CN101128164A - 由钛合金制备的关节假体 - Google Patents
由钛合金制备的关节假体 Download PDFInfo
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- CN101128164A CN101128164A CNA2006800060754A CN200680006075A CN101128164A CN 101128164 A CN101128164 A CN 101128164A CN A2006800060754 A CNA2006800060754 A CN A2006800060754A CN 200680006075 A CN200680006075 A CN 200680006075A CN 101128164 A CN101128164 A CN 101128164A
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- China
- Prior art keywords
- prosthesis
- alloy
- articular prosthesis
- titanium
- handle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C14/00—Alloys based on titanium
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
- C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
- C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
- C22F1/18—High-melting or refractory metals or alloys based thereon
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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Abstract
本发明涉及具有由钛合金制备的柄的关节假体;根据本发明,至少所述柄(10)是精密铸造的并具有体心立方晶体结构。具有所述晶体结构的钛合金(称作β-钛合金)有利地具有和生理学需求匹配的低弹性模量。而且,成形铸件形式的实施方式使得可以实现复杂成形。特别便利的是以人工髋关节的股骨假体(1)的形式实施,其具有长柄(10),柄上具有用于骨锚定的凹槽(14)和锯齿状凸起(15)。
Description
本发明涉及具有由钛合金制备的柄(schaft)的关节假体。
人体的主要关节承受着大的机械载荷。因此,运动器官的关节必须承受大部分的身体重量,而且它们在每走一步时都移动。所以,支撑关节的骨头具有强壮的皮质骨结构。它们的完整性对于关节充分发挥功能而言很重要。臂关节也是如此。尽管它们的重量载荷较低,但它们移动得更加频繁,所以经受相当大的劳损。而且,它们的尺寸更小,更容易受到伤害。
用于永久性植入的假体(内用假体)不仅仅必须具有足以保证所需功能的机械性质,而且必须具有尽可能得高以至于保证了在长时间内病人可以容忍的生物相容性。尤其是后一方面极其重要,这是因为出现的任何不相容通常都要求取出假体。这等同于假体失效。
已知载荷从假体向周围骨传递不当会导致骨组织退化。这样常常导致假体变松。所以,为了避免这种退化,重要的是确保载荷尽可能符合生理学地通过假体。测试表明,弹性模量较低的髋假体和采用刚性假体相比,产生的受力状况更加符合生理学。例如,对于股骨假体的情况,已经出现了从弹性模量极高(大约200000N/mm2)的钴钼合金移向弹性模量较低的钛合金(比如例如TiAl6V4,模量大约是100000N/mm2)的情况。但是,这些值仍然远远高于皮质骨的弹性模量(大约25000N/mm2)。
本发明基于对在引言中描述的关节假体类型进行改进以实现载荷传递更符合生理学的目标。
根据本发明的解决方案在于具有独立权利要求特征的关节假体。有利的进一步限定构成了从属权利要求的主题。
根据本发明,在具有由钛合金制备的柄的关节假体中,至少所述柄是精密铸造的,并且具有体心立方晶体结构(称作β-钛合金)。
