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植入物和植入物部件

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Publication number
CN101102727B
CN101102727B CN 200580042791 CN200580042791A CN101102727B CN 101102727 B CN101102727 B CN 101102727B CN 200580042791 CN200580042791 CN 200580042791 CN 200580042791 A CN200580042791 A CN 200580042791A CN 101102727 B CN101102727 B CN 101102727B
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implant
member
implant member
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CN 200580042791
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CN101102727A (zh )
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里卡德·布雷恩马克
彼得·汤姆森
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里卡德·布雷恩马克咨询公司
生物材料开发哥德堡公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • A61B17/866Material or manufacture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • A61C8/0013Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating
    • A61C8/0015Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating being a conversion layer, e.g. oxide layer
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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
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    • A61C8/0013Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating
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    • A61F2/00Filters 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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    • A61F2002/3085Special external and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes, grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

一种包含用于连接到人体或动物体的活的生物组织装置(1、12、9.12)的植入物,该植入物具有包含第一部分和第二部分的外表面,这两部分在每部分与生物组织的生物相容性方面具有不同的属性,其中该植入物包含至少一个表面部(2、15、20),该表面部包含构成所述第一部分的基础表面(3、16、21)和一个或若干构成所述第二部分的界定区域(4、5、6、7、17、22、23、24、25、26、27、28、29、30、31)。一种用于制造所述植入物的方法,其中将穿孔的掩蔽单元(9、5.9、6.9)施加到该植入物上,以及一种用于所述方法的掩蔽单元(9、5.9、6.9)。一种包含用于连接到人体或动物体的活的生物组织装置(40)的植入物部件,该植入物具有外表面,其中所述外表面包含至少一个表面区域(41),该表面区域的表面进行表形修改,以及一种用于制造该植入物部件的方法。

Description

植入物和植入物部件

技术领域

[0001] 本发明涉及一种植入物,其包含连接到人体或动物体的活的生物组织的装置,该植入物具有包含第一部分和第二部分的外表面,这两部分在每一部分与生物组织的生物相容性方面具有不同的属性,还涉及制造该植入物的方法,以及涉及所述方法中使用的掩蔽单元。此外,本发明涉及植入物部件,其包含连接到人体或动物体的活生物组织的装置,该植入物具有外表面,并涉及制造该植入物部件的方法。

背景技术

[0002] 长期以来,在患者治疗中已经使用由各种材料制造的不同类型的植入物,作为去除骨组织的代替品用于骨折的固定,例如,在固定托牙或牙桥的牙科手术中,以及在其它应

用中。在二十世纪末,用不同类型的植入物材料,诸如金、陶瓷和银进行了试验。在二十世纪30年代,建议使用维他良(Vitallium)金属合金,该金属合金是生物相容性材料,从那时开始在该金属合金上做了大量的研究,并且该金属合金在今天仍在使用。在二十世纪50年代偶然发现钛有利的生物相容性,当时发现钛植入物能够与骨组织结合。这形成了骨性结合的概念基础。从那时起,钛由于其良好的生物相容性,已经以纯的形式或以合金的形式被用于植入物。随着时间的进展,钛和钛合金显示了出众的长期结果,尤其是发现钛是非致癌物的,这一结果得到了很好的证实。然而,开始时,与能更好地与生物系统、例如周围组织反应的更具生物活性的材料对比,由于植入物中的钛和钛合金有关的仿生学属性,即不能与生物系统进行反应,所以植入物中钛和钛合金的使用仅限于高质量的骨组织。

[0003] 为了增强植入物与周围组织的反应能力,大致需要两种处理来修改表面。其中一种处理是植入物的表形修改,例如使表面形成图案或浮雕/刻花来改进植入物与组织间的接触,另一种处理是植入物表面的化学修改,但也可能是这两种处理的组合。

[0004] 如今,对于表面的化学修改,存在若干已知合适的生物活性材料,其具有与生物系统进行反应的能力并且例如通过不同的沉积技术,诸如等离子体喷涂、脉冲激光沉积、溅射、爆喷等能将其应用到植入物的外表面上。例如,这些生物活性材料的示例为磷酸钙,诸如羟磷灰石和磷酸三钙。

