Osteoimplant comprising an insoluble fibrous polymer

Abstract

Methods for making an osteoimplant are provided. In one embodiment the method includes applying a mechanical force to an aqueous slurry of insoluble collagen fibers to entangle the insoluble collagen fibers so as to form a semi-solid mass of entangled insoluble collagen fibers; and lyophilizing the semi-solid mass of entangled collagen fibers to form the osteoimplant. An osteoimplant containing entangled insoluble collagen fibers is also provided.

1 .- 20 . (canceled) 
     
     
         21 . An osteoimplant comprising entangled insoluble collagen fibers in an amount of from 75% to 100% by weight based on the total weight of the collagen in the osteoimplant. 
     
     
         22 . The osteoimplant of  claim 21 , wherein the entangled insoluble collagen fibers comprise crosslinked and non-crosslinked purified fibrillary collagen. 
     
     
         23 . The osteoimplant of  claim 21 , further comprising ceramic granules in an amount from about 0.1% to about 85% by weight based on the total weight of the osteoimplant. 
     
     
         24 . The osteoimplant of  claim 23 , wherein the ceramic granules comprise biphasic calcium phosphate comprising tricalcium phosphate and hydroxyapatite in a ratio from about 40:60 to about 95:5. 
     
     
         25 . The osteoimplant of  claim 23 , wherein the ceramic granules have an average particle diameter in the range from about 0.5 to about 1.6 mm. 
     
     
         26 . The osteoimplant of  claim 21 , further comprising a polysaccharide comprising starch or alginate in an amount from about 0.1% to about 12.5% by weight based on the total weight of the osteoimplant. 
     
     
         27 . The osteoimplant of  claim 21 , further comprising a hydrating agent comprising polyethylene glycol in an amount from about 0.01% to about 1.5% by weight based on the total weight of the osteoimplant. 
     
     
         28 . The osteoimplant of  claim 21 , further comprising a biologically active agent, the biologically active agent comprising a growth factor, a bone morphogenic protein, an analgesic, an anti-inflammatory, and antibiotic, a cytokine, a chemotherapeutic agent or a mixture thereof. 
     
     
         29 . The osteoimplant of  claim 21 , further comprising an osteoinductive additive comprising calcium phosphates, calcium sulfate, particulate demineralized bone matrix, naturally-derived allogenic bone mineral, naturally-derived autogenic bone mineral or mixtures thereof. 
     
     
         30 . The osteoimplant of  claim 24 , wherein the biphasic calcium phosphate is in a range from about 1% to about 85% by weight based on the total weight of the osteoimplant. 
     
     
         31 . The osteoimplant of  claim 21 , wherein the insoluble collagen fibers comprise purified fibrillary collagen in an amount from about 1% to about 40% by weight based on the total weight of the osteoimplant. 
     
     
         32 . The osteoimplant of  claim 21 , wherein the osteoimplant has a density of about 0.7 g/cc. 
     
     
         33 . The osteoimplant of  claim 21 , wherein the osteoimplant has a density of 0.70 g/cc and the osteoimplant comprises about 12.5 wt. % of starch or alginate, about 12.5 wt. % of insoluble purified fibrillary collagen, about 75 wt. % of biphasic calcium phosphate and about 1.5 wt. % PEG. 
     
     
         34 . The osteoimplant of  claim 21 , further comprising a semi-solid mass of entangled insoluble collagen fibers comprising an aqueous slurry of insoluble collagen fibers, entangled by applying a mechanical force using a grinder or a blender. 
     
     
         35 . The osteoimplant of  claim 34 , wherein the aqueous slurry of insoluble collagen fibers comprises purified fibrillary collagen. 
     
     
         36 . The osteoimplant of  claim 21 , further comprising a gel comprising the semi-solid mass of entangled collagen fibers, starch or alginate, polyethylene glycol (PEG) and deionized water. 
     
     
         37 . The osteoimplant of  claim 21 , wherein the osteoimplant is moldable. 
     
     
         38 . The osteoimplant of  claim 37 , wherein the moldable osteoimplant comprises lyophilized osteoimplant. 
     
     
         39 . The osteoimplant of  claim 36 , wherein the semi-solid mass further comprises crosslinked insoluble collagen fibers prior to lyophilization. 
     
     
         40 . The osteoimplant of  claim 38 , wherein the lyophilized osteoimplant further comprises a fluid comprising physiologically acceptable water, physiological saline, sodium chloride, dextrose, Lactated Ringer's solution, phosphate buffer solution, blood, bone marrow aspirate, bone marrow fractions or a combination thereof in an amount sufficient to render the lyophilized osteoimplant moldable.