Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (22): 3603-3608.doi: 10.3969/j.issn.2095-4344.3175
Wen Zhijing1, Gu Pengzhen1, He Xijing1, 2, Li Jialiang1, Wang Yibin1, Wang Yiqun1
Received:
2020-06-18
Revised:
2020-06-24
Accepted:
2020-07-29
Online:
2021-08-08
Published:
2021-01-21
Contact:
He Xijing, MD, PhD, Professor, Doctoral supervisor, Chief physician, Department of Orthopedics, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China; Xi’an International Medical Center Hospital, Xi’an 710100, Shaanxi Province, China
About author:
Wen Zhijing, Doctoral candidate, Department of Orthopedics, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
Supported by:
CLC Number:
Wen Zhijing, Gu Pengzhen, He Xijing, Li Jialiang, Wang Yibin, Wang Yiqun. Development of high molecular polymer polyetherketoneketone and its prospects in medical applications[J]. Chinese Journal of Tissue Engineering Research, 2021, 25(22): 3603-3608.
2.1 聚醚酮酮的起源及合成 早在20世纪60年代初,美国杜邦公司的BONER就率先提出了聚醚酮酮的合成方法,聚醚酮酮树脂可以采用亲核和亲电两种聚合路线的方法来合成,并且该公司于1987年实现了亲电路线合成聚醚酮酮的工业化生产[6]。 亲电取代合成法:是合成聚醚酮酮最常用的方法,首先在60-80 ℃下使二苯醚和对苯二甲酰氯在硝基苯溶液中进行缩合产生聚醚酮酮,但是由于反应温度高导致得到的聚醚酮酮分子质量较低,因此采用低温下聚合的方法,以AlCl3为催化剂、1,2-二氯乙烷为溶剂,并在N2气氛下二苯醚和对苯二甲酰氯通过傅-克反应,最终得到分子质量较高的聚醚酮酮,该方法容易操作、成本较低且工艺相对简单,但是产物的性能纯度不够[6,8]。 亲核取代反应:以二苯砜作为溶剂,经过 K2CO3/Na2CO3的催化,N2气氛下对苯二酚和4,4’-双(对氟苯甲酰基)苯在300 ℃高温下反应五六小时合成,该方法合成的聚醚酮酮性能稳定,但是由于反应条件复杂难以控制,因此成本相对较高[6,8]。 2.2 聚醚酮酮在非医学领域的应用 自开发以来,聚醚酮酮由于高温稳定性等性能及与许多增强剂(玻璃和碳纤维)的相容性和比其他许多金属具有更高的强度等特性,使其在航空航天领域率先应用起来,现在已经成为其不可或缺的一部分[2]。由于其较强的抗辐射能力,可用作飞机等电线的包覆材料;另外其优异的机械性能可用来制作耐热的连接器等,可以利用其作为基体复合碳纤维、玻璃纤维等增强复合材料制备飞机的舱体、操纵杆及直升飞机尾翼等[6,8]。 在工业中,由于聚醚酮酮具有良好的耐化学腐蚀等性能,常用来制作压缩机阀门、活塞片及各种化工用泵等零部件;在汽车制造业中,由于其良好的力学性能,可以代替不锈钢和钛等金属用于制造发动机内罩,另外包括轴承、离合器齿轮等汽车零部件均使用聚醚酮酮制作而成;除此之外,在电子电气领域还被用作制造电子绝缘膜片、晶片承载器等各种连接器件[5]。 