Catheter Guidance System for RF Ablation of Arrhythmias

描述（由申请人提供）：基于先前的I期和II期NIH SBIR拨款（Infoscitex是主要机构，MIT是分包商）的成就，在此II期竞争性续期拨款申请中，我们建议开发一种商业质量的导管引导系统，该系统将允许临床医生使用射频（RF）消融治疗室性心动过速（VT）。该系统采用创新的单等效移动偶极子（SEMD）逆算法，减少了定位心律失常部位所需的总时间，精确定位射频消融导管，并且只需要患者在心律失常中维持几次。在最初的两年里，Infoscitex的团队将设计和构建商业质量的导管引导系统，而麻省理工学院的Cohen教授将使用在第二阶段开发的导管引导系统原型进行动物研究，以完善使用该系统的算法和程序，并测试该系统在VT动物模型中的有效性。麻省理工学院的科恩博士将在VT的动物模型上测试商业质量系统，Infoscitex的工程团队将根据动物测试的要求实施任何修改。此外，在第二阶段的竞争性更新期间，我们将采取必要的步骤，通过分拆创业公司或通过将技术授权给成熟公司，为这项技术的成功商业化做好准备。公共卫生相关性：缺血性心脏病可能是室性心动过速（VT）发展的最常见病理生理底物。室性心动过速也发生在多种不同类型的结构性心脏病中，包括非缺血性扩张性心肌病、肥厚性心肌病、瓣膜病、先天性心脏病和原发性电生理异常，如Wolff-Parkinson-White综合征[3]。然而，据估计，80%由心律失常引起的心源性猝死发生在既往有心肌梗死（MI）的患者中。梗死组织的电特性可引起重入回路的形成和致死性室速的沉淀。这些区域也可成为异常启动脉冲活动的点。短暂性心肌缺血，可能由冠状动脉痉挛或不稳定的血小板血栓引起，可通过相同的机制导致死亡。本研究旨在开发一种商业质量的导管引导系统，以促进临床医生使用射频（RF）消融治疗VT。该系统采用创新的单等效移动偶极子（SEMD）逆算法，减少了定位心律失常部位所需的总时间，精确定位射频消融导管，并且只需要患者在心律失常中维持几次。该临床系统最终将使射频消融术成为治疗各种室性心动过速的有效工具，降低这一普遍临床问题的死亡率和发病率。

DESCRIPTION (provided by applicant): Building on the accomplishments of the prior Phase I and Phase II NIH SBIR grants in which Infoscitex was the lead institution and MIT was the subcontractor, in this Phase II competitive renewal grant application we propose to develop a commercial quality catheter guidance system that will allow clinicians to treat ventricular tachycardia (VT) with radio frequency (RF) ablation. This system features an innovative single equivalent moving dipole (SEMD) inverse algorithm that reduces the total time required to locate the site of arrhythmia, precisely position an RF ablation catheter, and only requires that the patient be maintained in the arrhythmia for a few beats. During the first two years the team at Infoscitex will design and construct the commercial quality catheter guidance system while Professor Cohen at MIT will conduct animal studies using the prototype catheter guidance system developed during Phase II in order to refine the algorithms and procedures for using this system and to test the efficacy of the system in animal models of VT. During year 3 of this project, Dr. Cohen at MIT will test the commercial quality system in animal models of VT and the engineering team at Infoscitex will implement any modifications dictated by the animal testing. In addition, during the Phase II competitive renewal, we will take the steps needed to prepare for the successful commercialization of this technology either by spinning out a startup company or through licensure of the technology to an established company. PUBLIC HEALTH RELEVANCE: Ischemic heart disease is perhaps the most common pathophysiologic substrate for the development of ventricular tachycardia (VT). VT also occurs in a wide variety of different types of structural heart disease including non-ischemic dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular disease, congenital heart disease, and primary electrophysiological abnormalities such as Wolff-Parkinson-White Syndrome [3]. However, it is estimated that 80% of sudden cardiac deaths attributed to arrhythmias occur in patients with a prior myocardial infarction (MI). The electrical properties of infarcted tissue can cause formation of a reentrant circuit and precipitation of a lethal VT. These regions can also become points of abnormal initiation of impulse activity. Transient myocardial ischemia, perhaps caused by coronary spasm or unstable platelet thrombi, can lead to death via the same mechanisms. This research is aimed at the development of a commercial quality catheter guidance system that will facilitate clinicians in treating VT with radio frequency (RF) ablation. This system features an innovative single equivalent moving dipole (SEMD) inverse algorithm that reduces the total time required to locate the site of arrhythmia, precisely position an RF ablation catheter, and only requires that the patient be maintained in the arrhythmia for a few beats. This clinical system will ultimately permit RF ablation to become an effective and efficient tool for treating a wide variety of VT, reducing mortality and morbidity from this prevalent clinical problem.