焦点与界面之间的分离的函数。在代表临床 HIFU 程序的条件下,即使在光束焦点距离骨骼超过 4 厘米的情况下,也发现骨表面的热剂量可能超过坏死的阈值。实验表明,从骨骼反射回换能器的 HIFU 光束会引起高达 +/-15%的温度波动,并且在足够高的声功率下,这可能是安全分析的重要考虑因素。还讨论了线性传播模型在预测界面附近热剂量的适用性。线性模型虽然低估了焦点处的热剂量,但在骨骼表面提供了热剂量的保守(轻微高估)估计。最后,计算了由于 HIFU 光束在骨骼中产生的剪切波吸收引起的温度升高。在热分析中模拟剪切波传播表明,当包括剪切波吸收时,轴外预测的温度升高高达 30%,这表明由于剪切波吸收引起的加热增强是非常重要的,即使对于垂直入射的 HIFU 光束也是如此。