Bone matrix composition and methods for making and using same

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Matrices

Reexamination Certificate

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C424S423000, C424S422000, C424S549000

Reexamination Certificate

active

06340477

ABSTRACT:

FIELD OF THE INVENTION
The invention is directed to a composition for use in the repair and healing of osseous tissue. The composition contains particulate bone including allogenic, autogenic, or xenogenic bone; cancellous, corticocancellous, and/or cortical bone; and one or more semi-synthetic polymers including for example one or more cellulosics. The composition may also optionally contain one or more pharmaceutically active agents. The composition can be formulated as a gel, putty, paste, cake, or solid.
BACKGROUND OF THE INVENTION
The use of bone material derived from demineralized allogenic or xenogenic bone in surgical repair of bone defects, is known. Bone material contains substances for example, bone morphogenic protein, which induce bone regeneration at a defect site. U.S. Pat. Nos. 5,405,390; 5,314,476; 5,284,655; 5,510,396; 4,394,370; and 4,472,840, disclose compositions containing demineralized bone powder. These prior art compositions are problematic in that they are difficult to handle during surgery or implantation; and wash away during lavage (i.e. does not remain at the implant site). The inventive composition exhibits excellent properties, does not wash away during surgical lavage; and can be formulated as a gel, a putty, paste, or solid, depending on the characteristics desired for the particular application.
SUMMARY OF THE INVENTION
The invention is directed to a bone matrix composition, including bone and one or more semi-synthetic polymers.
The invention is directed to a bone matrix composition where the one or more semi-synthetic polymers include one or more water soluble semi-synthetic polymers.
The invention is yet further directed to a bone matrix composition where the bone is allogenic bone, autogenic bone, or xenogenic bone.
The invention is directed to a bone matrix composition where the one or more semi-synthetic polymers are non-liquid.
The invention is also directed to a bone matrix composition where the composition is in the form of a gel, a putty, a paste, a cake, or a solid.
The invention is directed to a bone matrix composition, including one or more of the following: ground demineralized bone, ground mineralized bone, and ground partially mineralized bone, and one or more semi-synthetic polymers.
The invention is further directed to a bone matrix composition, including one or more of the following: ground demineralized bone, ground mineralized bone, and ground partially mineralized bone, with the bone present in an amount of from 10 wt % to about 85 wt %, preferably from about 20 wt % to about 75 wt %, and more preferably from about 30 wt % to about 70 wt %, and most preferably, from about 35 wt % to about 70 wt %, and including one or more semi-synthetic polymers.
The invention is also directed to a bone matrix composition where the composition is a gel, and the gel includes from about 15 wt % ground demineralized bone to about less than 60 wt % ground demineralized bone.
The invention is also directed to a bone matrix composition where the composition is a putty, and the putty includes from about 30 wt % ground demineralized bone to about 80 wt % ground demineralized bone.
The invention is further directed to a bone matrix composition, including ground, demineralized, xenograft bone and one or more semi-synthetic polymers.
The invention is directed to a bone matrix composition where the composition is a gel, which includes ground demineralized bone present in an amount of from 15 wt % to about less than 60 wt % and one or more cellulosics.
The invention is also directed to a bone matrix composition including one or more plasticizers.
The invention is also directed to a reconstructed bone graft including a bone matrix composition containing demineralized and/or partially demineralized bone and one or more semi-synthetic polymers, which composition has been remineralized.
The invention is directed to a bone matrix composition where the bone is demineralized and/or mineralized and/or partially demineralized cancellous bone.
The invention is directed to a bone matrix composition where the bone is demineralized and/or mineralized and/or partially demineralized, cancellous bone and/or cortical bone and/or corticocancellous bone.
The invention is also directed to a composition including demineralized cortical bone and one or more semi-synthetic polymers, in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is further directed to a bone matrix composition where the cellulosic and/or semi-synthetic polymer, are non-liquid.
The invention is further directed to a composition including demineralized cancellous bone and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including mineralized cancellous bone and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including mineralized cortical bone and one or more semi-synthetic polymers in a putty, a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including surface demineralized cortical bone and one or more semi-synthetic polymers, in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including demineralized cancellous bone and cortical bone (mineralized and/or demineralized and/or partially demineralized and/or surface demineralized) and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is also directed to a composition including partially demineralized cortical bone and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is further directed to a composition including partially demineralized cancellous bone and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including partially demineralized cortical bone and partially demineralized cancellous bone and one or more semi-synthetic polymers in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is directed to a composition including partially demineralized cortical and/or cancellous bone; and mineralized and/or demineralized, cortical and/or cancellous bone; and one or more semi-synthetic polymers; in a gel, a putty, a paste, a cake, or a solid formulation.
The invention is further directed to a method for making a bone matrix composition including the steps of mixing bone with one or more dry semi-synthetic polymers to form a dry mixture; and adding water to the dry mixture to form a gelled composition.
The invention is further directed to a method for making a solid composition including the steps of mixing bone with one or more non-liquid semi-synthetic polymers to form a dry mixture; adding water to the dry mixture to form a gelled composition; and removing moisture from the gelled composition, for example using freeze-drying and/or subjecting the gelled composition to negative pressure or positive pressure, to form a solid composition.
The invention is also directed to a method for making a solid composition including the step of subjecting the gelled composition to positive pressure or negative pressure.
The invention is also directed to a method for making a solid composition where moisture is removed from the gelled composition by freeze drying the gelled composition.
The invention is also directed to a method for making a bone matrix composition, where the composition is produced under sterile conditions.
The invention is directed to a method for making a bone matrix composition, including sterilizing the composition produced using radiation.
The invention is directed to a bone matrix composition where one or more water soluble semi-synthetic polymers include one or more cellulosics.
The invention is further directed to a bone matrix composition where the one or more cellulosics include one or more of the following: carboxy met

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