WO2021081857A1 - 一种金属和陶瓷复合的关节假体及其应用和制作方法 - Google Patents

一种金属和陶瓷复合的关节假体及其应用和制作方法 Download PDF

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Publication number
WO2021081857A1
WO2021081857A1 PCT/CN2019/114541 CN2019114541W WO2021081857A1 WO 2021081857 A1 WO2021081857 A1 WO 2021081857A1 CN 2019114541 W CN2019114541 W CN 2019114541W WO 2021081857 A1 WO2021081857 A1 WO 2021081857A1
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WIPO (PCT)
Prior art keywords
root
boundary layer
joint
joint prosthesis
layer
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PCT/CN2019/114541
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English (en)
French (fr)
Inventor
张卫平
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北京爱康宜诚医疗器材有限公司
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Application filed by 北京爱康宜诚医疗器材有限公司 filed Critical 北京爱康宜诚医疗器材有限公司
Priority to US15/734,679 priority Critical patent/US11690724B2/en
Priority to PCT/CN2019/114541 priority patent/WO2021081857A1/zh
Priority to EP19929183.2A priority patent/EP3845204B1/en
Priority to JP2020567957A priority patent/JP7100159B2/ja
Publication of WO2021081857A1 publication Critical patent/WO2021081857A1/zh

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    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00179—Ceramics or ceramic-like structures

Definitions

  • the invention relates to the field of orthopedic implants, in particular to a metal and ceramic composite joint prosthesis and its application and manufacturing method.
  • implant products for artificial joint replacement surgery usually have two very important surfaces, that is, the joint friction surface and the osseointegration interface. Since each joint friction surface is in contact with the friction surface of the contralateral joint that constitutes the joint friction pair, it is required It has good friction properties, including sufficient hardness and toughness, low wear rate, good lubrication performance, resistance to deformation, etc., to meet functional requirements.
  • the industry generally recognizes ceramic interface as a friction pair for unilateral or even bilateral joint friction The surface can effectively reduce the wear of the articular surface; and the osseointegration interface is the interface between the implant and the human bone.
  • porous metal surface has a good bone ingrowth effect, making the human bone cell tissue easy to grow into the porous material
  • the internal pores thus achieve effective fusion between bone tissue and porous metal, so that the implant can be firmly fixed with the bones of the human body.
  • the purpose of the present invention is to provide a metal and ceramic composite joint prosthesis and its application and manufacturing method.
  • the joint prosthesis integrates the ceramic joint friction surface and the porous metal osseointegration interface into A joint prosthesis not only reduces the wear of the joint friction surface but also ensures a good bone ingrowth effect.
  • a metal and ceramic composite joint prosthesis comprising a metal body and a ceramic body.
  • the metal body is integrally formed and comprises a porous structure layer, a boundary layer, and a root layer.
  • the boundary layer is located in the porous structure layer and the root layer.
  • the root layer includes a plurality of root-shaped filament clusters connected to the boundary layer that are not in contact with each other, and the root-shaped filament clusters include a main root that is perpendicularly connected to the boundary layer and a connection
  • the several fibrous roots on the side of the main root extend obliquely to the side away from the boundary layer, and the ceramic body covers the root-shaped filament clusters and is formed on the boundary layer.
  • the part where the fibrous root is connected to the main root is close to the connection point of the main root and the boundary layer.
  • the boundary layer has a plate-shaped structure, and a plurality of the root filament clusters are regularly connected to the surface of the boundary layer.
  • a number of regularly arranged grooves are provided on the plate-shaped structure, and supporting walls are formed between adjacent grooves, and the root-shaped filament clusters are connected to the upper surface of the intersection of different supporting walls.
  • the groove is a groove with a cubic structure, and the root filament clusters are connected to the upper surfaces of the four supporting walls that intersect each other perpendicularly.
  • the thickness of the supporting wall is 0.1-3 mm, and the height is 0.25-2.5 mm.
  • a plurality of regularly arranged strip-shaped reinforcing ribs are arranged on the plate-shaped structure, and the root-shaped filament clusters are connected to the upper surface of the reinforcing ribs at equal intervals.
  • reinforcing ribs intersecting perpendicularly in two directions are arranged on the boundary layer, and a plurality of the reinforcing ribs are arranged in each direction.
  • the thickness of the reinforcing rib is 0.1 to 3 mm, and the height is 0.25 to 2.5 mm.
  • the material of the metal body is tantalum metal or tantalum alloy.
  • the pore size of the porous structure layer is 50-1200 microns.
  • the material of the ceramic body is alumina-based ceramics, zirconia-based ceramics or silicon carbide-based ceramics.
  • the included angle between the fibrous root and the main root axis is less than or equal to 45°.
  • the included angle between the fibrous root and the main root axis is 30°.
