[Multifunctional testing of PTCA balloon catheters].
New in vitro measuring methods for balloon catheters used for percutaneous transluminal coronary angioplasty (PTCA) and their verification in a complex test device are presented. This system can mimic all relevant application situations. The central element of the test device is a coronary vessel model matching the physiological situation in terms of geometrical structure and frictional properties. Reactive force sensors are used to measure the application-relevant forces exerted by the catheter on the model vessel walls and accessories, such as guide wire and guiding catheter. To generate a kink-free advancement of the catheter and permit measurement of the active forces, an alternating drive unit has been specially developed. The testing and application of the newly developed methods revealed statistically significant differences between various types of catheter. The test device closes a gap between complex but subjective clinical tests, and individual objective, but application-removed in vitro test setups for PTCA catheters. While the initial prototype had shortcomings with regard to the reproducibility of measurements, successor systems developed for industrial use are now in production. The properties of these measuring systems developed for the benefit of manufacturer and reprocessor of PTCA catheters are discussed.
Vanguard GmbH, Medical Services for Europe, Berlin. Kraft@vanguard.de
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M
Kraft
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H
Schmitz
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R
Schulte
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U
Boenick
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001696:Biomechanical Phenomena; D002404:Catheterization / Q000295:instrumentation*; D019544:Equipment Failure Analysis; D006801:Humans; D066298:In Vitro Techniques; D008955:Models, Cardiovascular; D015203:Reproducibility of Results