Valveless pump device implanted during the Fontan surgical procedure in patients with single-ventricle congenital heart disease.

The Fontan procedure is a lifesaving surgery for patients with single-ventricle congenital heart disease, where only one chamber of the heart is functional. The operation reroutes blood flow from the heart to the pulmonary system to improve circulation. Children two to four years old typically undergo the Fontan procedure, with approximately 1,000 operations occurring annually in the United States and 50,000-80,000 globally. To avert complications from this surgery including decreased cardiac output and organ failure, there is a need for cardiovascular assist devices. Existing mechanical circulatory support devices possess valves, which are common points of failure and can cause thrombosis.

To improve venous return to the heart and pulmonary blood flow after the Fontan procedure, a valveless pump can be embedded within or around the rerouted vessels. Unlike existing mechanical circulatory support devices, the valveless pump creates unidirectional blood flow without clotting or causing blood trauma. The valveless pump is also energy efficient without requiring large external battery packs.

The valveless pump is embedded within or around newly connected vessels during the Fontan procedure or used in later revision surgeries. The device employs a Liebau system, using wave mechanics to create unidirectional blood flow. An electromagnetically driven piston is positioned off-center in a compliant segment of tubing, surrounded by less-compliant tubing. The piston deforms the compliant tubing to generate a fluid wave. This bulk fluid flow improves circulation in rerouted vessels.

• Valveless system reduces risk for thrombosis and failure of mechanical circulatory support systems
• Unlike centrifugal devices like impellers, the valveless pump does not cause blood trauma
• The device is energy efficient and does not require large external battery packs, which is helpful for small children
• Additional applications of the valveless pump exist in engineering and industrial settings