CN105030376B - 一种全髋表面置换植入物 - Google Patents

一种全髋表面置换植入物 Download PDF

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CN105030376B
CN105030376B CN201510070811.3A CN201510070811A CN105030376B CN 105030376 B CN105030376 B CN 105030376B CN 201510070811 A CN201510070811 A CN 201510070811A CN 105030376 B CN105030376 B CN 105030376B
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acetabular cup
femoral component
cup part
hip resurfacing
femur
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CN105030376A (zh
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朱健
徐龙伟
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Suzhou Zhongke Biomedical Material Co., Ltd.
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Jiangsu Okani Medical Technology Co Ltd
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Priority to CN201510070811.3A priority Critical patent/CN105030376B/zh
Priority to EP15881442.6A priority patent/EP3257475B1/en
Priority to AU2015383053A priority patent/AU2015383053B2/en
Priority to PCT/CN2015/000662 priority patent/WO2016127280A1/zh
Priority to US15/550,359 priority patent/US11318021B2/en
Priority to ES15881442T priority patent/ES2901737T3/es
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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
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
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    • A—HUMAN NECESSITIES
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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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
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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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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Abstract

本发明公开一种全髋表面置换植入物，包括股骨部件和髋臼杯部件，其中：股骨部件外形为半球壳形，其由聚醚醚酮(PEEK)或其衍生物构成；髋臼杯部件的外形与股骨部件外形相配合并且紧贴于股骨部件的半球壳的外表面，髋臼杯部件由超高分子量聚乙烯构成；或者股骨部件可以由超高分子量聚乙烯构成，同时髋臼杯部件由聚醚醚酮(PEEK)或其衍生物构成。本发明的全髋表面置换植入物，由于采用了有机高分子对有机高分子的摩擦组合，因此降低了材料对生物体的毒性，由于有机高分子的刚度与人体的自然骨骼更加匹配，因此降低了植入物在使用过程中的磨损；通过股骨髁上定位柱的优化设计,避免导致早期股骨颈断裂和中长期骨吸收的临床问题。

