Project Description:

Single ventricle congenital patients have one functional ventricle and undergo multiple open-heart palliation operations, including the Fontan procedure, to reroute venous return to the lungs. While the Fontan conduit is effective in childhood, complications such as increased venous pressure, liver damage, clotting, and oxygenation issues arise over time, resulting in patients eventually needing a heart transplant. With limited accessibility, long wait times, and high risk associated with heart transplantation, there is an urgent need for a lower-risk, long-term solution to improve Fontan physiology and delay or prevent its failure.

To combat this issue, we have invented a device designed for patients with Fontan circulation. The invention features inflatable cuffs that surround the existing conduit. The cuffs sequentially inflate and deflate to generate non-steady, pulsatile flow, mimicking the heart’s natural pumping action to improve blood flow to the lungs. The pulsatile flow combined with the pressure gradient drives venous return into the pulmonary arteries and the lungs for oxygenation. By actively driving venous return, the device reduces stress on the heart and can prevent backflow of blood into vital organs, potentially extending the life of the Fontan circulation and improving quality of life.

This device offers a novel solution to a persistent challenge. Unlike prior attempts that rely on blood-contacting pumps, which can lead to clotting and infection, this device offers active flow without contacting the blood. With no comparable solution on the market, this invention addresses an unmet need in the population of Fontan patients. It offers a minimally invasive longer term solution for Fontan patients, with the potential to delay or prevent Fontan failure and reduce healthcare costs in the long term. The design is compatible with pediatric and adult Fontan anatomies, making it an optimal opportunity for strategic partnerships by companies aiming to lead in life-sustaining cardiovascular devices.