Catheter Guidance System for RF Ablation of Arrhythmias

描述(由申请人提供)：在前两期NIH SBIR拨款的基础上，我们建议开发一种商业质量的导管引导系统，使临床医生能够通过射频消融治疗室性心动过速(VT)。该系统具有创新的单等效动偶极子(SEMD)逆算法，可减少定位心律失常位置所需的总时间，精确定位射频消融导管，并且只需要患者在心律失常中保持几个节拍。在最初的两年里，Infscitex的团队将设计和建造商业质量的导管引导系统，而麻省理工学院的科恩教授将使用第二阶段开发的原型导管引导系统进行动物实验，以完善使用该系统的算法和程序，并在VT的动物模型中测试该系统的有效性。在该项目的第三年，麻省理工学院的科恩博士将在VT的动物模型中测试商业质量系统，Infscitex的工程团队将实施动物测试所要求的任何修改。此外，在第二阶段竞争更新期间，我们将采取必要的步骤，通过剥离一家初创公司或将该技术授权给一家老牌公司，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)发生的最常见的病理生理基础。室性心动过速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电生理异常，如Wolff-Parkinson-White综合征[3]。然而，据估计，80%可归因于心律失常的心脏性猝死发生在既往有心肌梗死(MI)的患者中。梗塞组织的电特性可导致折返回路的形成和致死性室速的沉淀。这些区域也可能成为冲动活动的异常起始点。短暂性心肌缺血，可能是由冠状动脉痉挛或不稳定的血小板血栓引起的，也可以通过同样的机制导致死亡。这项研究旨在开发一种商业质量的导管引导系统，以帮助临床医生使用射频消融治疗室性心动过速。该系统具有创新的单等效动偶极子(SEMD)逆算法，可减少定位心律失常位置所需的总时间，精确定位射频消融导管，并且只需要患者在心律失常中保持几个节拍。这一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，降低这一普遍存在的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.