Custom Fit 3D-Printed Pediatric Respiratory Masks

定制 3D 打印儿童呼吸面罩

• 批准号: 9012431
• 负责人: Gregory John Seifert
• 金额: $ 22.5万
• 依托单位: ADVANCED MEDICAL ELECTRONICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-18 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9012431
• 关键词: 3D Print; Adoption; Anatomic Models; Anterior nares; Applied Research; Biocompatible; Chairperson; Childhood; Clinic; Clinical; Clinical Trials; Collaborations; Computer software; Consensus; Continuous Positive Airway Pressure; Critical Care; Custom; Deposition; Development; Devices; Distal; Doctor of Medicine; Doctor of Philosophy; Effectiveness; Elastomers; Engineering; Ensure; Environment; Evaluation; Extremely Low Birth Weight Infant; FDA approved; Face; Hardness; Head; Health; Human Development; In Vitro; International; Laboratories; Lead; Life; Manufacturer Name; Marketing; Masks; Mechanics; Medical; Medical Device; Medical Electronics; Medicine; Methodology; Modeling; Morbidity - disease rate; Neonatal; Neonatal Intensive Care Units; Nose; Outcome; Patients; Performance; Phase; Physician Executives; Pliability; Polymers; Polyurethanes; Population; Printing; Process; Pulmonology; Research; Research Personnel; Scanning; Science; Skin; Solutions; Specific qualifier value; Staging; Structure; Support System; System; Systems Development; Technology; Testing; To specify; Weight; advanced system; adverse outcome; biomaterial compatibility; college; copolymer; expectation; experience; improved; innovation; meetings; mortality; nCPAP Ventilation; neonatal care; neonate; novel; point of care; pressure; prototype; public health relevance; research study; respiratory; seal; soft tissue

 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.

 描述（由适用提供）：该项目将开发FDA批准的过程，3D打印系统和高级3D打印材料，适用于新生儿的定制拟合连续正气道（CPAP）掩码的现有型号制造。在极低的出生体重婴儿中，鼻CPAP治疗是通过柔软的，生物相容性的，新生儿大小的鼻膜进行的，适用于插入纳雷斯的长期直接皮肤接触，并首先保持在面部。为了使所需的压力传播到远端气道并最大程度地减少并发症，面膜鼻叉和鼻孔内周长的柔软尖端之间需要紧密的密封。目前，临床医生可以使用有限的CPAP鼻prongs（通常只有4个尺寸），这些临床医生必须为成长中的婴儿加权不到400克，而婴儿加权超过4公斤。不合适的鼻径促进了这个脆弱人群的广告结果。 3D打印的最新进展支持了在患者护理的有效制造的定制新生儿鼻CPAP prongs的可能性。不幸的是，尚未完全开发聚合物和打印机系统，可以使建议的FDA批准的医疗设备类型。材料和应用研究对于证明科学和商业市场是必要的，以推动3D打印机和3D可打印材料制造商的开发以及临床医生的收养。这个创新项目的目的是开发一个能够在本应用程序中生成柔软的医疗设备的材料和打印系统组合，该设备可以满足或超过通过FDA指南和国际共识标准所适用的可比设备的期望。

项目成果

Workflow to develop 3D designed personalized neonatal CPAP masks using iPhone structured light facial scanning.

• DOI: 10.1186/s41205-022-00155-7
• 发表时间: 2022-08-01
• 期刊: 3D PRINTING IN MEDICINE
• 影响因子: 3.7
• 作者: Kamath, Amika A.;Kamath, Marielle J.;Ekici, Selin;Stans, Anna Sofia;Colby, Christopher E.;Matsumoto, Jane M.;Wylam, Mark E.
• 通讯作者: Wylam, Mark E.