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可打印材料，适用于为新生儿定制的持续正压(CPAP)口罩的护理点式制造。对于极低出生体重的婴儿，鼻腔CPAP治疗是通过柔软的、生物兼容的、新生儿大小的适合长期直接皮肤接触的鼻罩进行的，插入鼻孔并牢牢地贴在脸上。为了将所需的压力传递到远端呼吸道，并将并发症降至最低，面罩鼻尖和鼻孔内周软组织之间需要紧密密封。目前，临床医生可以使用的CPAP鼻叉尺寸有限，通常只有4种，必须为体重不到400克的成长婴儿到体重超过4公斤的婴儿服务。在这一脆弱的人群中，不合适的鼻尖会导致不利的结果。3D打印的最新进展支持在患者护理地点有效地制造定制的新生儿鼻腔CPAP叉子的可能性。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批准的拟议类型的医疗设备。为了推动3D打印机和3D可打印材料制造商的发展以及临床医生的采用，材料和应用研究对于证明科学和商业市场都是必要的。这一创新项目的目标是开发一种材料和打印系统的组合，能够在这一应用中生产出柔韧的医疗设备，通过FDA的指导和国际共识标准，达到或超过应用于同类设备的期望。

 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.