Novel Flexible Access Port for Extra-Cardiac Beating Heart Repair

ABSTRACT The overall goal of this Phase I STTR project is to develop an epicardial endoscopic instrumentCardioPort ECfor safe and precise dissection and stabilization of the heart surface to enable epicardial ablation of ventricular arrhythmiasEffective treatment of ventricular tachycardiaa lifethreatening arrhythmiain patients with ischemic heart disease often requires both endocardial and epicardial ablationThe use of minimally invasive surgery is challenging because of the frequent presence of adhesions and the difficulty of accurately positioning an ablation catheter on a beating heartThereforethis procedure is typically achieved by open thoracotomya highly invasive procedure in these very high risk patientsThere is a critical unmet need for a minimally invasiveyet safe and precisemethod for navigating around the pericardial sac on the epicardial surface of the heartthat provides the ability to visualize coronary vesselssafely lyse adhesions and epicardial fat that may be presentand stably position the ablation catheterNido Surgical Incis developing the CardioPort ECa novel steerable pericardial endoscope for minimally invasive epicardial ablation of ventricular arrhythmiasCardioPort EC incorporates a camera to visualize the epicardial vessels and adhesionsand an instrument channel for insertion of surgical instruments for lysis of adhesions and radiofrequency ablationImportantlyit has a novel and innovative balloon system that creates a surgical working area between the heart surface and the pericardium and has surface characteristics that can stabilize the heartPreliminary studies with a first generation prototype showed that a balloon system with surface features resembling snake skin provides directional friction that can stabilize catheter instruments against the heart surface enough to enable precise surgical proceduresThe objective of Phase I is to confirm feasibility by completing two design objectivesoptimize visualization of the epicardial surface of the beating heart inside the pericardial sacandprovide stable positioning of the endoscope over the heart surface to enable safe and precise dissection of adhesions and epicardial ablationThereforeAimis to optimize the position and size of a balloon system on the endoscope to create a working area between the heart surface and pericardiumA prototype scope with balloons will be tested on the bench using a simulated chest rib cage and pericardial sacand ex vivo in pig heartsAimis to create and evaluate a directionalanisotropicfriction surface on the custom made balloon system that stabilizes the endoscopeTissue directional friction will be quantified in ex vivo and in vivo pig studiesThe final deliverables will be a prototype of the CardioPort EC thatprovides a working area with a radius oftocm in front of the tip of the scopestabilizes the field of view and target tissue enough to advance a surgical tool to the target site with precision accuracy ofmmandprovides a balloon surface that will resist a pull out for ofN in the axial direction of the scope without damage to epicardial vessels PROJECT RELEVANCE Patients with ischemic heart disease who have ventricular arrhythmia require open chest surgery that is highly invasive and riskyThe overall goal of this program is to develop the Nido Surgical IncCardioPort ECa novel endoscopic instrument that will enable safe and precise surgical repair of ventricular arrhythmia by a minimally invasive method that does not require open chest surgery or use of cardiopulmonary bypass on a heart lung machineSuccessful completion of this Phase I STTR project will establish the feasibility of the CardioPort EC and will lead to development of a functional prototype instrument that can be used to obtain FDA clearance for future clinical studies