Harvard’s scientists have developed an innovative synthetic heart valve that has the potential to benefit growing children in the future. Known as FibraValve, this implant is the result of collaborative efforts between Harvard’s Wass Institute and John A. Paulson School of Engineering and Applied Sciences (SEAS). The valve’s intricate flaps, which are crucial for its functionality, are shaped on a microscopic scale using a rapid spun-fiber technique. These flaps are designed to be colonized by the patient’s own living cells, allowing them to grow and develop alongside the individual.
FibraValve builds upon the success of its predecessor, JetValve, an artificial heart valve created by the same team in 2017. The updated version incorporates a technique called “focused rotary jet spinning,” which utilizes focused air streams to efficiently and accurately gather synthetic fibers on a rotating mandrel. This advancement enables precise fine-tuning of the valve’s shape. Consequently, the micro- and nano-fibers of the polymer used in FibraValve closely mimic the tissue structure of a natural heart valve. Notably, the manufacturing process takes less than 10 minutes, a significant improvement compared to alternative methods that can take hours.
In addition, FibraValve employs a novel polymer material called PLCL, which combines polycaprolactone and polylactic acid. This custom polymer can remain within a patient’s body for approximately six months, providing sufficient time for the patient’s cells to infiltrate the structure and assume control. While successful tests have only been conducted in sheep thus far, the ultimate vision is for the resulting organic tissue to develop alongside human children as they mature, potentially eliminating the need for risky replacement surgeries as their bodies grow. Kevin “Kit” Parker, the corresponding author, expressed this goal, stating, “Our aim is for the patient’s native cells to use the device as a blueprint to regenerate their own living valve tissue.”
During the team’s experimentation on a live sheep, the FibraValve exhibited immediate functionality, with its leaflets opening and closing in synchronization with the heartbeat to facilitate blood flow. Within the first hour, the scientists observed the accumulation of red and white blood cells as well as fibrin protein on the valve’s scaffolding. No signs of damage or other complications were observed with the synthetic valve. Michael Peters, a co-author of the study, highlighted the potential of this heart valve replacement approach, stating, “This opens the door to customized medical implants that can regenerate and grow with the patient, ultimately improving the lives of children.”
While the research is still in its preliminary stages, the team plans to conduct extended animal testing spanning weeks and months to further evaluate the FibraValve. They also envision broader applications for their breakthrough, such as the creation of different valves, cardiac patches, and blood vessels. For more details, the complete paper is available on Matter.
Frequently Asked Questions (FAQs) about synthetic heart valve
What is FibraValve?
FibraValve is a synthetic heart valve developed by Harvard’s Wass Institute and John A. Paulson School of Engineering and Applied Sciences. It is designed to grow with the human body and potentially eliminate the need for risky replacement surgeries in children.
How does FibraValve work?
FibraValve utilizes a spun-fiber method to shape the delicate flaps of the valve on a microscopic level. These flaps are then colonized by the patient’s living cells, allowing them to develop and mature alongside the individual. The valve’s design and manufacturing process aim to closely replicate the structure of an organic heart valve.
What is the benefit of FibraValve growing with the body?
The ability of FibraValve to grow with the body is a significant advantage, particularly for children. As their bodies mature, the valve can develop alongside them, potentially eliminating the need for risky replacement surgeries. This personalized approach could greatly improve the quality of life for pediatric patients.
What materials are used in FibraValve?
FibraValve incorporates a custom polymer material called PLCL, which combines polycaprolactone and polylactic acid. This material is designed to last inside the patient’s body for approximately six months, allowing sufficient time for the patient’s cells to infiltrate the structure and regenerate their own living valve tissue.
Has FibraValve been tested on humans?
Currently, FibraValve has only been successfully tested in sheep. However, the researchers plan to conduct longer-term animal testing over weeks and months to evaluate its effectiveness further. Human trials may be considered in the future if the results continue to show promise.
What other applications could FibraValve have?
Apart from its potential in pediatric cardiology, FibraValve’s breakthrough could have broader applications. The technology and principles used in its development may be applied to creating different types of valves, cardiac patches, and blood vessels. This could open doors to customized medical implants that regenerate and grow with patients, benefiting individuals of all ages.