Evaluation of the unscanned soft-tissue thermal index.

The monopole-source solution was used to calculate the three-dimensional complex acoustic pressure field for focused circular apertures in a medium having homogeneous acoustic and thermal properties. The three source diameters were 1, 2, and 4 cm and the eight transmit f-numbers (ratio of the radius of curvature/source diameter) were 0.7, 1.0, 1.3, 1.6, 2.0, 3.0, 4.0, and 5.0. For these focused field geometries, eight ultrasonic frequencies were evaluated (1, 2, 3, 4, 5, 7, 9, and 12 MHz) from which the three-dimensional temperature distribution was calculated using the bio-heat transfer equation in homogeneous, perfused media (attenuation=absorption=0.3 dB/cm-MHz; perfusion length: 1.0 cm). For each of the 192 cases, the acoustic field was normalized to the derated spatial peak, temporal average intensity (I(SPTA.3)) of 720 mW/cm(2), the maximum value allowed by the FDA 510(k) diagnostic ultrasound equipment approval process. Using the normalized acoustic field, the axial temperature increase profiles and the maximum temperature increases (DeltaT(max)) were determined for each case. Also, from the normalized acoustic field, the unscanned soft-tissue thermal index (TIS) was determined. In general, DeltaT(max), TIS, and source power increase with increasing transmit f-number, source diameter, or frequency. The TIS generally underestimates (is less than) DeltaT(max) for f-numbers </=2, conditions for which DeltaT(max)</=0.30 degrees C and TIS</=0.40. This suggests that, for transmit f-numbers </=2, TIS would not need to be displayed according to the ODS display requirements. With the exception of the longer-focus, larger-diameter, higher-frequency sources, TIS generally tracks DeltaT(max) for f-numbers >/=3. These exceptions suggest a breakdown of the ODS procedures far calculating TIS.