Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants

Abstract

Inspired Therapeutics (Merritt Island, FL) is developing a mechanical circulatory support (MCS) system designed as a single driver with interchangeable, extracorporeal, magnetically levitated pumps. The NeoMate system design features an integrated centrifugal rotary pump, motor, and controller that will be housed in a single compact unit. Conceptually, the primary innovation of this technology will be the combination of disposable, low-cost pumps for use with a single, multi-functional, universal controller to support multiple pediatric cardiopulmonary indications. In response to the paucity of clinically available pediatric devices, Inspired Therapeutics is specifically targeting the underserved neonate and infant heart failure (HF) patient population first. In this article, we present the development of the prototype Inspired Therapeutics NeoMate System for pediatric left ventricular assist device (LVAD) support, and feasibility testing in static mock flow loops (H-Q curves), dynamic mock flow loops (hemodynamics), and in an acute healthy ovine model (hemodynamics and clinical applicability). The resultant hydrodynamic and hemodynamic data demonstrated the ability of this prototype pediatric LVAD and universal controller to function over a range of rotary pump speeds (500–6000 RPM), to provide pump flow rates of up to 2.6 L/min, and to volume unload the left ventricle in acute animals. Key engineering challenges observed and proposed solutions for the next design iteration are also presented.

Anatomical and Hemodynamic Characterization of Totally Artificial Hearts

“…Mock flow loop experiments were performed on Claw TAH, Beating TAH and Cute TAH to assess hemodynamic performance using methods published previously by our laboratory. 13,14 Briefly, Claw TAH and Beating TAH’s compact integrated electronics/motor/battery systems were first removed and then securely covered by an echocardiography probe sheath to protect it from liquid and minimize risk of electrical short. The electronics system was then placed back inside the TAH and glued to the TAH housing.…”