CN103052410B - 抗菌医疗产品及其制备方法 - Google Patents
抗菌医疗产品及其制备方法 Download PDFInfo
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Abstract
本发明涉及具有施加在基体上的含有杀生物剂的抗菌硬质材料涂层的医疗产品。该硬质材料涂层包含至少一个内层和一个外层，其中在外层中的杀生物剂浓度基本上恒定并且大于在内层中的杀生物剂浓度，和在内层中的杀生物剂浓度大于或者等于0.2at%。
Description
本发明涉及医疗产品，特别是医疗工具或仪器，其含有施加在基体上的抗菌硬质材料涂层。
定义和测试方法
按照1993年6月14日关于医疗产品的理事会93/42/EWG号规范，医疗产品是指所有单独或彼此相连使用的仪器、器械、装置、软件、材料或其他物品，包括制造商专门指定用于诊断和/或治疗目的的和用于医疗产品无缺陷运转的软件，其由制造商指定为了下列目的用于人类：
- 疾病的辨识、预防、监测、治疗或缓解；
- 受伤或者残疾的辨识、监测、治疗、缓解或弥补；
- 人体构造或生理过程的研究、替代或改变；
- 避孕，
和它们常规的在人体内或上的主要作用既不是通过药物或者免疫的手段，也不是通过代谢作用而实现的，但是可以通过这些手段促进其起作用的方式。
此外，按照1993年6月14日关于医疗产品的理事会93/42/EWG号规范，附件是指一种物品，其本身不是产品，而是按照其由制造商专门确定的用途和产品一起使用，以便它可以按照由产品的制造商确定的产品用途而得到使用。
本专利中医疗产品不仅指医疗产品，也指医疗产品的附件（根据1993年6月14日关于医疗产品的理事会93/42/EWG号规范对于医疗产品和附件的定义），但是还用于动物，以下情况除外：
- 内假体（Endoprothesen）或医疗产品的内假体（Endoprothesen），其将被植入体内且永久或者至少很长时间地保留于此。
- 材料及其他医疗产品或医疗产品的附件，其不具有固体表面。
硬质材料具有高的硬度和耐磨性。这些材料在工业上具有重要意义。基于各种各样的性质和不同的应用领域，很难找到一个对硬质材料的全面定义。如下的特征性质适用于大部分硬质材料：高硬度、高耐磨性、高熔点、化学稳定性，其它的机械性质，如抗拉强度、伸长率和弯曲断裂强度非常依赖于硬质材料的类型。这同样适用于导电性。在一般情况下，硬质材料的性质与这些化合物的电子结构密切相关。分别根据是否存在金属键或共价键，由此产生金属型和非金属型硬质材料之间的明显差异。
在本发明中，对于被称为硬质材料涂层的涂层特别考虑到了其层硬度或者层体系的硬度，和特征是硬度至少为1500 HV（维氏硬度）或者17 GPa（马丁硬度）。
所报告的硬度值是根据马丁硬度检测方法使用“Fischerscope
H100C”来测量的。维氏金刚钻被用作压头。马丁硬度检测方法在DIN EN ISO 14577（金属材料 – 用于确定硬度及其它材料参数的仪表化的压入检验方法）中已经标准化。在该方法中，力和压入深度在负荷阶段和去负荷阶段期间连续地被测量。马丁硬度被定义为最大力和相应的接触面积的比值，且其单位为牛顿每平方毫米。马氏硬度HM由力/压入深度-曲线在试验力增加期间的测量值（优选在达到确定的试验力后）来计算，并且在这种情况下在使用维氏金刚钻作为压头时适用于下面的定义：
其中F为试验力[N]和h为在该试验力下的压入深度[mm]。
该给出的硬度定义原则上也可应用于薄层。然而，要注意几个特别的地方。在试样压入时通常同时发生层和基材的变形。由此确定复合硬度Hc，其适用于下面的关系式：
其中，Hf，Hs为层硬度、基材硬度和Vf，Vs为变形的层体积、基材体积。
压头的压入深度越小，则变形的基材体积越小；因此，压入深度和试验力越小，确定的复合硬度越接近实际的层硬度。在测量层体系的硬度时，通常（按照Bückle规则）认为在压入深度
其中df为层厚度
确定的硬度几乎等于层硬度。在本发明的范畴内，报道的层硬度值是在考虑到Bückle规则的情况下确定的。
