title: A new double-cone nitinol device for PDA occlusion: design, manufacturing and initial in vivo results.
abstract: 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.
authors.affiliation: Group of Biomedical Engineering, Universidad de los Andes, Bogota, DC, Colombia. c-vallec@uniandes.edu.co
authors.forename: Carolina
authors.initials: C
authors.lastname: Vallecilla Erazo
authors.forename: Ana Carolina
authors.initials: AC
authors.lastname: Silva
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Mugnier
authors.forename: Alberto
authors.initials: A
authors.lastname: García-Torres
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Briceño
mesh_terms: D000497:Alloys / Q000494:pharmacology; D000818:Animals; D000831:Animals, Newborn; D001672:Biocompatible Materials / Q000737:chemistry; D002404:Catheterization; D002417:Cattle; D004374:Ductus Arteriosus, Patent / Q000601:surgery* / Q000628:therapy*; D004621:Embolization, Therapeutic / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D023421:Models, Animal; D019736:Prostheses and Implants; D011474:Prosthesis Design / Q000295:instrumentation; D013927:Thrombosis
chemical_list: D000497:Alloys; D001672:Biocompatible Materials; C013616:nitinol