In-situ formed intervertebral fusion device and method

Abstract

An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon and a hardenable material within said balloon. In some embodimnents, the balloon has a footprint that substantially corresponds to a perimeter of a vertebral endplate. An inflatable device is inserted through a cannula into an intervertebral space and oriented so that, upon expansion, a natural angle between vertebrae will be at least partially restored. At least one component selected from the group consisting of a load-bearing component and an osteobiologic component is directed into the inflatable device through a fluid communication means.

What is claimed is:  
     
         1 . An orthopedic device for implanting between adjacent vertebrae comprising: 
 an arcuate balloon; and    a hardenable material within said balloon.    
     
     
         2 . The device of  claim 1  wherein said device has a footprint that substantially corresponds to at least a portion of the perimeter of a vertebral endplate.  
     
     
         3 . The device of  claim 1  wherein the balloon has an upper area, a lower area, an anterior area and a posterior area, and whereupon filling the balloon, said anterior area is unequal to said posterior area.  
     
     
         4 . The device of  claim 3  wherein said upper and lower areas each have a footprint substantially corresponding to a rim of a vertebral endplate.  
     
     
         5 . The device of  claim 1  wherein the balloon is cylindrical and further wherein said device has a footprint that substantially corresponds to a central portion of a vertebral endplate.  
     
     
         6 . The device of  claim 1  wherein the balloon further includes metalic wires thereby providing imageable means.  
     
     
         7 . The device of  claim 1  wherein at least one said balloon defines a plurality of lumena.  
     
     
         8 . The device of  claim 1  wherein at least one said balloon comprises a resorbable, semi-permeable material selected from the group consisting of porous and non-porous films, fabrics (woven and non-woven) and foams.  
     
     
         9 . The device of  claim 1  wherein at least one said balloon includes a material selected from the group consisting of a polyolefin copolymers, polyethylene, polycarbonate, polyethylene terephthalate, an ether-ketone polymer, a woven fiber, a nonwoven fibers, a fabric and a metal mesh.  
     
     
         10 . The device of  claim 1  wherein the balloon defines at least one opening.  
     
     
         11 . The device of  claim 1  wherein at least one of said upper and lower areas include at least one outward projection.  
     
     
         12 . The device of  claim 11  wherein the outward projection includes polyetherether ketone (PEEK).  
     
     
         13 . The device of  claim 11  wherein the upper area includes at least one material selected from the group consisting of polyether block copolymer (PEBAX), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene (ANS), delrin acetal; polyvinyl chloride (PVC), polyethylene napthalate (PEN), polybutylene terephthalate (PBT), polycarbonate, polyetherimide (PEI), polyether sulfone (PES), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyamide, aromatic polyamide, polyether, polyester, polymethylmethacrylate, polyurethane copolymer, ethylene vinyl acetate (EVA), ethylene vinyl alcohol, polyethylene, latex rubber, FEP, TFE, PFA, polypropylene, polyolefin, polysiloxane, liquid crystal polymer, ionomer, poly(ethylene-co-methacrylic) acid, silicone rubber, styrene acrylonitrile (SAN), nylon, polyether block amide and thermoplastic elastomer.  
     
     
         14 . The device of  claim 1  wherein the balloon contains a load-bearing component.  
     
     
         15 . The device of  claim 14  wherein the load-bearing material is a strut.  
     
     
         16 . The device of  claim 14  wherein the load-bearing component further includes at least one compound selected from the group consisting of antibacterial agents and antifungal agents.  
     
     
         17 . The device of  claim 14  wherein the load-bearing component further includes at least one antibody that has affinity for connective tissue progenitor stem cells.  
     
     
         18 . The device of  claim 14  wherein the load-bearing component further includes at least one member of the group consisting of vitamins, hormones, glycoproteins, fibronectin, peptides, proteins, carbohydrates, proteoglycans, antiangiogenic agents, oligonucleotides, bone morphogenetic proteins, demineralized bone matrix, antibodies and genetically altered cells.  
     
     
         19 . The device of  claim 14  wherein the load-bearing component further includes an osteobiologic component.  
     
