US20040230309A1 — In-situ formed intervertebral fusion device and m…

Claim 1

Independent Claim 21 words

1 . An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon; and a hardenable material within said balloon.

Claim 2

Dependent Claim 21 words

1 . An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon; and a hardenable material within said balloon.

Claim 3

Dependent Claim 28 words

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.

Claim 4

Dependent Claim 38 words

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.

Claim 5

Dependent Claim 26 words

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.

Claim 6

Dependent Claim 31 words

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.

Claim 7

Dependent Claim 18 words

6 . The device of claim 1 wherein the balloon further includes metalic wires thereby providing imageable means.

Claim 8

Dependent Claim 18 words

7 . The device of claim 1 wherein at least one said balloon defines a plurality of lumena.

Claim 9

Dependent Claim 34 words

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.

Claim 10

Dependent Claim 44 words

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.

Claim 11

Dependent Claim 15 words

10 . The device of claim 1 wherein the balloon defines at least one opening.

Claim 12

Dependent Claim 23 words

11 . The device of claim 1 wherein at least one of said upper and lower areas include at least one outward projection.

Claim 13

Dependent Claim 15 words

12 . The device of claim 11 wherein the outward projection includes polyetherether ketone (PEEK).

Claim 14

Dependent Claim 99 words

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.

Claim 15

Dependent Claim 14 words

14 . The device of claim 1 wherein the balloon contains a load-bearing component.

Claim 16

Dependent Claim 14 words

15 . The device of claim 14 wherein the load-bearing material is a strut.

Claim 17

Dependent Claim 28 words

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.

Claim 18

Dependent Claim 26 words

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.

Claim 19

Dependent Claim 44 words

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.

Claim 20

Dependent Claim 16 words

19 . The device of claim 14 wherein the load-bearing component further includes an osteobiologic component.

Claim 21

Dependent Claim 34 words

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.

Claim 22

Dependent Claim 23 words

21 . The device of claim 20 wherein said polymer is selected from the group consisting of a linear anhydride and a fumarate.

Claim 23

Dependent Claim 13 words

22 . The device of claim 14 wherein the load-bearing component is resorbable.

Claim 24

Dependent Claim 60 words

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.

Claim 25

Dependent Claim 19 words

24 . The device of claim 23 wherein said polymer is polycaprolactone and said calcium phosphate compound is hydroxyapatite.

Claim 26

Dependent Claim 36 words

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.

Claim 27

Dependent Claim 13 words

26 . The device of claim 19 wherein the osteobiologic component is resorbable.

Claim 28

Dependent Claim 47 words

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.

Claim 29

Dependent Claim 39 words

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.

Claim 30

Dependent Claim 51 words

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.

Claim 31

Dependent Claim 55 words

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.

Claim 32

Dependent Claim 24 words

31 . The device of claim 30 wherein the mesencymal cells are mammalian mesenchymal stems cells encapsulated in polylysine and polyethyleneimine cross-linked alginate membranes.

Claim 33

Dependent Claim 29 words

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.

Claim 34

Dependent Claim 152 words

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.

Claim 35

Dependent Claim 72 words

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.

Claim 36

Dependent Claim 50 words

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.

Claim 37

Dependent Claim 39 words

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.

Claim 38

Dependent Claim 27 words

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.

Claim 39

Dependent Claim 37 words

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.

Claim 40

Dependent Claim 40 words

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.

Claim 41

Dependent Claim 23 words

40 . The device of claim 39 wherein said balloon has a footprint that describes an arc of at least about 200 degrees.

Claim 42

Dependent Claim 17 words

41 . The device of claim 39 wherein said open cavity is filled with a load-bearing material.

Claim 43

Dependent Claim 21 words

42 . The device of claim 41 wherein the load-bearing material that fills said open cavity further includes an osteobiologic component.

Claim 44

Dependent Claim 52 words

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.

Claim 45

Dependent Claim 52 words

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.

Claim 46

Dependent Claim 23 words

44 . The device of claim 43 wherein said device has a footprint that substantially corresponds to a perimeter of a vertebral endplate.

Claim 47

Dependent Claim 15 words

45 . The device of claim 43 wherein the load-bering component includes an osteobiologic component.

Claim 48

Dependent Claim 50 words

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.

Claim 49

Dependent Claim 30 words

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.

Claim 50

Dependent Claim 96 words

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.

Claim 51

Dependent Claim 96 words

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.

Claim 52

Dependent Claim 14 words

49 . The device of claim 48 wherein the anterior frame is partially rigid.

