Evaluation of In Vivo Biocompatibility in Preclinical Studies of a Finger Implant Medical Device Correlated with Mechanical Properties and Microstructure

ACS Appl Mater Interfaces. 2024 Jan 10;16(1):376-388. doi: 10.1021/acsami.3c16742. Epub 2023 Dec 22.

Abstract

The aim of the experiment was to evaluate the biocompatibility of four 3D-printed biomaterials planned for use in the surgical treatment of finger amputees: Ti-6Al-4 V (Ti64), ZrO2-Al2O3 ceramic material (ATZ20), and osteoconductive (anodized Ti64) and antibacterial (Hydroxyapatite, HAp) coatings that adhere well to materials dedicated to finger bone implants. The work concerns the correlation of mechanical, microstructural, and biological properties of dedicated materials. Biological tests consisted of determining the overall cytotoxicity of the organism on the basis of in vivo tests carried out in accordance with the ISO 10993-6 and ISO 10993-11 standards. Clinical observations followed by diagnostic examinations, histopathological evaluation, and biochemical characterization showed no significant differences between control and tested groups of animals. The wound healed without complication, and no pathological effects were found. The wear test showed the fragility of the hydroxyapatite thin layer and the mechanical stability of the zirconia-based ceramic substrate. Electron microscopy observations revealed the layered structure of tested substrates and coatings.

Keywords: anodization of Ti64 alloy; finger inplant; in vivo intradermal reactivity; lithalox; microstructure; osteoinductivity.

MeSH terms

  • Alloys / chemistry
  • Alloys / pharmacology
  • Animals
  • Biocompatible Materials* / chemistry
  • Biocompatible Materials* / pharmacology
  • Ceramics / pharmacology
  • Durapatite / pharmacology
  • Materials Testing
  • Prostheses and Implants*
  • Surface Properties
  • Titanium / chemistry
  • Titanium / pharmacology

Substances

  • Biocompatible Materials
  • Durapatite
  • Titanium
  • Alloys