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:10571860
- 负责人:
- 金额:$ 62.09万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-03-01 至 2025-04-30
- 项目状态:未结题
- 来源:
- 关键词:2 year old3D Print9 year oldAddressAdultAffectAgeAirAnatomyAwardBreathingCell SurvivalCertificationChildChildhoodCleft LipCleft lip with or without cleft palateCollaborationsConsumptionContinuous Positive Airway PressureCraniofacial AbnormalitiesCustomCyclic GMPDataDevelopmentDevicesDimensionsEnsureExtravasationFaceFormulationGasesGoalsHumanInferiorInjectionsInjuryIntubationKnowledgeManikinsManufacturerMarketingMasksMedicalMedical DeviceMethodsModelingMoldsNeonatalNoseOutcomePainPathway interactionsPatient-Focused OutcomesPatientsPediatric HospitalsPediatricsPerformancePhasePhiladelphiaPlant ResinsPositive-Pressure RespirationPrintingProcessResearchSalesScanningSiteSmall Business Innovation Research GrantStructureSystemTestingTidal VolumeTimeTracheostomy TubeTubeValidationVariantVentilatorVomitingaspiratebiomaterial compatibilitycommercializationcostcraniofacialcytotoxicitydecubitus ulcerdesignendotrachealfabricationfile formatflexibilityhigh riskimprovedinterestmanufacturemanufacturing processneonatal patientnon-compliancepatient home carepediatric patientspressureresearch clinical testingsealskeletalskin damagestandard carestandard of caretechnological innovationventilation
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)
在这个快速通道中,SBIR驱动医疗公司正在与费城儿童医院合作
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)
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Roger Brooks Bagwell其他文献
Roger Brooks Bagwell的其他文献
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{{ 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:
$ 62.09万 - 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:
$ 62.09万 - 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:
10258024 - 财政年份:2021
- 资助金额:
$ 62.09万 - 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:
$ 62.09万 - 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:
$ 62.09万 - 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:
$ 62.09万 - 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:
$ 62.09万 - 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:
$ 62.09万 - 项目类别:
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