Methods for the in situ formation of a bioprosthetic device, particularly vertebral disc bioprosthetics

A method for the formation of a bioprosthetic vertebral disc nucleus comprising:

• (a) providing a vertebral disc having a fibrillar outer annulus which surrounds and defines an interior cavity formed by removal of at least a substantial portion of a gelatinous core therefrom;
• (b) filling the cavity defined by the fibrillar outer annulus with a flowable proteinaceous biopolymeric material which includes a first reactable component consisting of a human or animal derived protein material, and a second reactable component consisting of a di- or polyaldehyde material, and
• (c) allowing the first and second reactable components to cross-link so that the proteinaceous biopolymeric material at least partly solidifies in situ within the cavity and intercalates and chemically binds to the surrounding biological tissue of the cavity thereby forming the bioprosthetic vertebral disc nucleus, the vertebral disc having the bioprosthetic vertebral disc nucleus therein exhibiting flexibility comparable to a biologically natural vertebral disc.

A method for the formation of a bioprosthetic vertebral disc nucleus comprising:

• (a) providing a vertebral disc having a fibrillar outer annulus which surrounds and defines an interior cavity formed by removal of at least a substantial portion of a gelatinous core therefrom;
• (b) filling the cavity defined by the fibrillar outer annulus with a flowable proteinaceous biopolymeric material which includes a first reactable component consisting of a human or animal derived protein material, and a second reactable component consisting of a di- or polyaldehyde material, and
• (c) allowing the first and second reactable components to cross-link so that the proteinaceous biopolymeric material at least partly solidifies in situ within the cavity and intercalates and chemically binds to the surrounding biological tissue of the cavity thereby forming the bioprosthetic vertebral disc nucleus, the cross-linked proteinaceous biopolymeric material being capable of withstanding compression for 100 and 1000 cycles at a compression rate of 100 mm/min between a minimum stress of 200 kPa and a maximum stress of 800 kPa without exhibiting fracture, permanent deformation, and loss of hydration.