In-situ formed intervertebral fusion device and method

• US 20040230309A1
• Filed: 02/13/2004
• Published: 11/18/2004
• Est. Priority Date: 02/14/2003
• Status: Abandoned Application

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Aquino, Lauren, Kelly, James Edward, Woodrow, Hal Brent, DiMauro, Thomas M., Serhan, Hassan, Cooper, Kevin, Bartish, Charles M. Jr., Kadiyala, Sudhakar, Slivka, Michael Andrew, Malone, John Daniel, Rohr, William L., Moore, Bradley Thomas
• Application Number:
  US10/778,684
• Publication Number:
  US 20040230309A1
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30308 : banana-shaped
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30622 : Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30953 : using a remote computer network, e.g. Internet
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0065 : telescopic
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61K 49/006 : Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 9/0024 : Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/252 : Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/256 : Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/404 : Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/43 : Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/64 : Animal cells
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/06 : Titanium or titanium alloys
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3821 : Bone-forming cells, e.g. osteoblasts, osteocytes, osteoprogenitor cells
• CPC Class Codes: A61L 27/3839 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3847 : Bones
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges

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.

Claims

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-β

1, transforming growth factors-β

2, transforming growth factors-β

3;

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:

M²⁺_(10-n)N¹⁺_2n(ZO₄^3-)₆mY^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;

ZO₄ 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.

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.

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.

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-β

1, transforming growth factors-β

2, transforming growth factors-β

3;

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:

M²⁺_(10-n)N¹⁺_2n(ZO₄^3-)₆mY^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;

ZO₄ 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.

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.

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.

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.

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.

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.