Cardiac radiofrequency ablation catheter with integrated OCT imaging

 描述（由申请人提供）：本研究项目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，以改善心律失常患者的护理。该项目旨在通过在导管头端提供显微图像引导来改善射频消融（RFA）治疗，这是许多心律失常的标准治疗。这可能会改善结局和安全性，并缩短手术时间。本提案的具体目标是设计、制作原型并确认在导管头端集成前视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，通过经皮穿刺进行的基于导管的RFA已成为许多心律失常潜在治愈性治疗的护理标准。导管消融的目标是通过产生热损伤（通常在心脏的内膜表面上）来靶向并根除异常折返回路或异常异位部位的关键成分，同时最大限度地减少或避免对健康正常心脏组织的损伤。心脏RFA的实践需要高水平的技能和培训。电生理学家目前在导管头端没有实时指导，无法识别要靶向或避免的关键基质和结构，无法可视化导管-组织接触，也无法监测病变或并发症的位置。因此，目前在临床实践中实施RFA与显著未满足的技术需求相关。附加导管头端技术可缩短手术时间（从而减少辐射剂量）、改善结局并提高患者和操作者的安全性。先前的结果表明，OCT成像可以解决这些未满足的需求，并且可以通过经皮入路在心脏内完成。导管尖端组织的实时亚表面成像可能会以四种特定方式改善RFA治疗：（1）确认导管与心脏壁的接触和定向，（2）可视化和识别基质以引导治疗部位的位置，（3）监测损伤形成以确认能量输送，以及（4）防止并发症，例如蒸汽爆裂、穿孔，或通过检测过度治疗、薄壁和导管尖端处的血液的早期迹象来检测血栓形成。本设计导向项目的具体目标是：目标1：设计、原型制作和验证集成心脏RFA/OCT导管。目的2：在动物模型中验证集成RFA/OCT导管的主要功能。该为期两年的设计导向项目的可交付成果将是在动物模型中验证和确认的集成RFA/OCT导管设计。如果成功，结果将证明通过大型动物和临床试验将该技术进一步开发和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.