A long-term mechanical cavopulmonary support device for patients with Fontan circulation

In patients with a single ventricle, failure of the cardiovascular system may be prevented by substituting the missing sub-pulmonary ventricle with a pump. The aim of this study was to design and evaluate a device for long-term cavopulmonary support. A radial pump with two inlets and two outlets, a single impeller, mechanical bearings, and dual motor configuration was developed. Motor and fluid dynamic components were designed and simulated using computational methods including thermal effects. Hydraulic properties were determined in-vitro with 3D-printed prototypes. The pump design was virtually implanted in an MRI-derived total cavopulmonary connection (TCPC). Computational fluid dynamics (CFD) showed flow fields without regions of flow stagnation (velocity < 0.1 m/s) and only minor recirculations within the pump between 2-10 L/min against pressure heads of 0-50 mmHg at 2500-5000 rpm. The computed maximum temperature increase of blood due to motor heat was 1.3 K. Virtual implantation studies showed that the pump would introduce an additional volume of approximately 4 mL. Experimentally determined hydraulic performance results agreed well with CFD (deviation of <1.3 mmHg) and indicated pressure-sensitive characteristics (∼-2.6 mmHg/(L/min)) while balancing the two inlet pressures (∆P < 2.5 mmHg) under imbalanced inflow conditions. Through in-silico and in-vitro investigations, we demonstrated a promising pump design, which fulfills the basic requirements for long-term cavopulmonary support.