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性疾病，在美国影响3万名患者，平均寿命为 37岁，大多数(85%)的死亡是由肺部疾病引起的。呼吸道清除疗法(ACT) 被患者广泛使用，用于强力机械清除在呼吸道中积聚的粘液 压力和高频振动。然而，使用ACTS是侵扰性的、痛苦的、不舒服的 给患者带来巨大的负担，他们被要求每天进行1-2个小时的操作。如果没有 有效的ACT，粘液堵塞的呼吸道捕获引起感染、炎症、呼吸道的细菌 失败，以及其他复杂的情况。有肺部疾病的患者也可以使用ACT，那里的粘液清除 必要的(例如，支气管扩张、慢性阻塞性肺病、哮喘)。 ACT的工作原理是震动肺部以增加粘液的流动性。理想情况下，这种疗法 需要个人化和持续适应，才能有效清除。然而，目前没有一个 ACT设备和技术，包括胸部理疗、高频胸部按压、振荡、 和声振疗法，都是自适应的。当前ACT设备面临的挑战： 1.暴力方法：患者有不同的呼吸道几何形状、粘液堆积水平和阻塞 地点。最佳治疗需要输入频率与特定呼吸道的共振频率相匹配 目标粘液清除。目前的ACT设备工作在一种设定的振动模式(背心、OPEP、CPT)或“感觉-- 基于输入频率和呼吸道位置(频率、振动肺)的主观调整，通常渲染 它们都是无效的。2.主观评估：目前没有一种设备通过测量肺功能来提供 定量评估呼吸道阻塞或治疗进展，将患者的负担增加到 确定治疗效果。3.生活质量差：结果是，患者进行了不舒服的行为 长期服用会看到积极的效果，导致对ACT的依从性较差。此外，家庭行为是 由于缺乏个性化治疗，被认为对很大一部分患者群体无效。 Cognita实验室提出的解决方案SonoHeal将成为第一个实时适应治疗的设备 根据患者的肺状况，使右呼吸道成为刺激/振动的目标，以减少 依靠患者的猜测，并通过定位呼吸道清除来提供有效的治疗。SonoHeal 将利用Cognita正在申请专利的呼吸道监测技术，测量实时- 时间到了。结合量化的肺反应和粘液定位信息，SonoHeal将 算法调节正确的共振频率以针对患者的呼吸道并促进有效的粘液 移走。在这项提案中，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 SonoHeal设备在实验室设置中的可行性和效率。