SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology

SonoHeal：智能共振闭环气道清除技术

• 批准号: 10385490
• 负责人: Rajoshi Biswas
• 金额: $ 78.02万
• 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 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385490
• 关键词: 3-Dimensional; 3D Print; Acoustics; Adherence; Affect; Airway Resistance; Algorithms; Animal Model; Asthma; Bacteria; Bronchiectasis; Chest; Chronic Obstructive Pulmonary Disease; Complex; Crossover Design; Cystic Fibrosis; Data; Device Designs; Device Safety; Devices; Disease; Excision; Family suidae; Feasibility Studies; Feedback; Feeling; Frequencies; Generations; Genetic Diseases; Geometry; Germ; Goals; High-Frequency Chest Wall Compression; Home; Human; In Vitro; Individual; Infection; Inflammation; Intervention; Joints; Knee; Learning; Legal patent; Local Therapy; Location; Longevity; Lung; Machine Learning; Measures; Mechanics; Modeling; Modernization; Monitor; Movement; Mucous body substance; Obstruction; Outcome; Patients; Pattern; Peak Expiratory Flow Rate; Performance; Phase; Physical therapy; Physiology; Population; Probability; Proxy; Psychological reinforcement; Quality of life; Research Design; Resistance; Respiratory Failure; Rewards; Schedule; System; Techniques; Technology; Time; Training; Translations; Treatment Effectiveness; Validation; Vent; Violence; Work; airway obstruction; algorithm development; base; commercialization; cystic fibrosis patients; design; design verification; effective therapy; experience; experimental study; human study; human subject; improved; innovation; learning algorithm; machine learning model; mortality; mucus clearance; novel; optimal treatments; patient population; personalized medicine; pressure; programs; prototype; pulmonary function; resistance frequency; response; satisfaction; sensor technology; standard of care; success; three-dimensional modeling; usability; vibration; wireless

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 disease1. Airway Clearance Therapies (ACT) are extensively used by patients for forceful mechanical clearance of mucus accumulated in airways using high pressure and high frequency vibrations2. However, the use of ACTs is tedious, inconvenient, and poses a tremendous burden on patients who are recommended to perform ACTs several times daily4,5. 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 build the devoce, conduct in-vitro experimentation on multiple lung models and validate in a human trial. Sonoheal’s goal is to improves adherence, delivers ACT adaptively, comfortably in a shorter period and quantitatively for each patient individualized to their physiology.

项目摘要 囊性纤维化是一种遗传疾病，影响美国30,000名患者的平均寿命为37年 大多数死亡率（85％）是肺部病的结果1。气道通关疗法（ACT）广泛 由患者使用高压和高的粘液在气道中积聚的粘液的强大机械清除率 频率振动2。但是，行为的使用是乏味的，不便的，并且对患者造成了巨大的灼伤 建议每天几次执行行为4,5。没有有效的行动，粘液拔空的气道陷阱 引起感染，感染，呼吸衰竭和其他并发症的细菌。患者也使用了ACT 在需要粘液清除的肺部条件下（例如，支气管扩张，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，疗法必须是 个性化的，不断适应有效清除。但是，当前的ACT设备都没有 技术，包括胸部理疗，高频胸部压缩，振荡和声学振动 疗法是适应性的。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，粘液积水水平和客观位置。 最佳疗法需要输入频率以匹配特定气道的共振频率以靶向粘液 清除。当前的ACT设备可用于设定的振动模式（背心，OPEP，CPT）或“基于感觉的”主观 调整输入频率和气道位置（viberr，vibralung），通常使它们无效。 2。 主观评估：当前的设备均未衡量肺功能来提供定量评估 气道异议或治疗的进展使患者烧伤以确定治疗效果。 3。穷人 生活质量：结果，患者长时间长期表现出不舒服的行为，以看到积极的效果，导致 依从性不佳。此外，对大部分患者人群的家庭行为被认为无效 由于缺乏个性化治疗。 Cognita Labs提出的解决方案Sonoheal将是第一个基于该治疗的设备 患者的肺状况，使得正确的气道针对模拟/振动，以减少浮雕 患者的猜测以及通过定位气道间隙提供有效的治疗方法。 Sonoheal将利用Cognita的 实时测量气道异议的申请专利气道监测技术。与量化的结合 带有粘液定位信息的肺反应，Sonoheal将算法将正确的谐振频率调整为 针对患者的气道并促进有效的粘液去除。在此提案中，Cognita的团队将带来多年的呼吸道 建模，设备技术和商业化经验，以​​建立Devoce，进行体外实验 在多个肺模型上，并在人类试验中验证。 Sonoheal的目标是提高依从性，执行法案 对于每个患者的生理学，在较短的时期内舒适，舒适地进行定量。