Optimum Sterilization Methods of Biocompatible Hybrid Material for Artificial Organs

• Inoue Yusuke

  Institute of Development, Aging and Cancer, Tohoku University Graduate School of Medicine, University of Tokyo Advanced Medical Engineering Research Center, Asahikawa Medical University

• Tashiro Ayaka

  Graduate School of Medicine, University of Tokyo

• Kawase Yukino

  Graduate School of Medicine, University of Tokyo

• Isoyama Takashi

  Graduate School of Medicine, University of Tokyo

• Saito Itsuro

  Graduate School of Medicine, University of Tokyo

• Ono Toshiya

  Graduate School of Medicine, University of Tokyo

• Hara Shintaro

  Graduate School of Medicine, University of Tokyo

• Ishii Kohei

  National Institute of Technology, Kagawa College

• Yurimoto Terumi

  Central Institute for Experimental Animals

• Shiraishi Yasuyuki

  Institute of Development, Aging and Cancer, Tohoku University

• Yamada Akihiro

  Institute of Development, Aging and Cancer, Tohoku University

• Yambe Tomoyuki

  Institute of Development, Aging and Cancer, Tohoku University

• Abe Yusuke

  Graduate School of Medicine, University of Tokyo Department of Medical and General Sciences, Nihon Institute of Medical Science

Abstract

We previously reported the development of a new hybrid medical material comprising bio-based materials with high biocompatibility and artificial materials with characteristics of excellent strength and processability. This material shows sufficient biocompatibility and excellent stability in vivo. Moreover, when applied to the surface of an implantable sensor, the biological reaction on the sensor function surface can be well controlled. For commercialization and widespread use of hybrid materials with such superior properties, sterilization and storage are critical considerations, given that hybrid materials must be processed outside the body prior to application as medical materials in vivo, thus posing a risk of contamination despite best efforts. Therefore, the aim of the present study was to establish an optimal sterilization method that will not impair the biocompatibility of the hybrid material. Toward this end, we tested six sterilization methods for the hybrid material: autoclave (121℃, 20 min), dry heat (160℃, 120 min), ethylene oxide gas (37℃, 120 min), hydrogen peroxide plasma (45℃, 45 min), and gamma ray (25 kGy) with and without lyophilization. After sterilization, the material was cultured with vascular endothelial cells to evaluate the engraftment rate, and was observed with light and scanning electron microscopy to determine shape and structure changes. The results demonstrated that gamma sterilization without lyophilization was the best sterilization method for this material, which preserved the collagen network and showed no change in number of adhered vascular endothelial cells compared to the pre-sterilized material. These findings are useful to promote the commercialization of this hybrid material with combined advantages of synthetic and bio-based materials for widespread clinical application in the engineering of artificial organs.

Journal

• Advanced Biomedical Engineering

  Advanced Biomedical Engineering 9 (0), 83-92, 2020

  Japanese Society for Medical and Biological Engineering

Keywords

• biocompatible material
• artificial heart
• sterilization
• antithrombotic
• inflammation

Details

• CRID: 1390285300157916160
• NII Article ID: 130007843386
• DOI: 10.14326/abe.9.83
• ISSN: 21875219
• Web Site: https://www.jstage.jst.go.jp/article/abe/9/0/9_9_83/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2021123626
• Text Lang: en
• Data Source:
  • JaLC
  • Crossref
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed