A Not-Motorized Implantable Device for Partial Circulatory Support: A Proof of Concept Experiment

Abstract

A fully implantable circulatory assistance device without external connection and lifetime energy supply can eliminate a significant source of morbidity and mortality for patients. Here, we present and discuss concept and preliminary results of an original project for a not-motorized, fully implantable circulatory assistance device. The not-motorized implantable circulatory assistance device (NICA) has been tested into a cardiac simulator that was conceived according to the FDA and ISO standards. The instrumentation incorporated to the cardiac simulator includes probes for the aortic pressure (AoP) proximally to the device, a temperature control system, and one electromagnetic flowmeter to acquire the flow rate (AoF) proximally to the device. A control software allows to modulate the drive parameters such as velocity, acceleration, number of revolutions, the stroke volume, and the heart rate. Experiments have been performed with three different circuit resistances: 2100 dyn s/cm5, 1400, and 700. The AoF increased in the assisted cycles: 71% at 2100 dyn s/cm5, 67% at 1400 dyn s/cm5, and 25% at 700 dyn s/cm5. NICA performs a partial but significant support of AoF without energy supply. The improvement of AoF increases with the increasing of vascular resistances. The feedback received by this preliminary bench experiment acted as a preliminary proof of concept of this new device.

Not-motorized Implantable Cardiac Assistance (NICA): Hemodynamic concepts and clinical perspectives

“…The inclusion in the AAB of an EEC speci ically designed with high ef iciency elastomer, with design and volume optimized to maximize the compliance effect of AAB and the elastic return of EEC. As reported by the authors in previous publication [1] the actual support of NICA varies inversely to the peripheral resistance (from 2100 dyn s / cm5 to 700dyn s / cm5 respectively from + 71% to + 25%) and this according to its passive hemodynamic model [6]. Naturally NICA can only perform partial assistance.…”

“…The not-motorized implantable circulatory assistance device (NICA) is described in detail by authors in a previous paper and patent [5,6]. It is an aortic-aortic bypass of the descendent thoracic aorta including an elastically expandable chamber (EEC) as described in igure 1.…”

“…In the case of adequate recovery of cardiac function, the device can stay in place with a mild thromboembolic prevention therapy or easily removable without the use of CPB. In particular, unlike devices with apical ventricular connection, the removal is devoid of embolic risk and does not involve losing the function of the apical myocardium [6].…”