Ballistic devices that generate radial pressure waves are used for the treatment of different therapeutic indications. In order to assess the effectiveness of these devices and to interpret and transfer the results of clinical trials, it is important to know their acoustic output. In this paper, two ballistic devices and their reproducibility at different clinically relevant settings were investigated in the same in-vitro test setup. Pressure curves were measured in water at different intensity levels and pulse repetition rates. The sound field parameters (peak pressures, positive pulse intensity integral) were calculated from the pressure curves. Additionally, the surface velocity of the applicator was determined in air using a vibrometer. Both devices show a good pulse-to-pulse reproducibility. While the peak maximum pressure and the positive pulse intensity integral decrease only slightly (pmax up to 12%, PII+ up to 18.8%) comparing 1 Hz and 25 Hz for one device, they drop sharply (pmax up to 68.4%, PII+ up to 90.2%) for the other device comparing 1 Hz to 21 Hz. The same effect was observed in the vibrometer measurements. The results show that with increasing pulse repetition rate the stability of the parameters varies between different devices. Hence, all sound field parameters should be compared before transferring settings from one device to another.

Radial shock wave therapy is used for different therapeutic indications. In order to assess the effect on the treated tissue, it is important to know the sound field parameters. However, it is challenging to measure the pressure curves of ballistic devices, especially at high pulse repetition rates. In the new standard IEC 63045:2020 two possibilities for sound field measurements of non-focusing devices are described, a wet and a dry test bench. The whole sound field can be characterised using a wet test bench, but the process is cumbersome and cavitation is likely to occur at high pulse repetition rates. This effect is avoided using a dry test bench where the measurement position is limited to a single spot. Therefore, a hybrid test bench was developed combining the dry bench’s device mounting and coupling with a small water basin. The ballistic device was coupled to the basin filled with degassed ultrapure water using a latex membrane covered with ultrasound gel and the contact pressure was applied with a spring. A fibre optic probe hydrophone was used for the sound field measurements. The pressure curves of every 10th shot were measured on the beam axis in a distance of 1mm to the membrane. The device was analysed at 3.5 bar with different pulse repetition rates (1 Hz, 10 Hz, 20 Hz). The test setup enables an easy handling and reproducible results at all pulse repetition rates. The ballistic device provides constant peak pressures over different frequencies. The small water basin has the advantage that the water quality is easy to control and the measuring process is fast and uncomplicated. Cavitation suppression requires a clean water basin filled with degassed ultrapure water kept at a constant, low temperature. The hybrid test bench can be used to easily study shock wave parameters of ballistic devices at high repetition rates.

Cavitation is a major fracture mechanism in extracorporeal shock wave lithotripsy (ESWL). However, it can cause tissue trauma and its effects on kidney stones and surrounding tissue are not fully understood. Therefore experimental setups enabling systematic parameter studies are crucial. We developed and evaluated a testing rig comprising three measuring methods in order to examine this mechanism. Our initial evaluation of this setup based on standard components showed promising results. Primary cavitation was displayed by high-speed photography 195 μs after the shock front had passed the focal zone. The effect of different pulse repetition rates (30, 60, 90, 120 SW/min) on the extension of the cavitation area was determined. The lifetime of secondary cavitation was analysed by B-mode ultrasound imaging. In a post processing progress the images showing bubbles were compared to a reference picture for both types of cavitation and the number of pixels that changed colour was counted. Furthermore stone comminution at different pulse repetition rates (30, 60, 90, 120 SW/min) was investigated by fixed-dose fragmentation. We observed an inverse correlation of cavitation and fragmentation. As the pulse repetition rate increases, the area of primary cavitation grows whereas the fragmentation efficiency decreases. B-mode imaging showed that secondary cavitation bubbles persisted between the shocks and can serve as nuclei. The higher the pulse repetition rate is, the more of these nuclei remain and thus facilitate formation of primary cavitation. The experimental setup provides reproducible results regarding the development of primary and secondary cavitation on the one hand and the fragmentation of phantom stones on the other hand. Therefore it can be utilized to further investigate the effect of different boundary conditions and shock wave parameters on cavitation and stone comminution. The impact of different focal sound fields is subject of ongoing research.