CN106232060A - 植入件连接 - Google Patents

植入件连接 Download PDF

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CN106232060A
CN106232060A CN201580017421.8A CN201580017421A CN106232060A CN 106232060 A CN106232060 A CN 106232060A CN 201580017421 A CN201580017421 A CN 201580017421A CN 106232060 A CN106232060 A CN 106232060A
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parts
coupling part
implantation
prosthese
coating
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H·D·林克
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Waldemar Link GmbH and Co KG
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    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30107—Properties of materials and coating materials using materials or accessories for preventing galvanic or electrolytic corrosion
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • A—HUMAN NECESSITIES
    • 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
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/365—Connections of heads to necks
    • A—HUMAN NECESSITIES
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys
    • A—HUMAN NECESSITIES
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00419—Other metals
    • A61F2310/00491—Coating made of niobium or Nb-based alloys

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
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  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种植入部件，其具有至少一个连接部分。所述连接部分至少部分地涂覆有TiNb涂层，所述涂层的厚度为1至20μm、优选为1至6μm。本发明还涉及一种包括该类型的植入部件的模块化内假体。

Description

植入件连接
技术领域
本发明涉及一种如在模块化植入件中所用的具有连接部分的植入部件，还涉及一种模块化植入件。
背景技术
目前，内假体常具有模块化结构，即它们由至少两个可单独选择的部件组装而成。这种结构为这些假体提供对用于病人治疗的个性化需求的高适应性。
模块结构的优势在于：无论内假体对病人的解剖学和生物力学条件的适应性如何变化，仅需相当少量的不同模块保持可用。这些模块例如可考虑不同的形状和/或材料。由此，这种模块结构尤其具有下述优势：用于任何可能的置换的植入件不必保持储备或单独制造。
模块化结构的内假体以连接部分组装。锥形连接在这方面被证明是尤其成功的。在锥形连接中，一个植入部件具有凹锥形，另外的植入部件具有凸锥形。当将该连接部安装在一起时，利用由锥角产生的作用在锥形表面上施加法向力，以便实现两个锥形之间的摩擦连接。由此，这种已实现的植入部件夹持在一起。
例如，锥形连接可在髋部内假体中用于连接各植入部件。简单的模块化髋部内假体具有位于假体轴与股骨头之间的植入件连接。
然而，在引入这种模块化内假体之后，在锥形连接部中观察到出现缝隙腐蚀和摩擦腐蚀，这在最坏的情况下可导致植入件的致命故障。据推测，腐蚀由两个植入部件的连接表面之间的微小运动和它们之间出现的张力引起。这导致植入材料的表面上的保护性氧化层的裂缝和磨损，从而导致上述磨损现象。
这通过对假体设计的改变和更精确的制造过程来消除。除了形状精度之外，还提高了接触表面的表面状况。
之后投入市场的多模块内假体还具有布置在假体轴与股骨头之间的连接件。因此，假体轴与连接件之间以及连接件与股骨头之间都具有植入件连接。具有这种连接件的假体系统发展成使得能够更好地调整倾侧/子宫前倾以及假体的长度和偏置以适应病人的需求。
在这些多模块假体中，腐蚀主要发生在假体轴与连接件的交界处。在模块化假体中还发现，腐蚀现象不仅发生在金属-金属配对中，而是还发生在金属-陶瓷配对中，例如在具有金属轴和陶瓷头的髋部内假体中。
由于腐蚀，还观察到金属离子、金属氧化物、金属有机磷酸酯和小金属颗粒的释放，这进而导致增强了机械磨损。因此可出现疼痛、无菌性松动和对周围组织的负面连锁反应。也可能发生过敏反应，这可能还需要假体的修正。
鉴于此，本发明的一个目的是提供一种能够与另外的植入部件连接的植入部件，而由此消除对病人而言在模块化假体中存在的前述已知的缺陷。
发明内容
为了实现上述目的，本发明提供了根据权利要求1的植入部件和根据权利要求8的模块化内假体。
根据本发明的植入部件具有至少一个连接部分，所述连接部分至少部分地涂覆有TiNb涂层。
惊人地，根据本发明涂覆的连接部分不仅防止二次过敏反应，而且同时在选择了适当的厚度时确保可靠的摩擦锁定，从而更好地防止腐蚀。
类似于钛，钛铌涂层具有高度的生物相容性。而该金属合金的机械性能更适于本发明提供的涂层。特别地，所述涂层具有所需的低硬度，使得硬耦合部件与被涂覆的凸锥形之间的死锁通过锥形连接的初始表面结构的协作来保证。
如上文已经说明的，典型的是试图通过连接部分中的植入材料的相应的加工表面来实现可靠的摩擦锁定。换句话说，由于涂层的机械性能，当连接部分与另一植入部件的匹配连接部分发生接触时，出现法向力，通过由此在连接部分的表面之间产生的摩擦力而形成充分的夹持作用。
通常，氮化物涂层被用于改善植入部件的磨损性能。因此，它们例如被用于内假体的跑合表面，然而其中，其它的磨损条件在连接区域中起主导作用。这可能是氮化物涂层没有产生令人满意的结果的一个原因。
连接部分上的涂层的厚度优选为1至20μm、优选为1至6μm，因为在该范围内可实现植入部件的稳定的、持续的和有复原力的连接。优选地，该涂层通过PVD法或本领域技术人员公知的植入方法来施加。
在一特别优选的实施例中，涂层具有3至6μm的、更优选地3至5μm的层厚度。
目标在于选择足够高的层厚度，以便获得承受机械负载的涂层。同时，目标是不选择太厚的涂层，使得锥形表面的结构不被阻塞/干扰，从而不妨碍连接区域的表面之间的稳定的摩擦锁定。
在另一优选实施例中，所述连接部分由凹锥形和/或凸锥形形成。在此，连接部分以下述方式实现：它能够与另外的植入部件的匹配的锥形相连接。
另外的植入部件可以同样是根据本发明的具有被涂覆的连接部分的植入部件，但也可以是来自现有技术的任何其它植入部件。在这两种情况下，在独立于其它植入部件的情况下，基本上实现了防止连接部分腐蚀的效果。
在植入部件的一个特别优选的实施例中，连接部分形成为旋转对称的。
这使得植入部件能够关于连接部分的旋转轴对准，由此，使得能够更好地适应病人特有的解剖学和生物力学的需求。
但是，也可以是下述情况：植入部件绕其纵向轴线的相对运动恰恰是不期望。在这种情况下，连接部分不具有旋转对称的连接部分，以防止根据本发明的植入部件相对于所述植入部件所连接的部件转动。
在一个优选实施例中，根据本发明的连接部分用在包括金属合金的植入部件中。
这特别是在金属合金的情况下具有优势，其中，众所周知，断开的或分离的部件导致对于受影响的患者的不良后果。
因此，在一特别优选的实施例中，植入部件包括钴铬合金。
根据本发明的连接部分优选地用在关节内假体中。这可以是假体轴、连接件、关节头和/或这种关节内假体的任何部件。
此外，本发明还提供一种模块化内假体，所述模块化内假体具有至少一个根据本发明的植入部件，所述植入部件具有根据上述实施例之一的被涂覆的连接部分。
这种模块化假体具有模块结构的最初提到的优点，但避免了腐蚀损伤和其不良后果。
本发明还提供了TiNb涂层的一种用途，所述用途为防止植入部件的连接部分上的腐蚀，所述涂层的厚度为1至20μm、优选为1至6μm。
应理解，该涂层不仅能够用在连接区域，而且能够用在连接区域以外的植入件表面或整个植入件表面。这种涂层具有下述优势：例如由于不需要植入件的不被涂覆的遮盖部分的花费，因此所述涂层可以以更简单且更节约的方式制造。