已经发现,根据本发明的关节假体可用于获得显著降低的弹性模量。取决于所用的钛合金和实施的热处理,可以获得大约60000N/mm2的弹性模量。这对应于以前用钛合金所获得弹性模量的一半左右。而且,本发明规定至少所述柄是精密铸造的。这样使得可以获得更复杂形状的假体。目前为止主要用于钛假体的锻造方法仅能制备相对简单的结构。这个限制通过本发明得到了克服。结果,根据本发明的假体可以和待吸收的载荷更好的相配。例如,假体的成形可以根据在多种情况下的局部应力更精细地变化。假体仅仅需要在具体的高应力区域中更加坚固,因而具有刚性更大的尺寸;而在其它区域中,它可以较弱,并因而具有弹性更强的设计。这样使得假体和解剖学状况的适配性可以得到进一步改善。而且,固定元件,比如凸起,可以容易地和假体整体形成。能够提供更大量的、更复杂的固定元件。所以,假体更适于无水泥植入。本发明的优点在于,即使对于由β-钛合金制备的假体而言,可以获得通过锻造方法实际上不能获得的复杂形状。一般而言,假体和柄一起以一件式进行精密铸造和热处理,但是由包括柄的多个部件组装成假体的可能性也不应被排除。
本发明可以有利地用于人工髋关节,尤其是股骨假体。这些假体是应力最大的假体之一,具有用于在股骨中植入的形状复杂的柄。已经发现,如果植入的是刚性太大的假体,那么尤其在股骨的上部区域,很容易发生退化现象。这通常导致假体失效。在根据本发明的股骨假体的情况下,弹性模量显著较低,所以更接近股骨上部区域中骨材料的生理学水平。根据本发明的股骨假体成功了抵消了退化的风险。这同样适用于膝假体形式的实施方案,其通常具有相当长的柄。
优选钛合金是钛钼合金。钼的加入稳定了钛合金的所谓β相。这样使得可以形成所需的体心立方晶体结构。钼作为合金化元素,具有比其它同样稳定β-相的合金化元素,尤其是铌或者钒,更低的毒性。毒性下降对于旨在长期植入的假体而言,是重要的益处。
合金中钼或钼等同物的含量便利地为7.5-25%。这样的结果是,尤其对于钼含量为至少10%的情况而言,直至室温范围β-相也充分稳定。优选所述含量为12-16%。这样使得可以通过在铸造后的快速冷却来获得亚稳β-相。晶体结构的平均晶粒尺寸是至少0.3mm,优选0.5mm。通常无需加入另外的合金形成元素。尤其而言,无需加入钒或者铝。消除这些元素带来了上述优点,即源于这些合金形成元素的毒性可以被避免。这同样相应地适用于铋,铋的生物相容性也不能和钛的相比。而且,和已知的合金比如TiAl6V4相比,钛钼合金具有模填充性质得到改善的优点。这使得可以通过精密铸造方法形成边缘更尖锐的结构。
已经证明,特别合适的是本发明的假体的至少柄进行热等静压和固溶退火。已经发现,通过以此方式热处理的材料,在脆性方面得到了显著改善。热等静压通过溶解树枝状晶体之间的沉淀,抵消了如下不利的效应:钼在树枝状晶体中富集,而在剩余熔体中贫乏化。低于β-转变温度,尤其是低至多100℃的温度,是有利的。已经证明,对于钼含量为15%的钛钼合金而言,710℃-760℃的温度,优选大约740℃,是合适的。固溶退火改善了合金的延展性。已经证明,对此而言,至少700℃直至880℃,优选800℃-860℃的温度是合适的。在热等静压之前或者之后,无需初步时效硬化(vorauslagerung)。为了在固溶退火之后进行冷却,便利的是用水使柄淬火。
下面参考附图更详细解释本发明,所述附图举例说明了有利的示例性实施方案。在附图中:
图1示出了根据本发明的关节假体的第一实施方案的示意图;
图2示出了根据本发明的关节假体的又一实施方案的示意图;
图3示出了在熔融铸造后即刻的晶体结构图像(放大1000倍);
图4示出了在热等静压和固溶退火之后的晶体结构图像;和
图5的表列出了根据本发明的假体的机械性质。
图1中所示的实施方案示出了用于人工髋关节的股骨假体。股骨假体1由β-钛合金,即TiMo15,构成。该合金在室温时是体心立方晶体结构。
股骨假体1用于在股骨上端植入。它可以和已经植入在骨盆骨中的髋臼部件2相互作用。股骨假体1具有作为骨锚定元件的长柄10,和以钝角和柄连接的颈11。在远离柄的端部设置有关节头12,关节头与髋臼部件2的支承嵌件22(Lagerinsatz)一起形成球形关节。植入包括完全或者部分切除大腿骨颈部的头部,打开到股骨骨髓腔的通道。经由此通道,股骨假体1的柄10插入到所述骨髓腔中,在此被锚定。取决于实施方案,提供水泥作为锚定手段或者不使用水泥实现固定。
股骨假体1将作用在髋关节上的机械载荷引入到股骨中,所述载荷当站立时为静态载荷,当行走时为动态载荷。为了将股骨假体1永久可靠地锚定在股骨的骨材料中而言,重要的是载荷进行生理学有利的转移。如果股骨假体1是非常刚性设计,那么它吸收大部分的载荷,由此减轻在骨材料,尤其在股骨上部区域中的骨材料上的载荷。从长期来看,这样导致该区域中股骨退化。从而导致出现股骨假体1变松并最终使得假体失效的危险。为了防止出现这种失效模式,已知的做法是通过采用生理学上有利的低弹性模量设计,使得股骨假体1的刚性较低,即弹性更强。特别地,在此方面,股骨假体1的柄10很关键。在皮质骨区域,股骨骨材料的弹性模量为大约20000-25000N/mm2。根据本发明,股骨假体1的弹性模量为大约60000N/mm2。这是有利的值,显著低于通常使用的材料,比如TiAl6V4。这些材料的弹性模量为大约100000N/mm2,或者在钴-铬合金的情况下甚至为200000N/mm2。
