Harvard Researchers develop a 3D-printed synthetic heart valve that grows with children. This groundbreaking pediatric 3D-Printed synthetic heart valve is being developed by a team at Harvard’s Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS), led by Kevin Kit Parker, PhD.
After nearly a decade of research and development, in 2017 Parker and Hoerstrup released their first artificial heart valve, the JetValve. This was produced using an early version of FRJS, which involves extruding biocompatible synthetic polymer via a nozzle, spinning the resulting long nanofibers, and then collecting them on a valve-shaped mandrel. The two could implant their JetValve into a sheep’s heart, where it worked as intended and collected live cells to rebuild new tissue. However, they saw that their design might be improved upon.
Rheumatic fever can cause permanent damage to a child’s heart valves, which can progress into rheumatic heart disease and eventually cause stroke and heart failure. Surgery can be used to mend heart valves, but it is far more challenging for youngsters since their bodies are still developing. It can take many invasive procedures to replace the valves with larger ones, and creating artificial heart valves is a time-consuming and expensive. To avoid having to perform additional operations on young patients, researchers at Harvard University are developing a 3D-printed synthetic heart valve that can expand as the kid does.
How does the 3D-printed Synthetic Heart Valve work?
The FibraValve, made with a novel technique called focused rotary jet spinning (FRJS), can be 3D printed in about 10 minutes from a mix of polycaprolactone (PCL) and polylactic acid (PLA) called PLCL. The method enables precise control over the valve’s nanoscale structure and function. Collaborators at the Wyss Zurich Translational Centre lead by Wyss Associate Faculty member Simon Hoerstrup, MD, PhD, found that the 3D printed valve was “readily colonised by living cells” in vitro and in large animal model tests.
The novel 3D-printed synthetic heart valve was created by a team of researchers that envisioned a frame in the shape of a valve and then, utilising FRJS, inserted jet streams of air to fill the frame with liquid polymer. The pace at which fibres were deposited onto the mandrel could be increased, and the final form could be easily adjusted. The resulting device is a 3D-printed synthetic heart valve, a mesh of nanofibers that can support the infiltration and growth of cells.
Harvard bioengineering professor and study co-author Parker said, “Cells operate at the nanometer scale, and 3D printing can’t reach down to that level, but focused rotary jet spinning can put nanometer-scale spatial cues in there so that when cells crawl up into that scaffold, they feel like they’re in a heart valve, not a synthetic scaffold.”
In addition to facilitating the invasion of live cells after the FibraValve is implanted, the team’s unique PLCL polymer material is biodegradable. The scaffolding of a FibraValve is more elastic and conducive to uniform cell dispersion than its forerunner. The researchers also worked to optimise the form of the valve’s inner “leaflets” to cut down on lost blood. As a result of these enhancements, the FibraValve is well suited for children with congenital heart disease whose hearts are still developing. In addition, printing one that is ready to be colonised by living cells takes minutes.
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3D-Printed Synthetic Heart Valve was implanted into sheep
The 3D-printed Synthetic Heart Valve was implanted into an actual sheep’s heart by Hoerstrup’s team in Zurich, where it instantly began operating, with leaflets opening and closing to allow the controlled flow of blood with each pulse. After one hour, the researchers noticed no symptoms of adverse reactions, thrombosis, or any other complications. Still, they did see a substance called fibrin being formed on the surface of the valve and red and white blood cells entering its porous structure. The next step for the researchers is to conduct long-term animal testing to assess the FibraValve’s efficacy and regeneration potential.
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