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Tribological Model System Testing of Urinary Catheters with Lubricant and Artificial Skin

Medical devices face high demands in terms of product safety and performance, as well as from FDA and MDR regulations. Tribological model system testing can be one approach to optimize medical devices such as urinary catheters. Within this study we present a methodology in which one can run tribological model system tests with urinary catheters on artificial skin to very closely mimic real life conditions, but with the added potential of gaining insights far beyond macroscopic product testing.

Introduction

Urinary catheters can be used either for diagnostic reasons or therapeutic indications. Diagnostic indications are, for instance, the filling with contrast agents or sampling of urine. Examples of therapeutic indications are micturition disturbance or the obstruction of urine flow below the bladder, for example due to prostate enlargement or postoperative swelling. Urinary catheters can either be suprapubic or transurethral. Typically, urinary catheters are made of Polyvinyl chloride (PVC), or silicon. Different coatings such as hydrogel coatings or antibiotic coatings can be applied. When inserting a transurethral catheter through the urethra, lubricants can be used. In addition to reducing friction, they may also act as local anesthesia. This means that the lubricants need to perform well in terms of rheological function (the catheter should stay in the urethra after instillation) and tribological function.

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