镍钛形状记忆合金在脊柱外科的应用

镍钛（NiTi）形状记忆合金以其优良的形状记忆效应、超弹性和生物组织相容性在骨科领域得到越来越广泛的应用。近年来脊柱外科飞速发展，脊柱内固定器械层出不穷，对于极具发展潜力的生物医用材料—NiTi合金备受关注。     

钛铌涂层镍钛记忆合金的骨组织生物相容性

目的对镍钛(NiTi)记忆合金植入物进行表面修饰是屏蔽Ni离子释放的有效方法 ,钛铌(TiNb)合金作为涂层材料不会影响NiTi的超弹性和记忆效应。对TiNb涂层的NiTi记忆合金植入体植入骨组织后的骨组织生物相容性进行评价,为临床应用提供实验依据。方法对直径4mm、长12mm的NiTi记忆合金圆柱体采用磁控溅射技术分别进行Ti涂层和TiNb涂层,另一组仅表面抛光清洗不进行涂层。取成年杂种犬15只,体重(15±2)kg,随机分为3组,每组5只,分别为NiTi组、Ti涂层组和TiNb涂层组。制备犬双侧股骨干假体植入模型,垂直股骨外侧皮质分别植入NiTi无涂层、Ti涂层和TiNb涂层记忆合金圆柱体,每只犬植入10枚,间距1.0～1.5cm。术后12个月处死动物取材,X线片观察植入体植入方向,未与股骨皮质垂直的植入体标本作为无效标本放弃,其余有效标本一部分(NiTi组、Ti涂层组和TiNb涂层组标本数分别为12、10和14枚)进行生物力学推出实验,计算最大剪切强度;另一部分(NiTi组、Ti涂层组和TiNb涂层组标本数分别为8、5和10枚)行不脱钙切片用于组织学观察和计算骨性结合率。结果 Ti涂层组和TiNb涂层组的剪切强度分别为(95.10±10.03)、(91.20±15.42)MPa,明显高于NiTi组的(71.60±14.24)MPa(P0.01);2个涂层组间比较差异无统计学意义(P0.05)。Giemsa染色示3组植入体周围均未见明显巨噬细胞和中性粒细胞浸润,偶尔可见少量淋巴细胞。NiTi组、Ti涂层组和TiNb涂层组的骨性结合率分别为21.30%±0.23%、32.50%±0.31%和38.60%±0.58%,3组间比较差异均有统计学意义(P0.01)。结论各植入体和骨组织均具有良好的生物相容性;Ti涂层和TiNb涂层的骨生物相容性相近,但从骨性结合率结果分析,TiNb涂层的骨组织生物相容性更佳。     

镍钛合金钛与钛铌涂层防止Ni2+析出的体内实验研究

[目的]探讨镍钛合金（NiTi）表面金属钛（Ti）、钛铌合金（TiNb）涂层后对Ni2＋析出的影响.[方法]成年犬18只,随机分为4组,NiTi组、Ti涂层组、TiNb涂层组各5只,空白组3只,分别于骶棘肌内和股骨内植入立方体试件和圆柱型试件各10枚,12个月后处死取材,用石墨炉原子吸收仪分别检测心、肝、脾,肺、肾、脑、骨、鼻咽粘膜、血液、肌肉、试件周围的骨组织和肌肉组织的Nit2＋含量.[结果]非修饰的NiTi组试件周围的骨组织和肌肉组织的Ni2＋含量与同组同种组织、异组同种组织的Ni2＋含量有显著差异（P〈0.05）.[结论]本试验初步证明,NiTi表面金属钛、钛铌合金涂层起到了防止Ni2＋析出的作用.     

可降解镁合金腐蚀及生物相容性

镁合金有良好的生物相容性和可降解性,有潜力成为骨科临时性植入材料,为创伤或病变组织愈合期间提供暂时的机械支持.新型可降解镁合金生物材料已引起高度关注.该文就镬合金腐蚀、腐蚀影响因素及生物相容性等作一综述.     

