A new double-cone nitinol device for PDA occlusion: design, manufacturing and initial in vivo results

• Published in: ASAIO journal (1992) Vol. 55; no. 4; p. 309
• Main Authors: Vallecilla Erazo, Carolina, Silva, Ana Carolina, Mugnier, Jacqueline, García-Torres, Alberto, Briceño, Juan Carlos
• Format: Journal Article
• Language: English
• Published: United States 01.07.2009
• Subjects: Alloys - pharmacology; Animals; Animals, Newborn; Biocompatible Materials - chemistry; Catheterization; Cattle; Ductus Arteriosus, Patent - surgery; Ductus Arteriosus, Patent - therapy; Embolization, Therapeutic - instrumentation; Embolization, Therapeutic - methods; Equipment Design; Models, Animal; Prostheses and Implants; Prosthesis Design - instrumentation; Thrombosis
• ISSN: 1538-943X
• DOI: 10.1097/MAT.0b013e3181a4f77d

Use of occluder devices for a patent ductus arteriosus (PDA) closure is restricted to small diameter PDAs and involves high device costs. The objective of this study was to develop a new nitinol implant for the closure of a PDA and to evaluate its safety and efficacy in an animal model. The design consists of a device that promotes thrombus formation in the PDA. The device has a double-cone shape with their vertices joined. The cones are made of a nitinol wire helix with dacron fibers attached. The proximal end of the helix can be screwed to a conventional catheter release wire. In vitro testing was performed to verify the effectiveness of the implantation of the device and its releasing system; all trials (n = 30) were successful, showing accurate placement and release of the device. Complete and successful implantation of the device was achieved in all in vivo experiments (n = 5). There was one case of embolization due to premature detachment; a second device was successfully implanted. Histological evaluation after 42.3 +/- 3.1 days demonstrated complete PDA occlusion. The retrieved PDA showed total closure of the defect, endothelization of the PDA outlets and proper lodging of the device.