CN101842062B - 非骨水泥型胫骨托的制造方法 - Google Patents
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Abstract
本发明提供了胫骨托(10)及其制造方法。根据一个实例,可形成具有上表面(40)的基底(12)。多孔金属材料(14)可附着于所述基底的上表面之上。可去除所述基底的选定区域,以形成所述胫骨托的第一构造。可去除聚合物部分的选定区域,以形成所述胫骨托的第二构造。
Description
本申请要求2007年9月25日提交的美国临时申请No.60/975,012的权益。上述申请的全部公开内容通过引用并入本文。
技术领域
本发明涉及胫骨托及其制造方法。
背景技术
多孔金属植入物或者具有多孔金属部分的植入物用于促进周围的骨组织和软组织向内生长到所述植入物中。当所述金属的孔隙度、完整度和连续性足够时,多孔植入物用作组织向内生长的支架从而提供宿主骨骼期望的固定。所述多孔材料可通过从金属基质中除去若干小块而形成,例如通过蚀刻金属固体块来实现。所述多孔材料也可以通过使用小的金属颗粒(例如粉末)来形成。
发明内容
本发明提供了胫骨托及其制造方法。根据一个实例,可形成具有上表面的基底。多孔金属材料可附着于所述基底的上表面之上。可去除所述基底的选定区域,以形成所述胫骨托的第一构造。可去除聚合物部分选定区域,以形成所述胫骨托的第二构造。
根据一些附加构造,所述多孔金属材料的附着可包括将所述多孔金属材料烧结于所述基底的上表面上。所述聚合物部分的附着可包括将所述聚合物部分模制在所述多孔金属材料上。所述基底中选定区域的去除可包括形成胫骨柄(tibial stem)的部分。所述聚合物部分中选定区域的去除可包括形成所述胫骨托的上表面,其包括适于选择性地与支承结构固定(secure a bearing)的附着构造。
根据另一些特征,可以在所述多孔金属部分与所述聚合物部分之间附着箔片屏障。
另外,通过下文提供的详细说明,本发明的适用领域将显而易见。应当理解,所述详细说明和具体实施例仅旨在举例说明,而非限制本发明的范围。
附图说明
图1是本发明基底的前视图;
图2是附着有多孔金属材料的图1所示基底的前视图;
图3A是附着有聚合物部分的图2所示基底和多孔金属材料的前视图;
图3B是图2所示基底和多孔金属材料的前视图,其中聚合物部分附着于根据一些附加构造沿所述多孔金属材料延伸的箔片屏障;
图4是图3A所示基底、多孔金属和聚合物组件的前视图,并显示所述基底的一部分被去除;
图5是根据本发明构建的胫骨托的前视图,其中所述胫骨托显示聚合物部分和基底部分的选定部分被去除,以形成所述胫骨托的一些附加构造;
图6是包含图5之胫骨托的示例性膝关节假体的前视图;以及
图7示意制造图5之胫骨托的示例性程序。
发明详述
以下描述仅为示例性质,并且不旨在以任何方式限制本发明、其应用或用途。尽管可描述与用于胫骨托之多孔金属植入物相关的多个实施方案,但是应当理解,本发明的植入物和方法可以包括任何合适的基底或形状,并可用于任何合适的方法,而非仅仅所列举的那些。
首先参见图5,其显示根据本发明构建的胫骨托,一般记为附图标记10。胫骨托10一般地包含固体金属基底部分12、多孔金属部分14以及聚合物部分18。如所描述地,胫骨托10可以是一体的,并由连续的制造工艺形成。胫骨托10可提供引导骨向内生长的多孔金属下表面。 聚合物部分18可限定胫骨托10的上面部分22。胫骨托10可包含一对整体形成的柱26和28,其由聚合物部分18形成,并且其沿着胫骨托10的前缘向上延伸。所述柱26和28可限定出有效容纳锁定棒(lockingbar)30(图6)的凹槽(未具体显示),所述锁定棒能够以下文所述的方式将胫骨插入物32(图6)与胫骨托10固定。
