Endobronchial Supervalve for the Treatment of Emphysema

项目总结 在美国，慢性阻塞性肺病以每年10万人的死亡位居第三。估计有15个 2010年，有100万人被卫生保健提供者诊断为慢性阻塞性肺疾病，估计有1200万潜在病例 仍未确诊。肺气肿是一种进行性的、无法治愈的慢性阻塞性肺病，会导致显著的发病率。 和死亡率。肺气肿的特征是肺弹性丧失，呼气流量减少和 恶性通货膨胀。众所周知，肺减容术是治疗中度-慢性阻塞性肺疾病的有效选择。 严重的肺气肿，但由于手术的侵袭性，很少有患者符合条件。微创 最近已经开发出使用单向瓣膜的支气管内肺减容术来解决这一问题 未得到满足的需求，并在2018年得到FDA的批准。 这项提议将验证一种新的下一代超级瓣膜用于支气管内肺容量减少， 将扩大这种方法在治疗肺气肿患者中的应用。我们的创新利用了解剖学 使用单个部位而不是3-6个部位来实现肺容量减少 当前方法所需的。这反过来将导致更快和更有效的程序，减少 手术总时间和总成本。 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 在试验台上和急性临床前研究中，瓣膜的设计和技术概念的演示证明 我们的超级瓣膜可以部署在大叶的呼吸道中，并且它可以承受生理压力。在……里面 在这项建议的第二阶段，我们通过开发以下功能来使慢性植入的瓣膜设计成熟 在正常呼吸和咳嗽的情况下，确保气密密封，防止移位。到时候我们会的 验证和确认符合FDA标准的人体级瓣膜系统，并确保其植入是安全的 病人的生命周期。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。 学习。在第二阶段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.