ADVANCED MEDICAL ELECTRONICS CORP — Department of Health and Human Services STTR Phase I: NICHD

Description

DESCRIPTION provided by applicant This project will develop an FDA approved process D printing system and advanced D 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 sizes of CPAP nasal prongs available to clinicians that must serve growing babies weighing less than grams up to babies weighing over kg Ill fitting nasal prongs contribute to adverse outcomes in this fragile population Recent advances in D 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 D printer and D 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 PUBLIC HEALTH RELEVANCE The proposed research aims to improve the efficacy of nasal continuous positive airway pressure nCPAP in the neonatal care environment Respiratory support in neonates ranging in weight from grams up to babies weighing over kg is extremely consequential to long term health and development Therapy effectiveness at this stage of human development is life altering