粘附级别是按照洛氏试验确定的。在借助洛氏试验按照VDI规范3198以及3824-4检测层粘附性时，评价在HRC压痕的边缘范围中涂层的裂纹网络以及剥落的大小和类型，并且按照图1所示的用来确定PVD-层在工具或者高速钢上的粘附强度级别（HF1:非常好到HF6：非常差）的略图或者说图列（Bilderreihe）由此直接得出粘附强度的结论。为了应用该方法，基底材料的洛氏硬度和层厚度或者层体系的厚度分别不小于54HRC和不大于5μm。借助HRC压痕（150kp）在100倍放大下直接在显微镜中做出评价。
作为用于层体系表面的色度测量的测量仪，使用Dr. Lange 公司的3-区比色仪(Farbmessgerät)MIKRO
COLOR II，其利用氙气闪光灯在样品表面产生漫反射，紧接着根据DIN 5033 测量其值。作为校准的参考标准(Bezugsstandard)，使用具有标准色值X：84.6 Y：89.4和Z：91.8的白色标准。在每次色度测量后，由此产生的色值按照CIELAB三维坐标系统（L*a*b*）显示在比色仪的显示屏上，其中a*轴表示颜色的绿色或者红色部分，其值为-150到100（负值表示绿色而正值表示红色）；b*轴表示颜色的蓝色或者黄色部分，其值为-100到150（负值表示蓝色而正值表示黄色）；L*轴表示颜色的亮度（照度），其值为0到100。
现有技术
如今市场上存在需要具有抗菌或者抗微生物性质的各种产品。特别是为了预防传染病，寻求具备抗菌和/或抗微生物性质的卫生产品和医疗产品。已知的有银及其离子作为无机杀生物剂用于处理材料，其随着时间的推移释放出其中含有的杀生物剂，以便减小或者完全阻止微生物在这些材料上和甚至在其周围的定殖（Ansiedlung）或者繁殖（Vermehrung）。为达到这个目的，到目前为止已研究和开发了多种抗微生物的银技术。其它已知的无机杀生物剂还有例如铜和锌，其出于某些原因（例如与银相比更高的毒性和不那么有效的抗微生物作用）在医疗技术方面的应用方面不那么受欢迎。
通过HyProtectTM-技术，尤其将例如薄的（<200nm）抗微生物涂层施加到医疗产品上，该涂层由纯银（通过PVD（物理气相沉积）法沉积）和氧化硅层（通过CVD（化学气相沉积）法沉积）的组合层构成。这种技术可以在不同的表面产生尤其是所想要的光学的和抗微生物性质，但是不能很好地提高磨损保护。
已知的还有在真空下使用物理的和/或化学的和/或等离子辅助化学的涂覆方法，即用硬质材料层（如用TiN，CrN和DLC）PVD和/或CVD和/或PACVD（等离子辅助的CVD）涂覆医疗产品。由此，通常可以在医疗产品的表面上达到所想要的光学以及摩擦学性质。尽管如此，其不具备足够的抗微生物作用。
申请人在其产品组合中有不同的涂层，其特别为医疗产品而开发，以便在这些医疗产品表面上除了承载特定的摩擦学性质之外也承载一定的光学性质。特别的是通过这些涂层除了提高的耐磨性和改善的摩擦性质也实现一定的有光泽的或者无光泽的颜色。
层体系的例子和颜色有：
· TiN → 金色，
· AlTiN或a-C:H → 黑色，
· TiAlN → 铜色，
· CrN → 银色，和
·WC/C → 灰色。
层体系的例子和摩擦学和/或对于医疗产品所想要的光学性质有：
· TiN → 用于植入物-试验柄（Probierschäften）的安全标记
· TiN和WC/C → 用于钻头套筒体的磨损保护和减小摩擦
· WC/C和CrN → 用于牙钻的磨损保护
· WC/C → 用于骨头螺栓紧固工具、牙齿植入物螺栓紧固工具、骨钻、骨锯、植入枪、动脉清洗弹簧（Arterienreinigungsfeder）的减小摩擦和/或磨损保护
· WC/C → 用于使眼外科手术刀具有抗反射性
· DLC → 用于牙石去除器（Zahnsteinentferner）的腐蚀保护和/或安全标记和/或也使其具有抗反射性。（DLC经常也称为a:CH）。
不同的研究机构已经发表了若干关于抗微生物的含银硬质材料层（例如Ag-TiN，Ag-CrN和Ag-a-C:N）的PVD沉积和/或CVD沉积和/或PACVD沉积的研究工作，其可应用于医疗技术，尤其是用于涂覆内假体（Endoprothese）。在这些工作中试图研究抗微生物性质和/或摩擦学性质，以及在一些情况下还有如此构成的层体系的生物相容性，但是完全没有考虑到光学性质（如颜色和反射），其特别对一些医疗技术工具和仪器起非常重要的作用。
