Minimally invasive implantable fetal micropacemaker: mechanical testing and technical refinements
Li Zhou1, Adriana Nicholson Vest2, Raymond A Peck2
1Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA. zhou15@usc.edu.
Abstract:
This paper discusses the technical and safety requirements for cardiac pacing of a human fetus with heart failure and hydrops fetalis secondary to complete heart block. Engineering strategies to meet specific technical requirements were integrated into a systematic design and implementation consisting of a novel fetal micropacemaker, a percutaneous implantation system, and a sterile package that enables device storage and recharging maintenance in a clinical setting. We further analyzed observed problems on myocardial fixation and pacing lead fatigue previously reported in earlier preclinical trials. This paper describes the technical refinements of the implantable fetal micropacemaker to overcome these challenges. The mechanical performance has been extensively tested to verify the improvement of reliability and safety margins of the implantation system.
