SBIR Phase II: Novel Image Guided Suturing System For Endoscopic Surgery

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是开发一种新型的图像引导全层缝合系统，该系统简单，易于使用，并且具有成本效益，用于胃肠道（GI）缺陷。这些问题更可能需要重症监护和长期住院，发病率和死亡率都很高。与外科手术相比，内镜治疗胃肠道缺陷具有明显的优势，包括缩短住院时间、减少术后疼痛、更快恢复和降低总护理费用。所提出的技术是一次性的，一次性的，并附加在内窥镜（如结肠镜，胃镜）上，以获得更好的患者结果。这项小型企业创新研究（SBIR）二期项目将推进一种新型、低成本、图像引导的柔性内窥镜缝合设备的开发，该设备使用简单、直观。目前，没有很好的解决方案存在的内镜组织逼近和封闭大胃肠道（GI）缺陷。内镜夹仅对粘膜闭合和小尺寸缺陷有效，唯一的内镜缝合装置被认为是笨重、难以使用和昂贵的。该装置的技术创新包括一种圆形针和一种用于简化缝合技术的新型针驱动机构。该项目将特别侧重于技术进步、产品开发、设计验证和设备验证。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 the development of a novel image-guided full-thickness suturing system that is simple, easy to use, and cost-effective for gastrointestinal (GI) defects. These issues are more likely to require intensive care and a long hospital stay and have high rates of morbidity and mortality. Managing gastrointestinal defects endoscopically has obvious advantages over surgical intervention, including shorter hospital stays, reduced post procedure pain, faster recovery, and reduced total cost of care. The proposed technology is single-use, disposable, and attached to an endoscope (such as colonoscope, gastroscope), for better patient outcomes. This Small Business Innovation Research (SBIR) Phase II project will advance the development of a novel, low-cost, image-guided suturing device for flexible endoscopes simple and intuitive to use. Currently, no good solutions exist for endoscopic tissue approximation and closure of large gastrointestinal (GI) defects. Endoscopic clips are only effective for mucosa closure and small size defects and the only endoscopic suturing device is considered cumbersome, difficult to use, and expensive. The technical innovation of the proposed device comprises a circular needle and a novel needle drive mechanism for a simplified suturing technique. This project will be specifically focused on the advancement of the technology, product development, design verification and validation of the device.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.