發(fā)布時(shí)間：2018-01-08 14:23

  本文關(guān)鍵詞：生物可降解膽管覆膜支架的制備及其壓縮性能數(shù)值模擬　出處：《東華大學(xué)》2017年博士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： FCBBS 網(wǎng)狀結(jié)構(gòu) 壓縮性能 有限元 體外降解

【摘要】：肝膽類疾病以發(fā)病率和死亡率高、并發(fā)癥多等特點(diǎn)成為當(dāng)今威脅人類生命健康的疾病之一,其中最為常見(jiàn)的是良惡性肝膽管疾病引起的膽管狹窄阻塞,導(dǎo)致梗阻性黃疸、膽管炎、胰腺炎、膽管結(jié)石等并發(fā)癥的產(chǎn)生,嚴(yán)重威脅人類生活質(zhì)量。目前治療良惡性膽管狹窄的主要手段是借助放射介入技術(shù)膽管支架植入:內(nèi)鏡下膽管支架植入和經(jīng)皮肝穿刺膽管支架植入,該方法能夠很大程度改善膽管引流,緩解患者病情,并且創(chuàng)傷及痛苦小。膽管支架安放成功率超過(guò)90%,已經(jīng)得到醫(yī)生及患者的肯定。目前臨床上,常用的膽管支架有塑料膽管支架和金屬膽管支架,隨著臨床實(shí)踐的積累,塑料支架與金屬支架遠(yuǎn)期療效存在缺陷,并發(fā)癥(支架狹窄、堵塞、移位等)發(fā)生率較高,需要反復(fù)取出更換,增加患者治療風(fēng)險(xiǎn)與經(jīng)濟(jì)負(fù)擔(dān)。因此,研究完全可降解的生物可降解膽管覆膜支架(FCBBS)具有重要意義。FCBBS是一種能有效對(duì)膽管狹窄部位進(jìn)行一定時(shí)間持續(xù)擴(kuò)張,并能自行降解,反應(yīng)產(chǎn)物對(duì)人體無(wú)毒副作用,還可依托覆膜結(jié)構(gòu)能夠防止支架再狹窄,減少了支架植入并發(fā)癥產(chǎn)生的風(fēng)險(xiǎn)。本文根據(jù)紡織技術(shù),設(shè)計(jì)并制備了一系列不同結(jié)構(gòu)參數(shù)的FCBBS,通過(guò)壓縮測(cè)試與有限元方法,闡述了結(jié)構(gòu)參數(shù)與覆膜結(jié)構(gòu)對(duì)支架壓縮性能、應(yīng)力應(yīng)變的影響。主要研究?jī)?nèi)容如下:本文首先設(shè)計(jì)了fcbbs,該支架由生物可降解膽管裸支架(ncbbs)與覆膜部分組成。ncbbs是菱形網(wǎng)狀結(jié)構(gòu),具有一定孔隙率、交織點(diǎn)多、結(jié)構(gòu)平整穩(wěn)定的特點(diǎn);采用靜電紡技術(shù)對(duì)ncbbs進(jìn)行覆膜得到fcbbs,覆膜層具有纖維直徑小、比表面積大、高孔隙率的特點(diǎn)。本文選用具有良好生物相容性的可降解材料聚對(duì)二氧環(huán)己酮(pdo)單絲作為ncbbs用材料,首先研究pdo單絲力學(xué)性能和體外降解性能,研究結(jié)果顯示:pdo單絲具有較好力學(xué)性能,其中,pdo單絲拉伸斷裂強(qiáng)度隨單絲直徑增大而減小,抗彎剛度隨單絲直徑增加而增加;體外降解試驗(yàn)顯示:pdo單絲在整個(gè)降解過(guò)程中的前8周,表面形態(tài)保持較好,質(zhì)量變化很小,質(zhì)量保持率維持在97.5%以上,在降解過(guò)程后期12-16周,pdo單絲表面出現(xiàn)裂紋,并有片狀脫落現(xiàn)象發(fā)生,pdo單絲試樣在16周后的質(zhì)量保持率為80.42%;pdo單絲拉伸斷裂強(qiáng)度、抗彎剛度測(cè)試能夠維持12周,在降解過(guò)程末期,pdo單絲變得脆弱易碎,容易被拉伸測(cè)試儀的夾頭夾碎,導(dǎo)致測(cè)試無(wú)法繼續(xù)進(jìn)行。在整個(gè)降解過(guò)程中,pdo單絲拉伸斷裂強(qiáng)度保持率逐漸降低,降解過(guò)程進(jìn)行到10周時(shí),強(qiáng)度保持率僅為16.39%。pdo單絲抗彎剛度隨降解時(shí)間的增長(zhǎng)而增加,12周時(shí),抗彎剛度增加了45.45%;采用可降解聚己內(nèi)酯材料(pcl),利用正交試驗(yàn)研究了不同靜電紡工藝參數(shù)對(duì)pcl薄膜中纖維形態(tài)、纖維直徑、孔隙率、表面積-體積比以及力學(xué)性能指標(biāo)的影響,確定了適合制備fcbbs覆膜材料的最優(yōu)靜電紡工藝參數(shù):pcl濃度:18.0g/100ml,聚二甲基甲酰胺(dmf)百分比:43%,電壓:15kv。利用不同直徑pdo單絲,制備了12種不同結(jié)構(gòu)參數(shù)ncbbs,利用優(yōu)選的靜電紡方法對(duì)網(wǎng)狀菱形結(jié)構(gòu)ncbbs和商用mtn-da型鎳鈦合金膽管支架(mtn-da)進(jìn)行覆膜,制備了12種不同結(jié)構(gòu)參數(shù)fcbbs和1種mtn-da型鎳鈦合金膽管覆膜支架(fcm),通過(guò)壓縮測(cè)試,對(duì)比分析兩種覆膜支架以及生物可降解膽管支架覆膜前后的壓縮性能。研究結(jié)果顯示:fcbbs和fcm的壓縮回復(fù)曲線基本相同,均表現(xiàn)出一定程度的塑性變形;同種直徑不同編織頭數(shù)的fcbbs的最大壓縮力隨編織頭數(shù)的增大而增大,相同編織頭數(shù)的fcbbs的最大壓縮力隨pdo單絲直徑增大同樣增大;在壓縮過(guò)程中,對(duì)fcbbs與fcm出現(xiàn)的最大壓縮力進(jìn)行比較,結(jié)果表明:單絲直徑為0.29mm時(shí),12頭fcbbs的最大壓縮力較大一些,而10頭fcbbs接近于fcm最大壓縮力。單絲直徑為0.36mm時(shí),8頭、10和12頭fcbbs最大壓縮力均大于fcm,由此可知,上述結(jié)構(gòu)參數(shù)fcbbs力學(xué)性能夠達(dá)到臨床要求;比較生物可降解膽管支架覆膜前后最大壓縮力可知,fcbbs最大壓縮力大于對(duì)應(yīng)結(jié)構(gòu)參數(shù)ncbbs。本文根據(jù)實(shí)測(cè)用fcbbs與ncbbs,利用solidworks和abaqus軟件,設(shè)計(jì)不同編織頭數(shù)、pdo單絲直徑的ncbbs和fcbbs數(shù)值模型,并對(duì)上述支架數(shù)值模型進(jìn)行線彈性和彈塑性壓縮數(shù)值模擬分析,研究支架結(jié)構(gòu)在壓縮過(guò)程中對(duì)其應(yīng)力應(yīng)變的影響,以及覆膜結(jié)構(gòu)對(duì)支架應(yīng)力應(yīng)變的影響。研究結(jié)果顯示:對(duì)單絲直徑(0.36mm)4種編織頭數(shù)ncbbs進(jìn)行線彈性壓縮數(shù)值模擬預(yù)分析,比較壓縮數(shù)值模擬結(jié)果與對(duì)應(yīng)支架試樣壓縮試驗(yàn)結(jié)果,壓縮數(shù)值模擬結(jié)果與試樣壓縮試驗(yàn)結(jié)果表現(xiàn)出很高一致性。