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

SBIR II 期：用于内窥镜手术的新型图像引导缝合系统

• 批准号: 2111775
• 负责人: Azadeh Khanicheh
• 金额: $ 100万
• 依托单位: ENVISION ENDOSCOPY, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2111775&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; Image

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.

这项小型企业创新研究（SBIR）II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的全厚度缝合系统，该系统简单，易于使用且对胃肠道（GI）缺陷具有成本效益。这些问题更有可能需要重症监护和长期住院，并且发病率和死亡率很高。内镜下管理胃肠道缺陷在外科干预方面具有明显的优势，包括较短的医院住院，减少后手术后疼痛，更快的康复速度和降低的总护理成本。 提出的技术是一次性的，一次性的，并附着在内窥镜上（例如结肠镜，胃镜），以获得更好的患者预后。 这项小型企业创新研究（SBIR）II期项目将推动开发一种新颖，低成本，图像引导的缝合装置，以简单且直观地使用柔性内窥镜。目前，对于内窥镜组织近似和大胃肠道（GI）缺陷的闭合，尚无良好的解决方案。内窥镜夹仅适用于粘膜闭合和小尺寸缺陷，唯一的内窥镜缝合装置被认为是繁琐，难以使用且昂贵的。所提出的设备的技术创新包括圆形针和新颖的针驱动机制，以简化缝合技术。该项目将专门针对技术的进步，产品开发，设计验证和设备的验证。该奖项反映了NSF的法定任务，并使用基金会的智力优点和更广泛的影响评估标准，认为值得通过评估来获得支持。