# Degradation and Fatigue Behavior of 3D Printed Bioresorbable Tracheal Splints

> **NIH NIH R01** · GEORGIA INSTITUTE OF TECHNOLOGY · 2020 · $408,678

## Abstract

Abstract
Tracheobonchomalacia (TBM) is a congenital or acquired deficiency of tracheal and/or bronchial
cartilages that presents with dynamic airway collapse, respiratory difficulties, and, in severe
cases, acute life-threatening events. TBM prevalence is estimated at 1 in 2,200 children1, and
severe cases can result in death or require tracheostomy with ventilation for 2-3 years, a
significant burden on the child and family2,3. We recently developed a bioresorbable, patient
specific 3D printed polycaprolactone (PCL) splint to treat TBM, reporting the first case in the
New England J. of Medicine4. Three subsequent children with life threatening TBM were saved
with the splint and the first child continues to be asymptomatic 30 months post-surgery.
However, long term clinical application of the splint requires further engineering to reduce the
risk of fatigue failure in addition to understanding how resorption of the splint affects mechanical
deformation and remodeling of the airway to improve safety and efficacy of the splint. In
addition, the FDA also requires such data for regulatory approval based on our August 22, 2014
meeting with the FDA to initiate a phase I clinical trial for Humanitarian Device Exempt (HDE)
approval. We will address these questions in two specific aims using both in vitro and in vivo
preclinical model, the Yorkshire pig. The first aim will characterize splint degradation both in
vitro and in vivo for up to 2 years. The second aim will use this data to characterize how the
splint affects airway mechanics.

## Key facts

- **NIH application ID:** 9988850
- **Project number:** 5R01HD086201-06
- **Recipient organization:** GEORGIA INSTITUTE OF TECHNOLOGY
- **Principal Investigator:** Scott J Hollister
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $408,678
- **Award type:** 5
- **Project period:** 2016-08-19 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9988850

## Citation

> US National Institutes of Health, RePORTER application 9988850, Degradation and Fatigue Behavior of 3D Printed Bioresorbable Tracheal Splints (5R01HD086201-06). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9988850. Licensed CC0.

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