新配方生物可降解镁锌合金的研究进展

镁合金作为人体组织可降解材料具有优良的物理特性,已经成为材料科学、生物医学等领域的研究热点,其在骨植入物、心血管支架等领域得到了广泛研究。但目前植入物多为商用镁合金,生物降解性能、生物相容性不够理想,给植入生物材料的安全性带来很大隐患。本文回顾一系列体内体外实验,就新型镁锌合金——Mg-6Zn的生物降解和生物相容性研究进展进行总结,认为Mg-6Zn合金生物降解行为基本符合要求,生物相容性良好,具有广阔应用前景。     

抗菌金属植入材料的研究进展

传统金属植入材料（如不锈钢、钛及其合金）具有良好的生物相容性、综合力学性能和生物环境下的抗腐蚀性,已被广泛大量应用于临床。但有统计数据提示,美国每年200万例院内感染病例中大约一半与植入物有关,英国每年植入物相关感染大约花费700—1100万英镑。     

镁钙合金的细胞毒性研究

目的观察镁钙合金对体外细胞生长的影响,对镁钙合金的生物相容性进行评价。方法根据ISO10993-5:1999及GB/T16886.5-2003标准,将不同浓度镁钙合金浸提液与L-929细胞接触培养,进行细胞的形态学观察及四甲基偶氮唑盐(MTT)比色,评价镁钙合金的细胞毒性。结果细胞形态学观察显示,阳性对照组细胞脱落、死亡,其余各组细胞贴壁生长,形态正常。MTT显示镁钙合金浸提液对细胞的毒性0级,无明显细胞毒性。结论镁钙合金的细胞毒性为0级,符合临床应用的要求。     

钛铌锆β钛合金生物相容性的体外实验研究

[目的]通过体外实验对自行研发的低弹性模量、高强度新型β型钛合金人工关节假体材料生物相容性进行评价。[方法]（1）采用L-929细胞（小鼠成纤维细胞）对合金进行细胞毒性试验,将细胞相对增殖率（RGR）转换成6级材料毒性进行评级。（2）将1μm左右的钛铌锆合金（Ti-Nb-Zr）颗粒与J774A.1巨噬细胞体外共同培养24～48h后,采用倒置相差显微镜和透射电镜观察细胞变化、RT-PCR方法测定IL-6和TNF-α表达、ELISA法测定细胞培养上清TNF-α等方法对Ti-Nb-Zr的生物相容性进行评价,并与传统的人工关节假体材料进行比较。[结果]Ti-Nb-Zr的细胞毒性为0级。吞噬了Ti-Nb-Zr颗粒的J774A.1巨噬细胞形态改变明显轻于钴铬钼颗粒组和钛铝钒颗粒组。巨噬细胞与钛铝钒合金颗粒、钴铬钼合金颗粒和Ti-Nb-Zr颗粒共同培养48h后都有IL-6和TNF-αmRNA表达的增加,钴铬钼颗粒和钛铝钒颗粒引起增加更加明显。ELISA方法测定显示：巨噬细胞吞噬Ti-Nb-Zr颗粒48h后分泌TNF-α的量明显低于钛铝钒和钴铬钼（P〈0.05）。[结论]低弹性模量Ti-Nb-Zr钛合金具有优良的体外组织相容性,是一种有前途的骨科内植物材料。     

医用金属表面的钽涂层制备及其临床应用趋势

金属钽具有极佳的耐腐蚀性和优异的生物相容性,目前受到越来越多的医学和材料科学工作者的关注,但其高昂的原料成本限制了其在生物医用领域的广泛应用,因此人们采用多种方法制各钽涂层以降低成本。该文综述钽的生物学优势,医用金属（不锈钢、钛合金、钴铬合金）表面的钽涂层制备及其临床应用趋势。     

低弹性模量骨科植入物材料-β钛合金的研制与实验研究

[目的]研制一种低弹、高强、生物相容性更好的新型β型钛合金骨科植入物材料。[方法]采用国内先进工艺将合金元素（钛、铌、锆）熔炼、浇注成铸造态合金。在高温区锻造，得到锻造变形合金。共制备了四种元素比例不同的合金。采用X线衍射分析、扫描电镜和透射电镜观察合金的微观晶体结构，采用拉伸实验初步研究其低弹、高强的力学性能。[结果]X线衍射分析证实四种合金均为单一的β相。合金抗拉强度：706～874Mpa，弹性模量：59～66Gpa，延伸率：5．4％～20％。时效处理提高了合金的强度，对合金的弹性模量无明显影响。[结论]钛铌锆β合金是一种有前途的骨科植入物材料。     