[0005] 然而,存在与使用新材料和物质相关的缺点,因为它们的长期效果是未知的。

[0006] 存在调整植入物与生物组织反应的需求。制造两种不同材料的植入物先前是众所周知的,其中第一种材料覆盖植入物表面的一部分而第二种材料覆盖植入物表面的另一部分。因此,在一定程度上有可能使植入物适合不同的需求。然而,这一解决方式不够灵活并且不能提供充分适应的植入物。

[0007] 此外,存在调整植入物与生物组织反应的需求从而提供表面具有生物活性属性的植入物,使其因此可以与周围组织进行反应,同时具有很好验证的长期效果。

[0008] 因此本发明的目的是提供一种具有改进表面属性和良好生物相容性的植入物,尤其是一种具有生物活性属性的植入物,同时它还具有很好验证的长期效果。此外,本发明的目的是提供制造这种植入物的方法。发明内容

[0009] 通过提供在权利要求1的前序部分中限定的植入物,并通过提供分别在权利要求17和19的前序部分中限定的方法和掩蔽单元来实现上述目的,其中该植入物包含至少一个表面部,该表面部包含构成所述第一部分的基础表面和构成所述第二部分的一个或若干界定区域,所述一个或若干界定区域由大量的界定面积组成,其数量超过五个;该方法和该掩蔽单元分别包含在权利要求17或18和19的特征部分中所提到的特定尺寸和特征。

[0010] 通过提供包含基础表面和一个或若干预先分布的界定区域的表面部,其中基础表面就其与生物组织生物相容性的属性不同于所述一个或若干界定区域的属性,提供表面的多相组织使其提供调整植入物与不同特定生物系统反应的可能性,这不可能用表面的同相组织来实现,其中该植入物的外表面包含就生物相容性相同属性的大片面积,例如相同材料的大片面积。可在植入物上的特定位置提供所述的表面部,其中在移植之后与生物系统的特定部位具有某种反应是可取的。基础表面可以具有与植入物剩余外表面相同的材料,即外表面在所述表面部之外,或者界定区域可以具有与植入物剩余外表面相同的材料。 [0011] 根据本发明植入物的有利实施例,不同的属性在关于所述生物组织的范围效果方面和/或关于每部分与生物组织反应的时间方面是不同的。

[0012] 所述界定面积的数量可有利地超过20个,并且在一些情况下超过50个。所述界定面积可分别具有0.1到0. 3mm2的大小,并对最邻近的其它界定面积具有至少I到3_的距离,有利地至少为2_。通过这一面积分布,使在和生物组织生物相容性方面的第一属性被具有在和生物组织生物相容性方面的其它属性的基础表面包围,在特定区域内植入物可给出特定的生物相容性,这便于所述植入物在组织中的结合。

[0013] 根据本发明植入物的又一有利实施例,所述一个或若干界定区域形成基本上是圆形、椭圆形和/或条状或所述形状的过渡形状的界定面积。

[0014] 根据本发明植入物的又一有利实施例,所述一个或若干界定区域由施加到基础表面上的沉积物(deposit)或涂层组成,该沉积物可具有0.05到5iim的厚度,优选0.1到3um0有利的,这些沉积物具有不均匀的厚度,并且它们朝着它们的边缘区域变薄。沉积物的不均匀厚度和不平坦表面促进了植入物和组织之间的接触。

[0015] 根据本发明植入物的有利实施例,基础表面覆盖植入物表面部的50到98%,在一些情况下为它的70到95%,而在其它情况下甚至为它的85到95%。

[0016] 根据本发明植入物的另外的有利实施例,植入物的外表面包含至少两种不同的材料,所述基础表面包含第一材料,并且所述一个或若干界定区域包含至少一个第二材料。这一实施例能够,尤其能够产生具有生物活性属性的生物相容性植入物,其同时具有很好验证的长期效果,所述第一材料例如是钛、氧化钛和/或钛合金,它们是公知的并具有很好验证的长期效果,而所述至少一个第二材料包含一种或若干生物活性材料,其以生物活性的方式与周围生物组织进行反应,反之亦然。

[0017] 可用来代替钛的其它材料的示例,例如是元素铌、铪、锆、钽和各种合金或所述元素的氧化物,以及诸如不锈钢、钴铬等其它合金。

[0018] 生物活性材料的示例是周期表中化学族的盐,其包含钙,例如包含磷酸钙的物质,或更精确地包含羟磷灰石、聚合物、高分子、氨基酸、缩氨酸、蛋白质、药物、细胞和其它晶状体和/或无定形态的生物活性陶瓷的材料。这些可再吸收或不可再吸收。已经发现羟磷灰石对牙科植入物特别有利。

