Polymeric coating of surface modified nitinol stent with POSS-nanocomposite polymer

Colloids and Surfaces B: Biointerfaces

Volumn 86, Issue 1, 2011, Pages 93-105

  Bakhshi, Raheleh ^a   Darbyshire, Arnold ^a   Evans, James Eaton ^b   You, Zhong ^b   Lu, Jian ^c   Seifalian, Alexander M ^a,d  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d ROYAL FREE LONDON NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Aminosilane; Electrohydrodynamic spraying; Nanocomposite; NiTi; Stent; Surface modification

Indexed keywords

ADHESION STRENGTHS; AMINOSILANES; ARTERIAL OCCLUSIONS; BIOLOGICAL MEDIA; BIOLOGICAL REACTION; CORONARY ARTERY DISEASE; CORONARY STENTS; DRUG-ELUTING STENTS; ENDOTHELIALIZATION; HUMAN BODIES; IN-SITU; INNOVATIVE APPROACHES; LATE STAGE; NANOCOMPOSITE POLYMERS; NITI; NITI ALLOYS; NON-BIODEGRADABLE POLYMERS; PEEL STRENGTH; PHYSIOLOGICAL SOLUTION; POLYHEDRAL OLIGOMERIC SILSESQUIOXANES; POLYMER DEPOSITION; POLYMERIC COATINGS; POST-EXPOSURE; STENT; SURFACE MODIFICATION; SURFACE-MODIFIED;

BIOCOMPATIBILITY; BIODEGRADABLE POLYMERS; DISEASES; ELECTROHYDRODYNAMICS; NANOCOMPOSITES; OLIGOMERS; SURFACE TREATMENT; UREA;

PLASTIC COATINGS;

NANOCOMPOSITE; NITINOL; POLY(CARBONATE UREA)URETHANE; POLYHEDRAL OLIGOMERIC SILSESQUIOXANE; POLYMER; UNCLASSIFIED DRUG;

ADHESION STRENGTH; ARTICLE; BIOCOMPATIBILITY; CHEMICAL BOND; CHEMICAL REACTION; CONTROLLED STUDY; CORROSION; DRUG ELUTING STENT; ELECTROHYDRODYNAMIC SPRAYING; HYDROLYSIS; MATERIAL COATING; OXIDATION; PEEL STRENGTH; PEROXIDATION; PRIORITY JOURNAL; STRENGTH; SURFACE PROPERTY;

ALLOYS; BIOCOMPATIBLE MATERIALS; DRUG-ELUTING STENTS; HUMANS; NANOCOMPOSITES; NICKEL; ORGANOSILICON COMPOUNDS; OXIDATION-REDUCTION; POLYMERS; SERUM ALBUMIN; SERUM GLOBULINS; SURFACE PROPERTIES; TITANIUM;

EID: 79955837421     PISSN: 09277765     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.colsurfb.2011.03.024     Document Type: Article

References (63)

