FINITE ELEMENT MODELING OF ICD LEAD SILICONE SOFT-TIPS

Although highly underutilized by the medical device industry, Finite Element Analysis (FEA) in the development of new technologies is gaining popularity as regulatory bodies such as the Food and Drug Administration (FDA) begin to require additional proof of safety through scientific methods. Non-lin...

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Bibliographic Details
Main Author: Lepe, Jose J
Format: Others
Published: DigitalCommons@CalPoly 2010
Subjects:
ICD
Online Access:https://digitalcommons.calpoly.edu/theses/286
https://digitalcommons.calpoly.edu/cgi/viewcontent.cgi?article=1299&context=theses
Description
Summary:Although highly underutilized by the medical device industry, Finite Element Analysis (FEA) in the development of new technologies is gaining popularity as regulatory bodies such as the Food and Drug Administration (FDA) begin to require additional proof of safety through scientific methods. Non-linear FEA allows engineers to realistically simulate the mechanical behavior of implants as seen in the in-vitro, or in some cases, the in-vivo configurations. The work presented in this report investigates how computational methods can be used to simulate the interaction of a St. Jude Medical silicone soft-tip as it passes through a Peel-Away Sheath (i.e. introducer). In this analysis the soft-tips were modeled as axisymmetric with hyperelastic material properties assigned to the soft-tips. An Ogden, second order hyperelastic material model was used to describe the non-linear stress-strain behavior of silicone soft-tips. The finite element program, ABAQUS/Standard was used to simulate the soft-tip/introducer interactions. The reaction forces obtained through these simulations represent the force required to push a lead through an introducer, and were then compared to experimental data.