CN106913398A - 一种髋关节置换假体 - Google Patents

一种髋关节置换假体 Download PDF

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Publication number
CN106913398A
CN106913398A CN201510990925.XA CN201510990925A CN106913398A CN 106913398 A CN106913398 A CN 106913398A CN 201510990925 A CN201510990925 A CN 201510990925A CN 106913398 A CN106913398 A CN 106913398A
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hole
hip
vestibule
joint replacement
replacement prosthesis
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CN106913398B (zh
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叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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  • Life Sciences & Earth Sciences (AREA)
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  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)
  • Dispersion Chemistry (AREA)

Abstract

本发明涉及一种髋关节置换假体。它包括有股骨柄（1）和股骨颈（2），其特征在于：所述股骨颈（2）的下部末端由两部分组成，其中一部分为弹性倒钩（4），另一部分为柱状体（5），且弹性倒钩（4）与柱状体（5）之间设有间隔缝隙（6）；所述股骨柄（1）的头部内设置有L形通孔（7）；所述股骨颈（2）的下部插入到所述L形通孔（7）内，且弹性倒钩（4）勾卡在L形通孔（7）上的横向孔（9）内；所述股骨柄（1）的下部外表附着有采用多级孔材料制成的凸棱（11）。本发明结构设计合理，植入后兼具较高的连接稳定性和生物相容性。

Description

一种髋关节置换假体
技术领域
本发明涉及人体关节置换，尤其涉及一种髋关节置换假体。
背景技术
目前，现有的髋关节置换假体大多为一体式设计，此结构虽然具有便于加工成型，便于安装等优点，但是应用中因受力不均等因素的作用，若出现其个别部位断裂如颈部断裂等情形，则将会导致其结构整体功能失效，这无疑造成了巨大的浪费。此外，现有的髋关节置换假体还存在植入前期与人体组织间连接稳定性不高，极易松动、脱落；生物相容性较差，植入后期易与人体组织产生排斥，使用寿命较短等共性难题，这些问题单纯依靠优化结构设计难以全部实现。
多孔材料具有相对密度低、比强度高、比表面积高、重量轻、渗透性好等特性，在化工、医药等诸多领域具有广泛的应用。在多孔材料中，多级孔材料由于其独特的性能---同时具有各级孔的优势，又同时具有单一孔的材料所不具备的优势，因而得到了越来越多的关注。例如，具有三维有序的大孔(孔径＞50nm)—介孔(2nm＜孔径＜50nm)—微孔(孔径＜2nm)结构的分子筛，结合了多级孔道结构及分子筛纳米晶两者的优势，赋予了分子筛更开放的三维孔道结构，同时纳米分子筛晶体大大缩短了物质传输路径，有效地提高了所得分子筛的物化活性；具有分级结构介孔－大孔的SiO2材料可作为固载生物分子，如固载溶菌酶的客体材料，具有很高的吸附速率和很大的酶固载量。然而，目前的人工关节置换假体中采用的多孔结构大多为单一孔材料，而关于选用多级孔材料的报道更是十分有限。