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CN102470035A - 多孔医疗装置中的螺纹布置 - Google Patents

多孔医疗装置中的螺纹布置 Download PDF

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Publication number
CN102470035A
CN102470035A CN201080029352XA CN201080029352A CN102470035A CN 102470035 A CN102470035 A CN 102470035A CN 201080029352X A CN201080029352X A CN 201080029352XA CN 201080029352 A CN201080029352 A CN 201080029352A CN 102470035 A CN102470035 A CN 102470035A
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China
Prior art keywords
porous
insert
orthopedic implant
parts
anchoring piece
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CN201080029352XA
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莫巴拉克·穆罕默德
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Zimmer Inc
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Zimmer Inc
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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

提供用于制造诸如矫形锚固件之类的多孔矫形植入件中的内螺纹的方法。在一个实施方式中，通过将预形成的内螺纹部件结合于矫形植入件来在矫形植入件中形成内螺纹。在另一个实施方式中，通过将固体塞子结合于矫形植入件或将表面涂层形成在矫形植入件上并且接着机加工固体塞子或表面涂层，来在矫形植入件中形成内螺纹。

Description

多孔医疗装置中的螺纹布置
相关申请的交叉引用
本申请要求2009年6月30日提交的、标题为“SCREW THREADPLACEMENT IN A POROUS MEDICAL DEVICE”的序列号为61/221,614的美国临时专利申请的优先权，其公开内容在此全部以参引的方式明确地并入本申请中。
技术领域
本发明涉及矫形植入件。更具体地，本发明涉及多孔矫形植入件中的内螺纹的布置。
背景技术
矫形植入件包括多孔骨骼接触表面以激励骨骼向内生长。骨骼向内生长促进矫形植入件至相邻骨骼组织的增强的固定。然而，与固体结构相比，高孔隙率使矫形植入件的可用于接合相邻矫形构件的表面面积减小。高孔隙率还影响以紧公差机加工矫形植入件的能力。
发明内容
本发明提供用于制造诸如矫形锚固件之类的多孔矫形植入件中的内螺纹的各种方法。在一个实施方式中，通过将预形成的内螺纹部件结合于矫形植入件来在矫形植入件中形成内螺纹。在另一个实施方式中，通过将固体塞子结合于矫形植入件或将表面涂层形成在矫形植入件上并且接着机加工固体塞子或表面涂层，来在矫形植入件中形成内螺纹。
根据本发明的实施方式，提供一种构造成接收螺纹紧固件的多孔矫形植入件。所述多孔矫形植入件包括：多孔本体，所述多孔本体具有用于接触患者的骨骼的外表面，所述多孔本体包括由所述多孔本体的内壁限定的内孔；以及插入件，所述插入件位于所述多孔本体的所述内孔内，所述插入件联接于所述多孔本体的所述内壁以抵制所述插入件相对于所述多孔本体的转动和轴向平移，所述插入件限定有螺纹，所述螺纹构造成接收所述螺纹紧固件。
