Abstract
Poly(ether) urethane (PEtU)–polydimethylsiloxane (PDMS) based materials have been processed by a spray, phase-inversion technique to produce microfibrillar small-diameter vascular grafts; however the effect of sterilization upon these grafts is still unknown. This study investigated the effect of gamma irradiation on grafts made of PEtU–PDMS materials containing different PDMS concentrations. Sterilisation-induced changes in surface chemical structure and morphology were assessed by infrared spectroscopy, light and scanning electron microscopy. Tensile tests were used to examine changes in mechanical properties and the cytotoxicity evaluation was performed on L929 fibroblasts. The study demonstrated that physical–chemical and mechanical properties of PEtU–PDMS grafts, at each PDMS concentration, were not significantly affected by the exposure to gamma irradiation, moreover no sign of cytotoxicity was observed after sterilisation. Although in vitro experiments have been promising, further in vivo studies are necessary to evaluate the biodegradation behaviour of PEtU–PDMS graft after gamma irradiation, before any clinical application.
Similar content being viewed by others
References
Panayiotopoulos YP, Edmondson RA, Reidy JF, Taylor PR. A scoring system to predict the outcome of long femorodistal arterial bypass grafts to single calf or pedal vessels. Eur J Vasc Endovasc Surg. 1998;15:380–6.
Taylor RS, Loh A, McFarland RJ, Cox M, Chester JF. Improved technique for polytetrafluoroethylene bypass grafting: long-term results using anastomotic vein patches. Br J Surg. 1992;79:348–54.
Okoshi T. New concept of microporous structure in small diameter vascular prostheses. Artif Organs. 1995;19(1):27–31.
Soldani G, Bernabei M, Losi P, Crucean A, Chiappino D, Burchielli S, et al. In vitro experiments and in vivo implants to evaluate a new silicone-based polyurethane material for replacement of small vessels. Cardiol Young. 2004;14:20–3.
Okoshi T, Soldani G, Goddard M, Galletti PM. Penetrating micropores increase patency and achieve extensive endothelialization in small diameter polymer skin coated vascular grafts. ASAIO J. 1996;42(5):M398–401.
Briganti E, Losi P, Raffi A, Scoccianti M, Munaò A, Soldani G. Silicone based polyurethane materials: a promising biocompatible elastomeric formulation for cardiovascular applications. J Mater Sci Mater Med. 2006;17:259–66.
Okoshi T, Goddard M, Galletti PM, Soldani G. In vivo evaluation of porous versus skinned polyurethane–polydimethylsiloxane small diameter vascular grafts. ASAIO Trans. 1991;37(3):M480–1.
Abraham GA, Frontini PM, Cuadrado TR. Physical and mechanical behavior of sterilized biomedical segmented polyurethanes. J Appl Polym Sci. 1997;65:1193–203.
Hirata N, Matsumoto K-I, Inishita T, Takenaka Y, Suma Y, Shintani H. Gamma-ray irradiation, autoclave and ethylene oxide sterilization to thermosetting polyurethane: sterilization to polyurethane. Radiat Phys chem. 1995;46:377–81.
Hooper KA, Cox JD, Kohn J. Comparison of the effect of ethylene oxide and γ-irradiation on selected tyrosine-derived polycarbonates and poly(l-lactic acid). J Appl Polym Sci. 1997;63:1499–510.
Soldani G. Elastomeric material and process for preparation thereof. U.S. Patent 7,157,118B2, January 2, 2007.
Okoshi T, Chen H, Soldani G, Galletti PM, Goddard M. Microporous small diameter PVDF–TrFE vascular grafts fabricated by a spray phase inversion technique. ASAIO J. 1992;38(3):M201–6.
Soldani G. Apparatus for and method of producing porous membranes for medical use. U.S Patent 02425778.4, June 23, 2004.
Soldani G, Losi P, Milioni C, Raffi A. Light microscopy evaluation of polyurethane vascular grafts porosity by Sudan Black B staining. J Microsc. 2002;206:139–45.
Gogolewski S, Mainil-Varlet P, Dillon JG. Sterility, mechanical properties, and molecular stability of polylactide internal-fixation devices treated with low-temperature plasmas. J Biomed Mater Res. 1996;32:227–35.
Lamba NMK, Woodhouse KA, Cooper SL. Polyurethanes in biomedical applications. Boca Raton: CRC Press; 1998.
Hergenrother RW, Wabers HD, Cooper SL. Effect of hand segment chemistry and strain on the stability of polyurethanes: in vivo biostability. Biomaterials. 1993;14(6):449–58.
Stokes K, McVenes R, Anderson JM. Polyurethane elastomer biostability. J Biomater Appl. 1995;9(4):321–54.
Martin DJ, Poole-Warren LA, Gunatillake PA, McCarthy SJ, Meijs GF, Schindhelm K. Polydimethylsiloxane/polyether-mixed macrodiol-based polyurethane elastomers: biostability. Biomaterials. 2000;21(10):1021–9.
Spiller D, Losi P, Briganti E, Sbrana S, Kull S, Martinelli I, et al. PDMS content affects in vitro hemocompatibility of synthetic vascular grafts. J Mater Sci Mater Med. 2007;18(6):1097–104.
Rhodes NP, Bellon JM, Bujan MJ, Soldani G, Hunt JA. Inflammatory response to a novel series of siloxane-crosslinked polyurethane elastomers having controlled biodegradation. J Mater Sci Mater Med. 2005;16:1207–11.
Massey LK. The effect of sterilization methods on plastics and elastomers. 2nd ed. NY: William Andrew; 1994.
Tang YW, Labow RS, Santerre JP. Isolation of methylene dianiline and aqueous-soluble biodegradation products from polycarbonate–polyurethanes. Biomaterials. 2003;24:2805–19.
Haugen HJ, Brunner M, Pellkofer F, Aigner J, Will J, Wintermantel E. Effect of different γ- irradiation doses on cytotoxicity and material properties of porous polyether–urethane polymer. J Biomed Mater Res B Appl Biomater. 2007;80B:415–23.
Shintani H, Nakamura A. Formation of 4, 4’-methylenedianiline in polyurethane potting materials by either γ-ray or autoclave sterilization. J Biomed Mater Res. 1991;25:1271–5.
Zhang YZ, Bjursten LM, Freij-Larsson C, Kober M, Wesslen B. Tissue response to commercial silicone and polyurethane elastomers after different sterilisation procedures. Biomaterials. 1996;17:2265–72.
Acknowledgements
The authors wish to thank Marco Vaghetti MD for the precious help in the revision of the manuscript.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Briganti, E., Kayal, T.A., Kull, S. et al. The effect of gamma irradiation on physical–mechanical properties and cytotoxicity of polyurethane–polydimethylsiloxane microfibrillar vascular grafts. J Mater Sci: Mater Med 21, 1311–1319 (2010). https://doi.org/10.1007/s10856-009-3943-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10856-009-3943-6