Abstract: The sterilization of biological material of animal or human origin, which is to be used as an implant or transplant, is performed according to a validated sterilization method with a margin of safety of 106 germs by which harmful microorganisms are physically separated and chemically sterilized in four successive steps, initially in an antibiotic, then in deoxicholic acid, then in a surface-active substance and finally in primary alcohol, respectively accompanied by rinsing steps involving an aqueous solution after steps two to four. A bioprosthesis sterilized with a margin of safety>106 germs can be implanted without any further treatment, does not have a tendency towards calcification, and ensures a long service life.
Type:
Grant
Filed:
September 8, 2005
Date of Patent:
October 21, 2008
Assignee:
AutoTissue GmbH
Inventors:
Marita Stein-Konertz, Wilhelm Erdbrügger