根据本发明的另一个实施方式，提供一种构造成接收螺纹紧固件的多孔矫形植入件。所述多孔矫形植入件包括：第一多孔部件，所述第一多孔部件限定所述多孔矫形植入件的用于接触患者的骨骼的外表面；以及第二部件，所述第二部件的孔比所述第一部件的孔少，所述第二部件联接于所述第一部件以抵制所述第二部件相对于所述第一部件的转动和轴向平移，所述第二部件限定所述多孔矫形植入件的用于接收所述螺纹紧固件的内螺纹。
根据本发明的又一个实施方式，提供一种制造构造成接收螺纹紧固件的多孔矫形植入件的方法。所述方法包括如下步骤：提供具有用于接触患者的骨骼的外表面的多孔本体，所述多孔本体包括由所述多孔本体的内壁限定的内孔；以及将插入件联接于所述多孔本体的所述内壁以抵制所述插入件相对于所述多孔本体的转动和轴向平移，所述插入件限定有与所述螺纹紧固件协作的螺纹。
附图说明
参照结合附图进行的本发明的实施方式的下列描述，本发明的以上提到和其它的特征和优点以及获得它们的方式将变得更加显而易见，并且将更好地理解发明本身，其中：
图1是具有以植入在其中的多孔锚固件为形式的示例性矫形植入件的患者的股骨的立体图，示出的锚固件联接于螺钉和垫圈；
图2是图1的锚固件的横截面图，示出了结合于锚固件的线螺纹插入件；
图3是图1的锚固件的另一个横截面图，示出了通过中间聚合物层结合于锚固件的线螺纹插入件；
图4是图1的锚固件的另一个横截面图，示出了通过中间烧结金属粉末层结合于锚固件的线螺纹插入件；
图5是图1的锚固件的又一个横截面图，示出了结合于锚固件的固体插入件；
图5A是与图5的视图相似的视图，示出了形成到图5的固体插入件中的内螺纹；
图6是图1的锚固件的又一个横截面图，示出了锚固件上的表面涂层和形成到表面涂层中的内螺纹；以及
图7是联接于髋臼壳体的图1的锚固件的立体图，并且示出结合于锚固件的线螺纹插入件。
对应的附图标记在所有若干视图中表示对应的部件。本文中提出的范例说明本发明的示例性实施方式，并且该范例不被解释为以任何方式限制本发明的范围。
具体实施方式
图1描绘了锚固件10形式的矫形植入件。锚固件10(以虚线)示出为植入在患者的股骨16中使得锚固件10的外表面11接触骨骼和/或软组织。锚固件10构造成接收外螺纹紧固件，诸如螺栓或螺钉12。例如，将诸如螺钉12之类的螺纹紧固件联接于锚固件10可以提供锚固件10与另一个矫形植入件之间和/或锚固件10与患者的骨骼之间的固定锁止接合。虽然矫形植入件在本文中描述和描绘为锚固件10，但是本公开的矫形植入件可以为构造成接收外螺纹紧固件的任何合适的植入件，例如包括胫骨部件(诸如胫骨增强部件)、大腿骨部件、髋臼部件或脊柱融合部件(诸如经后路椎体间融合植入件)。
锚固件10可以使用在各种应用中。例如，如图1所示，锚固件10植入在患者的股骨16中以接收螺钉12和垫圈18用于使韧带、腱、肌肉或其它软组织结构夹紧抵靠股骨16。作为另一个实施例，并且如图7所示，锚固件10联接于髋臼壳体14以将髋臼壳体14固定于患者的骨盆(未示出)。在2007年3月19日提交并且转让给本申请的受让人的、标题为“IMPLANT ANCHORING DEVICE”、授予威斯等人的美国专利公开No.2008/0046091中描述了示例性锚固件和髋臼壳体组件，该专利的全部公开内容以参引的方式明确地并入本文中。
接着参照图2，例如，锚固件10可以限定中空室20，中空室20完全延伸穿过锚固件10使得锚固件10是中空的并且能够接收导线或其他插入工具。在本发明的范围内，锚固件10还可以是可扩展装置。例如，锚固件10可以包括能够径向移位的指状物(未示出)，使得螺钉12(图1)到锚固件10中的插入使锚固件10扩展。
锚固件10可以由多孔的开孔型材料构成，以激励骨骼生长到锚固件10中。当在本文中使用时，“开孔型材料”是包含彼此连接且形成互连网络的孔的材料。锚固件10可以具有低至55％、60％或65％和高达80％、85％或90％或更多的孔隙率。