Description

一种全髋表面置换植入物
技术领域
本发明涉及一种医疗康复器械，尤其涉及一种全髋表面置换植入物。
背景技术
近年来，研究人员发现新一代的高稳定性，高强度和高生物相容性的聚醚醚酮(PEEK)高分子材料对超高分子量聚乙烯(UHMWPE)摩擦面具有比CoCrMo对聚乙烯更高的耐磨性(Wang AG,Zhang ZT,Lawrynowicz DE and Yau SS(2010)Orthopedic PAEK-on-polymer bearings,HOWMEDICA OSTEONICS CORP,IPC8Class:AA61F230FI,USPC Class:6231811,Patent application number:20100312348,2010-12-09；Singh,V，Ogden,C，Sitton,K and Sitton,K(2012)Wear evaluation of different polymeric materialsfor total disc replacement(TDR),Proceedings of the ASME/STLE InternationalJoint Tribology Conference,Los Angeles,CA,2011,35-37,2012)。此一发现为PEEK对聚乙烯作为人工关节摩擦面组合提供了可行性的实验数据。由于聚醚醚酮和聚乙烯具有和人体自然骨更相匹配的刚度，此组合有可能解决CoCrMo对CoCrMo人工关节置换中存在的金属离子毒性的问题。
但经过研究发现，PEEK对聚乙烯滑动表面的摩擦，在全髋置换中球窝结构的磨损量(16.5±1.8mm3/million,Wang AG,Zhang ZT,Lawrynowicz DE and Yau SS(2010)ORTHOPEDIC PAEK-ON-POLYMER BEARINGS,HOWMEDICA OSTEONICS CORP,IPC8Class:AA61F230FI,USPC Class:6231811,Patent application number:20100312348,2010-12-09)不是非常理想，我们分析这是由于全髋置换中PEEK假体股骨部件的刚度不够，导致转动轴心不稳，使得球窝结构的摩擦面不稳定，增加了球窝结构表面磨损量。因此PEEK对聚乙烯滑动表面的磨损，在全髋置换中应用效果不够理想。
全髋表面置换在理念上有很多优于全髋置换的地方(Amstutz,H.C.,Grigoris,P.,and Dorey,F.J.Evolution and future of surface replacement of thehip.J.Orthop.Sci.,1998,3,169–186)。首先，表面置换保存了大量的股骨骼；其次，表面置换采用人体自然骨大小相当的股骨骼，从而大大提高了关节的稳定性；最后，表面置换一旦出现问题，可以通过传统的全髋置换来翻修，从而减少了对病人自然骨的切除度。
早在上世纪三十年代，全髋表面置换就被应用于治疗关节炎病人。早期研究曾针对高分子材料聚四氟乙烯(Polytetrafluoroethylene，PTFE)，对PTFE的摩擦面组合进行尝试(Charnley,J.Arthroplasty of the hip:a new operation.Lancet,1961,1,1129–1132)，但由于过度的磨损而导致组织不良反应和假体破坏而被终止(Charnley,J.Tissuereactions to polytetrafluoroethylene(letter).Lancet,1963,2,1379)。进入上世纪下半叶，CoCrMo合金对CoCrMo合金的磨损组合在全髋置换得到广泛应用(August AC,AldamCH,Pynsent PB.The McKee-Farrar hip arthroplasty.A long-term study.J BoneJoint Surg Br.1986Aug；68(4):520-7)。进入上世纪七十年代，随着Charnley对超高分子量聚乙烯在人工髋关节置换的成功应用，CoCrMo合金对CoCrMo合金全髋置换被逐渐淘汰，代之而起的是CoCrMo对超高分子量聚乙烯的摩擦面组合(Wroblewski BM.Charnley low-friction arthroplasty.Review of the past,present status,and prospects for thefuture.Clin Orthop Relat Res.1986Sep；(210):37-42)。进入上世纪九十年代，CoCrMo对CoCrMo摩擦组合通过冶金和设计上的改良又得到在表面置换临床上的重新应用(Sieber,H.P.,Rieker,C.B.,and Kottig,P.Analysis of 118second generation metal-on-metalretrieved hip implants.J.Bone Jt Surg.,1999,81B,46–50；McMinn,D.,Treacy,R.,Lin,K.,and Pynsent,P.Metal-on-metal surface replacement of thehip.Clin.Orthop.,1996,329S,S89–S98)。进入二十一世纪，CoCrMo对CoCrMo在表面置换得到更进一步的应用(Grigoris P,Roberts P,Panousis K,Jin Z.Hip resurfacingarthroplasty:the evolution of contemporary designs.Proc Inst Mech EngH.2006Feb；220(2):95-105.Review)。但是，由于CoCrMo合金的磨消及其离子引起人体不良反应的案例增多，CoCrMo对CoCrMo摩擦组合又很快地退出临床应用，包括全髋置换和全髋表面置换(Singh G,Meyer H,Ruetschi M,Chamaon K,Feuerstein B,Lohmann CH,Large-diameter metal-on-metal total hip arthroplasties:a page in orthopedichistory,J Biomed Mater Res A.2013Nov；101(11):3320-6.doi:10.1002/jbm.a.34619.Epub 2013Mar 25)。
CoCrMo合金对CoCrMo合金在表面置换上的缺陷，除了金属磨粒和金属离子的毒性外(Delaunay C,Petit I,Learmonth ID,Oger P,Vendittoli PA.Metal-on-metalbearings total hip arthroplasty:the cobalt and chromium ions releaseconcern.Orthop Traumatol Surg Res.2010Dec；96(8):894-904.doi:10.1016/j.otsr.2010.05.008.Epub 2010Sep 15)，其刚度远远高于人的自然骨，在使用过程中由于金属刚度较高，应力集中在金属置换植入物上，使植入物周围的骨头弱化，植入物不能与骨头结合，后期易出现脱落折断等问题。