在自主的研发工作中可以发现，通过硬质材料层（例如氮化钛（TiN））的银掺杂会负面影响到决定性的层参数，如粘附强度、硬度和粗糙度（见图1、2、3）。特别可以发现，银含量越高，则对基体的粘附强度越低。此外，通过银掺杂还会影响到初始的层体系的光学性质（参见图4）。
发明目的
本发明的目的在于，改善现有技术的上述缺陷。特别是应给出适合于医疗产品的涂层，其产生预定的抗菌性质和提高已经在基材上具有的摩擦学性质，例如耐磨性和减小摩擦。为此，涂层必须主要能够具有对医疗产品基体足够的粘附性。其抗腐蚀性应该保留或者至少仅仅在允许的范围内减小。其中优选地尝试，使医疗产品具有让使用者接受的光学性质。
本发明的目的特别在于，在所述医疗产品的表面上达到这样的性质，特别是借助涂覆在工具和仪器的表面达到这样的性质，特别是通过PVD和/或PACVD涂覆。
此外必须考虑到，在涂覆方法中的基材温度一定要顾及基材材料的热稳定性，即不得超过基材材料的最高允许温度。
特别是，通常在涂覆医疗产品（例如相应的仪器和工具）时，由于常常使用的基材类型（例如不锈钢1.4542）温度不应该超过300℃。
解决方案
根据本发明，该任务通过在医疗产品的基体（1）上施加的含有杀生物剂的抗菌硬质材料涂层而全面实现。该硬质材料涂层含有至少一个厚度d1至少为0.2μm的内层（5）和厚度d2至少为0.5μm的外层（9）。内层（5）设置在外层和基体（1）之间，而外层（9）含有跨整个层厚度基本上恒定的杀生物剂浓度bcI（大于或者等于2at%）。在本说明书的范畴内，对杀生物剂浓度的说明总是指跨至少20nm深度的平均值。内层（5）具有最大值大于或者等于0.2at%的杀生物剂浓度。内层（5）的杀生物剂浓度在整个层厚度小于基本上恒定的外层（9）杀生物剂浓度bcI。沿着其层厚度，在内层（5）中的银浓度可变化，且特别是沿着从基体（1）到外层（9）的方向增加。因此，与不含有本发明的内层的层体系相比，本发明形成的层体系具有改善的对基材的粘着。
发明描述
本发明接下来借助实施例来解释，其中在所示的图片涉及到：
附图中示出：
图1a：行为：不含有根据本发明的嵌入内层的沉积在抛光的（Ra:0.05μm）Leg.工具钢1.2842上的Ag/TiN层体系的粘附强度vs.银浓度。
图1b：粘附强度级别的示意图
图2：行为：沉积在抛光的（Ra:0.05μm）Leg.工具钢1.2842上的Ag/TiN层体系的马丁硬度vs.银浓度。
图3：行为：沉积在抛光的（Ra:0.05μm）Leg.工具钢1.2842上的Ag/TiN层体系的粗糙度vs.银浓度。
图4：行为：沉积在抛光的（Ra:0.05μm）Leg.工具钢1.2842上的Ag/TiN层体系的光学性质（例如按照CIELAB体系的色值）vs.银浓度。
图5：用于按照本发明制备抗菌医疗产品的涂层或者层体系的示例性设计，其中：
（1）...基体
（2）...用于提高粘附强度的机械和/或电化学的预处理
（3）...粘附层和/或磨损保护层
（5）...本发明的包含杀生物剂的内层
（7）...包含杀生物剂的中间层，其具有比外层更高的杀生物剂浓度
（9）...外层
（10）...用于降低粗糙度的机械后处理，如抛光
图6：用于按照本发明制备抗菌医疗产品的涂覆设备的示例性配置。
不同的PVD涂覆方法应用于制备掺杂银的TiN层。
实施例1：通过组合的电弧/溅射方法和/或混合的AIP + MSIP方法，制备掺杂银的TiN层体系或Ag/TiN层体系。图6示意性展示了真空涂覆设备701的配置，其中将起杀生物剂作用的层体系沉积在医疗产品和/或试样的基体上。作为材料源，应用分开的钛靶703、703'、703''、703'''和银靶705、705'。具有不同银浓度的层体系通过对钛靶703、703'、703''、703'''的电弧电流的变化，对Ag靶705、705'的溅射功率的变化（Sputter-Leistung）和对基材的偏置电压的变化来制备。此外，可以通过活性的钛靶和/或银靶数目的变化来改变银浓度。Ag/TiN层通过压力调节在过程压力为0.02mbar在Ar/N2气氛下沉积而成。在涂覆期间基材位于具有两倍和三倍旋转的旋转配置707上。基材的转速保持恒定。在由不同的钢品种以及硬质合金构成的试样或者医疗产品的表面上，按照相应的加热过程和蚀刻过程在真空涂覆室中借助AIP技术沉积出由TiN构成的非常薄的粘附层（厚度≤0.3μm），且紧接着如上所述在恒定的过程参数下借助组合的AIP技术和MSIP技术沉积出Ag/TiN层。图1到4展示了银浓度对硬度、粗糙度、光学性质的影响，其是在不同的银溅射功率（Sputterleistung）而除此之外相同的过程参数下沉积而成的。可以发现（如图1a所示），在提高的银浓度下粘附强度明显变差。