利用通常能够从印第安纳州华沙镇的Zimmer公司获得的Trabecular MetalTM技术生产这种材料的示例。Trabecular MetalTM是Zimmer技术有限公司的商标。这种材料可以由网状玻璃碳泡沫基底形成，该网状玻璃碳泡沫基底以1994年2月1日提交的标题为“OPENCELL TANTALUM STRUCTURES FOR CANCELLOUS BONEIMPLANTS AND CELL AND TISSUE RECEPTORS”的、授予卡普兰的美国专利No.5,282,861中详细公开的方式通过化学气相沉积(“CVD”)过程渗透和涂履有诸如钽之类的生物相容金属，该专利的全部公开内容以参引的方式明确地并入本文中。除钽之外，还可以使用诸如铌、钽铌合金或钽和铌与其它金属的合金之类的其它的金属。
通常，例如，多孔钽结构包括多个联结物，在多个联结物之间限定有开孔或开放空间，其中，每个联结物通常包括被诸如钽之类的金属的薄膜覆盖的碳芯。联结物之间的开放空间形成没有尽头的连续通道的母体，从而松质骨穿过多孔钽结构的生长不会受到抑制。多孔钽可以具有低至55％、60％或65％和高达80％、85％或90％或更多的孔隙率。因此，多孔钽是轻质且坚固的多孔结构，其在组成上基本上是均匀且一致的，并且与自然的松质骨的结构非常相似，由此提供松质骨可以生长到其中的母体以提供锚固件10到患者骨骼中的固定。
多孔钽结构可以按各种密度制造以选择性地匹配用于特定应用的结构。特别地，如在以上并入的美国专利No.5,282,861中讨论的，多孔钽实际上可以制造成具有任何期望的孔隙率和孔尺寸，并且因此可以与周围的自然骨骼相匹配以提供用于骨骼向内生长和矿化的改进母体。
如针对图1在上面讨论的，锚固件10构造成接收诸如螺钉12之类的外螺纹紧固件。虽然锚固件10的高孔隙率促进锚固件10经由骨骼向内生长固定于患者的骨骼，但是锚固件10的高孔隙率减小了锚固件10可用于接触和接合螺钉12的表面面积。因此，多孔锚固件10可能具有不以紧密的摩擦配合接合充分地接触螺钉12的小表面面积。锚固件10的高孔隙率还影响按照紧公差机加工锚固件10的能力。因此，可能很难以足够的精确度和一致性将内螺纹直接机加工到锚固件10中。
本公开提供用于制造锚固件10中的内螺纹的各种方法，不过锚固件10仍具有高孔隙率。在实施方式中，并且如图2至4所示，通过将诸如金属线螺纹插入件30之类的预形成内螺纹部件结合于锚固件10，在锚固件10中形成内螺纹。合适的线螺纹插入件30包括施必牢(Spiralock)TM线螺纹插入件和海利克(Helicoil)TM线螺纹插入件，二者通常能够从康涅狄格洲谢尔顿市的Emhart技术公司获得。如图1和2所示，线螺纹插入件30是形成内螺纹36的紧密缠绕的螺旋线圈，内螺纹36构造成与诸如螺钉12之类的相应螺纹紧固件协作。在另一个实施方式中，并且如图5至6所示，通过将固体塞子60结合于锚固件10或在锚固件10上形成表面涂层70并且接着将螺纹62、72机加工到该塞子60或表面涂层70中，在锚固件10中形成内螺纹。
根据本发明的示例性实施方式，如图2所示，线螺纹插入件30经由扩散结合方法结合于锚固件10。扩散结合过程可以根据2007年3月2日提交的标题为“DIRECT APPLICATION OF PRESSURE FORBONDING POROUS COATINGS TO SUBSTRATE MATERIALSUSED IN ORTHOPAEDIC IMPLANTS”、授予劳古特等人的美国专利公开No.2008/0195222中公开的方法执行，该专利的全部公开内容以参引的方式明确地并入本文中。
首先，将锚固件10制备成用于接收线螺纹插入件30。将锚固件10制备成用于接收线螺纹插入件30可以包括模制锚固件10以使合适大小的孔32或钻孔32包括到锚固件10后制造中。此外，将锚固件10制备成接收线螺纹插入件30可以包括对锚固件10的围绕孔32的内壁34进行成形或攻螺纹以接合线螺纹插入件30。接着，将线螺纹插入件30插入到锚固件10的孔32中。在螺钉12的随后插入过程中(图1)，线螺纹插入件30可以向外扩展抵靠锚固件10的内壁34以提供螺钉12、线螺纹插入件30以及锚固件10之间的紧密的摩擦配合接合，这降低了按照紧公差机加工锚固件10的内壁34的需要。
