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

项目摘要/摘要： 这项提议的目标是创造一种新的低成本、针状大小的可控内窥镜，使其 有可能使用微创经咽鼓管入路来调查和诊断中耳疾病， 使患者免于进行侵入性手术。 fi的临床意义来自于每年对以下患者进行的84,000例手术(仅在美国 患有一种名为胆脂瘤的中耳疾病，需要进行探查手术才能确诊，这是 目前是通过手术抬起鼓膜露出中耳空间来实现的。手术是目前唯一的 Defi是诊断这些患者的有效方法。更糟糕的是，为了检查复发，还进行了第二次手术 一年后-尽管到那时67%的患者将没有疾病。我们寻求取代外科手术 用简单的内窥镜检查，由我们新的超薄可操纵内窥镜通过 咽鼓管。我们的中心假设是，我们的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外科手术所提供的。这有可能让许多人 患者从与手术相关的疼痛和并发症中解脱出来，通过简单的内窥镜检查来代替它 穿过鼻子。 创新来自于利用不对称刚性薄壁管中的弹性相互作用来创建一个 可操纵的内窥镜：(1)足够小，可以通过咽鼓管，同时(2)携带一个微小的 摄像机和光学照明fi在其自身的中心管腔内工作。咽鼓管的小直径 排除使用笨重的标准内窥镜转向机构。相反，我们利用了刚性不对称。 编码为两个管子的材料特性，这两个管子的尖端相连，从而将细小的轴向 在内窥镜手柄上的动作变成内窥镜尖端的灵巧的局部弯曲。结果是一个 价格便宜，针头大小，一次性，可控制的内窥镜，用于经输卵管中耳可视化。 我们在目标1中的方法是使用激光微制造和导管启发的设计工艺来制造 具有集成成像和照明的临床可操控内窥镜尖端。AIM 2结合了严格的 基于质量和人为因素的设计改进，使我们的设备为FDA 510(K)许可审查做好准备 在第二阶段结束时立即进行。目标3专注于通过统计实验来评估我们的假设 我们的新的可转向瞄准尖端将使中耳检查和胆脂瘤诊断得以进行 使用非手术、经咽鼓管入路，与同等诊断质量的视觉覆盖率进行比较 达到外科标准的护理。这些假说的成功验证将有力地推动未来的第三阶段 我们完成FDA的活动(在第二阶段SBIR结束后得到私人资本的支持) 510(K)审批流程，并将我们的设备投放市场。

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.