SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology

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 而大多数(85%)的死亡是由肺部疾病引起的。呼吸道清除疗法(ACT)广泛应用于 患者使用高压高压强力机械清除呼吸道内积聚的粘液。 频率振动2.然而，ACTS的使用繁琐、不便，并给患者带来了巨大的负担 建议他们每天做几次动作4、5.如果没有有效的动作，粘液堵塞的呼吸道就会堵塞 引起感染、发炎、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的工作原理是震动肺部以增加粘液的流动性。理想情况下，治疗需要 个人化和持续适应，以实现有效的清除。然而，目前的ACT设备和 技术，包括胸部理疗、高频胸部按压、振动和声学振动 治疗，是适应性的。当前ACT设备面临的挑战： 1.暴力方式：患者具有不同的呼吸道几何形状、粘液堆积水平和阻塞位置。 最佳治疗需要输入频率与特定呼吸道的共振频率相匹配，以靶向粘液 通行证。目前的ACT设备工作在一种设定的振动模式(背心、OPEP、CPT)上，或者是基于感觉的主观 调整输入频率和呼吸道位置(频率、振动肺)，通常使它们无效。2. 主观评估：目前没有一种设备通过测量肺功能来提供对 呼吸道阻塞或治疗进展将负担放在患者身上，以确定治疗效果。3.贫穷 生活质量：因此，患者长时间进行不舒服的ACT以看到积极的效果，从而导致 对ACT的遵从性很差。此外，家庭行为被认为对很大一部分患者群体无效。 由于缺乏个性化治疗。 Cognita Labs提出的解决方案SonoHeal将成为第一个基于 患者的肺状况，使右呼吸道成为刺激/振动的目标，以减少对 患者的猜测，以及通过定位呼吸道清除提供有效的治疗。SonoHeal将利用Cognita的 正在申请专利的呼吸道监测技术，可实时测量呼吸道阻塞。与量化相结合 肺反应与粘液定位信息，SonoHeal将通过算法调整正确的共振频率以 针对患者的呼吸道，促进有效的粘液清除。在这项提案中，科格尼塔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，并在人体试验中验证。索诺海尔的目标是提高遵从性，交付ACT 适应，舒适，在较短的时间内和数量为每个患者个性化的生理。

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.