Mechanical and in vitro evaluation of an experimental canine patent ductus arteriosus occlusion device

Patent ductus arteriosus (PDA) is a congenital cardiovascular malformation in which a fetal connection between the aorta and pulmonary artery remains patent after birth. This defect commonly results in clinical complications, even death, necessitating closure. Surgical ligation is the most common treatment but requires a thoracotomy and is therefore invasive. A minimally invasive option is preferable. A prototype device for PDA occlusion which utilizes shape memory polymer foams has been developed and evaluated using mechanical and in vitro experiments. Removal force and radial pressure measurements show that the prototype device exhibited a lower removal force and radial pressure than a commercially available device. The in vitro experiments conducted within simplified and physiological PDA models showed that the prototype does not migrate out of position into the pulmonary artery at either physiological or elevated pressures in multiple model configurations. While the radial pressure and removal force were lower than commercial devices, the device performed acceptably in the in vitro benchtop experiments warranting further prototype development.