2.3 聚醚酮酮在生物医学领域的应用 金属材料如不锈钢、钛及其合金等作为常见的植入物材料在骨科、口腔科等已被广泛运用,但是由于其弹性模量(不锈钢:199 GPa,医用钛合金:114 GPa)与皮质骨(0.8-22.3 GPa)及牙本质(17.7-21.1 GPa)等差异较大[9-10],会产生应力遮挡,从而引起植入物塌陷等并发症,严重影响疾病的预后。近年来由于高分子材料的飞速发展,聚醚酮酮作为一种新兴的生物相容高性能聚合物,其弹性模量为4.5 GPa,与皮质骨及牙本质接近,已被美国FDA批准作为植入物设备逐渐被应用于生物医学领域[11]。 2.3.1 聚醚酮酮在骨科领域的应用 颈椎前路椎体切除后前路融合术和颈椎前路椎间盘切除后前路融合术已成为治疗多节段颈椎管狭窄的常用方法,自1958年SMITH和 ROBINSON[12]在颈椎前路、椎间盘摘除和椎间融合方面做出的开创性工作之后,自体骨移植(最多取自体髂骨)结合前路钢板-螺钉植骨仍然是椎体置换的金标准,相关报道融合率很高,接近于100%[13]。近年来许多植入物被开发并应用于临床,如聚醚酮酮材料等可以用来替代自体骨移植修复重建椎体结构,不仅可以改善术前脊髓压迫症状,而且可以避免自体骨移植引起的供区并发症,如失血、感染、血肿及供体部位疼痛等[14]。 在任何关节置换中,植入物的磨损都是不可避免的,这使得磨损颗粒的发生发展成为全关节成形术后的一个可能并发症。MOORE等[15]为了开发接近于骨弹性模量且保留优异强度特性的全关节假体,研发了两种不同的复合材料(聚醚酮酮/石墨烯纤维和聚砜/石墨烯纤维),研究结果证明聚醚酮酮复合物衍生的颗粒在大鼠皮下气囊炎症模型中引起的炎症反应最小,与生理盐水对照组相同,明显小于聚砜/石墨烯纤维衍生颗粒所引起的炎症反应,且两种聚合物与假体常用材料聚甲基丙烯酸甲酯及聚乙烯等相比的炎症程度都很低。因此,该研究为聚醚酮酮类复合材料成为关节假体的组成部分提供了一定基础条件。 骨科植入物的无菌性松动往往引起植入失败,导致无菌性松动的原因有以下几点:①由于结构行为不匹配,假体周围骨骼的应力屏蔽可能导致骨吸收;②磨损碎片导致的骨溶解;③植入物与骨组织之间的相对运动导致软组织界面的发生[16]。CONVERSE等[17-18]结合粉末加工、压塑及颗粒浸出法研发制备了一种羟基磷灰石晶须增强的聚醚酮酮支架,并以骨小梁为基准,用单轴压缩的方式评估了聚醚酮酮支架的力学性能,验证其力学性能与骨小梁是否相匹配,最终75%孔隙率和20%体积含量的羟基磷灰石聚醚酮酮支架的平均弹性模量和屈服强度与人骨小梁最接近,可用作永久性植入物固定,包括椎间融合。有研究以羟基磷灰石为基底,通过原位聚合方法合成聚醚酮酮,随后制备了聚醚酮酮/羟基磷灰石复合材料,实验结果表明,聚醚酮酮/羟基磷灰石复合材料不仅提高了弹性模量(15.6 GPa)及硬度(570 MPa),与人体骨骼相当,同时还改善了生物相容性,细胞增殖率显著提升,该研究初步验证了聚醚酮酮/羟基磷灰石复合材料有着优异的生物相容性和力学匹配性,在骨科植入物应用方面前景良好。 多项研究表明,间充质干细胞可以成功用于各种目的的骨再生[19-21],并且可以在一定的体外条件下培养(β-甘油磷酸钠、抗坏血酸和地塞米松)分化为成骨细胞[22],增强体内新形成的骨量,这使得间充质干细胞成为骨科、颌面外科等骨移植材料干细胞应用的理想候选者。而聚醚酮酮作为性能良好的生物材料,可以与间充质干细胞结合作为组织工程骨骼构建的理想基础。ADAMZYK等[23]在体外验证了聚醚酮酮与间充质干细胞结合的细胞相容性;在绵羊颅骨缺损模型中,聚醚酮酮结合自体绵羊间充质干细胞植入12周后并未观察到新形成骨的体积和质量增加,与其他研究认为间充质干细胞可以促进支架新骨形成不同[21,24-25],可能与培养时间、植入时间、动物模型或间充质干细胞的来源及材料与植入支架的结构等有关。尽管如此,该研究的体外实验结果仍表明聚醚酮酮材料有利于人和绵羊间充质干细胞的附着、生长及分化,进一步的研究将对聚醚酮酮植入物进行改进以用于骨组织工程。