这可能主要是由于现有的多孔材料本身也存在着伴随着孔隙率的提高，结构力学强度会显著下降，因此孔隙率普遍偏低，贯通性较低，不利于人体组织内物质的高效交换，生物相容性不佳，自重较重，术后人体感受不佳，以及空隙分布不均导致力学强度、弹性模量等不均匀分布，造成了质量隐患等缺陷。如CN201210185031公开了一种多级(微米/纳米)孔结构的仿生人工骨的制备方法，然而采用该方法得到的三维多级孔结构，由于其孔结构的随机性、不规则性，仍然不能满足仿生人工骨的功能要求。此外，作为应用于仿生人工骨的多级孔材料，需要材料本身均匀，即孔径大小、孔的分布均匀，以使得性能均匀一致，但实际上，有很多多级孔材料达不到该要求，其均匀性不足；尽管有的材料自称达到了较高的均匀性，但其均匀性仍是大体积尺度下的均匀性，若用小体积尺度进行衡量比较，比如在材料上任取多块体积不大于一立方厘米的三维体，分别测其质量，其不均匀程度差异仍然非常大，因此造成多级孔材料的各种性能如力学强度、弹性模量等不均匀，从而严重影响其功能。
发明内容
本发明的目的在于提供一种髋关节置换假体，其结构设计合理，植入后兼具较高的连接稳定性和生物相容性。
本发明的目的通过以下技术方案实现：
一种髋关节置换假体，它包括有股骨柄和股骨颈，其特征在于：所述股骨颈的下部末端由两部分组成，其中一部分为弹性倒钩，另一部分为柱状体，且弹性倒钩与柱状体之间设有间隔缝隙；所述股骨柄的头部内设置有L形通孔；所述股骨颈的下部插入到所述L形通孔内，且弹性倒钩勾卡在L形通孔上的横向孔内；所述股骨柄的下部外表附着有采用多级孔材料制成的凸棱。
为在植入手术实施过程前期固定股骨柄位置，并防止其下沉和旋转，上述股骨柄的中部上增设有孔，该孔内增设配合有紧固插杆。
为方便手术实施过程中产品的安装定位操作，上述股骨柄的头部上端增设有定位孔。
为进一步防止植入后股骨柄发生旋转，且更进一步提高其结构的生物相容性，上述采用多级孔材料制成的凸棱为沿着股骨柄轴向均匀分布的多个。
为满足不同患者个性化需求，以达到最好的安装效果要求，上述股骨颈的下部整体呈正柱体状，上部设为偏置倾斜柱。根据不同患者的情况，通过控制股骨颈上部的长度，以及股骨颈上下部之间的倾斜角度，即可使股骨颈具有许多种可变的规格，以适应不同患者的需求。
作为进一步的选优，上述凸棱所采用的上述多级孔材料，具体可由多级多孔材料构成，包括材料本体，本体是以材料孔径大小进行分级的孔腔，及围绕形成孔腔的腔壁构成，其孔腔呈均匀性分布，呈三维空间围绕构成上级孔腔的腔壁上设置下级孔腔；各级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通，孔腔呈均匀性分布是指各孔腔在多级孔材料上任意单位级体积下均呈均匀性分布。
更具体地说，上述的多级孔材料，其本体内的每级多孔材料自为一连续结构体。且其每一级多孔材料的最大外边界与整个材料本体的空间边界相当。即每级多孔材料都可以作为一级独立的多孔材料存在于本体中，且具有其独自的物化性能。这样的结构可以使得各级多孔材料的物化性能有所差异，在相对固定的材料整个空间中具有不同的物化性能，更好地满足多方面的功能需求。
更具体地说，上述多级孔材料，上级孔腔的腔壁可以由下一级多孔材料构成，以使孔腔逐级分层，并合理布置孔腔的结构及孔径大小；上级孔腔的腔壁还可以由其下级的多级多孔材料复合构成，或是由其下级的各级多孔材料复合构成，以使得材料满足特定的功能需求。
更具体地说，上述单位级体积是指立方厘米级或立方毫米级或更小单位级体积。
更具体地说，上述孔腔呈均匀性分布是指在该多级孔材料上任取的体积不大于1立方厘米的相同大小的三维体，它们质量基本相当。
更具体地说，上述质量基本相当是指在多级孔材料上任取的多个体积不大于1立方厘米的相同大小的三维体，分别称其质量，得到它们质量的平均值，而任一三维体质量相对于质量平均值的偏差绝对值不大于三维体质量平均值的4％。
本发明中的上述多级孔材料，具体可采用常规医用的金属、合金和非金属等材料制成。且为简便部件间的连接固定，采用上述多级孔材料制成的凸棱，可经粘结、焊接或烧结等常规的工艺，实现附着于股骨柄的下部外表，并与其彼此固定。