本发明使得可以通过精密铸造简单地制备更复杂的形状。例如,股骨假体1在其柄10上具有多个凹槽和锯齿状凸起。这些用于改善股骨假体1在股骨中的锚定,从而使得可以进行无水泥植入。提供了多个沿着柄10的纵向延伸的沟槽14。它们排列在柄10的前面和后面,但也可以提供在侧面。在柄10的上部区域中提供有多行锯齿状凸起15。而且,在朝向颈11的过渡处,提供有围绕环13。它可以设计成独立的元件,但本发明使得它也可以和柄10以及颈11整体化。通常,优选一件式设计的假体,除了可以更换的或者任选的附着性部件或者耐磨部件以外。而且,在柄10的和环13相邻处可以提供固定凸起1作为防旋转装置。如此复杂形状的关节假体传统上仅仅可以由TiAl6V4制备。但是,该材料具有不同的、不利的晶体结构,所以具有不希望的高弹性模量。
本发明也可以有利地用于其它类型地关节假体。图2示出了膝假体3作为另一实施方案。它包括股骨部分31和胫骨部分30。股骨部分31具有长柄33作为骨锚定元件。其设计成用于植入在股骨的骨髓腔中,所述骨髓腔已经通过切除自然膝关节来打开。和股骨假体的情况一样,在这种情况下,如果膝假体3,尤其是其柄33,被制备成刚性太强,则也会发生周围皮质骨结构退化的问题。这同样适用于胫骨部分30的柄32。
根据本发明的关节假体也可以用于其它关节,例如在肘或者肩处。
下面将描述实施本发明的方式。
原材料是钼含量为15%的β-钛合金(TiMo15)。该合金可以以小坯块(锭)的形式购得。
第一步骤涉及精密铸造髋假体的部件。提供铸造设备用于熔融和铸造TiMo15。铸造设备优选是冷壁坩锅真空感应熔融和铸造设备。借助这种类型的设备可以达到可靠熔融TiMo15以进行精密铸造所需的高温。TiMo15的熔点是1770℃,为了可靠的精密铸造,要再加上大约60℃。所以,总体而言,必须达到1830℃。然后,通过公知的方法,例如采用蜡芯和陶瓷模具作为消耗性的模具(verloren Form),实施熔体的精密铸造。已知这种类型的精密铸造技术已经用于精密铸造TiAl6V4。结果是体心立方晶体结构。结构的图像如图3所示。
在精密铸造后去除了浇铸模具之后,将铸件进行热处理。为此在刚好低于β-转变温度的温度进行的热等静压(HIP)。所述温度可以是710℃-760℃,优选大约740℃,在1100-1200巴的氩气压力下。为此,在铸造过程中可能会形成的、称作(α相)的、硬脆层形式的表面区域,很容易通过酸洗去除。该层的厚度通常为大约0.03mm。
在热等静压之后,铸件的延展性低。假定该变脆现象是归因于热等静压和后续通常从热等静压温度缓慢冷却的过程中出现的二次沉淀。
为了溶解破坏性的沉淀,将铸件在氩气保护气氛下在箱式炉中退火。为此,选择温度范围是大约700℃-860℃,持续数小时,一般是两小时。在本文中,在温度和持续时间之间存在着倒数关系;温度越高,更短的时间就足够,反之亦然。在固溶退火之后,将铸件用冷水淬火。图4示出了所得的结构。
图5中的表中列出了在固溶退火之后获得的力学性质。
可以发现,弹性模量随着固溶退火期间温度的增加而下降,具体而言,低至60000N/mm2的水平。韧性值随着强度和硬度的下降而增加。例如,在800℃固溶退火两小时之后,得到的弹性模量为60000N/mm2、断裂时的伸长量是大约40%,断裂强度Rm是大约730N/mm2。
Claims (10)
1.具有由钛合金制成的柄的关节假体,特征在于至少所述柄(10,32,33)是精密铸造的,并具有体心立方晶体结构。
2.权利要求1的关节假体,特征在于它被设计成股骨假体(1)。
3.权利要求1的关节假体,特征在于它被设计成膝假体(3)。
4.前述权利要求之一的关节假体,特征在于钛合金是钛钼合金。
5.权利要求4的关节假体,特征在于钼含量是7.5-25%。
6.前述权利要求之一的关节假体,特征在于晶体结构的平均晶粒尺寸是至少0.3mm,优选0.5mm。
7.前述权利要求之一的关节假体,特征在于至少所述柄(10,32,33)是热等静压和固溶退火的。
8.权利要求7的关节假体,特征在于所述热等静压在最高等于钛钼合金的β-转变温度和最低比所述β-转变温度低100℃的温度进行。
9.前述权利要求之一的关节假体,特征在于所述钛合金不含钒和铝。
10.前述权利要求之一的关节假体,特征在于所述钛合金不含铋。
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EP05004178.9 | 2005-02-25 | ||
EP05004178A EP1695675A1 (de) | 2005-02-25 | 2005-02-25 | Gelenkprothese aus einer Titan-Molybdän-Legierung |