[0019] 根据本发明植入物的有利实施例,第一材料和至少一个第二材料两者都由包含一种或若干上述生物活性材料的材料组成。

[0020] 根据本发明植入物的另外的有利实施例,所述至少一个表面部的表面是例如通过形成图案或浮雕/刻花进行表形修改的。例如通过加工、微制、喷制、低温喷制、蚀刻、抛光、磨蚀或通过各种激光技术来有利地实现表面的表形修改。

[0021] 根据本发明植入物的又一有利实施例,连接装置设有至少一种螺纹,但是其它连接装置也是可以的。对螺纹的可选方案例如是提供具有粗糙表面的连接装置,其借助于压力,例如,用纵向凹槽等连接到骨组织。

[0022] 此外,通过提供在权利要求21前序部分中限定类型的植入物部件可实现上述目的,其中所述外表面包含至少一个表面区域,通过例如形成图案或浮雕/刻花,以及通过在权利要求32的前序部分中限定的方法对该表面区域的表面进行表形修改,所述方法包含借助于激光使所述表面区域形成图案的特定措施。

[0023] 根据本发明植入物部件,通过提供若干凹陷来使该表面区域形成图案,并且将该表面区域定位在连接装置的区域内,连接装置设有至少一个螺纹,并将表面区域定位在所述至少一个螺纹的根部/谷底,并且沿根部纵向延伸一个接一个地设置所述凹陷。

[0024] 根据本发明植入物部件其它有利实施例,穿过所述凹陷,表面区域在连接装置的横截平面上具有波纹形状,并且该表面区域延伸至少一圈螺纹,或至少一个螺距。

[0025] 根据本发明植入物部件的有利实施例,该表面区域具有在0. 8到IOiim之间的Sa的表面,Sa优选在1. 2到5 y m之间,其中Sa通过下面等式计算:

[0026]

[0027] Sa是用于说明在植入物技术领域中表面粗糙度的公认参数。公式中参数Sa和变量的完整定义公开于,尤其是Ann Wennerberg的论文“OnSurface Roughness and ImplantIncorporation,,,Dept, of Biomaterial s/Handi cap Research, Institute for SurgicalSciences and Dept, of Prosthetic Dentistry, Goteborg University, Sweden,1996,ISBN91-628-1940-2 中。

[0028] RickardBrdnemark 的论文 “A Biomechanical Study ofOsseointegrationIn-vivo Measurements in Rat, Rabbit, Dog and Man”,G6teborg, Sweden, 1996,ISBN91-628-2267-5,公开了一种具有低Sa的加工表面,其具有较差的弹性变形属性和替代的充分塑性变形属性,这在生物力学上解释为表面在微观水平上太光滑以至与骨衔接远未到界面的含意。此外,在牙科植入物上的研究显示表面“大”或“粗糙”的结构,例如包含具有直径200-400 u m的孔或具有直径100-5000 u m的球形烧结都成问题。

[0029] 在申请人的研究中,已经发现根据本发明植入物部件所述实施例的表面区域Sa的特定间隔对植入物部件与生物组织的反应非常有利,并且已发现提供最佳的生物力学。此夕卜,如果将具有根据上述间隔Sa表面的表面区域与所述凹陷组合,这在连接装置的横截平面中给予表面区域波形形状,它可能深深地触及组织使得穿过组织与植入物之间界面的无定形区,同时,并没有出现在“粗糙”表面存在下出现的问题。[0030] 根据本发明植入物部件另一有利实施例,植入物部件的外表面由钛和/或钛合金构成。

[0031] 根据本发明植入物部件又一有利实施例,该植入物部件包含植入物的特定特征,该特征在权利要求1至16中任一项中提及。

[0032] 根据本发明植入物的有利实施例,该植入物包含植入物部件的特定特征,这些特征在权利要求21至28中任一项中提及。

[0033] 通过将根据权利要求1至16中任一项的植入物的特定特征与根据权利要求21至28中任一项的植入物部件的特定特征相结合,提供处于外表面形式的协同效果,这对关于植入物或植入物部件与生物组织间的生物相容性非常有利,并且即使在存在螺纹、法兰等的情况下增强反应,这通过组织中的深层衔接导致了力学/生物力学的稳定性。 附图说明

