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.

项目摘要/摘要： 该提案的目标是创建一种新的低成本经内窥镜激光/篮式瞄准工具，使 输尿管镜肾结石清除术对医生来说更容易，因此需要侵入性手术的患者更少。 临床意义来自每年 230,000 名患者（仅在美国）患有较大结石， 对于他们来说，外科医生目前面临着两难的境地。他们必须选择侵入性手术，或者进行长时间的手术 输尿管镜检查会增加并发症发生率，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，我们的新设备将减少手术时间 对于较大结石的患者，该比例超过 25%。实现这一目标将使更多的患者成为候选者 输尿管镜检查；它可以像移除较小的石头一样快速地移除较大的石头 今天。 创新来自于利用不对称刚性薄壁管中的弹性相互作用来创建 可操纵的瞄准头，其 (1) 小到足以穿过标准输尿管镜端口，同时 (2) 携带 其开放的中央管腔内有激光纤维或肾结石篮。管材的刚度不对称性（ 连接在其尖端）将内窥镜手柄上施加的小轴向运动转化为灵巧的局部运动 内窥镜尖端弯曲。结果是一种廉价的、一次性的、用于灵巧转向的发光装置 激光纤维和肾结石篮，与现有的内窥镜、激光纤维和篮兼容。 我们的目标 1 的方法是通过使用受导管启发的尖端设计来构建我们设备的 OR-ready 版本 具有适合实用、可扩展制造的外科医生界面的流程。目标 2 包含严格的 基于质量和人为因素的设计增强和改进，使我们的设备做好接受测试的准备 第二阶段结束后立即进行 FDA 510(k) 审批流程。目标 3 侧重于统计功效 实验来评估我们的假设，即我们的新型可操纵瞄准头将减少平均手术时间 25%——这将使较大结石患者的手术时间符合当前（小结石）标准 护理——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 以获得最长的安全输尿管镜检查持续时间。成功验证这些假设将强烈激励未来 第三阶段活动（第二阶段 SBIR 结束后由私人资本支持），我们完成 FDA 510(k) 审批流程，并将我们的设备推向市场。