CN107111770B - 用于牙科植入部件的个体可追溯方法和系统 - Google Patents

用于牙科植入部件的个体可追溯方法和系统 Download PDF

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CN107111770B
CN107111770B CN201580070599.9A CN201580070599A CN107111770B CN 107111770 B CN107111770 B CN 107111770B CN 201580070599 A CN201580070599 A CN 201580070599A CN 107111770 B CN107111770 B CN 107111770B
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Abstract

用于牙科植入部件的个体可追溯方法和系统，其包含：将所制造的每一部件(1)与单一辨识码(2)的关联；将记录在射频标签(5)上及/或打印在胶粘标签(6)上的该码(2)合并入个体包装(3)中，而部件(1)在个体包装(3)中分配和销售；以及，在与码(2)相关的具有每一特定部件(1)的可追溯性信息的因特网网站(4)中实施特定的管理软件，关联具有附件的植入物并向使用者提供网站(4)的登录服务。该单式辨识系统由下述组成：用于每一部件(1)的独特且不同的码(2)，该码是数字码；以及与每一码(2)关联的具有每一部件(1)的可追溯性信息的特定管理软件。

Description

用于牙科植入部件的个体可追溯方法和系统
发明目标
如本说明性报告的标题所表达，本发明指代用于牙科植入部件的个体可追溯过程和用于实施这一过程的单式辨识系统，因此对先前技术贡献一系列将会在后文中详细揭示的益处和创新性特征，并得出该领域的重要新进展。
特别地，本发明的目标为用于实施特定牙科植入物及其适配假体的全体、个体可追溯性的过程，以允许任何希望这么做的患者或牙医在任何需要的时候获取该植入物的特征、说明书或技术加工报告。这一过程基于通过射频操作的单一部件辨识系统的使用，该系统包含用于每一部件的唯一码和令通过因特网进行获取成为可能的特定管理软件。
技术领域
本发明的领域为牙医学领域，尤其是植入物和植入物修复学方面。
背景技术
如在其它领域中一样，采用下述法律：通过表明制造和质控流程及所用起始材料的批号的手段，建立牙科植入物及其附件的生产登记义务；这一进程被称为可追溯性。可根据不同标准定义这些批次的分组，依据所选择的标准，每组所包括的部件数较大或较小，但在全部例子中，均包括复数个单元。
全部这些信息和用户数据(通常为牙医或每一批次部件交付的牙科诊室)一起通过事件的途径记录并存储在，对每一批次进行控制且，若需要，可召回每一批次中包括的部件。
尽管此可追溯性可提供关于所制造的植入物批次的某些信息，其在涉及具体植入物的信息上存在限制。例如，这可能与下述假定情况有关：希望对该植入物采取行动的牙医并非最初负责实施对该患者的植入过程的牙医。
此外，应当说，基于每一情况的需要，每一植入物可具有广范围的不同假体。已知，假体或假体性附件构建该植入物之间的楔石或连接元件以及牙冠，其中，该楔石或连接元件是插入骨内的金属部件，而牙冠是外围部件。众多的种类导致与不同植入物组合的多种可能性以及置于每一患者体内的多种假体。
因此，本发明的目标为研发一可追溯过程，该过程比追踪批次更进一步且聚焦于独立制造的每一部件。特别地，其许可监控每一部件的个体可追溯性选项，该追溯为从其制造用于终端患者的时间至该植入物被任何需要基于任何理由而采取特定植入行动的牙医放入的时刻，从而访问任何时间和来自任何地点的信息。
另一方面，参考先前技术，应当说，尽管存在用于产品的可追溯性和辨识的不同系统和方法，至少本发明人并未意识到存在任何宣传或揭示本文所主张过程的过程或发明。
发明内容
因此，随着上文陈述的理想目标被基于该创新的实施且以详尽的方式得以实现，令这一可能确切包括于依附于本说明书的最终权利要求书中，本发明提出的用于植入物和假体的个体可追踪过程和单式辨识系统成为该领域的重要创新。
特别地，如前文所述，本发明首先提出一种确保牙科植入物及与之连接的假体的可追溯性的过程，提供该植入物和假体的完全且独立的信息，尤其是其精确的制造时刻，并因此允许任何患者或牙医获知关于该部件生产的特征、说明或技术信息；其次，本发明提出一种单一辨识系统，其基于数字码和管理软件而执行个体可追溯性。
更详而言之，该可追溯过程包含使用与该部件链接的唯一数字码，该数字码是独特的且每一部件的数字码均不相同。
此数字码是辨识每一部件的单式手段，且用来通过管理软件的手段访问待提供的部件的制造信息。因此，当该数字码被输入网站的特定部分，通过使用上述管理软件的因特网服务器而通告用于该目标时，给出对含有与该数字码相关的部件的前述信息的文件的访问。