接着，线螺纹插入件30经由扩散结合熔合至锚固件10上。例如，线螺纹插入件30可以在施加的压力下保持抵靠锚固件10的内壁34，同时部件被加热至升高的温度持续几分钟到几小时的时间。例如，可以在保护性惰性气氛下或在真空下执行扩散结合过程。升高的温度可以低于两个部件的熔点。有利地，即使最初没有以紧公差机加工锚固件10的内壁34，扩散结合过程也可消除部件之间的间隙以将多孔锚固件10和线螺纹插入件30熔合在一起。
根据本发明的另一个示例性实施方式，线螺纹插入件30经由化学气相沉积(CVD)方法结合于锚固件10。可以根据以上并入的美国专利No.5,282,861中公开的方法执行CVD方法。
首先，锚固件10形成为低于其最终密度。例如，通过在氯化钽气体和氢气气氛中在热壁炉中加热合适成形的碳泡沫基底以使第一量的钽沉积在碳泡沫基底上以及碳泡沫基底内，来将锚固件10形成为低于其最终密度。接着，将线螺纹插入件30插入到部分涂履的锚固件10的孔32中。
接着，通过将线螺纹插入件30安置在部分地涂履的锚固件10的孔32中，锚固件10形成为具有其最终密度。例如，可通过将部分地涂履的锚固件10和线螺纹插入件30返回至热壁炉用于在氯化钽气体和氢气气氛下进一步加热以将第二量的钽沉积在部分地涂履的锚固件10上，将锚固件10形成为具有其最终密度。有利地，除了将锚固件10形成为具有其最终可植入密度之外，即使最初未以紧公差机加工锚固件10的内壁34，该随后的CVD步骤将金属沉积在锚固件10的内壁34与线螺纹插入件30之间以填充部件之间的间隙和/或与部件穿插从而使多孔锚固件10和线螺纹插入件30熔合在一起。如必要，可以对线螺纹插入件30遮护起来以避免钽不期望的沉积到线螺纹插入件30本身上。
根据本公开的另一个示例性实施方式，并且如图3所示，线螺纹插入件30通过中间聚合物层40结合于锚固件10。可以根据2005年4月18日提交的标题为“METHOD OF ATTACHING A POROUS METALLAYER TO A METAL SUBSTRATE”、授予沙勒布瓦等人的美国专利公开No.2005/0184134中公开的方法执行聚合物结合过程，该专利的全部公开内容以参引的方式明确地并入本文中。
首先，将锚固件10制备成用于接收线螺纹插入件30和聚合物层40。将锚固件10制备成用于接收线螺纹插入件30和聚合物层40可包括模制锚固件10以使合适大小的孔32或钻孔32包括到锚固件10后制造中。锚固件10的孔32的大小可以设计成使得锚固件10的内壁34至少部分地接触线螺纹插入件30，诸如沿着线螺纹插入件30的最宽部分。可替代地，锚固件10的孔32的大小可以设计成使得锚固件10的内壁34避免与线螺纹插入件30接触，其中，中间聚合物层40将锚固件10的内壁34与线螺纹插入件30的甚至最宽部分隔开。
接下来，将聚合物层40压缩模制、注射模制或以其他方式施加于锚固件10的内壁34。例如，可以将聚合物层40压缩模制或注射模制到锚固件10的孔32中以基本上填充孔32。根据示例性实施方式，聚合物层40施加成至少部分地穿插到多孔锚固件10中。聚合物材料可以包括诸如聚乙烯、聚醚醚酮(PEEK)、聚芳醚酮(PEAK)、超聚芳醚酮(超PEAK)或其他合适的生物相容聚合物之类的生物相容聚合物。
接着，在聚合物层40已经充分硬化之后，将聚合物层40机加工或攻螺纹成用于接收线螺纹插入件30。在对聚合物层40进行机加工或攻螺纹之前使聚合物层40硬化可以激励聚合物层40穿插到多孔锚固件10中并形成与多孔锚固件10的坚固连接，但是也可将仍然柔软的聚合物层40成形用于接收线螺纹插入件30，这也是在本公开的范围内的。可以利用由具体的线螺纹插入件30的制造商提供的工具执行该机加工或攻螺纹步骤。如果聚合物层40最初施加成基本上或全部填充锚固件10的孔32，诸如在将聚合物材料注射到锚固件10的孔32中时，那么可以在该机加工步骤过程中去除聚合物层40的绝大部分。
