Method and apparatus for rehydration of lyophilized biologic materials

摘要

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 may be packaged for delivery to the surgical site in a sealed, flexible/expandable, sterile inner pouch. The inner pouch may be further packaged within an outer, sterile package. The inner pouch contains a resealable port 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.

主权项

1. An apparatus for hydrating a lyophilized medical implement comprising:
a lyophilized medical implement, the lyophilized medical implement intended to be properly hydrated with a certain volume of rehydration liquid; a sealed container constructed of a flexible and substantially non-stretchable material, the sealed container comprising an expandable structure having a first state and a second state; and a resealable port on the sealed container for receiving rehydration liquid therethrough into the sealed container; wherein: in the first state, the sealed container has a first internal volume; in the second state, the sealed container has a second internal volume that is a maximum internal volume of the sealed container, the sealed container being configured to have the maximum internal volume being predetermined to correspond to a combined volume of the lyophilized medical implement and the certain volume of rehydration liquid; and the lyophilized medical implement is contained within the sealed container; whereby, the sealed container facilitates proper hydration of the lyophilized medical implement by providing predetermined maximum internal volume that structural limits receipt of rehydration liquid to no more than the certain volume of rehydration liquid for properly hydrating the lyophilized medical implement.