接着，无论是否为植入物或假体，每一部件与其制造时的唯一数字码关联。该数字码记录在合并于包装内的RFID(射频识别)射频标签上或记录在条形码上，该包装有限为泡罩型封装，该部件以该包装被分配和销售。
此外，该数字码也以图片形式分别印刷在粘附在部件包装上的胶粘标签上，从而这些标签之一可通过获得该植入物或假体并对患者实施植入过程的牙医提交，而另一个可由患者自己保留。
因此，由于每一植入物具有与之相连的假体或附件，实施该植入的保健专业人士将能够通过管理软件将假体码与各患者体内植入的植入物链接。因此，正常情况下，每一患者将拥有具有其植入物数字码的标签，且植入该患者体内的假体性附件的码将通过软件链接至该数字码，从而令患者经由上述网址访问两种部件的加工信息。这可在任何时间任何地点通过任何允许访问因特网的装置进行。
用这种方法，该过程令患者获知他们的植入物或假体性附件的确切特征、工程图、材料、加工日期和验证日期甚至参与每一加工进程的人、部件验证和各自的证明文件以及批次编号、以及全部待提供的其它信息。
通过网站，需要获得植入物和假体信息的患者、医生和牙医将进入各自部分的数字码，且能访问令他们能获知该植入物及附件的技术特征的数据；例如，螺钉类型、材料或与患者的植入物相关的其它信息。该数据将可用于对该连接或植入的假体性附件提供额外信息，如植入物的螺距、与该植入物连接的附件或制造用于患者牙齿空间的个性化假体的尺寸，而无需获取或拆卸该牙冠或植入物。
因此，举例而言，考虑到目前在世界任何地方旅行的容易程度，在受苦于其假体问题的情况下，患者可拜访将能迅速且容易地获取置于该患者体内的植入物的信息如植入物类型、连接、螺距、假体性附件等的牙医，并由此使用适当共价解决该问题。
鉴于前文阐明，所揭示的用于牙科植入物的个体可追溯过程和用于实施该可追溯性的单式辨识系统，是具有迄今未知用于其预期目标的结构和构成特征的创新，而且，这些原因连同其实践和使用特性足以奠定令它们获取所寻找的排他性特权的基础。
附图说明
为了完善本说明书，且着眼于帮助获得对本发明特征的更好理解，一组图式依附于本说明性报告，形成该报告的不可分割的一部分，图式显示于下，用作实例而非限制：
图1显示牙科植入物位于其商用包装内的实例的图解，其中，包括具有与该植入物相关联的数字码的标签，为了获取其可追溯性而构建用于该标签的单一辨识方法。
图2给出了根据本发明的可追溯过程的示意图。
具体实施方式
图1显示位于独立泡罩型包装(3)的牙科植入物部件(1)的实例，(该部件具体为植入物，虽然必须认为它也可以是假体或假体性附件)，以该包装分配并销售，其中，创新性元件是该部件特有的用于取得其可追溯性的唯一辨识码(2)。
特别地，该码(2)将优选为多位数的数字码，包括在该包装(3)上，记录于射频标签(5)上；或是以图片形式印刷在两个胶粘标签(6)上的条形码。逻辑上，由便利化或需要而定，该码(2)可记录在射频标签(5)上且可作成更多或更少备份，及/或记录为更多或更少条形码，及/或印刷在更多或更少胶粘标签(6)上。
无论如何，每一部件(1)独有的该唯一的数字码(2)连同与每一码(2)关联/链接的特定管理软件一起，构成将允许进行部件(1)的个体可追溯性的单一辨识系统，其中，每一码(2)均具有与之关联的各部件(1)的可追溯信心和特定制造特征，根据所揭示的过程，在网站(4)上实施用于该目标的管理软件，由于各自服务器的存在，该网站可经由因特网访问并允许使用者通过输入特定部件(1)的码(2)而获取可追溯性信息。换言之，每一特定部件(1)的特定制造特征。
总而言之，该可追溯性过程包含：
在完成加工进程之后，将部件(1)与用于每一部件(1)的独特且不同的码(2)关联；
将所关联的独特辨识码(2)并入个体包装(3)中，每一部件(1)以该个体包装(3)分配和销售；
以及，在因特网的网站(4)中实施与该部件链接的特定管理软件，该网站链接每一部件(1)的唯一辨识码(2)，而该码具有该具体部件(1)的可追溯性信息和特定制造特征，使部件(1)的辨识码(2)由将植入物与由附件或假体组成的另一部件(1)的辨识码组成关联，存储两个部件的全部可追溯性信息(保健专业人士用来实施植入过程，以将附件的码(2)与他放入患者体内的植入物的码关联)，还提供当使用者将植入物部件(1)的码(2)输入网站(4)时对该信息的获取。
接着，允许实施本过程的该单式辨识系统由下述组成：用于每一部件(1)的独特且不同的数字码(2)；以及，使每一码(2)和与其关联的个特定部件(1)的可追溯性信息和特定加工特征关联/链接的特定管理软件，且该辨识码(2)待链接至植入物部件(1)以辨识附件或假体性部件(1)。
本发明的特性及其实践模式已经得以足够详细地揭示，因此，做出任何更详细的说明以令该领域技术人员理解其范畴及其所带来的益处，并不被认为是必需的。在这一基本设计中，阐明了可通过其它细节不同于实施例所说明的实施方法进行实践，若未变更、改变或修改基本原理，则这些方法也属于保护范畴。

