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

描述（由申请人提供）：这项小型企业创新研究（SBIR）第一阶段提案的主要目标是开发和演示形状记忆合金（SMA）驱动导管技术，最终将导致用于微创手术和置管的紧凑型机器人导管的开发。这项技术有可能通过提供前所未有的可操作性、可视化和进入体内开放空间来改变这些程序。得益于计算机控制的精确性和可重复性，这些导尿管有可能影响各种医学领域，包括心脏病学、心脏外科、儿科外科和泌尿外科。最终目标（第一阶段和第二阶段）是开发一种sma驱动的机器人导管，能够在体内（心脏内外）的开放空间中导航。这种新型产品的成功开发将显著改善导尿程序，并推进对sma驱动手术技术的科学知识和理解。它比现有的机器人导尿管便宜得多，体积也小得多。这种机器人导管将围绕柔性导管构建，以促进设备功能，在远端有两个SMA驱动的节段（每个节段有两个DOFs）。我们的设计工作将集中在增强导管的功能性、稳健性和可靠性上。我们将为导管导航开发有效的控制算法和直观的用户界面。这里的重点将是提高准确性和带宽与导管段被驱动。将开发多输入多输出（MIMO）控制策略并进行实验评估，以确保实时跟踪性能和鲁棒性。将开发一个定制的用户界面，以实现对导管尖端的直观和精确的远程操作。最后，提出的研究和发展将在猪尸体模型的一系列手术评估中达到高潮。这些评估将证明和验证机器人导尿的潜力。该技术的最初应用是心导管插入术。心血管疾病正迅速成为一种世界性的流行病，每年在美国夺去的生命比排在其后的六种死因加起来还要多。随着心血管疾病的治疗向微创方法过渡，许多手术现在使用导管来快速方便地进入心脏内解剖。虽然导管在许多血管内手术（血管成形术、支架部署、房室结消融等）中被证明是有效的，但它们在心脏内外开放空间导航方面的有效性受到严重限制。具体来说，它们的基本结构使它们不适合心内膜内心房射频消融（RFA），这需要在开放空间精确导航，以及心外膜手术，如心脏再同步化治疗的起搏导联放置。SMA驱动导管的开发将成为此类手术的使能技术。公共卫生相关性：一种新型的形状记忆合金驱动机器人导管将被开发用于微创手术和导尿。这项技术提供了前所未有的可操作性，可视化和进入体内开放空间。得益于计算机控制的精确性和可重复性，这些导尿管有可能影响各种医学领域，包括心脏病学、心脏外科、儿科外科和泌尿外科。

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.