最后，将线螺纹插入件30插入到锚固件10的孔32中以接触攻螺纹的聚合物层40。可替代地，可以在聚合物层40诸如通过施加热而被稍微软化时将线螺纹插入件30压配合到聚合物层40中，这也是在本发明的范围内的。有利地，即使最初未以紧公差机加工锚固件10的内壁34，硬化的中间聚合物层40也可以填充在间隙中和/或与多孔锚固件10互相穿插并且形成用于与线螺纹插入件30接合的基本上坚固的表面。
根据本公开的另一个示例性实施方式，并且如图4所示，线螺纹插入件30通过中间烧结金属粉末层50结合于锚固件10。可以根据以上并入的美国专利公开No.2005/0184134中公开的方法执行烧结过程。
首先，将锚固件10制备成用于接收线螺纹插入件30和金属粉末层50。将锚固件10制备成用于接收线螺纹插入件30和金属粉末层50可以包括模制锚固件10以使合适大小的孔32或钻孔32包括到锚固件10后制造中。锚固件10的孔32的大小可以设计成使得锚固件10的内壁34至少部分地接触线螺纹插入件30，诸如线螺纹插入件30的最宽部分。可替代地，锚固件10的孔32的大小可以设计成使得锚固件10的内壁34避免与线螺纹插入件30接触，其中，中间金属粉末层50使锚固件10的内壁34与线螺纹插入件30的甚至最宽部分分隔开。
接下来，将金属粉末层50喷射、涂覆、注射或以其他方式施加于锚固件10的内壁34。例如，金属粉末层50可以注射到锚固件10的孔32中以基本上填充孔32。根据示例性实施方式，金属粉末层50施加成至少部分地穿插到多孔锚固件10中。金属粉末层50可以在施加于锚固件10之外还施加于线螺纹插入件30，或者施加于线螺纹插入件30而不施加于锚固件10，这都在本发明的范围内。合适的生物相容金属粉末包括例如不锈钢、钴铬合金、铪、锰、铌、钯、钛-6、铝-4、钒合金、铝-7、钛镍合金、锆、锆合金、Ti-6Al-4V、Ti-6Al-7Nb、商业纯钛、钛合金以及钴-铬-钼。金属粉末可以附加有机粘结剂，该有机粘结剂构造成最初将金属粉末保持在位和在加热时分解。合适的有机粘结剂包括例如凝胶、甘油、聚乙烯醇(PVA)或它们的组合。
接下来，组件加热成使金属粉末颗粒烧结于彼此并且烧结到锚固件10的内壁34上。例如，可以在保护性惰性气氛下或在真空下和在从几分钟到几小时的时间内执行烧结过程。
接着，在金属粉末层50已经充分硬化之后，将金属粉末层50机加工或攻螺纹成用于接收线螺纹插入件30。在对金属粉末层50进行机加工或攻螺纹之前使金属粉末层50硬化可以激励金属粉末层50穿插到多孔锚固件10中并形成与多孔锚固件10的坚固连接。可以利用由具体的线螺纹插入件30的制造商提供的工具执行该机加工或攻螺纹步骤。如果金属粉末层50最初施加成基本上或全部填充锚固件10的孔32，诸如在将聚合物材料注射到锚固件10的孔32中时，那么可以在该机加工步骤过程中去除金属粉末层50的绝大部分。
最后，将线螺纹插入件30插入到锚固件10的孔32中以接触攻螺纹的金属粉末层50。可替代地，可以将线螺纹插入件30压配合到金属粉末层50中，并且整个组件加热成使金属粉末颗粒烧结于彼此、并且烧结到锚固件10的内壁34上以及烧结到线螺纹插入件30上，这也在本发明的范围内。在该实施方式中，在部件被加热到升高的温度几分钟到几小时的同时，线螺纹插入件30可以在施加的压力下保持抵靠金属粉末层50和锚固件10的内壁34。例如，可以在保护性惰性气氛下或在真空下执行烧结过程。有利地，即使最初未以紧公差机加工锚固件10的内壁34，那么一旦加热，中间金属粉末层50就可以填充在间隙中和/或与多孔锚固件10穿插并且形成用于与线螺纹插入件30接合的基本上坚固的表面。
根据本公开的另一个示例性实施方式，并且如图5和5A所示，塞子60结合于锚固件10，接着，将内螺纹62机加工到塞子60中。塞子60可以由生物相容金属、诸如聚乙烯之类的刚性聚合物或具有比锚固件10的孔隙率小的孔隙率的其他合适的材料构成，并且可以设置成已经为固体的形式。在以上描述的实施方式中，锚固件10接收线螺纹插入件30、线螺纹插入件30又接合螺钉12(图1)，在这里，机加工的内螺纹62本身可以构造成接合螺钉12。