Titanium-nickel alloy stand for urethrostenosis caused by prostatauxe]

Self-made spiral tubular stand of titanium-nickel alloy, characterized by shape memory effect and good biocompatibility, was used in 15 patients with urethro-stenosis caused by prostatauxe. Of these patients, 14 restored normal urination and 1 failed because of technical problems. With the shape memory feature of titanium-nickel alloy, the stand may be easily inserted and long-term set in the prostatic urethra. This safe, simple method is particularly suitable to the aged patients.     

On Dwyer's scoliosis operation using memory alloy wire (author's transl)

In Dwyer's spinal column correction a titanium cable is stretched from vertebra to vertebra by a special clamp and secured to each vertebra with screws and clips. It is suggested to replace the titanium wire with wire consisting of the memory alloy NiTi. This will permit the prestretched wire to be tensioned by heating it to 60 deg C after it has been fixed at its ends in the vertebrae. The functional principle of the NiTi memory wire was demonstrated in an experiment carried out on a plastic model. This consists of 8 plastic vertebrae with 30 mm sides which are connected by interposed wedge-shaped soft rubber discs, giving the model a curved shape. Memory wire prestretched by 7% is led through eylets on the convex side and fixed at the ends. On being heated (electrically in this experiment for the sake of simplicity), the wire shortens, righting the model so that it assumes a straight shape. The authors also describe in detail the manufacture of the alloy, i.e. the melting and shaping operations, as well as the properties of the material, that is, the stress-strain and strain-temperature relationships and the transformation temperatures, as well as mechanical problems.     

类金刚石镀膜形状记忆合金与成骨细胞生物相容性的研究

目的研究类金刚石(diamond-like carbon, DLC)镀膜形状记忆合金对体外培养的成骨细胞生物学行为的影响. 方法选择规格相同的DLC镀膜镍钛(NiTi)记忆合金(镀膜组)、非镀膜记忆合金(非镀膜组)各30片与体外培养的成骨细胞混合培养,并设立空白对照组(不加材料的单纯细胞培养组),观察细胞的增殖情况.收集第1～5 天的细胞培养液,测定其中的碱性磷酸酶(alkaline phosphatase,ALP)、Ni2 含量及成骨细胞计数. 结果镀膜组和对照组细胞计数及ALP浓度均高于非镀膜组;细胞计数,第3、4及5天,镀膜组及对照组与非镀膜组比较,差异有统计学意义(P<0.05);ALP浓度,镀膜组第2、3及5天,对照组第3、4及5天,与非镀膜组比较,差异有统计学意义(P＜0.05).Ni2 含量低于非镀膜组,第3、4及5天与非镀膜组比较,差异有统计学意义(P<0.05). 结论 DLC镀膜形状记忆合金的组织相容性明显优于非镀膜组.     

Zur dwyerschen skoliosenoperation mittels drähten aus memory-legierungen

Zusammenfassung Bei der Dwyerschen Wirbelsäulenkorrektur wird mittels einer Spezialspannzange ein Titankabel von Wirbelkörper zu Wirbelkörper verspannt und an jedem einzelnen mittels Schrauben in Agraffen festgeklemmt. Hier wird vorgeschlagen, das Titankabel durch einen Draht aus Memory-Legierung NiTi zu ersetzen. Dies ermöglicht das Spannen des vorgereckten Drahtes durch einfache Erwärmung auf etwa 60°C, nachdem dieser an den Enden in den Wirbelkörpern verankert wurde.Die Wirkungsweise des NiTi-Drahtes wurde in einem prinzipiellen Versuch an einem Kunststoffmodell demonstriert. Das Modell besteht aus 8 Kunststoff wirbeln von 30 mm Kantenlänge, die durch dazwischengeklebte keilförmige Weichgummischeiben verbunden sind. Dadurch erhält das Modell eine gekrümmte Form. Der auf der konvexen Seite durch Ösen geführte und an den Enden verankerte Memory-Draht ist um 7% vorgereckt. Er wird in diesem Versuch der Einfachheit halber elektrisch aufgeheizt, verkürzt sich und richtet das Modell in eine gerade Form aus.In diesem Zusammenhang werden auch ausführlich die Herstellung der Legierung, d. h. Erschmelzen und Umformen, die Eigenschaften, d. h. Spannungs-Dehnungs-Verhalten, Dehnungs-Temperatur-Verhalten und Umwandlungstemperaturen sowie mechanische Probleme beschrieben.