[0034] 为了例证的目的,现在借助于实施例并参考附带的附图将更详细地描述本发明,其中:

[0035] 图1是根据本发明植入物实施例的侧视图,具有若干沉积物形式的界定面积,

[0036] 图2是通过根据本发明方法的实施例应用第一沉积物的表形图的示意性侧视图,

[0037] 图3是通过根据本发明方法的实施例应用第二沉积物的表形图的示意性侧视图,

[0038] 图4是根据本发明掩蔽单元实施例的侧视图,

[0039] 图5是植入物实施例的侧视图,其中利用图4的掩蔽单元,通过根据本发明的方法实施例拟用条带状沉积物涂覆指示的界定面积,

[0040] 图6是图5所指示的界定面积的放大,

[0041] 图7是图解根据本发明方法实施例的示意性流程图,

[0042] 图8是根据本发明植入物有利实施例的示意性侧视图,

[0043] 图9是根据本发明植入物第二有利实施例的示意性侧视图,

[0044] 图10是根据本发明植入物部件实施例的一部分的示意图,

[0045] 图11显示沿图10的线AA的截面,

[0046] 图12是显示图10的实施例和生物组织之间反应的柱形图;和

[0047] 图13是根据本发明植入物部件实施例的侧视图。

具体实施方式

[0048] 图1显示包含装置I用于永久或暂时连接到人体或动物体活的生物组织的牙科植入物,该组织可以坚硬或柔软的。在这该情况下连接装置I包含螺纹固定部分。该植入物具有两种不同材料的外表面,其中第一种材料形成表面的第一部分,而至少一个第二种材料形成表面的第二部分。第一种材料是钛,但其它生物相容性材料也是可以的,而第二种材料是包含羟磷灰石的材料,该羟磷灰石有生物相容性和生物活性,但其它生物活性和/或生物相容性材料也是可以的。钛和羟磷灰石在每种材料与生物组织的生物相容性方面具有不同的属性,该不同的属性在关于所述生物组织的范围效果(range effect)方面是不同的。该外表面包含表面部2,其由钛的基础表面3和若干界定面积(delimitedarea)构成,该基础表面3覆盖所述表面部2的70到90%,而若干界定面积由若干沉积物4、5、6、7构成,这些沉积物由包含羟磷灰石的材料组成,该若干沉积物已经施加到连接装置I的螺纹的根部8,这已经发现是有利的。沉积物4、5、6、7具有0.1到3iim的厚度,具有不均匀的厚度并朝着它们的边缘区域变得薄,这在图2和3中有所显示,图2和3分别显示通过根据本发明的方法实施例施加的第一和第二沉积物的表形图。这导致了表面的Sa低于IOii m。沉积物4、

5、6、7覆盖大致为圆形、椭圆和/或条带状或者所述形状的过渡形状的界定面积。沉积物4、5、6、7可沉积在特定区域中或以特定的图案沉积以实现所需的生物效果。牙科植入物基部的直径为大约4. 1_,而牙科植入物顶部的直径为大约3. 75_。该螺纹的尺寸满足:在螺纹的两个牙顶之间存在大约0. 6mm的距离。

[0049] 图4显示根据本发明的掩蔽(masking)单元的实施例,根据本发明其可用在制造植入物的方法中(见图7)。当施加沉积物,或以其它方式,例如通过喷砂在螺旋状的植入物上提供表面结构时,使用中空的圆柱状掩蔽单元9,其内周适于植入物的外周。特别的,在植入物的外周和掩蔽单元9的内周之间应该有足够的距离,使得当在处理后去除掩蔽单元9时,所施加的沉积物不会被刮去。掩蔽单元9包含若干纵向孔10,在根据本发明的方法中,·材料能够穿过该孔并到达植入物。掩蔽单元9由钛构成,但也可由钛合金或另一合适的材料构成。

[0050] 在图5中显示图4掩蔽单元的切除掩蔽单元5. 9,这样显示被掩蔽单元5. 9包围并具有指示的界定面积11的植入物,当将植入物插入到掩蔽单元5. 9中时,图4中所示孔10定位在界定面积11的上方。