首先，将锚固件10制备成用于接收塞子60。将锚固件10制备成用于接收塞子60可以包括模制锚固件10以使合适大小的孔32或钻孔32包括到锚固件10后制造中。此外，将锚固件10制备成用于接收塞子60可包括将锚固件10的围绕孔32的内壁34成形为接合塞子60的外表面64。例如，如图5所示，塞子60的外表面64包括径向隔开的突出部66，并且锚固件的内壁34包括相应的凹入部68，以使部件之间的接触表面面积增大用于改进结合。
接着，塞子60插入到锚固件的孔32中并且结合于围绕锚固件10的孔32的内壁34。塞子60最初可以压配合到孔32中。然而，因为多孔锚固件10的孔32可能未以紧公差形成，所以可能必需有附加的步骤使塞子60牢固地结合于锚固件10。用于将塞子60结合于锚固件10的合适方法在前面针对线螺纹插入件30进行了描述。例如，塞子60可以经由扩散结合、CVD工艺、中间聚合物层、中间烧结金属层或其他合适的工艺熔合至锚固件10上。
接着，如图5A所示，将内螺纹62机加工、攻螺纹或以其他方式形成到塞子60中。塞子60的机加工内螺纹62构造成与诸如螺钉12之类的相应螺纹紧固件协作(图1)。
根据本公开的又一个示例性实施方式，并且如图6所示，将内表面涂层70施加于锚固件10，并且接着，将内螺纹72机加工到内表面涂层70中。表面涂层70可以由生物相容金属、诸如聚乙烯之类的聚合物或其他合适的材料形成，以形成具有比锚固件10本身的孔隙率小的孔隙率的表面层。在以上描述的实施方式中，锚固件10接收线螺纹插入件30、线螺纹插入件30又接合螺钉12(图1)，这里，机加工的内螺纹72本身可以构造成接合螺钉12。
首先，将锚固件10制备成用于接收表面涂层70。将锚固件10制备成用于接收表面涂层70可以包括模制锚固件10以使合适大小的孔32或钻孔32包括到锚固件10后制造中。
接下来，将表面涂层70喷射、涂覆、注射、压缩或以其他方式施加到锚固件10的内壁34上。与用于接收线螺纹插入件30的以上描述的实施方式相似，表面涂层70可以注射到锚固件10的孔32中以基本上填充孔32。如上所述，示例性表面涂层70包括金属粉末并且可选地包括有机粘结剂。当使用金属粉末时，涂覆步骤可以包括将金属粉末和粘结剂注射到锚固件10的孔32中以基本上或完全填充孔32和穿插到多孔锚固件10中。涂覆步骤还可以包括将部件加热至升高的温度以使金属粉末颗粒烧结于彼此和烧结到锚固件10的内壁34上。例如，可以在保护性惰性气氛下或在真空下执行烧结过程。另一个示例性表面涂层70包括诸如聚乙烯之类的刚性聚合物。当使用聚合物材料时，涂覆步骤可以包括将柔软的或流体的聚合物压缩模制或注射模制到锚固件10的孔32中以基本上或完全填充孔32和穿插到多孔锚固件10中。
接着，如图6所示，在表面涂层70已经充分硬化之后，将内螺纹72机加工、攻螺纹或以其他方式形成到表面涂层70中。在使表面涂层70经受机加工或攻螺纹之前使表面涂层70硬化可以激励表面涂层70穿插到高孔锚固件10中并形成与多孔锚固件10的坚固连接。如果表面涂层70最初施加成基本上或完全填充锚固件10的孔32，诸如在将金属粉末或聚合物注射到锚固件10的孔32中时，则可以在该机加工步骤过程中去除表面涂层70的绝大部分。内螺纹72构造成与诸如螺钉12(图1)之类的相应螺纹紧固件协作。
本公开的方法适应标准部件，诸如能够在市场上买到的螺钉12和相应的线螺纹插入件30。当前的方法要求使用定制的内螺纹部件，该定制的内螺纹部件设有键或特别地成形以抵制相对于多孔矫形植入件的转动。这些内螺纹部件不结合于多孔矫形植入件，为了抵制轴向拔出，紧固件必须延伸到相邻的非多孔植入件中。
附加地，本公开的方法避免必须以紧公差机加工多孔锚固件10中的孔32。当前的方法要求使用尺寸设计成接收相似地成形的螺纹部件的多孔矫形植入件中的特别地成形的孔。多孔矫形植入件的围绕特别地成形的孔的壁必须机加工成摩擦地接合螺纹部件以抵制螺纹部件相对于多孔矫形植入件的转动。该方法利用昂贵且耗时的程序来使多孔矫形植入件成形，诸如电火花加工(EDM)。
