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： 该提案的目的是创建一种新的低成本跨镜激光/篮子瞄准工具，以使 对于医生来说，输尿管镜肾结石清除更容易，因此较少的患者需要进行侵入性手术。 临床意义来自每年230,000名患者（仅在美国），石材尺寸较大， 外科医生目前面临困境。他们必须选择侵入性手术，或进行冗长 输尿管镜会增加并发症发生率，并消耗过多的手术室时间。我们的中心 假设是，通过增加激光和篮子敏捷，我们的新设备将通过 较大石头的患者超过25％。实现这一目标将使更多的患者候选 输尿管镜检查；它将可以像去除较小的石头一样快地去除较大的石头 今天。 创新来自利用不对称僵硬，薄壁管中的弹性相互作用，以创建一个 （1）足够小以通过标准输尿管镜端口，（2）携带的瞄准尖端 开放的中央管腔内的激光纤维或肾结石篮。管的刚度不对称性（其中 附着在其尖端上）将内窥镜手柄上应用的小轴向运动转换为灵巧的局部 内窥镜尖端弯曲。结果是一种廉价的，一次性的腔内装置，用于灵活地转向 激光纤维和肾结石篮，与现有的内窥镜，激光纤维和篮子兼容。 AIM 1中的方法是使用以导管启发的提示设计来构建我们的设备的或准备的版本 具有外科医生界面的过程，可以适应实用，可扩展的制造。 AIM 2融合了严格的 质量和人为因素的设计增强和重新构件，以便我们的设备准备好进行 FDA 510（k）清除过程立即在第二阶段结束时。 AIM 3专注于统计上的动力 评估我们的假设的实验，即我们的新可进入的目标尖端将减少平均外科手术持续时间 25％ - 这将带来较大石头患者的工作时间 护理 - 减少许多大型石头患者的最大持续时间，将其纳入临床指南 为了最大的安全输尿管镜持续时间。成功验证这些假设将强烈激励未来 第三阶段活动（在本阶段II阶段SBIR结束后得到私人资本的支持），我们完成 FDA 510（k）清除过程，并在市场上启动我们的设备。