Novel pericardial access device: Design features and in vitro evaluation

We have designed, built and tested a novel needle for percutaneously accessing the pericardial space. The problem with accessing pericardial space is that the pericardium is against the heart. Our novel device incorporates a single spiral tine at the distal tip of a 10-gauge needle, which engages the parietal pericardium tangentially to the surface of the heart. One can then pull the pericardium away, thus minimizing the risk of ventricular perforation associated with oblique axial approaches. Using linear low-density polyethylene film as a surrogate pericardium, we have demonstrated reliable pericardial engagement with successful first-time engagement rates of up to 72% (n=25 attempts) at approach angles ranging from 0° (normal incidence) to 30°. The associated torques were approximately 1 N mm. The performance limits of the model and the implications for clinical use of such a device are discussed.