CN102933177A - 用于生产植入体的方法和具有至少一条断开线的植入体 - Google Patents
用于生产植入体的方法和具有至少一条断开线的植入体 Download PDFInfo
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Abstract
本发明涉及一种用于生产植入体(1)的方法,该植入体(1)具有至少一个具有至少一条断开线(3)的表面部分,所述断开线(3)用于为揭开开口或凹槽而刻画出可在力的作用下与所述表面部分分离的封闭部(2)。在第一种优选涉及机械加工的步骤中,首先生产出所述植入体(1)的子组件。在第二个步骤中,通过材料变形,弱化所述断开线(13)区域内的材料强度。
Description
本发明涉及一种用于根据权利要求1的前序部分的植入体的生产方法。
在植入体中,如果比如各个螺钉孔或开口能被选择性地打开将是十分有利的。这对于髋关节的关节窝来说尤其重要,因为来自关节窝的磨损粒子会穿越未使用的螺钉孔并进入到植入体和骨头之间的区域。然而,在接骨板中,可选择性地封闭单个螺钉孔或能够移除植入体的某些区域也可能是十分有利的。
因此,专利文件FR 2826865提议生产这样的髋关节窝,在该关节窝中,螺钉孔被盖子封闭,而该盖子被单独的焊点固定至关节窝的外侧。如果需要使用所述螺钉孔中的一个,该盖子可借由破坏所述焊点而被移除。
专利文件US 5,782,929公开了一种由钛制作的髋关节窝,在该关节窝中,所述螺钉孔被烧结在该关节窝的钛塞封闭。所述钛塞与所述髋关节窝分别进行生产,之后才将该钛塞安装至所述螺钉孔内。所述钛塞通过在大约1200°C温度下在炉内熔烧几个小时而连接至所述关节窝。
所述两种方法的缺点在于该关节窝的生产涉及好几个步骤,因此比较复杂。此外,所述盖子或钛塞与关节窝的连接强度可能因为所述开口而各不相同。
专利文件WO 2010/023447描述了一种由碳纤维增强的聚醚醚酮(CFR-PEEK)制成的假体。在一个实施例中,所述开口可被多个可断开(破坏)的部件封闭。在生产过程中,通过有针对性地减少材料厚度而在开口区域形成预设的断开线。该假体可由一个工件通过机械加工制成,还可以通过注射成型制得。
从专利文件EP 0701420可知,具有可断开的可移除盖子的髋关节窝可通过在该关节窝的内表面上钻设圆柱形盲孔而制得。该盲孔可这样形成,即在所述关节窝和开孔的端部之间保留厚度小于0.65mm的材料。这样,所述盲孔上方的盖子可在需要时被断开。
专利文件FR 2838329描述了一种髋关节窝,该关节窝具有被盖子封闭的螺钉开口,该盖子是材料连接至所述髋关节窝的。所述盖子的边界由一个材料厚度被减小的区域形成,这使得盖子可很容易被断开。朝着所述关节窝的内部,该盖子还具有凸部,另有塞子可被安装至所述凸部内。
同样,从专利文件US 5,370,702可知,螺钉孔上方的可移除盖子可通过减少材料厚度而制得。该专利中所公开的盖子在朝髋关节窝的内部方向上具有销钉一样的突起,该突起可被合适的工具夹持并使得该盖子易于断开。
专利文件EP 1338256描述了一种具有螺钉开口的髋关节窝,该螺钉开口可被冲开。该髋关节窝的在所述开口区域的材料厚度被减小以使得这些开口更易为冲开。该文件还描述了用于冲开所述螺钉开口的工具。所述材料厚度被减小的区域还可具有环形刻痕以进一步减小将其移除所需的冲开力。
所述盖子的主要缺陷在于其通过机械加工进行生产和必须具有很小的材料厚度所造成的问题,因为所述材料厚度通常落在常用的机器在多重夹紧时的容错范围内。此外,由于其需要较高的精度,它们的生产十分费钱费力。