Claims (6)

1.一种用于牙科植入部件的个体可追溯方法，该牙科植入部件特别是构建牙科植入物的第一部件(1)和构建待连接至该植入物的假体的第二部件，其特征在于，该方法包括下列步骤：
一旦该第一部件(1)和第二部件的加工进程结束时，将该第一部件(1)和第二部件与用于第一部件中的每一第一部件(1)和用于第二部件中的每一第二部件的独特且不同的独特辨识码(2)关联；
将与每一第一部件关联的独特辨识码(2)并入其中分配和销售每一第一部件(1)的第一个体包装(3)中；
将与每一第二部件关联的独特辨识码并入其中分配和销售每一第二部件的第二个体包装中；以及
对链接该第一部件和第二部件的因特网网站(4)上进行特定管理软件的实施，该网站分别使该每一第一部件(1)和第二部件的独特辨识码(2)分别与该第一部件(1)或第二部件的可追溯性信息和特定加工特征关联，该网站将第一部件(1)的该独特辨识码(2)与第二部件(1)的该辨识码相关联，存储第一部件和第二部件的全部可追溯性信息，并在使用者将该第一部件(1)或第二部件的该独特辨识码(2)输入该网站(4)时给出对该信息的获取。
2.如权利要求1所述的用于牙科植入部件的个体可追溯方法，其特征在于，该独特辨识码(2)是数字码。
3.如权利要求1或2所述的用于牙科植入部件的个体可追溯方法，其特征在于，该独特辨识码(2)被并入该每一第一部件(1)的该第一个体包装(3)中以及被并入每一第二部件的第二个体包装中，或至少记录在射频标签(5)上。
4.如权利要求1或2所述的用于牙科植入部件的个体可追溯方法，其特征在于，该独特辨识码(2)被并入每一第一部件(1)的第一个体包装(3)中以及被并入每一第二部件的第二个体包装中，或至少打印在胶粘标签(6)上。
5.如权利要求1或2所述的用于牙科植入部件的个体可追溯方法，其特征在于，记录在射频标签(5)上和打印在两个胶粘标签(6)上的该独特辨识码(2)被并入每一第一部件(1)的第一个体包装(3)中以及被并入每一第二部件的第二个体包装。
6.一种单式辨识系统，用于实施如权利要求1至5中所述用于牙科植入部件的个体可追溯方法，特别是构建牙科植入物的第一部件(1)和构建待连接至该植入物的假体的第二部件，其特征在于，该系统由下述组成：用于该每一第一部件(1)和每一第二部件的独特且不同的该独特辨识码(2)；以及，使每一独特辨识码(2)和与其关联的每一第一部件(1)的该可追溯性信息和特定加工特征关联，且关联/链接该第一部件(1)的该独特辨识码(2)与该第二部件的该独特辨识码(2)的特定管理软件。
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