Soft robotic sensor arrays for fast and efficient mapping of cardiac arrhythmias.

摘要-- Conform Medical正在应用材料科学、软机器人技术和可拉伸电子技术， 以室性心动过速开始的心律失常基础异常电信号的标测和消融 (VT)然后扩展到其他类型的心律失常，如心房颤动（AFib）。 医院和心脏中心的心脏电生理学专家通常因缺乏工具而感到痛苦 以足够的速度有效地标测心室病灶以诊断VT。这种广泛复杂的快速性心律失常 通常由缺血性心脏病引起，VT与心室颤动（VF）一起沿着， 在美国每年发生的450，000例心脏性猝死中，有75%的人电生理标测至关重要 对于VT管理，特别是对于仅通过药物不能很好地管理VT的患者。在 在这些情况下，治疗包括诱发VT的手术和微创电极导管 用于绘制心脏电信号并确定相关异常电通路的来源 关于VT使这些患者处于诱发性心律失常状态仅在短时间内是安全的，通常 就几分钟。然而，当前的标测导管不能采集足够详细的激活标测图 在这么短的时间内心室的收缩。这些限制导致结果不佳，近90%的室性心动过速患者 被视为“不可映射”。 Conform Medical通过一种由柔软的机器人和可伸缩的 电子技术，这将使快速和准确的心室病灶的心脏标测。这个装置很软 机器人传感器阵列（SRSA）通过液压使80个柔性传感器均匀地符合左心室组织。 致动传统篮形标测导管形式的弹性薄壁聚合物。所述软机器人 篮子与由低成本、可扩展的柔性PCB形成的可拉伸传感阵列集成， 一种专有的基于激光的加工方法，使它们具有高度的可拉伸性。这种创新方法 克服了开发用于心脏标测的全室篮状导管的主要挑战， 即可缩放的制造、集成和一致性。 该I期项目的目标是通过优化3D输送来降低该技术在心室中使用的风险 打印模型，概括了所需的导管可跟踪性和解剖特征/功能，确认其 在体内的性能，并证明与开放的，商业心脏标测系统的兼容性。的 该项目的具体目标是：1）优化3D打印心脏模型中的导管输送系统; 2） 在猪模型中证明该装置的体内功能;以及3）将该装置与 商业心脏标测系统，以确定空间标测的准确性并验证 电读数这项创新技术将为室性心律失常日益加重的负担提供一个答案， 这需要新的和有效的治疗方法，并且也可以应用于AFib和其他心律失常。

Abstract - Conform Medical is applying materials science, soft robotics, and stretchable electronics to revolutionize the mapping and ablation of the aberrant electrical signals underlying arrythmias, starting with ventricular tachycardia (VT), then expanding to other types of cardiac arrythmia such as atrial fibrillation (AFib). Cardiac electrophysiology specialists at hospitals and cardiac centers are commonly pained by the lack of tools to efficiently map ventricular foci with enough speed to diagnose VT. This wide, complex tachyarrhythmia is usually caused by ischemic heart disease, and VT, along with ventricular fibrillation (VF), are responsible for 75% of the 450,000 sudden cardiac deaths that occur yearly in the U.S. Electrophysiological mapping is critical for VT management, especially for patients for whom VT cannot be well managed by pharmaceuticals alone. In these cases, treatment comprises a procedure in which VT is induced and a minimally invasive electrode catheter is used to map cardiac electrical signals and determine the source of the aberrant electrical pathways associated with the VT. Keeping these patients in a state of induced arrythmia is only safe for a short period of time, often just minutes. However, current mapping catheters are not able to acquire a sufficiently detailed activation map of the ventricle in such a short time. These limitations lead to suboptimal results, with nearly 90% of VT patients deemed ‘unmappable’. Conform Medical addresses these critical needs with a novel device composed of soft robotic and stretchable electronic technology, which will enable fast and accurate cardiac mapping of ventricular foci. The device’s soft robotic sensor array (SRSA) uniformly conforms 80 flexible sensors to the left ventricular tissue by hydraulically actuating an elastic thin-walled polymer in the form of a traditional basket mapping catheter. The soft robotic basket is integrated with a stretchable sensing array formed from low-cost, scalable flex-PCBs, and undergoes a proprietary laser-based processing method to render them highly stretchable. This innovative approach overcomes the main challenges in the development of a whole chamber basket catheter for cardiac mapping, namely scalable fabrication, integration, and conformability. The goal of this Phase I project is to de-risk the use of the technology in ventricles by optimizing delivery in 3D printed models that recapitulate the required catheter trackability and anatomic features/functions, validating its performance in vivo, and demonstrating compatibility with an open, commercial cardiac mapping system. The specific aims for this project are: 1) Optimize the catheter delivery system in a 3D printed heart model; 2) Demonstrate the functionality of the device in vivo in porcine models; and 3) Integrate the device with a commercial cardiac mapping system to determine accuracy of spatial mapping and validate the quality of electrical readings. This innovative technology will offer an answer the growing burden of ventricular arrhythmias, which calls for novel and effective therapies, and can also be applied to AFib, and other arrythmias.