The effect of sterilisation on a poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol-based polyurethane elastomer

Biomaterials

Volumn 27, Issue 25, 2006, Pages 4484-4497

  Simmons, Anne ^a   Hyvarinen, Jari ^a   Poole Warren, Laura ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

Biostability; Degradation; Environmental stress cracking (ESC); Poly (dimethylsiloxane); Polyurethanes; Sterlisation

Indexed keywords

DEGRADATION; FOURIER TRANSFORM INFRARED SPECTROSCOPY; GAMMA RAYS; GEL PERMEATION CHROMATOGRAPHY; POLYURETHANES; SCANNING ELECTRON MICROSCOPY;

BIOSTABILITY; ENVIRONMENTAL STRESS CRACKING (ESC); POLY (DIMETHYLSILOXANE); STERLISATION;

THERMOPLASTIC ELASTOMERS;

DIMETICONE; ELASTOMER; ETHYLENE OXIDE; POLY(HEXAMETHYLENE OXIDE); POLYURETHAN; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; AUTOCLAVE; CHEMICAL STRUCTURE; CONTROLLED STUDY; DEVICE; ELECTRON MICROSCOPY; EXPOSURE; GAMMA IRRADIATION; GAS; GEL PERMEATION CHROMATOGRAPHY; IMPLANTATION; INFRARED SPECTROSCOPY; INSTRUMENT STERILIZATION; LIQUID; NONHUMAN; PRIORITY JOURNAL; SHEEP; SYNTHESIS; TENSILE STRENGTH; VAPOR; WATER VAPOR;

CHROMATOGRAPHY, GEL; DIMETHYLPOLYSILOXANES; MATERIALS TESTING; MICROSCOPY, ELECTRON, SCANNING; MOLECULAR WEIGHT; POLYURETHANES; SILICONES; SPECTROSCOPY, FOURIER TRANSFORM INFRARED;

ANIMALIA; OVIS ARIES;

EID: 33646497641     PISSN: 01429612     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2006.04.017     Document Type: Article

References (49)

