An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation

一种改进的心律失常消融机器人电生理学平台

• 批准号: 10481922
• 负责人: Francis Milton Creighton
• 金额: $ 110.34万
• 依托单位: UNANDUP, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10481922
• 关键词: 3-Dimensional; Ablation; Adopted; Angiography; Animal Model; Animals; Arrhythmia; Atrial Fibrillation; Blood coagulation; Cardiac ablation; Catheters; Cause of Death; Cessation of life; Clinical; Clinical Investigator; Complement; Complex; Computer software; Consensus; Custom; Cyclic GMP; Data Set; Development; Devices; Electrodes; Electromagnetics; Electrophysiology (science); Eligibility Determination; Fatigue; Feasibility Studies; Fluoroscopy; Funding; Goals; Heart; Histopathology; Hospitalization; Hospitals; Human; Industrialization; Injury; Innovation Corps; Investments; Irrigation; Laboratories; Learning; Magnetism; Manuals; Mechanics; Medical Care Costs; Membrane; Methods; National Institute of Neurological Disorders and Stroke; Outcome; Pathway interactions; Performance; Pharmacologic Substance; Phase; Physicians; Prevalence; Privatization; Procedures; Property; Publishing; Recurrence; Robotics; Roentgen Rays; Safety; Shapes; Signal Transduction; Software Validation; Surface; System; Technology; Telerobotics; Tensile Strength; Testing; Time; Tissues; Torsion; Toxic effect; Training; Underserved Population; United States National Institutes of Health; Ventricular Fibrillation; Ventricular Tachycardia; Weight; Work; animal safety; arm; base; biomaterial compatibility; cost; cost effective; cytotoxicity; design; digital; efficacy study; experience; fighting; haptics; heart rhythm; hemocompatibility; human data; improved; in vivo; irritation; magnetic field; meetings; meter; mortality; novel; phantom model; phase 1 study; porcine model; pre-clinical; prevent; prototype; robotic system; safety and feasibility; safety assessment; safety study

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.

心律失常是由心脏内杂乱无章的电信号导致的不规则收缩引起的， 这是美国主要的死因。室性心动过速和纤颤是最严重的心律失常。 导致美国每年30万人死亡，紧随其后的是13万人死于房颤(AF)。使用一个 在美国，房颤的患病率为600万，是最常见的心律失常，每年导致美国75万人住院治疗。 到2035年，与房颤相关的医疗成本将超过500亿美元。房颤疗法首先依靠药物来预防 血液凝块和恢复节律。如果这些方法失败，则进行电生理(EP)程序 它通过电流(或冷却剂)穿过导管的尖端，破坏组织破坏正常 电信号。然而，手动导尿管依赖于从仪表上操作的复杂的张力线设计。 这会使有效的导管控制变得困难，导致损伤和房颤复发。 几十年来，机器人平台一直在努力改善导管控制。大多数机器人系统都会操纵 标准的手动导管；然而，学习曲线仍然很高，导管尖端的控制没有改善。 使用磁管的磁铁系统改善了控制；然而，这些系统并不实用。 体积大，使用困难，需要定制的血管造影剂套件。因为所有现有的机器人解决方案 尽管如此，此类系统的成本高得令人望而却步，但只在数量有限的大容量中心才能找到 在所有提供消融的医院中，超过80%是低容量的中心。现在需要的是一种负担得起的 和工作流程友好的机器人技术，改进了导管控制，并使专业知识在 数量较少的EP中心将与较低数量的中心远程共享，以提供培训和程序支持。 UNandUP的MAP-EP(EP磁助力平台)系统控制新型连杆磁力 导尿管使用的磁铁质量比以前可能的小50倍。因此，MAP-EP系统可以 安装到现有的数字血管造影室中，而不需要新的C形臂或房间结构。 由于能量不消耗战斗导管恢复力，低磁场实现稳定， 准确的，精确的心壁接触。该技术是对标准EP工作流程的补充，经济实惠 用于低容量的EP中心，并提供远程机器人访问大容量中心内的专业知识。 在第一阶段的工作中，建造了一个原型磁体工作站，并开发了新型磁性材料 开发用于制造比以前可能的更小和更复杂的磁体和原型 使用已知的心脏模体成功地制造和评估了导管。I-兵团和塔巴参与 已完成，并举行了FDA提交前会议，以支持测绘[510(K)]、消融(PMA)、 和早期的可行性研究。对于拟议的努力，UNandUP将开发其系统的临床前版本。 疗效研究将使用已知的心脏跳动模体完成。生物兼容性测试和大型- 动物安全和可行性研究将按照公布的方法进行。