Laser Cather for Ablation of Ventricular Tachycardia

描述(申请人提供)：室性心动过速是一种 危及生命的疾病，其特征是发病率异常高。 脑室收缩。在室性心动过速期间，脑室缺乏充盈的时间。 每次收缩前的血液往往会导致头晕、失血 意识和心脏骤停。导管消融术已经被证明是 是治疗许多心律失常的有效方法，但目前的方法还不是 能够凝结中心肌或心外膜下区域的组织 室性心动过速的病灶源多为起源。我们已经研制出一种冷却尖端激光器。 导管(CTLC)能够产生大的病变，延伸到这些 对心内膜热损伤很小或没有的区域。 在我们的第一阶段研究中，我们设计、建造和测试了CTLC的原型 系统。目前的系统由8F可偏转导管组成，该导管 里面有一根光纤和一条盐水循环通道。我们成立了一家 低成本的泵浦系统和一个低功率的半导体激光器来完成系统。急性 并进行了慢性动物研究，以测试原型系统和 结果确实是戏剧性的。使用我们的CTLC系统，我们成功地生产了 大的(直径1厘米)病变开始于平均下方1毫米处 受辐射的表面。这些损伤没有炭化或碳化，而且完好。 以清晰的边界将病变与正常组织分开。 我们方法的其他优势包括能够实时监控 激光能量传递过程中的电生理活动。在第二阶段，我们 计划通过包括功能标测电极和 提高机动性。动物研究的目的是描述一种 彻底处理我们系统的剂量响应，将其与电流进行比较 最先进的烧蚀技术，并获取必要的数据 提交FDA的临床研究设备豁免 审判。 建议的商业应用： 这项研究的具体目标是开发一种用于治疗室性心动过速的改良型激光导管。在美国，包括室性心动过速(VT)和室颤(VF)在内的心律失常每年导致40万人猝死。与其他疗法不同，我们的导管具有为室速患者提供治疗手段的潜力，因此可能成为此类患者的首选治疗方法。

DESCRIPTION (provided by applicant): Ventricular Tachycardia (VT) is a life-threatening condition characterized by an abnormally high rate of ventricular contraction. During VT, the ventricles lack sufficient time to fill with blood prior to each contraction often resulting in dizziness, loss of consciousness and sudden cardiac arrest. Catheter ablation has been shown to be an effective means for curing many arrhythmias, but current approaches are not able to coagulate tissue in the midmyocardium or subepicardial regions where foci responsible for VT often originate. We have developed a cooled-tip laser catheter (CTLC) capable of creating large lesions that extend into these regions with little to no thermal damage to the endocardium. In our phase I study we designed, built, and tested prototypes of the CTLC system. The current system is comprised of an 8F deflectable catheter, which houses a fiber optic and a pathway for circulation of saline. We incorporated a low cost pump system and a low-power diode laser to complete the system. Acute and chronic animal studies were performed to test the prototype system and the results were indeed dramatic. Using our CTLC system, we successfully produced large (1 cm in diameter) lesions that began on average 1 mm below the irradiated surface. These lesions were free of char or carbonization and well circumscribed by a distinct border separating the lesion form normal tissue. Additional advantages of our approach include the ability to monitor real-time electrophysiological activity during delivery of laser energy. In Phase II we plan to refine the current CTLC by including functional mapping electrodes and improving maneuverability. Animal studies are designed to characterize in a thorough manner the dose response for our system, compare it against current state of the art ablation technologies, and acquire data necessary for submission of an investigational device exemption from the FDA for clinical trials. PROPOSED COMMERCIAL APPLICATION: This research is specifically targeted towards the development of an improved laser-based catheter for treatment of VT. Cardiac arrhythmias including ventricular tachycardia (VT) and ventricular fibrillation (VF) are responsible for 400,000 cases of sudden death in the U.S. each year. Unlike other therapies, our catheter has potential for providing a curative means for patients who suffer from VT, and therefore could become the treatment of choice in such patients.