CN102006838B - 内置式假肢部件 - Google Patents

内置式假肢部件 Download PDF

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Publication number
CN102006838B
CN102006838B CN200880106040.7A CN200880106040A CN102006838B CN 102006838 B CN102006838 B CN 102006838B CN 200880106040 A CN200880106040 A CN 200880106040A CN 102006838 B CN102006838 B CN 102006838B
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CN
China
Prior art keywords
coating
ceramic material
endoprosthesis
component
endoprosthesis component
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CN200880106040.7A
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English (en)
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CN102006838A (zh
Inventor
林克·D·赫尔穆特
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Waldemar Link On Shares LP
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Deru GmbH
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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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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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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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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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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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • 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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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
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    • B24C1/08—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for polishing surfaces, e.g. smoothing a surface by making use of liquid-borne abrasives
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    • C04B35/10—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on aluminium oxide
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    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
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    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
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    • C04B41/50—Coating or impregnating, e.g. injection in masonry, partial coating of green or fired ceramics, organic coating compositions for adhering together two concrete elements with inorganic materials
    • C04B41/51—Metallising, e.g. infiltration of sintered ceramic preforms with molten metal
    • C04B41/5133—Metallising, e.g. infiltration of sintered ceramic preforms with molten metal with a composition mainly composed of one or more of the refractory metals
    • C—CHEMISTRY; METALLURGY
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    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B41/00—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone
    • C04B41/80—After-treatment of mortars, concrete, artificial stone or ceramics; Treatment of natural stone of only ceramics
    • C04B41/81—Coating or impregnation
    • C04B41/85—Coating or impregnation with inorganic materials
    • C04B41/88—Metals
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
    • C23C4/04—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the coating material
    • C23C4/06—Metallic material
    • C23C4/08—Metallic material containing only metal elements
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Abstract

本发明涉及一种由一陶瓷材料(9)制成的内置式假肢部件(1，2)，所述内置式假肢部件(1，2)的陶瓷材料(9)部分具有钛合金涂层。所述内置式假肢部件(1，2)的有涂层的一些表面部分用于与骨头(6，7)相连。根据本发明，陶瓷材料(9)与涂覆涂层的部分之间的分界面(8)的不平整度Ra为2.5μm至7μm。因此形成了涂层(10)与陶瓷材料(9)之间的稳固连接。本发明还涉及一种用于制造这种内置式假肢部件的方法。本发明最终涉及一种制造用于制备根据本发明的内置式假肢部件的陶瓷部件。为了使表面觉有预期的不平整度，在880℃至980℃之间预烧结陶瓷部件，接着使用溅射材料对陶瓷部件进行处理。

