Affecting approximately 4 million pregnancies in the US annually, fetal obstructive hydrocephalus is a devastating condition that causes permanent brain damage due to increased intracerebral pressure. It is usually caused by fetal aqueductal stenosis (AS), a narrowing of passageways that drain cerebrospinal fluid from the brain. Obstruction of the flow of cerebrospinal fluid (CSF) causes it to accumulate within the cerebral ventricles, leading to increased intracerebral pressure, decreased blood flow, and neuron damage. Current management involves serial ultrasounds through gestation and preterm delivery via cesarean section, followed by post-natal shunting; the majority of survivors have long-term neurologic disability. In-utero relief of increased intracerebral pressure can facilitate normal brain development and prevent lifelong disability.
Description
This novel ventriculo-amniotic shunt represents a treatment breakthrough. Designed to meet specific performance requirements for in-utero drainage of CSF, VASFAS has a low profile to allow for percutaneous, ultrasound-guided placement, is atraumatic to brain and intrauterine tissues, and has systems to prevent dislodgement and clogging. VASFAS also features a one-way valve to prevent inflow of amniotic fluid into the cerebral ventricles. Combined with technology to detect and select appropriate AS cases, VASFAS has the potential to allow for full-term progression of pregnancies and preservation of neurological function during prenatal development.
Applications
· In-utero treatment of fetal obstructive hydrocephalus from isolated aqueductal stenosis
· In-utero treatment of obstructive hydrocephalus from other causes
· In-utero treatment of lower urinary tract obstruction
· In-utero treatment of pressure hydrothorax
Advantages
· Prevents brain damage
· May allow for in-utero healing of damaged brain tissue
· Percutaneous, ultrasound-guided insertion for minimal maternal risk
· Atraumatic design
· Anchoring system prevents dislodgement or migration
· Nitinol wire cages on both ends prevent clogging
· One-way valve prevents inflow of amniotic fluid
Invention Readiness
In vivo data
IP Status
https://patents.google.com/patent/US10744308B2
