Advanced Test Methods for Medical Devices used in Pediatric Respiratory Support

儿科呼吸支持医疗器械的先进测试方法

• 批准号: RGPIN-2020-04393
• 负责人: Martin, Andrew
• 金额: $ 1.97万
• 依托单位: University of Alberta
• 依托单位国家: 加拿大
• 项目类别: Discovery Grants Program - Individual
• 财政年份: 2022
• 资助国家: 加拿大
• 起止时间: 2022-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=760229
• 关键词: Advanced; Test; Methods; Medical; Devices

The long-term goal of the proposed research program is to improve the design and performance of medical gas delivery devices used in supporting pediatric patients suffering from respiratory diseases.  Childhood respiratory diseases present a major burden on global health.  Therapies and devices used for providing respiratory support to neonates, infants, and young children are critically important both in alleviating acute respiratory distress and treating chronic respiratory disorders. Despite the frequent need to provide respiratory support to young children, optimal device designs and delivery parameters for children are not well established.  Even for low-flow oxygen supplied through nasal prongs, used for decades as a standard therapy, estimates of inhaled oxygen concentrations are not well established for children.  For nasal high flow therapy, a relatively new form of noninvasive respiratory support which has seen rapid increase in use over recent years, little consensus exists regarding how interplay between device design, delivered flow rates, and patient airway geometry influences therapy. In recent years, the applicant's research group has done extensive work developing benchtop test methods for evaluating medical gas delivery devices.  The present research proposal aims to extend this work to address specific applications involving the treatment of neonates, infants, and young children. This work will focus on improving mechanistic understanding of nasal high flow therapy and low-flow oxygen therapy.  In carrying out the proposed research, experiments will be conducted in a laboratory environment using custom-built realistic pediatric nose-throat airway replicas coupled with a lung simulator.  Experiments will be conducted to evaluate existing commercial devices and patient interfaces, in order to improve prediction of gas concentrations and airway pressures delivered to children.   In addition, insights gained from evaluating existing devices will be used to propose novel, prototype device and interface designs. In all cases, experimental data will be compared with empirical and analytical models describing dependence of airway pressure and gas concentrations on delivered gas flow rates, upper airway geometry, and interface geometry (e.g. size and shape of nasal prongs), so as to validate predictive models that assist in early stage device and interface development. Results of the proposed research program will be of value to engineers working in the medical devices industry to evaluate and improve upon existing device designs, as well as to biomedical engineers, technologists and clinicians working within health systems to establish recommendations for selecting device and delivery parameters.  Students trained in the program will be well positioned to start their careers in the medical device industry.

拟议研究计划的长期目标是改进用于支持患有呼吸系统疾病的儿科患者的医用气体输送装置的设计和性能。儿童呼吸道疾病是全球卫生的一个重大负担。用于为新生儿、婴儿和幼儿提供呼吸支持的疗法和设备在缓解急性呼吸窘迫和治疗慢性呼吸系统疾病方面都至关重要。尽管经常需要为幼儿提供呼吸支持，但儿童的最佳设备设计和交付参数尚未得到很好的确定。即使通过鼻尖提供低流量氧气，作为几十年来的标准治疗方法，对儿童吸入氧浓度的估计也没有很好的确定。对于鼻高流量治疗，一种相对较新的无创呼吸支持形式，近年来使用迅速增加，关于设备设计，输送流量和患者气道几何形状之间的相互作用如何影响治疗，几乎没有共识。近年来，申请人的研究小组在开发评估医用气体输送装置的台式测试方法方面做了大量工作。目前的研究计划旨在扩展这项工作，以解决涉及治疗新生儿，婴儿和幼儿的具体应用。本工作将着重于提高对鼻腔高流量和低流量氧治疗机制的理解。在进行拟议的研究中，实验将在实验室环境中进行，使用定制的真实儿科鼻咽喉气道复制品以及肺部模拟器。将进行实验以评估现有的商业设备和病人接口，以便改进对输送给儿童的气体浓度和气道压力的预测。此外，从评估现有设备中获得的见解将用于提出新颖的原型设备和界面设计。在所有情况下，实验数据将与经验和分析模型进行比较，这些模型描述了气道压力和气体浓度对输送气体流速、上气道几何形状和界面几何形状（例如鼻尖的大小和形状）的依赖性，从而验证有助于早期设备和界面开发的预测模型。拟议的研究计划的结果将有价值的工程师在医疗器械行业工作，以评估和改进现有的设备设计，以及生物医学工程师，技术人员和临床医生在卫生系统内工作，以建立选择设备和输送参数的建议。在该计划中训练的学生将很好地定位在医疗器械行业开始他们的职业生涯。