BONE FIBER COMPOSITIONS

• US 20140212471A1
• Filed: 01/28/2013
• Published: 07/31/2014
• Est. Priority Date: 01/28/2013
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Drapeau, Susan J., Wei, Guobao
• Granted Patent: US 10,071,120 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder

Abstract

An osteoinductive implantable composition comprising a mixture of demineralized bone fibers and mineralized bone fibers is provided. The mixture is visible under X ray and remodels more easily than comparable mixtures of demineralized bone matrix and surface demineralized cortical bone chips. The osteoinductive implantable compositions comprises demineralized bone fibers in an amount from about 30 vol % to about 45 vol % and mineralized bone fibers in an amount from about 55 vol % to about 70 vol %. The osteoinductive implantable compositions can be delivered in delivery systems including mesh coverings for administration at surgical sites. A method of treating a bone defect caused by injury, disease, wounds, or surgery utilizing the osteoinductive implantable composition comprising a mixture of demineralized bone fibers and mineralized bone fibers is also provided.

Claims

1. An osteoinductive composition implantable into a mammal, the composition comprising a mixture of demineralized bone fibers and mineralized bone fibers.

2. An osteinductive composition according to claim 1, wherein the mixture is visible under X ray and remodels easily.

3. An osteinductive composition according to claim 1, wherein the mixture further comprises autograft bone.

4. An osteinductive composition according to claim 1, wherein the mixture comprises demineralized bone fibers in an amount from about 30 vol % to about 45 vol % and mineralized bone fibers in an amount from about 55 vol % to about 70 vol %.

5. An osteinductive composition according to claim 1, wherein after implantation at a surgical site for about 28 days the mixture exhibited an osteoinductivity of about 3.2.

6. An osteoinductive composition according to claim 1, wherein the demineralized bone fibers are comprised in a demineralized bone matrix.

7. An osteinductive composition according to claim 1, wherein the bone fiber has an average length from about 0.5 cm to about 9 cm.

8. An osteinductive composition according to claim 1, wherein the bone fiber has an average length from about 2.1 cm to about 9 cm.

9. An osteinductive composition according to claim 1, wherein the aspect ratio of the elongated demineralized bone fiber is from about 50:

1 to about 1000;

1, from about 50;

1 to about 950;

1, from about 50;

1 to about 750;

1, from about 50;

1 to about 500;

1, from about 50;

1 to about 250;

1, from about 50;

1 to about 100;

1, from about 10;

1 to about 50;

1, or from about 5;

1 to about 10;

1.

10. An osteinductive composition according to claim 1, further comprising an additive selected from collagen, collagen derivatives, antiviricides, antimicrobials, antibiotics, biocidal sugars, amino acids, peptides, vitamins, inorganic elements, co-factors for protein synthesis, hormones, endocrine tissue, endocrine tissue fragments, enzymes, polymer cell scaffolds with parenchymal cells, angiogenic drugs, collagen lattices, antigenic agents, cytoskeletal agents, cartilage fragments, living cells, natural extracts, tissue transplants, demineralized bone powder, autogenous tissues, bioadhesives, bone morphogenic proteins (BMPs), angiogenic factors, transforming growth factor (TGF-beta), insulin-like growth factor (IGF-1), growth hormones, bone digestors, antitumor agents, immuno-suppressants, permeation enhancers, enamine derivatives, nucleic acids or combinations thereof.

11. An osteinductive composition according to claim 1, further comprising at least one additive selected from stem cells, autograft bone marrow aspirate, autograft bone, preparations of selected autograft cells, autograft cells containing genes encoding bone promoting action, autograft cells expanded outside the body and returned or combinations thereof.

12. An osteoinductive composition according to claim 1, further comprising adhesives, fillers, plasticizers, flexibilizing agents, biostatic/biocidal agents, surface active agents, binding and bonding agents.

13. An osteoinductive composition according to claim 1, further comprising a carrier, the carrier comprising collagen;

synthetic hydroxyapatites;

polymers;

hydrogels;

starches;

polyethylene glycol, tricalcium phosphate, sintered hydroxyapatite, settable hydroxyapatite;

polylactic acid;

tyrosine polycarbonate;

calcium sulfate;

collagen sheets;

settable calcium phosphate;

polymeric cements;

settable poly vinyl alcohols, polyurethanes;

resorbable polymers;

polysaccharides and other large polymers;

or liquid settable polymers.

14. An osteoinductive composition according to claim 1, formed into a configuration comprising a sheet, plate, disk, tunnel, cone, or tube.

20. A method of treating a bone defect caused by injury, disease, wounds, or surgery comprising administering surgically at the bone defect site to a patient in need thereof an effective amount of an osteoinductive implantable composition according to claim 1.

15. A delivery system comprising a covering having at least one compartment, the covering comprising an osteoinductive implantable composition comprising a mixture of demineralized fibers and mineralized fibers in a ratio from about 1:

1.2 to about 1;

2.3.

16. A delivery system according to claim 15, wherein the osteoinductive implantable composition comprises demineralized bone fibers in an amount from about 30 vol % to about 45 vol % and mineralized bone fibers in an amount from about 55 vol % to about 70 vol %.

17. A delivery system according to claim 15, wherein the bone fiber has an average length from about 0.5 cm to about 9 cm.

18. A delivery system according to claim 15, wherein the demineralized bone fibers are contained in a demineralized bone matrix.

19. A delivery system according to claim 15, wherein the covering comprises a mesh.