Composite bone graft, method of making and using same

• US 6,200,347 B1
• Filed: 08/03/1999
• Issued: 03/13/2001
• Est. Priority Date: 01/05/1999
• Status: Expired due to Term

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Anderson, Billy G., Wolfinbarger, Lloyd Jr.
• Primary Examiner(s): Hirsch, Paul J.
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/368,263
• Time in Patent Office: 588 Days
• Field of Search: 623/11, 623/16, 606/70
• US Class Current: 623/16.11
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• 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 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30154 square
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30158 trapezoidal
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30263 : cubical
• CPC Class Codes: A61F 2002/3028 : polyhedral different from parallelepipedal and pyramidal
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30387 : Dovetail connection
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/30494 : Cooperating protrusions and recesses, e.g. radial serrations, located on abutting end surfaces of a longitudinal connection
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0021 : square
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00329 : Glasses, e.g. bioglass
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/02 : Inorganic materials
• CPC Class Codes: A61L 27/14 : Macromolecular materials
• CPC Class Codes: A61L 27/36 : containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen 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 27/40 : Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 27/446 : with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 27/46 : with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

The invention is directed to a composite bone graft for implantation in a patient, and methods of making and using the composite bone graft, along with methods for treating patients by implanting the composite bone graft at a site in a patient. The composite bone graft includes two or more connected, discrete, bone portions, and includes one or more biocompatible connectors which hold together the discrete bone portions to form the composite bone graft. The composite bone graft may include one or more textured bone surfaces. The textured surface preferably includes a plurality of closely spaced protrusions, preferably closely spaced continuous protrusions. The composite bone graft is useful for repairing bone defects caused by congenital anomaly, disease, or trauma, in a patient, for example, for restoring vertical support of the anterior and/or posterior column. Implantation of the composite bone graft results in improved graft stability and osteoinductivity, without a decrease in mechanical strength. The composite bone graft does not shift, extrude or rotate, after implantation. The present composite bone graft can be appropriately sized for any application and can be used to replace traditional non-bone prosthetic implants.

Claims

1. A composite bone graft, comprising:

a first cortical bone portion comprising one or more cortical bone planks, and having a first face comprising a single protrusion;

a second cortical bone portion comprising one or more cortical bone planks, and having a second face comprising a single depression complimentary to said single protrusion provided on said first face, said second cortical bone portion is provided on said first cortical bone portion such that said first face and said second face interlock to form a graft unit; and

a cortical bone locking pin located approximately parallel to the interface of said first cortical bone portion and said second cortical bone portion, said cortical bone locking pin partially traverses said graft unit wherein said composite bone graft does not comprise an adhesive.

19. The composite bone graft of any one of claims 1, 2, 4, 6-8, 14, or 15, said bone portions comprising allogenic or xenogenic bone.

2. A composite bone graft, comprising:

a first substantially planer cortical bone portion;

a second substantially planer cortical bone portion provided on said first substantially planer cortical bone portion to form a graft unit;

one or more biocompatible mechanical connectors for holding together said graft unit, said one or more biocompatible mechanical connectors are provided perpendicular to or parallel to an interface of said first substantially planer cortical bone portion and said second substantially planer cortical bone portion; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portion, wherein said composite bone graft does not comprise an adhesive.

13. The composite bone graft of any one of claims 2, 4, 6, 7, or 8, said composite bone graft further comprising a first top surface and a second bottom surface, said first top surface and said second bottom surface comprising a plurality of protrusions defining a saw-tooth pattern.

27. The composite bone graft of claim 13, said plurality of protrusions having a height of from about 0.1 mm to about 5.0 mm.

3. A composite bone graft, consisting essentially of:

a first substantially planer cortical bone portion;

a second substantially planer cortical bone portion provided on said first substantially planer cortical bone portion to form a graft unit;

one or more biocompatible mechanical connectors for holding together said graft unit, said one or more biocompatible mechanical connectors are provided perpendicular to or parallel to an interface of said first substantially planer cortical bone portion and said second substantially planer cortical bone portion; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions.

4. A composite bone graft, comprising:

two or more distinct, adjacent, cortical bone portions, said distinct, adjacent, cortical bone portions each comprising a face complimentary to a face on an adjacent cortical bone portion, each face comprising a single projection or a single depression, such that adjacent faces are complimentary, and a single projection interlocks with a single depression, to provide an interlocking fit between said adjacent bone portions; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions, wherein said composite bone graft does not comprise an adhesive.

26. The composite bone graft of any one of claims 4-6, or 7, each of said cortical bone portions comprises one or more cortical bone planks.

5. A composite bone graft, consisting essentially of:

two or more distinct, adjacent, cortical bone portions, said distinct, adjacent, cortical bone portions each comprising a face complimentary to a face on an adjacent cortical bone portion, each face comprising a single projection or a single depression, such that adjacent faces are complimentary, and a single projection interlocks with a single depression, to provide an interlocking fit between said adjacent bone portions;

one or more locking pins comprising cortical bone, partially or entirely traversing a dimension of said composite bone graft, said one or more locking pins provided perpendicular to or parallel to an interface between adjacent bone portions, and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions.

6. A composite bone graft, comprising:

two or more distinct, adjacent, cortical bone portions, said distinct, adjacent, cortical bone portions each comprising a face complimentary to a face on an adjacent cortical bone portion, each face comprising a single projection or a single depression, such that adjacent faces are complimentary, and a single projection interlocks with a single depression, to provide an interlocking fit between said adjacent bone portions;

one or more locking pins comprising cortical bone, partially or entirely traversing a dimension of said composite bone graft, said one or more locking pins provided perpendicular to or parallel to an interface between adjacent bone portions; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of said adjacent bone portions, wherein said composite bone graft does not comprise an adhesive.

