title: Safety and efficacy of nano lamellar TiN coatings on nitinol atrial septal defect occluders in vivo.
abstract: Atrial septal defect (ASD) occlusion devices made of nickel-titanium (NiTi) have a major shortcoming in that they release nickel into the body. We modified NiTi occluders using Arc Ion Plating technology. Nano lamellar titanium-nitrogen (TiN) coatings were formed on the surfaces of the occluders. The safety and efficacy of the modified NiTi occluders were evaluated in animal model. The results showed that 38 out of 39 rams (97%) survived at the end of the experiment. Fibrous capsules formed on the surfaces of the devices. Gradual endothelialization took place through the attachment of endothelial progenitor cells from the blood and the migration of endothelial cells from adjacent endocardium. The neo-endocardium formed more quickly in the coated group than in the uncoated group, as indicated by the evaluation of the six month study group. After TiN coating, there was no significant difference in endothelial cell cycle. TiN coating significantly reduced the release of nickel in both in vivo and in vitro indicating an improved biocompatibility of the nitinol ASD occluders. Superior and modified ASD occluders may provide a good choice for people with nickel allergies after sFDA registration, which is expected in one to two years.
authors.affiliation: Research Institute of Peking University in Shenzhen, Shenzhen 518057, China. Top5460@163.com
authors.forename: Zhi xiong
authors.initials: Zx
authors.lastname: Zhang
authors.forename: Bu fang
authors.initials: Bf
authors.lastname: Fu
authors.forename: De yuan
authors.initials: DY
authors.lastname: Zhang
authors.forename: Zhi wei
authors.initials: Zw
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Cheng
authors.forename: Li yuan
authors.initials: Ly
authors.lastname: Sheng
authors.forename: Chen
authors.initials: C
authors.lastname: Lai
authors.forename: Ting fei
authors.initials: Tf
authors.lastname: Xi
mesh_terms: D000497:Alloys / Q000009:adverse effects*; D000818:Animals; D002453:Cell Cycle; D020099:Coated Materials, Biocompatible / Q000009:adverse effects*; D004699:Endocardium / Q000378:metabolism / Q000473:pathology / Q000648:ultrastructure; D042783:Endothelial Cells / Q000378:metabolism / Q000473:pathology; D006344:Heart Septal Defects, Atrial / Q000097:blood / Q000628:therapy*; D020007:Implants, Experimental; D008297:Male; D049329:Nanostructures / Q000009:adverse effects* / Q000648:ultrastructure; D009532:Nickel / Q000009:adverse effects* / Q000097:blood; D019919:Prosthesis Implantation; D055989:Septal Occluder Device; D012756:Sheep; D014025:Titanium / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000497:Alloys; D020099:Coated Materials, Biocompatible; C040654:titanium nickelide; C013616:nitinol; D009532:Nickel; D014025:Titanium
keywords: Atrial septal defects (ASDs) occluders; Nano lamella; Nickel release; Nickel-titanium (NiTi); Safety and efficacy animal evaluation; TiN coating