Modulith SL 10/20--experimental introduction and first clinical experience with a new interdisciplinary lithotriptor.

More than 20 second-generation lithotriptors have been introduced for extracorporeal shock-wave lithotripsy. Despite great technical progress, each machine still has its specific short-comings. In cooperation, Storz Medical (Kreuzlingen, Switzerland) and the Department of Urology (Klinikum Mannheim, FRG), have developed a new lithotriptor designed to overcome these drawbacks. Energy source: Electromagnetic cylinder with paraboloid reflector (40 cm) for focusing, providing a wide range of pressure (190-1,000 bar) and a focal zone of 28 x 6 mm. The focal depth is maximally 15 cm. Coupling and positioning: Water cushion with patient lying on a specially designed 'acoustic cradle' consisting of an impedance-adapted foil. This is integrated in either a manually or automatically operated table. Localization: Coaxial ultrasound probe for real-time scanning and integrated C arm with pulsed fluoroscopy using a virtual focus (moved along x-axis) for stone localization. In 1989, we commenced with the first treatment based on our own in vitro and in vivo studies to determine the range of energy required for safe application. We treated 137 stones (100 caliceal, 19 pelvic and 18 ureteral) in 88 patients. The mean generator voltage was 16 kV (10-18 kV). Successful disintegration was achieved in 83 patients (95%) employing an average of 2,359 impulses (940-3,500). Thirteen percent of the treatments were performed without any anesthesia on lower generator voltage (10-15 kV), whereas the majority of calculi were treated under intravenous analgesia. The 5 failure cases included 2 stones in a caliceal diverticulum. Moreover, 12 patients with biliary calculi (11 gallstones and 1 bile duct stone) were successfully treated; 1 of these cases required a second treatment session.