Medical device design, manufacture and testing systems
    6.
    发明授权
    Medical device design, manufacture and testing systems 有权
    医疗器械设计,制造和检测系统

    公开(公告)号:US09388451B2

    公开(公告)日:2016-07-12

    申请号:US14038080

    申请日:2013-09-26

    摘要: Described are methods and systems for testing lumens of cannulated delivery components or assemblies thereof that may be used to deliver cells to a patient. Test cells are contacted with walls of the lumens and/or liquids that contact walls of the lumens, potentially over an incubation period. The test cells are then assessed for an effect of the wall contact, or the liquid contact, on at least one and preferably multiple characteristics of the test cells such as innate immune response, metabolic activity, viability, cytotoxic response, and/or motility. Methods and systems as described can be used in the development and/or manufacture of cannulated delivery devices, for example providing specifications for design or process inputs or outputs, design or process validations, and/or device lot approvals. Also described are devices or products produced in accordance with such methods and systems.

    摘要翻译: 描述了用于测试可用于将细胞递送至患者的插管输送组件或其组件的腔的方法和系统。 可能在潜伏期内,将测试细胞与腔内壁和/或液体壁接触。 然后评估测试细胞对测试细胞的至少一个优选多个特征(例如先天免疫应答,代谢活性,存活力,细胞毒性反应和/或运动)的壁接触或液体接触的影响。 所描述的方法和系统可以用于开发和/或制造插管式输送装置,例如提供设计或过程输入或输出的规范,设计或过程验证和/或装置批次批准。 还描述了根据这些方法和系统生产的设备或产品。