Researchers at Harvard’s Wass Institute and John A. Paulson School of Engineering and Applied Sciences (SEAS) have made significant progress in developing a synthetic heart valve with potential applications for growing children. Known as FibraValve, this implant can be created in a matter of minutes using a spun-fiber technique that enables the shaping of the valve’s delicate flaps at a microscopic level. The valve is designed to be colonized by the patient’s own living cells, allowing it to develop and grow as the child matures.

FibraValve builds upon the team’s previous creation, JetValve, an artificial heart valve introduced in 2017 that shared similar principles. The updated version incorporates “focused rotary jet spinning,” which utilizes streams of focused air to more rapidly and precisely collect synthetic fibers on a spinning mandrel. This enhancement facilitates finer adjustments to the valve’s shape, enabling the polymer’s micro- and nano-fibers to more accurately mimic the tissue structure of a natural heart valve. The entire manufacturing process can be completed in less than 10 minutes, in contrast to alternative methods that may take hours.

The technique employs a novel custom polymer material known as PLCL, a blend of polycaprolactone and polylactic acid, which can remain in the patient’s body for approximately six months. This duration allows sufficient time for the patient’s cells to infiltrate the structure and assume control. While successful testing has been conducted on sheep, the ultimate goal is for the resulting organic tissue to develop alongside human children, potentially eliminating the need for risky replacement surgeries as their bodies grow. “Our goal is for the patient’s native cells to use the device as a blueprint to regenerate their own living valve tissue,” explained corresponding author Kevin “Kit” Parker in a press release from Harvard.

During the researchers’ live testing on a sheep, the FibraValve demonstrated immediate functionality, with its leaflets opening and closing synchronously with each heartbeat to facilitate blood flow. Within the first hour, they observed the accumulation of red and white blood cells and fibrin protein on the valve’s scaffolding. The synthetic valve exhibited no signs of damage or complications. “This approach to heart valve replacement might open the door towards customized medical implants that regenerate and grow with the patient, making children’s lives better,” added co-author Michael Peters in the same press release.

Although the research is still in its preliminary stages, the team intends to conduct longer-term animal testing spanning weeks and months to further evaluate the technology. They also envision potential applications beyond heart valves, including the creation of different types of valves, cardiac patches, and blood vessels.

By Impact Lab