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.

项目概要 囊性纤维化是一种遗传性疾病，影响美国 30,000 名患者，平均寿命为 37 岁 大部分（85%）的死亡是由肺部疾病造成的1。气道清除疗法 (ACT) 已被广泛应用 患者使用高压和高压对气道中积聚的粘液进行强力机械清除 频率振动2。然而，ACTs的使用繁琐、不方便，给患者带来巨大的负担 建议每天执行多次 ACT 4,5。如果没有有效的 ACT，粘液堵塞的气道就会陷入困境 引起感染、炎症、呼吸衰竭和其他并发症的细菌。 ACT也被患者使用 需要清除粘液的肺部疾病（例如支气管扩张、慢性阻塞性肺病、哮喘）。 ACT 的工作原理是振动肺部以增加粘液流动性。理想情况下，治疗需要 个性化并持续适应有效的清除。然而，目前的 ACT 设备和 技术，包括胸部物理治疗、高频胸部按压、振荡和声振动 疗法，具有适应性。当前 ACT 设备面临的挑战： 1. 强力方法：患者具有不同的气道几何形状、粘液积聚水平和阻塞位置。 最佳治疗需要输入频率与特定气道的共振频率相匹配以靶向粘液 清除。当前的 ACT 设备采用设定的振动模式（Vest、oPEP、CPT）或“基于感觉”的主观振动模式 调整输入频率和气道位置（Frequencer、VibraLung），通常会使它们无效。 2. 主观评估：目前没有任何设备可以测量肺功能来提供对肺功能的定量评估。 气道阻塞或治疗进展给患者带来了确定治疗效果的负担。 3. 穷 生活质量：因此，患者需要长时间进行不舒服的 ACT 才能看到积极的效果，从而导致 ACT 依从性差。此外，家庭 ACT 被认为对大部分患者群体无效 由于缺乏个性化治疗。 Cognita Labs 提出的解决方案 SonoHeal 将是第一个根据患者的情况实时调整治疗的设备 患者的肺部状况，以便对右气道进行刺激/振动，以减少对呼吸的依赖 患者的猜测以及通过定位气道间隙提供有效的治疗。 SonoHeal 将利用 Cognita 的 正在申请专利的气道监测技术可实时测量气道阻塞情况。结合量化 根据粘液定位信息的肺部反应，SonoHeal 将通过算法调整正确的共振频率 针对患者气道并促进有效去除粘液。在这项提案中，Cognita 团队将带来多年的气道 构建设备、进行体外实验的建模、设备技术和商业化经验 在多个肺部模型上进行并在人体试验中进行验证。 Sonoheal 的目标是提高依从性，提供 ACT 根据每位患者的生理情况，在更短的时间内、定量地、适应性地、舒适地进行个性化治疗。