Studying the Effect of Temperature on the Tensile Strength of an Intravascular Catheter Using a Degradation Model

Abstract

The accelerated aging process is incorporated into the design and development of intravascular catheters to assess their reliability assuring that this medical device is safe and effective for the intended use during their shelf life. The accelerated aging process is based on a common approach that assumes that the rate of aging increases by a factor of , where is the temperature increment. However, with the life data obtained from this empirical method is difficult to do inferences about reliability. This paper presents an accelerated destructive degradation test using thermal stress to obtain degradation data directly relates reliability to critical performance characteristic, which is the tensile strength in the intravascular catheter tip considered as a critical concern in patients’ safety. The degradation data model is given by a stochastic Wiener process with the drift parameter being represented as Arrhenius function. The parameters of the Wiener process and Arrhenius function are estimated using maximum likelihood; these parameters are used to estimate the first-passage time (time to failure) distribution when the intravascular catheters degradation path reaches a tensile strength critical value in each thermal stress level. Based on this, a complete product reliability assessment is performed and presented.