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

超薄可操纵经鼻内窥镜取代探索性中耳手术

• 批准号: 10469684
• 负责人: Joshua B Gafford
• 金额: $ 66.16万
• 依托单位: ENDOTHEIA, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469684
• 关键词: Brain Abscess; Cadaver; Caliber; Capital; Catheters; Cessation of life; Cholesteatoma; Clinic; Clinical; Device Designs; Devices; Diagnosis; Diagnostic; Disease; Endoscopes; Endoscopy; Engineering; Eustachian Tube; Excision; Exposure to; Fiber; Future; Goals; Human; Image; Intellectual Property; Joints; Lasers; Lifting; Lighting; Meningitis; Motion; Nature; Needles; Nose; Operative Surgical Procedures; Optics; Otologic Surgical Procedures; Pain; Patients; Pattern; Persons; Phase; Positioning Attribute; Privatization; Procedures; Process; Property; Protocols documentation; Quality Control; Recurrence; Research; Second Look Surgery; Secure; Small Business Innovation Research Grant; Specimen; Structure; Surgeon; Surveys; Symptoms; Testing; Thinness; Time; Tube; Tympanic membrane; United States; Validation; Visual; Visualization; accurate diagnosis; base; clinically significant; cost; deafness; design; digital; experimental study; in vitro Model; innovation; middle ear; middle ear disorder; minimally invasive; patient subsets; prototype; public health relevance; recruit; standard of care; success

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.

项目摘要/摘要： 该提案的目标是创造一种新型低成本、针头大小的可操纵内窥镜，使其能够 可以使用微创经咽鼓管方法来调查和诊断中耳疾病， 使患者免于侵入性手术。 临床意义来自于每年（仅在美国）针对以下患者进行的 84,000 例手术： 患有一种称为胆脂瘤的中耳疾病，需要进行探查手术才能诊断，这是 目前通过手术抬起鼓膜以暴露中耳空间来实现。目前唯一的办法是手术 诊断这些患者的最终方法。更糟糕的是，进行第二次手术以检查是否复发 一年后——尽管那时 67% 的患者将不再患病。我们寻求替代手术 通过我们的新型超薄可操纵内窥镜进行简单的内窥镜检查 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当今手术所提供的可视化。这有可能让很多人省下来 通过用简单的内窥镜检查代替手术，患者可以免受与手术相关的疼痛和并发症 通过鼻子。 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 可操纵内窥镜，其 (1) 小到足以穿过咽鼓管，同时 (2) 携带一个微小的 相机和光学照明光纤位于其自己的中央腔内。咽鼓管的小直径 避免使用笨重的标准内窥镜转向机构。相反，我们利用刚度不对称性 编码到连接在其尖端的两根管子的材料属性中，从而改变小的轴向 在内窥镜手柄处施加的运动转变为内窥镜尖端处的灵巧的局部弯曲。结果是 廉价、针头大小、一次性、可操纵的内窥镜，用于经输卵管观察中耳。 我们的目标 1 的方法是使用激光微制造和导管启发设计工艺来制造 具有集成成像和照明功能的临床就绪可操纵内窥镜尖端。目标 2 包含严格的 基于质量和人为因素的设计增强，为我们的设备准备 FDA 510(k) 许可审查 立即在第二阶段结束时。目标 3 侧重于统计有力的实验来评估我们的假设 我们新的可操纵瞄准头将能够进行中耳检查和胆脂瘤诊断 使用非手术、经咽鼓管的方法，与相比具有相同的诊断质量视觉覆盖范围 达到手术护理标准。成功验证这些假设将有力地推动未来的第三阶段 我们完成 FDA 的活动（第二阶段 SBIR 结束后得到私人资本的支持） 510(k) 许可流程，并将我们的设备推向市场。