從壓縮數(shù)值模型中提取壓縮力,4種不同編織頭數(shù)ncbbs壓縮力均隨壓縮位移的增加而增加,其中12頭ncbbs壓縮力最大,其次是10頭和8頭,最小的是6頭ncbbs;ncbbs中應(yīng)力集中部位主要分布在支架頭端“拱形結(jié)構(gòu)”和單絲交織點(diǎn)處。比較4種編織頭數(shù)ncbbs在壓縮過(guò)程中出現(xiàn)的最大應(yīng)力值,編織頭數(shù)越大的ncbbs出現(xiàn)的最大應(yīng)力值越大,說(shuō)明越容易發(fā)生損害。對(duì)9種不同編織頭數(shù)、單絲直徑的fcbbs進(jìn)行彈塑性壓縮數(shù)值模擬分析,提取fcbbs壓縮數(shù)值模型中壓縮力,fcbbs壓縮力大小隨支架單絲直徑增加而增加,同樣隨支架編織頭數(shù)增加而增加,比較壓縮力的壓縮數(shù)值模擬結(jié)果與試樣壓縮試驗(yàn)結(jié)果,兩者表現(xiàn)出較高一致性;fcbbs中裸支架應(yīng)力集中較高區(qū)域主要分布在支架頭端、支架兩側(cè)和支架中心部分,且應(yīng)力大小變化劇烈,分布不均勻,fcbbs覆膜部分應(yīng)力集中區(qū)域主要分布在薄膜頭端和中間部位,應(yīng)力大小變化平緩,分布比較均勻;比較不同結(jié)構(gòu)參數(shù)fcbbs最大應(yīng)力值,單絲直徑相同時(shí),fcbbs最大應(yīng)力值隨編織頭數(shù)增大而增大,當(dāng)編織頭數(shù)相同時(shí),fcbbs最大應(yīng)力值隨單絲直徑增加而增大;fcbbs塑性耗散能隨壓縮時(shí)間增長(zhǎng)而增加,其中,pdo單絲直徑0.29mm(12頭)與0.36mm(12頭)2種fcbbs塑性耗散能大于其它7種fcbbs塑性耗散能,說(shuō)明上述結(jié)構(gòu)參數(shù)fcbbs較難發(fā)生塑性變形;9種fcbbs在壓縮過(guò)程中均產(chǎn)生塑性形變,其中5種fcbbs塑性應(yīng)變僅發(fā)生在薄膜部分,分別是:pdo單絲直徑0.29mmm(8頭、10頭)2種fcbbs與pdo單絲直徑0.23mmm(8頭、10頭、12頭)3種fcbbs。比較fcbbs與ncbbs彈塑性壓縮數(shù)值模擬結(jié)果可知,從壓縮數(shù)模模型中提取壓縮力,fcbbs壓縮力大于對(duì)應(yīng)結(jié)構(gòu)參數(shù)ncbbs壓縮力值;fcbbs最大應(yīng)力值大于對(duì)應(yīng)結(jié)構(gòu)參數(shù)ncbbs最大應(yīng)力;對(duì)比不同結(jié)構(gòu)參數(shù)fcbbs與ncbbs塑性耗散能,fcbbs塑性耗散能大于對(duì)應(yīng)結(jié)構(gòu)參數(shù)ncbbs產(chǎn)生的塑性耗散能;9種結(jié)構(gòu)參數(shù)fcbbs最大塑性應(yīng)變值均大于零,已經(jīng)發(fā)生塑性應(yīng)變,而ncbbs僅單絲直徑0.36mm3種編織頭數(shù)(8頭、10頭、12頭)類型支架的最大塑性應(yīng)變大于零,發(fā)生塑性應(yīng)變;比較fcbbs中裸支架與ncbbs最大塑性應(yīng)變變化規(guī)律,pdo單絲直徑0.36mm3種編織頭數(shù)(8頭、10頭、12頭)與pdo單絲直徑0.29mm(12頭)fcbbs模型中裸支架部分發(fā)生塑性應(yīng)變,而ncbbs模型中,只有pdo單絲直徑0.36mm,3種編織頭數(shù)(8頭、10頭、12頭)ncbbs發(fā)生塑性應(yīng)變。本文將fcbbs放置到無(wú)菌人體膽汁環(huán)境中,研究其體外降解規(guī)律,與細(xì)胞共同培養(yǎng),了解其生物相容性情況,研究結(jié)果顯示:fcbbs在降解前后,結(jié)構(gòu)發(fā)生顯著變化,在降解前,fcbbs結(jié)構(gòu)完整,支架中pdo單絲顏色為藍(lán)色,pcl薄膜完整無(wú)破裂,且與fcbbs中裸支架粘附較好。隨降解過(guò)程逐步進(jìn)行,pdo單絲顏色逐漸消失變?yōu)榘胪该鳡?pcl薄膜與fcbbs中裸支架粘附作用減弱,甚至發(fā)生脫落。降解過(guò)程后期,fcbbs中pdo單絲出現(xiàn)斷裂,支架發(fā)生坍塌,失去支撐能力;9種FCBBS在降解過(guò)程前2周,其最大壓縮力值明顯下降,降解過(guò)程2-10周,FCBBS最大壓縮力呈不穩(wěn)定態(tài)勢(shì)增加,在降解過(guò)程中后期,FCBBS最大壓縮力又開(kāi)始下降,直到支架發(fā)生坍塌無(wú)法測(cè)量,其中,單絲直徑0.36mm(8頭、10頭、12頭)FCBBS壓縮力保持時(shí)間最長(zhǎng),約為24周。其次是單絲直徑0.29mm(8頭、10頭、12頭)FCBBS,壓縮力保持時(shí)間為22周,壓縮力保持時(shí)間最短的是單絲直徑0.23mm(8頭、10頭、12頭)FCBBS,保持時(shí)間為16周;9種FCBBS質(zhì)量變化趨勢(shì)基本相同,在降解過(guò)程前8周,質(zhì)量變化不明顯,在降解過(guò)程中后期,FCBBS質(zhì)量加快減小;將臍帶靜脈內(nèi)皮細(xì)胞種植到FCBBS中PDO單絲和覆膜PCL材料上面共同培養(yǎng),經(jīng)過(guò)七天時(shí)間生長(zhǎng)后,細(xì)胞數(shù)量明顯增多,細(xì)胞骨架和細(xì)胞核完全伸展,生存狀態(tài)良好,說(shuō)明FCBBS具有良好生物相容性。綜上所述,本文在紡織結(jié)構(gòu)FCBBS的設(shè)計(jì)、選材、制備、性能測(cè)試以及有限元方法模擬分析方面進(jìn)行了系統(tǒng)研究,為支架結(jié)構(gòu)優(yōu)化以及臨床應(yīng)用提供參考依據(jù)。
