Objectives

The posterior cricoid split with rib graft is a procedure that elegantly corrects pediatric posterior glottic stenosis and subglottic stenosis. Currently, the procedure requires harvesting of rib cartilage which leaves room for optimization. With use of three dimensional printing technology, our objective was to design a device that would negate the need for costal cartilage harvesting in this procedure.

Methods

An optimized, novel polycaprolactone scaffold was designed using computer aided design software and three dimensional printing. A pilot proof of concept study was conducted with implantation of the device in three porcine animal subjects. Device was evaluated by post-procedural clinical course, endoscopic exams, post-mortem exam, and histological evaluation.

Results

A series of variably sized scaffolds were created. The scaffolds showed structural integrity and successfully expanded the cricoid cartilage in the porcine model study. Post-operative endoscopy and clinical exams demonstrated no signs of implant instability or failure. Gross and histologic exams showed successful mucosalization over the scaffold and cartilage ingrowth by six weeks.

Conclusion

This porcine animal pilot study demonstrated early success of a computer-aided designed, 3D printed, bioresorbable PCL posterior graft scaffold. The scaffolds eliminate the need for costal cartilage harvesting and had excellent surgical usability. The scaffolds functioned as designed, offering proof of concept and grounds for further evaluation to expand on this small pilot study with larger animal studies and continued design refinement.

中文翻译：

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一种新颖的、计算机辅助设计的、3D 打印的、生物可吸收的后环状支架的早期临床前评估

目标

肋骨移植后环状软骨分裂是一种优雅地矫正小儿后声门狭窄和声门下狭窄的手术。目前，该过程需要收获肋软骨，这为优化留有余地。通过使用三维打印技术，我们的目标是设计一种设备，在此过程中无需进行肋软骨采集。

方法

使用计算机辅助设计软件和三维打印设计了一种优化的新型聚己内酯支架。通过在三只猪动物受试者中植入该装置进行了概念研究的试点验证。通过术后临床过程、内窥镜检查、验尸检查和组织学评估来评估设备。

结果

一系列不同大小的脚手架被创造出来。在猪模型研究中，支架显示出结构完整性并成功扩展环状软骨。术后内窥镜检查和临床检查显示没有植入物不稳定或失败的迹象。大体和组织学检查显示，六周内支架和软骨向内生长成功。

结论

这项猪动物试验研究证明了计算机辅助设计的 3D 打印生物可吸收 PCL 后部移植支架的早期成功。支架消除了肋软骨收获的需要，并具有出色的手术可用性。支架按设计发挥作用，为进一步评估提供概念证明和依据，以通过更大的动物研究和持续的设计改进来扩展这项小型试点研究。