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Medicoat AG在人体植入装置上喷涂涂层

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Company Introduce 公司介绍

 

As indicated in our name, Medicoat AG manufactures coatings on implant devices. Starting with the design and construction for our own thermal spray equipments, we now have a competent team of specialists in our system engineering field. We deliver complete coating systems as well as single components for any spraying technology and coating application. 

如我们名字所示Medicoat AG在人体植入装置上喷涂涂层。随着自行设计和生产热喷涂设备,公司拥有了由系统工程领域专家组成强大专业团队,可提供全套的涂层系统和用于任何喷涂技术和涂层应用的单个组件。

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More than 20 years experience in thermal spraying and the advantage of having medical coating, equipment constructing and process control / regulation engineering under one roof, allows us to provide our clients always with the best solution, customized to their requirements. The R&D team preserves our leading position and makes Medicoat to the right partner for your coating development. img4

在热喷涂领域超过20年的经验,在医疗涂层、设备制造和过程控制/工艺控制上的优势,使我们能够为客户提供最好的解决方案,并根据他们的要求定制设备。我们的研发团队保证我们的领先地位,并使Medicoat成为您涂层发展的正确伙伴。

 

 

History of Medicoat   Medicoat 的历史

 1984                Rough Ti-structure by VPS 

用真空等离子喷涂粗Ti结构涂层

1986                Hydroxyapatite (HA)-coatings by VPS

用真空等离子喷涂羟基磷灰石(HA)涂层

1989                Foundation of Medicoat (Niederrohrdorf)  

                        Medicoat 成立         Niederrohrdorf )

1990                 First VPS-system (actual 4 equipments)

第一台VPS系统(实际上是4台设备)

1995                    New building in Mägenwil 

在Mägenwil建立新办公楼

1996                   Foundation of MC/F  

创立MC/F

 1997                   Certified ISO 9001 

通过ISO 9001认证

2003                   Start of in-house HA-production 

开始生产羟基磷灰石产品

2006                ISO-Certification of HA-powder production 

HA粉末制备通过ISO认证

2007                ISO Certified equipment production 

设备生产通过ISO认证

2009                Certification ISO 13485

通过 ISO 13485认证  

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Operational activities:

业务范围

 

 

1. Medical Coatings 医用涂层

 Ti, HA, Ti/HA

 

2. Thermal Spraying Technology:热喷涂技术

 Systems, Components, Spare parts 系统,部件,备件

 

3. Spray Powders: 喷涂粉末

 Hydroxyapatite, Ti-powders, Ceramics羟基磷灰石粉末,Ti粉,陶瓷粉末

 

4. Industrial Coatings: 工业用涂层

 DC/HF-VPS, APS, HVOF, Cold Gas 

 

5. Research and Engineering: 研究与工程

 FlowWatch, TrueVoltage, PowderSwitch 流速计,实际电压,粉末开关

 

References:

参考:

42 Equipments, 50 Powder feeders 42台设备,50个送粉器

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20000 Coated Implants (2008) 喷涂20000个植入涂层(2008

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DC - VPS coating process                                         HF - VPS coating process

DC - VPS 涂层工                                                    HF - VPS 涂层工艺

 

 

 

 

 

 

 

 

 

 

Machine and Process Control 设备与工艺控制

 

To improve the process of thermal spraying, our enterprise has specialized in the machine and process control. A core component of our coating equipment is the PC / PLC - combination for control and regulation: All relevant parameters are maintained to constant values and visualized as a function of time with defined alarm barriers. Apart from easy data handling (EXCEL), the PC allows the integration of additional software (for example permanent calculation of coating costs, process monitoring and so on). As the PC is only the working surface, there is no danger of a machine stand still caused by the PC.

 

为了提高热喷涂工艺,我们企业有专门的机器来控制工艺过程。涂层设备的核心组成是PC/PLC来联合控制和调节。所有的相关参数保持不变值并作为定义报警障碍是可视化的。除处理简单的(EXCEL)数据外,PC还可以允许更多的软件集成(例如持续计算涂层成本,以及过程检测等。由于电脑只是工作表面,没有任何机器设备的危险是由PC引起的。

 

Process control of thermal spraying热喷涂的工艺控制

 

Modern thermal spray operation is based on the coordination of the plasma plume or flame characteristics and powder properties. A central controller is needed which is linked with all the components of the spraying system.

 现代热喷涂操作的基础是协调等离子体或者焰流特性及粉末性能,必须通过一个中央控制器来连接喷涂系统所有组件

 

The core element for the process control by Medicoat is a PC in combination with a programmable logic controller (picture 1). The PLC proved to be the best solution for an automatic spraying process based on parameter sets stored in the E-PROM. The PC is however much more powerful in data registration, storage and visualisation which are needed for a certified coating production. Newly developed software enables us to make a link between the PLC and the PC. For the communication with the individual components Profibus DP is used. An optimised process performance with high stability and reproducibility is the result.

Medicoat工艺控制的核心元件是带有可编程序逻辑控制器PC(见1)。这个可编程序逻辑控制器PLC)基于参数设置存储E-PROM,是自动喷涂工艺最好的解决方案。PC则在涂层生产中的数据录入、存储和可视化具有极为强大的优势。新开发的软件使我们可以轻松地PLCPC连接起来,采用Profibus DP进行单个部件的通信。故此拥有高稳定性和重复性的优化工艺性能。  

 

 

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A specific property of our central process control is the package of security, which guarantees high availability under production conditions, based on the validation according to DIN ISO EN 9001 and putting into operation according to DIN-32521.

