SBIR Phase II: Advanced Balloon Endoscopy Overtube

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力在于解决不完全结肠镜检查程序中未满足的需求。不完整的结肠镜检查程序可能导致漏诊结直肠癌，并最终增加与随访程序相关的医疗保健支出。结肠镜检查时使用当前气囊插管可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的报销很少，这给内窥镜医生带来了相当大的压力，他们必须以最小的成本最大化内窥镜实验室的病人吞吐量。目前球囊式套管由于其滑脱问题和应用效率低下，除了在具有挑战性和高度曲折的条件下，还没有得到广泛应用。该项目将为内窥镜医师提供一种术中工具，可以将不完整的结肠镜检查转变为完整的手术，成本仅为一小部分。这项小型企业创新研究（SBIR）二期项目旨在证明一种可在术中使用的集成气囊外管的可行性。该技术代表了一种中期手术，在内窥镜上增加了时间效率，以帮助完成具有挑战性的结肠镜检查，并最大限度地减少结肠镜检查不完整的发生。该项目的目标是实现一种安全、有效、可制造的设备，并展示临床可接受的用户界面。先进的球囊覆盖管直接解决了最大限度地完成结肠镜检查的需要，以改善患者的健康状况，使用成本有效的内窥镜配件，易于使用和节省时间。这种新颖的方法提供了一种将不完整的程序转换为完整程序的新方法，以最大限度地降低成本，同时改善患者的预后和整体临床体验。在这个项目中产生的技术专长将解决结肠镜检查市场上一个关键的未满足的需求，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。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.