Description

内置式假肢部件
技术领域
本发明涉及一种由一陶瓷材料制成的内置式假肢部件，此种内置式假肢部件的陶瓷材料部分具有钛合金涂层。内置式假肢部件无涂层的一些表面部分作为滑动面与另一内置式假肢部件配合作用。内置式假肢部件有涂层的一些表面部分用于与骨头相连。本发明还涉及一种制造这种内置式假肢部件的方法。本发明最后涉及一种制造可涂覆钛合金涂层的陶瓷部件的方法。在所述方法中，将粉末状原材料注入使陶瓷部件成型的模具中。然后经多个步骤将陶瓷部件烧结。
背景技术
陶瓷材料可提供高机械强度，且在保持形状稳定的情况下在生物学上具有良好的相容性。因此使用陶瓷材料来制造内置式假肢。
取代关节的内置式假肢必须在假肢与骨骼之间形成稳固的连接。相对于其他材料，陶瓷材料在这方面并无优势，这是由于陶瓷材料的气密表面难以与骨骼连接在一起。由WO 99/30634已知，内置式假肢部件与骨骼相连的那部分表面上须涂覆钛合金涂层。此涂层的孔隙度高于陶瓷材料。骨骼可以向孔隙里生长，从而与内置式假肢部件稳固相连。
钛合金与陶瓷材料既不形成化合也不形成金属化合。钛合金与陶瓷材料之间仅形成纯粹的机械连接。根据WO 99/30634，应使用等离子喷射法将钛合金涂覆至陶瓷材料上。陶瓷材料待涂覆的表面应表面不平整，这有利于形成较好的机械连接。
实践已证明，使用这种方法所涂覆的涂层并非可与所有不平整的表面足够稳固地连接。如果不平整度Ra低于2μm，涂覆的涂层就会在承受负载的情况下从陶瓷材料上脱落。
发明内容
本发明的目的在于，提供一种开篇所述类型的内置式假肢部件，所述内置式假肢部件的涂层能够更好的固定在陶瓷材料上。本发明的目的还在于，提供一种制造这种假肢部件的方法以及一种制造相应陶瓷部件的方法。本发明的目的通过独立权利要求所述的特征而达成。有利的实施形式参见从属权利要求。根据本发明，陶瓷材料与涂覆涂层的部分之间的分界面的不平整度Ra为2.5μm至7μm，优选为3.5μm至5μm。
首先要对一些概念进行解释。不平整度是指用数值表示的表面的不平整程度。本发明中的不平整度说明涉及按照DIN EN ISO 4288及3274中的平均不平整度Ra。
内置式假肢部件由陶瓷材料制成。由陶瓷材料构成的表面中部分涂覆钛合金。钛涂层并非必须是内置式假肢部件的最外层，也可以在钛涂层上涂覆一层可促进骨骼生长的涂层。表面中的一部分无涂层，其作为滑动面与另一内置式假肢部件配合作用。无涂层的区域并非一定是滑动面。
有涂层的区域中存在一个陶瓷材料与钛合金之间的分界面。涂层与陶瓷材料之间连接的牢固度由分界面上陶瓷材料的构造决定。实践证明，如果陶瓷材料在分界面上的不平整度Ra低于2μm，涂层与陶瓷材料就无法稳固相连。不平整度Ra高于2.5μm，可使连接牢固。如果Ra高于3.5μm，连接将更加牢固。
值得追求的目标是，在一个单独工序中完成涂层的涂装。如果不平整度过高，则须逐个涂覆多个涂层，从而完全覆盖陶瓷表面以及使表面上个各处具有足够的层厚。因此，陶瓷材料在分界面上的不平整度Ra不得高于7μm，优选不得高于5μm。
美国食品与药品管理局FDA规定，ASTM F1147规定涂层与陶瓷材料之间的抗压强度至少为22Mpa。为了达到这个安全标准，根据本发明的内置式假肢部件中涂层与陶瓷材料之间的抗拉强度应至少为25Mpa，优选至少为30Mpa，更为优选至少为40Mpa。ASTM F1854规定的涂层厚度优选为100μm至250μm，更为优选为150μm至200μm。
如果涂层具有以下特性，涂层就可与骨骼良好连接。ASTM F1854规定的孔隙比率为20％至40％。同样为ASTM F1854规定的孔径为30μm至70μm，优选为40μm至60μm。
二氧化锆、三氧化二铝以及这两者的混合物适合用于作为制造按照本发明的内置式假肢部件的陶瓷材料。钛合金中含纯钛。
内置式假肢部件优选为一个关节半月板的多个部件中的一个部件。设计为滑动面的部分构成关节半月板的滑动面。
在按照本发明的内置式假肢部件的制造方法中，首先选择一具有适当形态的陶瓷部件，此陶瓷部件的待涂层表面的不平整度Ra为2.5μm至7μm，优选为3.5μm至5μm。使用等离子喷射法将钛合金涂覆至待涂层的表面上。等离子喷射法是使用电弧导引气体并从而使其离子化。将粉末状的涂层材料置入离子化气体中，通过气流将其输送到待涂层的工件上。
实践已证明，要制备待涂层表面不平整度Ra为2.5μm至7μm的陶瓷部件并不是非常简单。使用常规制造方法时，表面不平整度通常很小，而且也无法额外使陶瓷部件具有高不平整度。在制备陶瓷部件时，首先将粉末状的陶瓷原料装填为陶瓷部件所规定的形状。由于经过一系列的加工步骤之后陶瓷部件的体积缩小，所以装填的型模应大于陶瓷部件成品。接下来的烧结将使陶瓷部件具有牢固的内部结构。烧结使粉末颗粒之间形成牢固的连接。
