Laser Cather for Ablation of Ventricular Tachycardia

激光导管消融室性心动过速

• 批准号: 6527230
• 负责人: Ashok Gowda
• 金额: $ 37.33万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-28 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6527230
• 关键词: biomedical equipment development; dogs; electrodes; electrophysiology; fiber optics; heart catheterization; heart electrical activity; laser therapy; lasers; myocardium; tachycardia; temperature

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.

描述（由申请人提供）：室性心动过速（VT）是一种 以异常高的发病率为特征的危及生命的状况 心室收缩在室性心动过速期间，心室缺乏足够的时间来充盈 每次收缩前的血液往往导致头晕， 意识和心脏骤停导管消融已被证明是 是治疗许多心律失常的有效手段，但目前的方法不是 能够凝固心肌中层或心外膜下区域的组织， 导致VT的病灶通常起源于。我们开发了一种冷却尖端激光器 CTLC导管（CTLC）能够产生延伸到这些 对内皮细胞几乎没有热损伤的区域。 在我们的第一阶段研究中，我们设计、建造并测试了CTLC的原型 系统当前系统由8F可偏转导管组成， 容纳光纤和盐水循环路径。我们成立了一个 低成本泵浦系统和低功率二极管激光器来完成该系统。急性 和慢性动物研究进行测试的原型系统和 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（直径1 cm）病变开始于平均1 mm以下， 辐照表面。这些病变没有烧焦或碳化， 由将病变与正常组织分开的明显边界限定。 我们的方法的其他优点包括能够实时监控 激光能量输送过程中的电生理活动。在第二阶段，我们 计划通过纳入功能标测电极和 提高机动性。动物研究旨在表征 彻底的方式剂量响应为我们的系统，比较它与电流 最先进的消融技术，并获取必要的数据， 向FDA提交临床试验用器械豁免 审判 拟定商业应用： 本研究专门针对开发用于治疗VT的改进型激光导管。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40万例猝死。与其他疗法不同，我们的导管有可能为室性心动过速患者提供治疗手段，因此可能成为此类患者的首选治疗方法。