发明内容
为了解决上述问题及缺陷，本发明的目的是提供一种全髋表面置换植入物。该全髋表面置换植入物可降低髋部剩余骨骼与植入物之间的应力，降低植入物的磨损。
为了实现上述目的，本发明采用以下技术方案：
一种全髋表面置换植入物，包括股骨部件和髋臼杯部件，其中：
所述股骨部件外形为半球壳形；
所述髋臼杯部件的外形与所述股骨部件外形相配合并且紧贴于所述股骨部件的半球壳的外表面；并且
所述股骨部件由聚醚醚酮或其衍生物构成，所述髋臼杯部件由超高分子量聚乙烯构成；或者所述股骨部件由超高分子量聚乙烯构成，所述髋臼杯部件由聚醚醚酮或其衍生物构成。
进一步地，所述股骨部件半球壳外表面的粗糙度Ra＜1.0μm以及所述股骨部件半球壳内表面的粗糙度Ra＞0.1μm。
进一步地，所述股骨部件半球壳内侧中心部位设有实心定位柱。
进一步地，所述股骨部件半球壳内侧中心部位设有空心定位柱，所述空心定位柱内设有金属柱芯。
进一步地，所述金属柱芯的上端低于股骨表面部件和定位柱结合部。
进一步地，所述半球壳内表面以及定位柱的外表面涂有非骨水泥固定材料。
进一步地，所述半球壳内表面以及定位柱的外表面设有一层多孔金属层，所述多孔金属层厚度大于0.5mm并且孔隙度高于20％。
进一步地，所述髋臼杯部件为高交联的超高分子量聚乙烯。
进一步地，所述髋臼杯部件与骨骼相连接的一侧涂有非骨水泥固定材料。
进一步地，所述髋臼杯部件与骨骼相连接的一侧设有一层多孔的金属层，所述多孔金属层厚度小于0.5mm以及孔隙率高于20％。
由于采用以上技术方案，本发明与现有技术相比具有如下优点：
本发明的全髋表面置换植入物，由于采用了有机高分子对有机高分子的摩擦组合，因此降低了材料对生物体的毒性，另外有机高分子特别是采用聚醚醚酮(PEEK)高分子材料对超高分子量聚乙烯(UHMWPE)的组合，刚度与人体的自然骨骼更加匹配，在运动中起到一定缓冲作用，降低了植入物在使用过程中的对球窝结构的磨损；加了金属柱芯，避免导致早期股骨颈断裂和中长期骨吸收的临床问题。
附图说明
图1是本发明的新型全髋表面置换植入物的一个实施例的示意图；
图2是本发明的新型全髋表面置换植入物的股骨部件的一个实施例的示意图；
图3是本发明的新型全髋表面置换植入物的股骨部件的一个实施例的示意图；
图4是本发明的新型全髋表面置换植入物的股骨部件的一个实施例的示意图；
图5是是本发明的新型全髋表面置换植入物的髋臼杯部件的一个实施例的示意图。
附图标记说明
100股骨部件、110股骨部件半球壳、111半球壳外表面、112半球壳内表面、113PEEK外层、114PEEK与金属泡沫结合部件、115金属壁垒、116非骨水泥固定材料、120定位柱、121定位柱外表面、122金属柱、200髋臼杯部件、201聚合物层、202聚合物与金属泡沫结合部件、203金属壁垒、204非骨水泥固定材料。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合附图和实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
如图1和图2所示，本发明的新型全髋表面置换植入物，包括股骨部件100和髋臼杯部件200，其中：股骨部件100包括半球壳110，其由聚醚醚酮(PEEK)或其衍生物构成，PEEK中可以包含显影添加物，髋臼杯部件200的外形与所述股骨部件100的半球壳110的外形相配合并且紧贴于股骨部件100的半球壳110的外表面111，髋臼杯部件200由超高分子量聚乙烯构成。
在一优选实施例中，股骨部件100由超高分子量聚乙烯构成，而髋臼杯部件200由聚醚醚酮(PEEK)或其衍生物构成，PEEK中可以包含显影添加物。
在一优选实施例中，如图2所示，股骨部件100的半球壳110内侧中心部位设有截面为圆形或锥形的实心定位柱120，其用于将股骨部件固定在人体骨骼上。
在一优选实施例中，如图3所示，股骨部件100的半球壳110内侧中心部位设有截面为圆形或锥形的空心定位柱120’，其空心内镶入一个与其形状和尺寸都匹配的金属柱芯，金属柱芯的上端低于股骨半球壳110和定位柱120’的结合部位。在植入物植入初期，半球壳110与骨骼之间还存在部分缝隙，而有机高分子材料的刚度不足以使该结构稳定，其轴心不稳会导致球窝结构的摩擦面易受到不同方向的应力，加快材料的失效。设置金属柱芯可以起到加固的作用，但金属柱芯的位置对材料的寿命也有较大的影响。当金属柱芯的顶部高于股骨半球壳110和定位柱120’的结合部位时，由于金属的弹性模量较高，股骨部件承受的应力大部分都集中在金属柱芯上，球窝受力较低，弱化了球窝内骨头的生长，骨头无法与植入物接合，植物部件的支撑长期依靠金属柱芯，易引起骨裂。因此金属柱芯上端应低于定位柱和半球壳结合部，这样可以增加该区域的中长期的骨质生长，避免了该区域的骨吸收而导致定位柱成为独立受力部，从而最终引起断裂。
另一方面，半球壳110的外表面111的粗糙度Ra＜1.0μm，最好为Ra＜0.1μm，表面光洁度越好，PEEK外层与髋臼杯部件200在使用中的摩擦越小，部件的磨损越小，半球壳110的内表面112的粗糙度Ra＞0.1μm，最好为Ra＞1μm。内表面112与人体骨骼相接触，其粗糙程度会影响植入物与骨骼之间的结合力。
在一优选实施例中，如图2和图4所示，半球壳110的外表面111以及定位柱120、120’的外表面121涂有非骨水泥固定材料116，主要为生物固定涂层，包括但不限于羟基磷灰石(HA)、钛或钛合金涂层、钽或钽合金、锆铌合金涂层等，其用于促进植入物与骨骼之间的结合，进而起到固定作用。
在一优选实施例中，如图4所示，半球壳110的内表面112设有一层多孔的金属层，包括但不限于金属泡沫，半球壳110的外层为PEEK 113，PEEK外层113内部设有一层金属壁垒115，其具有支撑整个外壳的作用同时也具有显影效果，为了使PEEK外层113与金属壁垒115结合更牢固，二者之间设有PEEK结合金属泡沫的部件114。此外，定位柱的外表面121上也设有一层多孔金属层，半球壳110以及定位柱120、120’的多孔金属层厚度大于0.5mm并且孔隙度高于20％，骨骼可以长入金属空隙内，通过这样的结构使植入物与骨骼结合更加牢固。
在一优选实施例中，本发明所采用的多孔金属层由激光或电子束3D打印成型，所述多孔金属层与所述股骨部件通过机械挤压镶嵌或注塑而结合。
在一优选实施例中，髋臼杯部件为高交联的超高分子量聚乙烯。
在一优选实施例中，如图5所示，髋臼杯部件200的内表面为光洁度高的聚合物层201，其外层为金属壁垒203，在聚合物层201和金属壁垒203之间设有聚合物与金属泡沫结合部件202，在金属壁垒的外层还设有非骨水泥固定材料204，非骨水泥固定材料204包括但不限于羟基磷灰石(HA)、钛或钛合金涂层、钽或钽合金、锆铌合金涂层等，其用于促进植入物与骨骼之间的结合，进而起到固定作用。
在一优选实施例中，髋臼杯部件200与骨骼相连接的一侧设有一层多孔的金属层，多孔金属层厚度小于0.5mm以及孔隙率高于20％，骨骼可以长入金属空隙内，通过这样的结构使植入物与骨骼结合更加牢固。
以上所述仅为本发明的较佳实施例，并非用来限定本发明的实施范围；如果不脱离本发明的精神和范围，对本发明进行修改或者等同替换，均应涵盖在本发明权利要求的保护范围当中。