     
         20 . The device of  claim 19  wherein the load-bearing component includes: 
 a) a polymer flowable at between about 40° C. and 80° C.;  
 b) mesenchymal stem cells; and  
 c) a bone morphogenetic protein.  
 
     
     
         21 . The device of  claim 20  wherein said polymer is selected from the group consisting of a linear anhydride and a fumarate.  
     
     
         22 . The device of  claim 14  wherein the load-bearing component is resorbable.  
     
     
         23 . The device of  claim 22  wherein the load-bearing component includes 
 a) a polymer that flows at a temperature of between about 40° C. and about 80° C. and is present in an amount of between 50% and 70% by volume; and  
 b) calcium phosphate compound present in an amount of between about 10% and about 30% by volume.  
 
     
     
         24 . The device of  claim 23  wherein said polymer is polycaprolactone and said calcium phosphate compound is hydroxyapatite.  
     
     
         25 . The device of  claim 14  wherein the sum total of load-bearing capacity of the resorbable load-bering material and a new bone growth is at least sufficient to support a spinal load between the vertebrae.  
     
     
         26 . The device of  claim 19  wherein the osteobiologic component is resorbable.  
     
     
         27 . The device of  claim 19  wherein the load-bearing component comprises at least one compound selected from the group consisting of poly(lactic acid), poly(glycolic acid), p-dioxanone fibers, polyarylethyl, polymethylmethacrylate, polyurethane, amino-acid-derived polycarbonate, polycaprolactone, aliphatic polyesters, calcium phosphate, unsaturated linear polyesters, vinyl pyrrolidone and polypropylene fumarate diacrylate.  
     
     
         28 . The device of  claim 27  wherein the load-bearing component comprises two cross-linkable polymer, and wherein, upon exposure to at least one cross-linking agent, each of the cross-linkable polymer cross-links with itself, thereby resulting in an interpenetrating network.  
     
     
         29 . The device of  claim 27  wherein the load-bearing component comprises a first cross-linkable polymer and a second cross-linkable polymer, and wherein, upon exposure to at least one cross-linking agent, the first cross-linkable polymer cross-links with itself, while the second cross-linkeable polymer remains unaffected, thereby resulting in a semi-interpenetrating network.  
     
     
         30 . The device of  claim 19  wherein the osteobiologic component includes at least one member selected from the group consisting of mesenchymal stem cells, growth factors, cancellous bone chips, hydroxyapatite, tri-calcium phosphate, polylactic acid, polyglycolic acid, polygalactic acid, polycaprolactone, polyethylene oxide, polypropylene oxide, polysulfone, polyethylene, polypropylene, hyaluronic acid, bioglass, gelatin, collagen and polymeric fibers.  
     
     
         31 . The device of  claim 30  wherein the mesencymal cells are mammalian mesenchymal stems cells encapsulated in polylysine and polyethyleneimine cross-linked alginate membranes.  
     
     
         32 . The device of  claim 19  wherein the osteobiologic material includes at least one member selected from the group consisting of an osteoinductive component and an osteoconductive component.  
     
     
         33 . The device of  claim 32  wherein the osteoinductive component includes at least one compound selected from the group consisting of fibroblast growth factor-1, fibroblast growth factor-2, fibroblast growth factor-4, platellet derived growth factor-AB, platellet derived growth factor-BB, platellet derived growth factor-AA, epithelial growth factors, insulin-like growth factor-I, insulin-like growth factor-II, osteogenic protein-1, transforming growth factors-β, transforming growth factors-β1, transforming growth factors-β2, transforming growth factors-β3; osteoid-inducing factor (OIF), angiogenin, endothelin, hepatocyte growth factor, keratinocyte growth factor, osteogenin, bone morphogenetic proteins-2; bone morphogenetic proteins-2A, bone morphogenetic proteins-2B, bone morphogenetic proteins-7; heparin-binding growth factors-1, heparin-binding growth factors-2, an isoform of platelet-derived growth factors, an isoform of fibroblast growth factors, an isoform of epithelial growth factors, an isoform of insulin-like growth factors, an isoform of bone morphogenic proteins, an isoform of growth differentiation factors, Indian hedgehog, sonic hedgehog, desert hedgehog, interleukin-1, interleukin-2, interleukin-3, interleukin-4, interleukin-5, interleukin-6, colony-stimulating factor-1, granulocyte-colony-stimulating factor and granulocyte-macrophage colony-stimulating factor.  
     