  • the diameters of the taproot and the fibrous root are both 0.1-2 mm.
  • the lines of the three adjacent and closest root-shaped filament clusters at the projection center of the boundary layer constitute an equilateral triangle.
  • the present invention also provides an application of the above-mentioned joint prosthesis, and its technical scheme is as follows:
  • a hip joint prosthesis comprising: a hip joint ball head prosthesis installed on a human femur, a hip joint acetabular cup prosthesis matched with the hip joint ball head prosthesis, the hip joint ball head prosthesis and
  • the hip joint acetabular cup prosthesis is made of the above-mentioned joint prosthesis; wherein, the boundary layer of the hip joint ball head prosthesis is a curved plate-like structure, and all the hip joint ball head prosthesis
  • the boundary layer is a structure in which a flat plate has been bent many times.
  • the present invention also provides another application of the above-mentioned joint prosthesis, and its technical scheme is as follows:
  • a knee joint prosthesis comprising a knee joint femoral condyle prosthesis installed on a tibial platform, the knee joint femoral condyle prosthesis is made of the above-mentioned joint prosthesis; wherein, the knee joint femoral condyle prosthesis
  • the boundary layer is a structure in which a flat plate has been bent many times.
  • the present invention also provides a method for manufacturing the above-mentioned metal and ceramic composite joint prosthesis, the method comprising:
  • the metal body after printing and molding is implanted into a molding die of the ceramic body, and the root layer side is filled with ceramic blank powder and a sintering aid adhesive, the molding die is closed, and the ceramic The billet powder and the sintering aid binder are pressurized to form the billet before sintering;
  • FIG. 1 is a schematic diagram of the structure of connecting a single root-shaped filament cluster to a metal body in Embodiment 1 of the present invention
  • FIG. 2 is a schematic cross-sectional structure diagram of FIG. 1;
  • Example 3 is a schematic diagram of the structure of the metal body in Example 1 of the present invention.
  • Fig. 4 is a schematic top view of Fig. 3;
  • FIG. 5 is a schematic structural diagram of Embodiment 1 of the present invention.
  • Fig. 6 is a schematic diagram of the forming process of embodiment 1 of the present invention.
  • Figure 7 is a schematic view of the molding of Example 1 of the present invention.
  • Embodiment 8 is a schematic diagram of the structure of the second type of boundary layer in Embodiment 1 of the present invention.
  • Embodiment 9 is a schematic diagram of the structure of the third type of boundary layer in Embodiment 1 of the present invention.
  • FIG. 10 is a schematic diagram of the structure of the third type of boundary layer in Embodiment 1 of the present invention.
  • Figure 11 is a schematic diagram of a first application example of the present invention.
  • Figure 12 is a schematic diagram of a second application example of the present invention.
  • Root layer 1-1, tap root; 1-2, fibrous root;
  • the embodiment shown in Figures 1-7 provides a metal and ceramic composite prosthesis of the present invention including a metal body and a ceramic body 4.
  • the metal body is integrally formed and includes a porous structure layer 3, a boundary layer 2 and roots.
  • the root layer 1 and the boundary layer 2 are located between the porous structure layer 3 and the root layer 1.
  • the root layer 1 includes several root filament clusters connected to the boundary layer and not in contact with each other, and the root filament clusters include perpendicular to the boundary layer.
  • the connected main root 1-1 and several fibrous roots 1-2 connected to the side of the main root, the fibrous roots 1-2 extend obliquely to the side away from the boundary layer, and the ceramic body 4 covers the root-shaped filament clusters and is formed on the boundary layer 2.
  • the metal and ceramic composite joint prosthesis of this embodiment realizes the composite of metal and ceramic in a joint prosthesis product, which not only satisfies the wear-resistant ceramic body 4 required by the joint friction surface, but also satisfies the osseointegration surface.
  • the root filament clusters of the root layer 1 are rooted in the ceramic body 4, so that a close and stable connection is formed between the ceramic body 4 and the metal body, and the root clusters are not in contact with each other, which avoids the joint prosthesis During the cooling process of the product after the ceramic body 4 is sintered, the contact between the root-shaped filament clusters locally isolates the ceramic body 4 to generate internal stress concentration in the ceramic body 4 to prevent the ceramic body 4 from fragmenting or cracking locally.
  • the metal body in this embodiment can be obtained by 3D printing, metal particle sintering, high temperature spraying, etc.
  • the material of the metal body is tantalum metal or tantalum alloy, which is specifically selected according to the use needs and application cost of the joint.
  • the porous structure layer 3 The pore size is 50 to 1200 microns.
  • the material of the ceramic body in this embodiment may be alumina-based ceramics, zirconia-based ceramics, silicon carbide-based ceramics, and other ceramic materials that meet the requirements of medical implantation.
