SBIR Phase I: Simplified Pneumatic Otoscopy

SBIR 第一阶段：简化的气动耳镜检查

• 批准号: 1548970
• 负责人: Ryan Shelton
• 金额: $ 15万
• 依托单位: PhotoniCare, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1548970&HistoricalAwards=false
• 关键词: SBIR; Phase; Simplified; Pneumatic; Otoscopy

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project, if successful, is an improvement in diagnosis and treatment of middle ear infections, a disease that affects greater than 90% of the world's population. Middle ear infections are the leading cause of hearing loss in children and responsible for more surgeries than any other childhood disease. Correct diagnosis of fluid in the middle ear space is crucial to proper treatment to avoid extended hearing loss. The American Academy of Pediatrics recommends pneumatic otoscopy as a key diagnostic for the identification of fluid in the middle ear, yet only 25% of physicians even attempt this exam because it is difficult to obtain a seal of the ear canal, which is a requirement for the technique. Over-prescription of antibiotics has become a significant problem, leading to antibiotic resistance and wasted resources. This project will prove the concept of a pneumatic otoscopy technique that does not require a seal of the ear canal, leading to a much simpler, yet equally effective exam. This will, in turn, lead to increased compliance with the academy-recommended guidelines and improved patient outcomes. The proposed project will develop tools to improve the success rate of pneumatic otoscopy, enabling physicians to comply with the guidelines set forth by the American Academy of Pediatrics and to better diagnose and treat otitis media with effusion. In pneumatic otoscopy, a physician views the surface of the eardrum while changing the pressure in the ear canal to cause the eardrum to move. If the middle ear is filled with fluid, then the eardrum does not move appreciably. The proposed tools will leverage thermodynamic principles in novel ways to abolish the requirement of sealing the canal. They will be low-cost, enabling access to the technology even for the solo practitioner. The proposed project will (1) design and build prototypes of these tools, (2) characterize the tools on a lab bench, and (3) characterize the tools in a simulation model of the human ear. The project will culminate in data that teaches whether or not the proposed tools will suitably inform the physician about the presence of fluid in the ear.

这个小企业创新研究（SBIR）第一阶段项目如果成功，其更广泛的影响/商业潜力是改善中耳感染的诊断和治疗，这种疾病影响着世界90%以上的人口。中耳感染是儿童听力损失的主要原因，比任何其他儿童疾病都要多。中耳腔积液的正确诊断是正确治疗的关键，以避免延长性听力损失。美国儿科学会（American Academy of Pediatrics）建议将气动耳镜检查作为识别中耳液体的关键诊断方法，但只有25%的医生尝试过这种检查，因为很难密封耳道，而这是该技术的要求。抗生素的过度处方已成为一个严重的问题，导致抗生素耐药性和资源浪费。该项目将证明气动耳镜技术的概念，该技术不需要封闭耳道，导致更简单，但同样有效的检查。反过来，这将增加对学院推荐的指南的依从性，并改善患者的预后。拟议的项目将开发工具以提高气动耳镜检查的成功率，使医生能够遵守美国儿科学会制定的指导方针，并更好地诊断和治疗积液性中耳炎。在气动耳镜检查中，医生观察鼓膜表面，同时改变耳道内的压力，使鼓膜移动。如果中耳充满液体，则耳膜不能明显移动。所提出的工具将利用热力学原理，以新颖的方式废除密封运河的要求。它们将是低成本的，即使是单独的从业者也可以使用这项技术。拟议的项目将(1)设计和构建这些工具的原型，(2)在实验室工作台上对工具进行表征，以及(3)在人耳模拟模型中对工具进行表征。该项目最终将获得数据，以确定所建议的工具是否能够适当地告知医生耳内液体的存在。