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

This Small Business Innovation Research (SBIR) Phase II project will finalize the Grip-Act-Reposition (GAR) Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs - with initial focus on treating Atrial Fibrillation (AF). A common procedure for treating AF is Radiofrequency (RF) Catheter Ablation in the heart. A catheter with an electrode is used to deliver RF electrical current to tissue ? burning paths that electrically isolate the fibrillation trigger sources. With existing catheter-based devices, ablation lines must be formed from a high number of discrete lesions created sequentially. Forming contiguous lesions in the beating heart is challenging, resulting in long procedure times and first-time success rates as low as 30% for some forms of AF. GAR will revolutionize catheter-based minimally invasive procedures. GAR will (i) provide a mechanism to enter a body cavity or organ, including those such as the heart or lungs which move constantly; (ii) clamp to a tissue wall, and (iii) create a stable platform from which to operate and/or deliver various local treatments (energy, pharmaceuticals) to tissues. Additionally, the rotating gear mechanism and simple grasp-and-release function will allow repositioning within the cavity in a continuous line or arc without losing contact with the tissue wall. The broader impact/commercial potential of this project is to a) improve healthcare in both the U.S. and worldwide and b) generate revenue and US manufacturing jobs in a $5 billion market space. Atrial Fibrillation (AF) affects 2-3 million Americans, and approximately 20 million people worldwide. The cost to the U.S. healthcare system is an estimated $6.65 billion annually in procedures and, more commonly, maintenance medications. Major limitations to existing catheter ablation procedures are cost ($12,000+), time (4+ hours), and success rate (30-80%). Typical solutions to AF are often treatment with medications costing $3,000+ yearly with many side-effects. GAR will reduce procedure time - in the case of RF ablation to 1 hour- and improve success rates, reducing the need for repeat catheter ablation procedures. Cardiac ablation will become a more viable treatment for patients on maintenance medications. Additionally, GAR can be applied in other medical applications and conditions, such as repairing difficult bleeds in the intestines, where precise navigation within a moving organ, loose tissue, or a body cavity is desired. The project will also result in additional collaboration between academic and commercial institutions to take the technology to market, along with training opportunities for both high-school and college interns.