Mechanical and in vitro evaluation of an experimental canine patent ductus arteriosus occlusion device. (June 2016)

• Record Type: Journal Article
• Authors: Wierzbicki, Mark A.; Bryant, Jesse; Miller, Matthew W.; Keller, Brandis; Maitland, Duncan J.
• Is Part Of: Journal of the mechanical behavior of biomedical materials. Volume 59(2016)
• Page Start: 156
• Page End: 167
• Publication Date: 2016-06
• Subjects: DA Ductus arteriosus -- MPA Main pulmonary artery -- PDA Patent ductus arteriosus -- AVP Amplatzer™ Vascular Plug -- ADO Amplatzer™ Duct Occluder -- ACDO Amplatz® Canine Ductal Occluder -- MDD Minimal ductal diameter -- SMP Shape memory polymer -- Tg Glass transition temperature -- NFC Nitinol foam cage -- SS Stainless steel -- WA Wide ampulla -- CTA Computed tomographic angiogram.; Patent ductus arteriosus -- ACDO -- Shape memory polymer; Biomedical materials -- Periodicals; Biomedical materials -- Mechanical properties -- Periodicals; Biomedical materials; Biomedical materials -- Mechanical properties; Periodicals; Electronic journals; 610.28
• DOI: 10.1016/j.jmbbm.2015.12.014
• Languages: English
• ISSNs: 1751-6161

Abstract

Abstract: 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. Graphical abstract: Highlights: Patent ductus arteriosus occluder fabricated and compared to commercial device. Prototype exerted similar or lower radial pressure to ampulla wall. Prototype showed minimal migration and higher flow reduction in vitro. Scalable device frame allows for reduction in delivery system size of large devices. Positive clinician feedback including easy retraction and passage through catheter.