PCT/EP2006/001791 WO2006089791A1 (de) | 2005-02-25 | 2006-02-27 | Gelenkprothese aus einer titanlegierung |
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CN101128164A true CN101128164A (zh) | 2008-02-20 |
CN101128164B CN101128164B (zh) | 2010-12-15 |
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EP (2) | EP1695675A1 (zh) |
JP (1) | JP5033644B2 (zh) |
KR (1) | KR101224338B1 (zh) |
CN (1) | CN101128164B (zh) |
AR (1) | AR055735A1 (zh) |
AT (1) | ATE546111T1 (zh) |
AU (1) | AU2006218030B2 (zh) |
BR (1) | BRPI0608554A2 (zh) |
CA (1) | CA2597249C (zh) |
ES (1) | ES2381679T3 (zh) |
MX (1) | MX2007010440A (zh) |
RU (1) | RU2397738C2 (zh) |
TW (1) | TWI441623B (zh) |
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Cited By (5)
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CN102581185A (zh) * | 2011-01-05 | 2012-07-18 | 山西泰舆生物材料有限公司 | 一种钛合金精密锻造髋关节假体材料的制造工艺 |
CN105232169A (zh) * | 2015-10-16 | 2016-01-13 | 福建中科康钛材料科技有限公司 | 多段式种植体组件及其制备方法 |
CN105769315A (zh) * | 2010-10-21 | 2016-07-20 | 思必瑞特脊椎股份有限公司 | 人工髋关节置换系统 |
CN105943202A (zh) * | 2016-05-17 | 2016-09-21 | 嘉思特华剑医疗器材(天津)有限公司 | 释药治疗关节术后感染的假体组件 |
CN113171209A (zh) * | 2021-04-27 | 2021-07-27 | 山东大学 | 一种增材制造镍钛合金股骨柄假体及其制备方法 |
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KR101509023B1 (ko) | 2013-06-17 | 2015-04-08 | (주)오티스바이오텍 | 금속 대 금속 인공 고관절 |
US10687956B2 (en) | 2014-06-17 | 2020-06-23 | Titan Spine, Inc. | Corpectomy implants with roughened bioactive lateral surfaces |
CN108472730A (zh) | 2015-11-20 | 2018-08-31 | 泰坦脊椎公司 | 增材制造骨科植入物的处理 |
TWI726940B (zh) | 2015-11-20 | 2021-05-11 | 美商泰坦脊柱股份有限公司 | 積層製造整形外科植入物之方法 |
KR102606691B1 (ko) * | 2016-06-08 | 2023-11-28 | 주식회사 코렌텍 | 다공성층이 형성된 인공관절 및 그 성형방법 |
EP3493769B1 (en) | 2016-08-03 | 2022-03-30 | Titan Spine, Inc. | Titanium implant surfaces free from alpha case and with enhanced osteoinduction |
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JP4152050B2 (ja) | 1999-04-23 | 2008-09-17 | テルモ株式会社 | Ti−Zr系合金 |
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2005
- 2005-02-25 EP EP05004178A patent/EP1695675A1/de not_active Withdrawn
