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

描述（由申请人提供）：本小型企业创新研究（SBIR）I期提案的主要目的是开发和证明形状记忆合金（SMA）驱动导管技术，最终将开发用于微创手术和导管插入术的紧凑型机器人导管。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，这些导管有可能影响各种医疗领域，包括心脏病学、心脏外科、儿科手术和泌尿外科。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（心脏外部和内部）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管插入术，并推进对SMA驱动手术技术的科学知识和理解。它将比少数可用的机器人导管便宜得多，而且体积更小。该机器人导管将围绕柔性导管构建，以促进器械功能，远端有两个SMA驱动节段（每个节段有两个DOF）。我们的设计工作将侧重于增强导管的功能性、稳健性和可靠性。我们将为导管导航开发高效的控制算法和直观的用户界面。这里的重点将是提高导管节段致动的精度和带宽。将开发和实验评估多输入多输出（MIMO）控制策略，以确保实时跟踪性能和鲁棒性。将开发定制的用户界面，以实现导管头端的直观和精确的远程操作。最后，拟议的研究和开发将最终在猪尸体模型上进行一系列手术评价。这些评价将证明和验证机器人导管插入术的潜力。所提出的技术的最初应用是心导管插入术。心血管疾病正在迅速成为一种世界性的流行病，每年在美国夺去的生命比接下来的六种死亡原因的总和还要多。随着心血管疾病的治疗向微创方法过渡，现在许多手术利用导管快速且容易地进入心内解剖结构。虽然导管已被证明在许多血管内手术（血管成形术、支架展开、AV结消融等）中有效，它们在心脏内外的开放空间中导航的有效性受到严重限制。具体而言，其基本结构使其不适合用于需要在开放空间中精确导航的腔内心房内射频消融（RFA）和心外膜手术（例如用于心脏起搏治疗的起搏电极导线放置）。（SMA）驱动导管的开发将成为此类手术的一项使能技术。公共卫生相关性：将开发一种新型形状记忆合金驱动机器人导管，用于微创手术和导管插入术。这项技术提供了前所未有的机动性、可视化以及进入体内开放空间的能力。得益于计算机控制的精确性和可重复性，这些导管有可能影响各种医疗领域，包括心脏病学、心脏外科、儿科手术和泌尿外科。

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.