Squashing the Scope Superbug: A Disposable System for ERCP that Saves Patients from Bacterial Cross-Contamination

项目摘要/摘要： 该提案的目标是创建一种新的低成本、一次性系统，使可靠、安全、 标准内窥镜取代昂贵的定制十二指肠镜，后者最近被证明 以惊人的速度引起感染。 fi的临床意义来自于每年有40,000名患者被不干净的十二指肠感染。 在每年接受内窥镜逆行胰胆管造影术(ERCP)的70万名患者中， 只有美国。这样做的原因是十二指肠镜含有微小的运动部件，用于瞄准经内窥镜 内窥镜尖端的工具是侧面的，里面藏有细菌。为了应对令人震惊的感染率，8月份 2019年FDA发布了一项行动号召，要求医疗器械制造商开发新型的一次性设备，用于 一旦有了ERCP，医院就可以迅速采用。 我们的创新是通过用一种新型的低成本一次性内窥镜增强标准内窥镜来实现ERCP 可转向护套/端盖系统。我们创新的可操控护套(穿过内窥镜端口) 在两个薄壁管内使用刚度不对称，以实现携带的经内窥镜器械的转向 它的大中央管腔。管子的顶端连接在一起，使得刚度不对称可以改变小的 轴管在内窥镜尖端进入灵活的局部弯曲。其结果是一种廉价的一次性产品 用于灵活控制fl柔性导丝、套管和括约肌切开术的装置。在 内窥镜尖端，鞘穿过内置在定制端盖中的弯曲通道，该通道(1)将其对准侧面 以及(2)通过集成镜提供侧视可视化。 我们在目标1中的方法是通过优化设计我们的可引导鞘/帽系统的临床就绪版本 为可扩展制造而设计时的管材机械性能。目标2专注于设计终端 用于最佳工具交付和基于侧视镜的可视化的帽。目标3专注于统计上的动力 将我们的新设备与标准十二指肠镜在乳头插管率方面进行比较的实验，可以- 产卵时间和导航到十二指肠的时间，以及一项动物先导研究，以证明在体内的可用性。 这些目标的成功将有力地推动商业化战略中描述的第三阶段活动 我们完成FDA的文件(在第二阶段SBIR结束后得到私人资本的支持) 510(K)审批程序，并将我们的设备发布到商业市场。

Project Summary/Abstract: The objective of this proposal is to create a new low-cost, disposable system that enables reliable, safe, standard endoscopes to replace expensive, customized duodenoscopes, which have recently been shown to cause infections at an alarming rate. Clinical significance comes from the fact that 40,000 patients per year will be infected by unclean duodeno- scopes, among the 700,000/year who undergo endoscopic retrograde cholangiopancreatography (ERCP) in the USA alone. The reason for this is that duodenoscopes contain tiny moving parts, used to aim transendoscopic tools sideways at the endoscope tip, which harbor bacteria. In response to the alarming infection rates, in August 2019 the FDA issued a call-to-action for medical device manufactures to develop novel, disposable devices for ERCP, and for hospitals to rapidly adopt them once available. Our Innovation is to enable ERCP by augmenting a standard endoscope with a novel low-cost disposable steerable sheath/endcap system. Our innovative steerable sheath (which passes through the endoscope port) uses stiffness asymmetry in two thin-walled tubes to enable steering of trans-endoscopic instruments carried in its large central lumen. The tubes are attached at their tips, enabling the stiffness asymmetry to transform small axial tube motions into dexterous local bending at the endoscope tip. The result is an inexpensive, disposable device for dexterously steering the flexible guidewires, cannulas, and sphincterotomes used in ERCP. At the endoscope tip, the sheath passes through a curved channel built into a custom endcap that (1) aims it sideways and (2) provides side-view-visualization via an integrated mirror. Our approach in Aim 1 is to design a clinically-ready version of our steerable sheath/cap system by optimizing tube mechanical properties while designing for scalable manufacturing. Aim 2 focuses on designing the end cap for optimal tool delivery and side-view mirror-based visualization. Aim 3 focuses on statistically powered experiments to compare our new device to standard duodenoscopes in terms of papilla cannulation rate, can- nulation time, and navigation time to the duodenum, and an animal pilot study to demonstrate in vivo usability. Success in these aims will strongly motivate the Phase III activities described in the Commercialization Strategy document (supported by private capital after the conclusion of this Phase II SBIR) where we complete the FDA 510(k) clearance process, and release our device to the commercial market.