本发明具有以下的有益效果：
(1)本发明提供了一种髋关节置换假体，其股骨颈具有多种可变的规格，适应了不同患者的个性化需求；结构中股骨颈与股骨柄之间通过弹性倒钩与L形通孔的插入式勾卡作用，而连接结合在一起，防止了股骨颈从股骨柄中脱离；而当颈部出现断裂等情形时，又可实现将股骨颈与股骨柄分离开来，避免了因部件失效而导致整体结构的失效浪费。此外，通过在股骨柄中部上增设的孔内配合紧固插杆，即简便地实现了防止股骨柄的下沉和旋转等作用，加强了其连接牢固性，而在植入后期还可协同增强采用多级孔材料制成的凸棱所贡献的稳固作用。
(2)其股骨柄下部外表附着的凸棱，由多级孔材料制成；该多级孔材料是三维贯通的(包括每级孔三维贯通，各级孔互相三维贯通)，其贯通性得到极大的改善，充分满足了材料作为仿生人工骨的多种功能需求，例如，同时兼具良好的结构力学性能和较高的孔隙率，极大的减轻了结构自重，增强了人体组织间物质的高效交换，大大加快了术后恢复期；且通过在股骨柄下部外表这一特定区域，附着由该多级孔材料制成的凸棱，在植入前期增大了其结构与股骨间的接触面积，增大了附着力，防止了股骨柄发生旋转，而在植入后期，随着人体组织快速生长进入各级空隙等部位，进而形成了多级长入稳固结构，极大地提升了结构的连接稳定性等；其多级孔材料中的孔腔构成了多级空隙分布，且其总体分布方式近似部分人体组织，极大地降低了人体的排斥反应，以及由此带来的不良感受。
(3)本发明中还对多级孔材料的孔腔分布均匀提出了具体明确的度量方式，明确了是在较小单位级体积的尺度下来度量多级孔材料的孔分布均匀性，这样的多级孔材料是高度均匀的，从而保证了多级孔材料的各种性能的均匀一致性，避免了选材的内部缺陷。
附图说明
图1为本发明实施例1中所述髋关节置换假体的结构示意图。
图2为图1中所述髋关节置换假体中肱骨柄结构的A-A剖视图。
图3为本发明实施例2中所述髋关节置换假体的结构示意图。
图4为本发明实施例3中所述髋关节置换假体的结构示意图。
具体实施方式
以本发明技术方案为前提，以下给出了其详细的实施方式，但本发明的保护范围不仅限于下述的实施方式。在不脱离和改变本发明上述技术思想情况下，根据本领域的普通技术知识和/或惯用手段，显然还可以做出多种形式的替换或变更，并均应包括在本发明的范围之内。
实施例1
如说明书附图1-2所示，一种髋关节置换假体，它包括有股骨柄1、股骨颈2和紧固插杆3；其股骨颈2的下部整体呈正柱体状，上部设为偏置倾斜柱；其股骨颈2的下部末端由两部分组成，其中一部分为弹性倒钩4，另一部分为柱状体5，且弹性倒钩4与柱状体5之间设有间隔缝隙6；其股骨柄1的头部内设置有L形通孔7，且该股骨柄1的头部上端增设有定位孔8；其股骨颈2的下部插入到L形通孔7内，且弹性倒钩4勾卡在L形通孔7上的横向孔9内；其股骨柄1的中部上增设有孔10，该孔10内过盈配合有紧固插杆3；其股骨柄1的下部外表附着有采用多级孔材料制成的凸棱11，该凸棱11为沿着股骨柄1轴向均匀分布的四个；本实施例中制作凸棱11所采用的多级孔材料为多孔钛，具有三级孔，其中，均匀分布、相互贯通的第一级孔腔的腔壁上有均匀分布、相互贯通的第二级孔腔，第二级孔腔的腔壁上有均匀分布、相互贯通的第三级孔腔；且各级孔腔相互间也彼此贯通，所述的贯通为三维贯通。每级多孔材料自为一连续结构体，每一级多孔材料的最大外边界与整个材料本体空间边界相当，每级多孔材料具有独自的物化性能。总有效孔隙率为75％，第一级孔平均孔径为450μm，在第一级孔的腔壁上有平均孔径30μm的贯通的第二级孔，在第二级孔的腔壁上有平均孔径670nm的贯通的第三级孔。
用常规机械加工方法在该多孔钛上任取9件10mm×10mm×10mm的相同尺寸的三维体，用梅特勒-托利多XP26Microbalance天平测试其质量，结果如表1所示，其中，相对于平均值的偏差绝对值用百分比表示，其值为相对于平均值的偏差绝对值除以质量平均值，由表1可知，其质量偏差不大于4％。
表1
件号 质量(mg) 相对于平均值的偏差绝对值(％)
1 1156.184 1.4％
2 1135.077 3.2％
3 1151.493 1.8％
4 1157.356 1.3％
