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: 10081927
• 负责人: Joshua B Gafford
• 金额: $ 61.76万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081927
• 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; Modeling; 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; 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.

项目概要/摘要： 该提案的目的是创建一种新的低成本一次性系统，该系统能够实现可靠、安全， 标准的内窥镜，以取代昂贵的定制内窥镜，最近已经显示， 以惊人的速度引发感染 临床意义来自于这样一个事实，即每年有40，000名患者将被不洁支原体感染， 内镜，在700，000/年接受内镜逆行胰胆管造影术（ERCP）的患者中， 美国独自。其原因是内窥镜包含微小的移动部件，用于经内窥镜瞄准 内窥镜尖端的工具侧面，这是细菌的温床。为了应对令人震惊的感染率， 2019年，FDA向医疗器械制造商发出行动号召，要求他们开发新型一次性器械， ERCP，并为医院迅速采用它们一旦可用。 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 可控鞘管/端帽系统。我们的创新可操纵鞘管（穿过内窥镜端口） 在两个薄壁管中使用刚度不对称性， 其巨大的中央管腔。这些管在其尖端连接，使刚度不对称性能够转换小 轴向管运动到内窥镜尖端处的灵巧局部弯曲。其结果是一种廉价的一次性 用于灵活操纵ERCP中使用的可伸缩导丝、套管和括约肌切开器的器械。在 内窥镜头端，鞘管穿过定制端帽中内置的弯曲通道，（1）将其侧向对准 以及（2）通过集成的反射镜提供侧视可视化。 我们在目标1中的方法是通过优化我们的可控鞘管/帽系统， 管的机械性能，同时设计可扩展的制造。目标2侧重于设计最终目标 最佳的工具输送和侧视镜为基础的可视化。目标3侧重于统计功效 在乳头插管率方面比较我们的新器械与标准内窥镜的实验，可以- 排卵时间和到十二指肠的导航时间，以及证明体内可用性的动物初步研究。 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结束后由私人资本支持） 510（k）许可流程，并将我们的器械投放商业市场。