  • the ceramic body 4 is covered by ceramic blank powder with root filament clusters and sintered to form on the boundary layer.
  • the root filament clusters and the ceramic body 4 expand due to thermal expansion.
  • the coefficient difference causes different degrees of deformation.
  • the root-shaped filament clusters and the ceramic body 4 generate internal stress, because the tantalum metal or tantalum alloy itself has good ductility, the root-shaped filament clusters can deform to adapt to the ceramic body through its own deformation.
  • the material of the ceramic body 4 in this embodiment is selected from alumina-based ceramics, zirconia-based ceramics or silicon carbide-based ceramics , Because the above-mentioned materials have very similar thermal expansion coefficients to tantalum.
  • the thermal expansion coefficient of alumina ceramics is 7.5 ⁇ 10 -6 /°C
  • the thermal expansion coefficient of zirconia is 9.6 ⁇ 10 -6/ °C
  • the thermal expansion coefficient of silicon carbide The thermal expansion coefficient of tantalum metal is 4.7 ⁇ 10 -6 /°C
  • the thermal expansion coefficient of tantalum metal is 6.6 ⁇ 10 -6 /°C, so that the ceramic body 4 and root filament clusters have similar thermal expansion conditions.
  • the melting point of tantalum metal is as high as 2995°C.
  • the sintering temperature is higher than that of the ceramic, so that during the sintering process, the ceramic body 4 and the root-shaped filament clusters will not generate unnecessary internal stress due to the excessive thermal expansion coefficient difference, and further ensure that the root-shaped filament clusters and the ceramic body 4 can be closer together. ⁇ Ground combination.
  • the connecting part of the root 1-2 and the main root 1-1 is close to the junction of the main root 1-1 and the boundary layer 2, so that the root 1-2 can be more firmly connected to the main root 1-1.
  • the angle ⁇ is less than or equal to 45°. The ceramic body between the root 1-2 and the boundary layer 2 generates excessive tensile stress or compressive stress.
  • the boundary layer 2 in this embodiment is a plate-shaped structure, and several root-shaped filament clusters are regularly connected to the surface of the boundary layer 2.
  • connection lines of the three adjacent and closest root filament clusters at the projection center of the boundary layer constitute an equilateral triangle, as shown in Figures 3 and 4, the vertical direction between adjacent horizontal root filament clusters The distances are equal, the root filament clusters between different horizontal rows are arranged at intervals, and the distance between adjacent root filament clusters is equal.
  • the arrangement of root-like filament clusters makes the root-like filament clusters evenly distributed in the ceramic body 4, and the distance between adjacent root-like filament clusters in all directions in the ceramic body 4 is equal, so that the root-like filament clusters can bear more evenly Load.
  • the diameters of the taproot 1-1 and the fibrous root 1-2 are both 0.1-2 mm.
  • the boundary layer 2 in this embodiment may be a flat structure as shown in FIG. 5, or a structure as shown in FIG. 8, that is, a plurality of grooves 2 regularly arranged on the plate structure shown in FIG. 5 -1, a supporting wall 2-2 is formed between adjacent grooves, and the root-shaped filament tufts are connected to the upper surface of the intersection of different supporting walls 2-2.
  • the groove 2-1 is a groove with a cubic structure. When opening the groove, it is necessary to ensure that the thickness of the bottom wall of the groove meets the strength requirements, and the root filament clusters are connected to four mutually perpendicular support walls 2 -2 The upper surface that intersects.
  • the arrangement of the supporting wall 2-2 can enhance the strength of the boundary layer 2, and the root filament clusters are connected to the upper surface of the intersection of the different supporting walls 2-2 to ensure the connection strength between the root filament clusters and the boundary layer 2.
  • the thickness of the supporting wall 2-2 is 0.1 to 3 mm, and the height is 0.25 to 2.5 mm.
  • the spatial shape of the groove 2-1 is not limited to a cubic structure, and can also be other shapes, such as cylindrical, prismatic, and other irregular three-dimensional shapes.
  • the groove 2- of the boundary layer in FIG. 9 1 is triangular prism shape.
  • the boundary layer 2 can also be a structure as shown in FIG. 10, in which a number of regularly arranged strip-shaped reinforcing ribs 2-3 are arranged on the plate-shaped structure, and the root-shaped filament clusters are connected to the reinforcing ribs 2 at equal intervals. -3's upper surface. As shown in Figure 9, two reinforcing ribs 2-3 perpendicular to each other are arranged on the boundary layer, and several reinforcing ribs are arranged in each direction. Root-like filament clusters are connected to the upper surface of the reinforcing ribs 2-3 at equal intervals. The thickness of the rib 2-3 is 0.1-3mm, and the height is 0.25-2.5mm.
  • the boundary layer of the present invention can also be provided with a structure that combines at least two of a flat plate, a groove and a reinforcing rib on the boundary layer.
