TY - JOUR
T1 - Optimum sterilization methods of biocompatible hybrid material for artificial organs
AU - Inoue, Yusuke
AU - Tashiro, Ayaka
AU - Kawase, Yukino
AU - Isoyama, Takashi
AU - Saito, Itsuro
AU - Ono, Toshiya
AU - Hara, Shintaro
AU - Ishii, Kohei
AU - Yurimoto, Terumi
AU - Shiraishi, Yasuyuki
AU - Yamada, Akihiro
AU - Yambe, Tomoyuki
AU - Abe, Yusuke
N1 - Funding Information:
This work was supported by JSPS KAKENHI Grant Numbers JP25670105, JP15K12503, JP19K12772. And this work was supported by the cooperation program of research institutes in Tohoku University.
Publisher Copyright:
© 2020, Japanese Society for Medical and Biological Engineering. All rights reserved.
PY - 2020
Y1 - 2020
N2 - 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. There-fore, the aim of the present study was to establish an optimal sterilization method that will not impair the bio-compatibility of the hybrid material. Toward this end, we tested six sterilization methods for the hybrid materi-al: autoclave (121°C, 20 min), dry heat (160°C, 120 min), ethylene oxide gas (37°C, 120 min), hydrogen peroxide plasma (45°C, 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.
AB - 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. There-fore, the aim of the present study was to establish an optimal sterilization method that will not impair the bio-compatibility of the hybrid material. Toward this end, we tested six sterilization methods for the hybrid materi-al: autoclave (121°C, 20 min), dry heat (160°C, 120 min), ethylene oxide gas (37°C, 120 min), hydrogen peroxide plasma (45°C, 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.
KW - Antithrombotic
KW - Artificial heart
KW - Biocompatible material
KW - Inflammation
KW - Sterilization
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U2 - 10.14326/abe.9.83
DO - 10.14326/abe.9.83
M3 - Article
AN - SCOPUS:85087134469
VL - 9
SP - 83
EP - 92
JO - Advanced Biomedical Engineering
JF - Advanced Biomedical Engineering
SN - 2187-5219
ER -