Degradation and Fatigue Behavior of 3D Printed Bioresorbable Tracheal Splints

Georgia Institute Of Technology, Atlanta GA

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): 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. Two subsequent children with life threatening TBM were saved with the splint and the first child continues to be asymptomatic 30 months post-surgery. Based on these results, we met with the FDA on August 22, 2014 to initiate a phase I clinical trial for Humanitarian Device Exempt (HDE) approval. These preclinical questions dealt with the degradation mechanisms and fatigue behavior of the splint, how splint design and 3D printing orientation affect splint degradation and fatigue, and how the splint affects airway mechanics over time with degradation. 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.