Development and Analysis of a Minimally Invasive Post-Infarction Epicardial Patch Delivery Device

Abstract

After a myocardial infarct (heart attack), the heart develops scar tissue that can impede normal function and eventually result in heart failure. There are a number of methods currently employed in the field to slow this degeneration, but none focus on explicitly returning the heart to pre-heart attack levels of function. The Roche lab has developed an epicardial patch that can mechanically reinforce the heart back to prevent it from progressing into heart failure after a heart attack , but current implantation methods are too invasive. In this study, researchers designed and developed a delivery tool that would adhere the hydrogel and composite based epicardial patches on infarcted hearts in a minimally invasive operation. The device is a collapsible and inflatable sleeve prototyped using thermoplastic polymer films and casted silicone rubber components, designed for minimally invasive subxiphoid surgery. It utilizes vacuum for stabilization during application.

By characterizing the material properties with a universe mechanical tester, it was also found that the tool can reliably supply the necessary pressure to properly adhere the hydrogel patches. Through a series of ex vivo and in situ porcine experiments, it was found that the sleeve is effective at effectively positioning and adhering the patches to the epicardium. Such a tool would be helpful in applying therapeutics like the patch, presenting a low-cost, accessible solution for interventionalists. This delivery tool is still in development, as it is on its fourth iteration and in the future, would require extensive preclinical studies before moving into human trials..