[Abstract]:Hepatobiliary disease with high morbidity and mortality, complications and other characteristics has become one of the most life-threatening disease today, which is the most common benign and malignant bile duct stricture of bile duct obstruction caused by disease, cause obstructive jaundice, cholangitis, pancreatitis, biliary stone and other complications, a serious threat to human life quality. Is the use of interventional biliary stent implantation mainly means the treatment of benign and malignant biliary stenosis: endoscopic biliary stenting and percutaneous transhepatic biliary stent implantation, this method can greatly improve the biliary drainage, alleviate the patient's condition, and little trauma and pain. Biliary stent placement success rate of over 90%, has been doctors and patients sure. The current clinical, biliary stents are commonly used plastic biliary stent and metal stent, with the clinical practice and the accumulation of plastic stents and gold The long-term curative effect of stent is defective, complications (stent blockage, displacement) occurred at a higher rate, the need to repeatedly removed, increasing the risk of patient treatment and economic burden. Therefore, the research of bile duct stent biodegradable completely biodegradable (FCBBS) has the important significance of.FCBBS is an effective for stenosis of bile duct was the duration of expansion, and self degradation reaction product of toxic side effects on the human body can also rely on the structure of film can prevent the stent restenosis, reduce the risk of stent implantation complications. According to the textile technology, and design a series of different structural parameters were prepared by FCBBS, by the compression test and the finite element method, elaborated the structure parameters and the structure of film on the compression performance of stents, the influence of stress and strain. The main research contents are as follows: firstly, the design of the fcbbs, the stent is made of biodegradable Bile duct stent (ncbbs) is composed of.Ncbbs and coated diamond mesh structure has certain porosity, interlacing points, structure formation and stability characteristics of ncbbs film; fcbbs by electrostatic spinning technology, coating layer has small fiber diameter, large surface area, high porosity. The selection of good biocompatibility biodegradable material poly two oxygen cyclohexanone (PDO) monofilament as ncbbs material, first study the properties and in vitro degradation of PDO monofilament mechanics, the results showed that PDO monofilament had good mechanical properties, the tensile strength of PDO monofilament with monofilament diameter increases, the flexural stiffness with fiber diameter increased increase; display in vitro degradation test: PDO monofilament during the whole degradation process in the first 8 weeks, the surface morphology is very good, the quality change is very small, the quality of maintenance in more than 97.5%, in the degradation process During the period of 12-16 weeks, PDO filament surface cracks and flaking phenomenon, PDO monofilament sample retention rate was 80.42% in quality after 16 weeks; PDO monofilament tensile strength test, flexural stiffness can be maintained for 12 weeks in the degradation process of the late PDO monofilament crumbly easily, tensile tester the chuck is broken, causing the test to continue. During the whole