[0051] 图6显示所述指示的界定面积6. 11的放大。

[0052] 图7显示图解根据本发明方法实施例的示意性流程图,在该方法中使用根据本发明的掩蔽单元。最初,在7.1中,在植入物上装配穿孔的掩蔽单元。将设有掩蔽单元的植入物插入到溅射室中,在该溅射室中设有包含羟磷灰石材料的靶,并且在7. 2中,用合适的基本压力对该室加压。在7. 3中,溅射气体,在该情况下为氩与活性气体的混合物一起引入到该室中直到达到合适的工作压力。在7. 4中,在大约100瓦和大约13. 56MHz频率下运行射频发生器,这样在靶和设有掩蔽单元的植入物之间施加具有高频率的高电压,从而电离内部气体,离子从靶上敲下粒子。在7. 5中,这些粒子以某一角度穿过掩蔽单元的孔,该孔限定拟涂覆的面积,并且粒子沉积到植入物的所述面积中,该面积对应孔的形状。这一溅射过程持续一小时,从而提供大约0.1 y m的沉积物。此后,在7. 6中,旋转设有掩蔽单元的植入物以便以第二角度溅射该植入物,从而实现包含羟磷灰石或任何其它合适材料的所需材料沉积物,于是在7. 5中来自所述靶的新粒子穿过掩蔽单元的孔并沉积在植入物的所述面积中。在7. 7中,在以需要数量的其它角度执行溅射之后,完成植入物的涂覆。

[0053] 此外,在如下方法中可使用类似的掩蔽单元,该方法中首先将钛植入物用包含羟磷灰石的材料涂层,其后将其插入到穿孔的掩蔽单元中,于是包含羟磷灰石的材料从掩蔽单元的孔面积上去除。

[0054] 掩蔽单元的孔图案适于在植入物表面部形成沉积物的图案。当然,存在用于制造根据本发明植入物上的所述表面部的若干其它可能的方法,例如蚀刻。

[0055] 图8显示包含装置12的第二牙科植入物,装置12呈现螺纹固定部分的形式,用于永久或暂时连接到人体或动物体的活的生物组织。该组织可以是坚硬或柔软的。此外,该植入物具有基部13和可选设计的顶部14。该植入物具有包含两种不同材料的外表面。该外表面包含由钛的基础表面16和若干界定面积组成的表面部15,其中基础表面16覆盖所述表面部15的50到80%,若干界定面积由包含羟磷灰石的材料构成的沉积物17所组成,而沉积物17已施加到连接装置12螺纹的根部18。沉积物17具有螺旋形状,其连续在螺纹的根部18中盘绕,并且该沉积物17具有0.1到3 y m的厚度。然而,该植入物具有邻接基部13的底部19,底部19的两圈螺纹不包括所述沉积物17。

[0056]图9显示第三牙科植入物,其以基本与图8的牙科植入物相同的方式设计,并具有带表面部20的外表面,该表面部20由钛的基础表面21和若干界定面积构成,其中该基础表面21覆盖所述表面部20的55到85%,若干界定面积为包括若干沉积物22、23、24、25、26、27、28、29、30、31的不连续螺旋形状,该若干沉积物由包含羟磷灰石材料构成,该若干沉积物已施加到连接装置9. 12螺纹的根部9. 18。沉积物22、23、24、25、26、27、28、29、30、31彼此由间隔隔开(该间隔包含基础表面21),并沿螺纹的根部9. 18延伸,使得沉积物22、23、24、25、26、27、28、29、30、31之间的间隔围绕牙科植入物的中心轴线不规则地定位。同样可将沉积物22、23、24、25、26、27、28、29、30、31有利地分布成使得它们以这样的方式沿螺纹的根部9. 18延伸,从而沉积物22、23、24、25、26、27、28、29、30、31之间的间隔围绕牙科植入 物的中心轴线规则地定位,使得这些间隔沿植入物的纵向延伸彼此对齐地定位。

[0057] 图10以牙科植入物的形式显示根据本发明植入物部件的实施例的一部分。更精确地,图10显示用于连接到人体或动物体活的生物组织的连接装置40。连接装置40设有至少一个螺纹。牙科植入物外表面由钛和/或钛合金构成,并且所述外表面包含至少一个表面区域41,该表面区域41的表面通过形成图案(patterning),例如借助于激光进行表形修改。所述至少一个表面区域41定位在螺纹牙顶43之间的所述至少一个螺纹的根部42。连接装置40的最大直径,即螺纹牙顶43和直径相对的螺纹牙顶之间的距离是3. 75mm,而连接装置40的最小直径是3. 11mm。通过以下方式为该表面区域形成图案:沿根部42纵向延伸一个接一个地设置若干凹陷。在根部42中,凹陷相当于彼此可横向位移,从而提供轻微的“Z字形”结构。该表面区域沿螺纹的至少一圈延伸。

