Cardiac radiofrequency ablation catheter with integrated OCT imaging

 描述(申请人提供)：该研究计划的长期目标是开发基于导管的光学相干断层扫描(OCT)成像工具，以改善对心律失常患者的护理。该项目旨在通过在导管末端提供显微图像指导来改进射频消融(RFA)治疗，这是许多心律失常的标准护理。这可能会改善结果和安全性，并减少手术时间。这项建议的具体目标是设计、原型和验证一种在导管尖端集成了前视OCT成像的心脏RFA导管。心律失常是美国发病率和死亡率的主要来源，经皮途径的基于导管的RFA已成为许多心律失常潜在根治性治疗的标准护理。导管消融的目的是通过在心脏心内膜表面造成热损害，靶向并根除异常折返回路或异常异位部位的关键组件，同时最大限度地减少或避免对健康、正常的心脏组织的损害。心脏RFA的实践需要高水平的技能和训练。电生理学家目前在阴极尖端没有实时指导来识别要靶向或避免的关键底物和结构，可视化导管-肌腱接触，也没有监测病变或并发症的位置。因此，目前RFA在临床实践中的实施与重大的未得到满足的技术需求有关。额外的导管尖端技术可能会减少手术时间(从而减少辐射剂量)，改善结果，并提高患者和操作员的安全性。先前的结果表明，OCT成像可以解决这些未得到满足的需求，并可以通过经皮途径在心脏内完成。对导管尖端的组织进行实时亚表面成像可能会从四个方面潜在地改进RFA治疗：(1)确认导管与心壁的接触和方向，(2)可视化和识别底物以指导治疗部位的位置，(3)监测病变形成以确认能量传递，以及(4)通过检测过度治疗、薄壁和导管尖端的血液来预防并发症，如蒸汽爆裂、穿孔或血栓形成。这个以设计为导向的项目的具体目标是：目标1：设计、制作和验证一种集成的心脏RFA/OCT导管。目的2：在动物模型上验证RFA/OCT一体化导管的主要功能。这个为期两年的设计指导项目的成果将是一个在动物模型中得到验证和验证的集成RFA/OCT导管设计。如果成功，结果将证明进一步开发这项技术并通过大型动物和临床试验将其转化为临床设备是合理的。

 DESCRIPTION (provided by applicant): The long-term goal of this research program is to develop catheter-based optical coherence tomography (OCT) imaging tools that will improve the care of patients suffering from cardiac arrhythmias. This project aims to improve radiofrequency ablation (RFA) therapy, which is the standard of care for many arrhythmias, by providing microscopic image guidance at the tip of the catheter. This may potentially improve outcomes and safety and reduce procedure times. The specific objective of this proposal is to design, prototype, and validate a cardiac RFA catheter integrated with forward-viewing OCT imaging at the catheter tip. Cardiac arrhythmias are a major source of morbidity and mortality in the United States and catheter-based RFA through percutaneous access has emerged as the standard of care for the potential curative treatment of many arrhythmias. The goal of catheter ablation is to target and eradicate the critical component of an abnormal reentrant circuit or abnormal ectopic site by creating thermal lesions, usually on the endocardial surface of heart, while minimizing or avoiding damage to healthy, normal heart tissue. Practice of cardiac RFA requires a high level of skill and training. Electrophysiologists currently do not have real-time guidance at the cathete tip to identify critical substrates and structures to target or to avoid, to visualize catheter-tisue contact, nor to monitor the placement of a lesion or complications. Thus, current implementation of RFA in clinical practice is associated with significant unmet technological needs. Additional catheter-tip technology may decrease procedural time (and therefore radiation dose), improve outcomes and improve patient and operator safety. Previous results indicate that OCT imaging can address these unmet needs and can be accomplished within the heart via percutaneous access. Real-time, sub-surface imaging of the tissue at the catheter tip may potentially improve RFA therapy in four specific ways: (1) confirming catheter contact and orientation with the heart wall, (2) visualizing and identifying substrates to guide location of treatment sites, (3) monitorig lesion formation to confirm energy delivery, and (4) preventing complications such as steam pops, perforations, or thrombosis by detecting early signs of overtreatment, thin walls, and blood at the catheter tip. The specific aims of this design-directed project are: Aim 1: Design, prototype, and verify an integrated cardiac RFA/OCT catheter. Aim 2: Validate the primary functions of the integrated RFA/OCT catheter in animal models. The deliverable outcome of this two-year design-directed project will be an integrated RFA/OCT catheter design that is verified and validated in animal models. If successful, the results will justify further development and translation of the technology into a clinical device through large animal and clinical trials.