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

摘要- Conform Medical正在应用材料科学、软机器人和可拉伸电子技术来彻底改变 起始于室性心动过速的心律失常下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，如房颤(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脑室病灶以诊断室性心动过速。这种广泛而复杂的快速性心律失常 通常由缺血性心脏病引起，室性心动过速和室颤(VF)是 美国每年发生的45万例心脏性猝死中的75%。电生理标测是关键 对于室速管理，特别是对于那些仅靠药物不能很好地管理室速的患者。在……里面 这些病例的治疗包括诱发室性心动过速和微创电极导管。 用于标测心脏电信号并确定相关异常电路径的来源 与VT一起工作。让这些患者处于诱发性心律失常状态只在很短的一段时间内是安全的，通常 就几分钟。然而，当前的标测导管不能获得足够详细的激活图 在这么短的时间内完成脑室的手术。这些限制导致了不理想的结果，近90%的VT患者 被认为是“不可映射的”。 Conform Medical通过一种由软机器人和可伸缩设备组成的新型设备满足了这些关键需求 电子技术，这将使快速和准确的心脏标测的室壁病灶。设备的软性 机器人传感器阵列(SRSA)通过液压将80个柔性传感器均匀地整合到左心室组织上 以传统篮形映射导管的形式驱动弹性薄壁聚合物。软体机器人 篮子与由低成本、可扩展的Flex-PCB形成的可伸缩传感阵列集成在一起，并经历 一种专有的基于激光的加工方法，使它们具有高度的延伸性。这一创新方法 克服了开发用于心脏标测的全腔篮式导管的主要挑战， 即可扩展的制造、集成和符合性。 这个第一阶段项目的目标是通过优化3D传输来降低该技术在脑室中的使用风险 打印模型，概括了所需的导管可跟踪性和解剖特征/功能，验证了其 在体内的表现，并展示了与开放的商业心脏标测系统的兼容性。这个 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) 在活体动物模型中演示该设备的功能；以及3)将该设备与 商用心脏标测系统用于确定空间标测的准确性并验证 电子读数。这项创新技术将为日益加重的室性心律失常负担提供答案， 这需要新的有效的治疗方法，也可以应用于房颤等心律失常。

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.