接下来参见图1-5,描述了形成所述胫骨托的示例性方法。开始时,所述基底12可形成为具有大致平的上部36和圆柱部分38。基底12可由固体生物相容性材料形成,例如但不限于钛。基底12可通过任何合适的手段形成如图1所示的形状,例如机械加工、模制、浇铸或其它方法。本文中使用的术语“模制”用于表示任何模制方法,例如但不限于注塑或(直接)加压模制。
参见图2,多孔金属材料14可附着于所述上部36的上表面40。在一个实例中,多孔金属材料14可以由金属粉末、间隔剂(spacing agent)(未显示)和非极性液体粘合剂(未显示)的混合物形成。多孔金属材料14可通过如下步骤形成:加热所述混合物至足以除去所述间隔剂和非极性液体粘合剂的温度,从而在相互连接的金属粉末颗粒44之间留下多个孔42。
多孔金属材料14可以是任何适用作植入物并提供所需强度、承载能力和变得多孔之能力的金属或合金。合适的示例性金属包括钛、钴、铬或钽、其合金、不锈钢,及其组合。金属粉末颗粒44可具有约5微米至约1500微米的直径。在多个实施方案中,金属粉末44可以为至少两种不同粒径。
间隔剂可占据产生多孔金属材料14之孔42的空间。所述间隔剂可从所述混合物中除去,并且可能期望所述间隔剂在多孔金属材料14中没有残留。此外,可能理想的是,所述间隔剂膨胀或收缩从而在多孔金属材料14中辅助形成所需尺寸的孔42。所述间隔剂可选自:过氧化氢、尿素、碳酸氢铵、碳酸铵、氨基甲酸铵、磷酸氢钙、萘及其混合物,或者可以是任何其它合适的升华材料和空隙形成材料。一般地,所述间隔剂可具有约小于250摄氏度的熔点、沸点、升华温度等。所述间隔剂可在热循环过程之前和期间提供所述生物相容性金属粉末的大孔隙和微孔隙,这是因为在所述间隔剂分解以及金属粉末颗粒44之间形成冶金 键之后,孔(即,孔42)或空隙保持在原先所述间隔剂的位置。一种合适的多孔金属及其制造方法可见于Biomet Manufacturing Corp.ofWarsaw,Indiana所拥有的2006年2月17日提交的名为“FormingPorous Metal Implants”的美国专利申请(序列号11/357,929),其内容通过引用并入本文。
改变所述混合物组分的比率和/或所述组分的尺寸可提供具有较高或较低孔隙度、承载能力提高、最佳的骨向内生长能力的多孔金属材料14,并且可有助于针对机体的特定区域(例如本发明实施例中的膝)调节多孔金属材料14。使用8∶1的金属粉末与间隔剂的比例可提供孔非常细的相对致密的多孔金属材料14。在另一实例中,在具有3∶1金属粉末与间隔剂比率的混合物中,如果所述间隔剂具有至少约25微米的直径,所述金属粉末具有约10微米的直径,则形成大的孔。如果金属粉末与间隔剂直径的尺寸对调,则会形成较小的孔。应当理解,这些构造仅仅是示例性的,多孔金属材料14可具有任何适当的孔隙度。例如,在一些实施方案中,多孔金属材料14可包含尺寸为约100微米至约600微米的孔。在一些实施方案中,所述孔的尺寸平均可以为约300微米。
所述混合物还可包含不同颗粒尺寸的金属粉末。通过包含至少两种不同尺寸的金属粉末颗粒,可实现孔隙度梯度。孔隙度梯度可以使多孔金属材料14之孔隙度在多孔金属材料14的厚度方向上升高或降低高达80%。孔隙度梯度可以是连续的,并且扩大(缩小)至所需的量,或者孔隙度梯度可包括不同的孔隙度区域(例如,从80%孔隙度区域过渡至40%孔隙度区域,其又过渡至75%孔隙度区域)。在多孔金属材料14中所述区域之间的过渡可以是连续的。为了提供不同的孔隙度,可以将对应于特定孔隙度的混合物堆叠在具有不同孔隙度的混合物之上或其附近。
