Investigations of the pushability behavior of cardiovascular angiographic catheters.

The placement of angiographic catheters into the vascular system is a routine procedure in modern clinical business. The definition of objective but not yet available evaluation protocols based on measurable physical quantities correlated to the empirical clinical findings is of utmost importance for catheter manufacturers for in-house product screening and optimization. In this context, we present an assessment of multiple mechanical and surface catheter properties such as static and kinetic friction, bending stiffness, microscopic surface topology, surface roughness, surface free energy and their interrelation. Theoretical framework, description of experimental methods and extensive data measured on several different catheters are provided and in conclusion a testing procedure is defined. Although this procedure is based on the measurement of several physical quantities it can be easily implemented by commercial laboratories testing catheters as it is based on relatively low-cost standard methods.

Change of the mechanical properties of two different balloon catheters with increasing numbers of cycles of resterilization.

An increasing number of centers are reusing PTCA catheters even though manufacturers warrant single use only. This prospective bench laboratory trial addresses the quality of PTCA balloon catheters after up to three resterilization cycles in order to determine whether a larger trial is warranted to discern whether catheters should be reused. Forty PTCA catheters from two different manufacturers (nominal diameters 1.5 and 3.0 mm) were taken from the shelf. An independent institute tested mechanical properties such as burst pressure, nominal diameter, crossing profile, and balloon surface. The crossing profile increased by 22.5%-39.2% with no additional deterioration after repeated sterilizations. The nominal diameter either increased or decreased by a maximum of 47%. In all 1.5 mm balloons, the burst pressure remained above the manufacturers' values, whereas in the 3.0 mm balloons, the value dropped below the rated burst pressure in 40%-50% of the trials. In conclusion, in both catheter types analyzed, reuse was associated with a considerably worse quality, which puts in question their routine clinical use.