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令人震惊。据世界卫生组织的全球抗击慢性呼吸系统疾病联盟估计，全球有超过10亿人患有此类疾病，包括哮喘、慢性阻塞性肺疾病(COPD)、睡眠呼吸暂停和肺动脉高压。仅COPD一项就占全球死亡人数的约5%，与在医院治疗COPD病情恶化以及在家庭医疗环境中控制症状相关的医疗成本都是巨大的。将改进的治疗和医疗设备纳入疾病管理计划显然是必要的；然而，随着包括研发支出在内的医疗支出压力越来越大，这种进步的成本必须低于之前的预期。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，并确定那些有足够承诺承担与临床环境中的研究相关的费用的少数人。工程分析和设计在医疗器械的开发中发挥着关键作用。申请者的愿景是建立一个专门研究用于控制和监测向肺部输送治疗性气体和蒸气的设备的特定子类别的研究计划。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，这还包括用于补充氧气的设备，这是医院、急救和家庭护理环境中的支柱。目前，全球有200多万患者在家中接受长期氧疗。随着人口老龄化，以及越来越多的激励措施鼓励在家中治疗患者，而不是在医院或诊所，这一数字预计将增加。与此同时，最近的临床研究得出结论，现有氧气输送装置的机械和临床性能高度不同，使用现有方法评估的明显相同的技术特征并不能保证同等的治疗功能。通过强调用于分析输送装置与患者之间接口的实验方法，预计拟议的研究将在建立具有代表性的装置评估测试平台方面发挥主导作用，并通过对现有装置性能的全面工程分析来确定未满足的技术要求。这些将作为设计新设备的关键工具和投入，以提高剂量的一致性，监测输送数量，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传输过程的数学模型相结合，借鉴了呼吸生理学和吸入毒理学的大量档案出版物。通过这种方式，人体内发生的气体传输和肺力学将与体外设备层面上可以监测和控制的参数联系在一起。拟议的研究计划预计将对未来医疗气体设备的发展产生重大影响。将鼓励本科生和研究生尽早与医疗保健专业人员和行业联系人接触，以确定他们项目的关键要求和交付成果，并寻求对新解决方案的知识产权保护。该项目的毕业生将做好充分准备，参与将加拿大定位为新兴的医疗器械创新中心。

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.