MICROINVASIVE TREATMENT OF SLEEP APNEA WITH THE LINGUAFLEX TISSUE RETRACTOR II

描述（由申请人提供）：该提案要求为第二代新型微创睡眠呼吸暂停器械LinguaFlex组织牵开器（LTR-II）的开发和概念验证测试提供资金。阻塞性睡眠呼吸暂停（Obstructive sleep apnea，OSA）是一种发病率和死亡率都很高的常见疾病.据估计，多达20%的美国人口受到影响，而大多数患者仍未确诊。一项新技术，LinguaFlex舌牵开器（LTR-I），最近在临床前和临床试验中进行了测试。人体试验证明了第一代设备的安全性，并且该疗法在大约三分之二的受试者中有效减少了气道阻塞。第一代LTR通过针注射插入舌中线，并通过防止舌根在睡眠期间向后塌陷来工作。它被设计用于治疗更严重的OSA病例。LTR-II正在开发用于治疗轻度至中度形式的疾病。它使上气道的所有三个区域收缩，这些区域的塌陷直接导致OSA中的气道阻塞，即舌根、软腭和咽侧壁。初步工作表明，这种采用第二代装置的侧向入路非常有前途。本研究将在动物模型中提供LTR-II安全性和有效性的概念验证。此外，将在人体尸体模型中研究LTR-II和上气道的组织相互作用和张力特性，以表征器械的最佳功能特性。这两种模型都成功地用于LTR-I的开发。与第一代器械相比，外侧技术还具有侵入性更小、疼痛更小、患者更舒适、操作更简单的优点。计划在这些研究完成时提交I期临床试验的SBIR提案。如果成功，这些设备将提供CPAP的可接受替代方案，并在所有严重程度的疾病中显著推进OSA治疗。 公共卫生相关性：睡眠呼吸暂停是一种影响数百万美国人的疾病，其中一个人在睡眠期间停止呼吸10秒或更长时间。这些事件被称为呼吸暂停。患有严重睡眠呼吸暂停症的人在夜间每小时可以有数百次这样的发作。未经治疗的睡眠呼吸暂停会增加患高血压、中风、糖尿病甚至死亡的风险。目前治疗睡眠呼吸暂停的方法包括大手术或终身使用夜间呼吸器。该项目允许开发一种旨在以舒适和可接受的方式治疗睡眠呼吸暂停的新疗法。该疗法包括在局部麻醉下将一个薄的弹性植入物插入舌侧。该器械将在动物和人尸体标本中进行试验。这些研究将导致进一步开发该器械进行临床试验。该项目的具体目标是开发和测试这种新的医疗器械，以预防睡眠呼吸暂停，并在后续研究中进行小型安全性临床试验。

DESCRIPTION (provided by applicant): The proposal requests funding for the development and proof-of-concept testing of the second generation of a novel, minimally invasive sleep apnea device, the LinguaFlex Tissue Retractor (LTR-II). Obstructive sleep apnea (OSA) is a common disorder with high morbidity and mortality. It is estimated that up to 20% of the United States population is affected while most patients remain undiagnosed. A new technology, the LinguaFlex Tongue Retractor (LTR-I), was developed and recently tested in pre-clinical and clinical trial. The human trial proved safety of the first-generation device and the therapy was effective in reducing airway obstructions in approximately two-thirds of the subjects tested. The first-generation LTR is inserted in the tongue midline by a needle injection and works by preventing backward collapse of the tongue base during sleep. It was designed to treat the more severe cases of OSA. LTR-II is being developed to treat mild to moderate form of the disease. It retracts all three areas of the upper airway whose collapse directly contributes to airway obstructions in OSA, namely the tongue base, the soft palate and the lateral pharyngeal walls. Preliminary work shows that this lateral approach with the second-generation device is highly promising. This study will provide proof-of-concept of the safety and efficacy of LTR-II in an animal model. Moreover, tissue interaction and tension characteristics of LTR-II and the upper airway will be studied in the human cadaver model to characterize the device specifics for optimum function. Both models were successfully used in the development of LTR-I. The lateral technique also offers the advantage in being less invasive and painful and more comfortable for the patients while being easier to perform compared to the first-generation device. An SBIR proposal for Phase I clinical trial is planned for submission at the completion of these studies. If successful, the devices will provide an acceptable alternative to CPAP and a significant advance in OSA treatment across all severity range of the disease. PUBLIC HEALTH RELEVANCE: Sleep apnea is a disorder that affects millions of Americans in which a person stops breathing during sleep for 10 seconds or longer. These episodes are known as apneas. People who have a severe form of sleep apnea can have hundreds of such episodes per hour during the night. Untreated sleep apnea results in increased risks for high blood pressure, stroke, diabetes, and even death. Current therapies for sleep apnea include major surgery or lifelong use of a nightly respirator. This project allows for the development of a new therapy intended to treat sleep apnea in a comfortable and acceptable manner. The therapy involves the insertion of a thin, elastic implant into the side of the tongue, under local anesthesia. The device will be tested in animals and human cadaver specimen. These studies will lead to further development of the device for clinical trial. The specific goals of this project are to develop and test this new medical device to prevent sleep apnea and later perform a small safety clinical trial in a follow up study.