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2006
- 2006-02-24 TW TW095106327A patent/TWI441623B/zh not_active IP Right Cessation
- 2006-02-24 AR ARP060100694A patent/AR055735A1/es active IP Right Grant
- 2006-02-27 AT AT06707302T patent/ATE546111T1/de active
- 2006-02-27 ES ES06707302T patent/ES2381679T3/es active Active
- 2006-02-27 EP EP06707302A patent/EP1850801B1/de not_active Not-in-force
- 2006-02-27 AU AU2006218030A patent/AU2006218030B2/en not_active Ceased
- 2006-02-27 BR BRPI0608554-7A patent/BRPI0608554A2/pt not_active Application Discontinuation
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CN105769315A (zh) * | 2010-10-21 | 2016-07-20 | 思必瑞特脊椎股份有限公司 | 人工髋关节置换系统 |
CN102581185A (zh) * | 2011-01-05 | 2012-07-18 | 山西泰舆生物材料有限公司 | 一种钛合金精密锻造髋关节假体材料的制造工艺 |
CN105232169A (zh) * | 2015-10-16 | 2016-01-13 | 福建中科康钛材料科技有限公司 | 多段式种植体组件及其制备方法 |
CN105943202A (zh) * | 2016-05-17 | 2016-09-21 | 嘉思特华剑医疗器材(天津)有限公司 | 释药治疗关节术后感染的假体组件 |
CN113171209A (zh) * | 2021-04-27 | 2021-07-27 | 山东大学 | 一种增材制造镍钛合金股骨柄假体及其制备方法 |
CN113171209B (zh) * | 2021-04-27 | 2023-10-20 | 山东大学 | 一种增材制造镍钛合金股骨柄假体及其制备方法 |
Also Published As
Publication number | Publication date |
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EP1850801B1 (de) | 2012-02-22 |
EP1695675A1 (de) | 2006-08-30 |
CA2597249A1 (en) | 2006-08-31 |
WO2006089791A1 (de) | 2006-08-31 |
KR20070115992A (ko) | 2007-12-06 |
KR101224338B1 (ko) | 2013-01-18 |
AU2006218030A1 (en) | 2006-08-31 |
CA2597249C (en) | 2016-02-09 |
AR055735A1 (es) | 2007-09-05 |
EP1850801A1 (de) | 2007-11-07 |
JP2008536535A (ja) | 2008-09-11 |
ES2381679T3 (es) | 2012-05-30 |
CN101128164B (zh) | 2010-12-15 |
TWI441623B (zh) | 2014-06-21 |
ATE546111T1 (de) | 2012-03-15 |
ZA200707588B (en) | 2008-09-25 |
BRPI0608554A2 (pt) | 2010-01-12 |
JP5033644B2 (ja) | 2012-09-26 |
MX2007010440A (es) | 2007-11-08 |
AU2006218030B2 (en) | 2012-02-02 |
TW200640431A (en) | 2006-12-01 |
RU2397738C2 (ru) | 2010-08-27 |
RU2007135065A (ru) | 2009-03-27 |
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