Free flap surgery is considered the gold standard in head and neck reconstructive surgery but comes with a dangerous risk of failure. Monitoring blood flow can help predict free flap failure, but the current industry standard, the Cook-Swartz Doppler Probe and System, suffers from false positive rates as high as 30%, leading to surgical re-exploration that can cost anywhere from $20-30k per incident. The Cook-Swartz device also requires trained, experienced personnel to interpret its output.
The false positive rate for this free flap failure detection device is much lower than the industry standard, especially at increasingly larger window sizes.
Description
A new automated early-onset free flap failure detection device has the ability to detect failure before it occurs. This novel detection device provides a real-time estimate of the free flap blood flow status. Decision-making intelligence is automating, removing the need for experienced operators. The early-detection threshold can be engineered for individual specific applications. This technology can be implemented with an ultra-low-power microchip implant or can be integrated into implantable wireless stents to monitor peripheral arterial disease. False positive rates can be reduced to nearly 10% and human error eliminated as compared to the current industry standard.
Applications
· Monitoring blood flow to predict free flap failure in surgery
Advantages
· A significant reduction in false positive rates, from 30% to 10%
· Removes the need for experienced, highly trained human personnel, and reduces the likelihood of human error
· Early-detection threshold can be engineered for specific application
· Decision making is automated
· Can be implemented with a microchip or an implantable wireless stent
Invention Readiness
Prototype
IP Status
https://patents.google.com/patent/WO2019027693A1Related Publication(s)
Rothfuss, M. A., Franconi, N. G., Star, A., Akcakaya, M., Gimbel, M. L., & Sejdic, E. (2018). Automatic Early-Onset Free Flap Failure Detection for Implantable Biomedical Devices. IEEE Transactions on Biomedical Engineering, 65(10), 2290–2297. https://doi.org/10.1109/tbme.2018.2793763
