Minimally Invasive Access to the Pericardium for the Active and Adjustable Cardiac Support Device

According to the American Heart Association, congestive heart failure affected 5.7 million Americans age 20 and older in 2006, and had an estimated direct and indirect cost of $37.2 billion in 2009. Heart assist devices are proving useful in a population where the demand for donor hearts is much greater than the supply. These technologies have successfully improved heart function, but current devices bypass heart pathways, and require invasive surgical methods for placement. Dr. Criscione proposed the Active and Adjustable Cardiac Support Device (AACSD) that allows the heart to maintain some intrinsic motion to restore normal function in the myocytes of a failing heart. Ventricular recovery follows the uniform application of pressure, working on the principle that mechanical stimuli are the key to repairing a mechanical organ. There is a need for a less invasive surgical technique to place the AACSD into the pericardial space. The Pericardial Access and Support System (PASS) is designed to gain access to the pericardium through a 1-2 inch sub-xiphoid incision in ovine models, reducing recovery time, trauma, and costs of the surgery. The design process followed FDA design controls intended to produce a safe and effective device. This includes forming user needs and product function into design input requirements and translating requirements into detailed design specifications. Verification plans were made to confirm that the specifications are consistent with the requirements. Once a physical device is manufactured, validation will ensure that the product satisfies user needs