TY - JOUR
T1 - Effect of Ethylene Oxide and Gamma (γ-) Sterilization on the Properties of a PLCL Polymer Material in Balloon Implants
AU - Haim Zada, Moran
AU - Kumar, Awanish
AU - Elmalak, Omar
AU - Mechrez, Guy
AU - Domb, Abraham J.
N1 - Publisher Copyright:
Copyright © 2019 American Chemical Society.
PY - 2019/12/17
Y1 - 2019/12/17
N2 - Poly-l-lactide-co-ϵ-caprolactone (PLCL) is a unique polymer containing both polylactic acid and poly-ϵ-caprolactone (PCL) chain units, and thus it has better flexible and biodegradable properties. Based on these unique properties of PLCL, we have developed balloons that are now widely used in treating major medical problems [Biomaterials 2016, 105, 109-116]. One of the most important considerations needed for balloons is to ensure that the material properties remain similar after undergoing ethylene oxide (EtO) or gamma (γ-) sterilization treatments. From the biotechnological point of view, we focused on analyzing the vital molecular properties of the PLCL material after sterilization, such as changes in crystallinity, molecular weight distributions (Mw, Mn, and polydispersity index), and inherent viscosity (η). Analysis of the data reveals that EtO sterilization does not engender any change in crystallinity, melting temperature (Tm), molecular weights, and η of the polymer. On the contrary, γ-radiations induce chain scission and consequential decrease of ∼33 and ∼15% in molecular weights and η values, respectively. Based on our observations, we recommend EtO sterilization instead of γ-radiation for PLCL. This ensures prolonged stability of the polymer against degradation in a biological environment, long-shelf life, and absolute assurance that balloon failures do not occur after implantation.
AB - Poly-l-lactide-co-ϵ-caprolactone (PLCL) is a unique polymer containing both polylactic acid and poly-ϵ-caprolactone (PCL) chain units, and thus it has better flexible and biodegradable properties. Based on these unique properties of PLCL, we have developed balloons that are now widely used in treating major medical problems [Biomaterials 2016, 105, 109-116]. One of the most important considerations needed for balloons is to ensure that the material properties remain similar after undergoing ethylene oxide (EtO) or gamma (γ-) sterilization treatments. From the biotechnological point of view, we focused on analyzing the vital molecular properties of the PLCL material after sterilization, such as changes in crystallinity, molecular weight distributions (Mw, Mn, and polydispersity index), and inherent viscosity (η). Analysis of the data reveals that EtO sterilization does not engender any change in crystallinity, melting temperature (Tm), molecular weights, and η of the polymer. On the contrary, γ-radiations induce chain scission and consequential decrease of ∼33 and ∼15% in molecular weights and η values, respectively. Based on our observations, we recommend EtO sterilization instead of γ-radiation for PLCL. This ensures prolonged stability of the polymer against degradation in a biological environment, long-shelf life, and absolute assurance that balloon failures do not occur after implantation.
UR - http://www.scopus.com/inward/record.url?scp=85076252032&partnerID=8YFLogxK
U2 - 10.1021/acsomega.9b02889
DO - 10.1021/acsomega.9b02889
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C2 - 31867526
AN - SCOPUS:85076252032
SN - 2470-1343
VL - 4
SP - 21319
EP - 21326
JO - ACS Omega
JF - ACS Omega
IS - 25
ER -