This is an innovative medical device designed to address severe fetal central nervous system (CNS) ventriculomegaly, a condition that can lead to significant brain damage due to pressure hydrocephalus.
Description
This second version of the shunt incorporates modern prenatal diagnostics and advanced materials, such as superelastic nitinol, to improve upon earlier designs. The primary goal of VASFAS is to prevent brain injury, preserve neurological function, and support normal brain development in fetuses diagnosed with isolated aqueductal stenosis.
Applications
• Fetal Hydrocephalus
• Prenatal Ventricular Decompression
Advantages
The VASFAS device stands out due to its innovative design and materials. Unlike earlier ventriculoamniotic shunts, which were prone to clogging and migration, VASFAS employs buckling-resistant soft composite tubing and superelastic nitinol materials. These features enhance the device’s stability and functionality. The self-expanding nitinol anchors prevent dislodgement, while the low-profile one-way valve ensures effective cerebrospinal fluid (CSF) drainage without reflux. Additionally, the device’s percutaneous, ultrasound-guided insertion technique minimizes maternal harm, making it a safer option for both mother and fetus. These advancements collectively offer a more reliable and effective solution for managing fetal hydrocephalus.
Invention Readiness
The VASFAS device is currently at the prototype stage, with significant progress made in its design and fabrication. The prototype has been developed using advanced materials and manufacturing processes, such as laser cutting and gravitational drying. Initial testing has demonstrated the device’s ability to meet key performance characteristics, including prolonged drainage during fetal growth and atraumatic interaction with CNS structures. The next steps involve further validation and clinical trials to ensure safety and efficacy. With continued development and testing, VASFAS has the potential to become a groundbreaking solution in prenatal care.
IP Status
https://patents.google.com/patent/WO2020243394A1Related Publication(s)
Emery, S. P., Greene, S., Elsisy, M., Chung, K., Ye, S.-H., Kim, S., Wagner, W. R., Hazen, N., & Chun, Y. (2022). In vitro and in vivo assessment of a novel ultra-flexible ventriculoamniotic shunt for treating fetal hydrocephalus. Journal of Biomaterials Applications, 37(8), 1423–1435. https://doi.org/10.1177/08853282221125309