可通过任何合适的手段将多孔金属材料14附着于基底12,例如焊接、烧结、使用激光等。在多个实施方案中,所述基底12可以由金属形成,例如与多孔金属材料14同样的金属。用于将多孔金属材料14附着至基底12的温度和压力条件可以是使所述基底表面区域与相邻多孔金属表面之间实现扩散和冶金键合的那些。例如,在将多孔金属部分14和金属基底12加热至1000摄氏度的一个实施方案中,所施加的压力必 须使得所获得的结构具有用于植入受者的结构完整性而没有显著缺陷。
基底12可以在附着多孔金属材料14之前制备。可对基底12进行例如酸蚀刻、进行酸浴、喷砂或者超声清洗。其它制备包括向基底12添加沟槽、凹坑、凹槽、缺口、桥或孔洞。这些附加构造可提高多孔金属材料14对其下的基底12的附着。
可以在多孔金属材料14的至少一个表面上或其中涂覆其它试剂。试剂包括可吸收性陶瓷、可吸收性聚合物、抗生素、脱钙骨基质(demineralized bone matrix)、血液制品、血小板浓缩物、同种异体移植物、异种移植物、自体和同种异体的分化细胞或干细胞、营养物、肽和/或蛋白质、维生素、生长因子及其混合物,其会促进新组织向内生长至多孔金属材料14中。例如,如果所述其它试剂是肽,则可有利地将RGB肽掺入多孔金属材料14中。
接下来参见图3A,聚合物部分18可附着于多孔金属材料14。在一个实例中,可将聚合物部分18模制于多孔金属材料14中。根据一个实例,聚合物部分18可包含聚醚醚酮(PEEK)和/或碳纤维加强的PEEK(CFR-PEEK)。根据一些附加构造,可提供介于聚合物部分18和多孔金属材料14之间的箔片屏障46(图3B)。箔片屏障46可以单独形成,并置于多孔金属材料14上。在另一实例中,可以对多孔金属材料14的上表面进行平滑处理或“涂抹(smeared)”处理,例如通过机械操作以去除或基本上去除多孔金属材料14上表面的任何孔。在另一实例中,可以分别对聚合物部分18进行模制或机械加工,随后将其附着于多孔金属材料14的上表面或者箔片屏障46。此外,在一些实施方案中,箔片屏障46可位于多孔金属材料14中,从而使聚合物部分18模制于多孔金属材料14中,同时还避免聚合物部分18完全模制到多孔金属材料14中。
接着参见图4,去除基底12中基本上对应于上部36的部分。在一个实例中,可利用机械加工将基底12去除,以显露出下表面48上的多孔金属部分14。参见图5,形成胫骨托10的最终构造。在一个实例中,去除PEEK区域18(例如通过机械去除等),以形成柱26和28。同样地,可以在柱部分38上形成锥形凹部(female taper)。可以对胫骨托10进行机械加工、激光处理或以其它方式形成未具体显示的其它构造。 在一个替代性实例中,可首先形成包含聚合物部分18和柱部分38(以及任选地最终构造例如柱26和28等等)的基底12。然后,可以单独地形成多孔金属材料14。随后,可通过任何合适的方法将多孔金属材料14与所述基底偶连。在一个实例中,多孔金属材料14可具有从其中心穿过而形成的孔,用于在装配步骤中容纳所述柱部分38。在一个实施方案中,所述孔可以是锥形的,以与柱部分38的外锥几何形状相匹配,例如以莫氏锥度(Morse taper)连接。
参见图6,显示植入位置中作为膝关节假体50之一部分的胫骨托10。所述膝关节假体50可包含胫骨托10、支承结构32以及股骨组分52。就功能角度而言,膝关节假体50被描述为与通过手术切除的膝关节60的胫骨56和股骨58固定。在一个实例中,胫骨托10可以是非骨水泥型(cementless)。胫骨托10的柱38可插入外科医生在胫骨56的纵向中心所开的开口中。支承结构32可具有适于容纳胫骨托10之柱26和28的互补凹槽(未具体显示)。可在支承结构32上形成另一凹槽(未具体显示),其与第一和第二柱26和28上的凹槽匹配,从而容纳所述锁定棒30。应当理解,胫骨托10可用于形成和/或适用于任何种类的膝替代物,例如后稳定型(posterior stabilized,PS)膝、十字韧带保留型(crutiate retaining,CR)膝、铰链膝(hinged knee)、固定膝等。
