High Frequency Dielectric Sensing Cardiac Radio Frequency Ablation Monitoring and Lesion Assessment System

在美国，房颤(AF)影响着600多万人，是发病率的一个重要原因 和死亡率。经皮导管射频消融(RFA)是治疗房颤的标准 关注房颤的治疗。然而，由于不完全的原因，目前的手术复发率约为50% 而且由于射频能量沉积过多，有大约4%的并发症风险。有一件急事 未满足的临床需要，以提高心脏RFA手术的安全性和有效性。 为了满足这一临床需求，我们正在开发一种术中高频介电传感器 损害评估系统(HFDS-LAS)。我们的解决方案包括：设计射频消融电极 导管是一种“微型雷达”，用来监测天线附近组织的电学性质- 电极。该系统包括：a)具有集成天线-传感器消融的可定向消融导管 电极，b)矢量网络分析器，用于在10 MHz的频率范围内测量组织介电特性 至4 GHz，c)射频滤波器硬件，用于过滤烧蚀(KHz)和测量(MHz-GHz)频率和d) 直观的图形用户界面，显示程序参数、病变形成状态和警告 快速、准确地处理不良事件。 在第一阶段SBIR项目中，我们制作了首个心脏HFDS-LAS原型，包括9.5Fr RFA导管，带有天线传感器电极、波段选择性过滤硬件和原型制导装置 用户界面(GUI)。在试验台和动物(n=5)试验中，我们明确地证明了 术中监测心脏RFA操作以准确确认和量化电极组织 电接触；确定组织特征；确认和评估病变形成/消融程度；以及预测 微泡和蒸汽喷雾滴定射频功率，安全有效地传递心房病变。这个 该系统与所有EP CALLAB设备兼容，例如心脏标测系统等，不会更改 心脏RFA程序工作流程。 在项目的第二阶段，我们将对临床级HFDS-LAS进行优化和测试，以最终完成设计， 包括带有全方位天线传感器电极的8.5Fr导管、高保真过滤硬件和 图形用户界面显示组织类型、病变形成和关键操作参数。该系统将经历 体外验证和性能测试以及动物体内的验证测试以明确量化系统 性能；并允许提交预提交和向FDA提交以获得IDE批准 一项安全性和有效性的临床试验。

Atrial fibrillation (AF) affects over 6 million individuals in the USA and is a significant cause of morbidity and mortality. Percutaneous catheter Radio Frequency Ablation (RFA) treatment of AF is the standard of care for treatment of AF. However, current procedures have a ~50% recurrence rate, due to incomplete ablations and carry a ~4% risk of complications, due to excessive RF energy deposition. There is an urgent unmet clinical need to improve the safety and efficacy of cardiac RFA procedures. To address this clinical need; we are developing an intraoperative High Frequency Dielectric Sensing Lesion Assessment system (HFDS-LAS). Our solution involves; designing the ablation electrode of an RFA catheter as a “miniature radar” to monitor the electrical properties of the tissue adjacent to the antenna- electrode. The system comprises; a) steerable ablation catheter with an integrated antenna-sensor ablation electrode, b) vector network analyzer to measure tissue dielectric properties in a frequency range of 10 MHz to 4 GHz, c) RF filter hardware to filter ablation (KHz) and measurement (MHz-GHz) frequencies and d) intuitive graphic user interface which displays procedure parameters, state of lesion formation and warns of adverse events at high speed and accuracy. During Phase 1 SBIR project, we prototyped a first-of-its-kind Cardiac HFDS-LAS comprising a 9.5Fr RFA catheter with an antenna-sensor electrode, band selective filter hardware and a prototype Guidance User Interface (GUI). In bench and animal (n=5) testing, we definitively demonstrated feasibility of intraoperatively monitoring cardiac RFA procedures to accurately: confirm and quantify electrode-tissue electrical contact; characterize tissue; confirm and assess lesion formation/extent of ablation; and predict micro-bubbles and steam-pops to titrate RF power to safely and efficaciously deliver atrial lesions. The system is compatible with all EP cathlab equipment e.g. cardiac mapping systems, etc., with no changes to cardiac RFA procedural workflow. During Phase 2 of the project, we will optimize and test to finalize design of a clinical grade HFDS-LAS, comprising 8.5Fr catheter with omnidirectional antenna-sensor electrode, high fidelity filter hardware and a GUI displaying tissue type, lesion formation and critical procedure parameters. The system will undergo verification and performance testing in vitro and validation testing in animals to definitively quantify system performance; and enable submit a pre submission and a submission to the FDA for IDE clearance towards a safety and efficacy clinical trial.