     
         34 . The device of  claim 32  wherein osteoconductive component includes a compound having the formula:  
       M 2+   (10-n) N 1+   2n (ZO 4   3- ) 6   m Y x    
       where 
 n=1-10, and m=2 when x=1, and/or m=1 when x=2;  
 M and N are alkali or alkaline earth metals;  
 ZO 4  is an acid radical, where Z is phosphorus, arsenic, vanadium, sulfur or silicon; and  
 Y is a halide, hydroxide, or carbonate.  
 
     
     
         35 . The device of  claim 32  wherein the osteoconductive component includes at least one material selected from the group consisting of mono-calcium phosphate, di-calcium phosphate, octa-calcium phosphate, alpha-tri-calcium phosphate, beta-tri-calcium phosphate, or tetra-calcium phosphate, hydroxyapatite, fluorapatite, calcium sulfate, calcium fluoride, calcium oxide, silicon dioxide, sodium oxide, and phosphorus pentoxide.  
     
     
         36 . The device of  claim 19  wherein at least one of the load-bearing or the osteobiologic components further includes at least one water-soluble material selected from the group consisting of gelatin, a salt, a polysaccharides and a protein.  
     
     
         37 . The device of  claim 36  wherein, upon dissolution of the water-soluble material, at least one of the load-bearing or osteobiologic components forms a porous matrix.  
     
     
         38 . The device of  claim 37  wherein, upon delivering additional osteobiologic component into the porous matrix, said additional osteobiologic material including osteoprogenitor cells, said cells adhere to inner surfaces of the pores of the porous matrix.  
     
     
         39 . The device of  claim 1  wherein, upon at least partially filling the balloon, at least a portion of the device has a generally toroidal shape thereby defining an open cavity having an axial dimension and a radial dimension.  
     
     
         40 . The device of  claim 39  wherein said balloon has a footprint that describes an arc of at least about 200 degrees.  
     
     
         41 . The device of  claim 39  wherein said open cavity is filled with a load-bearing material.  
     
     
         42 . The device of  claim 41  wherein the load-bearing material that fills said open cavity further includes an osteobiologic component.  
     
     
         43 . An intervertebral spinal fusion device comprising at least one arcuate inflatable balloon whereby at least partially filling the balloon between two adjacent vertebrae at least partially restores a natural angle between the adjacent vertebrae, and wherein said asymetric balloon contains a load-bearing component within a lumen defined by the balloon.  
     
     
         44 . The device of  claim 43  wherein said device has a footprint that substantially corresponds to a perimeter of a vertebral endplate.  
     
     
         45 . The device of  claim 43  wherein the load-bering component includes an osteobiologic component.  
     
     
         46 . The device of  claim 45  wherein the load-bearing component includes at least one compound selected from the group consisting of poly(lactic acid), poly(glycolic acid), p-dioxanone fibers, polyarylethyl, polymethylmethacrylate, polyurethane, amino-acid-derived polycarbonate, polycaprolactone, aliphatic polyesters, calcium phosphate, unsaturated linear polyesters, vinyl pyrrolidone and polypropylene fumarate diacrylate or mixtures thereof.  
     
     
         47 . The device of  claim 46  wherein, the balloon has an inner surface that is chemically active, whereby the load-bearing component chemically bonds to the balloon while it polymerizes.  
     
     
         48 . An intervertebral spinal fusion device comprising: 
 a) an anterior frame having an upper inflatable rim and a lower inflatable rim, said anterior frame being detachably connected to a first fluid communication means; and    b) a rigid inflatable posterior frame attached to the upper and lower inflatable rims of the anterior frame, said posterior frame being detachably connected to a second fluid communication means,    wherein, upon at least partially filling the upper and lower inflatable rims and the posterior frame between two adjacent vertebrae, a natural angle between said vertebrae is at least partially restored.    
     
