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： 该提案的目的是创建一种新型的灵活输尿管镜，它几乎改变了Instanta- 从内窥镜到大亮的可通道的任务导管，可以快速去除大型肾结石 体积，从侵入性替代品中备剩下的患者。 临床意义来自每年患有肾结石的350万患者 仅美国，其中70万采取了干预程序来去除石头。其中23万 人们的肾结石量较大，因此要进行侵入性手术或超过长期 输尿管镜检查的并发症发生率和过量程序持续时间增加。我们的中心假设是 对于患者 大石头量。减少这一过程的持续时间将使更大的石头时代等同于小 Stone Times，使更多的患者候选人进行最少的侵入性干预措施。 创新来自一个新的机械驱动概念，使我们能够直接建立弯曲驱动 进入设备本身的外墙。这使一个开放的中央管腔几乎直径大大 作为内窥镜本身。管腔最初带有相机/照明芯，每当可以卸下 希望将设备转换为可通行的惊喜护套。为了将弯曲驱动到外墙， 我们利用不对称僵硬，薄壁管中的弹性相互作用。将这些管子连接到尖端后， 尖端弯曲可以通过管底部的小相对线性位移产生。结果是一个高度 具有输尿管镜的相同弯曲功能的灵巧装置，其具有较大的中央腔内高。 通过惊喜清除量的石头。 我们目标1的方法是设计，优化和构建我们可进入的护套的或准备的版本 使用可扩展的制造工艺和临床级，生物相容性的插入相机/照明芯 材料。 AIM 2的目的是创建可移动部分的用户界面和可移动的凸轮 - ERA模块，最终以与生产等效材料进行的小体积生产运行，并执行 Aspire系统的全面形成性人为因素评估。 AIM 3专注于统计上的功能 ERED实验以评估我们的假设，即我们的新可进入任务范围将减少平均外科手术 持续时间增加了38％，同时也表明非常大的石头手术持续时间减少和改善 无石费率。这将为具有较大石头的患者带来时间和无石费率 电流（小石材）护理标准，以便可以在临床指南中对其进行处理，以最大程度安全 输尿管镜检查持续时间。成功验证这些假设将强烈激励未来的III阶段活动 （在本阶段II阶段SBIR结束后得到私人资本的支持），我们完成FDA 510（k） 清除过程，并在市场上启动我们的设备。