SBIR Phase I: Bioabsorbable Scaffold for Tension-Free Laparoscopic Fascial Defect Closure

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种生物可吸收支架，不仅可以快速闭合腹腔镜筋膜缺损，还可以消除临床并发症，如套管针部位疝。该器械旨在取代所有腹腔镜穿刺器端口的缝合修复，仅在美国就有超过700万个穿刺器端口开口，每年的潜在市场超过4亿美元。腹腔镜减肥手术是一个很有前途的初始市场，因为疝的风险增加，并且在肥胖患者中难以使用手动缝合和/或基于针的闭合方法。每年在美国进行的腹腔镜减肥手术超过20万例，估计年增长率为36%。该器械通过确认新材料/机械设计，代表了一种上级筋膜缺损闭合技术，可促进穿刺器端口缺损的手术修复和组织愈合。这种新型器械的开发可广泛应用于其他腹部伤口闭合适应症，如脐疝、先天性腹壁缺损、单孔入路和机器人缺陷。拟议项目旨在开发一种生物可吸收支架系统，用于闭合腹腔镜套管针孔筋膜缺损。目前基于缝线的套管针端口闭合技术在其易用性和对伤口愈合的支持方面受到限制。接受腹腔镜减肥手术的患者尤其面临疝形成风险增加，由于难以使用弯针手动缝合器或基于缝线的输液港闭合器械而增加手术时间，以及由于输液港部位的缝线张力高而增加伤口愈合时间。支架系统将筋膜缺损边缘保持在一起，而没有肠撕裂或施加高缝合张力的风险。总体项目目标是在第I阶段确认生物可吸收支架器械概念，并在第II阶段进行临床前慢性评价。该I期项目的目标是：1）通过迭代建模、制造和测试原型进行设计优化，以快速安全地闭合筋膜缺损，2）证明无张力筋膜缺损边缘对齐的伤口愈合受到保护。最终，该第一阶段设计改进和概念验证项目将导致第二阶段活动，重点是开发适用于制造前研究的精选生物可吸收支架器械设计，包括慢性动物体内降解特性研究。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a bioabsorbable scaffold that not only rapidly closes laparoscopic fascial defects, but also eliminates clinical complications such as trocar site herniation. This device is intended to replace suture repair of all laparoscopic trocar ports, representing over 7 million trocar port openings and an addressable market of over $400 million annually in the U.S. alone. Laparoscopic bariatric surgery is a promising initial market due to the increased risk of herniation and the difficulty of using hand suturing and/or needle based closure methods in obese patients. There are over 0.2 million laparoscopic bariatric surgeries performed in the US each year, with an estimated annual growth rate of 36%. This device represents a superior fascial defect closure technology by validating a new material/mechanical design that facilitates surgical repair and tissue healing of trocar port defects. The development of this novel device holds broad applications for additional abdominal wound closure indications such as umbilical hernia, congenital abdominal wall defects, single port access, and robotic defects.The proposed project aims to develop a bioabsorbable scaffold system for closing laparoscopic trocar port fascial defects. Current suture-based trocar port closure technologies are limited in their ease-of-use and support for wound healing. Patients undergoing laparoscopic bariatric surgery in particular face increased risk of herniation, increased operating time due to difficulty of using curved needle hand suturing or suture-based port closure devices, and increased wound healing time due to high suture tension at port sites. The scaffold system holds fascial defect edges together without risk of bowel laceration or applying high suture tension. The overall project goal is to validate the bioabsorbable scaffold device concept in Phase I and preclinical chronic evaluation during Phase II. The objectives of this Phase-I project are to: 1) conduct design refinement by iteratively modeling, fabricating, and testing prototypes to rapidly and securely close fascial defects, and 2) demonstrate protected wound healing with tension-free fascial defect edge alignment. Ultimately, this Phase-I design refinement and proof-of-concept project will lead to Phase-II activities focused on developing a select bioabsorbable scaffold device design suitable for pre-manufacturing studies, including statistically-powered in vivo degradation profile studies in chronic animals.