烧结由多个步骤组成。在第一步骤，在较低的温度下将陶瓷部件预烧结，从而在粉末的颗粒间形成窄桥。在预烧结状态下可以对陶瓷部件进行机械加工。一方面是由于陶瓷部件的内部结构强度已经达到在承受机械作用的情况下仍保持原样的程度。这些桥仍可被轻易地解除，仍可相对容易地对材料进行处理。预烧结的温度越高，桥就越牢固，机械加工的耗费也就越高。因此，在确保桥的牢固度可以保证陶瓷部件形状不变的情况下，预烧结的温度应该尽可能的低。在机械加工之前，通常在850℃以下预烧结由二氧化锆(ZrO2)和三氧化二氯(Al2O3)构成的陶瓷部件。机械加工的典型步骤为凿钻和铣切。尚无可将表面不平整度Ra额外提高到2.5μm至7μm之间的机械加工步骤。
根据本发明，在880℃至980℃之间预烧结陶瓷部件，优选为900℃至950℃。接着使用溅射材料对陶瓷部件进行处理。实践证明，在上述温度范围内预烧结的陶瓷经溅射材料处理后可具有预期的表面平整度。预烧结之后陶瓷部件的内部结构为，可以借助溅射材料从陶瓷部件中分离出具有所预期尺寸的碎片。
根据本发明的内置式假肢部件的表面仅有一部分被涂层，而其他表面部分被设计为滑动面与另一内置式假肢部件配合作用。滑动面的表面不平整度应该尽可能小。应尽可能地实现一个尽可能光滑的滑动面，所以无需通过溅射材料来提高这部分表面的不平整度。因此，优选使用溅射材料进对一部分表面进行处理，而在此项处理中略过其他的表面部分。
溅射材料的颗粒大小优选与陶瓷原料的颗粒大小为相同数量级。溅射材料这样就可以尤其有效地作用于陶瓷部件。在使用这种溅射材料时首先存在这样的危险，即溅射材料的颗粒落入陶瓷材料中由于碎片脱落而形成的空隙之中。这些颗粒就成为了陶瓷材料中的杂质。使用与陶瓷材料粉末相同的粉末来作为溅射材料即可避免上述杂质。由于成份相同，进入陶瓷材料的颗粒不会改变陶瓷材料的成份。
附图说明
下面按照附图借助本发明的一个优选实施形式来对本发明进行进一步说明，其中：
图1为一关节半月板假肢的剖面图；
图2为如图1的关节半月板假肢的放大视图；
图3为陶瓷材料在原始状态下的内部结构示意图；
图4为如图3的陶瓷材料在预烧结之后的内部结构示意图；以及
图5为如图3的陶瓷材料在烧结之后的内部结构示意图。
具体实施方式
图1显示了一个设计为关节半月板假肢的内置式假肢被置入两个椎体6，7之间的椎间隙中。关节半月板假肢具有一第一连接板1和一第二连接板2。第一连接板1是一个用于与第一椎体6相连的内置式假肢件，第二连接板2是一个用于与第二椎体7相连的内置式假肢件。
第一连接板1和第二连接板2通过相互适配的滑动面3彼此贴近。滑动面3构成用于上连接板1与下连接板2之间运动的关节。
连接板1，2通过表面区域13与椎体6，7的骨骼紧贴，在连接板1，2的表面区域13中设置凸起12。凸起12在连接板1，2插入椎间隙一侧的方向上侧壁较为平滑，而在另一侧则侧壁较为陡峭。平滑的侧壁可使连接板1，2更易插入椎间隙中。较为陡峭的侧壁可防止凸起12侵入椎体6，7的骨骼中。较为陡峭的侧壁还可防止连接板1，2向相反的方向从椎间隙中脱出。
连接板1，2的凸缘4，5用于使连接板1，2紧贴椎体6，7的腹侧。凸缘4，5使得连接板1，2在脊背侧方向上无法插入椎间隙超出预期位置。
连接板1和连接板2由陶瓷材料9制成。连接板1，2上的滑动面3构建在陶瓷材料9的一个表面上。用于将连接板1，2与骨骼相连的区域13上涂有钛合金涂层10。
图2为连接板1，2的部分放大视图，显示了陶瓷材料9与涂层10之间的分界面8。陶瓷材料9在与涂层10之间的分界面8上的不平整度Ra至少为2.5μm。这种分界面8上的不平整度足以确保能够与涂层10稳固相连，但不足以确保能够与骨骼稳固相连。涂层10的不平整度及孔隙度均高于陶瓷材料9，因此与骨骼形成稳定连接。
为了将陶瓷部件制成一部分表面具有预期不平整度的内置式假肢件的形状，首先将粉末状原料装入一形状与待制造的陶瓷部件相同的模具中。由于在接下来的处理步骤中陶瓷部件在体积上会有损耗，所以模具的尺寸应大于陶瓷部件成品的尺寸。粉末在此模具中被机械压缩，例如晃动和压紧，这样粉末的颗粒14就会如图3所示相互紧贴。通过920℃的预烧结在颗粒14之间形成了如图4所示的桥。材料的内部结构已经稳固到可将陶瓷部件取出模具的程度。
桥15使陶瓷材料在结构上具有较高的稳定性，可以承受凿钻和铣切类型的机械加工。结构稳定性的调节方法为，使用与原料相同的粉末对陶瓷材料进行溅射，使碎片可从预烧结的陶瓷材料上脱落。预期的表面不平整度决定碎片的大小。
如果实现了预期的表面结构以及结束了机械加工，将在高于预烧结的温度下对陶瓷部件进行烧结。到现在为止仅通过桥15相连的颗粒的边缘上形成了平整的连接16。由于内部空腔消失，陶瓷部件的体积进一步缩小。被溅射材料处理的表面部分的表面不平整度现在约为4μm。涂覆在这部分表面上的钛合金涂层牢固地固定在表面上。

