The invention provides methodologies and apparatus for producing
devitalized soft-tissue implants where the implant retains metabolically
non-viable and/or reproductively non-viable cells, and preferably retains
large molecular weight cytoplasmic proteins, such implants produced both
in small quantities and in commercializable quantities. Such soft-tissue
implants include vascular graft substitutes. An devitalized graft is
produced by subjecting the tissue sample to an induced pressure mediated
flow of an extracting solution, optionally followed by inducing a pressure
mediated flow of a salt solution, then washing the tissue to produce the
devitalized graft. The devitalized grafts produced are uniform and
non-immunogenic. The inventive method allows for the production of
multiple devitalized soft tissue implants, where processing time is
significantly less than prior art processes and the number of implants
produced per day is increased over prior art processes. In clinical use,
the devitalized grafts produced exhibit significantly improved in
long-term durability and function, and enhanced recellularization
post-implantation.
