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: 10258024
• 负责人: Roger Brooks Bagwell
• 金额: $ 30.95万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258024
• 关键词: 2 year old; 3D Print; 9 year old; Address; Adult; Affect; Age; Air; Anatomy; Award; Breathing; Cell Survival; 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; Lead; Manikins; Manufacturer Name; 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; Process; Research; Sales; Scanning; Site; Small Business Innovation Research Grant; Structure; System; Technology; Testing; Tidal Volume; Time; Tracheostomy Tube; Tube; Validation; Variant; Ventilator; Vomiting; biomaterial compatibility; commercialization; cost; craniofacial; cytotoxicity; decubitus ulcer; design; endotracheal; file format; flexibility; high risk; improved; innovation; interest; manufacturing process; neonatal patient; non-compliance; patient home care; pediatric patients; pressure; research clinical testing; seal; skeletal; skin damage; standard care; standard of care; 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)

在此快速通道中，SBIR Actuated Medical, Inc. 与费城儿童医院合作 (CHOP) 和阿克伦儿童医院 (ACH) 开发生产更贴合口罩的工艺， 用于为年轻儿科患者（1 个月至 9 岁）提供无创通气 (NIV) 的鼻塞。 NIV 无需使用气管内或气管切开插管即可提供呼吸支持。 NIV 是由 接口（面罩或鼻塞）。一般来说，口罩仅覆盖鼻子以减少潜在的误吸 担心患者呕吐。鼻尖头旨在实现 100% 封闭贴合于患者的鼻腔内 鼻孔。对于面罩和插管而言，目标是提供气道支持，维持呼气末正压 压力（PEEP）。不合适的面罩可能会导致不合规、患者与呼吸机不同步、皮肤 损伤、疼痛、颅面骨骼问题，也可能导致提供次优压力或潮汐 容量，这会对通气结果产生不利影响，特别是在家庭护理环境中。此外， 贴合不良的 NIV 接口可能需要将它们紧紧地绑在患者身上以抵消贴合不良的影响，这可能会导致患者死亡。 导致压疮、皮肤损伤或鼻中隔损伤（如果是鼻塞）。虽然许多 NIV 交付 现有适用于新生儿患者的方法（3 种可用的面罩和 11 种鼻塞尺寸），但没有设计尺寸 专门针对配备适当头带的年轻儿科患者（1 个月至 9 岁）。这 对于相对较小的企业来说，验证制造方法的过程既昂贵又耗时 市场，限制了主要制造商填补这些空白的兴趣。当出现以下三个主要限制时 满足年轻患者的需求：1) 新生儿和成人接口之间的尺寸差距留下较差 针对年轻儿科患者的解决方案，2) 患者面部结构的变化导致 NIV 接口 为了消除或减少漏气而将面部推得太紧，以及 3) 颅面 异常 (CFA)（例如唇裂）进一步限制了实现良好密封的能力。需要一种方法来 生产 NIV 接口来弥补这些差距，同时符合 FDA 标准并且在经济上仍然可行。 第一阶段。假设。可以使用 3D 打印制造儿童专用尺寸的 NIV 面罩和插脚 改善台式模型通气效果的方法。目标 1. 验证改进的性能 通过面部扫描和注塑工艺制造的儿科大小的 NIV 设备。目标 2 – 直接 3D 打印方法的配方开发和测试。 第二阶段。假设。通过 3D 打印制造 NIV 设备可产生更好的适配接口，从而改善 NIV 在年轻儿科中的结果。目标 3 – 验证儿科 NIV 接口的制造方法。目标 4 – 最终确定直接 3D 打印方法并通过 CFA 评估性能。目标 5 – 多部位人体临床 评估（CHOP，n=29；ACH，n=24）