An Ultra-Thin Steerable Transnasal Endoscope to Replace Exploratory Middle Ear Surgeries

项目概要/摘要： 该提案的目的是创建一种新的低成本，针大小的可操纵内窥镜，使其 可以使用微创经耳咽管方法来调查和诊断中耳疾病， 使患者免于侵入性手术。 临床意义来自每年84，000例手术（仅在美国），这些手术的患者 患有中耳疾病，称为中耳炎，需要进行探查手术才能确诊， 目前是通过外科手术提起鼓膜以暴露中耳腔来实现的。手术是目前唯一 确诊这些患者的方法。更糟糕的是，第二次手术是为了检查复发 一年后，尽管67%的患者届时将无病。我们寻求取代外科手术 通过简单的内窥镜检查，由我们的新型超薄可操纵内窥镜通过 咽鼓管。我们的中心假设是，我们新的经输卵管内窥镜方法可以实现诊断 中耳的可视化相当于今天的手术提供的。这有可能使许多人免于 患者免受手术带来的疼痛和并发症，取而代之的是简单的内窥镜检查 通过鼻子。 创新来自于利用非对称刚性薄壁管中的弹性相互作用， 可操纵的内窥镜，其（1）小到足以穿过耳咽管，同时（2）携带微小的 摄像头和光学照明纤维在其自己的中央管腔内。耳咽管的小直径 排除了使用笨重的标准内窥镜操纵机构。相反，我们利用刚度不对称 编码到两个管的材料特性，这两个管在其尖端连接，从而将小轴向 在内窥镜手柄处施加的运动在内窥镜尖端处变成灵巧的局部弯曲。其结果是一个 廉价的、针头大小的、一次性的、可操纵的内窥镜，用于中耳的经输卵管可视化。 我们在目标1中的方法是使用激光微制造和导管设计工艺来制造 具有集成成像和照明的临床就绪的可操纵内窥镜尖端。目标2包含严格的 基于质量和人为因素的设计改进，为我们的器械进行FDA 510（k）许可审查做好准备 在第二阶段结束时。目标3侧重于统计功效实验，以评估我们的假设 我们的新型可操纵瞄准头将能够进行中耳检查和中耳炎诊断， 使用非手术、经咽鼓管入路，与对照组相比， 外科标准治疗成功验证这些假设将有力地推动未来的第三阶段 完成FDA的活动（在第二阶段SBIR结束后由私人资本支持） 510（k）许可流程，并将我们的器械投放市场。

Project Summary/Abstract: The objective of this proposal is to create a new low-cost, needle-sized steerable endoscope that makes it possible to survey and diagnose middle ear disease using a minimally-invasive trans-Eustachian tube approach, sparing patients from invasive surgery. Clinical significance comes from the 84,000 surgeries per year (in the USA alone) performed on patients who suffer from a middle ear disease called cholesteatoma that requires exploratory surgery for diagnosis, which is currently achieved surgically by lifting the eardrum to expose the middle ear space. Surgery is currently the only definitive way to diagnose these patients. Worse yet, a second surgery is performed to check for recurrence a year later – even though 67% of patients will be disease free at that time. We seek to replace surgical inspection with a simple endoscopy, facilitated by our new ultra-thin steerable endoscope passed through the Eustachian tube. Our central hypothesis is that our new trans-tubal endoscopic approach can achieve diagnostic visualization of the middle ear equivalent to that provided by surgery today. This has the potential to spare many patients from the pain and complications associated with surgery, by replacing it with a simple endoscopy done through the nose. Innovation comes from harnessing elastic interactions in asymmetrically stiff, thin-walled tubes to create a steerable endoscope that is (1) small enough to pass through the Eustachian tube, while (2) carrying a tiny camera and optical illumination fibers within its own central lumen. The small diameter of the Eustachian tube precludes the use of bulky standard endoscope steering mechanisms. Instead, we harness stiffness asymmetry encoded into the material properties of two tubes that are attached at their tips, thereby transforming small axial motions applied at the endoscope handle into dexterous local bending at the endoscope tip. The result is an inexpensive, needle-sized, disposable, steerable endoscope for trans-tubal visualization of the middle ear. Our approach in Aim 1 is to use laser micromanufacturing and catheter-inspired design processes to fabricate a clinic-ready steerable endoscope tip with integrated imaging and illumination. Aim 2 incorporates rigorous quality and human factors-based design enhancements, preparing our device for FDA 510(k) clearance review immediately at the end of Phase II. Aim 3 focuses on statistically powered experiments to evaluate our hypothesis that our new steerable aiming tip will enable middle ear inspection and cholesteatoma diagnoses to be performed using a non-surgical, trans-Eustachian tube approach, with equal diagnostic-quality visual coverage compared to the surgical standard-of-care. Success in validating these hypotheses will strongly motivate future Phase III activities (supported by private capital after the conclusion of this Phase II SBIR) where we complete the FDA 510(k) clearance process, and launch our device on the market.