degradation process, PDO monofilament tensile strength retention rate decreased gradually, the degradation process of the 10 week, the strength retention rate of only 16.39%.pdo monofilament bending stiffness degradation with the increase of time increased at 12 weeks, the bending stiffness increased 45.45%; the use of degradable polycaprolactone materials (PCL), the orthogonal experiment was conducted to study the effects of electrospinning parameters on PCL thin film fiber morphology, fiber diameter, porosity, surface effect volume ratio and mechanical properties were determined for the area. Preparation of fcbbs coated material optimal electrospinning parameters: PCL concentration: 18.0g/100ml, poly two methyl formamide (DMF) percentage: 43%, voltage: 15kv. with different diameters of PDO monofilament, 12 different structural parameters of ncbbs were prepared on diamond mesh structure ncbbs and commercial mtn-da type nickel titanium alloy stent by electrostatic the preferred method of spinning (mtn-da) coated with 12 different structural parameters, fcbbs and 1 mtn-da nickel titanium alloy stent was prepared by bile duct (FCM), through compression test, comparative analysis of two kinds of biodegradable stent and bile duct stent coating before and after compression performance. The results showed that fcbbs and FCM compression response curve is basically the same, showed a certain plastic deformation degree; the maximum compressive force with different diameter knitting head number fcbbs with the increase of the number of knitting head increases, the maximum compression force the same knitting head number fcbbs The same with the increase of PDO filament diameter increased; in the compression process, the fcbbs and FCM of the maximum compression stress were compared. The results show that the fiber diameter is 0.29mm, 12 fcbbs of the maximum compression stress is larger, and the 10 head fcbbs is close to FCM maximum compression force. The filament diameter is 0.36mm, 8. 10 and 12 fcbbs maximum compression force was greater than FCM, therefore, the structure parameters of fcbbs mechanical properties can meet the clinical requirement; comparison of biodegradable stent coating before and after the maximum pressure of the fcbbs maximum compression force is greater than the corresponding ncbbs. structural parameters according to the measured by fcbbs and ncbbs, using SolidWorks and ABAQUS software, the design of different braiding head the number of ncbbs and fcbbs numerical model of PDO filament diameter, and the support of numerical model of linear elastic and elastic-plastic compression numerical simulation analysis of support structure in the compression process of the The influence of stress and strain, and the structure of film to support the influence of stress and strain. The results showed that the fiber diameter (0.36mm) of 4 kinds of numerical simulation analysis of linear elastic knitting head pre compression ncbbs, compression numerical simulation results and experimental results corresponding