Claims (9)

1.一种植入部件，其具有至少一个连接部分，所述连接部分至少部分地涂覆有TiNb涂层，所述涂层的厚度为1至20μm、优选为1至6μm。
2.如权利要求1所述的植入部件，其特征在于，所述涂层的厚度为3至6μm、优选为3至5μm。
3.如前述权利要求中任一项所述的植入部件，其特征在于，连接部分由凹锥形和/或凸锥形形成。
4.如前述权利要求中任一项所述的植入部件，其特征在于，连接部分是旋转对称的。
5.如前述权利要求中任一项所述的植入部件，其特征在于，植入部件具有金属合金。
6.如前述权利要求中任一项所述的植入部件，其特征在于，植入部件具有钴铬合金。
7.如前述权利要求中任一项所述的植入部件，其特征在于，植入部件为假体轴、连接件或关节头。
8.一种模块化内假体，其具有至少一个如前述权利要求中任一项所述的植入部件。
9.TiNB涂层的一种用途，所述用途为防止植入部件的连接区域上的腐蚀，其中，所述涂层的厚度为1至20μm、优选为1至6μm。
CN201580017421.8A 2014-04-01 2015-03-25 植入件连接 Pending CN106232060A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102014206151.2A DE102014206151A1 (de) 2014-04-01 2014-04-01 Implantatverbindung
DE102014206151.2 2014-04-01
PCT/EP2015/056391 WO2015150186A1 (de) 2014-04-01 2015-03-25 Implantatverbindung

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CN106232060A true CN106232060A (zh) 2016-12-14

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US (1) US20170172745A1 (zh)
EP (1) EP3125829B1 (zh)
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RU2016142619A (ru) 2018-05-03
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US20170172745A1 (en) 2017-06-22
KR20160138532A (ko) 2016-12-05

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