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

基本信息

  • 批准号:
    10258024
  • 负责人:
  • 金额:
    $ 30.95万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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)

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Roger Brooks Bagwell其他文献

Roger Brooks Bagwell的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('Roger Brooks Bagwell', 18)}}的其他基金

Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients
用于长期监测高危患者静脉血栓栓塞的可穿戴石墨烯柔性传感器
  • 批准号:
    10505269
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
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
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
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:
    10547992
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients
用于长期监测高危患者静脉血栓栓塞的可穿戴石墨烯柔性传感器
  • 批准号:
    10062073
  • 财政年份:
    2020
  • 资助金额:
    $ 30.95万
  • 项目类别:
Wearable, Graphene-based Flexible Sensors for Chronic Monitoring of Venous Thromboembolism for High-Risk Patients
用于长期监测高危患者静脉血栓栓塞的可穿戴石墨烯柔性传感器
  • 批准号:
    10242942
  • 财政年份:
    2020
  • 资助金额:
    $ 30.95万
  • 项目类别:
BleedClear System: Rapid and Safe Removal of Coagulated Blood, Uncleared Fundal Pools, and Adherent Clots from the Stomach Through a 2.8 mm Endoscope Channel to Improve Efficacy in UGI Bleed Treatment
BleedClear 系统:通过 2.8 毫米内窥镜通道快速安全地清除胃中的凝固血液、未清除的胃底池和粘附凝块,以提高上消化道出血治疗的效果
  • 批准号:
    8980245
  • 财政年份:
    2015
  • 资助金额:
    $ 30.95万
  • 项目类别:
Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function
驱动式低应力气管内插管清洁器可改善新生儿肺功能
  • 批准号:
    8591919
  • 财政年份:
    2013
  • 资助金额:
    $ 30.95万
  • 项目类别:
Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function
驱动式低应力气管内插管清洁器可改善新生儿肺功能
  • 批准号:
    9046700
  • 财政年份:
    2013
  • 资助金额:
    $ 30.95万
  • 项目类别:

相似海外基金

Study on the use of 3D print models to improve understanding of geomorphic processes
研究使用 3D 打印模型来提高对地貌过程的理解
  • 批准号:
    22K13777
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Grant-in-Aid for Early-Career Scientists
3D print-on-demand technology for personalised medicines at the point of care
用于护理点个性化药物的 3D 按需打印技术
  • 批准号:
    10045111
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Grant for R&D
Regenerative cooling optimisation in 3D-print rocket nozzles
3D 打印火箭喷嘴的再生冷却优化
  • 批准号:
    2749141
  • 财政年份:
    2022
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Studentship
Development of a New Powder Mix and Process Plan to 3D Print Ductile Iron Parts
开发用于 3D 打印球墨铸铁零件的新粉末混合物和工艺计划
  • 批准号:
    548945-2019
  • 财政年份:
    2021
  • 资助金额:
    $ 30.95万
  • 项目类别:
    College - University Idea to Innovation Grants
Development of a New Powder Mix and Process Plan to 3D Print Ductile Iron Parts
开发用于 3D 打印球墨铸铁零件的新粉末混合物和工艺计划
  • 批准号:
    548945-2019
  • 财政年份:
    2020
  • 资助金额:
    $ 30.95万
  • 项目类别:
    College - University Idea to Innovation Grants
Administrative Supplement for Equipment: 6-axis Positioner to Improve 3D Print Quality and Print Size
设备管理补充:用于提高 3D 打印质量和打印尺寸的 6 轴定位器
  • 批准号:
    10801667
  • 财政年份:
    2019
  • 资助金额:
    $ 30.95万
  • 项目类别:
SBIR Phase II: Pellet based 3D print extrusion process for shoe manufacturing
SBIR 第二阶段:用于制鞋的基于颗粒的 3D 打印挤出工艺
  • 批准号:
    1738138
  • 财政年份:
    2017
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Standard Grant
Development of "artificial muscle' ink for 3D print of microrobots
开发用于微型机器人3D打印的“人造肌肉”墨水
  • 批准号:
    17K18852
  • 财政年份:
    2017
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Grant-in-Aid for Challenging Research (Exploratory)
I-Corps: Nanochon, a Commercial Venture to 3D Print Regenerative Implants for Joint Reconstruction
I-Corps:Nanochon,一家商业企业,致力于 3D 打印再生植入物进行关节重建
  • 批准号:
    1612567
  • 财政年份:
    2016
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Standard Grant
SBIR Phase I: Pellet based 3D print extrusion process for shoe manufacturing
SBIR 第一阶段:用于制鞋的基于颗粒的 3D 打印挤出工艺
  • 批准号:
    1621732
  • 财政年份:
    2016
  • 资助金额:
    $ 30.95万
  • 项目类别:
    Standard Grant
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了