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: 10704224
• 负责人: Francis Milton Creighton
• 金额: $ 98.26万
• 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/10704224
• 关键词: 3-Dimensional; Ablation; Adopted; Angiography; Animal Model; Animals; Arrhythmia; Atrial Fibrillation; Blood coagulation; Body Weight decreased; 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; Family suidae; Fatigue; Feasibility Studies; Fluoroscopy; Friends; Funding; Goals; Heart; Histopathology; Hospitalization; Hospitals; Human; Industrialization; Injury; Innovation Corps; Investments; Irrigation; Laboratories; Learning; Magnetism; Manuals; Maps; Mechanics; Medical Care Costs; Membrane; Methods; Modeling; 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; Work; animal safety; arm; biomaterial compatibility; cost; cost effective; cytotoxicity; design; digital; efficacy study; experience; fighting; haptics; heart rhythm; hemocompatibility; human data; improved; in vivo; invention; irritation; magnetic field; manufacture; meetings; meter; mortality; novel; phantom model; phase 1 study; pre-clinical; prevent; prototype; robotic system; safety assessment

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.

心律不齐是由心脏内部混乱的电信号导致不规则收缩的，并且是 美国的主要死亡原因。心室心动过速和纤颤是最严重的心律不齐 导致每年30万次死亡，随后由于房颤而导致13万美国死亡（AF）。与 在美国，AF的患病率为600万，是最常见的心律不齐，导致美国每年住院75万。 到2035 血液凝块并恢复节奏。如果这些方法失败，则进行电生理（EP）程序 哪些将电流（或冷却剂）通过导管的尖端，以破坏破坏适当的组织 电信号。但是，手动导管依赖于用米进行的复杂张力线设计 离开这使有效的导管控制变得困难，导致受伤和AF复发。 数十年来，机器人平台一直在努力改善导管控制。大多数机器人系统操纵 标准手动导管；但是，学习曲线保持较高，导管尖端控制未得到改善。 使用磁导管的基于磁铁的系统改善了控制；但是，系统不切实际 大型，难以使用，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 高昂的昂贵，此类系统仅在有限数量的高容量中心目的地中找到 在提供消融的所有医院中，超过80％的中心是较低体积的中心。需要的是负担得起的 以及对工作流友好的机器人技术，可改善导管控制并在高中提供专业知识 卷EP中心将与较低体积的中心远程共享，以进行培训和程序支持。 UNANDUP的MAP-EP（EP磁性辅助平台）系统控制新型链接的磁性 导管使用磁铁质量比以前可能小50倍。结果，MAP-EP系统可以是 安装在现有的数字血管造影套件中，而无需新的C臂或房间建筑。 由于无法探索能量的抗击导管恢复力，因此低磁场达到稳定， 准确，精确的心壁接触。技术完成标准EP工作流程，负担得起 对于小批量的EP中心，并为高批量中心内的专业知识提供了远程动物的访问。 在第一阶段的工作中，构建了原型磁铁工作站，新型磁性材料是 开发用于制造比以前更小，更复杂的磁铁和原型 使用已知的心脏幻象成功建造和评估导管。 I-Corps和Taba参与 已完成，举行了FDA预提交会议，以支持映射[510（k）]，消融（PMA）， 和早期可行性研究。为了拟议的努力，UnAndup将开发其系统的临床前版本。 功效研究将使用已知的Beat Heart Phantom完成。生物相容性测试和大型 在发布的方法之后，将进行动物安全和可行性研究。