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    • 10. 发明授权
    • Method and apparatus for rehydration of lyophilized biologic materials
    • 用于冻干生物材料再水合的方法和设备
    • EP2641564B1
    • 2017-08-30
    • EP13159810.4
    • 2013-03-18
    • C.R. Bard, Inc.
    • Benoit, Bethanie J.Kullas, Karen ElizabethShah, Devang Vijay
    • A61F2/00A61J1/10B65D81/00
    • A61F2/0095A61F2/0063A61J1/10A61J1/2096B65B55/22B65D31/147B65D75/5855B65D77/04B65D81/22
    • The present invention is a method and an apparatus for packaging lyophilized implants and other medical devices. In accordance with the invention, a lyophilized implant (101) may be packaged for delivery to the surgical site in a sealed, flexible/expandable, sterile inner pouch (100). The inner pouch may be further packaged within an outer, sterile package (103). The inner pouch contains a resealable port (105) through which rehydration liquid may be introduced into the inner pouch without opening the inner pouch. The inner pouch may be made of a flexible, substantially non-stretchable material so that the pouch can expand only to a predetermined maximum size to accept a predetermined volume of rehydration liquid. After rehydration, any excess rehydration liquid within the pouch may be removed via the same port. Next, the pouch is opened via a second opening to expose the implant for removal from the package.
    • 本发明是用于包装冻干植入物和其他医疗装置的方法和设备。 根据本发明,冻干的植入物(101)可以被包装用于在密封的柔性/可膨胀的无菌内袋(100)中递送至手术部位。 内袋可以进一步包装在外无菌包装(103)内。 内袋包含可重新密封的口(105),通过该口可以将重新水化液体引入内部袋而不打开内部袋。 内袋可以由柔性的,基本上不可拉伸的材料制成,使得袋可以仅膨胀至预定的最大尺寸以接受预定体积的再水化液体。 再水化后,袋内的任何多余的补液可以通过相同的端口去除。 接下来,通过第二开口打开袋以暴露植入物以从包装中取出。