Claims (17)

1.一种由一陶瓷材料（9）制成的内置式假肢部件（1，2），所述内置式假肢部件（1，2）的陶瓷材料（9）部分具有钛合金涂层，其中，无涂层的一些表面部分作为滑动面（3）与另一内置式假肢部件（1，2）配合作用，以及其中，有涂层的一些表面部分（13）用于与骨头（6，7）相连，其特征在于，陶瓷材料（9）与涂覆涂层的部分之间的分界面（8）的不平整度Ra为2.5μm至7μm。
2.根据权利要求1所述的内置式假肢部件，其特征在于，陶瓷材料（9）与涂覆涂层的部分之间的分界面（8）的不平整度Ra为3.5μm至5μm。
3.根据权利要求1所述的内置式假肢部件，其特征在于，涂层（10）与陶瓷材料（9）之间的抗拉强度应大于25Mpa。
4.根据权利要求3所述的内置式假肢部件，其特征在于，涂层（10）与陶瓷材料（9）之间的抗拉强度应大于30Mpa。
5.根据权利要求4所述的内置式假肢部件，其特征在于，涂层（10）与陶瓷材料（9）之间的抗拉强度应大于40Mpa。
6.根据权利要求1或3所述的内置式假肢部件，其特征在于，所述涂层（10）表面的不平整度Ra为15μm至35μm。
7.根据权利要求6所述的内置式假肢部件，其特征在于，所述涂层（10）表面的不平整度Ra为20μm至30μm。
8.根据权利要求1或3所述的内置式假肢部件，其特征在于，所述涂层（10）的厚度为100μm至250μm。
9.根据权利要求8所述的内置式假肢部件，其特征在于，所述涂层（10）的厚度为150μm至200μm。
10.根据权利要求1所述的内置式假肢部件，其特征在于，所述涂层（10）的孔隙比率为20％至40％。
11.根据权利要求1或10所述的内置式假肢部件，其特征在于，所述涂层（10）的孔径为30μm至70μm。
12.根据权利要求11所述的内置式假肢部件，其特征在于，所述涂层（10）的孔径为40μm至60μm。
13.根据权利要求1所述的内置式假肢部件，其特征在于，所述陶瓷材料（9）含有二氧化锆及/或三氧化二铝。
14.根据权利要求1所述的内置式假肢部件，其特征在于，设计为滑动面（3）的陶瓷表面部分构成关节半月板的一滑动面（3）。
15.一种制造根据权利要求1，3至14中任一项权利要求所述的内置式假肢部件的方法，其具有以下步骤：
a.选择一成型为内置式假肢部件的陶瓷部件，陶瓷材料与涂层之间的分界面的不平整度Ra为2.5μm至7μm；
b.使用等离子喷射法将钛合金涂覆至陶瓷材料上。
16.一种制造根据权利要求2中所述的内置式假肢部件的方法，其具有以下步骤：
a.选择一成型为内置式假肢部件的陶瓷部件，陶瓷材料与涂层之间的分界面的不平整度Ra为3.5μm至5μm；
b.使用等离子喷射法将钛合金涂覆至陶瓷材料上。
17.根据权利要求15或16中任一所述的方法，其特征在于，在一个工序中完成涂层的涂装。
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