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CN111743641A
CN111743641A CN202010231128.4A CN202010231128A CN111743641A CN 111743641 A CN111743641 A CN 111743641A CN 202010231128 A CN202010231128 A CN 202010231128A CN 111743641 A CN111743641 A CN 111743641A
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medical device
coating
ald
reuses
certain embodiments
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J·基维奥亚
N·奥克萨拉
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Picosun Oy
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Picosun Oy
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    • 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
    • C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
    • C23C16/44—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating
    • C23C16/455—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the method of coating characterised by the method used for introducing gases into reaction chamber or for modifying gas flows in reaction chamber
    • C23C16/45523—Pulsed gas flow or change of composition over time
    • C23C16/45525—Atomic layer deposition [ALD]
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    • C23C16/45529—Atomic layer deposition [ALD] characterized by the ALD cycle, e.g. different flows or temperatures during half-reactions, unusual pulsing sequence, use of precursor mixtures or auxiliary reactants or activations specially adapted for making a layer stack of alternating different compositions or gradient compositions
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Abstract

本公开的实施例涉及颜色编码。公开了一种医疗器械，包括用以指示医疗器械的类型的原子层沉积ALD涂层，以及ALD的指示医疗器械的重复使用次数的用途。

Description

颜色编码
技术领域
本发明总体上涉及涂层及其制造方法。
背景技术
本部分说明了有用的背景信息，但不认可本文描述的任何技术代表现有技术。
当前，在外科手术中使用的器械(例如钳子、剪刀、持针器、牵开器、内窥镜、刀轴但不限于这些)使用标记带或雕刻来进行标记，以指示该器械是一次性的(即单次使用的器械)还是可以被使用若干次(即可重复使用的)。一些器械的形状复杂，不能承受灭菌或再处理的过程，即设备特性可能会被改变从而导致性能下降、故障、吸收有害化学物质或毒素、腐蚀，未被测试用于多次使用，可能引起交叉感染，并且因此被制成一次性的。当在患者身上使用外科器械时，外科器械会被微生物玷污和污染，并且因此必须对其进行灭菌以对其进行彻底地清洁和消毒。如果该过程不充分，则过程中使用的生物碎片或化学化合物积聚在器械中，这可能使患者易于感染或组织发炎。经验证可多次使用的器械承受灭菌，具有较低的积聚过程中使用的生物碎片或化学物的风险，并且具有较低的技术故障的风险。使单次使用的一次性器械暴露给灭菌和多次使用会以故障、化学物的积聚或感染的形式造成潜在危害。
发明内容
本发明的某些实施例的目的是有利于不同类型的医疗器械的标识。
某些其他实施例的目的是帮助评估可重复使用的医疗器械的总体状况。
根据本发明的第一示例方面，提供了一种如所附专利权利要求1所限定的医疗器械。
第一方面的实施例在从属专利权利要求中被限定。
根据本发明的第二示例方面，提供了一种如所附专利权利要求8所限定的方法。
根据本发明的第三示例方面，提供了一种如所附专利权利要求9所限定的医疗器械的表面上的ALD涂层的用途。
根据本发明的示例方面，提供了一种医疗器械，包括：
原子层沉积ALD涂层，用以指示医疗器械的类型。
根据另一示例方面，提供了ALD的用以指示医疗器械的类型的用途。
在某些实施例中，提供了两种类型的医疗器械：一次性医疗器械和可重复使用的医疗器械。
在某些实施例中，提供了一种代码簿，该代码簿限定了与医疗器械的类型相匹配的(多个)预定涂层参数。在某些实施例中，(多个)涂层参数包括层厚度。在某些实施例中，(多个)涂层参数包括层材料。
根据本发明的另一方面，提供了一种医疗器械，包括：
多个ALD层，其被配置为通过预定过程被逐一(即，分别地，一个接一个地)剥离，以指示用医疗器械执行的重复使用次数。
在某些实施例中，预定过程是灭菌过程。
根据另一示例方面，提供了一种将涂层沉积到医疗器械上的方法，包括：
提供与医疗器械的类型相匹配的(多个)预限定的涂层参数；以及
基于(多个)上述涂层参数，通过ALD将涂层沉积到医疗器械上。
根据另一示例方面，提供了一种医疗器械，包括：
医疗器械的表面上的涂层，其中该涂层包括多个ALD层，该涂层指示医疗器械所经历的重复使用次数。
在某些方面或实施例中，所涉及的医疗器械用ALD来标记(以使其类型变得清晰)。在某些方面或实施例中，通过根据被沉积在医疗器械的表面上的ALD涂层的颜色来监测医疗器械的磨损或医疗器械的状况。
在实施例的某些方面，提供了医疗器械的增强属性。增强属性的示例是：防止其吸收化学物、生物碎片、细菌、毒素，防止腐蚀，防止磁化以及提高长期耐久性。
在某些实施例中，具有不同厚度的相同ALD涂层材料(例如，HfO2)被用来对物品(医疗器械)的使用目的进行编码以使差错最小化。
