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[Modulit SL-20. Its development and clinical trial]

K U Kohemann, T O Henkel, D Potempa

    Urologiia I Nefrologiia
    |September 1, 1994
    PubMed
    Summary

    The Modulit SZ-20, a third-generation lithotriptor, effectively disintegrates kidney and biliary stones with high success rates. This advanced device offers non-anesthetic procedures and dual localization methods for improved stone crushing.

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    Area of Science:

    • Biomedical Engineering
    • Urology
    • Medical Devices

    Background:

    • The Modulit SZ-20 is a third-generation lithotriptor.
    • It integrates ultrasonic and fluoroscopic localization with a multifunctional platform.
    • Previous generations focused on localization, with later developments targeting stone disintegration.

    Purpose of the Study:

    • To evaluate the efficacy of the Modulit SZ-20 lithotriptor for stone disintegration.
    • To assess its performance in localizing and breaking down nephroliths, ureteroliths, choleliths, and biliary stones.
    • To compare its effectiveness and potential for renal trauma against other lithotriptors.

    Main Methods:

    • Utilizes a cylindrical electromagnetic spiral and paraboloid reflector to generate shock waves.
    • Employs a water cushion and impedance-adapted layer for wave transmission.
    • Features on-line ultrasonic detection and integrated C-arm fluoroscopy for localization.
    • In vitro and animal experiments were conducted to assess efficacy and renal trauma.

    Main Results:

    • High disintegration efficacy demonstrated in in vitro and animal studies.
    • Successful evaluation of dose-related and reversible renal trauma.
    • Achieved a 94% disintegration rate after design improvements.
    • Reported complete stone disappearance in 88% of patients.
    • Demonstrated effectiveness against choleliths and biliary stones.

    Conclusions:

    • The Modulit SZ-20 is a highly effective third-generation lithotriptor.
    • It offers significant advantages in stone disintegration and patient comfort (no anesthesia required).
    • The device is recommended for its high stone-crushing capabilities in urolithiasis and cholelithiasis.

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