Bone graft materials and methods of use

Patent metadata

Field	Value
Publication number	US-9623153-B2
Application number	US-201414494353-A
Country	US
Kind code	B2
Filing date	Sep 23, 2014
Priority date	Sep 23, 2014
Publication date	Apr 18, 2017
Grant date	Apr 18, 2017

Abstract

Osteoinductive and osteoconductive compositions for bone graft which utilize less allograft tissue, and methods for their production, are provided. The compositions and methods contain a combination of fibers of demineralized bone matrix from allograft bone and fibers of non-allograft bone material. The fibers of non-allograft bone material comprise non-fibrous demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material. The non-allograft fibers of the composition contain a bone void filler of collagen and one or more ceramics embedded with demineralized bone matrix particles. In some embodiments, the composition also contains a bioactive agent.

First claim

What is claimed is:

1. An implantable composition comprising a combination of fibers of demineralized bone matrix obtained from allograft bone, and fibers of non-allograft bone material, the fibers of non-allograft bone material comprising non-fibrous demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material, wherein the fibers of the non-allograft bone material comprise a bioerodible polymer comprising porous collagen particles having a mean diameter of 50 microns to 500 microns, and one or more ceramics.

2. An implantable composition according to claim 1 , wherein the bioerodible polymer further comprises, hyaluronic acid, chitosan, keratin, chitin, cellulose, glycosaminoglycans and derivatives thereof, either alone or in combination.

3. An implantable composition according to claim 1 , wherein the one or more ceramic is a calcium phosphate ceramic and a silicon ceramic.

4. An implantable composition according to claim 3 , wherein the calcium phosphate ceramic is tricalcium phosphate.

5. An implantable composition according to claim 1 , wherein the ratio of fibers of demineralized bone matrix from allograft material to fibers of non-allograft material ranges from about 20:80 to about 70:30.

6. An implantable composition according to claim 5 , wherein the ratio of fibers of demineralized bone matrix from allograft material to fibers of non-allograft material ranges from about 40:60 to about 60:40.

7. An implantable composition according to claim 1 , wherein the demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material comprise from about 10 percent to about 50 percent of the composition by weight.

8. An implantable composition according to claim 1 , wherein the collagen comprises from about 5 percent to about 30 percent by weight of the composition.

9. An implantable composition according to claim 1 , wherein the ceramics comprise tricalcium phosphate ceramic and silicon ceramic, and demineralized bone matrix particles are embedded within or disposed on the fibers of non-allograft bone material.

10. An implantable composition according to claim 1 , further comprising a bioactive agent.

11. An implantable composition according to claim 1 , further comprising a covering.

12. A method for making an implantable composition according to claim 1 , comprising: combining allograft and non-allograft bone material fibers, wherein the non-allograft bone material is prepared by mixing a bioerodible polymer and a ceramic powder to form a slurry; drying the slurry to form a sheet or block; obtaining fibers by shaving, milling or pressing the sheet or block; embedding within or disposing on the fibers non-fibrous demineralized bone matrix particles; preparing non-fibrous demineralized bone matrix particles from the preparation of allograft fibers; combining non-allograft fibers with fibers of demineralized bone matrix from allograft bone to form a second slurry; the second slurry is then dried to form a sheet or block; fibers are obtained by shaving, milling or pressing the sheet or block; and shaping the fibers into a matrix using a binding agent which interlocks the fibers.

13. The method for making an implantable composition according to claim 12 , further comprising adding a bioactive agent.

14. The method for making an implantable composition according to claim 12 , wherein a binding agent is added to the fibers forming a matrix.

15. A method of generating or regenerating bone in a patient in need thereof, comprising implanting said patient with the implantable composition of claim 1 .

16. A kit for an implantable composition, the kit comprising: a combination of fibers of demineralized bone matrix from allograft bone; fibers of non-allograft bone material, the fibers of non-allograft bone material comprising non-fibrous demineralized bone matrix particles embedded within or disposed on the fibers of non-allograft bone material, the fibers of non-allograft bone material further comprising porous ceramics with pores ranging from 300-1000 μm and porous collagen particles having a mean diameter of 50 microns to 500 microns; and instructions for preparation.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Mckay William F

Classifications

• A61L27/10

  Ceramics or glasses · CPC title

• A61L27/3608

  Bone, e.g. demineralised bone matrix [DBM], bone powder · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61L27/46

  with phosphorus-containing inorganic fillers · CPC title

• A61L27/56 Primary

  Porous materials, {e.g. foams or sponges} · CPC title