This news immediately took me back to one of the most amazing things I have ever witnessed — open heart surgery on an infant. As part of our project, I observed this incredible and delicate feat of medical care along with Kent Kallsen, Design Concepts vice president of engineering. We both came away from this emotional experience highly motivated to do whatever we could to help Dr. Hopkin’s and his team improve and save the lives of these tiny patients.

Dr. Hopkins and his team at the Cardiac Regenerative Surgery Research Labs at Children’s Mercy Hospital, Kansas City are pioneering a technique for growing semi-autologous heart valves for replacement surgeries. In simple terms, this means a child could receive a heart valve that grows with them throughout the course of their lives. This has the potential to change the course of treatment to a single cardiac surgical event from the more typical course of treatment that involves many open heart surgeries over the course of childhood to replace valves no longer large enough for a growing heart.

A couple years ago, the team approached Design Concepts about developing the BioReactor to help them research and ultimately commercialize their process. The challenge was to provide a set of equipment that allowed three distinct stages: stripping the donor valve of all tissue, allowing the resulting scaffold to wick stem cells under controlled conditions, and finally placing the valve into a chamber to provide tension, pulsing action and a continuous stream of nutrients and other media to encourage full seeding.

Our design approach focused on keeping things simple. Our view throughout the project was to simply “get the job done” and make sure the equipment did not hinder or confuse any of the steps. The magic is in the medicine and the equipment should do the few things it needs to do, and do them well.

The largest architectural hurdle was to design the last two stages such that the valve would experience as little manipulation as possible when moving from its soaking container to its pulsation chamber. We designed a cap assembly that holds the valve and fits both chambers allowing movement from one step of the process to the other with minimal touching of the valve. This cap utilizes a drive screw and seals that allow for adjustment within each of the two chambers without breaking sterility. The soaking chamber required precise adjustment to dip the edge of the valve into the bone marrow sample. The pulsation chamber required that we “grab” the valve (using a magnet and a ferrous component temporarily sewn to the valve) and provide tension by adjusting the drive screw until the tissue was stretched. The design of this cap assembly allows full adjustment of valves from newborn to adult sizes without the physical envelope of the containers changing, making it possible to utilize standard laboratory ovens and avoid tipping and catching hazards along the way.

In the end we worked with Children's Mercy to procure production tooling and molded parts, resulting in a short production run of 250 full assemblies. These production parts have been used to treat and grow heart valves for implantation in sheep and primates. Taking advantage of the overall design and tune-ability of the BioReactor, they have been able to significantly reduce the time it will take to seed donor valves with the recipient’s stem cells and prepare the valves for implantation and growth within the patient. This development is another key step on the way to providing viable, growing valves to children within a window of only days from bone marrow harvest to completed implantation.

We hope to continue our support of this project and help Dr. Hopkins and his team bring a technology to children who will greatly benefit from advances in treatment. His team is doing amazing work and I look forward to seeing where this technology goes in the years to come. Learn more about this exciting project.