A Novel Approach to the Treatment of Cardiac Arrhythmia: A Robotic Catheter for E

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DESCRIPTION (provided by applicant): The primary objective of this small business innovative research (SBIR) Phase I proposal is to develop and demonstrate shape memory alloy (SMA) actuated catheter technology that will ultimately result in the development of compact robotic catheters for minimally invasive surgery and catheterization. This technology has the potential to transform such procedures by providing unprecedented maneuverability, visualization, and access to open spaces within the body. Benefiting from the precision and repeatability of computer-based control, these catheters have the potential to impact a variety of medical fields, including cardiology, cardiac surgery, pediatric surgery and urology. The ultimate goal (Phases I and II) is to develop an SMA-actuated robotic catheter capable of navigating open spaces inside the body (outside and inside the heart). The successful development of such a novel product would significantly improve catheterization procedures as well as advance scientific knowledge and understanding of SMA-actuated surgical technologies. It would be considerably less expensive and smaller than few available robotic catheters. This robotic catheter will be built around a flexible conduit to facilitate device functionality, with two SMA- actuated segments at the distal end (each with two DOFs). Our design efforts will focus on enhancing the functionality, robustness and reliability of the catheter. We will develop efficient control algorithms and an intuitive user interface for catheter navigation. The focus here will be enhancing the accuracy and bandwidth with which catheter segments are actuated. Multiple input, multiple output (MIMO) control strategies will be developed and experimentally evaluated to ensure real-time tracking performance and robustness. A customized user interface will be developed to enable intuitive and precise tele-operation of the catheter tip. Finally, the proposed research and development will culminate in a series of surgical evaluations on pig cadaver models. These evaluations will demonstrate and validate the potential of robotic catheterization. The initial application of the proposed technology is cardiac catheterization procedures. Cardiovascular disease is rapidly becoming a worldwide epidemic, claiming more lives in the United States each year than the next six causes of death combined. As the treatment of cardiovascular disease transitions toward minimally- invasive approaches, many procedures now utilize catheters for quick and easy access to intracardiac anatomy. While catheters have proven effective in a number of endovascular procedures (angioplasty, stent deployment, AV node ablation, etc.), their effectiveness in navigating open spaces inside and outside the heart is severely limited. Specifically, their basic structure makes them poor candidates for endocardial intra-atrial radiofrequency ablation (RFA), which requires precise navigation in open spaces, and epicardial procedures such as pacing lead placement for cardiac resynchronization therapy. The development of (SMA) actuated catheters will be an enabling technology for such procedures. PUBLIC HEALTH RELEVANCE: A novel shape memory alloy actuated robotic catheter will be developed for minimally invasive surgery and catheterization. This technology provides unprecedented maneuverability, visualization, and access to open spaces within the body. Benefiting from the precision and repeatability of computer-based control, these catheters have the potential to impact a variety of medical fields, including cardiology, cardiac surgery, pediatric surgery and urology.