SBIR Phase I: Grip-Act-Reposition Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs

This Small Business Innovation Research Phase I project will develop the ?Grip-Act-Reposition (GAR) Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs.? Working within or on moving organs ? like the heart or lungs ? is extremely challenging during minimally invasive procedures. The working end of the surgical tool must be deployed through a long (100 cm), narrow (3mm) catheter. The catheter needs significant flexibility to negotiate the path to the target organ - which inherently limits control of the working end. In catheter ablation for treating atrial fibrillation (AF), for example, a radiofrequency ablation catheter creates scar tissue lines to isolate AF sources from the remaining heart. The beating of the heart makes it extremely difficult to attach to the heart wall, burn in the correct depth lesion, and then shift to the next desired ablation position ? resulting in first-time success rates as low as 30% for some forms of AF. The GAR technology platform will enable a tight grip on the heart wall and precision clinician-controlled motion to the next burn location ? and can be integrated in a wide range of medical applications where stable positioning and relocation within a moving organ or body cavity is desired. The broader impact/commercial potential of this project has several aspects. This project will initiate long-term collaboration between cardiac surgeons and medical device development experts in industry. The Grip-Act-Reposition (GAR) system will ultimately be manufactured in the United States for a large commercial entity that distributes cardiac ablation catheter systems, generating $7.2 million in revenue and 20-30 jobs by 2017. Even greater potential revenue is anticipated when radiofrequency ablation in the left atrium is simplified ? using the GAR approach - and delivered effectively to the more than 2 million potential patients in the United States. Using the GAR system in cardiac surgery is only the first application. Surgery in the lungs and digestive tract are also complicated by the target organs and tissues moving during the procedure. The GAR approach will gain market share by allowing more effective contact with moving or loose tissues within the body where clinicians are normally limited by the inability of conventional systems to accurately determine and control the position of devices. This project will also engage interns and long term collaboration opportunities with nearby universities, tech schools, and high schools ? with a goal of training future engineers, and also evaluating potential hires.