1. Es-Souni M., Es-Souni M., Fischer-Brandies H. Assessing the biocompatibility of NiTi shape memory alloys used for medical applications. Analytical and Bioanalytical Chemistry 2005, 381(3):557-567.
2. Shabalovskaya S.A. Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. Biomedical Materials and Engineering 2002, 12(1):69-109.
3. Plant S.D., Grant D.M., Leach L. Surface modification of NiTi alloy and human platelet activation under static and flow conditions. Materials Letters 2007, 61(14-15):2864-2867.
4. Shafiq N., Malhotra S., Pandhi P., Grover A., Uboweja A. A meta-analysis of clinical trials of paclitaxel- and sirolimus-eluting stents in patients with obstructive coronary artery disease. British Journal of Clinical Pharmacology 2005, 59(1):94-101.
5. Bavry A.A., Bhatt D.L. Appropriate use of drug-eluting stents: balancing the reduction in restenosis with the concern of late thrombosis. Lancet 2008, 371(9630):2134-2143.
6. Karagkiozaki V.C., Logothetidis S.D., Kassavetis S.N., Giannoglou G.D. Nanomedicine for the reduction of the thrombogenicity of stent coatings. International Journal of Nanomedicine 2010, 5:239-248.
7. Maekawa K., Kawamoto K., Fuke S., Yoshioka R., Saito H., Sato T., et al. Severe endothelial dysfunction after sirolimus-eluting stent implantation. Circulation 2006, 113(23):E850-E851.
8. Webster M.W.I., Ormiston J.A. Drug-eluting stents and late stent thrombosis. Lancet 2007, 370(9591):914-915.
9. Bennett M.R. In-stent stenosis: pathology and implications for the development of drug eluting stents. Heart 2003, 89(2):218-224.
10. Finn A.V., Kolodgie F.D., Harnek J., Guerrero L.J., Acampado E., Tefera K., et al. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation 2005, 112(2):270-278.
11. Kollum M., Farb A., Schreiber R., Terfera K., Arab A., Geist A., et al. Particle debris from a nanoporous stent coating obscures potential antiproliferative effects of tacrolimus-eluting stents in a porcine model of restenosis. Catheterization and Cardiovascular Interventions 2005, 64(1):85-90.
12. Mazumder M.M., De S., Trigwell S., Ali N., Mazumder M.K., Mehta J.L. Corrosion resistance of polyurethane-coated nitinol cardiovascular stents. Journal of Biomaterials Science, Polymer Edition 2003, 14(12):1351-1362.
13. Trigwell S., De S., Sharma R., Mazumder M.K., Mehta J.L. Structural evaluation of radially expandable cardiovascular stents encased in a polyurethane film. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2006, 76(2):241-250.
14. Zdrahala R.J. Small caliber vascular grafts. Part II. Polyurethanes revisited. Journal of Biomaterials Applications 1996, 11(1):37-61.
15. Salacinski H.J., Tai N.R., Carson R.J., Edwards A., Hamilton G., Seifalian A.M. In vitro stability of a novel compliant poly(carbonate-urea)urethane to oxidative and hydrolytic stress. Journal of Biomedical Materials Research 2002, 59(2):207-218.
16. Seifalian A.M., Salacinski H.J., Tiwari A., Edwards A., Bowald S., Hamilton G. In vivo biostability of a poly(carbonate-urea)urethane graft. Biomaterials 2003, 24(14):2549-2557.
17. Kannan R.Y., Salacinski H.J., Odlyha M., Butler P.E., Seifalian A.M. The degradative resistance of polyhedral oligomeric silsesquioxane nanocore integrated polyurethanes: an in vitro study. Biomaterials 2006, 27(9):1971-1979.
18. Kannan R.Y., Salacinski H.J., De Groot J., Clatworthy I., Bozec L., Horton M., et al. The antithrombogenic potential of a polyhedral oligomeric silsesquioxane (POSS) nanocomposite. Biomacromolecules 2006, 7(1):215-223.
19. Punshon G., Sales K.M., Vara D.S., Hamilton G., Seifalian A.M. Assessment of the potential of progenitor stem cells extracted from human peripheral blood for seeding a novel vascular graft material. Cell Proliferation 2008, 41(2):321-335.
20. de M.A., Punshon G., Ramesh B., Sarkar S., Darbyshire A., Hamilton G., et al. In situ endothelialization potential of a biofunctionalised nanocomposite biomaterial-based small diameter bypass graft. Biomedical Materials and Engineering 2009, 19(4-5):317-331.
21. Kannan R.Y., Salacinski H.J., Sales K., Butler P.E., Seifalian A.M. The endothelialization of polyhedral oligomeric silsesquioxane nanocomposites: an in vitro study. Cell Biochemistry and Biophysics 2006, 45(2):129-136.
