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

SBIR 第一期：用于无张力腹腔镜筋膜缺损闭合的生物可吸收支架

• 批准号: 1548689
• 负责人: James Su
• 金额: $ 15万
• 依托单位: LAP IQ, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1548689&HistoricalAwards=false
• 关键词: SBIR; Phase; Bioabsorbable; Scaffold; Tension

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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是一种生物可吸收支架，它不仅可以快速闭合腹腔镜筋膜缺损，还可以消除套管针部位疝气等临床并发症。该设备旨在取代所有腹腔镜套管针端口的缝合修复，仅在美国就有超过 700 万个套管针端口开口和每年超过 4 亿美元的潜在市场。腹腔镜减肥手术是一个有前景的初始市场，因为肥胖患者的疝气风险增加，并且难以使用手工缝合和/或针闭合方法。美国每年进行超过 20 万例腹腔镜减肥手术，预计年增长率为 36%。该设备通过验证新材料/机械设计，代表了一种卓越的筋膜缺损闭合技术，有利于套管针端口缺损的手术修复和组织愈合。这种新型装置的开发对于其他腹部伤口闭合适应症具有广泛的应用，例如脐疝、先天性腹壁缺陷、单孔通路和机器人缺陷。该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端口筋膜缺陷。目前基于缝合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受到限制。接受腹腔镜减肥手术的患者尤其面临着疝气风险增加、由于难以使用弯针手缝合或基于缝合的端口闭合装置而导致的手术时间增加、以及由于端口部位的缝合张力较高而导致的伤口愈合时间增加。支架系统将筋膜缺损边缘固定在一起，没有肠撕裂或施加高缝合张力的风险。项目的总体目标是在第一阶段验证生物可吸收支架装置的概念，并在第二阶段验证临床前慢性评估。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细化，以快速、安全地闭合筋膜缺损，2）通过无张力筋膜缺损边缘对齐来演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，重点是开发适合预制造研究的精选生物可吸收支架装置设计，包括慢性动物体内统计驱动的降解概况研究。