1. Lamba N.M.K., Woodhouse K.A., and Cooper S.L. Polyurethanes in biomedical applications (1998), CRC Press, Boca Raton
2. Stokes K., McVenes R., and Anderson J.M. Polyurethane elastomer biostability. J Biomater Appl 9 4 (1995) 321-354
3. Pinchuk L. A review of the biostability and carcinogenicity of polyurethanes in medicine and the new generation of biostable polyurethanes. J Biomater Sci Polym Ed 6 3 (1994) 225-267
4. Shibayama M., Suetsugu M., Sakurai S., Yamamoto T., and Nomura S. Structure characterization of polyurethanes containing poly(dimethylsiloxane). Macromolecules 24 23 (1991) 6254-6262
5. Chun Y.C., Kim K.S., Shin J.S., and Kim K.H. Synthesis and characterization of poly(siloxane urethane)s. Polymer International 27 2 (1992) 177-185
6. Hergenrother R.W., Yu X.H., and Cooper S.L. Blood-contacting properties of polydimethylsiloxane polyurea-urethanes. Biomaterials 15 8 (1994) 635-640
7. Gunatillake P.A., Meijs G.F., McCarthy S.J., and Adhikari R. Poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol based polyurethane elastomers. I. Synthesis and properties. J Appl Polym Sci 76 (2000) 2026-2040
8. Martin D.J., Poole-Warren L.A., Gunatillake P.A., McCarthy S.J., Meijs G.F., and Schindhelm K. Polydimethylsiloxane/polyether-mixed macrodiol-based polyurethane elastomers: biostability. Biomaterials 21 10 (2000) 1021-1029
9. Simmons A., Hyvarinen J., Odell R.A., Martin D.J., Gunatillake P.A., Noble K.R., et al. Long term in vivo biostability of poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol-based polyurethane elastomers. Biomaterials 25 20 (2004) 4887-4900
10. Booth A.F. Sterilization of medical devices (1999), Interpharm Press, Buffalo Grove, Illinois
11. Lerouge S., Guignot C., Tabrizian M., Ferrier D., Yagoubi N., and Yahia L. Plasma-based sterilization: effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters. J Biomed Mater Res 52 4 (2000) 774-782
12. Nair P.D. Currently practised sterilization methods-some inadvertent consequences. J Biomater Appl 10 2 (1995) 121-135
13. Mazzu A.L., and Smith C.P. Determination of extractable methylene dianiline in thermoplastic polyurethanes by HPLC. J Biomed Mater Res 18 8 (1984) 961-968
14. Shintani H., and Nakamura A. Analysis of a carcinogen, 4,4′-methylenedianiline, from thermosetting polyurethane during sterilization. J Anal Toxicol 13 6 (1989) 354-357
15. Hyvarinen JP, Belgraver W, Noble K, Gunatillake PA, Simmons A. Effect of sterilisation on the mechanical properties of polyurethanes. In: 27th annual meeting of the society for biomaterials, 2001, Saint Paul, USA.
16. Martin D.J., Poole-Warren L.A., Gunatillake P.A., McCarthy S.J., Meijs G.F., and Schindhelm K. New methods for the assessment of in vitro and in vivo stress cracking in biomedical polyurethanes. Biomaterials 22 9 (2001) 973-978
17. Rutala W.A., and Weber D.J. Disinfection of endoscopes: review of new chemical sterilants used for high-level disinfection. Infect Control Hosp Epidemiol 20 1 (1999) 69-76
18. Anderson J.M., Bevacqua B., Cranin A.N., Graham L.M., Hoffman A.S., Klein M., et al. Implants and devices. In: Ratner B.D., Hoffman A.S., Schoen F.J., and Lemons J.E. (Eds). Biomaterials science (1996), Academic Press, London 415-420
19. Bathina M.N., Mickelsen S., Brooks C., Jaramillo J., Hepton T., and Kusumoto F.M. Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters. J Am Coll Cardiol 32 5 (1998) 1384-1388
20. McCarthy S.J., Meijs G.F., Mitchell N., Gunatillake P.A., Heath G., Brandwood A., et al. In-vivo degradation of polyurethanes: transmission-FTIR microscopic characterization of polyurethanes sectioned by cryomicrotomy. Biomaterials 18 21 (1997) 1387-1409
21. Terheyden H., Lee U., Ludwig K., Kreusch T., and Hedderich J. Sterilization of elastic ligatures for intraoperative mandibulomaxillary immobilization. Br J Oral Maxillofac Surg 38 4 (2000) 299-304
22. Zhang Y.Z., Bjursten L.M., Freij-Larsson C., Kober M., and Wesslen B. Tissue response to commercial silicone and polyurethane elastomers after different sterilization procedures. Biomaterials 17 23 (1996) 2265-2272
23. Abraham G.A., Frontini P.M., and Cuadrado T.R. Physical and mechanical behavior of sterilized biomedical segmented polyurethanes. J Appl Polym Sci 65 6 (1997) 1193-1203
24. Hemmerich K.J. Polymer materials selection for radiation-sterilized products. Med Device Diagn Ind Mag (2000)
25. Hermanson NJ, Steffen JF. The physical and visual property changes in thermoplastic resins after exposure to high energy sterilisation-gamma versus electron beam. In: Antec 93 conference proceedings, 1993.