在某些实施例中，对于可重复使用的物品，每个灭菌步骤(例如，高压灭菌处理)移除涂层的一个界限明确的外层。涂层/物品的颜色告知该物品被重复使用了多少次。
在某些实施例中，涂层的厚度(总计)小于200nm。在某些实施例中，涂层被实现为层压结构。在某些实施例中，医疗器械的基底材料是金属。在某些实施例中，涂层材料是金属氧化物。
在某些实施例中，涂层是MLD涂层。更一般地，医疗器械的表面上的上述涂层包括多个层，不一定是ALD层，而是基于所选的基于气相沉积的技术而沉积的层。
前面已经呈现了不同的非约束性示例方面和实施例。以上实施例和在本说明书中稍后描述的实施例被用来解释可以在本发明的实现中利用的所选方面或步骤。应当理解，对应的实施例也适用于其他示例方面。可以形成实施例的任何适当的组合。
附图说明
现在将参考附图仅以举例的方式描述本发明，其中：
图1a和图1b示出了根据某些实施例对医疗器械的类型进行标记；
图2示出了根据某些实施例的医疗器械上的涂层的厚度如何限定涂层的颜色；
图3示出了根据某些实施例的纳米层压结构；
图4示出了根据某些实施例的在预测重复使用次数中使用图3的结构；以及
图5示出了根据某些实施例的衬底(substrate)处理装置。
具体实施方式
在下面的描述中，原子层沉积(ALD)技术被使用作为示例。
ALD生长机制的基础是技术人员已知的。ALD是一种特殊的化学沉积方法，其基于将至少两个反应性前体物质顺序引入到至少一个衬底。然而，应当理解，当使用例如光子增强的ALD或例如PEALD的等离子体辅助的ALD时，这些反应性前体之一可以被能量取代，从而导致单个前体ALD过程。例如，诸如金属之类的纯元素的沉积仅需要一个前体。当前体化学物包含要被沉积的二元材料的两个元素时，可以用一个前体化学物来生成二元化合物，诸如氧化物。ALD生长的薄膜是致密、无针孔的且具有均匀的厚度。
通常在反应容器中将至少一个衬底暴露给时间上分离的前体脉冲，以通过顺序的自饱和表面反应来将材料沉积在衬底表面上。在本申请的上下文中，术语ALD包括所有适用的基于ALD的技术以及任何等效或紧密相关的技术，诸如例如以下的ALD子类型：MLD(分子层沉积)、等离子体辅助的ALD例如PEALD(等离子增强原子层沉积)和光子增强的原子层沉积(也被称为光ALD或闪光增强的ALD)。
基本ALD沉积循环包括四个顺序步骤：脉冲A、清除A、脉冲B和清除B。脉冲A包括第一前体蒸汽并且脉冲B包括另一前体蒸汽。惰性气体和真空泵通常被用于在清除A和清除B期间从反应空间中清除气态反应副产物和残留的反应物分子。沉积序列包括至少一个沉积循环。沉积循环被重复，直到沉积序列已产生所期望厚度的薄膜或涂层。沉积循环也可以更简单或更复杂。例如，循环可以包括通过清除步骤分离的三个或更多个反应物蒸汽脉冲，或者某些清除步骤可以被省略。另一方面，光增强的ALD具有各种选项，诸如仅一个活性前体，以及用于清除的各种选项。所有这些沉积循环形成定时的沉积序列，该定时的沉积序列由逻辑单元或微处理器来控制。
当不同的材料被使用作为彼此叠置的不同薄膜层时，它们被称为层压板或纳米层压板。
包括改变所需的待沉积材料(或层压结构)的装置的沉积设备是反应器装置，其优选地被配置为采用所选的基于气相沉积的技术的原理。就总体实现而言，反应器可以例如基于美国专利号8,211,235(Lindfors)中所描述的ALD安装，或者可以基于来自芬兰Picosun Oy的安装“Picosun R-200Advanced ALD system(Picosun R-200高级ALD系统)”。然而，本发明概念的基础特征可以被并入到任何其他化学沉积反应器中，例如被体现为ALD、PEALD(等离子体增强的ALD)、MLD(分子层沉积)或CVD(化学气相沉积)设备。
图1a和图1b示出了根据某些实施例对医疗器械的类型进行标记。图1a示出了单次使用的器械。在某些实施例中，通过ALD对单次使用的器械进行处理以沉积以第一颜色显现的涂层，或者可以保留单次使用的器械未涂覆。图1b示出了可重复使用的器械。在某些实施例中，通过ALD对可重复使用的器械进行处理以沉积以第二颜色显现的涂层，第二颜色不同于第一颜色以区别于单次使用的器械。
图2示出了根据某些实施例的医疗器械(诸如外科器械或牙科器械)上的涂层的厚度如何限定涂层的颜色。将具有厚度的ALD涂层101沉积在基底材料201上，该基底材料例如可以是不锈钢。入射光200从涂层101的表面反射210。传播到涂层101内部的光线从基底材料201和涂层101之间的界面反射260。反射线210和260的干涉使反射光以与入射光的颜色不同的颜色显现。由于涂层的厚度是原子层的倍数，因此干涉的差异是原子层厚度的函数，并且因此是可预测的。某个涂层厚度以可预测的颜色显现。因此，涂层的厚度是从颜色外观可得出的。另外，被沉积有ALD的不同材料关于厚度给出颜色外观的不同的可预测效果。例如，与移除某一厚度的另一材料相比，移除相同厚度的第一材料引起颜色外观的不同的可预测变化。在某些实施例中，结构的折射率基于材料选择而不同，这将以预测性的方式影响涂覆表面的外观。
图2中的涂层101内的水平线图示了涂层的层厚度可能最初不同，或者厚度随着涂层的磨损(或由于例如在灭菌过程中的原子层或保形ALD单层的逐一移除)而可能变得减小。
取决于涂层材料及其厚度，涂层/医疗器械的颜色或颜色差异由肉眼或扫描仪可见。在某些实施例中，从等待灭菌的一组医疗器械中立即其中哪些是一次性器械并且哪些是可重复使用的。
图3示出了被沉积在基底材料201上的纳米层压结构。该纳米层压结构包括以交替的方式彼此叠置的不同涂层材料A和B的涂层或材料层。
图4示出了根据某些实施例的在预测重复使用次数中使用图3的结构。在每个灭菌步骤中(例如，使医疗器械暴露于灭菌液体或蒸汽)，纳米层压结构的层溶解，并且涂层的颜色发生对应的变化。医疗器械的重复使用次数从涂层/医疗器械的颜色中得出。
图5示出了根据某些实施例的衬底处理装置(或沉积反应器)550。装置550包括反应室553和通向反应室553的至少一个涂层材料入口551。装置550还包括通向泵(用于排气)的前级管线552。在图5中所示的实施例中，用于涂层材料(或反应性化学物)的入口551被定位在反应室553的顶部部分中，并且前级管线552位于底部部分中，反应室553的总体流动方向因此是竖直的(向下)。
衬底支撑件554支撑例如从侧面装载到反应室553中的医疗器械555。通过ALD对医疗器械555进行处理以产生具有预定数目的(多个)预定材料层的涂层。
在不限制专利权利要求的范围和解释的情况下，以下列出了本文公开的一个或多个示例实施例的某些技术效果。技术效果有利于不同类型的医疗器械的标识。另一技术效果是通过ALD提供医疗器械的颜色编码。另一技术效果是有助于预测医疗器械的重复使用次数。
前述描述已经通过本发明的特定实现和实施例的非限制性示例的方式提供了发明人目前构想的用于实施本发明的最佳模式的全面和有益的描述。然而，对于本领域技术人员而言清楚的是，本发明不限于以上呈现的实施例的细节，而是可以在不脱离本发明的特征的情况下使用等效手段在其他实施例中实现本发明。
此外，可以在不对应地使用其他特征的情况下有利地使用本发明的上述公开的实施例的一些特征。如此，前述描述应被认为仅说明了本发明原理，而并非是对其的限制。因此，本发明的范围仅由所附专利权利要求书限制。

