Physics-driven impeller designs for a novel intravascular blood pump for patients with congenital heart disease

• Few therapies exist for patients having dysfunctional single ventricle physiology.
• Newly designed impellers based on first principles for dysfunctional Fontan physiology.
• Iterative numerical analysis and prototype testing was applied to enhance pump performance.
• Impeller design with 400° of blade twist proved to be the superior geometry.
• Long-term goal is to develop a new and viable medical device for Fontan patients.

Mechanical circulatory support offers an alternative therapeutic treatment for patients with dysfunctional single ventricle physiology. An intravascular axial flow pump is being developed as a cavopulmonary assist device for these patients. This study details the development of a new rotating impeller geometry. We examined the performance of 8 impeller geometries with blade stagger or twist angles varying from 100° to 800° using computational methods. A refined range of blade twist angles between 300° and 400° was then identified, and 4 additional geometries were evaluated. Generally, the impeller designs produced 4–26 mmHg for flow rates of 1–4 L/min for 6000–8000 RPM. A data regression analysis was completed and found the impeller with 400° of blade twist to be the superior performer. A hydraulic test was conducted on a prototype of the 400° impeller, which generated measurable pressure rises of 7–28 mmHg for flow rates of 1–4 L/min at 6000–8000 RPM. The findings of the numerical model and experiment were in reasonable agreement within approximately 20%. These results support the continued development of an axial-flow, mechanical cavopulmonary assist device as a new clinical therapeutic option for Fontan patients.