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

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.