Development of a new pericardiocentesis assist device: Design proposal and evaluation of the pericardium grasping mechanism

Complication ratio of the pericardiocentesis was reported 4.7%, due to the procedure using needle. To decrease complication of the pericardiocentesis, purposes of this study was to develop a new pericardiocentesis assist device without needle. The proposed device was able to aspirate fluid inside the pericardial space by grasping and cutting the pericardium. To cut the pericardium, the device needed to grasp the pericardium surely. In this paper, we designed pericardium grasping mechanism. The result of the structural analysis using the finite element method showed proposed grasping mechanism could keep grasping force of 120 N and pericardium elastic force of 2.7 N without fracture. Results of in vitro porcine pericardium grasping experiment using a proposed device model showed that the pericardiumgrasping force was elucidated to need more than 7.5 N, while the pericardium elastic force was 2.44 N. The proposed pericardium grasping mechanism could grasp a porcine pericardium securely without fracture.