An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation

心律失常是由心脏内紊乱的电信号引起的，导致不规则的收缩， 是美国的主要死因室性心动过速和室颤是最严重的心律失常 导致每年30万美国人死亡，随后13万美国人死于心房颤动（AF）。与 在美国的患病率为6个月，AF是最常见的心律失常，导致美国每年有75万人住院。 到2035年，AF相关的医疗费用将超过500亿美元。AF治疗首先依赖于药物来预防 血凝块恢复心律如果这些方法失败，则进行电生理（EP）程序 其通过导管的尖端传递电流（或冷却剂）以破坏组织， 电信号然而，手动导管依赖于复杂的张力线设计， 这使得有效的导管控制变得困难，导致损伤和AF复发。 几十年来，机器人平台一直在努力改善导管控制。大多数机器人系统 标准手动导管;然而，学习曲线仍然很高，并且导管尖端控制未得到改进。 使用磁性导管的基于磁体的系统改善了控制;然而，该系统是不切实际的。 体积大，使用困难，需要定制的血管造影套件。因为所有现有的机器人解决方案仍然存在 由于价格昂贵，这种系统仅在有限数量的高容量中心中发现， 提供消融的所有医院中超过80%是低容量中心。我们需要的是一个负担得起的 和工作流程友好的机器人技术，可改善导管控制， 容量EP中心与容量较小的中心远程共享，以提供培训和程序支持。 UNANDUP的MAP-EP（EP磁性辅助平台）系统控制新型基于连杆的磁性 导管使用的磁体质量比以前可能的小50倍。因此，MAP-EP系统可以是 安装到现有的数字血管造影套件中，而不需要新的C形臂或房间结构。 由于能量不消耗于对抗导管恢复力，低磁场实现稳定， 准确的心脏壁接触该技术补充了标准EP工作流程，价格实惠 为低容量电生理中心，并提供远程机器人访问的专业知识，在高容量中心。 在第一阶段的工作中，建造了一个原型磁铁工作站， 开发用于制造比以前更小，更复杂的磁体， 使用已知的心脏模型成功地构建和评估了导管。I-Corps和TABA参与 完成，并举行了FDA预提交会议，以支持标测[510（k）]、消融（PMA）， 早期可行性研究。对于拟议的努力，UNandUP将开发其系统的临床前版本。 将使用已知的跳动心脏模型完成疗效研究。生物相容性测试和大型- 动物安全性和可行性研究将按照公布的方法进行。

Arrhythmias result from disorganized electrical signals within the heart leading to irregular contractions and are a leading cause of death in the US. Ventricular tachycardia and fibrillation are the most serious arrhythmias resulting in 300k annual US deaths, followed by 130k US deaths due to atrial fibrillation (AF). With a prevalence of 6M in the US, AF is the most common arrhythmia, resulting in 750k annual US hospitalizations. AF-associated medical costs will exceed $50B by 2035. AF therapies first rely on pharmaceuticals to prevent blood clots and to restore rhythm. If these approaches fail, electrophysiology (EP) procedures are performed which pass electrical currents (or coolants) through the catheter’s tip to destroy tissues disrupting proper electrical signals. However, manual catheters rely on complex tension-wire designs operated from a meter away which makes effective catheter control difficult, leading to injury and AF recurrence. Robotic platforms have struggled to improve catheter control for decades. Most robotic systems manipulate standard manual catheters; however, learning curves remain high and catheter tip control is unimproved. Magnet-based systems that use magnetic catheters improve control; however, the systems are impractically large, difficult to use, and require a custom angiography suite. Because all existing robotic solutions remain prohibitively expensive, such systems are found only in a limited number of high-volume centers despite that more than 80% of all hospitals providing ablation are lower-volume centers. What is needed is an affordable and workflow-friendly robotic technology that improves catheter control and enables expertise within high- volume EP centers to be remotely shared with lower-volume centers for training and procedural support. UNandUP’s MAP-EP (Magnetic Assistive Platform for EP) system controls novel linkage-based magnetic catheters using a magnet mass 50X smaller than previously possible. As a result, the MAP-EP system can be installed into existing digital angiography suites without the need for a new c-arm or room construction. Because energy is not expended fighting catheter restoring forces, low magnetic fields achieve stable, accurate, and precise heart wall contact. The technology complements standard EP workflows, is affordable for low-volume EP centers, and provides telerobotic access to expertise within high-volume centers. In the Phase I effort, a prototype magnet workstation was constructed, novel magnetic materials were developed to manufacture smaller and more complex magnets than previously possible, and prototype catheters were successfully built and assessed using known heart phantoms. I-Corps and TABA participation were completed, and FDA pre-submission meetings were held in support of mapping [510(k)], ablation (PMA), and Early Feasibility Studies. For the proposed effort, UNandUP will develop preclinical versions of its system. Efficacy studies will be completed using known beating heart phantoms. Biocompatibility testing and large- animal safety and feasibility studies will be conducted following published methods.