CN105031745B - 一种用聚合物包裹金属假体的骨科内植入物 - Google Patents

一种用聚合物包裹金属假体的骨科内植入物 Download PDF

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CN105031745B
CN105031745B CN201510232420.7A CN201510232420A CN105031745B CN 105031745 B CN105031745 B CN 105031745B CN 201510232420 A CN201510232420 A CN 201510232420A CN 105031745 B CN105031745 B CN 105031745B
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朱健
徐龙伟
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Suzhou Zhongke Biomedical Material Co., Ltd.
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Shanghai Active Biotechnology Service Center
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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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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    • 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
    • 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
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials

Abstract

本发明涉及一种用聚合物包裹金属假体的骨科内植入物，其包括金属植入物本体以及包覆在植入物表面的高分子层。本发明的骨科内植入物采用了耐腐蚀的有机高分子材料包覆在金属植入物本体材料的表面，因此防止了人体液体对金属植入物所造成的腐蚀；在两个彼此接触的金属植入物之间包覆以有机高分子材料可以阻止金属与金属的接触，进一步抑制了金属对金属接触所产生的电化学反应，进而降低了金属离子溶解对人体造成的不良反应；同时高分子界面的存在有助于金属植入物之间加强锁定，防止和减少微动，加快手术愈合。

Description

一种用聚合物包裹金属假体的骨科内植入物
技术领域
本发明涉及一种医疗康复器械，尤其涉及一种用聚合物包裹金属假体的骨科内植入物。
背景技术
金属材料是骨科内植入物最常用的材料之一。金属材料具有强度高、韧性好等陶瓷和高分子材料所不具备的优点，所以被广泛应用于强度要求高的骨科内植入物的结构部件，如接骨板、髓内钉、骨螺钉、关节柄、股骨髁等。最常用的金属材料为钛及钛合金、CoCrMo合金、不锈钢等(Pezzotti G,Yamamoto K.Artificial hip joints:The biomaterialschallenge.J Mech Behav Biomed Mater.2014 Mar；31:3-20)。但是，金属材料在和人体液体接触的情况下会产生不同程度的腐蚀，腐蚀物包括金属离子，其会使人体产生不良反应，因此，降低或防止金属骨科内植入物的腐蚀是其应用的一项基本要求(Matusiewicz H,Potential release of in vivo trace metals from metallic medical implants inthe human body:from ions to nanoparticles--a systematic analytical review,Acta Biomater.2014 Jun；10(6):2379-403)。
此外，金属在体液中的腐蚀在微动磨损的状态下更为严重(Engh CA Jr,Ho H,Padgett DE.The surgical options and clinical evidence for treatment of wearor corrosion occurring with THA or TKA.Clin Orthop Relat Res.2014 Dec；472(12):3674-86)。例如接骨板与螺钉的结合部、髓内钉与交锁螺钉的结合部、脊柱螺钉与弹性棒的结合部(Brown SA,Hughes PJ,Merritt K.In vitro studies of frettingcorrosion of orthopaedic materials.J Orthop Res.1988；6(4):572-9)、关节柄与球头的结合部(Esposito CI,Wright TM,Goodman SB,Berry DJ,What is the trouble withtrunnions？Clinical,Biological and Bioengineering Study Groups from CarlT.Brighton Workshop.Clin Orthop Relat Res.2014 Dec；472(12):3652-8)、髋臼杯与内衬之间(Agne MT,Underwood RJ,Kocagoz SB,MacDonald DW,Day JS,Parvizi J,KraayMJ,Mont MA,Klein GR,Cates HE,Kurtz SM,Is there material loss at the backsidetaper in modular CoCr acetabular liners？Clin Orthop Relat Res.2015 Jan；473(1):275-85)、髋臼杯与螺钉的结合部(Kligman M,Furman BD,Padgett DE,WrightTM.Impingement contributes to backside wear and screw-metallic shell frettingin modular acetabular cups.J Arthroplasty.2007 Feb；22(2):258-64)、胫骨平台与螺钉的结合部以及其他任何金属对金属的结合部，这些位置均为腐蚀最易发生的地方。因此，如何防止或降低金属与金属接触面的腐蚀也是需要进一步解决的问题。本发明主要针对非滑动面，因此耐磨性不重要。针对金属对金属的非滑动界面，高分子界面的存在有助于加强锁定，防止和减少微动。
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用聚合物包裹金属假体的骨科内植入物。该骨科内植入物通过在金属骨科植入物表面包覆以有机高分子材料降低内植入物的腐蚀；在两个彼此接触的金属植入物之间包覆以有机高分子材料可以阻止金属与金属的接触，进一步抑制了金属对金属接触所产生的电化学反应，进而降低了金属离子溶解对人体造成的不良反应,进一步抑制金属离子对人体所产生的毒害作用；同时高分子界面的存在有助于金属植入物之间加强锁定，防止和减少微动，加快手术愈合。
为了实现上述目的，本发明采用以下技术方案：
一种用聚合物包裹金属假体的骨科内植入物，包括金属植入物本体以及包覆在植入物表面的高分子层。
进一步地，所述骨科内植入物包括接骨板、骨螺钉、髓内钉、脊柱固定钉棒、髋关节柄、髋臼杯、膝关节股骨髁以及膝关节胫骨平台。
进一步地，所述金属植入物本体的材料选自钛、钛合金、钴铬钼合金以及不锈钢。
进一步地，所述高分子层的材料选自聚醚醚酮、聚醚醚酮的衍生物、聚四氟乙烯、聚四氟乙烯的衍生物、超高分子聚乙烯以及超高分子聚乙烯的衍生物。
进一步地，所述高分子层的厚度范围为1-2000微米。
进一步地，所述高分子层的厚度范围为10-1000微米。
进一步地，所述高分子层只包覆在金属植入物与另一金属植入物结合的表面。
进一步地，所述高分子层将金属植入物完全包覆。
进一步地，所述金属植入物本体的表面是多孔结构，所述高分子层的外表面也为多孔结构。
进一步地，所述高分子层利用热喷涂技术、化学沉积技术、电化学沉积技术或注塑成型技术所形成。
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：
本发明的内植入物，由于采用了耐腐蚀的有机高分子材料包覆在金属植入物本体材料的表面，因此防止了人体液体对金属植入物所造成的腐蚀；在两个彼此接触的金属植入物之间包覆以有机高分子材料可以阻止金属与金属的接触，进一步抑制了金属对金属接触所产生的电化学反应，进而降低了金属离子溶解对人体造成的不良反应。
附图说明
图1是本发明的骨科内植入物的含有包裹层的接骨板的结构示意图；
图2是本发明的骨科内植入物的髋关节柄的结构示意图；
图3是本发明的骨科内植入物的髓内钉的结构示意图；
图4是本发明的骨科内植入物的脊柱固定钉棒的结构示意图；
图5是本发明的骨科内植入物的股骨髁的结构示意图；
图6是本发明的骨科内植入物的骨螺钉的结构示意图；
图7是本发明的骨科内植入物的胫骨托的结构示意图。
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。
本发明的用聚合物包裹金属假体的骨科内植入物包括但不限于用于固定以及保护人体的植入物，例如接骨板、骨螺钉、髓内钉、交锁螺钉、脊柱螺钉、弹性棒等；也可以是人工关节以及其中的某些部件，例如髋关节柄、髋臼杯、膝关节股骨髁以及膝关节胫骨平台等。
本发明的用聚合物包裹金属假体的骨科内植入物的植入物本体的材料为医用的金属材料，包括但不限于钛、钛合金、钴铬钼合金以及不锈钢等。
本发明的用聚合物包裹金属假体的骨科内植入物的植入物是在金属植入物本体的表面包覆了有机高分子材料层，该有机高分子材料可以防止人体液体对金属植入物本体的腐蚀，高分子材料层包括但不限于聚醚醚酮(PEEK)、聚醚醚酮的衍生物、聚醚醚酮复合材料、聚四氟乙烯(PTFE)、聚四氟乙烯的衍生物、超高分子聚乙烯(UHMWPE)以及超高分子聚乙烯的衍生物等。有机高分子材料包覆层可以利用例如热喷涂技术、化学沉积技术、电化学沉积技术或注塑成型技术等形成在金属植入物本体的表面。
在一优选实施例中，高分子层的厚度范围为1-2000微米，其优选范围为10-1000微米。包覆层的厚度如低于10微米，微小的表面缺陷会引起基体金属的暴漏及点腐蚀；包覆层的厚度如大于1000微米，被包裹内置物的整体强度及刚度会产生较大变化。
在一优选实施例中，对于应用在人体液体腐蚀不明显的环境中的金属骨科内植入物可以采用部分包覆的方式，即仅对一个金属植入物与另一金属植入物相互接触的结合位置包覆了有机高分子层，以防止金属与金属接触形成电化学反应对金属植入物的腐蚀。而对于应用在人体液体腐蚀较严重的环境中的金属骨科内植入物，则可以采用完全包覆的方式，即在金属骨科内植入物本体的外表面全部包覆了有机高分子层。
在一优选实施例中，金属植入物本体的表面是多孔结构，多孔结构可以增强植入物本体和有机高分子包覆层之间的结合力，从而在后续的使用中有机高分子包覆层不会从植入物本体剥离。所述高分子层的外表面也为多孔结构，该多孔结构可以利用机械处理或结构处理而获得，在多孔结构的表面还可以叠加有微粗糙的表面，微粗糙的表面可以利用化学处理而获得，该多孔及粗糙的表面使骨组织可以长入，从而使有机高分子包覆层与人体骨组织的结合更加牢固，增加植入物的耐用性。
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 (5)