LIN等[11]使用激光烧结技术制造了3D打印聚醚酮酮支架,并获取人滑囊液间充质干细胞接种在聚醚酮酮支架上培养,以评估细胞附着、增殖和成骨潜能,同时还建立了兔颅骨临界大小缺损模型,以测试人滑囊液间充质干细胞对聚醚酮酮的骨再生作用。最终体内外实验结果均表明,结合使用聚醚酮酮和人滑囊液间充质干细胞可有效促进骨缺损再生,该研究表明聚醚酮酮和人滑囊液间充质干细胞的联合植入可能是再生大型骨缺损一个很有前途的治疗方法。在另一个研究中,ROSKIES等[26]将脂肪干细胞种植到3D打印的多孔聚醚酮酮支架上,并建立了兔下颌骨缺损模型,将多孔聚醚酮酮支架植入到缺损中观察骨长入情况,结果表明聚醚酮酮材料复合脂肪干细胞的支架在骨缺损表面诱导出了垂直的骨再生,增加了对压缩力的抵抗力,且压缩强度是皮质骨的15倍之多。正因为聚醚酮酮/脂肪干细胞支架显示出良好的生物活性、生物相容性和生物力学强度,所以可以成为替代传统修复下颌骨缺损的一种材料,并应用于临床。YUAN等[27]设计和制作了致密及多孔的聚醚醚酮及聚醚酮酮材料,进行了体外类骨磷灰石形成实验及体内大鼠股骨缺损模型动物实验,结果表明经羟基磷灰石微球成孔剂浸出、磺化处理及模拟体液孵育等组合方法制备的聚芳醚酮类材料对骨整合性能有着显著的积极作用,且相同条件下的聚醚酮酮比聚醚醚酮拥有更好的骨整合能力,因此经过一定物理和化学处理表面改性的多孔聚醚酮酮作为骨科的永久植入物应用具有巨大的潜力。WU等[28]将氮化硅与聚醚酮酮混合制备了一种生物活性复合植入物,然后利用飞秒激光对该复合物表面进行改性获得了良好的微/纳米结构表面,通过体内外实验验证其生物相容性、抑菌性能及骨整合性能等,体外实验结果表明与普通聚醚酮酮相比,微纳米结构表面的复合物更有利于大鼠骨髓间充质干细胞的黏附、增殖和成骨分化;在体内兔股骨空洞缺损模型中,通过最大推出力等证实了微/纳米结构表面的氮化硅与聚醚酮酮复合物可以显著促进成骨和骨整合性能,在骨科领域显示出巨大的应用潜力。以上研究分别证实了经过了物理化学改性及复合了其他材料与细胞因子的聚醚酮酮作为骨科植入物的应用潜能,可以有效诱导骨再生、促进骨整合等。 骨科植入物的感染在逐步上升[29],翻修手术成为许多内植物植入失败造成感染的解决方案之一,其中就包括全膝关节置换[30]。另外,对于脊椎植入物成人的总感染率是2%(0.8%浅表感染和1.2%深部感染)[31],而使用纳米材料或纳米结构植入物表面在减少细菌附着并防止生物膜形成方面有着巨大的希望。WANG等[32]通过体外实验比较了具有纳米结构表面特征的聚醚酮酮与骨科行业标准聚醚醚酮的抗菌功能,旨在为临床上选择抗感染能力更强的骨科植入物,结果表明与传统聚醚醚酮表面相比,铜绿假单胞菌和表皮葡萄球菌在纳米级粗糙度聚醚酮酮表面上的黏附和生长减少,结果表明通过在聚醚酮酮表面形成纳米粗糙结构可以减少细菌数量,抑制细菌的感染作用。WU等[28]的实验结果也证实了经过表面改性之后获得良好微/纳米结构表面的氮化硅与聚醚酮酮复合物的抑菌性能也高于普通聚醚酮酮。因此进一步研究纳米结构的聚醚酮酮,可以提高骨科植入物的抗菌作用,利于临床推广。 2.3.2 聚醚酮酮在口腔颌面外科领域的应用 在口腔科领域,聚醚酮酮的使用主要是作为临时的种植体基体、牙科种植体、框架、可摘局部义齿的卡环等[33-37]。各种金属材料已被用于制造可摘局部义齿的卡环,而其中最常见的合金是钴铬合金[38]。KLUR等[39]从生物相容性、稳定性及舒适性等方面比较了高性能聚合物聚醚酮酮与钴铬合金制成的修复体的性能,结果表明与钴铬合金相比,聚醚酮酮临时修复体具有很高的美学优势,然而由聚醚酮酮制成的悬臂连接桥不够稳定,可能存在断裂的风险。除此之外,TANNOUS等[33]使用包括聚醚酮酮在内的热塑性树脂卡环与钴铬合金,通过插入/拔出实验模拟了卡环10年的使用,结果表明,保留一定设计的聚醚酮酮等材料树脂卡环虽然在保持力和抗疲劳性方面不能匹及钴铬合金,但是足够用于临床。 在临床上,口腔内使用聚醚酮酮修复体必须保持一定的黏合强度,因此需要验证黏合系统对聚醚酮酮修复体的黏合程度。FUHRMANN等[34]通过使用5种表面处理方法评价黏合系统对晶态、非晶态聚醚酮酮及纤维增强聚醚醚酮黏合强度和耐久性的影响,结果发现当黏合材料使用二氧化硅涂料、通用结合层和树脂树脂结合层时,可以实现对其最高且最持久的黏合。