Degradable properties of biodegradable composite stents in the trachea

doi:10.3969/j.issn.2095-4344.2013.29.017

Abstract

Abstract:

BACKGROUND: Through a full investigation of biodegradable scaffolds, we propose a new self-expanding degradable poly-L-lactide coated endotracheal stent based on the design, production, experimental and clinical applications of nickel titanium memory alloy stent.
OBJECTIVE: To design a kind of biodegradable endotracheal stent with poly-L-lactide and hydroxyapatite, and to test its mechanical properties, biocompatibility and biodegradation capacity.
METHODS: With the technology of computer aided design, the stents were prepared with poly-L-lactide (M_r150 000) and hydroxyapatite materials, 20 mm to 26 mm in diameter. The mechanical properties were tested using a universal testing machine. These poly-L-lactide/hydroxyapatite stents were implanted into dog models of tracheal stenosis at an appropriate size. The histopathological changes of the tracheas were observed, and biodegradation property was studied via molecular weight changes and weight loss ratio after 4, 8, 12, 16 weeks.
RESULTS AND CONCLUSION: The average radial supporting force of the tracheal stent was 7.8 kPa, the percentage of stent surface coverage was less than 20%, the stent expansion rate was ≥ 4%, and the stent longitudinal shortening rate was ≤ 9%, which reached the mechanical requirements for degradable endotracheal stents. After 4-16 weeks, there was no significant inflammatory response. The decline in molecular weight changes and weight loss ratio was higher for in vivo degradation than in vitro degradation at different time(P < 0.05). These findings indicate that poly-L-lactide/hydroxyapatite composite stents have good mechanical properties, biocompatibility and biodegradability.

Key words: biomaterials, tissue-engineered composite scaffold, tissue-engineered bone materials, trachea, biodegradable, stent, poly-L-lactide, hydroxyapatite, biocompatibility, other grants-supported paper

CLC Number:

R318

Ma Yong-fu, Liu Yang, Guo Jun-tang, Zhang Tao, Liang Chao-yang. Degradable properties of biodegradable composite stents in the trachea[J]. Chinese Journal of Tissue Engineering Research, 2013, 17(29): 5371-5378.

Figures/Tables 4

References

[1] Bond CJ.Note on the treatment of tracheal stenosis by a new T shaped tracheotomy tube.Lancet.1891;1:539.

[2] Langer R,Vacanti JP.Tissue engneering.Since. 1993;250: 920-926.

[3] Pollok JM,Vacanti JP,Future materials for foot surgery.Sem in Pediatr Surg.1996;5(3):191-196.

[4] Liu Y,Sun Y,Zhou N,et al. Nitinol alloy endotracheal stent for treatment of tracheal stenosis.Chin Med J.1997;11(7):540-542.

[5] 刘阳,郭锦芳.镍钛记忆合金支架治疗气管狭窄的实验研究及临床应用[J].中华外科杂志,1993,31(5):267-268.

[6] 刘阳,孙玉鹗.镍钛记忆合金气管腔内支架的实验研究[J].中华胸心血管外科杂志,1995,11(4):233-234.

[7] 崔福斋.可降解医用介入支架的研发进展[J].国外塑料,2005, 23(11):58-64.

[8] Free CE,Vunjak-novakovic G,Iron KJ.Biodegradable polymer scaffoids for tissue engineering. Biotechnology(NY). 1994; 12(7):689-693.

[9] Kulkarni RK,Pani KC,Neuman C，et al.Polylatic acid for surgical implants.Archs Surg.1966;6(3):839-843.

[10] Miller RA,Brady JM,Cutright DE.Degradation rates of oral resorbable implants(polylactates and polyglycolates):rate modification with changes in PLA/PGA copolymer ratios.J Biomed Mater Res.1977;11(5):711-719.

[11] 宋存先.可降解与吸收材料—生物医用材料[M].天津:天津大学出版社,2000:50.

[12] Weisberger EC,Eppley BL. Resorbable fixation plates in head and neck surgery.Laryngoscope.1997;107(6):716-719.

[13] 祖恩峰,杨青芳,马爱洁，等.生物医用材料聚L-乳酸的生物相容性及降解性能研究[J].中国胶粘剂,2005,14(9):7-10.

[14] Verheyen CCPM,Dhert WJA,Petit PLC,et al.In vitro study on the integrity of a hydroxylapatite coating when challenged with staphylococci.J Biomed Mater Res. 1993;27:775-781.

