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

消灭内镜超级细菌：一次性 ERCP 系统可帮助患者免受细菌交叉污染

• 批准号: 10218168
• 负责人: Joshua B Gafford
• 金额: $ 54万
• 依托单位: ENDOTHEIA, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10218168
• 关键词: Adopted; American; Animals; Bacteria; Blood Vessels; Cannulas; Cannulations; Capital; Catheters; Clinical; Complex; Coupled; Custom; Devices; Duodenoscopes; Duodenum; Elevator; Endoscopes; Endoscopic Retrograde Cholangiopancreatography; Engineering; Family suidae; Gastroscopes; Goals; Hospitals; Infection; Infection prevention; Injections; Intellectual Property; Intervention; Intestines; Intuition; Lasers; Lateral; Life; Manufacturer Name; Mechanics; Medical Device; Molds; Motion; Patients; Pattern; Phase; Physicians; Pilot Projects; Polymers; Positioning Attribute; Privatization; Procedures; Process; Public Health; Research; Secure; Side; Small Business Innovation Research Grant; Source; Squash; Superbug; Surgeon; System; Thinness; Time; Torsion; Training; Tube; Visualization; Work; base; clinically significant; commercialization; cost; design; dexterity; experimental study; flexibility; in vivo; infection rate; innovation; instrument; manufacturability; mechanical properties; novel; porcine model; prototype; public health relevance; recruit; response; success; tongue papilla; tool; usability

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.

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，以实现可靠、安全、 标准内窥镜取代昂贵的定制十二指肠镜，最近被证明可以 以惊人的速度引起感染。 临床意义在于每年有 40,000 名患者会被不洁的十二指肠细菌感染。 每年有 70 万人接受内镜逆行胰胆管造影 (ERCP) 仅美国。其原因是十二指肠镜包含微小的移动部件，用于瞄准经内窥镜 工具在内窥镜尖端的侧面，其中藏有细菌。为了应对令人震惊的感染率，8月份 2019 年 FDA 向医疗器械制造商发出行动号召，开发新型一次性器械 ERCP，并让医院在可用后迅速采用。 我们的创新是通过使用新型低成本一次性内窥镜增强标准内窥镜来实现 ERCP 可操纵护套/端盖系统。我们创新的可操纵护套（穿过内窥镜端口） 利用两个薄壁管中的刚度不对称性来实现经内窥镜器械的转向 它的大中央管腔。管子连接在其尖端，使刚度不对称性转变为小 轴向管运动在内窥镜尖端处产生灵巧的局部弯曲。结果是一种廉价的、一次性的 用于灵巧操纵 ERCP 中使用的柔性导丝、插管和括约肌切开器的装置。在 内窥镜尖端，护套穿过定制端盖内置的弯曲通道，(1) 将其瞄准侧面 (2) 通过集成镜子提供侧视可视化。 我们的目标 1 的方法是通过优化来设计临床就绪版本的可操纵护套/帽系统 管材机械性能，同时设计可扩展制造。目标 2 侧重于设计最终结果 用于最佳工具交付和基于侧视镜的可视化的上限。目标 3 侧重于统计功效 实验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，可以- 排卵时间、到达十二指肠的导航时间，以及证明体内可用性的动物试点研究。 这些目标的成功将强烈推动商业化战略中描述的第三阶段活动 文件（在第二阶段 SBIR 结束后得到私人资本的支持），我们在其中完成 FDA 510(k) 许可流程，并将我们的设备发布到商业市场。