本发明的目的在于提供一种前文所述类型的方法,其避免了所述缺陷,并可以十分精确地确定所述预设断开线的尺寸,而附近的区域并不会发生变形或在其尺寸精度方面受到影响或者在其他方面比如热方面负荷过重。此外,本发明并不昂贵并可适用于各种构型的植入体。该目的是通过权利要求1所述的方法得以实现的。
在根据本发明的方法中,通过第一生产步骤制得半成品植入体,该第一步骤优选涉及机械加工。然后通过使材料变形并减小材料厚度而形成预设的断开线。
可通过已知的生产方法实施所述第一方法步骤,比如铣和/或车削。之后再形成所述预设断开线。依据该植入体的设计,优选针对所述预设断开线的结构所形成的壁部基本是通过所述第一生产步骤比如以凹陷等结构预先形成的。尤其优选在所述半成品植入体中形成至少一个盲孔,同时在第二方法步骤中在所述孔的底部压印出预设断开线。
根据本发明的方法的一个尤其有益的方面在于,通过在预设断开线处的材料发生变形,可以有效地获得非常小的壁部厚度。而且,还可在具有复杂的表面结构的植入体上形成预设断开线。此外,其对所使用的压花模的最小化磨损意味着可获得很高的再现度。
在根据本发明的方法中,所述对材料的变形优选通过在冷状态下、也可在热状态下受压成形而实施。根据需要获得的构型而可以使用不同的压花模。通过改变压印压力和/或运动路径,可改变所述预设断开线区域的壁部厚度。在使用高强度材料的情况下,可通过热加工来减小压印力,或者可刻意增加成形度。
根据本发明的方法中,所述材料的变形优先以这样的方式予以实施,即所述成形力或材料流被引入所述封闭部。所述压花模可以具有这样的特征,即由所述压印压力所产生的压印力以及所产生的材料流可被引入所述封闭部。这防止了比如在所述植入体本体上发生破坏性的变形。另外,这还可以形成非常薄的、以需要的方式延伸并能非常准确地断开的预设断开线。
所述可移除封闭部优选以这样的方式生产,即形成有至少一个用于接合工具的接合结构。该接合结构优选呈具有根切的材料凸部的形式。然而,该接合结构还可为其他的形式,比如用于接合螺丝刀的裂缝,或螺纹等。这样的接合结构的优点在于所述封闭部更容易被断开。此外,相对所述预设断开线非对称设置的接合结构可使为移除所述封闭部所需的最大作用力的减小高达80%。
通过使所述材料变形,预设断开线区域的壁部厚度优选减小至0.01mm至1mm,尤其优选减小至0.1mm至0.3mm。该壁部厚度足以防止所述封闭部不小心被断开,然而也足够薄以使开口或凹槽在作用力的作用下无需机械的帮助即可被揭开。这使得比如可在手术过程中、有时甚至在植入体已被嵌入的情况下移除单个封闭部。
此外,该方法还优选包括:在使所述材料变形的步骤中,该封闭部还凸起地弯曲。作为替代方式,该使所述材料变形的步骤还形成内凹弯曲的或者波浪形式的封闭部。所述封闭部的内凹或凸起弯曲构型使得其更易接触以便移除而且也使移除本身更加容易。
可在使所述材料变形的过程中支撑所述预设断开线周围的壁部。这可防止周围的材料因为压力而发生变形。
本发明的另一个目的是提供一种植入体,其包括具有至少一条预设断开线的壁部。该目的是通过根据权利要求8的植入体得以实现的。
根据本发明的植入体包括具有至少一条预设断开线的壁部,该断开线通过使材料变形而减小该材料的厚度而形成。
该植入体优选为关节窝,尤其是髋关节窝。然而,作为替代方式,该植入体也可被设计成肩部关节窝、股骨干或肱骨干植入体、膝假体、髓内钉或接骨板。
由所述预设断开线限定的封闭部优选形成为圆形、卵形、椭圆形、多边形或者所述形状的组合。
或者,所述封闭部还可以这样的方式形成在所述植入体上,即其边界至少部分地由该植入体的外边缘予以界定。这样,可移除的边缘区域可形成在植入体上,比如在接骨板上。
所述植入体优选由金属材料制得,优选由钛金属、钛合金、钴铬合金、镁合金或钢合金制得。作为替代方式,所述植入体还可由非金属材料制得,比如聚醚醚酮(PEEK)或聚甲醛(POM)。
