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用于加速儿童喉气管重建的定制可编程互穿弹性体网络复合喉支架

A Bespoke Programmable Interpenetrating Elastomer Network Composite Laryngeal Stent for Expedited Paediatric Laryngotracheal Reconstruction.

临床研究咽喉科IF 19.8Q1

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中文摘要

背景: 喉气管重建手术(LTR)是儿童上气道狭窄的标准治疗方法,可实现气管造口拔管并恢复发声。在复杂婴儿病例中,术后支架置入对于移植物整合和减少再狭窄至关重要,然而现有的现成支架往往不适合小患者。方法:本文报告一例先天性喉闭锁基础上获得性喉闭锁病例,在婴儿期早期进行了重建。为支持该干预,开发了一种个性化喉支架,其由数字可编程互穿弹性体网络(IEN)复合材料制成,根据患者解剖结构定制,在结构刚度与表面柔软度之间取得平衡。该支架通过将3D反向打印热塑性聚氨酯(3D-TIPS)支架与真空辅助硅树脂灌注相结合来制造,形成具有适合儿科使用的可维持几何形状、硬度和生物力学顺应性的弹性体。结果:该支架按照英国良好生产规范指南制造,在5月龄行LTR时置入,并在6周后安全取出。支架支撑的修复愈合良好,27个月时拔管。在8年随访时,患者表现出强有力的发声、良好的气道保护和正常吞咽。结论:除该病例外,这项工作建立了一个通用平台,可快速制造具有可编程机械和表面特性的患者特异性弹性体植入物,用于软组织重建。

英文摘要

Laryngotracheal reconstruction surgery (LTR) is the standard treatment for paediatric upper airway stenosis, enabling tracheostomy decannulation, and restoration of vocalization. In complex infant cases, postoperative stenting is essential for graft integration and minimization of restenosis, yet available off-the-shelf stents are often unsuitable for small patients. Here, a case of acquired-on-congenital laryngeal atresia is reported, where early reconstruction in infancy was performed. To support this intervention, a personalized laryngeal stent was developed from a digitally programmable interpenetrating elastomer network (IEN) composite tailored to the patient's anatomy, balancing structural stiffness with surface softness. The stent was fabricated by combining 3D inverse-printed thermoplastic polyurethane (3D-TIPS) scaffolds with vacuum-assisted silicone resin infusion, yielding an elastomer with tenable geometry, hardness, and biomechanical compliance optimized for paediatric use. Manufactured in accordance with UK Good Manufacturing Practice guidelines, the stent was deployed during LTR at 5 months of age and safely removed after 6 weeks. The stented repair healed well, with decannulation at 27 months. At 8-year follow-up, the patient demonstrates strong vocalization, good airway protection, and normal swallowing. Beyond this case, this work establishes a versatile platform for rapid manufacture of patient-specific elastomer implants with programmable mechanical and surface properties for soft-tissue reconstruction.