26. Hermanson NJ, Navarette L, Crittendon P. The Effects of High-Energy and EtO Sterilisation on Thermoplastics. Med Device Diagn Ind Mag, 1997.
27. Sturdevant M. Plastics in medicine: how sterilisation changes long-term resin properties. Plast Eng 47 1 (1991) 27-32
28. Gorna K., and Gogolewski S. The effect of gamma radiation on molecular stability and mechanical properties of biodegradable polyurethanes for medical applications. Polym Degrad Stabil 79 3 (2003) 465-474
29. Shintani H., and Nakamura A. Degradation and cross-linking of polyurethane irradiated by gamma-rays. Polym Degrad Stabil 32 2 (1991) 191-208
30. Shintani H., Kikuchi H., and Nakamura A. Effects of gamma-ray irradiation on the change of characteristics of polyurethane. J Appl Polym Sci 41 3-4 (1990) 661-675
31. Meijs G.F., McCarthy S.J., Rizzardo E., Chen Y.C., Chatelier R.C., Brandwood A., et al. Degradation of medical-grade polyurethane elastomers: the effect of hydrogen peroxide in vitro. J Biomed Mater Res 27 3 (1993) 345-356
32. Liston E.M., Martinu L., and Wertheimer M.R. Plasma surface modification of polymers for improved adhesion: a critical review. J Adhes Sci Technol 7 (1993) 1091-1127
33. Lerouge S., Tabrizian M., Wertheimer M.R., Marchand R., and Yahia L. Safety of plasma-based sterilization: surface modifications of polymeric medical devices induced by Sterrad and Plazlyte processes. Biomed Mater Eng 12 1 (2002) 3-13
34. Gorna K., and Gogolewski S. Molecular stability, mechanical properties, surface characteristics and sterility of biodegradable polyurethanes treated with low-temperature plasma. Polym Degrad Stabil 79 3 (2003) 475-485
35. Brown S.A., Merritt K., Woods T.O., NcNamee S.G., and Hitchins V.M. Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices. Biomed Instrum Technol 36 (2002) 23-27
36. Tanzi M.C., Mantovani D., Petrini P., Guidoin R., and Laroche G. Chemical stability of polyether urethanes versus polycarbonate urethanes. J Biomed Mater Res 36 4 (1997) 550-559
37. Sheu M.S., Hudson D.M., and Loh I.H. Biomaterials surface modification using plasma gas discharge processes. In: Wise D.L., et al. (Ed). Encyclopedic handbook of biomaterials and bioengineering, part A. Materials (1995), Marcel Dekker, New York 865-894
38. Tucker R.C., Lestini B.J., and Marchant R.E. Surface analysis of clinically used expanded PTFE endoscopic tubing treated by the Steris Process. ASAIO J 42 (1996) 306-313
39. Malchesky P.S. Peracetic acid and its application to medical instrument sterilization. Artif Organs 17 3 (1993) 147-152
40. Stokes K., Urbanski P., and Upton J. The in vivo auto-oxidation of polyether polyurethane by metal ions. J Biomater Sci Polym Ed 1 3 (1990) 207-230
41. Zhao Q., Agger M.P., Fitzpatrick M., Anderson J.M., Hiltner A., Stokes K., et al. Cellular interactions with biomaterials: in vivo cracking of pre-stressed Pellethane 2363-80A. J Biomed Mater Res 24 5 (1990) 621-637
42. Zhao Q., Topham N., Anderson J.M., Hiltner A., Lodoen G., and Payet C.R. Foreign-body giant cells and polyurethane biostability: in vivo correlation of cell adhesion and surface cracking. J Biomed Mater Res 25 2 (1991) 177-183
43. Hergenrother R.W., Wabers H.D., and Cooper S.L. Effect of hard segment chemistry and strain on the stability of polyurethanes: in vivo biostability. Biomaterials 14 6 (1993) 449-458
44. Hergenrother R.W., Wabers H.D., and Cooper S.L. The effect of chain extenders and stabilizers on the invivo stability of polyurethanes. J Appl Biomater 3 1 (1992) 17-22
45. Sato M., Xi T., Nakamura A., Kawasaki Y., Umemura T., Tsuda M., et al. Degradation of polyetherurethane by subcutaneous implantation into rats. II. Changes of contact angles, infrared spectra, and nuclear magnetic resonance spectra. J Biomed Mater Res 29 10 (1995) 1201-1213
46. Xi T., Sato M., Nakamura A., Kawasaki Y., Umemura T., Tsuda M., et al. Degradation of polyetherurethane by subcutaneous implantation into rats. I. Molecular weight change and surface morphology. J Biomed Mater Res 28 4 (1994) 483-490
47. Ayzman I., Dibs S.R., Goldberger J., Passman R., and Kadish A. In vitro performance characteristics of reused ablation catheters. J Interv Card Electrophysiol 7 1 (2002) 53-59
48. Ma N., Petit A., Huk O.L., Yahia L., and Tabrizian M. Safety issue of re-sterilization of polyurethane electrophysiology catheters: a cytotoxicity study. J Biomater Sci Polym Ed 14 3 (2003) 213-226
49. Brown S.A., Merritt K., Woods T.O., McNamee S.G., and Hitchins V.M. Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices. Biomed Instrum Technol 36 1 (2002) 23-27