SBIR Phase II: Advanced Balloon Endoscopy Overtube

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是解决不完整的结肠镜检查程序中未得到满足的需求。不完整的结肠镜检查程序可能导致漏诊结直肠癌，并最终增加与后续程序相关的医疗支出。在结肠镜检查中使用当前的球囊超管可以显著提高盲肠插管率和总体结果；然而，在当今的医疗经济中，结肠镜检查和小肠内窥镜检查得到了适度的报销，这给内窥镜医生带来了相当大的压力，要求他们以最低的成本最大限度地提高内窥镜实验室的患者吞吐量。目前的球囊溢流管除了在具有挑战性和高度曲折的条件下，由于其麻烦的滑移和低效率的使用，并没有得到广泛的应用。该项目将为内窥镜医生提供一种术中工具，可以将不完整的结肠镜检查转变为完成的程序，而成本只需一小部分。这个小型企业创新研究(SBIR)第二阶段项目旨在证明可在术中使用的集成球囊覆盖管的可行性。这项技术代表了在内窥镜上添加一种节省时间的中期检查，以帮助完成具有挑战性的结肠镜检查，并将不完全结肠镜检查的发生降至最低。该项目的目标是实现一种安全、有效、可制造的设备，该设备具有临床可接受的用户界面。先进的球囊覆盖管直接满足了最大限度地完成结肠镜检查以改善患者健康的需要，使用方便且省时的经济实惠的内窥镜附件。这一新的方法提供了一种新的方法，将不完整的程序转换为完整的程序，以最大限度地减少成本，同时改善患者的结果和整体临床体验。在这个项目期间产生的技术专长将解决结肠镜检查市场中一个关键的未得到满足的需求，而未来的版本可能会转移到医疗程序领域的其他使用领域。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in addressing an unmet need in incomplete colonoscopy procedures. Incomplete colonoscopy procedures can result in missed colorectal cancer and ultimately increased healthcare expenditures related to follow-up procedures. Use of current balloon overtubes during colonoscopy can significantly improve cecal intubation rates and overall outcomes; However, operating in today’s healthcare economy, colonoscopies and small bowel endoscopy are modestly reimbursed placing considerable pressure on the endoscopist to maximize patient throughput in an endoscopy lab at minimal cost. Current balloon overtubes are not widely utilized except in challenging and highly tortuous conditions due to their troublesome slippage and inefficient application. This project will provide endoscopists with an intraoperative tool that can transition incomplete colonoscopies to completed procedures at a fraction of the cost.This Small Business Innovation Research (SBIR) Phase II project seeks to demonstrate the feasibility of an integrated balloon overtube that can be used intraoperatively. The technology represents a mid-procedure, time-efficient addition on the endoscope to aid in completing challenging colonoscopies and minimize the occurrence of incomplete colonoscopies. The goal of this project is to achieve a safe, effective, manufacturable device that exhibits a clinically acceptable user interface. The advanced balloon overtube directly addresses the need to maximize complete colonoscopies for better patient health, using a cost effective endoscopy accessory that is easy to use and time efficient. This novel approach provides a new way of converting incomplete procedures to completed procedures to minimize costs while improving patient outcomes and overall clinical experiences. The technological expertise that will be generated during this project will address a critical unmet need in the colonoscopy market, while future versions may be transferable to other fields of use in the medical procedure realm.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.