A New Double-Cone Nitinol Device for PDA Occlusion: Design, Manufacturing and Initial In Vivo Results
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 c...
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Veröffentlicht in: | ASAIO journal (1992) 2009-07, Vol.55 (4), p.309-313 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | 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. |
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ISSN: | 1058-2916 1538-943X |
DOI: | 10.1097/MAT.0b013e3181a4f77d |