Load bearing osteoimplant and method of repairing bone using the same

• US 6,440,444 B2
• Filed: 07/24/2001
• Issued: 08/27/2002
• Est. Priority Date: 02/23/1999
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Osteotech Incorporated (Medtronic Plc)
• Inventors: Manrique, Albert, Boyce, Todd M., Shimp, Lawrence A.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): GHALI, ISIS A D
• Application Number:
  US09/911,562
• Publication Number:
  US 20010043940A1
• Time in Patent Office: 399 Days
• Field of Search: 424/422, 424/423, 424/484, 623/16
• US Class Current: 424/422
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• 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
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3847 Bones
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof

Abstract

A load-bearing osteoimplant, method of making the osteoimplant and method for repairing bone using the osteoimplant are provided. The osteoimplant comprises a shaped, compressed composition of bone particles. The osteoimplant possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

Claims

1. An intervertebral implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

17. A method of repairing bone comprising implanting at a bone repair site the load-bearing osteoimplant of claim 1 comprising a shaped composition of bone particles, said osteoimplant possessing a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least 3 MPa.

18. The method of repairing bone of claim 17 selected from the group consisting of the repair of simple and compound fractures and non-unions, external and internal fixations, joint reconstructions, arthrodesis, general arthroplasty, cup arthroplasty of the hip, femoral and humeral head replacement, femoral head surface replacement and total joint replacement, repairs of the vertebral column, spinal fusion, internal fixation, tumor surgery, deficit filling, discectomy, laminectomy, excision of spinal cord tumors, anterior cervical and thoracic operations, repairs of spinal injuries, scoliosis, lordosis and kyphosis treatments, intermaxillary fixation of fractures, mentoplasty, temporomandibular joint replacement, alveolar ridge augmentation and reconstruction, onlay bone grafts, implant placement and revision, and sinus lifts.

2. A spinal implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

3. An implant possessing the shape of a cylinder, wedge, plate, threaded cylinder, fibular wedge, femoral strut or tibial strut which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

4. The osteoimplant of claim 3 further comprising at least one macroporous hole.

5. The osteoimplant of claim 4 wherein the macroporous hole contains therein an osteogenic material.

6. A bone plate which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

7. A disk which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

8. A bone screw which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

9. A femoral implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

10. An acetablular cup implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

11. A diaphyseal implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

12. An intercalary implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

13. An intramedullary implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

14. A reinforcement rod implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

15. A cranial bone implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

16. A maxillofacial implant which comprises a shaped composition of bone particles, wherein the composition possesses a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

19. An osteoimplant comprising a shaped, compressed composition of demineralized bone particles possessing chemical crosslinking of the surface-exposed collagen thereof, the osteoimplant possessing a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

20. The osteoimplant of claim 19 wherein the demineralized bone particles are selected from the group consisting of superficially demineralized bone particles, partially demineralized bone particles and substantially fully demineralized bone particles.

21. The osteoimplant of claim 19 wherein the bone particles are obtained from cortical, cancellous or corticocancellous bone of autogenous, allogenic or xenogeneic origin.

22. The osteoimplant of claim 19 wherein the bone particles are obtained from porcine or bovine bone.

23. The osteoimplant of claim 19 further comprising nondemineralized bone particles.

24. The osteoimplant of claim 19 wherein at least about 60 weight percent of the bone particles are elongate.

25. The osteoimplant of claim 19 wherein at least about 90 weight percent of the bone particles are elongate.

26. The osteoimplant of claim 19 further comprising at least one biocompatible component.

27. The osteoimplant of claim 26 wherein the biocompatible component is selected from the group consisting of biocompatible adhesive, binder, filler, fiber and bioactive substance.

28. The osteoimplant of claim 27 wherein the bioactive substance is selected from the group consisting of collagen, insoluble collagen derivatives, and soluble solids and/or liquids dissolved therein;

antiviricides, antimicrobials and/or antibiotics selected from the group consisting of erythromycin, bacitracin, neomycin, penicillin, polymycin B. tetracyclines, biomycin, ehloromycetin, streptomycins, cefaxolin, ampicillin, azactam, tobramycin, clindamycin and gentamicin;

biocidal/biostatic sugars selected from the group consisting of dextran, glucose, amino acids, peptides;

vitamins;

inorganic elements;

co-factors for protein synthesis;

hormones;

endocrine tissue or tissue fragments;

synthesizers;

enzymes selected from the group consisting of collagenase, peptidases, oxidases;

polymer cell scaffolds with parenchymal cells;

angiogenic drugs and polymeric carriers containing such drugs;

collagen lattices;

antigenic agents;

cytoskeletal agents;

cartilage fragments;

living cells selected from the group consisting of chondrocytes, bone marrow cells, mesenchymal stem cells, natural extracts, genetically engineered living cells or otherwise modified living cells, DNA delivered by plasmid or viral vectors, and tissue transplants;

demineralized bone powder;

autogenous tissues selected from the group consisting of blood, serum, soft tissue, bone marrow, bioadhesives, bone morphogenic proteins (BMPs);

osteoinductive factor (IFO);

fibronectin (FN);

endothelial cell growth factor (ECGF);

cementum attachment extracts (CAE);

ketanserin;

human growth hormone (HGH);

animal growth hormones;

epidermal growth factor (ECF);

interleukin-1 (IL-1);

human alpha thrombin;

transforming growth factor (TGF-beta);

insulin-like growth factor (IGF-1);

platelet derived growth factors (PDGF);

fibroblast growth factors (FGF, bFGF, etc.);

periodontal ligament chemotactic factor (PDLGF);

somatotropin;

bone digestors;

antitumor agents;

immuno-suppressants;

permeation enhancers;

enamine derivatives;

alpha-keto aldehydes; and

nucleic acids.

29. The osteoimplant of claim 23 wherein the weight ratio of nondemineralized bone particles to demineralized bone particles ranges from about 20:

1 to about 1;

20.

30. The osteoimplant of claim 23 wherein the weight ratio of partially demineralized bone particles to fully demineralized bone particles ranges from about 20:

1 to about 1;

20.