to support sample compression, compression and compression test specimens numerical simulation results the results show high consistency. The extraction of compression force from compression numerical model, 4 different braiding head number ncbbs compression force were increasing with the compression displacement, the maximum compression force of 12 ncbbs, followed by 10 and 8, the minimum is 6 ncbbs; the main distribution concentrated part of interlacing point at the end of "arch support structure" and the single stress ncbbs. Comparison of 4 kinds of knitting head number ncbbs in the compression process of the maximum stress, maximum knitting head the greater the number of ncbbs stress value is bigger, that is to The occurrence of the damage. On 9 different braiding head number, filament diameter fcbbs elastic plastic compression numerical simulation analysis, extraction pressure fcbbs compression numerical model of compression, fcbbs compression force increases with the increase of fiber diameter increased with the same bracket, bracket knitting head number increased, compared the simulation results with the compression compression force sample numerical compression test results, which showed high consistency; stent fcbbs stress concentration area mainly distributed in the higher end bracket, and the support bracket on both sides of the central part, and the stress size change, uneven distribution, fcbbs covered part of the stress concentration area is mainly distributed in the head end and the middle part of the film. Stress changes smoothly and evenly distributed; comparison of different structure parameters fcbbs the maximum stress value, the filament diameter is fcbbs at the same time, the maximum stress value increases with the knitting head number increases, when the knitting head number At the same time, the maximum stress value of fcbbs with the fiber diameter increased; fcbbs plastic dissipation energy increases with the compression time growth of which PDO filament diameter 0.29mm (12 head) and 0.36mm (12) of 2 kinds of fcbbs plastic dissipation energy is greater than the other 7 kinds of fcbbs plastic dissipation energy, the structure parameters fcbbs is difficult to occur plastic deformation; 9 kinds of fcbbs produce plastic deformation in the compression process, including 5 kinds of fcbbs plastic strain occurs only in the films, which are PDO 0.29mmm filament diameter (8 head, 10 head) 2 fcbbs and PDO 0.23mmm filament diameter (8 head, 10 head, 12 head) 3 fcbbs. fcbbs compared with ncbbs elastic-plastic compression numerical simulation results show that the compression force from the compression modulus extraction model, fcbbs compression force is greater than the corresponding structural parameters of ncbbs compression force; fcbbs maximum stress value is greater than the corresponding structural parameters of ncbbs maximum stress; comparison of different structural parameters fcbbs and ncbbs plastic dissipation Fcbbs energy, plastic dissipation energy is greater than the corresponding