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

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是开发一种新颖的图像引导全层超声系统，该系统简单，易于使用，并且具有成本效益，可用于胃肠道（GI）缺陷。这些问题更可能需要重症监护和长期住院，并且发病率和死亡率很高。内镜下处理胃肠道缺陷与外科手术相比具有明显的优势，包括住院时间更短，术后疼痛减少，恢复更快，总护理成本降低。 申报的技术是一次性使用的，并连接到内窥镜（如结肠镜、胃镜）上，以获得更好的患者结局。 该小型企业创新研究（SBIR）第二阶段项目将推进一种新型、低成本、图像引导的内窥镜设备的开发，该设备使用简单直观。目前，对于大的胃肠道（GI）缺陷的内窥镜组织缝合和闭合，不存在良好的解决方案。内窥镜夹仅对粘膜闭合和小尺寸缺损有效，并且唯一的内窥镜夹闭装置被认为是笨重、难以使用且昂贵的。所提出的装置的技术创新包括圆形针和新颖的针驱动机构，用于简化穿刺技术。该项目将特别关注技术的进步、产品开发、设计验证和设备的确认。该奖项反映了NSF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.