     
         49 . The device of  claim 48  wherein the anterior frame is partially rigid.  
     
     
         50 . The device of  claim 48  wherein, upon filling the upper and the lower inflatable rims and the posterior frame, the distance between the upper and the lower inflatable rims is different from the height the posterior frame.  
     
     
         51 . The device of  claim 49  wherein, upon at least partially filling the upper and the lower inflatable rims, said rims each have a footprint substantially corresponding to a rim of a vertebral endplate.  
     
     
         52 . The device of  claim 51  wherein, upon at least partially filling the upper and the lower inflatable rims and the posterior frame, the device defines an open cavity having an axial and a radial dimension.  
     
     
         53 . The device of  claim 48  further comprising at least one mesh element connected to the upper and the lower rims of the anterior portion.  
     
     
         54 . The device of  claim 48  wherein at least one of the upper and the lower rims of the anterior portion includes at least one outward projection.  
     
     
         55 . The device of  claim 48  wherein the posterior portion further includes at least one telescopically inflatable supporting element, each said supporting element being connected to the upper and the lower rims of the posterior portion.  
     
     
         56 . A method of implanting an intervertebral spinal fusion device, comprising the steps of: 
 a) performing a discectomy while preserving an outer annular shell;    b) inserting an inflatable device that includes a deflated arcuate balloon into an intervertebral space;    c) directing a hardenable material into the deflated arcuate balloon in an amount sufficient to inflate the balloon and distract the disc space.    
     
     
         57 . A method of implanting an intervertebral spinal fusion device, comprising the steps of: 
 a) inserting an inflatable device through a cannula into an intervertebral space, said inflatable device including an arcuate balloon connected to at least one fluid communication means, wherein said inflatable device upon expansion between two adjacent vertebrae at least partially restores a natural angle between the adjacent vertebrae;    b) orienting said inflatable device so that upon expansion a natural angle between vertebrae will be at least partially restored;    c) directing a load-bearing component into the inflatable device through the fluid communication means.    
     
     
         58 . The method of  claim 57  wherein the load-bearing material is resorbable and wherein the sum total of load-bearing capacity of the resorbable load-bering material and a new bone growth is at least sufficient to support a spinal load between the vertebrae.  
     
     
         59 . The method of  claim 57  wherein the load-bearing material includes an osteobiologic component.  
     
     
         60 . The method of  claim 57  wherein the balloon upon inflation has a footprint that substantially corresponds to a perimeter of a vertebral endplate.  
     
     
         61 . The method of  claim 59  wherein the load-bearing component includes a hardenable material.  
     
     
         62 . The method of  claim 59  wherein said inflatable device includes at least one inflatable balloon, said device defining an upper area, a lower area, an anterior area and a posterior area, and whereupon filling of the balloon said anterior area is unequal to said posterior area and said upper and lower areas each has a footprint substantially corresponding to a rim of a vertebral endplate.  
     
     
         63 . The method of  claim 62  wherein the anterior area of the device is oriented to face an anterior aspect of a vertebra and the posterior area of the device is oriented to face a posterior aspect of the vertebra.  
     
     
         64 . The method of  claim 62  wherein the load-bearing component is directed into the balloon by directing said component through the fluid communication means, thereby causing the balloon to expand and directing the upper area and the lower area of the balloon against the respective vertebral endplates, thereby at least partially restoring a natural angle between the adjacent vertebrae.  
     
     
         65 . The method of  claim 62  wherein the balloon defines a plurality of lumena.  
     
     
         66 . The method of  claim 62  wherein the balloon includes a resorbable material selected from the group consisting of the group consisting of poly(lactic acid), poly(glycolic acid), p-dioxanone fiber, polyarylethyl, polymethylmethacrylate, polyurethane, amino-acid-derived polycarbonate, polycaprolactone, aliphatic polyester, calcium phosphate, unsaturated linear polyester, vinyl pyrrolidone and polypropylene fumarate diacrylate.  
     
     
         67 . The method of  claim 62  wherein at least one balloon includes at least one material selected from the group consisting a of polyolefin copolymer, polyethylene, polycarbonate, polyethylene terephthalate, an ether-ketone polymer, woven fiber, non-woven fiber, fabric and metal mesh.  
     
