NovaSterilis Inc., specializing in developing applications for supercritical carbon dioxide, has been granted US Patent 8,034,288 B2. The patent, dated October 11, 2011 entitled “Method and Apparatus for Cleaning of Viable Donor Soft Tissue”, covers a new method for cleaning soft allograft tissue including tendon, fascia, and skin with a supercritical fluid, thus avoiding other harmful chemical solvents that may leave residual chemicals.
The patent describes a process using carbon dioxide at temperatures > 31.1°C and a pressure of 1099 PSI. At this “critical point,” carbon dioxide achieves the “supercritical” or dense gas phase having valuable properties of both the liquid and gas states. In this state CO2 is a potent organic non-polar solvent that liquefies fats, and as a penetrating fluid SCCO2 can be utilized to extract the imbedded fats and antigenic matter, in essence deep-cleaning the material. Tissue exposed to this cleaning step is significantly cleaner throughout the entire thickness of the material than tissue cleaned with other soaps and solvents.
Removing antigenic material from allograft tissue leaves the final product free of residual donor material, for example fat, blood and cellular material, reducing the potential to induce an inflammatory or immune response. This deep cleaned tissue which is primarily collagen acts as a scaffold for cell infiltration and incorporation which may improve patient outcomes. Collagen scaffolds are playing a central role in the field of regenerative medicine and NovaSterilis is working with a few researchers in this field.
“Donor tissue is a valuable resource; it is our goal to assist tissue banks to produce the cleanest and highest quality allograft tissue. This invention is a natural progression in our exploration of supercritical CO2 and sterilization noted David Burns, President of NovaSterilis. “We are proud of this patent; it complements our tissue sterilization process and produces a tissue that is extremely clean, safe and sterile (SAL6). Feedback from processors, distributors and surgeons place tissue processed with our SCCO2 technology among the best!”