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)

在这个快速通道SBIR驱动医疗公司，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， 鼻叉，用于向年轻儿科患者（1个月至9岁）提供无创通气（NIV）。 NIV提供呼吸支持，无需使用气管内或气管切开插管。NIV是由 接口（面罩或鼻叉）。一般来说，口罩只覆盖鼻子，以减轻潜在的吸入 担心患者会呕吐。鼻叉预期在患者的鼻内实现100%闭合配合。 鼻孔对于面罩和叉管，目标是提供气道支持，维持呼气末正压通气， 压力（PEEP）。不合适的面罩可能导致不依从、患者-呼吸机不同步、皮肤 损伤、疼痛、颅面骨骼问题，并且还可能导致递送次优压力或潮汐压力。 这可能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，本发明还 不合适的NIV接口可能需要将它们紧紧地绑在患者身上，以抵消不合适的配合，这可能 导致压力性溃疡、皮肤损伤或鼻中隔损伤（在鼻叉的情况下）。虽然许多NIV交付 存在用于新生儿患者的方法（3种可用面罩和11种鼻叉尺寸），没有设计尺寸 特别适用于配有适当头盔的年轻儿科患者（1个月至9岁）。的 对于相对较小的制造商来说，验证过程是昂贵和耗时的。 市场，限制了主要制造商填补这些空白的兴趣。三个主要限制出现时， 解决年轻患者的需求：1）新生儿和成人接口之间的尺寸差距使穷人 2）患者面部结构的变化导致NIV接口 用力推压面部，以消除或减少漏气，以及3）颅面 畸形（CFA）（例如唇裂）进一步限制了实现良好密封的能力。需要采取一种方法， 生产NIV接口，解决这些差距，同时符合FDA标准，经济上仍然可行。 一阶段假说.可使用3D打印制造儿科专用尺寸的NIV面罩和尖头 方法，以改善通风结果在台式模型。目标1。验证性能的改进 通过面部扫描和注射成型工艺制造的儿科大小的NIV装置。目标2- 直接3D打印方法的配方开发和测试。 第二阶段。假说.通过3D打印制造NIV设备可以产生更好的贴合界面，从而改善 年轻儿科的NIV结局。儿科NIV接口的目标3-重复制造方法。目标4 - 最终确定直接3D打印方法并使用CFA评估性能。目标5-多中心人体临床 评价（CHOP，n = 29; ACH，n = 24）