Helmus Michael N, Gibbons Donald F, Cebon David
Medical Devices, Biomaterials, Drug Delivery, and Nanotechnology, Worcester, Massachusetts 01609, USA.
Toxicol Pathol. 2008 Jan;36(1):70-80. doi: 10.1177/0192623307310949.
The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medical device. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medical devices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a "do no harm" mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing "good," that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medical devices will facilitate the use of existing and new biomaterials for new medical device designs.
将对聚合物、生物、金属和陶瓷生物材料的阵列进行生物相容性方面的综述，传统上生物相容性被视为开发安全医疗设备的一项要求。随着组合产品的出现，正在发生一种范式转变，现在要求将生物相容性设计到设备中。事实上，下一代医疗设备将需要通过使用例如药理剂、生物活性涂层、纳米纹理或包含控制生物相互作用以产生理想生物学结果的细胞的混合系统来提高生物相容性。生物相容性的概念正在从“不造成伤害”的使命（即无毒、无抗原性、无致突变性等）转变为“有益”的使命，也就是说，鼓励积极的愈合反应。这些新设备将促进正常健康组织的形成以及设备与相邻组织的整合。在某些情况下，生物相容性可能成为一种能够改变治疗范式的颠覆性技术（例如药物涂层支架）。用于获取现有医疗设备中结构材料生物相容性数据的新数据库工具将有助于将现有和新型生物材料用于新的医疗设备设计。
