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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是一种可生物吸收的支架，它不仅可以快速关闭腹腔镜筋膜缺损，还可以消除临床并发症，如套管针位置突出。该设备旨在取代所有腹腔镜套管针端口的缝合修复，仅在美国就代表着700多万个套管针端口开口和每年超过4亿美元的潜在市场。由于肥胖症患者使用手缝合和/或针缝合的难度增加，腹腔镜式减肥手术是一个很有前景的初始市场。美国每年有超过20万例腹腔镜减肥手术，估计年增长率为36%。该装置验证了一种新的材料/机械设计，便于套管针端口缺陷的手术修复和组织愈合，从而代表了一种卓越的筋膜缺陷闭合技术。这一新型设备的开发广泛应用于其他腹部伤口闭合指征，如脐带疝气、先天性腹壁缺陷、单端口通路和机器人缺陷。拟议的项目旨在开发一种可生物吸收的支架系统，用于闭合腹腔镜套管针端口筋膜缺陷。目前基于缝线的套管针端口闭合技术在易用性和对伤口愈合的支持方面存在局限性。接受腹腔镜减肥手术的患者尤其面临着更高的疝气风险，由于难以使用弧形针手缝合或基于缝合的端口关闭装置而延长手术时间，以及由于端口部位的高缝合张力而延长伤口愈合时间。支架系统将筋膜缺损处的边缘固定在一起，不会有肠道撕裂或应用高缝合张力的风险。项目的总体目标是在第一阶段验证生物可吸收支架设备的概念，并在第二阶段进行临床前慢性评估。该第一阶段项目的目标是：1)通过迭代建模、制造和测试原型来进行设计改进，以快速安全地关闭筋膜缺陷，以及2)通过无张力筋膜缺陷边缘对齐展示受保护的伤口愈合。最终，这一第一阶段的设计改进和概念验证项目将导致第二阶段的活动，重点是开发一种精选的生物可吸收支架设备设计，适用于制造前研究，包括在慢性动物身上进行的统计动力体内降解谱研究。

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.