虽然本发明已经描述成具有优选的设计，但是可以在本公开的精神和范围内进一步修改本发明。因此，本申请旨在涵盖本发明的利用其一般原理的任意变化、使用或修改。此外，本申请旨在涵盖偏离本公开的偏离方案，所述偏离方案在本发明所属的领域中的已知或习惯实施的范围内并且落入在所附权利要求的范围内。

Claims (21)

1.一种构造成接收螺纹紧固件的多孔矫形植入件，所述多孔矫形植入件包括：
多孔本体，所述多孔本体具有用于接触患者的骨骼的外表面，所述多孔本体包括由所述多孔本体的内壁限定的内孔；以及
插入件，所述插入件位于所述多孔本体的所述内孔内，所述插入件联接于所述多孔本体的所述内壁以抵制所述插入件相对于所述多孔本体的转动和轴向平移，所述插入件限定有螺纹，所述螺纹构造成接收所述螺纹紧固件。
2.如权利要求1所述的多孔矫形植入件，其中，所述多孔本体的孔比所述插入件的孔多。
3.如权利要求1所述的多孔矫形植入件，其中，在所述插入件与所述多孔本体的所述内壁之间安置有中间层，所述中间层与所述插入件和所述多孔本体二者协作以将所述插入件联接于所述多孔本体。
4.如权利要求1所述的多孔矫形植入件，其中，所述插入件是限定螺纹的螺旋线圈。
5.如权利要求1所述的多孔矫形植入件，其中，所述插入件是机加工形成所述螺纹的塞子和涂层中的一个。
6.如权利要求1所述的多孔矫形植入件，其中，所述多孔本体是锚固件、胫骨部件、股骨部件、髋臼部件和脊柱融合部件中的至少一个。
7.一种构造成接收螺纹紧固件的多孔矫形植入件，所述多孔矫形植入件包括：
第一多孔部件，所述第一多孔部件限定所述多孔矫形植入件的用于接触患者的骨骼的外表面；以及
第二部件，所述第二部件的孔比所述第一部件的孔少，所述第二部件联接于所述第一部件以抵制所述第二部件相对于所述第一部件的转动和轴向平移，所述第二部件限定所述多孔矫形植入件的用于接收所述螺纹紧固件的内螺纹。
8.如权利要求7所述的多孔矫形植入件，其中，所述第一部件形成所述多孔矫形植入件的大部分。
9.如权利要求7所述的多孔矫形植入件，其中，所述第二部件是限定所述内螺纹的螺旋线圈。
10.如权利要求7所述的多孔矫形植入件，其中，所述第二部件穿插到所述第一部件的孔中。
11.如权利要求7所述的多孔矫形植入件，还包括在所述第一部件与所述第二部件之间的中间部件，其中，所述中间部件穿插到所述第一部件的孔中。
12.如权利要求7所述的多孔矫形植入件，其中，在所述紧固件拧到所述第二部件中时，所述第一部件径向向外扩展。
13.一种制造构造成接收螺纹紧固件的多孔矫形植入件的方法，所述方法包括如下步骤：
提供具有用于接触患者的骨骼的外表面的多孔本体，所述多孔本体包括由所述多孔本体的内壁限定的内孔；以及
将插入件联接于所述多孔本体的所述内壁以抵制所述插入件相对于所述多孔本体的转动和轴向平移，所述插入件限定有与所述螺纹紧固件协作的螺纹。
14.如权利要求13所述的方法，其中，联接的步骤包括将所述插入件扩散结合于所述多孔本体的所述内壁。
15.如权利要求13所述的方法，其中，所述多孔本体设置成小于最终密度，并且，联接的步骤包括通过化学气相沉积将金属沉积到所述多孔本体上，从而所述多孔本体在所述联接的步骤过程中达到所述最终密度。
16.如权利要求13所述的方法，还包括将所述插入件机加工形成所述螺纹的步骤。
17.如权利要求16所述的方法，其中，所述机加工的步骤在所述联接的步骤之后发生。
18.如权利要求16所述的方法，其中，所述机加工的步骤去除所述插入件的大部分。
19.如权利要求13所述的方法，还包括如下步骤：
将涂层施加于所述多孔本体的所述内壁以形成所述插入件；以及
机加工所述涂层以形成所述螺纹。
20.如权利要求13所述的方法，还包括如下步骤：
用流体材料填充所述多孔本体的所述内孔以形成所述插入件；
使所述流体材料硬化成固体材料；以及
机加工所述固体材料以形成所述螺纹。
21.如权利要求13所述的方法，其中，所述插入件是限定有螺纹的螺旋线圈。
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