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中，Actuated Medical，Inc.与费城儿童医院合作 (CHOP)和阿克伦儿童医院(ACH)开发工艺，生产更适合的口罩和 为1个月至9岁的年轻儿科患者提供无创呼吸机(NIV)的鼻夹。 [和合]在不使用气管内或气管切开的情况下提供呼吸支持。[和合]由以下人员交付 接口(面罩或鼻尖)。一般情况下，口罩只遮住鼻子以减轻潜在的吸入。 担心病人会呕吐。鼻叉的目的是实现100%的咬合在患者的 纳尔。对于口罩和叉子，目标都是提供维持呼气末积极呼气的呼吸道支持 压力(呼气)。不合适的口罩会导致不依从、患者-呼吸机不同步、皮肤 损伤、疼痛、头面部骨骼问题，也可能导致次优压力或潮汐 这可能会对通风效果产生不利影响，特别是在家庭护理环境中。另外， 不适合的NIV接口可能需要将它们紧紧地绑在患者身上，以抵消较差的配合，这可能会 导致压疮、皮肤损伤或中隔损伤(在鼻尖的情况下)。虽然许多NIV交付 方法为新生儿患者提供(3个可用面罩和11个鼻尖尺寸)，没有设计尺寸 专门针对配备了适当头盔的年轻儿科患者(1个月至9岁)。这个 对于相对较小的制造方法来说，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。在以下情况下会出现三个主要限制 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很小 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界面 为了消除或减少漏气，把脸压得太紧了；3)头面部 畸形(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，它将 生产NIV接口，以弥补这些差距，同时符合FDA的要求，并且在经济上仍然可行。 第一阶段假设。可以使用3D打印来制造儿科专用大小的NIV口罩和叉子 改善台式模型通风效果的方法。目标1.验证改进的性能 通过面部扫描和注塑工艺制造儿童大小的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。制造带有3D打印的NIV设备可以产生更好的匹配界面，从而改进 [和合]年轻儿科的结局。目的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，并使用CFA评估性能。目标5-多部位人体临床 评估(CHOP，n=29；ACH，n=24)