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

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.