Endoscopic robotic CABG surgery with anastomotic devices

DESCRIPTION (provided by applicant): Coronary artery disease, the leading cause of death in the U.S., is treated by both interventional cardiology, including percutaneous transluminal coronary angioplasty (PTCA) and stenting, and by coronary artery bypass graft (CABG) surgery. CABG remains the gold standard for treating certain types of coronary artery disease, such as total occlusions and multi-vessel disease. Despite the well established trend in many medical fields to minimally invasive surgery and some progress in this direction for CABG, most cardiac bypass surgery continues to be a highly invasive procedure resulting in more patient trauma, longer hospital stays and a longer recuperation period. Our long term goal is to bring the benefits of minimally invasive surgery to cardiac surgery by being the enabling technology for totally endoscopic CABG (TECAB). The benefits of TECAB include improved outcomes, shortened hospital stays and a quicker return to productive life. Phase I of this effort will be to combine our established automated anastomotic technology with a surgical robot system to eliminate one of the obstacles to TECAB, completing the anastomosis of the bypass graft. The goals of Phase I are: (i) modification of our distal anastomosis technology to allow for endoscopic use with a surgical robotic arm, (ii) demonstration of the capability of the anastomosis device adopted for endoscopic use to load an artery graft and deploy it in a thoracic cavity model, and (iii) completion of 16 acute experiments with a porcine model to demonstrate the feasibility of the modified anastomosis device used with a surgical robot system for totally endoscopic CABG surgery. Phase II of this project will be conducted at animal labs at three U.S. centers with robot facilities to investigate acute and 3 month results for on pump and off pump procedures, suturing compared to anastomosis devices, and minimally invasive direct coronary artery bypass (MIDCAB) access compared to endoscopic surgery. The follow up to Phase II will be a major multi-center human clinical trial in the U.S.