     
         68 . The method of  claim 62  wherein at least one of said upper and lower areas has a plurality of outward projections and further wherein said outward projections include polyetherether ketone (PEEK).  
     
     
         69 . The method of  claim 62  wherein the upper area is made from at least one material selected from the group consisting of polyether block copolymer (PEBAX), ABS (acrylonitrile butadiene styrene), ANS (acrylonitrile styrene), delrin acetal; PVC (polyvinyl chloride), PEN (polyethylene napthalate), PBT (polybutylene terephthalate), polycarbonate, PEI (polyetherimide), PES (polyether sulfone), PET (polyethylene terephthalate), PETG (polyethylene terephthalate glycol), polyamide, aromatic polyamide, polyether, polyester, polymethylmethacrylate, polyurethane copolymer, ethylene vinyl acetate (EVA), ethylene vinyl alcohol, polyethylene, latex rubber, fluorinated ethylene polymer (FEP), polytetrafluoroethylene (PTFE), perfluoro-alkoxyalkane (PFA), polypropylene, polyolefin, polysiloxane, liquid crystal polymer, ionomer, poly(ethylene-co-methacrylic) acid, silicone rubber, SAN (styrene acrylonitrile), nylon, polyether block amide and thermoplastic elastomers.  
     
     
         70 . The method of  claim 62  wherein the load-bearing component includes at least one compound selected from the group consisting of poly(lactic acid), poly(glycolic acid), p-dioxanone fibers, polyarylethyl, polymethylmethacrylate, polyurethane, amino-acid-derived polycarbonate, polycaprolactone, aliphatic polyester, calcium phosphate, unsaturated linear polyesters, vinyl pyrrolidone and polypropylene fumarate diacrylate.  
     
     
         71 . The method of  claim 62  wherein the osteobiologic component includes at least one member selected from the group consisting of mesenchymal stem cells, a growth factor, cancellous bone chips, hydroxyapatite, tri-calcium phosphate, polylactic acid, polyglycolic acid, polygalactic acid, polycaprolactone, polyethylene oxide, polypropylene oxide, polysulfone, polyethylene, polypropylene, hyaluronic acid, bioglass, gelatin, collagen and a polymeric fiber.  
     
     
         72 . The method of  claim 62  wherein the osteobiologic component further includes a at least one water-soluble material selected from the group consisting of gelatin, a salt, a polysaccharides and a protein.  
     
     
         73 . The method of  claim 45  further including the step of directing an aqueous fluid into into the load-bearing material thereby dissolving at least one said water-soluble material, thereby forming a porous matrix.  
     
     
         74 . The method of  claim 62  wherein the osteoinductive component includes at least one compound selected from the group consisting of fibroblast growth factor-1, fibroblast growth factor-2, fibroblast growth factor-4, platellet derived growth factor-AB, platellet derived growth factor-BB, platellet derived growth factor-AA, epithelial growth factors, insulin-like growth factor-I, insulin-like growth factor-II, osteogenic protein-1, transforming growth factors-β, transforming growth factors-β1, transforming growth factors-β2, transforming growth factors-β3; osteoid-inducing factor (OIF), angiogenin, endothelin, hepatocyte growth factor, keratinocyte growth factor, osteogenin, bone morphogenetic proteins-2; bone morphogenetic proteins-2A, bone morphogenetic proteins-2B, bone morphogenetic proteins-7; heparin-binding growth factors-1, heparin-binding growth factors-2, an isoform of platelet-derived growth factors, an isoform of fibroblast growth factors, an isoform of epithelial growth factors, an isoform of insulin-like growth factors, an isoform of bone morphogenic proteins, an isoform of growth differentiation factors, Indian hedgehog, sonic hedgehog, desert hedgehog, interleukin-1, interleukin-2, interleukin-3, interleukin-4, interleukin-5, interleukin-6, colony-stimulating factor-1, granulocyte-colony-stimulating factor and granulocyte-macrophage colony-stimulating factor.  
     
