US20040097612A1 — Cohesive demineralized bone compositions

Claim 1

Independent Claim 63 words

1 . A demineralized bone matrix composition comprising: fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4; and a biocompatible liquid in an amount to produce a coherent, formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 2

Dependent Claim 63 words

1 . A demineralized bone matrix composition comprising: fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4; and a biocompatible liquid in an amount to produce a coherent, formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 3

Dependent Claim 29 words

2 . The composition of claim 1 , wherein the demineralized bone matrix fibers have an average thickness in the range from about 50 μm to about 250 μm.

Claim 4

Dependent Claim 17 words

3 . The composition of claim 1 , wherein the aspect ratio is greater than about 10.

Claim 5

Dependent Claim 22 words

4 . The composition of claim 1 , wherein the aspect ratio is in a range from about 10 to about 50.

Claim 6

Dependent Claim 27 words

5 . The composition of claim 1 , wherein the demineralized bone matrix fibers have an average width to average thickness ratio of less than about 5.

Claim 7

Dependent Claim 33 words

6 . The composition of claim 1 , wherein the biocompatible liquid is selected from the group consisting of water, saline, buffer solution, serum, bone marrow aspirant, blood, platelet-rich plasma, and mixtures thereof.

Claim 8

Dependent Claim 24 words

7 . The composition of claim 1 , further comprising particles of demineralized bone matrix having an aspect ratio of less than about 3.

Claim 9

Dependent Claim 16 words

8 . The composition of claim 1 , wherein the composition further comprises an osteoinductive additive.

Claim 10

Dependent Claim 40 words

9 . The composition of claim 8 , wherein the osteoinductive additive is selected from the group consisting of bone marrow aspirant, blood, blood products, synthetic and naturally-derived bone morphogenic proteins, growth factors, particulate demineralized bone matrix, and mixtures thereof.

Claim 11

Dependent Claim 16 words

10 . The composition of claim 1 , wherein the composition further comprises an osteoconductive additive.

Claim 12

Dependent Claim 38 words

11 . The composition of claim 10 , wherein the osteoconductive additive is selected from the group consisting of calcium phosphates, collagen, collagen-derivatives, calcium sulfate, particulate demineralized bone matrix, naturally-derived allogenic bone mineral, and naturally-derived autogenic bone mineral.

Claim 13

Dependent Claim 23 words

12 . The composition of claim 1 , wherein the composition further comprises an additive that modifies the handling characteristics of the composition.

Claim 14

Dependent Claim 19 words

13 . The composition of claim 12 , wherein the additive at least partially coats the demineralized bone fibers.

Claim 15

Dependent Claim 46 words

14 . The composition of claim 12 , wherein the additive is selected from the group consisting of gelatin, carboxymethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, hydroxyethyl cellulose, cellulose derivatives, alginate, hyaluronic acid, sodium salts, polyvinyl pyrrolidones, polyvinyl alcohol, arabic gum, guar gum, xantham gum, chitosans, and poloxamers.

Claim 16

Dependent Claim 28 words

15 . The composition of claim 1 , wherein the relative amounts of demineralized bone matrix fibers and biocompatible liquid range from about 1:10 to about 10:1 wt/wt.

Claim 17

Dependent Claim 28 words

16 . The composition of claim 1 , wherein the relative amounts of demineralized bone matrix fibers and biocompatible liquid range from about 1:4 to about 4:1 wt/wt.

Claim 18

Dependent Claim 24 words

17 . The composition of claim 1 , wherein the relative amount of demineralized bone matrix fibers and biocompatible liquid is about 1:1 wt/wt.

Claim 19

Dependent Claim 37 words

18 . The composition of claim 1 , wherein the demineralized bone matrix fibers are obtained from cortical autogenic, cortical allogenic, cortical xenogeneic, cancellous autogenic, cancellous allogenic, cancellous xenogeneic, corticocancellous autogenic, corticocancellous allogenic, or corticocancellous xenogeneic bone.

Claim 20

Dependent Claim 23 words

19 . The composition of claim 1 , wherein the composition has a consistency such that it is injectable through an 18-gauge needle.

Claim 21

Dependent Claim 89 words

20 . A demineralized bone matrix composition comprising: (a) a dry component comprising fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, wherein said demineralized bone matrix fibers are present in an amount greater than 40 wt % of said dry component, and (b) a biocompatible liquid in an amount to produce a coherent formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 22

Dependent Claim 89 words

20 . A demineralized bone matrix composition comprising: (a) a dry component comprising fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, wherein said demineralized bone matrix fibers are present in an amount greater than 40 wt % of said dry component, and (b) a biocompatible liquid in an amount to produce a coherent formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 23

Dependent Claim 29 words

21 . The composition of claim 20 , wherein the demineralized bone matrix fibers have an average thickness in the range from about 50 m to about 250 μm.

Claim 24

Dependent Claim 22 words

22 . The composition of claim 20 , wherein the demineralized bone matrix fibers have an aspect ratio greater than about 10.

Claim 25

Dependent Claim 27 words

23 . The composition of claim 20 , wherein the demineralized bone matrix fibers have an average width to average thickness ratio of less than about 5.