7. A composite bone graft, comprising:

two or more distinct, adjacent, bone portions layered to form a graft unit;

one or more biocompatible mechanical connectors provided perpendicular to an interface between adjacent bone portions; and

a first chamfered edge and a second chamfered edge, said first chamfered edge provided along a length of said composite bone graft at its top edge, and said second chamfered edge provided along a length of said composite bone graft at its bottom edge, such that the chamfered edges are diametrically opposed; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of portions adjacent bone portion, wherein said composite bone graft does not comprise an adhesive.

20. The composite bone graft of claim 7, said two or more distinct, adjacent, bone portions comprise one or more members selected from the group consisting of cortical bone and cancellous bone.

21. The composite bone graft of claim 20, said cortical bone and said cancellous bone, comprising allogenic bone or xenogenic bone.

22. The composite bone graft of claim 7, said composite bone graft further comprising a top surface;

a bottom surface;

a diameter of from about 10.0 mm to about 20.0 mm;

a width of from about 12.0 mm to about 25.0 mm;

an anterior composite height of from about 5.0 mm to about 10.0 mm; and

a posterior composite height of from about 5.0 mm to about 15.0 mm.

23. The composite bone graft of claim 22, said top surface and said bottom surface comprising a plurality of protrusions defining a saw-tooth pattern.

8. A composite bone graft, comprising:

a first cortical bone portion;

a second cortical bone portion provided on said first cortical bone portion to form a graft unit;

one or more biocompatible mechanical connectors for holding together said graft unit, said one or more biocompatible mechanical connectors are provided perpendicular to or parallel to an interface of said first cortical bone portion and said second cortical bone portion; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions, wherein said composite bone graft does not comprise an adhesive.

9. The composite bone graft of claim 8, said first cortical bone portion comprises one or more cortical bone planks, and said second cortical bone portion comprises one or more cortical bone planks.

10. The composite bone graft of claim 9, said first cortical bone portion comprises a first face comprising a single protrusion and said second cortical bone portion comprises a second face comprising a single depression complimentary to said first face, such that said first face and said second face interlock wherein said composite bone graft does not comprise an adhesive.

11. The composite bone graft of claim 10, said one or more biocompatible mechanical connectors comprise a single cortical bone pin.

12. The composite bone graft of claim 11, said cortical bone pin comprises a locking pin, said locking pin partially traverses said graft unit and is located approximately parallel to the interface of said first cortical bone portion and said second cortical bone portion.

14. A composite cervical wedge, comprising:

a first substantially planer cortical bone portion;

a second substantially planer cortical bone portion provided on said first substantially planer cortical bone portion to form a graft unit said graft unit having a top textured surface and a bottom textured surface;

one or more biocompatible mechanical connectors for holding together said graft unit, said one or more biocompatible mechanical connectors are provided perpendicular to or parallel to an interface of said first substantially planer cortical bone portion and said second substantially planer cortical bone portion; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions, forming said composite cervical wedge, said composite cervical wedge comprises;

a first width of from about 10.0 mm to about 24.0 mm;

a second width of from about 4.0 mm to about 16.0 mm;

a composite anterior height of from about 3.0 mm to about 30.0 mm;

a composite posterior height of from about 5.0 mm to about 50.0 mm; and

a diameter of from about 10.0 mm to about 20.0 mm, wherein said top textured surface and said bottom textured surface are opposing and are disposed parallel to interfaces of said bone portions, said top textured surface and said bottom textured surface comprises a plurality of protrusions defining a saw-tooth pattern, and wherein said composite bone graft does not comprise an adhesive.

16. The composite bone graft of any one of claims 2, 4, 6-8, 14, or 15, further comprising one or more osteoinductive substances provided in said through-hole, said osteoinductive substances are selected from the group consisting of demineralized cortical bone;

demineralized cancellous bone;

collagen;

partially demineralized cortical bone; and

partially demineralized cancellous bone.

17. The composite bone graft of claim 16, said one or more osteoinductive substances further comprising one or more members selected from the group consisting of bone morphogenic protein and a growth factor.

18. The composite bone graft of claim 17, said through-hole has a diameter of from about 2.0 mm to about 8.0 mm.

25. The composite bone graft of any one of claims 2, 3, 8, 14, or 15, said first cortical bone portion comprises one or more cortical bone planks, and said second cortical bone portion comprises one or more cortical bone planks.

15. A composite cervical block, comprising:

a first substantially planer cortical bone portion;

a second substantially planer cortical bone portion provided on said first substantially planer cortical bone portion to form a graft unit said graft unit having a top textured surface and a bottom textured surface;

one or more biocompatible mechanical connectors for holding together said graft unit, said one or more biocompatible mechanical connectors are provided perpendicular to or parallel to an interface of said first substantially planer cortical bone portion and said second substantially planer cortical bone portion; and

a through-hole entirely traversing said composite bone graft, said through-hole is disposed substantially perpendicular to interfaces of adjacent bone portions, forming said composite cervical wedge, said composite cervical wedge comprises;

a first width of from about 10.0 mm to about 24.0 mm;

a second width of from about 4.0 mm to about 16.0 mm;

a composite height of from about 3.0 mm to about 30.0 mm; and

a diameter of from about 10.0 mm to about 20.0 mm, wherein said top textured surface and said bottom textured surface are opposing and are disposed parallel to interfaces of said bone portions, said top textured surface and said bottom textured surface comprises a plurality of protrusions defining a saw-tooth pattern, and wherein said composite bone graft does not comprise an adhesive.

24. The composite bone graft of any one of claims 15, or 23, said plurality of protrusions having a height of from about 0.1 mm to about 5.0 mm.