Advanced Test Methods for Medical Devices used in Pediatric Respiratory Support

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疗气体输送设备的设计和性能。儿童呼吸道疾病是全球卫生的主要负担。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，但针对儿童的最佳装置设计和给药参数并未很好地确定。即使是通过鼻尖提供的低流量氧气，作为一种标准疗法已经使用了几十年，对儿童吸入氧气浓度的估计也没有很好的确立。对于鼻腔高流量治疗，一种相对较新的非侵入性呼吸支持形式，近年来使用迅速增加，关于设备设计、输送流量和患者呼吸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用于评估医疗气体输送装置的台式测试方法方面做了大量工作。本研究提案旨在扩大这项工作，以解决涉及新生儿、婴儿和幼儿治疗的具体应用。这项工作将集中于提高对鼻腔高流量氧疗和低流量氧疗的机理的理解。在进行拟议的研究时，实验将在实验室环境中进行，使用定制的逼真的儿科鼻咽部呼吸道复制品和肺部模拟器。将进行实验，以评估现有的商业设备和患者界面，以改进对提供给儿童的气体浓度和呼吸道压力的预测。此外，从评估现有设备中获得的见解将被用于提出新颖的、原型设备和接口设计。在所有情况下，实验数据将与描述气道压力和气体浓度对输送气体流速、上呼吸道几何形状和界面几何形状(例如鼻尖的大小和形状)的依赖关系的经验和分析模型进行比较，以验证有助于早期设备和接口开发的预测模型。 拟议的研究计划的结果将对医疗器械行业的工程师评估和改进现有的器械设计以及在卫生系统中工作的生物医学工程师、技术员和临床医生建立选择器械和输送参数的建议具有价值。接受过该项目培训的学生将为在医疗器械行业开始他们的职业生涯做好准备。

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.