Bone matrix compositions and methods for their preparation and use

Abstract

The present disclosure provides novel bone matrix (BM) materials, and methods for preparation and use of the demineralized bone matrix materials and compositions therefrom. The methods of preparation include the use of a closed-vessel demineralization system, as well as simple, easily reproducible process steps, and significantly shortened times for demineralization. These novel BM materials do not require the inclusion of carriers and/or delivery agents, or the addition of binders, and can be made in various forms, including a clay, putty, crush, powder, or gel. The novel BM compositions and methods disclosed herein may, illustratively, have applications in the medical field, such as in surgical bone graft applications, in the repair and/or regeneration of bone and bone-related tissue, and the like.

What is claimed is: 
     
         1 . An additive-free bone matrix composition comprising:
 bone powder;   brushite; and   monetite;   wherein the bone powder, brushite, and monetite are derived from bone;   wherein application of shear force to the additive-free bone matrix composition yields a self-binding putty;   wherein the self-binding putty exhibits sufficient wet-field integrity to be non-sticky and to resist degradation during lavage; and   wherein the self-binding putty exhibits decreasing viscosity with increased application of shear force.   
     
     
         2 . The additive-free bone matrix composition of  claim 1 , wherein the ratio of brushite to monetite present is from about 2.2 to about 0.25. 
     
     
         3 . The additive-free bone matrix composition of  claim 1  wherein the additive-free bone matrix composition contains less than 8 volume percent calcium. 
     
     
         4 . The additive-free bone matrix composition of  claim 1  wherein the bone powder is demineralized. 
     
     
         5 . The additive-free bone matrix composition of  claim 1  wherein the particle size ranges from 200 microns to 800 microns. 
     
     
         6 . The additive-free bone matrix composition of  claim 1 , wherein the composition further includes a physiologic compilation of bioavailable growth factors. 
     
     
         7 . The additive-free bone matrix composition of  claim 6 , wherein the physiologic compilation of bioavailable growth factors includes bone morphogenic proteins. 
     
     
         8 . The additive-free bone matrix composition of  claim 7 , wherein the bone morphogenic proteins are selected from the group comprising BMP-2, BMP-4, BMP-7, VEGF, and combinations thereof. 
     
     
         9 . A bone matrix composition, comprising:
 an organic phase;   a mineral phase, comprising:
 16-50% by weight monetite; 
 16-80% by weight brushite; 
 hydroxyapatite; 
   wherein the mineral phase comprises 46-74% by weight of the bone matrix.   
     
     
         10 . The bone matrix composition of  claim 9 , wherein the composition further includes bone morphogenic proteins. 
     
     
         11 . The bone matrix composition of  claim 10 , wherein the bone morphogenic proteins are selected from the group comprising BMP-2, BMP-4, BMP-7, VEGF, and combinations thereof. 
     
     
         12 . The bone matrix composition of  claim 9 , wherein the composition is a powder until sufficient shear stress is applied. 
     
     
         13 . The bone matrix composition of  claim 12 , wherein the composition is a putty after sufficient shear stress is applied. 
     
     
         14 . The bone matrix composition of  claim 9  wherein the particle size ranges from 200 microns to 800 microns. 
     
     
         15 . A human bone matrix composition, comprising:
 demineralized bone matrix containing both monetite and brushite;   wherein said composition maintains osteoinductive, osteoconductive, and osteogenic properties;   wherein said composition exhibits wet field integreity including self-binding;   wherein said composition is free of binders and carriers.   
     
     
         16 . The human bone bone matrix composition of  claim 15 , wherein the composition further includes a physiologic compilation of bioavailable growth factors. 
     
     
         17 . The human bone bone matrix composition of  claim 16 , wherein the physiologic compilation of bioavailable growth factors includes bone morphogenic proteins. 
     
     
         18 . The human bone bone matrix composition of  claim 17 , wherein the bone morphogenic proteins are selected from the group comprising BMP-2, BMP-4, BMP-7, VEGF, and combinations thereof.