22. R. Bakhshi, M.J. Edirisinghe, A. Darbyshire, Z. Ahmad, A.M. Seifalian, Electrohydrodynamic jetting behaviour of polyhedral oligomeric silsesquioxane nanocomposite. Journal of Biomaterials Applications (2008) [Epub ahead of print].
23. Gupta A., Seifalian A.M., Ahmad Z., Edirisinghe M.J., Winslet M.C. Novel electrohydrodynamic printing of nanocomposite biopolymer scaffolds. Journal of Bioactive and Compatible Polymers 2007, 22(3):265-280.
24. Hale P., Turgeon S., Horny P., Lewis F., Brack N., Van R.G., et al. X-ray photoelectron emission microscopy and time-of-flight secondary ion mass spectrometry analysis of ultrathin fluoropolymer coatings for stent applications. Langmuir 2008, 24(15):7897-7905.
25. Hopkins C.G., McHugh P.E., McGarry J.P. Computational investigation of the delamination of polymer coatings during stent deployment. Annals of Biomedical Engineering 2010, 38(7):2263-2273.
26. Hoffmann R., Mintz G.S., Haager P.K., Bozoglu T., Grube E., Gross M., et al. Relation of stent design and stent surface material to subsequent in-stent intimal hyperplasia in coronary arteries determined by intravascular ultrasound. American Journal of Cardiology 2002, 89(12):1360-1364.
27. Molitor P., Barron V., Young Y. Surface treatment of titanium for adhesive bonding to polymer composites: a review. International Journal of Adhesion & Adhesives 2001, 21:129-136.
28. Food and Drug Administration, Guidance for industry and FDA staff, non-clinical tests and recommended labeling for intravascular stents and associated delivery systems. , 2005. http://www%20fda%20gov/cdrh/ode/guidance/1545%20html.
29. Huang Y., Venkatraman S.S., Boey F.Y., Lahti E.M., Umashankar P.R., Mohanty M., et al. In vitro and in vivo performance of a dual drug-eluting stent (DDES). Biomaterials 2010, 31(15):4382-4391.
30. Unger F., Westedt U., Hanefeld P., Wombacher R., Zimmermann S., Greiner A., et al. Poly(ethylene carbonate): a thermoelastic and biodegradable biomaterial for drug eluting stent coatings?. Journal of Controlled Release 2007, 117(3):312-321.
31. Levy Y., Mandler D., Weinberger J., Domb A.J. Evaluation of drug-eluting stents' coating durability - clinical and regulatory implications. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2009, 91(1):441-451.
32. Hanefeld P., Westedt U., Wombacher R., Kissel T., Schaper A., Wendorff J.H., et al. Coating of poly(p-xylylene) by PLA-PEO-PLA triblock copolymers with excellent polymer-polymer adhesion for stent applications. Biomacromolecules 2006, 7(7):2086-2090.
33. Kim H.J., Moon M.W., Kim D.I., Lee K.R., Oh K.H. Observation of the failure mechanism for diamond-like carbon film on stainless steel under tensile loading. Scripta Materialia 2007, 57:1016-1019.
34. H. Salacinski, S. Hancook, A.M. Seifalian, inventors, Polymer for use in conduits, medical devices and biomedical surface modification, patent Int. App. PCT/GB2005/000489, 2005, 2005.
35. Cheng F.T., Shi P., Man H.C. Nature of oxide layer formed on NiTi by anodic oxidation in methanol. Materials Letters 2005, 59(12):1516-1520.
36. Blum F.D., Meesiri W., Kang H.J., Gambogi J.E. Hydrolysis, adsorption, and dynamics of silane coupling agents on silica surfaces. Journal of Adhesion Science and Technology 1991, 5(6):479-496.
37. ASTM D413-98(2007) Standard test methods for rubber property-adhesion to flexible substrate, 2009.
38. Michiardi A., Aparicio C., Planell J.A., Gil F.J. New oxidation treatment of NiTi shape memory alloys to obtain Ni-free surfaces and to improve biocompatibility. Journal of Biomedical Materials Research Part B-Applied Biomaterials 2006, 77B(2):249-256.
39. Shabalovskaya S., Anderegg J., Van H.J. Critical overview of Nitinol surfaces and their modifications for medical applications. Acta Biomaterialia 2008, 4(3):447-467.
40. van Ooij W.J., Zhu D., Palanivel V., Lamar J.A., Stacy M. Overview: the potential of silanes for chromate replacement in metal finishing industries. Silicon Chemistry 2006, 3:11-30.
41. Methods for producing adhesive bonds between substrate and polymer employing an intermediate oxide layer, inventors patent United States Patent 4364731, 1982, 1982.
42. Petrie E.M. Adhesion & bonding: silanes as primers and adhesion promoters for metal substrates. Metal finishing 2007, 105(7-8):85-93.
43. Sundararajan G.P., van Ooij W.J. Silane based pretreatments for automotive steels. Surface Engineering 2000, 16(4):315-320.