5 1145.630 2.3％
6 1217.159 3.8％
7 1197.225 2.1％
8 1191.362 1.6％
9 1201.915 2.5％
质量平均值 1172.600
该种多孔钛的制备方法是：
(1)材料准备
采用粒径为2μm的钛粉为原料，粒径为770nm的淀粉做为待制多级孔材料的最小一级孔腔的造孔剂，用粒径为770nm的硬脂酸作为粘合剂，按照钛粉：淀粉：硬脂酸：蒸馏水按体积比3：1：1：11配制成浆料。
采用棱直径为30μm的聚酯泡沫，将所述浆料用泡沫浸渍法均匀填充其中，形成坯体并干燥，然后破碎得到颗粒为30μm的含有原料、造孔剂与聚酯泡沫的混合颗粒。
(2)将混合颗粒、粒径为30μm的甲基纤维素按体积比3：1均匀混合后均匀地灌入棱直径为560±20μm、孔径为400±15μm的三维贯通的聚酯泡沫中，然后将聚酯泡沫放入密闭模具压制成致密坯体。
(3)将致密坯体真空烧结；烧结后的坯体按照钛材工艺进行常规后续热处理得到具有三级孔的多孔钛。
该种多孔钛作为骨再生材料，第一级孔尺寸特别适于满足血管等生命组织长入的需求；第二级孔特别适于多种细胞的寄居；第三级孔因其大量的纳米孔，特别有利于满足细胞的的黏附、分化需求，且比表面积很大，能负载很多的生长因子，与股骨间的附着力也更强，而且，孔的贯通性好，各级孔均各自相互贯通且各级孔相互间也彼此贯通，能充分满足血液、组织液的浸润、传输，实现蛋白质降解产物及新陈代谢产物的排出，因此它是一种真正的骨再生材料。此外，其股骨柄1中部上增设的孔10内配合紧固插杆3，即简便地实现了防止股骨柄1的下沉和旋转等作用，加强了其连接牢固性，而在植入后期还可协同增强采用多级孔材料制成的凸棱11所贡献的稳固作用。
实施例2
如说明书附图3所示，一种髋关节置换假体，它包括有股骨柄1和股骨颈2；其股骨颈2的下部整体呈正柱体状，上部设为偏置倾斜柱；其股骨颈2的下部末端由两部分组成，其中一部分为弹性倒钩4，另一部分为柱状体5，且弹性倒钩4与柱状体5之间设有间隔缝隙6；其股骨柄1的头部内设置有L形通孔7，且该股骨柄1的头部上端增设有定位孔8；其股骨颈2的下部插入到L形通孔7内，且弹性倒钩4勾卡在L形通孔7上的横向孔9内；其股骨柄1的下部外表附着有采用多级孔材料制成的凸棱11，该凸棱11为沿着股骨柄1轴向均匀分布的两个；本实施例中制作凸棱11所采用的多级孔材料为多孔钽，具有三级孔，其中，均匀分布、相互贯通的第一级孔腔的腔壁上有均匀分布、相互贯通的第二级孔腔，第二级孔腔的腔壁上有均匀分布、相互贯通的第三级孔腔；且各级孔腔相互间也彼此贯通，所述的贯通为三维贯通；每级多孔材料自为一连续结构体，每一级多孔材料的最大外边界与整个材料本体空间边界相当，每级多孔材料具有独自的物化性能。总有效孔隙率为80％，第一级孔平均孔径为510μm，在第一级孔的腔壁上有平均孔径25μm的贯通的第二级孔，在第二级孔的腔壁上有平均孔径780nm贯通的第三级孔。
用常规机械加工方法在该多级孔材料上任取9件10mm×10mm×10mm的相同尺寸的三维体，用梅特勒-托利多XP26Microbalance天平测试其质量，结果如表2所示，其中，相对于平均值的偏差绝对值用百分比表示，其值为相对于平均值的偏差绝对值除以质量平均值，由表2可知，其质量偏差不大于4％。
表2
件号 质量(mg) 相对于平均值的偏差绝对值(％)
1 3282.624 1.6％
2 3292.63 1.3％
3 3242.592 2.8％
4 3265.944 2.1％
5 3285.960 1.5％
6 3469.440 4％
7 3409.392 2.2％
8 3396.048 1.8％
9 3379.368 1.3％
质量平均值 3336
该种材料的制备方法是：
(1)材料准备
选取粒径为900±30nm的聚苯乙烯小球，将其组装形成三维有序排列的胶体模板，制备钽纳米晶溶液，将钽纳米晶溶液引入聚苯乙烯小球制成的三维胶体模板中，将三维胶体模板/钽纳米晶溶液的混合物干燥，然后破碎为粒径为5μm的颗粒；
