Novel mechanistic model and computational approximation for electromagnetic safety evaluations of electrically short implants

Abstract

This paper addresses unresolved issues related to the safety of persons with conductive medical implants exposed to electromagnetic (EM) fields. When exposed to EM fields compatible with the reference limits—in particular <100 MHz—implants may enhance local fields and energy absorption to values much higher than the basic restrictions that are considered safe. A mechanistic model based on transfer functions has been postulated for elongated active implants at magnetic resonance imaging (MRI) frequencies and used as a basis for standards dealing with MRI implant safety. However, this mechanistic model is inconsistent with the behavior observed for electrically short implants, such as abandoned leads in MRI or active implants under low-frequency exposure conditions (e.g. wireless power transfer). In this paper, a new mechanistic model for electrically short implants is proposed that allows implant safety assessment to be decomposed into separate steps. Per tip-shape, it requires only a single simulation or measurement of the implant exposed under (semi-)homogeneous conditions. To validate the approach, predictions of the mechanistic model were compared to results of numerical simulations for electric- and magnetic-field exposures. The impact of parameters such as tissue properties, length, tip shape, and insulation thickness on safety- and compliance-relevant quantities was studied. Validation involving an anatomically detailed computational human body model with a realistic implant at multiple locations under electric and magnetic exposures resulted in prediction agreement on the order of 7% (maximal deviation <15%). The approach was found to be applicable for electrical lengths up to 20% of the effective wavelength and can be used to derive suitable testing procedures as well as to develop safety guidelines and standards.