SBIR Phase II: Air-coupled MEMS-based Ultrasound Transducer for Assessment of Tympanic Membrane Motion

这个SBIR二期项目将使已知的第一个商用医用超声设备的开发利用空气耦合电容式微机械超声换能器(CMUT)技术来诊断中耳炎。中耳炎是儿童抗生素处方的头号适应症，也是儿童手术的头号原因，在美国每年花费150多亿美元，仅在美国每年就有3000万人去看医生。临床研究表明，诊断错误率平均为50%。今天的工具不能准确地确定中耳渗出的存在，更不用说渗出的类型了。这导致了抗生素的严重过量处方、过度转诊到专家那里，以及不必要的手术。OtoNexus医疗技术公司正在开发一种简单而敏感的医疗设备，以提供诊断数据，快速准确地诊断中耳炎的存在和类型。该项目的工作将通过电气和声学测量，建立对CMUT传感器制造性能的快速和经济的评估。OtoNexus将设计和建造测试系统，以快速评估CMUT传感器的电气和声学性能，以评估产品质量。电气矢量阻抗(EVI)测试夹具为声音输出提供了一种电气替代测量方法，可在100%采样的晶圆级快速执行。声学输出测量(AOM)测试夹具在镜片最终组装后评估CMUT发出的压力和其他声学性能参数。该项目将开发用于评估生产可靠性和工艺一致性的测试夹具、方法和工艺。OtoNexus超声设备将向儿科医生和其他初级保健医生销售，将减少预后的不确定性和由此导致的抗生素过量处方，并将更准确的诊断工具交到患者第一次就诊的临床医生手中。这将通过减少抗生素的使用和专家转介来降低成本，并通过使护士或其他医生扩展人员能够执行中耳炎测试来减少所需的医生时间。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This SBIR Phase II project will enable the development of the first known commercial medical ultrasound device utilizing air-coupled Capacitive Micromachine Ultrasound Transducer (CMUT) technology to diagnose otitis media. Otitis media is the number one indication for which antibiotics are prescribed for children, and the number one cause for surgery in childhood, costing $15+B annually in the US and resulting in 30M annual doctor visits in the US alone. Clinical studies show a diagnostic error rate averaging 50%. Today's tools are unable to accurately determine the presence, and much less the type, of effusion in the middle ear. This leads to significant over- prescription of antibiotics, over-referrals to specialists, and unnecessary surgeries. OtoNexus Medical Technologies, Inc. is developing a simple and sensitive medical device to provide diagnostic data to quickly and accurately diagnose both presence and type of otitis media.The work of this project will establish fast and economical assessment of CMUT sensor manufacturing performance, by electrical and acoustic measurements. OtoNexus will design and construct test systems to rapidly evaluate electrical and acoustical performance of CMUT sensors as an assessment of production quality. The Electrical Vector Impedance (EVI) test fixture provides an electrical surrogate measure for acoustic output, which can be performed rapidly at the wafer-level with 100% sampling. The Acoustic Output Measure (AOM) test fixture evaluates the pressure emitted by CMUT, and other acoustic performance parameters, after speculum final assembly. This project will develop test fixtures, methods, and processes for assessing production reliability and process consistency. The OtoNexus ultrasound device will be marketed to pediatricians and other primary care physicians, and will decrease prognostic uncertainty and resultant over-prescription of antibiotics, and place the tools for more accurate diagnosis into the hands of the very first clinician the patient sees. This will reduce costs by decreasing both antibiotic usage and specialist referrals and will also decrease required physician time by enabling a nurse or other physician extender to perform the test for otitis media.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.