所述封闭部优选具有用于附接工具的接合结构。该接合结构尤其优选被设置成(比如)具有根切的蘑菇形材料凸部。这使得可以使用工具简单而安全地移除所述封闭部。
如果所述封闭部的壁厚至少在一个载荷部随着从所述预设断开线向所述封闭部的中央的距离的增加而增加,以使所述材料的垂直所述封闭部的截面在所述载荷部的每处具有大致相同大小的面积,还可以获得其他的优点。该条件可尤其有利地在具有旋转对称构型的封闭部上得到满足。在壁厚朝着所述中央增加的同时,其半径减小,从而所述材料截面的圆柱形表面在每个半径处均保持相同。在封闭部非常薄的情况下,从而可以防止不可控制地在所述预设断开线外侧被断开。
用于实施所述方法的尤其有益的装置具有被设计成阴模和阳模的两个压花模或者被设计成阳模的两个压花模。另外,所述装置具有在所述预设断开线附近支撑所述壁部的支撑件。这防止了在所述预设断开线外侧发生不需要的变形,并允许将所述半成品植入体准确地定位在所述装置内。
所述封闭部的移除优选通过合适的工具予以实施。比如该工具具有长形的把手和接合装置。该接合装置可松释地连接至所述封闭部。
所述长形的把手可用于施加作用力以将所述封闭部从该植入体的壁部移除。所述接合装置用于将作用力从该把手传递至该封闭部,从而该封闭部可安全而容易地被从所述植入体壁部移除。
所述接合装置优选以这样的方式进行设计,即其可被连接至设置在所述封闭部上的接合结构。这样,所述封闭部可被牢固地连接至所述工具,该工具还可在该植入体已被嵌入的情况下移除封闭部。
根据本发明的封闭部还可借由压力或张力而被移除。这可比如通过挤压或敲打和通过牵拉来进行。作为替代方式,根据本发明的封闭部还可通过弯曲或旋转力被移除。
以下将通过对示例性实施例的描述和所示的附图,本发明的其他优点及各个特征将变得明了,其中:
图1示出了根据本发明的植入体的示意性截面图;
图2以放大视图示出了具有预设断开线的封闭部的截面图;
图3a-3e示出了具有预设断开线的可移除闭合部的五个不同的示意性截面图;
图4示出了用于生产植入体的装置的示意图;
图5a/5b示出了根据本发明的方法的成形步骤的示意图;
图6示出了附接有用于断开根据本发明的封闭部的装置的植入体的局部截面图;
图7以透视图和局部截面图示出了一个替代性示例性实施例;
图8示出了根据图7的封闭部已被断开的植入体;
图9示出了根据图8的具有被嵌入至开口内的螺杆的植入体;
图10示出了具有切口的另一个封闭部的放大截面图;
图11示出了另一个封闭部的透视图;
图12从另一个角度示出了根据图11的封闭部。
图1为植入体1的示意性截面图,其中,由预设的断开线3限定的封闭部2通过根据本发明的方法形成。植入体1作为实例被构型为髋关节窝。然而,作为替代方式,该植入体可以是其它的植入体,比如接骨板。该植入体1具有比如两个封闭部2。然而,植入体1也可仅具有一个封闭部2或者超过两个封闭部2。该封闭部2可以任何想要的布局布置在植入体1的表面上。
图2示出了植入体的封闭部的示意截面图,其中,由预设断开线3限定的封闭部2使用根据本发明的方法形成。与周围的壁部7相比,该预设断开线3具有更小的材料厚度D。该材料厚度D通常不到1mm。由成形工艺获得的作为举例以箭头示出的材料流优选被特别地引入封闭部2。然而,作为替代方式,该材料流也可被特别地引入所述周围的壁部内。该封闭部2具有接合结构4,在本实例中,该接合结构4被设计成具有根切5的材料凸部。作为替代方式,该接合结构4还可具有其他形状。该封闭部2还具有内凹的弓形部6。作为替代方式,该弓形部6还可是凸起的或波浪形的。或者,该封闭部2也可是平坦的。
