Calfee, Halter & Griswold LLP
Processing of implantable animal tissues for dry storage
A method that allows for dry storage of bioprosthetic devices comprising a tissue component is provided. The method comprises the steps of providing a device comprising a chemically cross-linked animal tissue component; treating the tissue component with an aqueous solution comprising a biocompatible, water soluble, organic molecule comprising a plurality of carbon atoms and a plurality of hydroxyl groups for a time sufficient to allow equilibration between the fluids in the interstices of the tissue component and the aqueous solution; and then sterilizing the treated tissue component using a sterilizing gas or ionizing radiation. The present invention also relates to an implantable tissue component that can be stored dry. The tissue component is chemically-fixed and comprises within the interstices thereof a dimensional stabilizer selected from the group consisting of a polyhydric alcohol and derivatives thereof, a water soluble carbohydrate, and a water soluble gum. The tissue component is disposed within the chamber of a package, the chamber being defined by one or more members formed from a material that is resistant to penetration by micro-organisms, particularly bacteria and fungi. The chamber and tissue component are sterile and essentially free of an aldehyde solution. Except for the liquids contained within the tissue component, the chamber is also essentially free of liquid.
The Cleveland Clinic Foundation
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Kent Ji-Feng
Wika Chen