[0058] 图11显示图10的截面AA,其没有根据比例进行显示。该表面区域在连接装置的横截平面上具有波纹形状,其中该波纹形状大致是正弦曲线。每个波峰45、55比波谷46高出距离50,该距离50不大于200 u m,有利地不大于150 u m,并且有利地距离50在5和40 u m之间,这是在图11中的情况。两个邻近波峰45、55之间的距离51有利地在50和200iim之间,更有利地在70和150 iim之间,更精确地在90和120iim之间。然而,在该实施例中距离51是在100和IlOiim之间。该表面区域表面的Sa介于1.2和511111之间,其中Sa通过下面等式计算:

[0060] 如前面提到的,Sa是用于在植入物技术领域中说明表面粗糙度的公认参数。尤其是在发明内容中提到的Ann Wennerberg的论文中公开了 Sa的完整定义。通过表面区域的该上述表面,能够在骨重塑之后到达完全钙化的骨组织,于是实现所需的生物力学效果。表面区域的所述表面具有表面充分小的修改以便当插入植入物时几乎不导致损伤,但同时它的表面粗糙修改可以提供生物力学效果。相反,可给出大/粗糙的表面结构,但不完全确定地给出增强的力学效果,而作为插入的结果具有增加的组织损伤,附加地,在骨必须生长的地方提供更长的距离以便达到相同的效果,对于粗糙表面这会导致更长的愈合周期以愈合该组织。

[0061] 图12示意性地显示申请人在动物上执行试验研究的结果。柱“I”显示了根据本发明用于植入物的去除扭矩,而柱“2”显示了仅以传统方式加工的植入物的去除扭矩。此外该研究显示除了根据柱状图的更高的去除扭矩以外,可实现不同的断裂力学,导致明显的骨折。这支持了这样的假设,即在去除根据本发明植入物的扭矩后,所需弹性变形与先前观察的以传统方式加工的植入物界面处占优势的塑性变形形成对比。

[0062] 图13显示示意性的图10所示类型的牙科植入物,并图解关于所述至少一个表面区域定位的四个不同的可选方案。根据第一可选方案Alt.1,沿整个连接装置40设置一个或若干表面区域。根据第二可选方案Alt. 2,除了紧靠牙科植入物基部47的螺纹第一或第·一和第二圈以外,沿螺纹的所有圈设置一个或若干表面区域。根据第三可选方案Alt. 3,沿彼此邻近的螺纹的两圈,优选关于牙科植入物基部47的螺纹的第三和第四圈,提供一个或若干表面区域。根据第四可选方案Alt. 4,沿仅一个螺纹圈,优选关于牙科植入物基础47的螺纹的第三圈,提供一个或若干表面区域。

[0063] 所述一个或若干表面区域的位置能有利地分别对应图8和图9中的每个表面部的沉积物或多个沉积物。

Claims (5)

1. 一种植入物部件,包含用于连接到人体或动物体的活生物组织的装置,该植入物具有外表面,其特征在于所述外表面包含至少一个表面区域,对该表面区域的表面进行表形修改;将该表面区域定位在所述连接装置的区域中;该连接装置设有至少一个螺纹,并且将该表面区域定位在所述至少一个螺纹的根部中;通过提供若干凹陷使该表面区域形成图案,其中沿所述至少一个螺纹的根部的纵向延伸一个接一个地提供所述凹陷,使得通过所述凹陷,所述表面区域在所述连接装置的横截面中具有波纹形状;并且该表面区域具有介 I N M于O. 8和10 μ m之间的Sa的表面,其中通过下面等式\ =ΙϋΣΣ|ζ(χ/,Α)|计算Sa。 J V y_l /-1
2.根据权利要求1的植入物部件,其特征在于该表面区域延伸所述螺纹的至少一圈。
3.根据权利要求1至2中任一项的植入物部件,其特征在于所述植入物部件的外表面由钛和/或钛合金构成。
4.根据权利要求1的植入物部件,其特征在于Sa介于1. 2和5 μ m之间。
5.根据权利要求1至4中任一项的植入物部件的制造方法,其特征在于借助于激光使所述表面区域形成图案。
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