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

描述（由申请人提供）：本II期研究的主要目的是设计、制造和手术评价用于腔内消融术的机器人导管。第一阶段的研究成功地证明了这一概念的可行性，通过开发一个远程操作的导管原型与形状记忆合金（SMA）驱动的弯曲段。第二阶段的研究将建立在第一阶段的成果，以生产一种具有完整消融能力、增强的可操作性、计算机控制的消融模式和消融能量应用期间的接触稳定性的导管。这项技术有可能通过提供前所未有的心脏内开放空间的通路和可操作性来改变消融手术。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，许多手术现在利用导管快速轻松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，它们在心脏内部的开放空间中导航的有效性是有限的。SMA驱动的机器人导管的开发将成为此类手术的一项使能技术。在第一阶段，我们的多学科研究团队（由工程师、外科医生、电生理学家和工业合作者组成）开发了一种具有双弯曲段和有前途功能的机器人导管原型。该远程操作装置使用基于计算机的控制来解释操纵杆命令并致动SMA腱以精确跟踪命令的尖端位置。该原型显示出导管头端的高移动性和精确定位，这是消融导管技术的两个理想属性。这项技术的成功改进将显著提高腔内消融术的疗效。拟议的研究还将推进SMA驱动手术技术的科学知识和理解。预计机器人导管将成为其他机器人手术系统的低成本替代品，使患者更容易获得并降低整体医疗成本。 公共卫生相关性：将开发一种新型内部驱动机器人导管用于腔内消融术。这项技术有可能通过提供前所未有的心脏内开放空间的通路和可操作性来改变消融手术。这种导管将成为其他机器人手术系统的低成本替代品，使患者更容易获得，并降低整体医疗成本。

DESCRIPTION (provided by applicant): The primary objective of this Phase II research is to design, fabricate, and surgically evaluate a robotic catheter for endocardial ablation procedures. Phase I research successfully demonstrated the feasibility of this concept through the development of a tele-operated catheter prototype with shape memory alloy (SMA) actuated bending segments. Phase II research will build upon the achievements of Phase I to produce a catheter with full ablation capabilities, enhanced maneuverability, computer-controlled ablation modes, and contact stability during ablative energy application. This technology has the potential to transform ablation procedures by providing unprecedented access and maneuverability to open spaces within the heart. 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 the heart is limited. The development of SMA-actuated robotic catheters will be an enabling technology for such procedures. In Phase I, our multidisciplinary research team (consisting of engineers, surgeons, electrophysiologists, and industrial collaborators) developed a robotic catheter prototype with dual bending segments and promising capabilities. This tele-operated device uses computer- based controls to interpret joystick commands and to actuate the SMA tendons for accurate tracking of the commanded tip position. This prototype exhibits high mobility and precise positioning of the catheter tip, two desirable attributes of ablation catheter technology. The successful refinement of this technology will significantly enhance the efficacy of endocardial ablation procedures. The proposed research will also advance scientific knowledge and understanding of SMA-actuated surgical technologies. It is anticipated that the robotic catheter will be a lower-cost alternative to other robotic surgical systems, making it more accessible to patients and reducing overall healthcare costs. PUBLIC HEALTH RELEVANCE: A novel internally actuated robotic catheter will be developed for endocardial ablation procedures. This technology has the potential to transform ablation procedures by providing unprecedented access and maneuverability to open spaces within the heart. This catheter will be a lower-cost alternative to other robotic surgical systems, making it more accessible to patients and reducing overall healthcare costs.