Claim 26

Dependent Claim 32 words

24 . The composition of claim 20 , further comprising an additive selected from the group consisting of osteoconductive additives, osteoinductive additives, and additives that modify the handling characteristics of the composition.

Claim 27

Dependent Claim 50 words

25 . A demineralized bone matrix fiber composition, comprising: a collection of fibers of demineralized bone matrix of which at least about 25 wt % have an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4.

Claim 28

Dependent Claim 50 words

25 . A demineralized bone matrix fiber composition, comprising: a collection of fibers of demineralized bone matrix of which at least about 25 wt % have an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4.

Claim 29

Dependent Claim 46 words

26 . The composition of claim 25 , wherein at least about 50 wt % of the demineralized bone matrix fibers have an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4.

Claim 30

Dependent Claim 46 words

27 . The composition of claim 25 , wherein at least about 75 wt % of the demineralized bone matrix fibers have an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4.

Claim 31

Dependent Claim 29 words

28 . The composition of claim 25 , wherein the demineralized bone matrix fibers have an average thickness in the range from about 50 μm to about 250 μm.

Claim 32

Dependent Claim 27 words

29 . The composition of claim 25 , wherein the demineralized bone matrix fibers have an average width to average thickness ratio of less than about 5.

Claim 33

Dependent Claim 32 words

30 . The composition of claim 25 , further comprising an additive selected from the group consisting of osteoinductive additives, osteoconductive additives, and additives that modify the handling characteristics of the composition.

Claim 34

Dependent Claim 77 words

31 . A preformed demineralized bone matrix article having a predetermined shape, said article comprising: fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4; and a biocompatible liquid in an amount to produce a coherent, formable mass, wherein said coherent mass is formed into said predetermined shape and retains its cohesiveness when immersed in a liquid.

Claim 35

Dependent Claim 77 words

31 . A preformed demineralized bone matrix article having a predetermined shape, said article comprising: fibers of demineralized bone matrix having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4; and a biocompatible liquid in an amount to produce a coherent, formable mass, wherein said coherent mass is formed into said predetermined shape and retains its cohesiveness when immersed in a liquid.

Claim 36

Dependent Claim 25 words

32 . The article of claim 31 , wherein said article has a density in the range of about 0.3 g/cc to about 0.7 g/cc.

Claim 37

Dependent Claim 20 words

33 . The article of claim 31 , wherein said article has a compression strength greater than about 10 MPa.

Claim 38

Dependent Claim 68 words

34 . A method for making a demineralized bone matrix composition, comprising: combining fibers of demineralized bone matrix, having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, and an amount of a biocompatible liquid to produce a coherent, formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 39

Dependent Claim 68 words

34 . A method for making a demineralized bone matrix composition, comprising: combining fibers of demineralized bone matrix, having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, and an amount of a biocompatible liquid to produce a coherent, formable mass, wherein said formable mass retains its cohesiveness when immersed in a liquid.

Claim 40

Dependent Claim 64 words

35 . A method for making a demineralized bone matrix fiber comprising: shaving a bone to obtain bone shavings such that the osteons are aligned within the plane of the bone shavings; and fragmenting the bone shavings along the direction of the osteons to obtain needle-like bone fragments; and before, during or after fragmentation, demineralizing the bone to obtain a demineralized bone matrix fiber.

Claim 41

Dependent Claim 64 words

35 . A method for making a demineralized bone matrix fiber comprising: shaving a bone to obtain bone shavings such that the osteons are aligned within the plane of the bone shavings; and fragmenting the bone shavings along the direction of the osteons to obtain needle-like bone fragments; and before, during or after fragmentation, demineralizing the bone to obtain a demineralized bone matrix fiber.

Claim 42

Dependent Claim 38 words

36 . The method of claim 35 , wherein the bone is selected from the group consisting of cortical autogenic, cortical allogenic, cortical xenogeneic, cancellous autogenic, cancellous allogenic, cancellous xenogeneic, corticocancellous autogenic, corticocancellous allogenic, and corticocancellous xenogeneic bone.

Claim 43

Dependent Claim 77 words

37 . A method of making a preformed demineralized bone matrix article having a predetermined shape comprising: combining fibers of demineralized bone matrix, having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, and an amount of a biocompatible liquid to produce a coherent, formable mass; forming the mass into a preformed article having the predetermined shape; and drying the preformed article.

Claim 44

Dependent Claim 77 words

37 . A method of making a preformed demineralized bone matrix article having a predetermined shape comprising: combining fibers of demineralized bone matrix, having an average fiber length in the range from about 250 μm to about 2 mm and an aspect ratio of greater than about 4, and an amount of a biocompatible liquid to produce a coherent, formable mass; forming the mass into a preformed article having the predetermined shape; and drying the preformed article.

Claim 45

Dependent Claim 14 words

38 . The method of claim 37 , wherein the preformed article is lyophilized.

Claim 46

Dependent Claim 19 words

39 . The method of claim 38 , wherein the preformed article has a density of about 0.3 g/cc.

Claim 47

Dependent Claim 15 words

40 . The method of claim 37 , wherein the preformed article is oven dried.

Claim 48

Dependent Claim 19 words

41 . The method of claim 40 , wherein the preformed article has a density of about 0.7 g/cc.

Cohesive demineralized bone compositions

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