Claims (8)

1.一种全髋表面置换植入物，其特征在于，包括股骨部件和髋臼杯部件，其中：
所述股骨部件外形为半球壳形，所述股骨部件半球壳内侧中心部位设有空心定位柱，所述空心定位柱内设有金属柱芯；
所述髋臼杯部件的外形与所述股骨部件外形相配合并且紧贴于所述股骨部件的半球壳的外表面；并且
所述股骨部件由聚醚醚酮或其衍生物构成，所述髋臼杯部件由超高分子量聚乙烯构成；或者所述股骨部件由超高分子量聚乙烯构成，所述髋臼杯部件由聚醚醚酮或其衍生物构成。
2.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述股骨部件半球壳外表面的粗糙度Ra＜1.0μm以及所述股骨部件半球壳内表面的粗糙度Ra＞0.1μm。
3.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述金属柱芯的上端低于股骨表面部件和定位柱结合部。
4.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述半球壳内表面以及定位柱的外表面涂有非骨水泥固定材料。
5.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述半球壳内表面以及定位柱的外表面设有一层多孔金属层，所述多孔金属层厚度大于0.5mm并且孔隙度高于20％。
6.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述髋臼杯部件为高交联的超高分子量聚乙烯。
7.根据权利要求1中所述的全髋表面置换植入物，其特征在于，所述髋臼杯部件与骨骼相连接的一侧涂有非骨水泥固定材料。
8.根据权利要求1中所述的全髋表面置换植入物，所述髋臼杯部件与骨骼相连接的一侧设有一层多孔的金属层，所述多孔金属层厚度小于0.5mm以及孔隙率高于20％。
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EP3257475A4 (en) 2018-11-07
EP3257475A1 (en) 2017-12-20
CN105030376A (zh) 2015-11-11
US11318021B2 (en) 2022-05-03
AU2015383053B2 (en) 2020-09-17
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US20180028321A1 (en) 2018-02-01
WO2016127280A1 (zh) 2016-08-18

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