Automation of online particle measurement during the simulated use of catheters and stent systems

Abstract

The assessment of the coating integrity of cardiovascular implants such as catheters and stent systems is of crucial importance for device approval. Released particles may represent a potential health risk for the patients. Thus, an analysis of the particles released at simulated in-vivo conditions depending on their size and number is required by international standards (ISO, ASTM) as well as national authorities. In this study, an automated test bench for online particle measurement is presented. For software controlled automation, sensor data transmission and solenoid valves were implemented. A user interface was created for setting test parameters and data recording. The setup was validated by investigating standard particles as well as those released during the simulated application of non-industrial coated balloons. The measurement data were compared with results generated using the previous manual test routine. The results show an improvement in the reproducibility of the measurements, which can be attributed to the simplified handling for the user.

Keywords

• automation
• particle measurements
• drug coated balloons (dcb)
• coating integrity
• in-vitro testing
• continuous online measurements