Catheter Guidance System for RF Ablation of Arrhythmias

描述（由申请人提供）：基于之前的第一阶段和第二阶段NIH SBIR赠款的成就，其中Infoscitex是牵头机构，MIT是分包商，在第二阶段竞争性更新资助申请中，我们建议开发一种商业质量导管引导系统，允许临床医生使用射频（RF）消融治疗室性心动过速（VT）。该系统具有创新的单一等效移动偶极子（SEMD）逆算法，可减少定位心律失常部位所需的总时间，精确定位射频消融导管，并且仅需要患者在心律失常中维持几次心跳。在前两年，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教授将使用第二阶段开发的原型导管引导系统进行动物研究，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。在该项目的第3年，MIT的Cohen博士将在VT动物模型中测试商业质量体系，Infoscitex的工程团队将实施动物试验所要求的任何修改。此外，在第二阶段竞争性更新期间，我们将采取必要措施，通过分拆一家初创公司或将该技术许可给一家老牌公司，为该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）发生的最常见病理生理基础。VT也发生在各种不同类型的结构性心脏病中，包括非缺血性扩张型心肌病、肥厚型心肌病、瓣膜病、先天性心脏病和原发性电生理异常，如Wolff-Parkinson-白色综合征[3]。然而，据估计，80%的心律失常引起的心脏性猝死发生在既往心肌梗死（MI）患者中。梗塞组织的电特性可导致折返性回路的形成和致命性VT的沉淀。这些区域也可以成为冲动活动异常启动的点。可能由冠状动脉痉挛或不稳定的血小板血栓引起的短暂性心肌缺血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，该系统将有助于临床医生使用射频（RF）消融治疗VT。该系统具有创新的单一等效移动偶极子（SEMD）逆算法，可减少定位心律失常部位所需的总时间，精确定位射频消融导管，并且仅需要患者在心律失常中维持几次心跳。该临床系统最终将使射频消融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.