  • the porous structure layer is connected with the human bones, so that the human bones can easily grow into the porous structure layer, so that the joint prosthesis can be fixed biologically, and the purpose of fixing the joint prosthesis more firmly is achieved.
  • the metal and ceramic composite joint prosthesis in this embodiment can be applied to various artificial joints, such as hip joint prosthesis, knee joint prosthesis, shoulder joint prosthesis, ankle joint prosthesis, temporomandibular joint prosthesis, and elbow joint prosthesis. Body, wrist prosthesis, etc.
  • Figure 11 and Figure 12 two application examples of the joint prosthesis of the above structure in this embodiment are provided.
  • Figure 11 is a schematic diagram of a hip joint prosthesis
  • Figure 12 is a schematic diagram of a knee joint prosthesis.
  • the boundary layer 2 of the middle knee joint tibial plateau prosthesis is a flat structure, and the rest of the joint prosthesis is a curved structure.
  • the boundary layer 2 of the metal body can be made as shown in Figure 11 hip joint hip
  • the curved plate-like structure shown in the cup prosthesis 7 can also be made into the boundary layer 2 as shown in Figure 11 hip joint ball head prosthesis 6 and Figure 12 knee joint femoral condyle prosthesis 9 after multiple bends
  • the schematic diagram of the folded structure shows that the two structures of the boundary layer 2 will have the root-shaped filament cluster axis intersecting.
  • the root-shaped filament cluster can be more firmly combined with the ceramic body 4, especially when the boundary layer 2 is In the curved plate-like structure, the bonding effect between the root-shaped filament clusters and the ceramic body 4 is better, and there will be no relative displacement between the ceramic body 4 and the root-shaped filament clusters, which will cause the internal wear of the ceramic body 4, and most joint false
  • the bodies are all curved, and the boundary layer needs to be one of the above-mentioned two structures, so that the joint prosthesis in this embodiment will have a longer service life.