Claim 53

Dependent Claim 39 words

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.

Claim 54

Dependent Claim 35 words

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.

Claim 55

Dependent Claim 37 words

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.

Claim 56

Dependent Claim 26 words

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.

Claim 57

Dependent Claim 28 words

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.

Claim 58

Dependent Claim 37 words

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.

Claim 59

Dependent Claim 63 words

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.

Claim 60

Dependent Claim 63 words

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.

Claim 61

Dependent Claim 97 words

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.

Claim 62

Dependent Claim 97 words

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.

Claim 63

Dependent Claim 43 words

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.

Claim 64

Dependent Claim 15 words

59 . The method of claim 57 wherein the load-bearing material includes an osteobiologic component.

Claim 65

Dependent Claim 25 words

60 . The method of claim 57 wherein the balloon upon inflation has a footprint that substantially corresponds to a perimeter of a vertebral endplate.

Claim 66

Dependent Claim 15 words

61 . The method of claim 59 wherein the load-bearing component includes a hardenable material.

Claim 67

Dependent Claim 67 words

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.

Claim 68

Dependent Claim 41 words

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.

Claim 69

Dependent Claim 60 words

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.

Claim 70

Dependent Claim 15 words

65 . The method of claim 62 wherein the balloon defines a plurality of lumena.

Claim 71

Dependent Claim 49 words

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.

Claim 72

Dependent Claim 41 words

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.

Claim 73

Dependent Claim 33 words

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).

Claim 74

Dependent Claim 106 words

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.

Claim 75

Dependent Claim 47 words

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.

Claim 76

Dependent Claim 57 words

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.

Claim 77

Dependent Claim 33 words

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.

Claim 78

Dependent Claim 34 words

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.

Claim 79

Dependent Claim 152 words

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.

Claim 80

Dependent Claim 70 words

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.

Claim 81

Dependent Claim 53 words

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.

Claim 82

Dependent Claim 44 words

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.

Claim 83

Dependent Claim 47 words

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.

Claim 84

Dependent Claim 22 words

79 . The method of claim 78 wherein the load-bearing material is directed into the open cavity defined by the expanded device.

Claim 85

Dependent Claim 15 words

80 . The method of claim 78 wherein the load-bearing material includes an osteobiologic material.

Claim 86

Dependent Claim 70 words

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.

Claim 87

Dependent Claim 70 words

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.

Claim 88

Dependent Claim 52 words

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.

Claim 89

Dependent Claim 61 words

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.

Claim 90

Dependent Claim 46 words

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.

Claim 91

Dependent Claim 88 words

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.

Claim 92

Dependent Claim 15 words

86 . The method of claim 81 wherein the load-bearing material includes a hardenable material.

Claim 93

Dependent Claim 45 words

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.

Claim 94

Dependent Claim 54 words

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.

Claim 95

Dependent Claim 20 words

89 . The method of claim 81 further including the step of directing a load-bearing material into the open cavity.

Claim 96

Dependent Claim 14 words

90 . The method of claim 89 wherein load-bearing material includes an osteobiologic component.

Claim 97

Dependent Claim 15 words

91 . The method of claim 89 wherein the load-bearing material includes a hardenable material.

Claim 98

Dependent Claim 32 words

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.

Claim 99

Dependent Claim 38 words

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.

Claim 100

Dependent Claim 129 words

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;

Claim 101

Dependent Claim 129 words

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;

Claim 102

Dependent Claim 65 words

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.

Claim 103

Dependent Claim 39 words

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.

Claim 104

Dependent Claim 39 words

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.

Claim 105

Dependent Claim 48 words

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.

Claim 106

Dependent Claim 48 words

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.

Claim 107

Dependent Claim 54 words

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.

Claim 108

Dependent Claim 54 words

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.

Claim 109

Dependent Claim 34 words

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.

Claim 110

Dependent Claim 34 words

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.

Claim 111

Dependent Claim 98 words

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.

Claim 112

Dependent Claim 98 words

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.

Claim 113

Dependent Claim 40 words

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.

Claim 114

Dependent Claim 40 words

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.

Claim 115

Dependent Claim 74 words

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.

Claim 116

Dependent Claim 74 words

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.

Claim 117

Dependent Claim 69 words

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.

Claim 118

Dependent Claim 69 words

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.

Claim 119

Dependent Claim 50 words

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.

Claim 120

Dependent Claim 50 words

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.

In-situ formed intervertebral fusion device and method

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