Medical Design Briefs - September 2023 - 43

derway since 2014, and they produced
their first synthetic heart valve, JetValve,
in 2017. The JetValve is manufactured
using a novel method called rotary jet
spinning, in which a biocompatible synthetic
polymer is extruded through a
nozzle and spun into long nanofibers -
similar to how a cotton candy machine
spins sugar crystals into fluffy clouds.
These nanofibers are collected on a
heart-valve-shaped mandrel, producing
biocompatible valves within minutes
compared to the hours required for other
manufacturing methods.
The JetValve was successfully implanted
into a sheep's heart using minimally
invasive surgery, functioned properly,
and recruited living cells to regenerate
new tissue on the device. But the team
knew they could do better. They re-visited
multiple aspects of the JetValve
- manufacturing, fiber material, and
geometric design - and challenged
themselves to improve them all.
For the manufacturing process, they
added streams of focused air to the polymer-extruding
stream to create focused
rotary jet spinning (FRJS). This allowed
them to improve the rate at which the
polymer fibers were deposited onto the
mandrel, and to easily adjust the resulting
valve to the final desired shape. The
polymer also produced networks of micro-
and nanofibers that better mimicked
the tissue structure of a human
heart valve.
The team also used a new, custom
polymer material to improve the infiltration
of living cells once the FibraValve is
implanted into the body. This material,
called PLCL, is a combination of polycaprolactone
(PCL) and polylactic acid
(PLA). Previous studies had shown that
PLCL lasts about six months when implanted
into rats, is infiltrated by living
cells and remodeled into functional tissue,
and safely biodegrades.
The resulting PLCL FibraValves were
Asahi_2023_MDB_printer.pdf 1 7/12/2023 3:31:35 PM
This representation of the FibraValve and FRJs appeared
on the cover of Matter. (Credit: Wyss Institute at Harvard
University)
softer and more elastic than JetValves. After
four weeks of being cultured with cells
isolated from the heart valves of sheep,
the FibraValve enabled a more even distribution
of cells throughout its scaffold
than valves made of other polymers.
Finally, they worked on improving the
geometry of the FibraValve - specifically,
optimizing the shape of the valve's
inner leaflets to minimize leakage of
blood backwards through the valve.
They were able to reduce the amount of
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