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

这一小型企业创新研究（SBIR）I期项目的更广泛影响通过开发一种简单易用且具有成本效益的新型图像引导全层活检器械，解决了内窥镜手术中大型胃肠道缺损组织缝合和闭合的临床需求。全层胃肠道缺损，如穿孔、吻合口漏和瘘是由各种类型的病理引起的严重疾病。他们更可能需要重症监护和长期住院，发病率和死亡率也很高。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。该项目如果成功，将证明一种新型、低成本、图像引导的、使用简单直观的电子设备的可行性。目前，对于大的胃肠道（GI）缺损的组织缝合和闭合，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，并且市场上唯一的内窥镜夹闭装置非常笨重，难以使用，并且其高成本通常妨碍使用。所提出的装置的技术创新包括圆形针和新型针驱动机构，其允许简化的穿刺技术。该器械为一次性使用器械，是内窥镜（如结肠镜、胃镜）的附件。本项目的技术目标侧重于开发和构建概念验证原型，包括定制针和针驱动机制、缝线锚钉和缝线交换机制;在胃模型中测试原型;通过医生反馈研究证明这种新型胃肠道手术技术的简单性;该奖项反映了NSF的法定使命，并被认为是值得通过使用基金会的学术价值和更广泛的影响审查标准。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project addresses the clinical needs for tissue approximation and closure of large gastrointestinal defects in endoscopic surgery through the development of a novel image-guided full-thickness suturing device that is simple and easy to use while cost-effective. Full-thickness gastrointestinal defects such as perforation, anastomotic leak, and fistula are severe conditions caused by various types of pathologies. They 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 project, if successful, will lead to demonstrating the feasibility of a novel, low cost, image-guided suturing device that is simple and intuitive to use. Currently, no good solutions exist for 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 on the market is very cumbersome, difficult to use, and its high cost often precludes usage. The technical innovation of the proposed device comprises a circular needle and a novel needle drive mechanism which allows for a simplified suturing technique. The device is single use, disposable, and an attachment to an endoscope (such as colonoscope, gastroscope). The technical goals of this project focus on developing and building a proof of concept prototype which includes custom needle and needle drive mechanism, suture anchors, and suture exchange mechanism; testing the prototype in a gastric model; proving the simplicity of this novel suturing technique through a physician feedback study; and validating the viability and scalability of design features for a commercialized product at a low cost.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.