Early Development of a Fontan Assist Device

Patients with hypoplastic left heart syndrome (HLHS) or single ventricle disease are typically treated with a series of surgeries culminating with Fontan Circulation. Paradoxically, the operation causes increased intravascular pressure proximal to pulmonary arteries leading to the lungs. Mechanical pumps have been used to alleviate Fontan circulation complications with varying success and usage in the market. This study developed a silicone balloon pump to help overcome the lung threshold pressure. A 3D-printed balloon pump housing was used to house a silicone balloon that was connected to an external piston pump. The balloon pump was placed within a vertical water column, and an external mechanical piston pump was used to inflate and deflate the pump at a constant rate. Three parameters were tested: balloon pump length, stroke length and water column height, and a two-way ANOVA statistical test was used to determine parameter significance. Preliminary results showed that the balloon pump was able to overcome pressure threshold (15 mmHg, 20 mmHg, and 25 mmHg) with water volume displacement ranging from 9.9 mL to 19.7 mL, from these parameters—balloon pump length and stroke length, with statistical significance p < 0.05.