Custom Fit 3D-Printed Pediatric Respiratory Masks

Period of Performance: 09/18/2015 - 08/31/2016


Phase 1 STTR

Recipient Firm

Advanced Medical Electronics Corporation
Principal Investigator


DESCRIPTION (provided by applicant): This project will develop an FDA-approved process, 3D printing system, and advanced 3D-printable material suitable for point-of-care manufacturing of custom-fit continuous positive airway pressure (CPAP) masks for neonates. In extremely low birth weight infants, nasal CPAP therapy is delivered via soft, biocompatible, neonatal-sized nasal masks suitable for long-term direct-skin contact inserted into the nares and held firmly against face. For the desired pressure to be transmitted to the distal airways and to minimize complications, a tight seal is required between the mask nasal prongs and the soft tissues of the internal circumference of the nostrils. Currently, there are limited, often just 4, sizes of CPAP nasal prongs available to clinicians that must serve growing babies weighing less than 400 grams up to babies weighing over 4 kg. Ill-fitting nasal prongs contribute to adverse outcomes in this fragile population. Recent advances in 3D printing support the possibility of custom-fit neonatal nasal CPAP prongs manufactured effectively at the patient point-of-care. Unfortunately, a polymer and printer system has not yet been fully developed that can make the proposed type of FDA-approved medical device. Materials and applied research are necessary to prove both the science and the commercial markets, in order to drive development from 3D printer and 3D printable materials manufacturers, and adoption from clinicians. The objective of this innovative project is to develop a material and printing system combination able to produce a pliable medical device in this application that can meet or exceed the expectations applied to comparable devices through FDA guidance and international consensus standards.