     
         75 . The method of  claim 62  wherein the osteobiologic component has the formula:  
       M 2+   (10-n) N 1+   2n (ZO 4   3- ) 6   m Y x    
       where 
 n=1-10, and m=2 when x=1, and/or m=1 when x=2;  
 M and N are alkali or alkaline earth metals;  
 ZO 4  is an acid radical, where Z is phosphorus, arsenic, vanadium, sulfur or silicon; and  
 Y is a halide, hydroxide, or carbonate.  
 
     
     
         76 . The method of  claim 62  wherein the osteobiologic component includes at least one material selected from the group consisting of mono-calcium phosphate, di-calcium phosphate, octa-calcium phosphate, alpha-tri-calcium phosphate, beta-tri-calcium phosphate, or tetra-calcium phosphate, hydroxyapatite, fluorapatite, calcium sulfate, calcium fluoride, calcium oxide, silicon dioxide, sodium oxide, and phosphorus pentoxide, or mixtures thereof.  
     
     
         77 . The method of  claim 57  wherein at least a portion of the device upon expansion has a substantially toroidal shape thereby forming an open cavity defined by an outer surface of the toroidal shape having an axial dimension and a radial dimension.  
     
     
         78 . The method of  claim 62  wherein at least a portion of the device is oriented so that the axial dimension of the open cavity is substantially parallel to a major axis of a spinal column of a patient in which the device has been implanted.  
     
     
         79 . The method of  claim 78  wherein the load-bearing material is directed into the open cavity defined by the expanded device.  
     
     
         80 . The method of  claim 78  wherein the load-bearing material includes an osteobiologic material.  
     
     
         81 . A method of at least partially restoring a natural angle between two adjacent vertebrae, comprising the steps of: 
 a) inserting an inflatable device through a cannula into an intervertebral space;    b) orienting said inflatable device so that upon expansion of the device a natural angle between vertebrae will be at least partially restored; and    c) expanding said inflatable device by directing a load-bearing component into said inflatable device.    
     
     
         82 . The method of  claim 80  wherein said inflatable device includes at least one arcuate inflatable balloon and a fluid communication means attached to at least one balloon and wherein at least one ballon upon expansion between two adjacent vertebrae at least partially restores a natural angle between two adjacent vertebrae.  
     
     
         83 . The method of  claim 81  wherein wherein said inflatable balloon, said device defining an upper area, a lower area, an anterior area and a posterior area, and whereupon filling the balloon said anterior area is unequal to said posterior area and said upper and lower areas each have a footprint substantially corresponding to a rim of a vertebral endplate.  
     
     
         84 . The method of  claim 83  wherein the step of orienting said inflatable device includes orienting the anterior area of the device to face the anterior aspect of a vertebra and the posterior area of the device to face the posterior aspect of a vertebrae.  
     
     
         85 . The method of  claim 83  wherein the step of inflating said inflatable device includes introducing at least one of a load-bearing component and an osteobiologic component into said device by directing at least one component through the fluid communication means, thereby causing the lower area and the upper area of the device to engage the respective endplates and the anterior area of the device to be greater than the posterior area of the device, thereby at least partially restoring a natural angle between the adjacent vertebrae.  
     
     
         86 . The method of  claim 81  wherein the load-bearing material includes a hardenable material.  
     
     
         87 . The method of  claim 82  wherein at least a portion of the device upon expansion has a substantially toroidal shape thereby forming an open cavity defined by an outer surface of the toroidal shape and having an axial dimension and a radial dimension.  
     
     
         88 . The method of  claim 87  wherein the step of orienting said inflatable device includes orienting at least a portion of the device so that the axial dimension of the open cavity is substantially parallel to a major axis of a spinal column of a patient in which the device has been implanted.  
     
     
         89 . The method of  claim 81  further including the step of directing a load-bearing material into the open cavity.  
     
     
         90 . The method of  claim 89  wherein load-bearing material includes an osteobiologic component.  
     
     
         91 . The method of  claim 89  wherein the load-bearing material includes a hardenable material.  
     
