Intraoperative Pulsed Field Ablation and Lesion Assessment System

超过600万美国人患有房颤（AF），这对他们的生活质量产生了负面影响 并且与高发病率和死亡率相关。脉冲电场消融（PFA）已经成为一种 有前途的;非热，组织特异性消融方式治疗AF。在PFA期间，超短脉冲序列 （µs持续时间）高压（~2KV）电脉冲通过单电极或多电极输送到心肌 导管通过感应电场（e场）导致损伤形成。 术中，通过局部电描记图（iEGM）的减少来评估PFA的有效性， 不可靠，并且可能被心肌顿抑和水肿形成混淆。目前没有 方法术中评估PFA程序，评估和确认持久的病变形成。 术中PFA-LAS，可评估手术参数，评估和确认持久病变 形成，将能够有效地提供连续的持久的透壁损伤;显著改善 PFA手术的安全性和有效性。 在第1阶段SBIR项目中，我们建议开发一种新的术中心脏PFA病变 使用开发的“高频介电传感”（HFDS）技术的评估系统（PFA-LAS） 我们的实验室HFDS技术涉及将PFA导管的消融电极重新设计为“微型”消融电极， 天线”;并在术中测量其高频反射阻抗电特性 （HFEP）在MHz-GHz频率下。这使得能够同时评估电介质的体积的介电性质。 与电极接触的经受消融的组织，并利用该电极输送高压PFA脉冲 电极;因此术中评估手术参数并确认持久损伤形成。的 系统适用于介入电生理实验室，手术工作流程无变更。 我们将在实验室和动物实验中设计、制作原型并进行测试，这是第一代PFA-LAS， 证明其在术中监测手术参数、评估和确认持久性的可行性 损伤形成。

Over 6 million Americans suffer from atrial fibrillation (AF), which negatively impacts their quality of life and is associated with high morbidity and mortality. Pulsed Electric Field Ablation (PFA) has emerged as a promising; non-thermal, tissue-specific ablation modality for treatment of AF. During PFA, trains of ultrashort (µs duration) high voltage (~2KV) electric pulses are delivered to the myocardium via single or multi-electrode catheters resulting in lesion formation by induced electric fields (e-fields). Intraoperatively, efficacy of PFA is assessed by diminution of local electrograms (iEGMs), which is unreliable and can be confounded by myocardial stunning and edema formation. Currently, there are no methods to intraoperatively assess PFA procedures, assess and confirm durable lesion formation. An intraoperative PFA-LAS, which can assess procedure parameters, assess and confirm durable lesion formation, will enable effectively deliver contiguous durable transmural lesions; significantly improving the safety and efficacy of PFA procedures. During this Phase 1 SBIR Project, we propose to develop a novel intraoperative Cardiac PFA Lesion Assessment System (PFA-LAS) using “High Frequency Dielectric Sensing” (HFDS) technology developed in our lab. HFDS technology involves redesigning the ablation electrodes of the PFA catheter as “miniature antennae”; and intraoperatively measuring their High Frequency Reflection Impedance Electrical Properties (HFEPs) at MHz-GHz frequencies. This enables simultaneously assess dielectric properties of the volume of tissue undergoing ablation in contact with electrode, and deliver the high voltage PFA pulses with the same electrodes; hence intraoperatively assess procedure parameters and confirm durable lesion formation. The system fits in an interventional EP lab, with no changes to procedural workflow. We will design, prototype and test in bench and animals, a first generation PFA-LAS, and definitively demonstrate its feasibility to intraoperatively monitor procedure parameters, assess and confirm durable lesion formation.