Endobronchial Supervalve for the Treatment of Emphysema

项目摘要 在美国，COPD在死亡原因中排名第三，每年有10万人死亡。估计有15 2010年，有100万人被卫生保健提供者诊断为COPD，估计有1200万潜在病例 仍未确诊。肺气肿是慢性阻塞性肺病的一种进行性、不可治愈的形式，可导致显著的发病率 and mortality.肺气肿的特征是肺弹性丧失，呼气流量减少， 恶性通货膨胀肺减容手术已知是中度- 严重的肺气肿，但由于手术的侵入性，很少有患者符合条件。微创 最近开发了使用单向阀的支气管内肺减容来解决这个问题 未满足的需求，并于2018年获得FDA批准。 该提案将确认用于支气管内肺减容的新一代超级阀， 将扩大这种方法在治疗肺气肿患者中的应用。我们的创新利用了 使用单个部位而不是3-6个部位实现肺减容 目前的方法要求。这反过来将导致更快和更有效的程序，减少 总手术时间和成本。 该项目将分几个连续阶段完成。对于第一阶段，我们将最终确定概念选择， 瓣膜设计，并在实验室和急性临床前研究中证明技术概念 我们的超级瓣膜可以在肺叶气道中展开，并且可以承受生理压力。在 在本提案的第II阶段，我们通过开发以下功能使长期植入的瓣膜设计成熟， 确保气密密封，并防止在正常呼吸和咳嗽的情况下发生迁移。然后我们将 验证和确认符合FDA标准的人体级瓣膜系统，并确保其可安全植入 病人的一生。我们的瓣膜的安全性和耐用性将在慢性临床前试验中得到证明。 问题研究II期获得的结果将用于支持与FDA的IDE前会议。

PROJECT SUMMARY In the United States, COPD ranks third in causes of mortality with 100,000 deaths annually. An estimated 15 million people had health care provider diagnosed COPD in 2010, and an estimated 12 million potential cases remain undiagnosed. Emphysema is a progressive, incurable form of COPD that causes significant morbidity and mortality. Emphysema is characterized by the loss of lung elasticity, reduced expiratory flow and hyperinflation. Lung volume reduction surgery is known to be an effective option for patients with moderate- severe emphysema, but few patients qualify due to the invasiveness of the procedure. Minimally invasive endobronchial lung volume reduction using one-way valves has recently been developed to address this unmet need and was approved by the FDA as recently as 2018. This proposal will validate a new, next generation Super Valve for endobronchial lung volume reduction that will broaden the use of this approach to treat patients with emphysema. Our innovation exploits the anatomy of the lobar segments of the lungs to achieve lung volume reduction using a single site instead of 3-6 sites required by the current methods. This, in turn, will lead to a faster and more efficient procedure, reducing overall surgical time and costs. This project will be completed in several sequential stages. For Phase I we will finalize concept selection for the valve design and demonstrate proof of technical concept on the bench and in acute preclinical studies that our Super Valve can be deployed in lobar airways and that it can withstand physiological stresses. In Phase II of this proposal we mature the Valve design for chronic implantation by developing features that ensure an air-tight seal and prevent migration in the setting of normal respiration and cough. We will then verify and validate a human grade valve system to FDA standards and ensure it is safe for implantation over the lifetime of the patient. The safety and durability of our valves will be demonstrated in chronic preclinical studies. The results obtained in Phase II will be used to support pre-IDE meeting with the FDA.