     
         92 . The method of  claim 91  wherein the osteobiologic material further includes at least one water-soluble material selected from the group consisting of gelatin, a salt, a polysaccharide and a protein.  
     
     
         93 . The method of  claim 92  further including the step of directing an aqueous fluid into the open cavity defined by the inflated device thereby dissolving at least one said water-soluble material and forming a porous matrix.  
     
     
         94 . A method of delivering an osteobiologic material comprising: 
 a) inserting an inflatable device into an intervertebral space wherein at least a portion of the device upon expansion has a substantially toroidal shape thereby forming an open cavity defined by an outer surface of the toroidal shape and having an axial dimension and a radial dimension;    b) orienting at least a portion of the device so that so that the axial dimension of the open cavity is substantially parallel to a major axis of a spinal column of a patient in which the device has been implanted;    c) inflating said inflatable device by directing a load-bearing component into said inflatable device;    d) directing an osteobiologic material into the open cavity, said material including at least one water-soluble material;    
     
     
         95 . The method of  claim 94  further including the steps of: 
 e) directing an aqueous fluid into into the open cavity defined by the inflated device thereby dissolving at least one said water-soluble material, and forming a porous matrix; and  
 f) delivering additional osteobiologic component into the porous matrix in the amount sufficient to fill at least 90% of the porous matrix by volume.  
 
     
     
         96 . An intervertebral fusion device comprising an in-situ formed osteobiologic component comprising: 
 a) a matrix having an internal surface defining an open porosity suitable for bone growth therethrough, and    b) an osteogenic component located within the open porosity.    
     
     
         97 . An intervertebral fusion device for providing bony fusion across a disc space, comprising: 
 a) an in-situ formed strut having a upper surface for bearing against the upper endplate and a lower surface for bearing against the lower endplate, and    b) an in-situ formed osteobiologic porous matrix.    
     
     
         98 . An intervertebral fusion device for providing bony fusion across a disc space, comprising an in-situ formed strut comprising: 
 a) an upper surface for bearing against the upper endplate,    b) a lower surface for bearing against the lower endplate, and    c) an injectable load bearing composition disposed between the upper and lower surfaces.    
     
     
         99 . An intervertebral fusion device comprising a matrix having an internal surface defining an open porosity suitable for bone growth therethrough, wherein the matrix is formed by a plurality of in-situ bonded beads.  
     
     
         100 . An intervertebral fusion device comprising a strut comprising: 
 a) a first component comprising: 
 i) a lower bearing surface adapted for bearing against a lower vertebral endplate, and,  
 ii) an upper surface comprising a leading end, an angled middle portion and a trailing end; and  
   b) a second component comprising: 
 i) an upper bearing surface adapted for bearing against an upper vertebral endplate, and,  
 ii) an upper surface comprising a leading end, an angled middle portion and a trailing end,  
 wherein the angled portion of the first component mates with the angled portion of the second component.  
   
     
     
         101 . A kit for providing interbody fusion across an intervertebral disc space, comprising: 
 a) a cannula defining an inner diameter;    b) a hardenable material capable of supporting intervertebral load;    c) a flowable osteobiologic composition; and    d) an arcuate balloon.    
     
     
         102 . An intervertebral fusion device for providing bony fusion across a disc space, comprising: 
 a) an in-situ formed strut having an upper surface for bearing against an upper endplate and a lower surface for bearing against a lower endplate, the upper surface and lower surface defining a height there between, and    b) an in-situ formed osteobiologic component,    wherein the height of the strut is no greater than the height of the disc space.    
     
     
         103 . A method of providing interbody fusion across an intervertebral disc space, comprising the steps of: 
 a) providing a cannula defining an inner diameter;    b) moving a load bearing composition through the cannula and into the disc space to form a in-situ formed load bearing arcuate strut; and    c) moving an osteobiologic composition through the cannula and into the disc space to form an in-situ formed osteobiologic composition.    
     
     
         104 . An intervertebral fusion device for providing bony fusion across a disc space, comprising an arcuate strut comprising: 
 a) an upper surface for bearing against the upper endplate,    b) a lower surface for bearing against the lower endplate, and    wherein the strut comprises an in-situ formed load bearing composition.