  • the present invention also provides a method for manufacturing the metal and ceramic composite joint prosthesis in Example 1, which method includes:
  • the metal body after printing and molding is implanted in the molding die of the ceramic body, the ceramic green powder and the sintering aid adhesive are filled to the root layer side, the molding die is closed, and the ceramic green powder
  • the body and the sintering aid adhesive are pressurized to form a blank before sintering; the presence of the boundary layer 2 prevents the ceramic blank powder from diffusing into the porous structure layer, and at the same time, provides a molding surface of the blank before sintering.
  • the purpose of the shaping is to make the ceramic blank powder and the root filament clusters have a good combination effect, so that the shape The latter ceramic body 4 can be more closely combined with the root-shaped filament clusters.
  • the joint friction surface on the ceramic body 4 is polished to ensure that the smoothness of the joint friction surface meets the requirements of movable friction.

Abstract

一种金属和陶瓷复合的关节假体，包括金属体和陶瓷体(4)，金属体一体成型制成，包括多孔结构层(3)、分界层(2)和根状层(1)，分界层(2)处于多孔结构层(3)和根状层(1)之间，根状层(1)包括若干个连接在分界层(2)上互不接触的根状丝簇，根状丝簇包括与分界层(2)垂直连接的主根(1-1)和连接在主根(1-1)侧面的若干须根(1-2)，须根(1-2)向远离分界层(2)侧倾斜延伸，陶瓷体(4)覆盖根状丝簇并成型在分界层(2)上。该关节假体实现金属和陶瓷的复合，既满足关节摩擦面所需要的耐磨陶瓷体又满足骨整合面所需的具有良好骨长入效果的多孔金属结构，防止陶瓷体(4)局部发生碎裂或产生裂纹。还同时公开了其应用和制作方法。

Description

一种金属和陶瓷复合的关节假体及其应用和制作方法 技术领域
本发明涉及骨科植入物领域，尤其是一种金属和陶瓷复合的关节假体及其应用和制作方法。
背景技术
目前，人工关节置换手术的植入物产品通常具有两个非常重要的表面，即关节摩擦面与骨整合界面，由于各关节摩擦面与组成关节摩擦副的对侧关节摩擦面相接触摩擦，需要其具有良好的摩擦性能，包括足够的硬度与韧性、低磨损率、良好润滑性能、抗变形的强度等等，以满足功能要求，当今业内普遍认可陶瓷界面作为摩擦副单侧甚至双侧的关节摩擦面能够有效降低关节面的磨损；而骨整合界面是植入物与人体骨骼接触的界面，经过近年的研究表明多孔金属表面具有良好的骨长入效果，使人体骨细胞组织容易长入多孔材料内部的孔隙从而达到骨组织与多孔金属之间的有效融合，使植入物能够牢固地与人体的骨骼固定在一起。
由于陶瓷材料难以制作成多孔结构且无法实现骨细胞的长入，而金属材质制成的关节摩擦面又无法达到陶瓷材质的优越耐磨性能。
申请内容
针对现有技术存在的问题，本发明的目的在于提供一种金属和陶瓷复合的关节假体及其应用和制作方法，该关节假体将陶瓷的关节摩擦面和多孔金属的骨整合界面整 合到一个关节假体上，既降低了关节摩擦面的磨损又能够保证良好的骨长入效果。
为实现上述目的，本发明的技术方案如下：
一种金属和陶瓷复合的关节假体，包括金属体和陶瓷体，所述金属体一体成型制成，包括多孔结构层、分界层和根状层，所述分界层处于所述多孔结构层和所述根状层之间，所述根状层包括若干个连接在所述分界层上互不接触的根状丝簇，所述根状丝簇包括与所述分界层垂直连接的主根和连接在所述主根侧面的若干须根，所述须根向远离所述分界层侧倾斜延伸，所述陶瓷体覆盖所述根状丝簇并成型在所述分界层上。
进一步，所述须根与所述主根连接的部位靠近所述主根与所述分界层的连接处。
进一步，所述分界层为板状结构，若干个所述根状丝簇规则连接在所述分界层的表面。
