Tissue Biocompatibility of Variously Treated DLC-coated NiTi Fragments using Rat Model Shin JH 1, Kim TH 1, Kim EY 1, Song HY 1, Moon MW 2, Lee KR 2, Han.

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Tissue Biocompatibility of Variously Treated DLC-coated NiTi Fragments using Rat Model Shin JH 1, Kim TH 1, Kim EY 1, Song HY 1, Moon MW 2, Lee KR 2, Han DK 3 1 Department of Radiology, University of Ulsan, College of Medicine Asan Medical Center, Seoul, Korea 2 Future Convergence Technology Lab., 3 Biomaterials Research Center, KIST (Korea Institute of Science and Technology), Seoul, Korea

Introduction Problems with a biomedical device - Biocompatibility, hematocompatibility, & cytotoxicity Ideal Biomaterials - Chemically and biologically inert to the surrounding tissues - Hard and wear-resistant with low friction - No release of toxic and carninogenic elements ** ‘surface properties’ are very important Introduction

DLC (diamond-like carbon) coatings - High hardness, low frictional coefficient, high wear & corrosion resistance, chemical inertness, high electrical resistivity, and excellent smoothness - Promising as a hemocompatible material - Doping or surface treatment is helpful for better mechanical properties and biocompatibility Introduction

To evaluate tissue biocompatibility of the variously treated DLC coated NiTi fragments by in-vivo experiments using rat model Purpose

Materials and Methods Test Specimens - Sample size: 5mm x 5mm, rectangular - NiTi-control (n=6) NiTi/Si-DLC (n=6) NiTi/Si-DLC/PEG (n=6) NiTi/Si-DLC/N 2 (n=6) NiTi/Si-DLC/CF 4 (n=6) NiTi Si DLC Materials and Methods PEG

Animal Experiment - Six for each test specimen, so total 30 specimens - Rat thigh muscle model (n=15) - Anesthesia with intraperitoneal injection of ketamine (100mg/kg) and xylazine (15mg/kg) - Fixation of the hind leg - Bilateral thigh muscle dissection - Implantation of test specimens into muscle belly - Suture of the incision site Materials and Methods

Follow-up and Histopathology - 6 weeks of follow-up to allow tissue response to the implanted specimens - Sacrifice with removal of each specimen and surrounding skeletal muscle Materials and Methods

- H & E staining for the skeletal muscle - Measurement of ‘fibrotic tissue thickness’ which indicates tissue response Materials and Methods

Statistics - Measure ‘fibrotic tissue thickness’ 3 times for each specimen - ANOVA test to evaluate significant difference of fibrotic tissue thickness between the five groups Materials and Methods

Results All rats tolerated the surgery well Post-implantation period was uncomplicated Implantation site healed without any complications Implanted specimens could be removed easily Fibrotic tissue was observed as a capsule around the implantation site Results

Fibrotic tissue thickness sample Mean fibrotic tissue thickness NiTi-control ㎛ (5 th ) NiTi/Si-DLC ㎛ (4 th ) NiTi/Si-DLC/PEG ㎛ (1 st ) NiTi/Si-DLC/N ㎛ (3 rd ) NiTi/Si-DLC/CF ㎛ (2 nd ) Results

NiTi-control Mean ㎛ NiTi/Si-DLC Mean ㎛ NiTi/Si-DLC/PEG Mean ㎛ No significant difference between five groups ; p=0.063 (ANOVA) (x100) Results

Minimal lymphocytic infiltration and fibrosis, suggesting chronic inflammation (x200) NiTi/Si-DLC/PEG

Discussion NiTi/Si-DLC/PEG showed the best tissue biocompatibility. - PEG is hydrophilic as a water-soluble polymer - PEG is flexible (high chain motility) - PEG has steric stabilization having exclude volume, - difficult for blood components to get close

Conclusion NiTi/Si-DLC/PEG showed the best tissue biocompatibility. Variously treated DLC coated NiTi specimens showed less tissue reaction compared with NiTi-control. This observation provides basis for feasibility of application of the stents made of treated DLC coated NiTi.

Acknowledgement Kim TH, Kim EY – Dept. of Radiology, Asan Medical Center Park CS - Dept. of Pathology, Asan Medical Center Lee KR, Moon MW - Future Convergence Technology Lab., KIST Han DK, Park K - Biomaterials Research Center, KIST Thank you for your attention !