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; 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)

在这个快速轨道上，SBIR Actieted 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无需使用内牙或气管造口管即可提供呼吸支撑。 NIV由 界面（面具或鼻插）。通常，口罩只能遮盖鼻子以减轻潜在抽吸 担心患者应该呕吐。鼻径旨在实现患者的100％闭塞 尼尔。对于面具和插脚，目标是提供维持正末期呼气的气道支持 压力（窥视）。贴合性口罩可能会导致不合规，患者 - 视频dys同步，皮肤 损害，疼痛，颅面骨骼问题，也可能导致次优压力或潮汐的交付 数量可能会对通风结果产生不利影响，尤其是在家庭护理环境中。此外， 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（对于鼻刺）。而许多NIV交付 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 适用于配备适当头饰的年轻小儿患者（1个月至9岁）。这 站立制造方法的验证过程成本高昂，且相对较小 市场，限制了主要制造商填补这些空白的兴趣。当 满足年轻患者的需求：1）新生儿和成人界面之间的大小差距使差 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 首先推到脸上，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。需要一种方法 产生NIV界面来解决这些差距，同时兼容FDA，并且仍然在经济上可行。 第一阶段假设。可以使用3D打印来制造小儿特异性大小的NIV面膜和插脚 改善台式模型中通风结果的方法。 AIM 1。验证提高的性能 通过面部扫描和注射成型过程制造的小儿大小的NIV设备。目标2 - 直接3D打印方法的制定开发和测试。 第二阶段。假设。具有3D打印的制造NIV设备可产生更好的拟合界面，以改善 年轻儿科的NIV结果。 AIM 3 - 验证小儿NIV界面的制造方法。目标4 - 最终确定直接3D打印方法并评估CFAS的性能。 AIM 5 - 多站点人类临床 评估（CHOP，n = 29; ACH，n = 24）