本文關(guān)鍵詞： 鎂合金 全降解氣管支架 降解性能 生物相容性　出處：《鄭州大學(xué)》2017年碩士論文　論文類(lèi)型：學(xué)位論文

【摘要】：近年來(lái),氣管狹窄引發(fā)的氣管及支氣管疾病呈現(xiàn)增多的趨勢(shì),眾多治療手段中,氣管支架是非常有效的介入手段。臨床常用支架因不可降解需進(jìn)行二次取出手術(shù),同時(shí)較差的生物相容性易產(chǎn)生肉芽增生導(dǎo)致氣管再狹窄,給病人造成痛苦和負(fù)擔(dān)。因此,新型全降解氣管支架的研發(fā)作為治療氣管狹窄的新技術(shù)備受關(guān)注。本文選取實(shí)驗(yàn)室自主研發(fā)的Mg-Zn-Y-Nd合金微絲,采用單絲一體化整體性編織技術(shù)及菱形編織結(jié)構(gòu),并輔以100°C×10min的熱處理工藝,制備新型全降解鎂合金氣管支架,支架直徑8mm、長(zhǎng)度20mm、網(wǎng)眼面積5mm~2,并采用拉伸測(cè)試、壓縮測(cè)試、電化學(xué)實(shí)驗(yàn)、浸泡實(shí)驗(yàn)、掃描分析、失重分析和動(dòng)物實(shí)驗(yàn)等手段,優(yōu)選最優(yōu)支架編織工藝,探討支架體內(nèi)和體外降解行為和生物相容性能。研究表明,對(duì)鎂合金氣管支架進(jìn)行軸向拉伸性能和徑向壓縮性能測(cè)試,直徑0.16mm、0.20mm、0.24mm、0.28mm微絲編織的支架抗拉強(qiáng)度分別為107MPa、193MPa、252MPa、310MPa,延伸率分別為35%、32%、49%、43%;壓縮強(qiáng)力分別為84c N、173cN、330cN、552cN,回彈率分別為87.3%、85.4%、84.6%、79.2%。同時(shí)對(duì)比商用Ni-Ti合金支架的力學(xué)性能,直徑0.24mm微絲編織支架的力學(xué)性能與Ni-Ti合金支架接近。對(duì)不同狀態(tài)鎂合金氣管支架在模擬氣道環(huán)境(GS)中的浸泡4周發(fā)現(xiàn):未退火態(tài)支架的平均降解速率為0.3085mm/y,退火態(tài)為0.0736mm/y。未退火態(tài)支架在降解過(guò)程中有裂紋出現(xiàn),退火態(tài)支架在浸泡4周后依然保持完成的結(jié)構(gòu),降解性能良好。退火態(tài)支架的降解行為如下:(i)在絲材搭接處,降解主要以局部的點(diǎn)蝕向外擴(kuò)展,隨著時(shí)間的延長(zhǎng)發(fā)展為全面降解,支架優(yōu)先在此部位發(fā)生斷裂;(ii)在支架的其它區(qū)域,降解過(guò)程以均勻的點(diǎn)蝕為主,點(diǎn)蝕坑小且淺,向四周擴(kuò)展形成均勻降解。通過(guò)球囊擴(kuò)張技術(shù)將鎂合金氣管支架植入實(shí)驗(yàn)兔氣管內(nèi),探究支架在體內(nèi)的降解性能和生物相容性能。結(jié)果表明,支架植入體內(nèi)4周時(shí)的平均降解速率為0.5536 mm/y,在動(dòng)物體內(nèi)的降解速率稍快于在體外GS中的降解速率。X射線觀察、CT顯影、氣管組織解剖及病理切片檢測(cè)發(fā)現(xiàn):鎂合金氣管支架植入體內(nèi)膨脹良好,4周后完全降解,氣管組織未出現(xiàn)肉芽增生及明顯炎癥,未發(fā)生結(jié)構(gòu)性病變,氣管上皮細(xì)胞生長(zhǎng)良好,說(shuō)明鎂合金支架具有良好的體內(nèi)生物相容性。血液和尿液鎂離子濃度檢測(cè)及臟器病理切片觀察結(jié)果顯示:支架植入后,未造成血液和尿液中離子濃度顯著變化,未引起心、肝、脾、腎等重要臟器發(fā)生病變,說(shuō)明鎂合金支架具有良好的生物安全性。
[Abstract]:In recent years, tracheal stenosis caused by trachea and bronchial diseases show an increasing trend, many treatment methods. Tracheal stent is a very effective interventional method. Because of non-degradable stents need to be removed for a second time, and poor biocompatibility is prone to granulation proliferation, resulting in tracheal restenosis. Therefore, the research and development of new fully degradable tracheal stent as a new technology for the treatment of trachea stenosis has attracted much attention. In this paper, Mg-Zn-Y-Nd alloy microwires developed by our laboratory are selected. A new type of fully degradable magnesium alloy tracheal scaffold was prepared by using monofilament integrated braiding technique and diamond braiding structure and heat treatment process of 100 擄C 脳 10 min. The diameter of the scaffold was 8 mm. The length was 20mm, the mesh area was 5mm / 2, and the optimum braiding technology was selected by means of tensile test, compression test, electrochemical test, immersion test, scanning analysis, weightlessness analysis and animal experiment. The degradation behavior and biocompatibility of magnesium alloy trachea scaffolds in vivo and in vitro were investigated. The axial tensile properties and radial compression properties of magnesium alloy trachea scaffolds were measured and the diameter of the scaffolds was 0.16mm / 0.20mm. The tensile strength of 0.24mm / 0.28mm microfilament braided scaffold was 107MPA ~ (193) MPA ~ (252MPa) ~ (310MPa), and the elongation was 350.32% respectively. 