Delivery, Transport, and Uptake of Inhaled Medical Gases

慢性呼吸道疾病对患者健康状况和医疗费用的全球影响是惊人的。据世界卫生组织的全球防治慢性呼吸道疾病联盟估计，全世界有超过10亿人患有此类疾病，包括哮喘、慢性阻塞性肺病（COPD）、睡眠呼吸暂停和肺动脉高压。仅COPD就占全球所有死亡的约5%，与在医院治疗COPD恶化以及在家庭医疗保健环境中管理症状相关的医疗保健成本是巨大的。显然需要改进治疗方法和医疗设备，并将其纳入疾病管理计划;然而，随着医疗支出（包括研发支出）的压力不断增加，这些进步必须以低于预期的成本实现。因此，迫切需要通过使用具有代表性的分析和实验建模来简化开发，以便在早期阶段更好地审查潜在的创新，并确定那些有足够希望承担临床研究相关成本的少数创新。 工程分析和设计在医疗器械的开发中起着至关重要的作用。 申请人的愿景是建立一个研究项目，专门用于控制和监测治疗气体和蒸汽输送到肺部的特定子类别器械。除了气体化合物在麻醉、重症监护和肺部成像中的专门应用外，还包括用于管理辅助供氧的设备，这是医院、急诊和家庭护理环境中的支柱。 目前，全世界有超过200万患者在家中接受长期氧疗。 随着人口老龄化，沿着越来越多的鼓励在家中治疗患者而不是在医院或诊所，预计这一数字将增加。 同时，最近的临床研究得出结论，现有氧气输送器械的机械和临床性能差异很大，并且使用当前方法评估的明显等同的技术特征不能保证等同的治疗功能。 通过强调用于分析输送设备和患者之间界面的实验方法，预计拟议的研究将在建立设备评估的代表性测试平台以及通过对现有设备进行彻底的工程分析来识别未满足的技术要求方面发挥主导作用。设备性能。这些将作为设计新型设备的关键工具和输入，用于改善给药的一致性，监测输送量，并最终改善患者的健康结果。 实验测量将与描述人类呼吸道中发生的流体力学和运输过程的数学模型相结合，从呼吸生理学和吸入毒理学的大量档案出版物中借用。 以这种方式，在体内发生的气体输送和肺力学将与可以在设备水平上在体外监测和控制的参数相关联。 该研究项目有望对医用气体装置的未来发展产生重大影响。 鼓励本科生和研究生学员尽早与医疗保健专业人员和行业联系人接触，为其项目指定关键要求和可交付成果，并寻求对新颖解决方案的知识产权保护。 该计划的毕业生将做好充分准备，参与将加拿大定位为医疗器械创新的新兴中心。

The global impact of chronic respiratory disease on patient health status and healthcare costs is staggering. It has been estimated by the World Health Organization’s Global Alliance against Chronic Respiratory Diseases that more than 1 billion people worldwide suffer from such diseases, which include asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, and pulmonary hypertension. COPD alone accounts for approximately 5% of all deaths globally, and healthcare costs associated both with treating exacerbations of COPD in hospital as well as managing symptoms in the home healthcare setting are enormous. Improved treatments and medical devices, incorporated into disease management programs, are clearly needed; however, with ever-increasing pressures on healthcare spending, including R&D spending, such advances must come at lower cost than previously expected. There is, therefore, an urgent need to streamline development through use of representative analytical and experimental modeling, so as to better vet potential innovations at an early stage, and identify those few with sufficient promise to bear the costs associated with investigation in the clinical setting. Engineering analysis and design play critical roles in the development of medical devices. The applicant’s vision is to establish a research program dedicated to the specific sub-category of devices used to control and monitor delivery of therapeutic gases and vapors to the lungs. In addition to specialized applications of gaseous compounds in anesthesia, critical care, and lung imaging, this includes devices used to administer supplemental oxygen, a mainstay throughout hospital, emergency, and home care settings. Currently, over 2 million patients worldwide receive long-term oxygen therapy in their homes. With aging populations, along with increasing incentives to treat patients at home versus in the hospital or clinic, this number is expected to increase. In parallel, recent clinical studies have concluded that the mechanical and clinical performance of existing oxygen delivery devices are highly variable, and that apparently equivalent technical features, as assessed using current methods, do not guarantee equivalent therapeutic function. Through an emphasis on experimental methods used to analyze the interface between delivery device and patient, it is anticipated that the proposed research will play a leading role both in establishing representative test platforms for device evaluation, and in identifying unmet technical requirements via thorough engineering analysis of existing device performance. These will serve as key tools and inputs in the design of novel devices for improving consistency of dosing, monitoring of delivered quantities, and, ultimately, patient health outcomes. Experimental measurements will be coupled with mathematical models describing fluid mechanics and transport processes occurring in the human respiratory tract, borrowing from an extensive set of archival publications in respiratory physiology and inhalation toxicology. In this manner, gas transport and lung mechanics occurring within the body will be linked with parameters that can be monitored and controlled external to the body, at the level of the device. The proposed research program is expected to have significant impact on future development of medical gas devices. Undergraduate and graduate trainees alike will be encouraged to engage with healthcare professionals and industry contacts early on in specifying key requirements and deliverables for their projects, and to seek intellectual property protection on novel solutions. Graduates of the program will be well-prepared to participate in positioning Canada as an emerging hub for medical device innovation.