1.一种用聚合物包裹金属假体的骨科内植入物，其特征在于，包括金属植入物本体以及包覆在植入物表面的高分子层，所述金属植入物本体的表面是多孔结构，所述高分子层的外表面也为多孔结构，在多孔结构的表面还叠加有利用化学处理而获得的微粗糙的表面，所述高分子层的厚度范围为1000-2000微米，所述金属植入物本体的材料选自钛、钛合金、钴铬钼合金以及不锈钢，所述高分子层的材料选自聚醚醚酮、聚醚醚酮的衍生物、聚四氟乙烯、聚四氟乙烯的衍生物、超高分子量聚乙烯以及超高分子量聚乙烯的衍生物。
2.根据权利要求1所述的用聚合物包裹金属假体的骨科内植入物，其特征在于，所述骨科内植入物包括接骨板、骨螺钉、髓内钉、脊柱固定棒、髋关节柄、髋臼杯、膝关节股骨髁以及膝关节胫骨平台。
3.根据权利要求1所述的用聚合物包裹金属假体的骨科内植入物，其特征在于，所述高分子层只包覆在金属植入物与另一金属植入物结合的表面。
4.根据权利要求1所述的用聚合物包裹金属假体的骨科内植入物，其特征在于，所述高分子层将金属植入物完全包覆。
5.根据权利要求1-4中任一项所述的用聚合物包裹金属假体的骨科内植入物，其特征在于，所述高分子层利用热喷涂技术、化学沉积技术、电化学沉积技术或注塑成型技术所形成。
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