[15] Shikinamn Y,Hata K,Okunu M.Ultra-high-strength resorbable implantsmade from bioactive ceramic particles/polylactide composites. Biocramic Proc Int Symp CeramMed.1996; 9: 391-394.

[16] Jones NL,Williams DF. Poly [L-Lactide] and Poly[L-Lactide] Ceramic filled Composites: A Long Term in- vivo / in-vitro Degradation Study. Trans.5th world Biomaterials congress. Toronto.1996,Ⅱ:441.

[17] 江东亮,漆宗能.纳米复合材料-复合材料[J].天津:天津科技大学出版社,2000:262-276.

[18] Skavtsas VI.Biomaterials and bone mechanotransduction. Biomaterials.2001;22(19):2581-2593.

[19] Suchanek WL,Shuk P,Byrappa K,et al. Mechanochemical-hydrothermal synthesis of carbonated apatite powders at room temperature.Biomaterials.2002;23: 699-714.

[20] Liu Q,Win JR,Bakker D,et al.Polyacids as bonding agents in hydroxyapatite polyester-ether (polyactiveTM30/70) composites.J Mater Sci Mater Med.1998;9:23-30.

[21] Horenstein LA.Chromosomal speciation and phenotypic evolution in the house mouse.Micro Tropical Med.2003; 275:99-112.

[22] Feng LY,Li SP,Yan YH.The Effect of CaCO3 and TiO2 Nanometer Particles on A549 and L929 Cells.Biocermics. 2000;13:325-328.

[23] 夏东,刁路明,杨飞,等.无机纳米粒子对人肺癌细胞A549和小鼠成纤维细胞L929生物学特性研究[J].湖北医科大学学报,2000, 21(2):109-111.

[24] Kim YH,Park SW,Lee CW,et al.Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions. Catheter Cardiovasc Interv.2006;67(2):181-187.

[25] 李毅,张佩华,王文祖,等.新型针织结构人工气管支架的开发及其力学性能初探[J].产业用纺织品,2002,20(12):23-26.

[26] Stack RS.Biodegradable systems.In,Bake RW,ed. Controlled release of biologically active agents.New York:John Wiley and Sons.1987:84.

[27] Swaua T.Short and long-term vascular tissue response in the Duke bioabsorbable stent.JACC.1993;21(suppl):484.

[28] Lincoff AM,Furst JG,Ellis SG,et al.Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model.J Am Coll Cardiol.1997;29:808-816.

[29] Yamawaki T,Shimokawa H,Kozai T,et al.Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo.J Am Coll Carddiol.1998;32:780-786.

[30] Tamai H, Igaki K,Kyo E,et al.Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation.2000;102:399-404.

[31] Korpela A,Aarnio P,Sariola H,et al.Bioabsorbable self-reinforced poly-L-lactide, metallic and silicone stents in the management of experimental tracheal stenosis.Chest. 1999;115(2):490-495.

[32] Leenslag JW,Penning AJ,Bos RRM,et al.Resorbable materials of poly (L-lactide) VI.Plates and screws for internal fracture. Biomaterials.1987;8: 311-314.

[33] 刘建伟,赵强.万昌秀.医用聚乳酸体内降解机理及应用研究进展[J].航天医学与医学工程,2001,14(4):308-312.

[34] 顾其胜,侯春林,徐政.实用生物医用材料学[M].上海:上海科学技术出版社,2005:87.

[35] 吴兰亭,沈正荣,朱家蕙,等.DL-聚乳酸微球大鼠体内的降解[J].生物医学工程学杂志,1994,11(2):98.

[36] Martinez J,Sanchez T,Moreno JJ. Regulation of prostaglandin E2 production by the superoxide radical and nitric oxide in mouse peritoneal macrophages. Free Radic Res.2000;32(4): 303-311.

[37] Rose ML,Rusyn I,Bojes HK,et al.Role of Kupffer cells and oxidants in signaling peroxisome proliferator-induced hepatocyte proliferation.Mutat Res.2000; 448(2):179-192.

[38] Chong IW,Lin SR,Hwang JJ,et al.Expression and regulation of macrophage inflammatory protein-2 gene by vanadium in mouse macrophages. Inflammation.2000;24(2):127-139.

[39] Li SM,Mc Carthy S.Further investigations on the hydrolytic degradation of poly(DL-lactide).Biomaterials.1999;20(1): 35-44.