进一步，所述板状结构上设置规则排列的若干个凹槽，相邻的凹槽之间形成支撑壁，所述根状丝簇连接不同支撑壁相交处的上表面。
进一步，所述凹槽为立方体结构的凹槽，所述根状丝簇连接在四个相互垂直相交的所述支撑壁的上表面。
进一步，所述支撑壁的厚度为0.1～3mm，高度为0.25～2.5mm。
进一步，所述板状结构上设置若干个规则排列的条状的加强筋，所述根状丝簇等间隔连接在所述加强筋的上表面。
进一步，所述分界层上设置两个方向相互垂直相交的所述加强筋，每个方向上设置若干个所述加强筋。
进一步，所述加强筋的厚为0.1～3mm，高度为0.25～2.5mm。
进一步，所述金属体的材质为钽金属或钽合金。
进一步，所述多孔结构层的孔径为50～1200微米。
进一步，所述陶瓷体的材质为氧化铝基陶瓷、氧化锆基陶瓷或碳化硅基陶瓷。
进一步，所述须根与所述主根轴线之间的夹角小于或等于45°。
进一步，所述须根与所述主根轴线之间的夹角为30°。
进一步，所述主根与所述须根的直径均为0.1～2毫米。
进一步，互相相邻且距离最近的三个所述根状丝簇在所述分界层投影中心的连线构成等边三角形。
本发明还提供了上述关节假体的一种应用，其技术方案如下：
一种髋关节假体，包括：安装在人体股骨上的髋关节球头假体，与所述髋关节球头假体配合的髋关节髋臼杯假体，所述髋关节球头假体和所述髋关节髋臼杯假体均由上述的关节假体制成；其中，所述髋关节球头假体的所述分界层为曲面板状结构，所述髋关节球头假体的所述分界层为平面板经过多次弯折的结构。
本发明还提供了上述关节假体的另一种应用，其技术方案如下：
一种膝关节假体，包括安装在胫骨平台上的膝关节股骨髁假体，所述膝关节股骨髁假体由上述的关节假体制成；其中，所述膝关节股骨髁假体的所述分界层为平面板经过多次弯折的结构。
本发明还提供一种上述金属和陶瓷复合的关节假体的制作方法，该方法包括：
设计所述金属体的三维模型；
将所述三维模型文件输入到3D打印设备中进行3D打印；
将打印成型后的所述金属体植入所述陶瓷体的成型模具中，向所述根状层一侧填充陶瓷坯料粉体及助烧粘接剂，关闭所述成型模具，将所述陶瓷坯料粉体及助烧粘接剂加压形成烧结前坯料；
将经过整形后的所述烧结前坯料置入烧结炉中，烧结形成结合在所述根状丝簇上的陶瓷体；
对所述陶瓷体上的关节摩擦面进行抛光。
附图说明
图1为本发明实施例1中金属体上连接单个根状丝簇的结构示意图；
图2为图1的剖面结构示意图；
图3为本发明实施例1金属体的结构示意图；
图4为图3的俯视示意图；
图5为本发明实施例1的结构示意图；
图6为本发明实施例1的成型过程示意图；
图7为本发明实施例1的成型示意图；
图8为本发明实施例1中第二种分界层的结构示意图；
图9为本发明实施例1中第三种分界层的结构示意图；
图10为本发明实施例1中第三种分界层的结构示意图；
图11为本发明的第一应用实例示意图；
图12为本发明的第二应用实例示意图；
图中：
1、根状层；1-1、主根；1-2、须根；
2、分界层；2-1、凹槽；2-2、支撑壁；2-3、加强筋；
3、多孔结构层；4、陶瓷体；5、成型模具；6、髋关节球头假体；7、髋关节髋臼杯假体；8、人体股骨；9、膝关节股骨髁假体；10、膝关节垫片；11、膝关节胫骨平台假体。
具体实施方式
为清楚地说明本发明的设计思想，下面结合示例对本发明进行说明。
为了使本领域的技术人员更好地理解本发明的方案，下面结合本发明示例中的附图对本发明示例中的技术方案进行清楚、完整地描述，显然，所描述的示例仅仅是本发明的一部分示例，而不是全部的示例。基于本发明的中示例，本领域的普通技术人员在没有做出创造性劳动的前提下，所获得的所有其他实施方式都应当属于本发明保护的范围。
在本实施方式的描述中，术语“上”、“下”等指示的方位或位置关系均为基于附图所示的方位或位置关系，仅仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
需要注意的是，这里所使用的术语仅是为了描述具体实施方式，而非意图限制根据本申请的示例性实施方式。如在这里所使用的，除非上下文另外明确指出，否则单 数形式也意图包括复数形式，此外，还应当理解的是，当在本说明书中使用术语“包含”和/或“包括”时，其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
实施例1
如图1-7所示的实施例提供了本发明的一种金属和陶瓷复合的假体包括金属体和陶瓷体4，金属体一体成型制成，包括多孔结构层3、分界层2和根状层1，分界层2处于多孔结构层3和根状层1之间，根状层1包括若干个连接在分界层上互不接触的根状丝簇，根状丝簇包括与分界层垂直连接的主根1-1和连接在主根侧面的若干须根1-2，须根1-2向远离分界层侧倾斜延伸，陶瓷体4覆盖根状丝簇并成型在分界层2上。
本实施例的金属和陶瓷复合的关节假体，在一个关节假体的产品中，实现金属和陶瓷的复合，既满足了关节摩擦面所需要的耐磨的陶瓷体4又满足了骨整合面所需的具有良好骨长入效果的多孔金属结构3。根状层1的根状丝簇植根于陶瓷体4内，使得陶瓷体4与金属体之间产生紧密而稳定的连接，并且，根状簇之间互不接触，避免了该关节假体产品在陶瓷体4烧结完成后的冷却过程中，根状丝簇之间的接触对陶瓷体4局部隔离而产生陶瓷体4内部应力集中，防止陶瓷体4局部发生碎裂或产生裂纹。