LEE等[40]对聚醚酮酮标本分别进行了95%硫酸蚀刻、50 μm氧化铝空气磨损和110 μm二氧化硅涂层氧化铝的空气磨损3种表面处理,并和5种不同黏合材料结合测定其剪切黏合强度,结果认为将树脂复合材料粘接到聚醚酮酮材料上时,建议将空气磨损表面处理与含10-甲基丙烯酰氧基癸基磷酸二氢酯或甲基丙烯酸甲酯的黏结材料相结合,而不需要对聚醚酮酮进行酸性表面处理。然而不管表面处理方法如何,含硅烷自酸蚀通用胶粘剂可作为聚醚酮酮的有效粘接材料。另外有研究表明,非等离子体处理结合喷砂处理可提高聚醚酮酮与树脂水泥之间的剪切黏合强度[41-42],浓硫酸酸蚀也能够有效提高聚醚酮酮材料的表面性能,使之与饰面树脂的粘接效果增强,且相对喷砂来说效果更为明显[43]。当用二氧化硅改性的氧化铝对聚醚酮酮柱进行喷砂处理并涂上硅烷偶联剂时,与树脂胶粘剂的黏结强度得到了最有效增强[42,44]。 PASSIA等[45]通过连接和分离循环实验评价了聚醚酮酮树脂基体附着系统的维持能力,认为其有良好的长期维持能力。CHOI等[46]在体外使用两种种植体下颌覆盖义齿模型评估咀嚼负荷和插入/拔除循环下尼龙插入物和聚醚酮酮插入物的保持能力,结果表明两者均提供了足够的维持力,且聚醚酮酮植入物的磨损更少、维持力变化小,可认为是一种很有前途的牙科连接系统。KOTTHAUS等[47]在体外比较了聚醚酮酮作为外冠与不同材料内冠结合之后的结合力和分离力,认为在经过了10 000个磨损周期(相当于10年的临床磨损期)之后依旧达到了覆盖义齿的固定力。KEWEKORDES等[48]评估了聚醚酮酮材料在不同拮抗剂作用下的磨损情况,拮抗材料分别为滑石粉、氧化锆和聚醚酮酮针头,模拟了120 万次咀嚼周期(相当于在体内模拟了5年),并使用激光扫描仪评估了加载试样的垂直物质缺失及体积缺失,结果表明在经过120 万次咀嚼后,尽管聚醚酮酮磨损量(垂直物质缺失及体积缺失)高于天然牙釉质的磨损量,但与滑石粉的磨损量相当,且显著低于氧化锆陶瓷的磨损量。因此可以认为聚醚酮酮的耐磨性较好,与滑石粉相当,且显著高于氧化锆陶瓷。 氧化锆陶瓷因其具有出色的强度和美学性能在牙科修复体中的使用越来越多[49]。BAE等[50]通过三维分析测量比较了聚醚酮酮制造及氧化锆陶瓷制造修复体与不同基牙边缘和内部的贴合度,结果表明聚醚酮酮修复体在边缘和内部贴合性方面优于氧化锆,因此有望作为修复体用于临床。LEE等[51]建立上颌中切牙的三维有限元分析模型,在牙冠腭表面上与牙齿纵轴呈45°的夹角施加50 N的循环加载力,比较了聚醚酮酮桩核系统与其他传统(金属和玻璃纤维)桩核材料的生物力学行为和长期安全性,结果表明尽管聚醚酮酮在弹性模量和弯曲强度上低于金属和玻璃纤维,但却在牙科桩核系统中表现出潜在的高抗断裂性;且相比于牙质拥有较低的弹性模量,表现出良好的应力分布曲线,相比于传统桩核材料来说发生根部折断的可能性就更小。SONG等[44]对比了聚醚酮酮桩与临床常用玻璃纤维桩的微拉伸强度,结果表明聚醚酮酮桩的微拉伸强度值要高于玻璃纤维,因此这些研究都表明聚醚酮酮有应用于临床的巨大潜能。 下颌骨节段性缺损通常是由创伤、感染和手术切除肿瘤引起的[52],临界尺寸的下颌骨缺损需要手术治疗,下颌骨重建的目标是恢复正常的外观和功能[53],其中很多重要的因素需要考虑,例如生物相容性、坚固耐用、生物活性等。微血管游离腓骨移植被认为是当代治疗下颌骨临界大小缺损的金标准,并广泛用于下颌骨重建[54-55]。聚醚酮酮作为一种可用作3D打印的生物相容性材料,具有与人体骨骼相似的力学性能。CHENG等[56]设计和分析用于下颌骨外科重建带有聚醚酮酮3D打印下颌骨模拟物的力学行为,将带有氧化锆冠的钛种植体和模拟骨内部结构的拓扑优化整合到3D虚拟模型中,进行功能加载模拟,并基于有限元模型比较了优化聚醚酮酮骨模拟模型与腓骨移植模型的应力和位移分布。结果表明,带有聚醚酮酮的骨模拟模型比腓骨移植模型产生更多的正常应力-应变轨迹,可能为下颌外科重建提供更好的功能和美观效果,值得推广使用。 "
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