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

项目概要/摘要： 该提案的目的是创建一种新型的可伸缩输尿管镜，几乎可以立即改变- 从内窥镜到大腔可操纵吸引导管，能够快速取出大的肾结石 体积，使患者免受侵入性替代品。 临床意义来自于每年350万肾结石患者， 仅在美国，就有70万人接受了介入手术来取出结石。其中23万个 人们有较大的肾结石体积，因此受到要么侵入性手术或过长 输尿管镜手术，其并发症发生率增加，手术时间过长。我们的核心假设是 我们的新型可变形输尿管镜将为以下患者减少36分钟或更多的手术时间 大量的石头。将手术时间减少这么多将使较大的石头时间相当于较小的石头时间 使更多的患者成为微创干预的候选人。 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 进入设备本身的外壁。这使得开放的中心腔的直径几乎与 就像内窥镜本身一样管腔最初携带摄像机/照明核心，无论何时， 期望将该装置转变成可操纵的抽吸鞘。为了在外壁中建立弯曲致动， 我们利用非对称刚性薄壁管中的弹性相互作用。在将这些管子的尖端连接起来之后， 尖端弯曲可以通过管基部处的小的相对线性位移产生。其结果是一个高度 具有与输尿管镜相同的弯曲能力的灵巧装置， 通过抽吸清除大量结石。 我们在目标1中的方法是设计、优化和构建我们的可控鞘管的OR就绪版本， 使用可扩展制造工艺和临床级生物相容的可插入照相机/照明芯 材料. Aim 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，最终以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。目标3侧重于统计功率- 我们的新的可操纵吸引镜将减少平均手术时间， 持续时间减少38%，同时也证明了非常大的结石的手术时间减少， 无结石率。这将使结石较大的患者的时间和结石清除率与 目前（小结石）的护理标准，使他们可以在临床指南内治疗，以最大限度地安全 输尿管镜检查持续时间。成功验证这些假设将有力地推动未来的第三阶段活动 （在第二阶段SBIR结束后由私人资本支持），我们完成FDA 510（k） 我们的设备投放市场

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.