本实施例中的金属体可以采用3D打印、金属颗粒烧结、高温喷涂等方法得到，金属体的材质为钽金属或钽合金，具体根据关节的使用需要及应用成本进行选择，多孔结构层3的孔径为50～1200微米。本实施例中的陶瓷体的材质可以是氧化铝基陶瓷、氧化锆基陶瓷、碳化硅基陶瓷及其他符合医疗植入要求的陶瓷材料。
如图6和图7所示，陶瓷体4是通过陶瓷坯料粉末将根状丝簇覆盖，烧结成型在分界层上，在陶瓷体4烧结的过程中，根状丝簇与陶瓷体4由于热膨胀系数的差异而 发生不同程度的形变，根状丝簇与陶瓷体4产生内应力时，因钽金属或钽合金本身具有良好的延展性，根状丝簇可通过自身的产生形变以适应陶瓷体4的变形，从而降低内应力，使根状丝簇与陶瓷体4能够更加紧密地结合；本实施例中陶瓷体4的材质之所以选择氧化铝基陶瓷、氧化锆基陶瓷或者碳化硅基陶瓷，是因为上述材料与钽具有极为相近的热膨胀系数，其中，氧化铝陶瓷的热膨胀系数为7.5×10 -6/℃，氧化锆的热膨胀系数为9.6×10 -6/℃，碳化硅的热膨胀系数为4.7×10 -6/℃，钽金属的热膨胀系数为6.6×10 -6/℃，使陶瓷体4和根状丝簇具有相近的受热膨胀情况，此外，钽金属的熔点高达2995℃，远高于陶瓷的烧结温度，使得烧结过程中，陶瓷体4与根状丝簇不会因过大的热膨胀系数差异而产生不必要的内应力，进一步保证根状丝簇与陶瓷体4能够更加紧密地结合。
如图1所示，须根1-2与主根1-1连接的部位靠近主根1-1与分界层2的连接处，使须根1-2能够更加牢固地连接到主根1-1上。如图2所示，须根1-2与主根1-1轴线之间的夹角α小于或等于45°，本实施例中α＝30°，在陶瓷体4烧结成型的过程中，不会对须根1-2与与分界层2之间的陶瓷体产生过大的拉应力或压应力。
如图5所示，本实施例中的分界层2为板状结构，若干个根状丝簇规则连接在分界层2的表面。
互相相邻且距离最近的三个根状丝簇在所述分界层投影中心的连线构成等边三角形，如图3和图4所示，相邻横排根状丝簇之间的竖向距离相等，不同横排之间的根状丝簇间隔设置，并且相邻的根状丝簇之间的距离相等。根状丝簇的这种布置形式使根状丝簇在陶瓷体4内均匀分布，并且处于陶瓷体4内各个方向相邻根状丝簇的间距 相等，使根状丝簇能够更均匀地承受载荷。
主根1-1与须根1-2的直径均为0.1～2毫米。
本实施例中的分界层2可以是如图5所示的平板结构，也可以是如图8所示的结构，即在图5所示的板状结构上设置规则排列的若干个凹槽2-1，相邻的凹槽之间形成支撑壁2-2，根状丝簇连接不同支撑壁2-2相交处的上表面。如图8所示，凹槽2-1为立方体结构的凹槽，在开设凹槽时，需要保证凹槽底壁的厚度满足强度要求，根状丝簇连接在四个相互垂直的支撑壁2-2相交的上表面。通过支撑壁2-2的设置能够增强分界层2的强度，并且，根状丝簇连接在不同支撑壁2-2相交处的上表面，保证了根状丝簇与分界层2的连接强度，支撑壁2-2的厚度为0.1～3mm，高度为0.25～2.5mm。
在本实施例中，凹槽2-1的空间形态不局限于立方体结构，也可以是其他形状，如圆柱状、棱柱状及其他不规则的立体形状，图9中分界层的凹槽2-1为三棱柱状。
本实施例中，分界层2还可以是如图10所示的结构，在板状结构上设置若干个规则排列的条状的加强筋2-3，根状丝簇等间隔连接在加强筋2-3的上表面。如图9所示，分界层上设置两个方向相互垂直相交的加强筋2-3，每个方向上设置若干个加强筋，根状丝簇等间隔连接在加强筋2-3的上表面，加强筋2-3厚度为0.1～3mm，高度为0.25～2.5mm。
本发明的分界层还可以根据患者骨床形状及生物力学方面的考量，将分界层设置层平板、凹槽和加强筋的至少其中两种相结合的结构。
本实施例中的关节假体，多孔结构层与人体骨骼连接，使人体骨骼容易长入多孔结构层中，使关节假体能够进行生物学的固定，达到更牢固地固定关节假体的目的。 本实施例中金属和陶瓷复合的关节假体可应用于各类人工关节，例如髋关节假体、膝关节假体、肩关节假体、踝关节假体、颞下颌关节假体、肘关节假体、腕关节假体等等。如图11和图12所示提供了两种本实施例中上述结构的关节假体应用实例，图11示为髋关节假体的示意图，图12为膝关节假体的示意图，其中，图12中膝关节胫骨平台假体的分界层2为平面结构，其余部分的关节假体为曲面结构，在进行关节假体的制作时，可以将金属体的分界层2制成如图11髋关节髋臼杯假体7所示的曲面板状结构，也可以将分界层2制成如图11髋关节球头假体6和图12膝关节股骨髁假体9所示的平面板经过多次弯折的结构示意图，分界层2的这两种结构均会存在根状丝簇轴线相交的情况，这种情况下的根状丝簇能够与陶瓷体4更加牢固地结合，尤其当分界层2为曲面板状结构时，根状丝簇与陶瓷体4的结合效果更好，陶瓷体4与根状丝簇之间不会产生相对位移而造成陶瓷体4的内部磨损，而大多数的关节假体都是曲面的，需要分界层为是上述的两种结构之一，这样本实施例中的关节假体就会有更长的使用寿命。
实施例2
本发明还提供了一种制造实施例1中金属和陶瓷复合的关节假体的制作方法，该方法包括：
设计金属体的三维模型；