structural parameters of ncbbs produced by the plastic dissipation energy; 9 kinds of structure parameters of fcbbs the maximum plastic strain values are greater than zero, have plastic strain, while the ncbbs only 0.36mm3 filament diameter knitting head (8 head, 10 head, 12 head) the type of stent the plastic strain is greater than zero, the plastic strain; fcbbs stent and ncbbs law of plastic strain change, PDO monofilament diameter 0.36mm3 braided head number (8 head, 10 head, 12 head) and PDO (12) 0.29mm monofilament diameter stents of fcbbs model plastic strain. While the ncbbs model, only PDO filament diameter 0.36mm, 3 knitting head number (8 head, 10 head, 12 head) plastic strain ncbbs. The fcbbs is placed into a sterile environment in human bile, study the degradation in vitro, co cultured with cells, understanding its biological compatibility condition, study shows in: fcbbs degradation Before and after, significant changes have taken place in the structure, before degradation, fcbbs structure, PDO monofilament stent for the color blue, PCL film complete rupture, and fcbbs stent with good adhesion. The degradation process step by step, PDO monofilament becomes translucent color gradually disappear, weaken the bare stent adhesion of PCL thin films and fcbbs and even drop. The degradation process of the late fcbbs PDO monofilament breakage, stent collapse, loss of support ability; 9 kinds of degradation of FCBBS in the first 2 weeks, the maximum compressive force value decreased, the degradation process of 2-10 weeks, FCBBS maximum compression force was not steady increase late during the degradation. FCBBS maximum compression force began to decline, until the stent collapse cannot be measured, the filament diameter 0.36mm (8 head, 10 head, 12 head) FCBBS compression force remains the longest time for about 24 weeks. Then the filament diameter 0.29mm (8 head, 10 head, 12 head) F CBBS, the compressive force is maintained for 22 weeks, the compressive force holding time is the shortest fiber diameter 0.23mm (8 head, 10 head, 12 head) FCBBS, keep time for 16 weeks; 9 FCBBS quality is basically the same trend, 8 weeks before the degradation process, the quality did not change significantly, late in the degradation process. In FCBBS, the quality of speed will decrease; human umbilical vein endothelial cells seeded onto the FCBBS PDO and PCL coated monofilament material co culture, after seven days of growth, the number of cells increased significantly, cytoskeleton and nucleus fully extended, survive in good condition, indicating that FCBBS has good biocompatibility. In summary, this paper design in textile the structure of the FCBBS material, preparation, simulation and analysis of aspects of the system performance test and the finite element method, provides the reference for the optimization of frame structure and clinical application.

【學(xué)位授予單位】：東華大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2017
【分類號(hào)】：R657.3;R318.08

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本文編號(hào)：1397472