图3a-3e示出了根据本发明的植入体的封闭部2的不同的实施例。图3a中的实施例具有呈圆柱形或棱柱形构型的接合结构4。图3b示出的实施例具有截头圆锥形的接合结构4。在该实施例中,限定所述封闭部2的预设断开线3具有比图3a中的实施例更大的材料厚度。图3c示出了另一个变体。在该变体中,封闭部4的外侧具有凸起的弓形部6。图3a所示的封闭部2可以是图3c中的封闭部2的生产中的中间步骤。图3d示出了封闭部2的另一个实施例,其中,在植入体的侧壁的两侧,预设断开线3的材料厚度均被减小。图3e示出了封闭部3的另一个实施例。在该实施例中,接合结构4不是居中且对称地而是偏心地设置在封闭部2上。所述封闭部2的各实施例的单个特征可以依需要相互结合。封闭部2的多个不同的实施例也可体现在同一个植入体上。
图4示出了用于生产植入体1的装置9。该植入体1被夹紧在两个模具10和11之间。另外还有支撑件12支撑着该植入体1。
图5a和5b根据装置的截面图示出了根据本发明的方法的示例性实施例。所述材料在变形之前的情况可见于图5a。根据第一生产方法制得的半成品植入体被夹紧在装置9内的模具10和11之间。该植入体1还受到支撑件12的支撑。植入体1相对模具10和11的正确定向通过定向件13得以实现。图5b示出了在材料变形过程中的装置9和植入体1。所述两个模具10和11相向挤压。所述支撑件12和13支撑预设断开线周围的壁部7。
图6示出了工具14的截面图,该工具14可松释地连接至封闭部2。该工具14包括长形的把手15和接合装置16。在此处所示的工具14的实施例中,所述接合装置16由长形的中空本体组成,该本体至少具有与所述接合结构4相同的横截面。该把手15至少在接合装置16的区域内同样被设置成中空本体,该中空本体可移动地布置在所述接合装置16上。在所示实例中,把手15在该区域内被分成三个部分,该三个部分被多个渐缩的裂缝相互分离。通过将把手15推至接合装置16上,使截面变小,或者说所述三个部分同心地相互挤压。这样,所述接合装置16可接合在所述接合结构4上。所述接合装置16优选具有能够接合在所述接合结构4的根切5内的附加的结构。
图7-9再次以示意的方式示出了髋关节窝形式的植入体1上的螺钉孔被揭开的过程。所述关节窝的外表面可以具有任何合适的表面结构以确保更好地锚固在骨头中。在断开封闭部2后,在合适的情况下所述髋关节窝已经安装就位,形成螺钉孔17的开口即被揭开。螺钉18被嵌入至该螺钉孔17内,所述螺钉的头部具有与所述螺钉孔17匹配的设计。
图10示出了包括具有呈蘑菇形横截面的接合结构4的封闭部2。所述材料厚度D在负载部20区域从预设断开线3向中轴线19连续增加。所述负载部大约对应于所述预设断开线3和根切5上的最小直径处之间的圆环。所述中央轴线19周围的材料截面在半径R1处和在半径R2处的面积相同。这可由公式2×R1×π×D1=2×R2×π×D2表示。该构型确保当封闭部2被接合时所述材料在预设断开位置3断开而不会以不可控的方式在负载部20的其他位置断开。
图11和12示出了封闭部2的另一个示例性实施例,该封闭部在此处已被断开。所述接合结构4大约为圆柱形并在上边缘具有倒角。所述根切4也为圆柱形。
Claims (15)
1.一种用于生产植入体(1)的方法,该植入体(1)包括至少一个具有至少一条预设断开线(3)的壁部,所述断开线(3)限定出可在力的作用下被从所述壁部移除以露出开口或凹槽的封闭部(2),其特征在于:
首先,在生产工艺中生产出半成品植入体(1),该生产工艺优选涉及机械加工;
然后,通过使所述预设断开线(3)区域内的材料发生变形而减小所述壁部的厚度进而形成所述预设断开线(3)。
2.如权利要求1所述的方法,其特征在于,所述使材料发生变形通过在冷或热的状态下受压成形而实现,尤其是通过挤压的方法实现。