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On DWYER'S scoliosis operation using memory alloy wire

Summary In Dwyer's spinal column correction a titanium cable is stretched from vertebra to vertebra by a special clamp and secured to each vertebra with screws and clips. It is suggested to replace the titanium wire with wire consisting of the memory alloy NiTi. This will permit the prestretched wire to be tensioned by heating it to 60 deg C after it has been fixed at its ends in the vertebrae.The functional principle of the NiTi memory wire was demonstrated in an experiment carried out on a plastic model. This consists of 8 plastic vertebrae with 30 mm sides which are connected by interposed wedge-shaped soft rubber discs, giving the model a curved shape. Memory wire prestretched by 7% is led through eylets on the convex side and fixed at the ends. On being heated (electrically in this experiment for the sake of simplicity), the wire shortens, righting the model so that it assumes a straight shape.The authors also describe in detail the manufacture of the alloy, i.e. the melting and shaping operations, as well as the properties of the material, that is, the stress-strain and strain-temperature relationships and the transformation temperatures, as well as mechanical problems.

     

研究使用新型内固定器融合舟骨和大小多角骨

目的研究新型舟骨和大小多角骨融合器的应用效果。方法根据所测国人舟骨、大小多角骨和舟骨、大小多角骨关节有关解剖学参数设计,选用镍钛记忆合金制出样品,利用大型有限元分析软件进行生物力学测试,修改后制作出成品,并将其应用于月骨无菌性坏死及舟骨旋转性半脱位的患者。结果2005--2010年,共30例月骨无菌性坏死及舟骨旋转性半脱位患者术后疼痛消失或者缓解,运动度较术前增加,平均握力为44．4kg,达到健侧的77％。结论镂空式镍钛记忆合金融合器进行舟骨和大小多角骨融合技术,可以提供足够的腕骨间固定强度,有效用于腕骨间融合。     

镍钛形状记忆合金锔钉用于硅橡胶涤纶丝网颅骨修补

为解决硅橡胶涤纶丝网颅骨修补用丝线固定手术操作繁琐、固定不牢等问题，先将镍钛形状记忆合金锔钉置于０℃～３℃水中，锔钉变软，用撑开器将其臂杆拉长３ｍｍ，锔钉的两脚与臂杆间夹角加大成直角。然后将锔钉的两脚钉入颅骨与成形片上的两个钻孔中，用热盐水纱布热敷锔钉，锔钉遇热立即恢复原状，并产生恢复力，将颅骨和成形片牢固锔在一起。１９８７年８月～１９９５年８月，临床应用这种锔钉行颅骨修补１０１例，随访到１００例，随访时间为１年～８年。结果，９８例术后无不良反应，２例额骨缺损者，术后第一天发现患侧额肌运动障碍，术后２个月恢复正常。无一例发生锔钉松动和成形片错位。认为，镍钛形状记忆合金锔钉用于硅橡胶涤纶丝网颅骨修补有以下优点：①手术操作简便；②固定牢固；③术后组织反应轻；④合并症少；⑤整形效果良好；⑥对颅脑ＣＴ及核磁共振检查无干扰；⑦锔钉用于颅骨修补未见致癌     

Electromagnetic induction heating of an orthopaedic nickel–titanium shape memory device

