I am the co-inventor of a pulmonary heart valve, developed for pediatric patients with congenital heart disease that is currently undergoing clinical trials.
Congenital heart disease is a life-threatening condition that often requires surgery and early valve replacement. This poses challenges for young patients that outgrow their valve repair and need to have multiple surgeries. This research work set out to develop a valve concept that can be implanted into a patient and accommodate growth. One of the key hypotheses behind this new valve concept was inspired by venous valves, which naturally adapt to vascular distension, such as during exercise.
As part of a team of clinicians and engineers, I developed research methodologies, prototypes, and experiments to test this growth-accommodating concept. A core design principle in this work is that the bi-leaflet valve's geometrical configuration can accommodate radial expansion over time. The findings of this research were published in Science Translational Medicine and the design concept is patented (US10966826B2).
The device is currently undergoing commercialization and is currently in clinical trials going (pivotal study NCT05006404).
The research work demonstrated that a bi-leaflet valve of constant length could theoretical tolerate expansion and remain competent through in vitro testing.
Functional prototypes were then developed which validated that balloon-dilation could expand the valve to accommodate growth and remain functional.
These designs were tested in vivo demonstrated valve competency and finally in a growing lamb model to illustrate long-term biocompatibility.
Images used with permission from Science Translational Medicine under the RightsLink agreement