增材制造植入体的质量保证
增材制造是一种现代制造方法。这为各种可定制的医疗设备提供了巨大的潜力:从髋关节和膝关节植入物到脊柱植入物、创伤组件,直至患者专用产品(PSP)。要生产出准确、可重复和符合FDA标准的快速成型医疗部件,必须满足严格的质量保证要求。
虽然存在许多不同的植入物和固定理念,解决方案也多种多样,但各个部件的制造过程仍十分相似。由于材料特性,骨科植入物可以根据制造过程进行分类。蔡司为不同的细分市场提供定制化的质量解决方案,助您提高制造过程中的生产率。了解金属制造过程和塑料制造过程的质量关。
Due to the shape of dental implants, the thread measurement of the entire component surface is most challenging. Manufacturers have to reliably measure small structures & tolerances in fast cycle times.
A shoulder implant consists of a glenosphere, a glenoid implant, peripheral screws, and a humeral stem. The measurement of narrow stem's freeform profile is the biggest metrological challenge for this type of implant.
The full inspection of rods without datum references is the greatest difficulty in measuring spinal implants. For these implants, intervertebral discs are fixed by spinal rods and monoaxial pedicle screws.
It is the low tolerance of multiple parts made of several materials that makes measurement of hip implants challenging. These implants are comprised of an acetabular cup, a polyethylene liner, a femoral head and a femoral stem.
When measuring knee implants accurately, it is important to ensure that no white marks are left behind. A knee implant consists of metallic and plastic components.
Bone screws and bone plates are used for implants in the field of trauma & extremities. The biggest metrology challenge of bone plates are multi-axis measurements of shallow bores on a freeform surface.
即使在苛刻的生理条件下,骨科植入物也必须能在人体内发挥良好作用。一个核心要求便是制造商必须对骨科材料(金属化合物、陶瓷和聚合物)以及由此产生的有机反应有着深刻的理解。金属加工流程中的重要步骤之一是评估原材料的特性,从而确保产品的性能。其他重要的挑战有几何切削、制造过程中的技术清洁度以及通过尽可能减少浪费来提高效率。
受制造过程影响,可以非常高效地大批量生产塑料植入物,或是单独生产。在某些情况下,这些植入物是专为患者定制的部件。这是因为塑料在医学上的最大优点是可以通过多种方法对其进行塑造,因此可以很好地适应患者的不同需求。特别是超高分子量聚乙烯(UHMWPE),由于其具有高耐磨性、高韧性和强生化惰性,在医疗植入物应用中取得了巨大的成功。借助超现代的机器和系统,现在也可制造有时几何形状十分复杂的微小部件。