Novel pericardial access device: design features and in vitro evaluation

Abstract

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 a10-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.

Keywords:

• Epicardial therapy
• Subxiphoid approach
• Pericardial access
• Thoracic probe
• Access trocar

Acknowledgements

We thank Mr B. H. Kent of the Machine Shop of the Department of Physics of the University of Virginia for several expert fabrications of the prototype devices. We also thank our colleagues Jason M. Tucker-Schwartz and David Chen for several useful discussions. We thank University of Virginia undergraduate student Caitlin E. Moffitt for making the penetration strength measurements of canine pericardial tissue. The work was funded in part by the Biomedical Innovation Fund which is co-sponsored bythe University of Virginia's Department of Biomedical Engineering and the Ivy Foundation, the University of Virginia BME/Coulter Translational Partnership, and also in part by the Kopf Family Foundation, Inc.

Declaration of interest: Authors Pollak, Mahapatra and Gillies may receive royalties from any licenses for the intellectual property related to this work that might be generated by agreements between the University of Virginia Patent Foundation and potential licensees.