Claims (9)

1.一种医疗器械，包括：
所述医疗器械的表面上的涂层，所述涂层包括多个ALD层，所述多个ALD层被配置为通过预定过程被逐一移除以指示利用所述医疗器械而被执行的重复使用次数。
2.根据权利要求1所述的医疗器械，其中所述涂层指示所述医疗器械经历的所述重复使用次数。
3.根据权利要求1或2所述的医疗器械，其中所述涂层通过所述涂层的颜色外观来指示所述重复使用次数。
4.根据权利要求3所述的医疗器械，包括所述涂层以指示由肉眼或由扫描仪所见的所述重复使用次数。
5.根据前述权利要求中任一项所述的医疗器械，其中所述预定过程是灭菌过程或高压灭菌过程。
6.根据前述权利要求中任一项所述的医疗器械，包括作为基底材料的金属，所述多个ALD层被沉积在所述基底材料上。
7.根据前述权利要求中任一项所述的医疗器械，其中所述涂层包括被沉积在基底材料上的纳米层压结构，所述纳米层压结构包括交替的第一材料层和第二材料层，其中所述第一材料层和所述第二材料层由不同的材料制成。
8.一种方法，包括：
将医疗器械装载到沉积反应器的反应室中；
通过ALD在所述医疗器械的表面上沉积涂层，所述涂层包括多个保形ALD单层，所述多个保形ALD单层被配置为通过预定过程被逐一移除以指示用所述医疗器械而被执行的重复使用次数。
9.医疗器械的表面上的ALD涂层的用以指示所述医疗器械的重复使用次数的的用途。
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