胫骨托10的一种示例性形成方法一般性地示于图7的流程图中(附图标记为70)。方法70始于步骤72。在步骤74中,形成基底12,例如由钛固体块形成。在步骤76中,多孔金属材料14被烧结至基底12上。在步骤78中,聚合物材料18可模制在多孔金属材料14上。在步骤80中,可去除基底12中的区域。在步骤82中,可在聚合物材料18和/或多孔金属材料14中形成托10的构造。所述方法终止于步骤84。
根据另一方法,可将多孔金属材料14烧结成不需要基底(即,例如基底12)的形状。在一个实例中,圆柱部分38可以由多孔金属材料14形成。然后,聚合物材料18可模制在多孔金属材料14上。接着,可通过机械加工聚合物材料18和/或多孔金属材料14来形成所述托的构造。在另一种形成胫骨托10的方法中,基底12可以与多孔金属材料14单独进行模制或机械加工。然后,可通过热膨胀过程以及随后的冷却回缩过程将这两块进行连接。在一个实例中,可加热基底12和多孔金属 材料14中的至少一个。然后,可将基底12置于多孔金属材料14上,并冷却基底12和多孔金属材料14中至少之一(和/或使其回复到室温)。在基底12和/或多孔金属材料14上形成的连锁(interlocking)构造(未具体显示)可以先膨胀(利用加热过程),随后收缩(利用冷却),最终将基底12与多孔金属材料14连锁。所述方法中的一种见于2008年2月27日提交的、共同所有的美国专利申请No.12/038,570中,其公开内容明确地通过引用并入本文。
本领域技术人员根据上述说明应当理解,本发明公开内容的宽泛教导可以多种形式来实施。因此,尽管本公开内容借助其具体实施例进行描述,但是本公开内容的真实范围不应受此限制,这是因为在研究了附图、说明书以及其后的权利要求书后,其它修改对于本领域技术人员来说是显而易见的。
Claims (27)
1.制造胫骨托的方法,该方法包括:
形成具有上表面的基底;
将多孔金属材料附着于所述上表面上;
将聚合物部分附着于所述多孔金属材料上;以及
去除所述基底的选定区域,以形成所述胫骨托的第一构造;以及
去除所述聚合物部分的选定区域,以形成所述胫骨托的第二构造。
2.根据权利要求1的方法,其中所述去除所述聚合物部分的选定区域以形成所述胫骨托的第二构造包括去除所述聚合物部分延伸超出所述多孔金属材料的选定区域并保留所述聚合物部分的其它区域以形成所述第二构造。
3.根据权利要求1的方法,其中所述多孔金属材料的附着包括将所述多孔金属材料烧结至所述基底的上表面上。
4.根据权利要求1的方法,其中所述聚合物部分的附着包括将所述聚合物部分模制在所述多孔金属材料上。
5.根据权利要求1的方法,其中去除所述基底的选定区域包括形成胫骨柄的部分。
6.根据权利要求1的方法,其中去除所述基底的选定区域包括暴露至少部分的所述多孔金属材料。
7.根据权利要求1的方法,其中去除所述聚合物部分的选定区域包括形成所述胫骨托的上表面,其包括适于选择性地与支承结构固定的附着构造。
8.根据权利要求1的方法,其还包括将箔片屏障附着于所述多孔金属材料与所述聚合物部分之间。
9.根据权利要求8的方法,其中所述箔片屏障的附着包括将所述箔片屏障附着于所述多孔金属材料上。
10.根据权利要求1的方法,其中所述基底的形成包括:
形成具有第一上表面的固体钛基底,其中通过向所述基底或多孔金属材料中至少之一施加热或压力中至少之一,从而将所述多孔金属材料附着于所述第一上表面,所述多孔金属材料具有第二上表面。
11.根据权利要求10的方法,其中所述聚合物部分的附着包括:
将聚醚醚酮(PEEK)模制于所述第二上表面上。
