Using biodesign methodology for the development and initial validation of a novel fetal shunt: The Vortex shunt Review
| Authors: | Blumenfeld, Y. J.; Sheth, K. R.; Johnson, E.; Danzer, E. |
| Review Title: | Using biodesign methodology for the development and initial validation of a novel fetal shunt: The Vortex shunt |
| Abstract: | Fetal lower urinary tract obstruction (LUTO) is a severe malformation that is associated with significant neonatal and pediatric morbidity and mortality risk. Existing fetal shunts aimed at bypassing the obstruction and improving neonatal survival have significant limitations, primarily shunt dislodgement. Repeat in-utero invasive shunt replacement procedures are associated with maternal, fetal, and obstetric risks, highlighting a clinical need for a novel fetal shunt with improved performance. We used a biodesign approach to develop and validate a novel fetal shunt, the Vortex shunt, which can potentially reduce dislodgement and improve both neonatal and maternal outcomes. In this review, we will discuss our approach to assessing the clinical need, the initial prototyping and benchtop testing, and animal feasibility studies of the Vortex shunt. We will also discuss existing challenges and opportunities for innovation in the fetal medicine and surgery space, and how biodesign methodology can inform novel instrument development in high-impact small market areas. © 2025 Elsevier B.V., All rights reserved. |
| Keywords: | human tissue; treatment outcome; histopathology; nonhuman; methodology; gold standard; phenotype; animal; animals; animal experiment; animal model; in vitro study; validation study; ultrasound; feasibility study; limb; surgeon; surgery; benchmarking; pregnancy; interview; pleura effusion; development; clinical effectiveness; fetus; ex vivo study; shunting; funding; developmental stage; abdominal wall; pig; vascular patency; bladder function; bladder; hemostasis; fetus development; fetus growth; fetal diseases; kidney development; anatomical variation; deterioration; oligohydramnios; fetal; fetus disease; premature labor; bladder dysfunction; devices; procedures; stent migration; proof of concept; lung cyst; sheep; umbilical cord; bladder emptying; fetal therapy; fetal therapies; hydrothorax; time interval; device safety; hydroureter; humans; human; female; article; tactile feedback; fetus echography; hysterotomy; fetus lung; urethral obstruction; bladder distension; three dimensional printing; stakeholder engagement; nitinol; urethra obstruction; lower urinary tract obstruction; vesico-amniotic shunt; vortex; anhydramnios; catheter kinking; congenital lung disease; fetal lower urinary tract obstruction; fetal megacystis; fetoscopy; fetus bladder; lamb; medical care need; stent dislodgement |
| Journal Title: | Clinical Obstetrics and Gynecology |
| Volume: | 68 |
| Issue: | 3 |
| ISSN: | 0009-9201 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2025-09-01 |
| Start Page: | 442 |
| End Page: | 447 |
| Language: | English |
| DOI: | 10.1097/grf.0000000000000954 |
| PUBMED: | 40804764 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Source: Scopus |