 我们的中心工艺控制器的一个特定性能是安全软件包,它可以保证基于DIN ISO EN 9001的生产条件和依DIN-32521的投入运行的条件下,拥有高可用/可靠性。

 

·       Every electrically measurable actual value is combined with an alarm in 3 steps of sensitivity: information, advice and constraint.

每个电测量的实际值与报警器的3个步骤的灵敏度相结合:信息,咨询和约束。

 

·       The permanent registration of all quality related spraying parameters, displayed as a function of time and printed out after the coating process is completed, is a very useful pre-warning in correlation to the tolerance range that have been defined for each parameter. Beside the constance in operation a significant prolongation of the lifetime of important parts and components is the result.

有关喷涂参数所有质量的永久录入,时间函数的展示和喷涂完成后打印,对每一个参数所定义的公差范围是非常有用的预警。因此除了在操作中的不变性,对重要部件和零件使用寿命也有非常显著的延长。

 

·       Servicing and recalibration by phone is done by means of a modem with secure internet connection.

凭借安全的因特网连接,可以通过电话来进行维修和再校准。

 

·       The complete PC software is ensured by a licensed duplicate using an integrated ghost hard disc, which can be activated if a failure forces an interruption.

通过使用了整合ghost硬盘的证书副本来保证完整PC软件。如果强制中断失效可以激活。

 

The data generated by the PLC during the spraying process fulfil the FDA requirement. The print-out of the data registration of the quality related spraying parameters as a function of the spraying time is accepted by ISO 13485 as process documentation.

在喷涂过程中,由PLC生成数据完全满FDA要求。打印出的关联喷涂参数如喷涂时间的函数的质量的录入数据完全符ISO13485工艺设计文件标准。

 

 

DC-VPS AnlageDC / HF-VPS Kombianlage

Medicoat  DC - VPS                                 Medicoat DC / HF - VPS 系统

 

Application 应用领域

 

Medical industry is our main activity as our name expresses.
正如我们的名字一样,医疗行业是我们应用的主要领域。
The technical specification for the Ti/HA-coating you ask for is exactly what we spray by VPS for some of our customer.

我们使用VPS给我们医疗行业的客户喷Ti/HA-涂层。

l        Ti-powder according ISO 5853 but grade 1 for the coating in relationship to ASTM F 1580.

 Ti粉符ISO5853,也同时满ASTM F1580 1级标准。

 

l          HA-powder according to ISO 13779-2.

HA-粉末符ISO13779-2标准。

 

l        Coating thickness as ASTM F 1854 requires, but adapted to the bone structure, in which the surgical implant will go in.

 涂层厚度符ASTM F1854的要求,并接适合外科植入部位的骨结构。

 

l        Regarding the coating properties, please see picture 9. Most important beside the crystallinity is the Ca/P-relationship, which indicates the content in beta-TCP or CaO. If the Ca/P-value is 1.69 ± 0.2, then only traces of both are detectable.

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 关于涂层性能,请看9。除结晶度外最重要的就是表beta-TCPCaO中含量的Ca/P关系,如Ca/P值是1.69 ± 0.2,就只能测出骨骼的痕迹。

 

 

 

 

 

 

 

 

 

 

 

 

 

  Also please consider the tensile adhesion strength for HA (40 MPa) due to the balance between our HA-powder and the spraying recipe.

由于我们HA粉末和喷涂配方之间的平衡,需同时考HA40 Mpa)粘附拉伸强度

 

The roughness of the coating (EN 4287) depends on the selected Ti-powder for the Ti-coating structure between the initial dense Ti-bond coat and the final HA-to coat.

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涂层的粗糙度(EN4287)取决于选择的最初的致Ti骨涂层和最后HA涂层之间Ti涂层结构所用Ti粉。
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Our business relationship in medical application is divided into 2 parts. One part is coating production for the implant producer the other in equipment for the in-house coating production of the implant producer. Also the job shoppers, which are using our equipments (APS and VPS) have a direct relationship to the implant producer (coating validation).

我们在医疗行业的业务分为两部分,一部分是为骨植入生产商提供涂层生产,另外一部分是用为骨植入生产商提供涂层生产的设备。也有与骨植入生产商(涂层验证)有直接关系的喷涂间使用我们设备(APSVPS)。

 

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Medical coatings 医用涂层

 

Medicoat has certified the medicine-technical coating production with vacuum-plasma-spraying (VPS) according to DIN EN ISO 9001-2000. Our customers are considerable prosthesis manufacturers. We coat their implants on the contact areas to the bone tissue with biocompatible materials to force a direct and long-term-stable osseointegration. Two of our VPS systems are exclusively reserved for medical applications. Some of our design variants are:

根据DIN EN ISO 9001-2000标准,用真空等离子喷(VPS) 医用技术喷涂Medicoat产品已通过认证。

 

Structured titanium layer (Ti) 钛结构涂层Ti

Adapted surface morphology with variable layer thickness and adjustable roughness. Ti in accordance with ISO 5832-2.

适合的表面形貌,涂层厚度和粗糙度可调。

 

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Average roughness: Ra < 25 micrometer. The picture corresponds to 1cm2

平均粗糙度:Ra < 25um。该图1cm2

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Average roughness: Ra > 40 micrometer. The picture corresponds to 1cm2

平均粗糙度:Ra > 40um。该图1cm2

2019年7月9日 14:18
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