Using Biodesign Methodology for the Development and Initial Validation of a Novel Fetal Shunt: The Vortex Shunt

Area of Science:

• Fetal Medicine and Surgery
• Biomedical Engineering
• Neonatal Malformations

Background:

• Fetal lower urinary tract obstruction (LUTO) presents significant risks for neonatal and pediatric morbidity and mortality.
• Current fetal shunts for LUTO have limitations, notably shunt dislodgement, necessitating repeat invasive procedures with associated maternal and fetal risks.
• There is a clear clinical need for improved fetal shunts to enhance neonatal survival and reduce procedural complications.

Purpose of the Study:

• To introduce and validate a novel fetal shunt, the Vortex shunt, developed using a biodesign approach.
• To address the limitations of existing shunts, specifically focusing on reducing dislodgement.
• To explore the potential of the Vortex shunt to improve both neonatal and maternal outcomes.

Main Methods:

• Utilized a biodesign methodology for systematic instrument development.
• Conducted initial prototyping and rigorous benchtop testing of the Vortex shunt.
• Performed animal feasibility studies to assess the performance and safety of the novel shunt.

Main Results:

• The Vortex shunt was developed and validated through a comprehensive biodesign process.
• Initial studies suggest the Vortex shunt has the potential to reduce dislodgement compared to existing devices.
• Feasibility studies in animal models demonstrated promising results for the novel shunt's performance.

Conclusions:

• The Vortex shunt represents a novel innovation for managing fetal lower urinary tract obstruction.
• This new device has the potential to overcome critical limitations of current treatments, improving patient outcomes.
• The biodesign approach offers a valuable framework for developing innovative medical instruments in fetal medicine.