SonoHeal: Smart Resonating Closed-loop Airway Clearance Device

SonoHeal：智能共振闭环气道清理装置

• 批准号: 10011518
• 负责人: Rajoshi Biswas
• 金额: $ 19.71万
• 依托单位: COGNITA LABS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011518
• 关键词: 3D Print; Acoustics; Adherence; Affect; Algorithms; Asthma; Bacteria; Breathing; Bronchiectasis; Chest; Chronic Obstructive Airway Disease; Complex; Cystic Fibrosis; Data; Data Set; Devices; Dimensions; Disease; Elasticity; Ensure; Excision; Feeling; Frequencies; Genetic Diseases; Geometry; Germ; High-Frequency Chest Wall Compression; Home environment; Hour; In Vitro; Individual; Infection; Inflammation; Intervention; Knee; Legal patent; Local Therapy; Location; Longevity; Lung; Lung diseases; Machine Learning; Measures; Mechanics; Modeling; Monitor; Movement; Mucins; Mucous body substance; Obstruction; Pain; Patients; Pattern; Phase II Clinical Trials; Physical therapy; Physics; Probability; Quality of life; Respiratory Failure; Respiratory physiology; System; Techniques; Technology; Testing; Time; Training; Treatment Effectiveness; Violence; Work; adaptation algorithm; age group; airway obstruction; base; commercialization; cystic fibrosis patients; effective therapy; electric impedance; experience; experimental study; flexibility; innovation; learning algorithm; mortality; mucus clearance; novel; optimal treatments; patient population; patient safety; personalized medicine; pressure; prototype; response; ventilation; vibration

Project Summary Cystic Fibrosis is a genetic disorder that affects 30,000 patients in the USA with an average life span of 37 years and the majority (85%) of the mortality is a result of lung disease. Airway Clearance Therapies (ACT) are extensively used by patients for forceful mechanical clearance of mucus accumulated in airways using high pressure and high frequency vibrations. However, the use of ACTs is intrusive, painful, uncomfortable, and poses tremendous burden on patients who are required to perform ACTs daily for 1-2 hours. Without effective ACT, the mucus-plugged airways trap bacteria causing infections, inflammations, respiratory failures, and other complications. ACT is also used by patients with lung conditions where mucus clearance is necessary (e.g. bronchiectasis, COPD, Asthma). ACT works on the principle of vibrating the lungs to increase mucus mobility. Ideally, the therapy needs to be individualized and continuously adaptive for effective clearance. However, none of the current ACT devices and techniques, including chest physiotherapy, high-frequency chest compression, oscillation, and acoustic vibration therapies, are adaptive. The challenges with current ACT devices: 1. Brute-force approach: Patients have diverse airway geometry, mucus accretion levels, and obstruction locations. Optimal therapy requires input frequencies to match the resonant frequency of specific airways to target mucus clearance. Current ACT devices work on a set vibration pattern (Vest, oPEP, CPT) or a “feeling- based” subjective tweaking of input frequencies and airway location (Frequencer, VibraLung), often rendering them ineffective. 2. Subjective Assessment: None of the current devices measure lung function to provide a quantitative assessment of the airway obstruction or therapy progress putting the burden on the patient to determine treatment effectiveness. 3. Poor Quality of Life: As a result, patients perform uncomfortable ACT for long durations to see a positive effect, leading to poor adherence to ACT. Further, home ACTs are considered ineffective for a large segment of the patient population due to the lack of personalized treatment. Cognita Labs’s proposed solution, SonoHeal, will be the first device to adapt the treatment in real-time based on the patient’s lung status, such that the right airways are targeted for stimulation/vibration to reduce the reliance on patient’s guesswork as well as provide effective therapy by localizing airway clearance. SonoHeal will utilize Cognita’s patent-pending airway monitoring technology that measures airway obstruction in real- time. Combined with quantified lung response with mucus localization information, SonoHeal will algorithmically tune the right resonant frequency to target patient’s airways and promote effective mucus removal. In this proposal, Cognita’s team will bring years of airway modeling, device technologies and commercialization experience to conduct in-vitro experimentation on multiple lung models to show the feasibility and efficiency of the SonoHeal device in a lab setup.

项目摘要 囊性纤维化是一种遗传疾病，在美国影响30,000名患者，平均寿命为 37年，死亡率的大多数（85％）是肺部疾病的结果。气道通关疗法（ACT） 患者广泛使用了使用高的机械机械清除粘液在气道中积聚的粘液 压力和高频振动。但是，行为的使用是侵入性，痛苦，不舒服的，并且 对需要每天进行1-2小时行动的患者构成巨大的伯宁。没有 有效的行动，粘液插入的气道诱捕了引起感染，感染，呼吸系统的细菌 失败和其他并发症。 ACT也由肺部清除率为肺部条件的患者使用 必要（例如，支气管ch，COPD，哮喘）。 ACT依靠振动肺以增加粘液迁移率的原理。理想情况下，疗法 需要个性化并持续适应有效清除。但是，没有一个 ACT设备和技术，包括胸部物理疗法，高频胸部压缩，振荡， 和声学振动疗法是自适应的。当前ACT设备的挑战： 1。蛮力方法：患者具有潜水的气道几何形状，粘液积水水平和阻塞 位置。最佳治疗需要输入频率将特定气道的共振频率与 目标粘液清除率。当前的ACT设备可在设定的振动模式（背心，OPEP，CPT）或“感觉 - 基于“输入频率和气道位置的主观调整”（veryrung，vibralung），经常呈现 他们无效。 2。主观评估：当前设备均未测量肺功能提供 对气道异议或治疗进展的定量评估，使患者烧伤 确定治疗效果。 3。生活质量差：结果，患者表现不舒服 长期以来，会看到积极的效果，导致行动的依从性不佳。此外，家庭法是 由于缺乏个性化治疗，因此被认为对大部分患者人群无效。 Cognita Labs提出的解决方案Sonoheal将是第一个以实时基于基于的治疗的设备 关于患者的肺状况，使正确的气道针对刺激/振动以减少 依靠患者的猜测以及通过定位气道通关通过可提供有效的治疗方法。 Sonoheal 将利用Cognita的申请专利的气道监控技术，以测量现实中的气道异议 时间。 Sonoheal将与量化的肺反应和粘液定位信息结合在一起，将 从算法上调整正确的谐振频率以靶向患者的气道并促进有效的粘液 消除。在此提案中，Cognita的团队将带来多年的气道建模，设备技术和 在多个肺模型上进行体外实验的商业化经验，以​​显示 Sonoheal设备在实验室设置中的可行性和效率。