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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是一个可生物吸附的支架，不仅可以迅速结束腹腔镜筋膜缺陷，而且还消除了诸如Trocar部位疝之类的临床并发症。该设备旨在替代所有腹腔镜套管港的缝合维修，仅在美国，每年在美国，每年超过4亿美元的可寻址市场。腹腔镜减肥手术是一个有前途的初始市场，因为在肥胖患者中使用手动缝合和/或基于基于针头的闭合方法的困难。每年在美国进行超过20万次腹腔镜减肥手术，估计年增长率为36％。该设备通过验证一种新的材料/机械设计来促进套管针端口缺陷的外科修复和组织愈合，代表了一种出色的筋膜缺陷闭合技术。这种新型设备的开发为额外的腹部伤口闭合指示提供了广泛的应用，例如脐疝，先天性腹部壁缺损，单端口通道和机器人缺陷。拟议的项目旨在开发一种可生物吸附的脚手架系统，用于封闭腹腔镜tocapic portocar port torcar port torcar formial Fastial Fastial Fastial formigial Fastial forcects。当前基于缝合的套管针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催眠的风险增加，由于难以使用弯曲针手动缝合或基于缝合的端口闭合装置而增加工作时间，并且由于端口部位的缝合力张力高而增加了伤口愈合时间。脚手架系统将筋膜缺陷边缘放在一起，而没有肠裂的风险或施加高缝合线张力。总体项目目标是验证I阶段I和II期临床前慢性评估的可生物吸收脚手架装置概念。该阶段I项目的目标是：1）通过迭代建模，制造和测试原型来迅速且安全地闭合筋膜缺陷，以及2）2）表现出保护受保护的伤口愈合，并通过无张力的筋膜缺陷边缘对齐。最终，这种I期设计的完善和概念验证项目将导致II期活动的重点是开发适合于制造前研究的精选生物吸附的脚手架装置设计，包括在慢性动物中具有统计驱动的体内降解谱研究。