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）是一种严重的状况，影响约4％ 人口。在睡眠期间，舌头可以掉入口咽并阻塞气道 患有这种情况的患者遭受了许多呼吸暂停的情况（完全停止 呼吸）和呼吸症（绝对低呼吸率的时期）。呼吸暂停 呼吸道指数（AHI）给出了每小时此类发作的数量，并指示 这种情况的严重程度（AHI <5是正常的，而AHI> 30很严重）。异常AHI是 与氧饱和度的显着降低相关，导致严重的合并症 例如中风，高血压，糖尿病，癫痫和心律不齐。费用 与OSA相关疾病协会在60至1600亿美元之间 一对一。当前的护理标准是连续的正气道压力（CPAP） 符合度较低（50％）的设备。还有其他治疗 侵入性或无创的方式，但没有一个非常有效。目前有 没有无创的解决方案可以确保患者依从性和效率。一个新 启动，开发和测试新型非侵入性口咽的建议 设备（OPA）能够提供有效性和合规性。这个新设备 通过将舌头固定装置直接放入 口咽阻止舌头阻塞气道。新设计可以 防止异议，而不会引起插科打反射并仍允许吞咽。这是 设计为更有效的其他口服电器，例如下颌 进步设备。如果成功，OPA可能会成为第一道防线 针对超过2500万美国人的OSA诊断为OSA。