发明人发现，通过在基体1和具有提高的银浓度的外层9之间设置内层5（如图5所示），含有提高的银含量的Ag/Ti层体系的粘附强度可以明显增强。
这也适用于，当在内层5和外层9之间设置含有相对于外层9提高了浓度的中间层7，其可作为对于外层9的银储备。
额外地还可以在基体1和内层5之间设置粘附层3或者磨损保护层3，由此还进一步提高粘附性。
如上述实施例所示，层的粘附强度借助本发明的层顺序和方法在提高的银含量下明显增强。按照下面的实施例2，另一种可能是在DLC层嵌入杀生物剂。从基材开始，举例来说施加粘附层（例如铬）。紧接着通过PACVD沉积DLC层，并同时活化银靶（Silbertarget）。在此，也首先施加少量的银，例如通过低的溅射功率。然后提高浓度，例如通过提高溅射功率而除此之外保持相同的涂覆参数。最后，在涂覆过程中保持银浓度恒定地高，以便制备具有恒定的杀生物剂浓度的外层。再次，本发明的层具有相对于现有技术改善的粘附性质。
现在，问题在于如何限制杀生物剂的浓度含量。实际上可能推测，杀生物剂浓度越高，效果越好。但令人吃惊的是，由发明人实施的测试与其相矛盾。其原因在于，当浓度超过15at%时，层的硬度（如图2所示）明显降低，且色感（Farbeindruck）明显改变（如图4所示）。因此建议使用最高15at%的杀生物剂浓度，优选最高13at%。
如图3所示，通过在经涂覆产品（特别是医疗产品）的表面引入银，可具有提高的粗糙度。发明人发现，提高的粗糙度导致杀生物效果的降低。这个可以通过表面的后处理，特别是机械后处理（例如抛光，湿喷射（Nasstrahlen）或者研磨或者合适的化学抛光剂）来抑制。由于在外层中的杀生物剂浓度恒定，这种后处理基本上对医疗产品应用的杀生物作用没有影响。
Claims (13)
1.医疗产品，其具有施加在基体（1）上的含有杀生物剂的抗菌硬质材料涂层，该涂层包含至少一个厚度d1至少为0.2μm的内层（5）和一个厚度d2至少为0.5μm的外层（9），其中该内层（5）设置在外层（9）和基体（1）之间，而外层（9）具有在其整个层厚度基本上恒定的跨至少20nm深度的平均杀生物剂浓度bcI，为大于或者等于2at%，其特征在于，内层（5）跨20nm深度的平均杀生物剂浓度的最大值bcII大于或等于0.2at%，且内层（5）跨其整个层厚度的杀生物剂浓度小于外层（9）的基本上恒定的杀生物剂浓度，其中在内层和基体之间或者任选地在内层和粘附层之间含有至少一个磨损保护层，其硬度大于或等于1500HV，并且由此对设置在其上面的层提供支承作用。
2.按照权利要求1的医疗产品，其特征在于，在内层（5）和基体（1）之间设置了至少一个基本上不含杀生物剂的粘附层和/或磨损保护层和/或硬质材料层（3）。
3.按照权利要求1或2的医疗产品，其特征在于，在内层（5）和外层（9）之间设置至少一个具有杀生物剂浓度bcIII的中间层（7），其中bcIII大于bcI。
4.按照权利要求1或2的医疗产品，其特征在于，该杀生物剂是一种无机杀生物剂或无机杀生物剂的组合。
5.按照权利要求4的医疗产品，其特征在于，该杀生物剂含有银。
6.按照权利要求1或2的医疗产品，其特征在于，所述硬质材料涂层或所述层体系含有TiN、TiAlN、AlTiN、CrN、WC/C和/或a-C:H。
7.制备按照前述权利要求之一的医疗产品的方法，其特征在于，为了沉积层体系而使用的涂覆方法为PVD（物理气相沉积）或者组合的PVD+PA-CVD（等离子辅助的化学气相沉积）方法。
8.按照权利要求7的制备医疗产品的方法，其特征在于，使用的PVD方法包括AIP（电弧离子镀）和/或MSIP（磁控管溅射离子镀）和/或混合AIP+MSIP方法。
9.按照权利要求8的制备医疗产品的方法，其特征在于，在涂覆方法中使用至少一个含有杀生物剂的固态靶作为杀生物剂源，所述靶含有一种或者多种杀生物剂。
