Bone Graft Material Containment Structures

• US 20100215718A1
• Filed: 02/25/2010
• Published: 08/26/2010
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Orthovita Inc. (Stryker Corporation)
• Original Assignee: Porex Surgical Incorporated (Stryker Corporation)
• Inventors: Swords, Greg Alan, Spagnoli, Daniel Bruce
• Granted Patent: US 9,433,707 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30724 Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
• 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 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 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30915 made of a stack of bonded perforated sheets, grids or wire meshes
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61L 2300/414 Growth factors
• 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 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• 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
• CPC Class Codes: C08L 23/06 : Polyethene

Abstract

The present invention provides biocompatible, non-resorbable porous containment structures for containment of bone graft material at a desired location for stimulation of bone growth. The porous containment structures have interconnected pores sized to allow fibrovascular integration with surrounding tissue and conduction of vascular tissue through the structure into the bone graft material.

Claims

1. A method of facilitating growth of bone at a desired location comprising:

obtaining a biocompatible, non-resorbable porous material comprising a porous matrix of interconnected pores;

shaping the porous material into a shaped porous material for placement into the desired location;

placing a bone graft material inside the shaped porous material;

stably fixing the shaped porous material containing the bone graft material to structures adjacent to the desired location; and

,

permitting bone to grow in the desired location.

2. The method of claim 1, wherein after fixing the shaped porous material containing the bone graft material to structures adjacent to the desired location, soft tissues are closed over the shaped porous material.

3. The method of claim 1, further comprising permitting blood vessels to infiltrate into the shaped porous material.

4. The method of claim 1, wherein the porous material is a polymer and the polymer is polyethylene, ultra high molecular weight polyethylene, high density polyethylene, polypropylene or PEEK.

5. The method of claim 1, wherein the porous material is sintered.

6. The method of claim 1, wherein the porous material is a metal and the metal is titanium, tantalum or surgical grade stainless steel.

7. The method of claim 1, wherein the porous material is formed by sintering particles of polymer or metal into the desired shape.

8. The method of claim 1, wherein the porous material further comprises a metal mesh, a metal wire, or multiple layers of metal mesh or metal wire sintered together.

9. The method of claim 1, wherein the bone graft material is bone, a synthetic material, a growth factor, a cell, or a combination thereof.

10. The method of claim 9, wherein the bone is autologous bone, autologous bone particulate, allogenic bone, human cadaver bone, xenograft bone, animal bone, or bone chips.

11. The method of claim 9, wherein the synthetic material is hydroxyapatite, calcium phosphate, ceramics, bioactive glass, calcium sulfate, or a polymer-based bone graft substitute.

12. The method of claim 9, wherein the growth factor is bone morphogenic protein (BMP), a BMP mimetic, recombinant human (rhBMP-2), platelet-rich plasma (PRP), transforming growth factor-beta (TGF-beta), platelet-derived growth factor (PDGF), recombinant human platelet derived growth factor (rhPDGF), insulin-like growth factor, fibroblast growth factor, a xenographic bone protein, a growth differentiation factor, calcitonin, or a calcitonin mimetic.

13. The method of claim 9, wherein the cell is a stem cell, a bone marrow cell, a mesenchymal stem cell, or a combination thereof.

14. The method of claim 1, wherein the porous matrix contains pores of average diameter of 40 to about 1000 microns, about 100 to about 800 microns, about 100 to about 500 microns, about 50 to about 500 microns, about 60 to about 400 microns, about 200 to about 400 microns, or about 100 to about 200 microns.

15. The method of claim 1, wherein the porous material has a pore volume from about 20% to about 60%, or from about 40% to about 50%.

16. The method of claim 1, wherein the porous material is a sintered thermoplastic material.

17. The method of claim 1, wherein the porous material has a thickness of from about 0.1 to about 2.0 mm, about 0.1 to about 1.0 mm, about 0.1 to about 0.9 mm, about 0.1 to about 0.8 mm, about 0.2 to about 0.4 mm, about 0.2 to about 0.3 mm, or about 0.25 mm.

18. The method of claim 1, wherein the desired location is in the mandible or the maxilla.

19. The method of claim 1, wherein the desired location is in the alveolar ridge.

20. The method of claim 1, wherein the desired location is in a bone of the appendicular skeleton.

21. The method of claim 1, wherein the pores are omnidirectional.

22. The method of claim 1, wherein the pores are multidimensional.

23. The method of claim 1, wherein the porous material is sintered polyethylene, the pores are in the range of about 40 to about 1000 microns in average diameter, the pore volume is about 20% to about 60%, and the porous material is about 0.1 to about 3.0 mm in thickness.

24. A composition comprising:

a biocompatible, non-resorbable porous material comprising a porous matrix of interconnected pores; and

,

a bone graft material, wherein the porous material is shaped into a shaped porous material and contains the bone graft material.

25. The composition of claim 24, wherein the porous material comprises a sintered thermoplastic material or a sintered metal and the bone graft material comprises bone morphogenic protein.

26. The composition of claim 24, wherein the porous material comprises polyethylene, ultra high molecular weight polyethylene, high density polyethylene, polypropylene or PEEK.

27. The composition of claim 24, wherein the porous material comprises:

sintered high density polyethylene;

pores in the range of about 40 to about 1000 microns in average diameter;

a pore volume of about 20% to about 60%; and

,

the porous material is about 0.1 to about 3.0 mm in thickness.

28. The composition of claim 24, wherein the pores are omnidirectional.

29. The composition of claim 24, wherein the pores are multidimensional.