3.如权利要求1或2所述的方法,其特征在于,所述使材料发生变形以这样的方法得以实现,即成形作用力或材料流被特别地引入所述封闭部(2)或植入体(1)。
4.如权利要求1-3中任一项所述的方法,其特征在于,所述可移除的封闭部(2)以这样的方式制造,即形成有至少一个用以附接工具的接合结构(4),该接合结构(4)优选为具有根切的材料凸部。
5.如权利要求1-4中任一项所述的方法,其特征在于,所述预设断开线(3)区域内的壁厚被减小至0.01mm至1mm,优选为0.1mm至0.3mm。
6.如权利要求1-5中任一项所述的方法,其特征在于,在所述使材料发生变形的过程中,所述封闭部(2)还被凸起、凹入、呈波浪形或呈平直形地弯曲。
7.如权利要求1-6中任一项所述的方法,其特征在于,在使所述材料发生变形的过程中所述预设断开线(3)周围的壁部有支撑。
8.一种植入体,其包括至少一个具有至少一条预设断开线(3)的壁部,所述断开线(3)限定出可在力的作用下被从所述壁部移除以露出开口或凹槽的封闭部(2),其特征在于,通过使所述材料发生变形而形成所述预设断开线(3)。
9.如权利要求8所述的植入体,其特征在于,所述植入体为关节窝,优选为髋关节窝。
10.如权利要求8或9所述的植入体,其特征在于,所述由预设断开线限定出的封闭部被成形为圆形、卵形、椭圆形、多边形或前述形状的组合。
11.如权利要求8-10中任一项所述的植入体,其特征在于,所述由预设断开线限定出的封闭部至少部分地以该植入体的外边缘为界。
12.如权利要求8-11中任一项所述的植入体,其特征在于,所述植入体(1)由金属材料制成,优选由钛、钛合金、钴铬合金、镁合金和/或钢合金制成。
13.如权利要求8-12中任一项所述的植入体,其特征在于,所述植入体(1)由非金属材料制成,优选由聚醚醚酮和/或聚甲醛制成。
14.如权利要求8-13中任一项所述的植入体,其特征在于,所述可移除封闭部(2)具有至少一个用于附接工具的接合结构(4),该接合结构(4)优选为具有根切的材料凸部。
15.如权利要求8-14中任一项所述的植入体,其特征在于,所述封闭部(2)的壁厚至少在一个载荷部内随着从所述预设断开线(3)向所述封闭部的中央(19)的距离的增加而增加,从而使垂直所述封闭部的所述材料的截面在所述载荷部的每处具有大致相同大小的面积。
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EP3768191A4 (en) * | 2018-03-21 | 2021-12-15 | Panthera Dental Inc. | SUBPERIOSTAL DENTAL IMPLANT |
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- 2011-05-04 CN CN201180022998.XA patent/CN102933177B/zh not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
US9173741B2 (en) | 2015-11-03 |
US20130053976A1 (en) | 2013-02-28 |
EP2384723B1 (de) | 2012-12-12 |
EP2384723A1 (de) | 2011-11-09 |
WO2011138353A1 (de) | 2011-11-10 |
CN102933177B (zh) | 2015-11-25 |
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