Method of demineralizing bone

摘要

The invention is directed to an apparatus for producing demineralized osteoinductive bone. The apparatus demineralizes bone by subjecting bone, including, for example, ground bone, bone cubes, chips, strips, or essentially intact bone, to either a rapid high volume pulsatile acidification wave process or to a rapid continuous acid demineralization process. The pulsatile acidification wave process includes subjecting bone to two or more rapid pulse/drain cycles in which one or more demineralizing acids is rapidly pulsed into a vessel containing bone, and after a desired period of time, is rapidly drained from the vessel. The continuous acid demineralization process includes subjecting bone to a continuous exchange of demineralizing acid solution in which the demineralizing acid solution is recirculated from the container holding the bone through an ion exchange media. Calcium and phosphate are thereby removed from the bone to produce a regenerated acid, and the regenerated acid is returned to the container holding the bone. Both processes allow bone to be rapidly demineralized to a precise and specific desired residual calcium level without sacrificing osteoinductivity.

主权项

1. A method of demineralizing bone comprising:
obtaining a bone, determining an initial calcium concentration of the bone prior to demineralizing, demineralizing the bone in an eluent acid solution in a closed reaction container, preparing a standard correlation between pH values of the eluent acid solution and residual calcium levels of the bone based on the initial calcium concentration of the bone, determining a stopping point during the demineralization by measuring a pH value of the eluent acid solution and determining a calcium concentration based on the pH value and the standard correlation, and stopping the demineralization of the bone sample.