10.按照权利要求9的制备医疗产品的方法，其特征在于，在稀有气体/活性气体的气氛中同时地借助MSIP技术运行至少一个含有杀生物剂的靶和借助AIP技术运行至少一个不含有杀生物剂的靶，其中通过对至少一个含杀生物剂的靶的溅射功率的变化和/或通过对至少一个不含杀生物剂的靶的电弧电流的变化控制在各上述的包含杀生物剂的层中的杀生物剂浓度。
11.按照权利要求7或8或9或10的制备医疗产品的方法，其特征在于，基体（2）的表面在涂覆前进行机械或者电化学处理。
12.按照权利要求7或8或9或10的制备医疗产品的方法，其特征在于，经涂覆的表面（10）在涂覆后进行机械处理。
13.按照权利要求7或8或9或10的制备医疗产品的方法，其特征在于，经涂覆的表面（10）在涂覆后进行抛光。
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| KR101491219B1 (ko) * | 2012-12-17 | 2015-02-06 | 현대자동차주식회사 | 저마찰 코팅층, 코팅방법 및 코팅장비 |
| CN103866242A (zh) * | 2014-03-20 | 2014-06-18 | 常州康鼎医疗器械有限公司 | 医疗器械物理气相沉积(pvd)表面涂层技术 |
| DE102018123874B4 (de) | 2018-09-27 | 2020-12-10 | Dot Gmbh | Implantat und Verfahren zu dessen Herstellung |
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| EP3744355B1 (en) | 2019-05-29 | 2022-12-21 | Metal Estalki, S. L. | Coating for non-permanent transcutaneous implant |
| BR112022013868A2 (pt) * | 2020-01-15 | 2022-09-13 | Oerlikon Surface Solutions Ag Pfaeffikon | Revestimentos duros de alta resistência coesiva que contêm metal macio |
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| Publication number | Publication date |
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| EP2590690B1 (de) | 2018-04-18 |
| WO2012003899A1 (de) | 2012-01-12 |
| RU2013105476A (ru) | 2014-08-20 |
| US20210169071A1 (en) | 2021-06-10 |
| CA2822170A1 (en) | 2012-01-12 |
| KR20130123369A (ko) | 2013-11-12 |
| US12022822B2 (en) | 2024-07-02 |
| CA2822170C (en) | 2018-10-09 |
| RU2604123C2 (ru) | 2016-12-10 |
| US20130224274A1 (en) | 2013-08-29 |
| US20190124915A1 (en) | 2019-05-02 |
| US10945430B2 (en) | 2021-03-16 |
| EP2590690A1 (de) | 2013-05-15 |
| US10143196B2 (en) | 2018-12-04 |
| CN103052410A (zh) | 2013-04-17 |
| DK2590690T3 (en) | 2018-06-25 |
| KR101959092B1 (ko) | 2019-03-15 |
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