Breaking the Scope Port Size Barrier: A New Kind of Endoscope that Removes Large Kidney Stones Rapidly

打破内窥镜端口尺寸障碍：一种可快速去除大肾结石的新型内窥镜

• 批准号: 10761408
• 负责人: Joshua B Gafford
• 金额: $ 92.92万
• 依托单位: ENDOTHEIA, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761408
• 关键词: American; Biocompatible Materials; Capital; Catheters; Clinical; Complication; Devices; Diameter; Elasticity; Endoscopes; Endoscopy; Engineering; Evaluation; Excision; Future; Goals; Guidelines; Hour; Human; Intellectual Property; Intervention; Kidney Calculi; Lasers; Light; Lighting; Marketing; Mechanics; Operating Rooms; Operative Surgical Procedures; Patients; Pattern; Persons; Phase; Physicians; Positioning Attribute; Privatization; Procedures; Process; Production; Research; Risk; Secure; Small Business Innovation Research Grant; Study Section; Suction; Surgeon; System; Techniques; Thinness; Time; Training; Tube; Ureteroscopes; Ureteroscopy; Validation; Visualization; Work; base; clinically significant; design; experimental study; flexibility; improved; innovation; manufacturability; manufacture; manufacturing process; manufacturing run; minimally invasive; novel; operation; prototype; public health relevance; recruit; standard of care; success; tool

Project Summary/Abstract: The objective of this proposal is to create a new kind of flexible ureteroscope that transforms nearly instanta- neously from endoscope to large-lumen steerable suction catheter to enable rapid removal of large kidney stone volumes, sparing patients from invasive alternatives. Clinical significance comes from the 3.5 million patients who suffer from kidney stones each year in the USA alone, 700,000 of whom have interventional procedures done to remove the stones. 230,000 of these people have larger kidney stone volumes, and thus are subject to either invasive surgery or excessively long ureteroscopy, with its increased complication rates and excessive procedure durations. Our central hypothesis is that our new transformable ureteroscope will reduce the procedure time by 36 minutes or more for patients with large stone volumes. Reducing procedure duration by this much will make larger stone times equivalent to small stone times, making many more patients candidates for minimally invasive interventions. Innovation comes from a new mechanical actuation concept that enables us to build bending actuation directly into the outer wall of the device itself. This enables an open central lumen that is nearly as large in diameter as the endoscope itself. The lumen initially carries a camera/illumination core that can be removed whenever desired to transform the device into a steerable suction sheath. To build bending actuation into the outer wall, we harness elastic interactions in asymmetrically stiff, thin-walled tubes. After attaching these tubes at their tips, tip bending can be created through small relative linear displacement at the tube bases. The result is a highly dexterous device with the same bending capabilities of a ureteroscope that has a large central lumen for high volume stone removal via suction. Our approach in Aim 1 is to design, optimize and build an OR-ready version of our steerable sheath and insertable camera/illumination core using scalable manufacturing processes and clinical-grade, biocompatible materials. The goal of Aim 2 is to create the user interface of the steerable section and the removable cam- era module, culminating in a low-volume production run with production-equivalent materials, and to perform comprehensive formative human factors evaluations of the Aspire system. Aim 3 focuses on statistically pow- ered experiments to evaluate our hypotheses that our new steerable suction scope will reduce average surgical duration by 38%, while also demonstrating a reduction in surgical duration of very large stones and improv- ing stone-free rates. This will bring times and stone free rates for patients with larger stones in line with the current (small stone) standard of care, so that they can be treated within clinical guidelines for maximum safe ureteroscopy duration. 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： 该提案的目的是创造一种新型输尿管软镜，几乎可以瞬间改变输尿管软镜的形状。 从内窥镜到大腔可操纵吸引导管，可快速清除大肾结石 量，使患者免受侵入性替代方案的影响。 临床意义来自每年 350 万肾结石患者 仅美国就有 700,000 人接受了介入手术，取出了其中 230,000 颗结石。 人们的肾结石体积较大，因此需要接受侵入性手术或时间过长 输尿管镜检查的并发症发生率较高且手术时间过长，我们的中心假设是。 我们的新型可变形输尿管镜将为患有以下疾病的患者减少 36 分钟或更多的手术时间 大量减少手术时间将使较大的碎石时间相当于较小的碎石时间。 石时代，使更多的患者成为微创干预的候选者。 创新来自新的机械驱动概念，使我们能够直接构建弯曲驱动 进入装置本身的外壁，这使得中心管腔的直径几乎相同。 与内窥镜本身一样，管腔最初带有一个可以随时移除的摄像头/照明核心。 希望将设备转变为可操纵的抽吸护套，以在外壁中建立弯曲驱动， 我们利用不对称刚性薄壁管中的弹性相互作用在将这些管连接到其尖端后， 尖端弯曲可以通过管基部的较小相对线性位移来产生，其结果是高度弯曲。 灵巧的装置，具有与输尿管镜相同的弯曲能力，具有大的中央管腔，可用于高 通过吸力去除体积结石。 我们的目标 1 的方法是设计、优化和构建我们的可操纵护套和手术室就绪版本 可插入式相机/照明核心采用可扩展的制造工艺和临床级、生物相容性 目标 2 的目标是创建可操纵部分和可移动凸轮的用户界面。 era 模块，最终使用生产等效材料进行小批量生产，并执行 Aspire 系统的综合形成性人为因素评估侧重于功率。 进行了实验来评估我们的假设，即我们的新型可操纵抽吸范围将减少平均手术费用 持续时间缩短了 38%，同时还证明了巨大结石的手术时间缩短并改善了 这将使较大结石患者的排石时间和排石率与标准一致。 当前（小结石）护理标准，以便他们可以在临床指南范围内进行治疗，以获得最大程度的安全 输尿管镜检查持续时间的成功验证这些假设将强烈推动未来的第三阶段活动。 （在第二阶段 SBIR 结束后得到私人资本的支持）我们完成了 FDA 510(k) 清关流程，并将我们的设备推向市场。