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

描述(由申请人提供)：这项第二阶段研究的主要目标是设计、制造和外科评估用于心内膜消融术的机器人导管。第一阶段研究通过开发具有形状记忆合金(SMA)驱动弯曲段的遥控导管原型，成功地证明了这一概念的可行性。第二阶段的研究将建立在第一阶段的成就基础上，以生产一种具有完全消融能力、增强的可操作性、计算机控制的消融模式以及在消融能量应用期间接触稳定性的导管。这项技术具有改变消融程序的潜力，因为它提供了前所未有的通道和机动性，可以打开心脏内部的空间。心血管疾病正在迅速成为一种世界性流行病，每年在美国夺走的生命比排在后面的六种死因的总和还要多。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、方便地进入心内解剖。虽然导管已被证明在许多血管内手术(血管成形术、支架部署、房室结消融等)中有效，但它们在导航心脏内开放空间方面的有效性是有限的。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)开发了具有双弯曲段和前景看好的功能的机器人导管原型。这种遥控装置使用基于计算机的控制来解释操纵杆命令，并启动SMA肌腱，以准确跟踪命令的尖端位置。该样机展示了导管尖端的高流动性和精确定位，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心内膜消融术的疗效。这项拟议的研究还将促进对SMA驱动的外科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方案，使患者更容易获得它，并降低整体医疗成本。 与公共卫生相关：一种新型的内部驱动机器人导管将被开发用于心内膜消融术。这项技术具有改变消融程序的潜力，因为它提供了前所未有的通道和机动性，可以打开心脏内部的空间。这种导管将是其他机器人手术系统的低成本替代方案，使患者更容易接触到它，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.