In vitro assessment of fragmentation and repulsion of handheld lithotripsie devices

Abstract

Introduction: Different laser-systems are currently used for stone fragmentation in the upper urinary tract. The aim of our study was to evaluate probe velocity and displacement, retropulsion and fragmentation characteristics two novel devices the electromechanically driven EMS LithoBreaker® (EMS Medical), and of the CO2 cartridge driven LMA StoneBreaker® (Cook Urological) in vitro test models.Testing of the LithoBreaker® included additionally two different cushion guides (harder, softer) to assess the effect of the damper properties on the impulse characteristics. Patients and methods: Maximum probe velocities and displacements were measured using high-speed photography at a resolution of 100.000 frames per second. Repulsion testing was conducted through a 7.5 Fr ureteroscope in an underwater set-up. The probes were projected against a non-frangible led mass placed in a 15 Fr horizontally mounted silicone tube as an <i>in-vitro</i> model of the ureter. Repulsion was determined by measuring the distance the lead mass (0.98g) was displaced. Fragmentation efficiency was assessed by measuring the number of single shots required to break Bego Stone phantoms hard (15:3) and soft (15:6) with an average size of 7.5 mm x 5.5 mm placed on a metal mesh (edge length 3.15mm) into &lt; 3 mm fragments. Mean and standard deviation were computed for all groups and statistical analysis was performed (student’s t-test). Results: The StoneBreaker® yielded the highest velocity of 22.0 &plusmn; 1.9 m/sec. followed by the LithoBreaker® assembled with the hard cushion guide of 14.2 &plusmn; 0.5 m/sec and the soft probe guide of 11.5 &plusmn;0.5 m/sec. accordingly. The maximum probe displacement for the StoneBreaker® was 1.04 mm and for the LithoBreaker® 0.9 mm and 1.1 mm (hard versus soft cushion guide). Repulsion produced using the 1mm probes showed no statistical differences between the devices. Using the 2mm probes, the hardness of the damper used significantly changed the repulsion behaviour of the LithoBreaker®. Using the 1mm probe, the amount of single shots for fragmentation of soft Bego Stones was significantly higher for the LithoBreaker® with soft cushion guide: mean 31.5 &plusmn; 11.31 and hard cushion guide: mean 21.5 &plusmn; 5.29 compared to the StoneBreaker®: mean 11.2 &plusmn; 2.65. Fragmentation efficiency for the hard Bego Stones showed similar statistically significant results. Conclusion: The electromechanic LithoBreaker® and the pneumatic Stonebreaker® were shown to be effective in cracking stone phantoms with relatively low number of pulses. Fragmentation characteristics improved substantially with the higher hardness of the cushion support higher velocity equals higher fragmentation performance of the LithoBreaker®. Repulsion produced were at comparable levels. More testing is required to more detailed information on impulse frequency and capacity for stone clearance time to be used in clinical practice.