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

项目摘要/摘要： 该方案的目的是创造一种新型的fl可伸缩输尿管镜，它几乎可以瞬间改变输尿管镜的形状。 经内窥镜到大管腔可控引流管快速取石 体积，使患者免受侵入性替代治疗。 fi的临床意义来自中国每年350万肾结石患者 仅在美国，就有70万人接受了介入性手术来取出结石。其中23万人 人们的肾结石体积较大，因此要么接受侵入性手术，要么时间过长。 输尿管镜检查，并发症发生率增加，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使患者的手术时间减少36分钟或更多 巨大的石块体积。将过程持续时间减少这么多，将使较大的石头时间等于较小的石头时间 石器时代，使更多的患者成为微创干预的候选对象。 创新来自一种新的机械驱动概念，使我们能够直接建立弯曲驱动 进入装置本身的外壁。这使得开放的中央管腔的直径几乎一样大 作为内窥镜本身。管腔最初带有一个相机/照明核心，该核心可以在任何时候移除 希望将该装置改造成可操纵的吸盘。为了将弯曲驱动装置安装到外壁中， 我们利用非对称刚性薄壁管子中的弹性相互作用。在将这些管子连接到它们的顶端后， 顶端弯曲可以通过在管子底部的小的相对线性位移来产生。结果是一个高度的 一种灵活的装置，具有与输尿管镜相同的弯曲能力，其中央管腔较大，可用于高位 通过负压吸出大量结石。 我们在目标1中的方法是设计、优化和构建一个OR-Ready版本的可控护套和 使用可扩展制造工艺和临床级生物兼容性的可插入式相机/照明核心 材料。目标2的目标是创建可转向部分和可拆卸凸轮的用户界面- ERA模块，最终使用与生产等量的材料进行小批量生产，并执行 Aspire系统的综合形成性人因评价。目标3专注于统计能力- 评估我们的假设，即我们的新的可控吸引器范围将减少平均外科手术 持续时间减少38%，同时也表明极大结石的手术时间缩短了，并改善了- ING无结石利率。这将使结石较大的患者的时间和结石排净率与 目前的(小结石)护理标准，以便可以在临床指南内进行最大限度的安全治疗 输尿管镜检查持续时间。这些假设的成功验证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)，在那里我们完成FDA 510(K) 批准程序，并将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.