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装置LinguaFlex组织牵引器（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（OSA）是一种常见的疾病，发病率和死亡率都很高。据估计，高达20%的美国人口受到影响，而大多数患者仍未得到诊断。LinguaFlex舌头牵开器（LTR-I）是一种新技术，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地减少了气道阻塞。第一代LTR是通过针头注射插入舌头中线，通过防止睡眠时舌根向后塌陷而起作用。它被设计用来治疗更严重的阻塞性睡眠呼吸暂停。正在开发LTR-II以治疗轻至中度形式的疾病。它使上呼吸道的所有三个区域收缩，这三个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，这种横向方法与第二代设备是非常有前途的。这项研究将在动物模型中验证LTR-II的安全性和有效性。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，以表征设备的最佳功能特性。这两种模型都成功地用于LTR-I的开发。与第一代设备相比，侧位技术还具有侵入性小、疼痛小、患者更舒适的优势，同时也更容易操作。计划在这些研究完成后提交一期临床试验的SBIR提案。如果成功，该设备将为CPAP提供可接受的替代方案，并在所有严重程度的OSA治疗中取得重大进展。

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.