44. Hu T., Chu C.L., Yin L.H., Pu Y.P., Dong Y.S., Guo C., et al. In vitro biocompatibility of titanium-nickel alloy with titanium oxide film by H2O2 oxidation. Transactions of Nonferrous Metals Society of China 2007, 17(3):553-557.
45. Pohl M., Glogowski T., Kuhn S., Hessing C., Unterumsberger F. Formation of titanium oxide coatings on NiTi shape memory alloys by selective oxidation. Materials Science and Engineering A-Structural Materials Properties Microstructure and Processing 2008, 481:123-126.
46. El Abedin S.Z., Welz-Biermann U., Endres F. A study on the electrodeposition of tantalum on NiTi alloy in an ionic liquid and corrosion behaviour of the coated alloy. Electrochemistry Communications 2005, 7(9):941-946.
47. Wisbey A., Gregson P.J., Peter L.M., Tuke M. Effect of surface-treatment on the dissolution of titanium-based implant materials. Biomaterials 1991, 12(5):470-473.
48. Liu X.P., Wang Y.N., Yang D.Z., Qi M. The effect of ageing treatment on shape-setting and superelasticity of a nitinol stent. Materials Characterization 2008, 59(4):402-406.
49. Yin Y., Wise S.G., Nosworthy N.J., Waterhouse A., Bax D.V. Covalent immobilisation of tropoelastin on a plasma deposited interface for enhancement of endothelialisation on metal surfaces. Biomaterials 2009, 30:1675-1681.
50. Xi T., Gao R., Xu B., Chen L., Luo T., Liu J., et al. In vitro and in vivo changes to PLGA/sirolimus coating on drug eluting stents. Biomaterials 2010, 31(19):5151-5158.
51. Shaulov Y., Okner R., Levi Y., Tal N., Gutkin V., Mandler D., et al. Poly(methyl methacrylate) grafting onto stainless steel surfaces: application to drug-eluting stents. ACS Applied Materials & Interfaces 2009, 1(11):2519-2528.
52. Hooper K.A. Characterization of the inflammatory response to biomaterials using a rodent air pouch model. Journal of Biomedical Materials Research 2000, 50(3):365-374.
53. Lee D. In vivo imaging of hydrogen peroxide with chemiluminescent nanoparticles. Nature Materials 2007, 6:765-769.
54. Unger F, Westedt U., Hanefeld P., Wombacher R., Zimmermann S., Greiner A., et al. Poly(ethylene carbonate): a thermoelastic and biodegradable biomaterial for drug eluting stent coatings?. Journal of Controlled Release 2007, 117(3):312-321.
55. Wan Y.Z., Wang Y.L., Zheng L.Y., Zhou F.G., Zhao Q., Cheng G.X. Influence of external stress on the in vitro degradation behavior of C3D/PLA composites. Journal of Materials Science Letters 2001, 20:1659-1957.
56. Cho H.H., Han D.W., Matsumura K., Tsutsumi S., Hyon S.H. The behavior of vascular smooth muscle cells and platelets onto epigallocatechin gallate-releasing poly(l-lactide-co-epsilon-caprolactone) as stent-coating materials. Biomaterials 2008, 29(7):884-893.
57. Hanefeld P., Westedt U., Wombacher R., Kissel T., Schaper A., Wendorff J.H., et al. Coating of poly(p-xylylene) by PLA-PEO-PLA triblock copolymers with excellent polymer-polymer adhesion for stent applications. Biomacromolecules 2006, 7(7):2086-2090.
58. Wang X., Zhang X., Castellot J., Herman I., Iafrati M., Kaplan D.L. Controlled release from multilayer silk biomaterial coatings to modulate vascular cell responses. Biomaterials 2008, 29(7):894-903.
59. Westedt U., Wittmar M., Hellwig M., Hanefeld P., Greiner A., Schaper A.K., et al. Paclitaxel releasing films consisting of poly(vinyl alcohol)-graft-poly(lactide-co-glycolide) and their potential as biodegradable stent coatings. Journal of Controlled Release 2006, 111(1-2):235-246.
60. Heintz C., Riepe G., Birken L., Kaiser E., Chakfe N., Morlock M., et al. Corroded nitinol wires in explanted aortic endografts: an important mechanism of failure?. Journal of Endovascular Surgery 2001, 8(3):248-253.
61. Berger-Gorbet M., Broxup B., Rivard C., Yahia L.H. Biocompatibility testing of NiTi screws using immunohistochemistry on sections containing metallic implants. Journal of Biomedical Materials Research 1996, 32(2):243-248.
62. Yang Y., Zhang Q., Wu K., Zhang L., Lin C., Tang P. A novel electrochemical strategy for improving blood compatibility of titanium-based biomaterials. Colloids and Surfaces. B, Biointerfaces 2010, 79(1):309-313.
63. Ye S., Johnson C.A., Woolley J.R., Murata H., Gamble L.J., Ishihara K., et al. Simple surface modification of a titanium alloy with silanated zwitterionic phosphorylcholine or sulfobetaine modifiers to reduce thrombogenicity. Colloids and Surfaces. B, Biointerfaces 2010, 79(2):357-364.