PLA/PLC “Smart Patch” functionality assessment for fetal duraplasty in prenatal myelomeningocele repair using a fetoscopic surgical simulator

BACKGROUND: Fetoscopy has emerged as a minimally invasive alternative to open hysterotomy for prenatal repair of myelomeningocele (MMC), which often requires a dural substitute. Our team developed a novel PLA/PCL patch optimized for fetoscopic surgery. This study compared the performance of the PLA/PCL patch with a human umbilical cord (HUC) graft. METHODS: Twenty-seven medical professionals with varied experience performed four MMC repair tasks in a fetoscopic simulator: patch introduction, manipulation, placement, and suture. In a randomized crossover design, each participant performed the tasks twice, once with each graft. Task times were recorded. After each attempt, participants completed task-specific difficulty questionnaires and the NASA Task Load Index (NASA-TLX); after both attempts, they completed a comparative questionnaire assessing overall preference and perceived performance. RESULTS: Participants included nine experts, nine intermediates, and nine novices. Introduction was significantly faster with PLA/PCL across all experience levels and overall (16 ± 7 s vs 35 ± 17 s, p < 0.001). Manipulation was also shorter with PLA/PCL (50 ± 29 s vs 69 ± 36 s, p = 0.05), whereas placement was longer (79 ± 71 s vs 43 ± 23 s, p = 0.017). Suturing time and total procedural time did not differ between grafts. NASA-TLX scores showed lower physical demand (p = 0.003) and effort (p = 0.018) with PLA/PCL. The pre-folded design was rated highly useful (mean=9.1/10), with minimal unfolding difficulty (mean = 2.1/10). Most participants found PLA/PCL easier for introduction (85%), manipulation (81%), placement (78%), and suturing (85%). CONCLUSION: The PLA/PCL patch is a promising dural substitute for prenatal MMC repair. Its shape-memory design enabled faster introduction and manipulation and reduced perceived workload compared with HUC, while maintaining comparable total procedural times. These findings support further preclinical evaluation of this novel graft.