Custom Fit 3D-Printed Pediatric Respiratory Masks

 描述（由申请人提供）：该项目将开发FDA批准的工艺、3D打印系统和先进的3D打印材料，适用于新生儿定制持续气道正压通气（CPAP）面罩的即时制造。对于极低出生体重的婴儿，鼻CPAP治疗是通过柔软、生物相容性、鼻孔大小的鼻罩进行的，鼻罩适合长期直接皮肤接触，插入鼻孔并紧贴面部。为了将期望的压力传递到远端气道并使并发症最小化，在面罩鼻叉和鼻孔内周的软组织之间需要紧密密封。目前，临床医生可用的CPAP鼻叉尺寸有限，通常只有4种，必须为体重小于400克的成长中婴儿到体重超过4公斤的婴儿提供服务。不合适的鼻叉有助于这一脆弱人群的不良结局。3D打印的最新进展支持在患者护理点有效制造定制新生儿鼻CPAP叉的可能性。不幸的是，聚合物和打印机系统还没有完全开发出来，可以制造FDA批准的医疗设备。材料和应用研究对于证明科学和商业市场都是必要的，以推动3D打印机和3D打印材料制造商的开发以及临床医生的采用。该创新项目的目标是开发一种材料和印刷系统组合，能够在该应用中生产柔韧的医疗器械，该医疗器械可以满足或超过FDA指南和国际共识标准中适用于可比器械的预期。

 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.