Real-time, High Resolution Ultrasound-based Image Guidance System for Pericardial Access

The cardiac electrophysiology ablation market is projected to exceed $6.5 billion by 2026 at a compound annual growth rate of 13.1% of which epicardial ablation is estimated as an $800 million market. Epicardial ablation that requires entry into the pericardial space is increasingly being used to address resistant cardiac arrhythmias. However, currently, access to the pericardial space remains a technical challenge because 1) a trial and error technique is used; 2) it is x-ray/fluoroscopy based so it entails x-ray radiation and toxic angiographic dye; 3) x-ray cannot differentiate between soft tissues so the operator is not able to visualize the pericardial border or differentiate between the pericardium and the heart, and 4) because it is somewhat blind, there is increased risk and it is time consuming. Perceptive Navigation has developed a forward-viewing, ultrasound-based, image-guidance platform that enables safe, reliable and accurate skin-to-target access. This Phase I SBIR submission seeks to build on that platform to facilitate access to the pericardial space to enable epicardial electrophysiology applications. Significant progress has been already achieved in building a working prototype of our ultrasound (US)-based image guidance platform. We have already (a) fabricated and characterized a forward-viewing phased array transducer for vascular and heart access, (b) successfully performed vascular access in live experimental models, (c) completed biocompatibility (cyto and systemic toxicity, chemo-irritation/ sensitization) testing of the vascular access catheter. Our overall phase I goals are to customize this platform via iterative design and fabricate a clinical-grade prototype of a pericardial access device. In phase I we propose fabricating and integrated, multicomponent device configured such that an advancing needle is continuously visualized in real-time. Portions of the device have already been developed and validated for vascular access. In pilot studies, an early prototype of proposed system provided real-time vision of the advancing needle and pericardium enabling complication-free pericardial entry in live domestic swine with pericardial effusions. We propose the following aims: Aim 1: Iteratively design and fabricate a clinical-grade device. Test feasibility and efficacy of this device for pericardial access in water-bath and tissue phantoms. Aim 2: Demonstrate functionality and efficacy of the device in explanted swine hearts and in live swine by testing for ease and success of pericardial entry. Selected designs will be optimized for additional in- vivo studies and first-in-human clinical trials in a future application. Our long-term goal is to commercialize a real-time, image-guided pericardial access system that is a novel means of enabling epicardial ablation procedures. The system would have low capital and operating cost, low profile (hand-carried) and potentially promote safe and reliable epicardial ablations with reduced complications.This Phase I SBIR proposal seeks to develop and fabricate a working prototype of an innovative ultrasound-guided, pericardial access device, demonstrate its feasibility, and optimize its design for future experimental and clinical studies.