SBIR Phase I: Cost-Effective Anastomotic System Featuring Compliant Anastomoses

Sterling Biomedical, Llc, Lynnfield MA

Investigators

Abstract

This Small Business Innovation Research (SBIR) Phase I project aims to develop a mechanical system for facilitating vascular anastomoses (end-to-side, end-to-end) technology that allows for the rapid and reproducible production of a non-penetrating, compliant vascular reconstruction. This one-shot technology represents a technical advance over the serial clip applier because the entire anastomotic circumference is formed simultaneously, thus facilitating the vascular reconstruction. Currently, there are no one-shot anastomotic systems on the market, thus the proposed technology would fill that much needed demand. This Phase I effort also will develop the manufacturing methods needed to produce these low-cost anastomotic devices that feature compliant polyurethane clips. Bench testing of the anastomoses will be conducted using well-established in vitro procedures. The broader impact/commercial potential of this project will be to reduce the time required to perform vascular anastomoses as well as vascular reconstruction in beating heart surgery. The $400 million surgical staples market urgently needs a new technology, as there is a significant unmet need to develop a novel, sutureless anastomotic device that applies 10 or 12 circumferential clips simultaneously. This should lead to rapid commercialization, especially since this advanced system will reduce surgical operating time.