Dexterity Enhancement for Flexible Endoscopic Interventional Tools

增强灵活内窥镜介入工具的灵活性

• 批准号: 10259133
• 负责人: Joshua B Gafford
• 金额: $ 72.45万
• 依托单位: ENDOTHEIA, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-19 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259133
• 关键词: American; Caliber; Capital; Catheters; Clinical; Complication; Consumption; Devices; Endoscopes; Endoscopy; Engineering; Excision; Face; Failure; Fiber; Future; Goals; Guidelines; Human; Industrialization; Intellectual Property; Intervention; Kidney; Kidney Calculi; Lasers; Motion; Operating Rooms; Operative Surgical Procedures; Patient risk; Patients; Phase; Physicians; Positioning Attribute; Privatization; Procedures; Process; Property; Protocols documentation; Quality Control; Radial; Research; Risk; Savings; Secure; Series; Small Business Innovation Research Grant; Study Section; Surgeon; Techniques; Testing; Thinness; Time; Tube; Ureteroscopes; Ureteroscopy; Validation; Work; base; clinically significant; cost; design; dexterity; experimental study; flexibility; innovation; instrument; manufacturing process; minimally invasive; porcine model; prototype; public health relevance; recruit; standard of care; success; tool

Project Summary/Abstract: The objective of this proposal is to create a new low-cost transendoscopic laser/basket aiming tool that makes ureteroscopic kidney stone removal easier for physicians, so that fewer patients require invasive surgery. Clinical significance comes from the 230,000 patients per year (in the USA alone) with larger stone sizes, for whom surgeons currently face a dilemma. They must either choose invasive surgery, or perform a lengthy ureteroscopy which increases complication rates, and consumes excessive operating room time. Our central hypothesis is that by increasing laser and basket dexterity, our new device will reduce the procedure time by more than 25% for patients with larger stones. Achieving this would make many more patients candidates for ureteroscopy; it will make it possible to remove larger stones almost as quickly as smaller stones are removed today. Innovation comes from harnessing elastic interactions in asymmetrically stiff, thin-walled tubes to create a steerable aiming tip that is (1) small enough to pass through a standard ureterosocope port, while (2) carrying a laser fiber or kidney stone basket within its open central lumen. The stiffness asymmetry of the tubes (which are attached at their tips) transforms small axial motions applied at the endoscope handle into dexterous local bending at the endoscope tip. The result is an inexpensive, disposable, luminal device for dexterously steering laser fibers and kidney stone baskets, which is compatible with existing endoscopes, laser fibers, and baskets. Our approach in Aim 1 is to build an OR-ready version of our device by using catheter-inspired tip design processes with a surgeon interface amenable to practical, scalable manufacturing. Aim 2 incorporates rigorous quality and human factors-based design enhancements and refinements so that our device is ready to undergo the FDA 510(k) clearance process immediately at the end of Phase II. Aim 3 focuses on statistically powered experiments to evaluate our hypotheses that our new steerable aiming tip will reduce average surgical duration by 25% – which will bring operative time for patients with larger stones in line with the current (small stone) standard of care – and reduce maximum duration for many more large stone patients, bringing it to 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.

项目概要/摘要： 本提案的目的是创建一种新的低成本经内窥镜激光/篮瞄准工具， 输尿管镜下肾结石清除更容易为医生，使更少的患者需要侵入性手术。 临床意义来自每年230，000例患者（仅在美国）患有较大结石， 外科医生目前面临着一个两难的境地。他们要么选择侵入性手术，要么进行长时间的 输尿管镜检查增加并发症发生率，并消耗过多的手术室时间。我们的中央 假设通过增加激光和篮的灵活性，我们的新器械将通过以下方式缩短手术时间： 大于25%的患者有较大的结石。实现这一目标将使更多的患者成为 输尿管镜检查;它将使更大的结石几乎可以像更小的结石一样迅速地被移除 今天 创新来自于利用非对称刚性薄壁管中的弹性相互作用， 可操纵瞄准头（1）足够小，可通过标准输尿管镜端口，同时（2）携带 在其开放的中心管腔内的激光纤维或肾结石篮。管的刚度不对称性（其 连接在它们的尖端）将施加在内窥镜手柄处的小的轴向运动转换成灵巧的局部运动 在内窥镜尖端弯曲。其结果是一个便宜的，一次性的，管腔装置灵巧地转向 激光纤维和肾结石篮，与现有内窥镜、激光纤维和篮兼容。 我们在目标1中的方法是通过使用导管启发的尖端设计来构建我们设备的OR就绪版本 具有外科医生界面的工艺适合于实际的、可扩展的制造。目标2包含严格的 质量和基于人为因素的设计增强和改进，使我们的设备准备好接受 FDA 510（k）批准程序在第二阶段结束时立即生效。目标3侧重于统计功效 实验旨在评估我们的假设，即我们的新型可控瞄准头端将通过以下方式缩短平均手术时间： 25% -这将使较大结石患者的手术时间符合当前（小结石）标准 并减少更多大结石患者的最长持续时间，使其符合临床指南 最大安全输尿管镜检查时间。验证这些假设的成功将有力地推动未来 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）许可流程，并将我们的器械投放市场。