Prototype development and validation of soft robotic sensor arrays for mapping cardiac arrhythmia

摘要 每年大约有20,000名患者接受消融治疗心房颤动(AF)，因为他们的病情 不能仅由药品来管理。虽然现有的消融方案可以在许多方面治疗这种疾病 在某些情况下，这些程序可能会很长(2-4小时)，而且只有一定的效果(~60%-70%)。这 手术的速度受到电生理工具的限制，这些工具仍然需要基于中庭的连续标测 关于围绕患者解剖结构连接电极(或电极阵列)。此外，因为自动对焦是一种 不稳定的心律失常，很难从这种类型的心电图中构建完全的时空分辨的心电图 序列映射。提供整个腔室的同时标测的一小部分设备具有 严重的限制，往往留下大部分的会议厅没有测绘。在这里，我们建议使用 灵活和共形的软机器人传感器阵列，允许快速、高效和高分辨率地绘制 左心房治疗房颤。我们的实验室已经建立了基于体外评估的原型设备 患者特定的3D打印模型。在这个提案中，我们将开发一个优化的原型，并关联 导管，基于一系列活体外科手术，最后是经皮大动物研究。一旦优化， 在R33阶段，我们将执行一系列基于ISO和ASTM标准的设备验证协议。 最后，在该提案的R33阶段，我们将使用大型动物模型在体内验证该系统。

ABSTRACT Roughly 20,000 patients per year are treated with ablation to treat atrial fibrillation (AF) because their condition cannot be managed by pharmaceuticals alone. While ablation protocols exist that can treat the disease in many cases, these procedures can be lengthy (2-4 hours) and are only somewhat effective (~60-70% success). This speed of the procedure is limited by electrophysiology tools, which still require serial mapping of the atrium based on articulating an electrode (or electrode array) around the patient anatomy. Furthermore, because AF is an unstable arrhythmia, it is difficult to construct full spatiotemporally resolved electrocardiograms from this type of serial mapping. The small subset of devices that provide simultaneous mapping of the entire chamber have serious limitations and often leave large portions of the chamber unmapped. Here, we propose the use of a flexible and conformal soft robotic sensor array that allows for rapid, efficient and high resolution mapping of the left atrium for treatment of AF. Our lab has already established prototype devices based in vitro assessments in patient specific 3D print models. In this proposal, we will develop an optimized prototype, and associated catheter, based on a series of in vivo surgical and finally, percutaneous large animal studies. Once optimized, during the R33 phase, we will perform a series of device validation protocols based on ISO and ASTM standards. Finally, during the R33 phase of the proposal we will validate the system in vivo using large animal models.