The Need

For people born with a single ventricle heart, options are scarce. They must either undergo a palliative series of open heart surgeries, ending with the Fontan, or receive a heart transplant. As the first Fontan patients reach adulthood, emerging data suggests that all Fontans will eventually fail. It is no longer a matter of if, but when. There are several complex and individualized factors that determine when and how failure will present, but once it does, the only option becomes a heart transplant. While heart transplants are lifesaving, they come with their own risks and another timeline for eventual failure. In 2000, while at Stanford University, Dr. Mark Rodefeld began rethinking the way Fontan patients should be treated. Guided by the belief that there must be a better approach toward stronger outcomes for single ventricle heart patients, he began his research. He sought to develop a treatment option for Fontan patients that would extend the life of the Fontan repair and put off, or eliminate, the need for a heart transplant. 

Watch our video below to learn more:

 

The Vision

 

It was in 2001 that Dr. Mark Rodefeld committed his research to creating a blood pump that would act as the missing ventricle in single ventricle hearts. He began by exploring existing technology – adapting it to support the Fontan circulation. These existing technologies ultimately failed, but armed with the knowledge that failure is key to future success, Dr. Rodefeld continued on with his project. Knowing he would need to build a pump from scratch, he reached out to fluids engineer Steve Frankel form Purdue University and began exploring the idea of a viscous pump. A viscous pump uses fluid viscosity to create flow. It met all the requirements for a successful addition to the Fontan circulation. Most importantly, if the pump were to fail, it would not obstruct blood flow – a critical factor in the development of a reliable blood pump. So from the comfort of his own garage, with a hobby shop motor and the help of a local woodworker, Dr. Rodefeld built the very first prototype of his Fontan Blood Pump. 

 

The Progress

 

In 2013, after years of research, Dr. Mark Rodefeld reached out to NASA for assistance in developing a conical motor for the Fontan Blood Pump. Unfortunately, the prototype built over the course of 3 years with NASA underperformed, not reaching the necessary speed or accounting for the viscosity of blood. With this information and some residual funds, Dr. Rodefeld assembled a team and got to work on the next prototype, which met the requirements for full functionality. He has received research grants from the National Institute of Health and The Children’s Heart Foundation, however, prototyping is extremely costly. It will take another estimated $300,000 to complete the build, and once finished, this prototype will be at near FDA-level sophistication. With the current regulations in place for testing and approval of prototypes – a working Fontan Blood Pump could be ready in 5 years.