Shape memory orthopaedic implants made from nickel–titanium (NiTi) might allow the modulation of fracture healing, changing their cross‐sectional shape by employing the shape memory effect. We aimed to show the feasibility and safety of contact‐free electromagnetic induction heating of NiTi implants in a rat model. A water‐cooled generator–oscillator combination was used. Induction characteristics were determined by measuring the temperature increase of a test sample in correlation to generator power and time. In 53 rats, NiTi implants were introduced into the right hind leg. The animals were transferred to the inductor, and the implant was electromagnetically heated to temperatures between 40 and 60°C. Blood samples were drawn before and 4 h after the procedure. IL‐1, IL‐4, IL‐10, TNF‐α, and IFN‐γ were measured. Animals were euthanized at 3 weeks. Histological specimens from the hind leg and liver were retrieved and examined for inflammatory changes, necrosis, and corrosion pits. Cytokine measurements and histological specimens showed no significant differences among the groups. We concluded that electromagnetic induction heating of orthopedic NiTi implants is feasible and safe in a rat model. This is the first step in the development of new orthopedic implants in which stiffness or rigidity can be modified after implantation to optimize bone‐healing. © 2010 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 28:1671–1676, 2010     

镍钛形状记忆合金蟹爪式聚髌器的研制及生物力学研究

目的　研究一种治疗髌骨骨折的新的内固定方法。　方法　根据国人髌骨的统计数据 ,采用镍钛形状记忆合金制做蟹爪式聚髌器 ,并进行生物力学研究。　结果　对髌骨横行骨折 ,蟹爪式聚髌器的固定作用明显优于改良张力带钢丝固定 (P <0 .0 0 1) ;对髌骨粉碎性骨折 ,聚髌器的固定作用亦明显优于环形钢丝固定 (P <0 .0 0 1)。　结论　蟹爪式聚髌器设计符合髌骨的解剖和生物力学特点 ,其对髌骨骨折的固定强度可满足临床应用之需要。     

头状骨、月骨、三角骨、钩骨测量及四角融合器的设计

目的测量头状骨、月骨、三角骨、钩骨,为研制适于腕骨四角融合术的内固定器械提供解剖学依据,并设计镍钛记忆合金腕骨四角融合器（NiTi shape memory alloy four—comer arthrodesis concentrator,NT—FCAC）。方法解剖45侧成人腕骨标本,保留腕掌、背侧韧带,切除大、小多角骨和手舟骨,游标卡尺测量头状骨、月骨、三角骨、钩骨各骨间距;然后,解剖出上述四腕骨,观察各骨形态,游标卡尺测量各参数;最后,依据测量结果及四腕骨解剖形态特点,结合镍钛记忆合金的特性,设计镍钛记忆合金腕骨四角融合器。结果头月间距最小为（24．75±3．13）mm,钩月间距（29．46±2．85）mm,月三角间距（26．48±2．08）mm;三角骨厚度最小为（8．76±0．91）mm;依据测量结果及镍钛记忆合金的特性,设计出了镍钛记忆合金腕骨四角融合器。结论依据头状骨、月骨、三角骨和钩骨解剖特点及测量结果,结合镍钛记忆合金的特性,能够设计出适于腕骨四角融合术的内固定器械。     

Flexor tendon repair using shape memory alloy suture: a biomechanical evaluation

The purpose of the current study was to test in vitro a new shape memory alloy suture for flexor tendon repair. Forty fresh-frozen human anatomic flexor superficialis and profundus tendons were divided and repaired via the cruciate four-strand technique using one of two suture materials (the shape memory alloy suture and the 4-0 Ethibond suture). The forces required to cause a 1, 2, and 3 mm gap, ultimate load to failure, and repair stiffness were compared. Twenty specimens of each suture material also were tensile tested for load to failure, tensile strength, and elongation at failure. The shape memory alloy suture had a significantly higher mean resistance force to 1, 2, and 3 mm gap formation than the 4-0 Ethibond suture (47 N versus 31 N, 51 N versus 36 N, and 57 N versus 41 N, respectively). The shape memory alloy suture repair was 40% stronger than the 4-0 Ethibond suture (61.9 +/- 8.8 N versus 44.3 +/- 10.6 N). Repair with the shape memory alloy suture was significantly stiffer than repair with the 4-0 Ethibond suture (8.1 +/- 1.0 N/mm versus 6.1 +/- 0.9 N/mm). The load to failure and tensile strength of the shape memory alloy suture were significantly higher than that of the 4-0 Ethibond suture. The values of elongation for the two materials were not significantly different. The results of the current study suggest that the shape memory alloy suture may be superior to the 4-0 Ethibond suture in resisting gap formation in the range of forces generated in the early rehabilitation protocol and may be the future material of choice for tendon repairs.