(2)取粒径为900±30nm的淀粉，按照重量比例1：40与蒸馏水混合，制成淀粉溶液，将上述颗粒、粒径为35μm的乙基纤维素及淀粉溶液按照重量比例12：1：8制成浆料，均匀地浸渍到孔径为600±20μm的聚酯泡沫上；
(3)将浸渍后的聚酯泡沫在真空或保护气氛中烧结，再按照钽工艺进行常规后续处理，制得具有三级孔的多孔钽。
类似于实施例1，该种材料特别适宜于做骨再生材料；应用中当出现颈部断裂等情形时，可用工具伸入横向孔9内，将弹性倒钩4向间隔缝隙6一侧推动，以使得弹性倒钩4和横向孔9之间失去勾卡作用，即实现了将股骨颈2与股骨柄1分离开来，避免了因颈部断裂等部件失效而导致整体结构的失效浪费。
实施例3
如说明书附图4所示，一种髋关节置换假体，它包括有股骨柄1和股骨颈2；其股骨颈2的下部整体呈正柱体状，上部设为偏置倾斜柱；其股骨颈2的下部末端由两部分组成，其中一部分为弹性倒钩4，另一部分为柱状体5，且弹性倒钩4与柱状体5之间设有间隔缝隙6；其股骨柄1的头部内设置有L形通孔7；其股骨颈2的下部插入到L形通孔7内，且弹性倒钩4勾卡在L形通孔7上的横向孔9内；其股骨柄1的下部外表附着有采用多级孔材料制成的凸棱11，该凸棱11为沿着股骨柄1轴向均匀分布的四个；本实施例中制作凸棱11所采用的多级孔材料与实施例1相同。
根据不同患者的实际情况，选择控制股骨颈2上部偏置倾斜柱的长度L，以及股骨颈2上下部之间的倾斜角度A，即使得股骨颈2具有了多种可变的规格，适应了不同患者的个性化需求。

Claims (10)

1.一种髋关节置换假体，它包括有股骨柄（1）和股骨颈（2），其特征在于：所述股骨颈（2）的下部末端由两部分组成，其中一部分为弹性倒钩（4），另一部分为柱状体（5），且弹性倒钩（4）与柱状体（5）之间设有间隔缝隙（6）；所述股骨柄（1）的头部内设置有L形通孔（7）；所述股骨颈（2）的下部插入到所述L形通孔（7）内，且弹性倒钩（4）勾卡在L形通孔（7）上的横向孔（9）内；所述股骨柄（1）的下部外表附着有采用多级孔材料制成的凸棱（11）。
2.如权利要求1所述髋关节置换假体，其特征在于：所述股骨柄（1）的中部上增设有孔（10），该孔（10）内增设配合有紧固插杆（3）。
3.如权利要求1或2所述髋关节置换假体，其特征在于：所述股骨柄（1）的头部上端增设有定位孔（8）。
4.如权利要求1-3任一所述髋关节置换假体，其特征在于：所述采用多级孔材料制成的凸棱（11）为沿着股骨柄（1）轴向均匀分布的多个；所述股骨颈（2）的下部整体呈正柱体状，上部设为偏置倾斜柱。
5.如权利要求1-4任一所述髋关节置换假体，其特征在于：所述多级孔材料，由多级多孔材料构成，包括材料本体，本体是以材料孔径大小进行分级的孔腔，及围绕形成孔腔的腔壁构成，其孔腔呈均匀性分布，呈三维空间围绕构成上级孔腔的腔壁上设置下级孔腔；各级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通，孔腔呈均匀性分布是指各孔腔在多级孔材料上任意单位级体积下均呈均匀性分布。
6.如权利要求5所述髋关节置换假体，其特征在于：所述的多级孔材料，其本体内的每级多孔材料自为一连续结构体，且其每一级多孔材料的最大外边界与整个材料本体的空间边界相当；材料本体内每级多孔材料具有独自的物化性能。
7.如权利要求5或6所述髋关节置换假体，其特征在于：所述多级孔材料内上级孔腔的腔壁，或由下一级多孔材料构成，或由其下级的多级多孔材料复合构成，或是由其下级的各级多孔材料复合构成。
8.如权利要求5-7任一所述髋关节置换假体，其特征在于：所述单位级体积是指立方厘米级或立方毫米级或更小单位级体积。
9.如权利要求8所述髋关节置换假体，其特征在于：所述孔腔呈均匀性分布是指在该多级孔材料上任取的体积不大于1立方厘米且相同大小的各三维体，它们质量基本相当。
10.如权利要求9所述髋关节置换假体，其特征在于：所述质量基本相当是指在多级孔材料上任取的多个体积不大于1立方厘米的相同大小的三维体，分别称其质量，得到它们质量的平均值，而任一三维体质量相对于质量平均值的偏差绝对值不大于三维体质量平均值的4%。
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