49 and 43; The compression strength is 84c Nu 173cN 330cN 552 CN, and the springback rate is 87.3% 85.4cN, 84.6% respectively. At the same time, the mechanical properties of commercial Ni-Ti alloy scaffolds were compared. The mechanical properties of 0.24mm microfilament braided scaffold were similar to those of Ni-Ti alloy scaffold. It was found that the average degradation rate of unannealed scaffolds was 0.3085mm / y after immersion for 4 weeks. The annealed state was 0.0736mm / y. there were cracks in the unannealed scaffold during the degradation, and the annealed scaffold remained the finished structure after 4 weeks of immersion. The degradation behavior of the annealed scaffold is as follows: 1. The degradation behavior of the annealed scaffold is as follows: (1) at the place where the wire is overlapped, the degradation mainly extends outward by local pitting corrosion, and develops into a total degradation with the extension of time. The fracture of the scaffold occurred in this area. In other regions of the scaffold, the degradation process was mainly pitting corrosion, the pitting pit was small and shallow, and it spread around to form a uniform degradation. The magnesium alloy tracheal stent was implanted into the trachea of the experimental rabbit by balloon expansion technique. The biodegradability and biocompatibility of the scaffolds were investigated. The results showed that the average degradation rate was 0. 5536 mm/y after 4 weeks of stent implantation. The degradation rate in animals was a little faster than that in GS in vitro. Ct imaging was observed. The trachea tissue anatomy and pathological sections showed that magnesium alloy trachea stent implantation had good expansion in vivo. After 4 weeks of complete degradation, there was no granulation proliferation and obvious inflammation in tracheal tissue, no structural lesions occurred, and the epithelial cells of trachea grew well. It showed that magnesium alloy scaffold had good biocompatibility in vivo. The results of magnesium ion concentration in blood and urine and pathological sections of viscera showed that there was no significant change of ion concentration in blood and urine after stent implantation. No pathological changes were found in heart, liver, spleen, kidney and other important organs, indicating that magnesium alloy scaffold has good biological safety.
【學(xué)位授予單位】：鄭州大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：TG146.22;R318.08

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