Non-Invasive Oropharynx Appliance to Maintain Airway Patency

用于保持气道通畅的非侵入性口咽器具

• 批准号: 9906411
• 负责人: DOMINIQUE M DURAND
• 金额: $ 29.97万
• 依托单位: ANEMED LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906411
• 关键词: 3D Print; Address; Adverse effects; Affect; American; Apnea; Arrhythmia; Biomedical Engineering; Breathing; Collaborations; Cone; Continuous Positive Airway Pressure; Custom; Data; Deglutition; Devices; Diabetes Mellitus; Diagnosis; Effectiveness; Ensure; Epilepsy; Funding; Home environment; Hour; Hypertension; Inflammation; Laboratories; Lung; Mandible; Mandibular Advancement; Maps; Measures; Mechanics; Modality; Muscle hypotonia; Normal Range; Nylons; Obstruction; Obstructive Sleep Apnea; Oral; Oropharyngeal; Oxygen; Patients; Phase; Physicians; Polysomnography; Population; Positioning Attribute; Pulmonology; Reflex action; Risk; Safety; Saliva; Severities; Sleep; Small Business Technology Transfer Research; Societies; Soft Palate; Stainless Steel; Statistical Data Interpretation; Stroke; Technology; Testing; Therapeutic; Tissues; Tongue; Tooth structure; Translating; United States National Institutes of Health; University Hospitals; X-Ray Computed Tomography; airway obstruction; base; commercialization; comorbidity; compliance behavior; cost; dental scanning; design; experimental study; falls; indexing; innovation; meetings; novel; patient safety; prevent; prototype; respiratory; standard of care

Obstructive Sleep Apnea (OSA) is a serious condition that affects about 4% of the population. During sleep, the tongue can fall into the oropharynx and occlude the airways Patients with this condition suffer many instances of apneas (complete cessation of breathing) and hypopneas (period of abnormally low respiratory rate). The apnea- hypopnea index (AHI) gives the number of such episodes per hour and indicates the severity of this condition (AHI<5 is normal while AHI>30 is severe). Abnormal AHIs are associated with significant decrease of oxygen saturation leading to severe co-morbidities such as stroke, high blood pressure, diabetes, epilepsy and cardiac arrhythmia. The cost to the society of OSA-related illnesses ranges between 60 and 160 billion dollars annually. The current standard-of-care is the continuous positive airway pressure (CPAP) device which has a low compliance of around (50%). There are also other therapeutic modalities either invasive or non-invasive but none are very effective. There is at present no non-invasive solution that can ensure both patient compliance and efficacy. A new start-up, ANÉMed proposes to develop and test a novel non-invasive oropharynx appliance (OPA) capable of providing both efficacy and compliance. This new appliance addresses the problem of OSA by placing a tongue retaining device directly into the oropharynx preventing the tongue from obstructing the airways. The new design can prevent obstruction without causing a gag reflex and still allowing swallowing. It is designed to be more effective that other oral appliances such as the mandibular advancement device. If successful, the OPA could become the first line of defense against OSA for over 25 million Americans with a diagnosis of OSA.

阻塞性睡眠呼吸暂停 (OSA) 是一种严重疾病，影响约 4% 的人 睡眠期间，舌头可能会落入口咽部并阻塞气道。 患有这种疾病的患者多次出现呼吸暂停（呼吸完全停止） 呼吸）和呼吸不足（呼吸频率异常低的时期）。 呼吸不足指数 (AHI) 给出每小时此类发作的次数，并指示 这种情况的严重程度（AHI<5 是正常的，而 AHI>30 是严重的）。 与氧饱和度显着降低相关，导致严重的并发症 例如中风、高血压、糖尿病、癫痫和心律失常的费用。 为 OSA 相关疾病带来的社会损失在 60 至 1600 亿美元之间 目前的护理标准是持续气道正压通气 (CPAP)。 依从性较低（50%）的装置还有其他治疗方法。 侵入性或非侵入性的方法目前都不是非常有效。 没有一种新的非侵入性解决方案可以确保患者的依从性和疗效。 初创公司 ANÉMed 提议开发和测试一种新型非侵入性口咽 这种新设备能够提供功效和合规性。 通过将舌头固定装置直接放入口腔中来解决 OSA 问题 口咽部的新设计可以防止舌头阻塞气道。 防止阻塞而不引起呕吐反射并仍然允许吞咽。 设计比其他口腔矫治器（例如下颌矫治器）更有效 如果成功的话，OPA 可能成为第一道防线。 为超过 2500 万被诊断为 OSA 的美国人提供对抗 OSA 的帮助。