The overall goal of this Phase I STTR project is to develop an epicardial endoscopic instrument (CardioPort-EC) for safe and precise dissection and stabilization of the heart surface to enable epicardial ablation of ventricular arrhythmias. Effective treatment of ventricular tachycardia, a life- threatening arrhythmia, in patients with ischemic heart disease often requires both endocardial and epicardial ablation. The 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 heart. Therefore, this procedure is typically achieved by open thoracotomy, a highly invasive procedure in these very high-risk patients. There is a critical unmet need for a minimally invasive, yet safe and precise, method for navigating around the pericardial sac on the epicardial surface of the heart, that provides the ability to visualize coronary vessels, safely lyse adhesions and epicardial fat that may be present, and stably position the ablation catheter. Nido Surgical Inc. is developing the CardioPort-EC, a novel steerable pericardial endoscope for minimally invasive epicardial ablation of ventricular arrhythmias. CardioPort-EC incorporates a camera to visualize the epicardial vessels and adhesions, and an instrument channel for insertion of surgical instruments for lysis of adhesions and radiofrequency ablation. Importantly, it 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 heart. Preliminary 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 procedures. The objective of Phase I is to confirm feasibility by completing two design objectives: 1) optimize visualization of the epicardial surface of the beating heart inside the pericardial sac; and 2) provide stable positioning of the endoscope over the heart surface to enable safe and precise dissection of adhesions and epicardial ablation. Therefore, Aim1 is to optimize the position and size of a balloon system on the endoscope to create a working area between the heart surface and pericardium. A prototype scope with balloons will be tested on the bench using a simulated chest rib cage and pericardial sac, and ex vivo in pig hearts. Aim 2 is to create and evaluate a directional (anisotropic) friction surface on the custom-made balloon system that stabilizes the endoscope. Tissue directional friction will be quantified in ex vivo and in vivo pig studies. The final deliverables will be a prototype of the CardioPort-EC that: 1) provides a working area with a radius of 1.5 to 2.5cm in front of the tip of the scope; 2) stabilizes the field of view and target tissue enough to advance a surgical tool to the target site with precision accuracy of 5mm; and 3) provides a balloon surface that will resist a pull-out for of 12N in the axial direction of the scope without damage to epicardial vessels.
Public Health Relevance Statement: PROJECT RELEVANCE Patients with ischemic heart disease who have ventricular arrhythmia require open-chest surgery that is highly invasive and risky. The overall goal of this program is to develop the Nido Surgical Inc. CardioPort-EC, a 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 machine. Successful 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.
Project Terms: Ablation; Adhesions; Animal Testing; Applied Research; Area; Arrhythmia; base; Boston; Cardiac; Cardiac ablation; cardiac repair; Cardiac Surgery procedures; Cardiopulmonary Bypass; Catheters; Characteristics; Chest; Clinical; Clinical Research; commercialization; Coronary Vessels; Custom; Cytolysis; design; Development; Dissection; effective therapy; Endoscopes; Engineering; experimental study; Failure; Family suidae; Fatty acid glycerol esters; Fiber; flexibility; Friction; Future; Generations; Goals; Heart; Heart-Lung Machine; high risk; Imagery; in vivo; Incidence; Individual; innovation; instrument; Lasers; Life; Mechanics; Medical Device; Methods; minimally invasive; Modeling; Myocardial Ischemia; Navigation System; next generation; novel; Operating System; Operative Surgical Procedures; Patients; Pediatric Hospitals; Pericardial body location; pericardial sac; Periodicity; Phase; Polyesters; Positioning Attribute; pre-clinical; Preparation; prevent; Procedures; product development; programs; Property; prototype; Radial; Radiofrequency Interstitial Ablation; repaired; rib bone structure; risk minimization; Schools; Silicones; simulation; Site; Skin; Small Business Technology Transfer Research; Snakes; Surface; Surgical Instruments; System; Testing; Thinness; Thoracic Surgical Procedures; Thoracotomy; Tissues; tool; Ventricular; Ventricular Arrhythmia; Ventricular Tachycardia; Work
