Design and Development of a Miniaturized Percutaneously Deployable Wireless Left Ventricular Assist Device: Early Prototypes and Feasibility Testing

Abstract

The current left ventricular assist devices (LVADs) are limited by a highly invasive implantation procedure in a severely unstable group of advanced heart failure patients. Additionally, the current transcutaneous power drive line acts as a nidus for infection resulting in significant morbidity and mortality. In an effort to decrease this invasiveness and eliminate drive line complications, we have conceived a wireless miniaturized percutaneous LVAD, capable of being delivered endovascularly with a tether-free operation. The system obviates the need for a transcutaneous fluid purge line required in existing temporary devices by utilizing an incorporated magnetically coupled impeller for a complete seal. The objective of this article was to demonstrate early development and proof-of-concept feasibility testing to serve as the groundwork for future formalized device development. Five early prototypes were designed and constructed to iteratively minimize the pump size and improve fluid dynamic performance. Various magnetic coupling configurations were tested. Using SolidWorks and ANSYS software for modeling and simulation, several geometric parameters were varied. HQ curves were constructed from preliminary in vitro testing to characterize the pump performance. Bench top tests showed no-slip magnetic coupling of the impeller to the driveshaft up to the current limit of the motor. The pump power requirements were tested in vitro and were within the appropriate range for powering via a wireless energy transfer system. Our results demonstrate the proof-of-concept feasibility of a novel endovascular cardiac assist device with the potential to eventually offer patients an untethered, minimally invasive support.

Electrical power to run ventricular assist devices using the Free-range Resonant Electrical Energy Delivery system

“…Over the years there have been significant discussions in the VAD community towards achieving a goal of reduced adverse events by eliminating drivelines for power delivery. We sincerely hope that the current investigation will be able to swing the pendulum in favor of eliminating driveline for the future designs of pumps 17,18 .…”

Electrostatic Discharge Causing Pump Shutdown in HeartMate 3

“…The current LVADs do relieve symptoms and save lives in advanced heart failure patients; yet, further innovation, like transcutaneous energy transfer systems ( 9 ) or the production of miniaturized percutaneously deployable wireless LVADs ( 10 ), are ongoing and may be necessary to justify utilization of LVADs in earlier stages of heart failure or for more widespread acceptance, especially for destination therapy, in advanced HF. Possible disturbance by external electrical sources like ESD of such devices must be proactively considered.…”

Systems of conductive skin for power transfer in clinical applications

“…Despite the overall progress, the implementation of a wireless-based solution for power transfer in LVADs is far from becoming part of the clinical routine. In this direction, new wireless solutions against tissue overheating and fibrotic responses will be essential to avoid power outage and tissue damage with life threatening consequences (Letzen et al 2018 ).…”