12.根据权利要求11的方法,其中去除所述聚合物部分的选定区域包括:
去除所述聚醚醚酮(PEEK)的选定区域以形成附着构造,所述附着构造被配置为选择性地与支承结构固定。
13.根据权利要求10的方法,其中所述多孔金属材料的附着包括将所述多孔金属材料焊接至所述第一上表面。
14.根据权利要求10的方法,其中所述多孔金属材料的附着包括将所述基底扩散键合或冶金键合至所述多孔金属材料。
15.制造胫骨托的方法,该方法包括:
形成具有上表面的基底;
将多孔金属材料附着于所述上表面;
在所述多孔金属材料上形成无孔屏障层;
将聚合物部分附着于所述无孔屏障层;以及
去除所述基底的选定区域,以形成所述胫骨托的第一构造。
16.根据权利要求15的方法,其中所述多孔金属材料的附着包括将所述多孔金属材料烧结至所述基底的上表面上。
17.根据权利要求15的方法,其中所述聚合物部分的附着包括加热所述聚合物部分和所述多孔金属材料中至少之一,将所述聚合物部分置于所述多孔金属材料上,以及冷却所述聚合物部分和所述多孔金属材料中至少之一。
18.根据权利要求15的方法,其中去除所述基底的选定区域包括形成胫骨柄的部分。
19.根据权利要求15的方法,其中去除所述基底的选定区域包括暴露至少部分的所述多孔金属材料。
20.根据权利要求15的方法,其中所述无孔屏障层的形成包括将箔片屏障附着于所述多孔金属材料上。
21.制造胫骨托的方法,该方法包括:
形成具有第一上表面的钛基底;
通过向所述基底和多孔金属材料中至少之一施加热和压力中至少之一,从而将多孔金属材料附着于所述第一上表面,所述多孔金属材料具有第二上表面;
将聚醚醚酮(PEEK)模制于所述第二上表面上;
去除所述基底的选定区域以形成柄;以及
去除所述聚醚醚酮(PEEK)的选定区域以形成附着构造,其被配置为选择性地与支承结构固定以及暴露至少一部分的所述多孔金属材料。
22.根据权利要求21的方法,其中所述多孔金属材料的附着包括将所述多孔金属材料烧结至所述基底的上表面。
23.根据权利要求21的方法,其中所述多孔金属材料的附着包括将所述多孔金属材料焊接至所述基底的上表面。
24.根据权利要求21的方法,其中所述多孔金属材料是钛。
25.根据权利要求24的方法,其中所述多孔金属材料的附着包括将所述基底扩散键合至所述多孔金属材料。
26.根据权利要求24的方法,其中所述多孔金属材料的附着包括将所述基底冶金键合至所述多孔金属材料。
27.根据权利要求21的方法,还包括将支承结构附着于所述聚醚醚酮(PEEK)。
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- 2008-09-24 JP JP2010526935A patent/JP5205462B2/ja not_active Expired - Fee Related
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Also Published As
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EP2205188A1 (en) | 2010-07-14 |
JP2010540077A (ja) | 2010-12-24 |
EP2205188B1 (en) | 2014-04-09 |
WO2009042150A1 (en) | 2009-04-02 |
US20090084491A1 (en) | 2009-04-02 |
JP5205462B2 (ja) | 2013-06-05 |
CN101842062A (zh) | 2010-09-22 |
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