A passive acoustic device for real-time monitoring of the efficacy of shockwave lithotripsy treatment.

Extracorporeal shockwave lithotripsy (ESWL) is the preferred modality for the treatment of renal and ureteric stone disease. Currently X-ray or ultrasound B-scan imaging are used to locate the stone and to check that it remains targeted at the focus of the lithotripter during treatment. Neither imaging modality is particularly effective in allowing the efficacy of treatment to be judged during the treatment session. A new device is described that, when placed on the patient's skin, can passively monitor the acoustic signals that propagate through the body after each lithotripter shock, and which can provide useful information on the effectiveness of targeting. These acoustic time histories are analyzed in real time to extract the two main characteristic peak amplitudes (m(1) and m(2)) and the time between these peaks (t(c)). A set of rules based on the acoustic parameters was developed during a clinical study in which a complete set of acoustic and clinical data was obtained for 30 of the 118 subjects recruited. The rules, which complied with earlier computational fluid dynamics (CFD) modeling and in vitro tests, allow each shock to be classified as "effective" or "ineffective." These clinically-derived rules were then applied in a second clinical study in which complete datasets were obtained for 49 of the 85 subjects recruited. This second clinical study demonstrated almost perfect agreement (kappa = 0.94) between the number of successful treatments, defined as >50% fragmentation as determined by X-ray at the follow-up appointment, and a device-derived global treatment score, TS(0), a figure derived from the total number of effective shocks in any treatment. The acoustic system is shown to provide a test of the success of the treatment that has a sensitivity of 91.7% and a specificity of 100%. In addition to the predictive capability, the device provides valuable real-time feedback to the lithotripter operator by indicating the effectiveness of each shock, plus an indication TS(t) of the cumulative effectiveness of the shocks given so far in any treatment, and trends in key parameters. This feedback would allow targeting adjustments to be made during treatment. An example is given of its application to mistargeting because of respiration. tgl@soton.ac.uk