Additive Manufacturing of Patient-Specific Masks and Nasal Prongs to Improve Pediatric Ventilation Outcomes and Reduce Pressure Sores

增材制造患者专用面罩和鼻叉，以改善儿科通气效果并减少压疮

• 批准号: 10571860
• 负责人: Roger Brooks Bagwell
• 金额: $ 62.09万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10571860
• 关键词: 2 year old; 3D Print; 9 year old; Address; Adult; Affect; Age; Air; Anatomy; Award; Breathing; Cell Survival; Certification; Child; Childhood; Cleft Lip; Cleft lip with or without cleft palate; Collaborations; Consumption; Continuous Positive Airway Pressure; Craniofacial Abnormalities; Custom; Cyclic GMP; Data; Development; Devices; Dimensions; Ensure; Extravasation; Face; Formulation; Gases; Goals; Human; Inferior; Injections; Injury; Intubation; Knowledge; Manikins; Manufacturer; Marketing; Masks; Medical; Medical Device; Methods; Modeling; Molds; Neonatal; Nose; Outcome; Pain; Pathway interactions; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Pediatrics; Performance; Phase; Philadelphia; Plant Resins; Positive-Pressure Respiration; Printing; Process; Research; Sales; Scanning; Site; Small Business Innovation Research Grant; Structure; System; Testing; Tidal Volume; Time; Tracheostomy Tube; Tube; Validation; Variant; Ventilator; Vomiting; aspirate; biomaterial compatibility; commercialization; cost; craniofacial; cytotoxicity; decubitus ulcer; design; endotracheal; fabrication; file format; flexibility; high risk; improved; interest; manufacture; manufacturing process; neonatal patient; non-compliance; patient home care; pediatric patients; pressure; research clinical testing; seal; skeletal; skin damage; standard care; standard of care; technological innovation; ventilation

In this Fast-track SBIR Actuated Medical, Inc., is partnering with the Children’s Hospital of Philadelphia (CHOP) and Akron Children’s Hospital (ACH) to develop processes to manufacture better fitting masks and nasal prongs for Non-invasive Ventilation (NIV) delivery to young pediatric patients (1 month to 9 years of age). NIV provides breathing support without the use of an endotracheal or tracheostomy tube. NIV is delivered by interfaces (a mask or nasal prongs). Generally, masks only cover the nose to mitigate potential aspiration concerns should a patient vomit. Nasal prongs are intended to achieve a 100% occlusive fit within a patient’s nare. For both masks and prongs, the goal is to deliver airway support maintaining positive-end expiratory pressure (PEEP). Poorly fitting masks can lead to non-compliance, patient–ventilator dys?synchronies, skin damage, pain, craniofacial skeletal issues, and can also result in delivery of sub-optimal pressures or tidal volume, which can adversely affect ventilation outcomes, particularly in the home care setting. Additionally, poorly fitting NIV interfaces can require them to be strapped to patients tightly to offset the inferior fit, which can lead to pressure ulcers, skin damage, or septum injury (in the case of nasal prongs). While many NIV delivery methods exist for neonatal patients (3 available mask and 11 nasal prong sizes), there are no sizes designed specific to young pediatric patients (1 month to 9 years old) that are equipped with appropriate headgear. The validation process to stand up a manufacturing approach is costly and time consuming for a relatively small market, limiting the interest of major manufacturers to fill these gaps. Three main limitations arise when addressing the needs of younger patients: 1) the size gap between neonatal and adult interfaces leave poor solutions for young pediatric patients, 2) variation in patient facial structure results in NIV interfaces being pushed too firmly against the face in an attempt to eliminate or reduce air leakage, and 3) craniofacial anomalies (CFAs) (e.g. cleft lip) further limit the ability to achieve a good seal. An approach is needed that will produce NIV interfaces that address these gaps, while being FDA-compliant and still economically feasible. Phase I. Hypothesis. Pediatric-specific sized NIV mask and prongs can be manufactured using 3D printing methods to improve ventilation outcomes in benchtop models. Aim 1. Verify improved performance of pediatric-sized NIV devices fabricated through facial scanning and injection molding process. Aim 2 – Formulation development and testing for direct 3D printing approach. Phase II. Hypothesis. Manufacturing NIV devices with 3D printing yields better fitting interfaces that improve NIV outcomes in young pediatrics. Aim 3 – Validate manufacturing approach for pediatric NIV interfaces. Aim 4 – Finalize direct 3D print approach and evaluate performance with CFAs. Aim 5 – Multi-site human clinical evaluations (CHOP, n=29; ACH, n=24)

在这最后一段轨道上，SBIR Actiped Medical，Inc。正在与费城儿童医院合作 （CHOP）和Akron儿童医院（ACH）开发制造更好合适口罩的过程 非侵入性通风（NIV）向年轻儿科患者（1个月至9岁）的鼻prongs。 NIV提供呼吸支撑，而无需使用气管或气管管。 界面（蒙版或鼻pr）。 担心患者呕吐物。 愚蠢的面具和插脚，目标是提供维持积极振动的气道支持 压力（偷窥） 损害，疼痛，颅面骨骼问题，也可以在次优压力或潮汐方面散发出来 在家庭护理环境中，卷会对通风结果产生不利影响。 拟合不佳的NIV界面可能要求将它们紧紧绑在患者身上以抵消劣等拟合，这可以 导致压力溃疡，皮肤损伤或隔膜损伤（对于鼻腔损伤）。 有新生儿患者的方法（3个可用的面膜和11个鼻尖尺寸），没有设计尺寸 特定于年轻的儿科患者（1个月至9岁），配备了适当的头饰 验证工艺以站立制造业，方法成本高昂，相对较小 市场，限制了主要制造商填补空白的兴趣。 满足年轻专利的需求：1）新生儿和成人之间的尺寸差距 年轻小儿患者的溶液，2）患者面部结构的变化导致NIV界面为 在反对的情况下太牢固地靠在面上，以消除或减少漏气，3）颅面 异常（CFAS）（例如，唇裂）进一步限制了获得良好密封的能力。 产生这些差距的NIV界面，同时兼容FDA且仍然是经济的。 第一阶段假设。 改善台式模型中通风结果的方法。 小儿大小的Nivices面料面料面料扫描和注射型工艺。 直接3D打印方法的制定开发和测试。 II阶段的假设。 NIV在小儿儿科3-验证小儿NIV界面的制造方法。 - 将直接的3D打印方法和CFA进行评估。 评估（CHOP，n = 29; ACH，n = 24）