Effect of reuse on surface characteristics of balloon angioplasty catheters.
Surfaces of reused angioplasty catheter balloons were characterized by scanning electron microscopy (SEM), image analysis, Fourier transform infrared (FT-IR) spectroscopy and X-ray photoelectron spectroscopy (XPS). The surfaces were found to have longitudinal ridges, cracks, wrinkled regions and particulates. Most of the particles were carbon-based, and contained traces of Cl and Si. The average number of particles ranged between 11 and 38 per mm2, while the average particle size ranged from 14 micron to 28 micron. About 70%-90% of the particles were larger then 10 micron which is approximately the diameter of the fine blood capillaries. The particles appeared to be firmly attached to the outer surface of the balloon. FT-IR and XPS analysis revealed the presence of Si, the absence of proteins, and suggested that the surface of the reused balloon catheters was oxidized. The study highlights the large number of particles created and released during angioplasty.
Karov
J
J
Medical Devices Bureau, TPP, Health Canada, Ottawa, Ontario.
Chawla
A S
AS
Hinberg
I
I
D000800:Angioplasty, Balloon / Q000295:instrumentation* / Q000592:standards*; D002244:Carbon / Q000032:analysis; D002404:Catheterization / Q000592:standards; D002713:Chlorine / Q000032:analysis; D004577:Electron Probe Microanalysis; D004866:Equipment Contamination / Q000517:prevention & control; D017743:Equipment Reuse / Q000592:standards; D008855:Microscopy, Electron, Scanning; D010084:Oxidation-Reduction; D012828:Silicones / Q000032:analysis; D013052:Spectrometry, X-Ray Emission; D017550:Spectroscopy, Fourier Transform Infrared; D013499:Surface Properties
D012828:Silicones; D002713:Chlorine; D002244:Carbon