将三维模型文件输入到3D打印设备中进行3D打印，得到实施例1中的根状层1、分界层2和多孔结构层3，其中，3D打印设备为金属3D打印设备；
将打印成型后的金属体植入所述陶瓷体的成型模具中，向所述根状层一侧填充陶 瓷坯料粉体及助烧粘接剂，关闭所述成型模具，将所述陶瓷坯料粉体及助烧粘接剂加压形成烧结前坯料；由于分界层2的存在阻挡了陶瓷坯料粉体向多孔结构层的扩散，同时，提供了烧结前坯料的成型面。
将经过整形后的烧结前坯料置入烧结炉中，烧结形成结合在根状丝簇上的陶瓷体4；整形的目的是使陶瓷坯料粉体与根状丝簇具有良好的结合效果，使成型后的陶瓷体4与根状丝簇能够更加紧密地结合。
对陶瓷体4上的关节摩擦面进行抛光，保证关节摩擦面的光滑程度满足活动摩擦的要求。
需要说明的是，除了上述给出的具体实施例之外，其中的一些结构可有不同选择。而这些都是本领域技术人员在理解本发明思想的基础上基于其基本技能即可做出的，故在此不再一一例举。
最后，可以理解的是，以上实施方式仅仅是为了说明本发明的原理而采用的实施例性实施方式，然而本发明并不局限于此。对于本领域普通技术人员而言，在不脱离本发明的原理和实质的情况下，可以做出各种变型和改进，这些变型和改进也视为本发明的保护范围。

Claims (19)

  1. 一种金属和陶瓷复合的关节假体，其特征在于，包括金属体和陶瓷体，所述金属体一体成型制成，包括多孔结构层、分界层和根状层，所述分界层处于所述多孔结构层和所述根状层之间，所述根状层包括若干个连接在所述分界层上互不接触的根状丝簇，所述根状丝簇包括与所述分界层垂直连接的主根和连接在所述主根侧面的若干须根，所述须根向远离所述分界层侧倾斜延伸，所述陶瓷体覆盖所述根状丝簇并成型在所述分界层上。
  2. 根据权利要求1所述的关节假体，其特征在于，所述须根与所述主根连接的部位靠近所述主根与所述分界层的连接处。
  3. 根据权利要求1所述的关节假体，其特征在于，所述分界层为板状结构，若干个所述根状丝簇规则连接在所述分界层的表面。
  4. 根据权利要求3所述的关节假体，其特征在于，所述板状结构上设置规则排列的若干个凹槽，相邻的凹槽之间形成支撑壁，所述根状丝簇连接不同支撑壁相交处的上表面。
  5. 根据权利要求4所述的关节假体，其特征在于，所述凹槽为立方体结构的凹槽，所述根状丝簇连接在四个相互垂直相交的所述支撑壁的上表面。
  6. 根据权利要求5所述的关节假体，其特征在于，所述支撑壁的厚度为0.1～3mm，高度为0.25～2.5mm。
  7. 根据权利要求3所述的关节假体，其特征在于，所述板状结构上设置若干个规则排列的条状的加强筋，所述根状丝簇等间隔连接在所述加强筋的上表面。
  8. 根据权利要求7所述的关节假体，其特征在于，所述分界层上设置两个方向相互垂直相交的所述加强筋，每个方向上设置若干个所述加强筋。
  9. 根据权利要求8所述的关节假体，其特征在于，所述加强筋的厚为0.1～3mm，高度为0.25～2.5mm。
  10. 根据权利要求1所述的关节假体，其特征在于，所述金属体的材质为钽金属或钽合金。
  11. 根据权利要求1所述的关节假体，其特征在于，所述多孔结构层的孔径为50～1200微米。
  12. 根据权利要求1所述的关节假体，其特征在于，所述陶瓷体的材质为氧化铝基陶瓷、氧化锆基陶瓷或碳化硅基陶瓷。
  13. 根据权利要求1所述的关节假体，其特征在于，所述须根与所述主根轴线之间的夹角小于或等于45°。
  14. 根据权利要求13所述的关节假体，其特征在于，所述须根与所述主根轴线之间的夹角为30°。
  15. 根据权利要求1所述的关节假体，其特征在于，所述主根与所述须根的直径均为0.1～2毫米。
  16. 根据权利要求1所述的关节假体，其特征在于，互相相邻且距离最近的三个所述根状丝簇在所述分界层投影中心的连线构成等边三角形。
  17. 一种髋关节假体，其特征在于，包括：安装在人体股骨上的髋关节球头假体，与所述髋关节球头假体配合的髋关节髋臼杯假体，所述髋关节球头假体和所述髋关节髋臼杯假体均由权利要求1-16任一项所述的关节假体制成；其中，所述髋关节球头假体的所述分界层为曲面板状结构，所述髋关节球头假体的所述分界层为平面板经过多次弯折的结构。
  18. 一种膝关节假体，其特征在于，包括安装在胫骨平台上的膝关节股骨髁假体，所述膝关节股骨髁假体由权利要求1-16任一项所述的关节假体制成；其中，所述膝关节股骨髁假体的所述分界层为平面板经过多次弯折的结构。
  19. 一种如权利要求1-16任一项所述的关节假体的制作方法，包括：
    设计所述金属体的三维模型；
    将所述三维模型文件输入到3D打印设备中进行3D打印；
    将打印成型后的所述金属体植入所述陶瓷体的成型模具中，向所述根状层一侧填充陶瓷坯料粉体及助烧粘接剂，关闭所述成型模具，将所述陶瓷坯料粉体及助烧粘接剂加压形成烧结前坯料；
    将经过整形后的所述烧结前坯料置入烧结炉中，烧结形成结合在所述根状丝簇上的陶瓷体；
    对所述陶瓷体上的关节摩擦面进行抛光。
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