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: 10471880
• 负责人: Joshua B Gafford
• 金额: $ 66.33万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10471880
• 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; Persons; 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： 该方案的目标是创建一种新的低成本的经内窥镜激光/篮筐瞄准工具，该工具可使 输尿管镜下取石对医生来说更容易，使更少的患者需要进行侵入性手术。 临床症状fiCance来自每年230,000名结石较大的患者(仅在美国)， 对他们来说，外科医生目前面临着两难境地。他们必须要么选择侵入性手术，要么进行漫长的 输尿管镜检查增加了并发症发生率，并消耗了过多的手术室时间。我们的中央 假设通过增加激光和篮筐的灵活性，我们的新设备将减少程序时间 对于结石较大的患者，超过25%。实现这一点将使更多的患者成为 输尿管镜检查；它将使取大结石的速度几乎和取小结石的速度一样快 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一个 可操纵的瞄准尖端，(1)足够小以通过标准的输尿管镜口，同时(2)携带 开放的中央管腔内的激光fi结石或肾结石篮子。管子的刚度不对称(这是 将内窥镜手柄上施加的微小轴向运动转化为灵活的局部运动 在内窥镜尖端弯曲。其结果是一种廉价的、一次性的、灵巧的转向装置。 激光fi和肾结石篮子，与现有的内窥镜、激光fi和篮子兼容。 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-Ready版本 具有符合实际、可扩展制造的外科医生界面的工艺。AIM 2结合了严格的 基于质量和人为因素的设计增强和更新，使我们的设备可以进行 FDA在第二阶段结束时立即批准510(K)过程。目标3专注于统计上的动力 对我们的假设进行评估的实验表明，我们的新可转向瞄准尖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与目前的(小结石)标准一致 护理-并缩短更多大型结石患者的最长持续时间，使其符合临床指南 以获得最大的安全输尿管镜检时间。这些假说的成功验证将有力地推动未来 第三阶段活动(在第二阶段SBIR结束后得到私人资本的支持)，我们完成 FDA 510(K)批准程序，并将我们的设备投放市场。