SHAPED LOAD-BEARING OSTEOIMPLANT AND METHODS OF MAKING SAME

• US 20070233272A1
• Filed: 06/06/2007
• Published: 10/04/2007
• Est. Priority Date: 02/23/1999
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Winterbottom, John, Manrique, Albert, Boyce, Todd, Shimp, Lawrence
• Application Number:
  US11/758,751
• Publication Number:
  US 20070233272A1
• Time in Patent Office: Days
• US Class Current: 623/23.630
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/74 Devices for the head or neck or trochanter of the femur trochanteric devices connected to the proximal part of an endoprosthetic femoral shaft A61F2/30739; endoprosthetic internal fixation devices for the head or neck of the femur A61F2/3601
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61C 8/0036 Tooth replica
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/2817 : 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 2002/2825 : Femur
• 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 2002/2871 : Radius
• CPC Class Codes: A61F 2002/2892 : Tibia
• 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 2002/30059 : differing in bone mineralization, e.g. made from both mineralized and demineralized 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 2002/30143 : hexagonal
• CPC Class Codes: A61F 2002/30146 : octagonal
• CPC Class Codes: A61F 2002/30148 : lozenge- or diamond-shaped
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30154 : square
• CPC Class Codes: A61F 2002/30158 : trapezoidal
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30237 : partial tubes
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30266 : wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30561 : breakable or frangible
• CPC Class Codes: A61F 2002/30622 : Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30962 : using stereolithography
• CPC Class Codes: A61F 2002/30968 : Sintering
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/365 : Connections of heads to necks
• CPC Class Codes: A61F 2002/3686 : bent
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• 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 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• 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 2250/0071 : breakable or frangible
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00173 : Graphite
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00347 : Nacre or mother-of-pearl
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• 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 27/3641 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• 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 27/3839 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• 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 which comprises a shaped, coherent aggregate of bone particles.

Claims

1. A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,

wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide, and

wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

2. The osteoimplant of claim 1, wherein the binder is polylactide.

3. The osteoimplant of claim 1, wherein the binder is polyglycolide.

4. The osteoimplant of claim 1, wherein the binder is polylactide-co-glycolide.

5. The osteoimplant of claim 1, wherein the bone particles are selected from the group consisting of nondemineralized bone, substantially fully demineralized bone, partially demineralized bone, superficially demineralized bone, and combinations thereof.

6. The osteoimplant of claim 5, wherein the bone particles comprise demineralized bone particles.

7. The osteoimplant of claim 5, wherein the bone particle comprise nondemineralized bone particles.

8. The osteoimplant of claim 5, wherein the bone particles comprise a combination of demineralized bone particles and nondemineralized bone particles.

9. The osteoimplant of claim 8, wherein the weight ratio of demineralized bone particles to nondemineralized bone particles ranges from about 20:

1 to about 1;

20.

10. The osteoimplant of claim 1, wherein the bone particles are in the form of powders, chips, elongate particles, or combinations thereof.

11. The osteoimplant of claim 1, wherein the bone particles are allogenic bone particles.

12. The osteoimplant of claim 1, wherein the bone particles are autogenous bone particles.

13. The osteoimplant of claim 1, wherein the bone particles are xenogenic bone particles.

14. The osteoimplant of claim 1 further comprising at least one additional component selected from the group consisting of binder, filler, coupling agent, plasticizer, wetting agent, surface active agent, biostatic/biocidal agent, bioactive substance, reinforcing material, reinforcing structure, and combinations thereof.

15. The osteoimplant of claim 14 further comprises a coupling agent.

16. The osteoimplant of claim 1, wherein the osteoimplant is configured as a sheet, plate, dish, cone, pin, screw, tube, tooth, tooth root, bone, bone portion, wedge, wedge portion, cylinder, dowel, interveterbral implant, or suture anchor.

17. The osteoimplant of claim 1, wherein the osteoimplant is an interveterbral implant.

18. The osteoimplant of claim 1, wherein the osteoimplant is a spinal implant.

19. The osteoimplant of claim 1, wherein osteoimplant comprises about 5% to about 95% by weight bone particles.

20. The osteoimplant of claim 1, wherein osteoimplant comprises about 20% to about 95% by weight bone particles.

21. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength of at least about 15 MPa.

22. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength of at least about 20 MPa.

23. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 15 MPa to about 130 MPa.

24. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 12 MPa to about 200 MPa.

25. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 17 MPa to about 200 MPa.

26. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 20 MPa to about 200 MPa.

27. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 31 MPa to about 200 MPa.

28. The osteoimplant of claim 1, wherein the osteoimplant has a wet compressive strength from about 56 MPa to about 200 MPa.

29. The osteoimplant of claim 1, wherein the osteoimplant has a bulk density of greater than about 1.0 g/cm³.

47. A method of repairing bone, the method comprising steps of:

implanting at a bone repair site a load-bearing osteoimplant of claim 1.

30. A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,

wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide;

and

wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm³.

31. A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,

wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide;

and

wherein the osteoimplant has a wet compressive strength of at least about 3 MPa.

32. A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,

wherein the binder is polylactide;

wherein the bone particles are mineralized bone particles, demineralized bone particles, or combinations thereof, and

wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

33. A method of preparing a load-bearing osteoimplant, the method comprising steps of:

combining bone particles and a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide; and

applying a compressive force of greater than about 50 psi to the composite to provide an osteoimplant having a bulk density greater than 0.7 g/cm³ and a wet compressive strength of at least about 3 MPa.

34. The method of claim 33, wherein the step of combining comprises combining bone particles and a polymer in the presence of an solvent.

35. The method of claim 34, wherein the solvent is ethanol.

36. The method of claim 33, wherein the compressive force is greater than about 1,000 psi.

37. The method of claim 33, wherein the compressive force is greater than about 2,500 psi.

38. The method of claim 33, wherein the compressive force ranges from about 2,500 psi and about 60,000 psi.

39. The method of claim 33, wherein the compressive force ranges from about 2,500 psi and about 20,000 psi.

40. The method of claim 33, wherein the compressive force is applied for about 0.1 hours to about 180 hours.

41. The method of claim 33, wherein the compressive force is applied for about 4 hours to about 72 hours.

42. The method of claim 33, wherein the compressive force is applied at a temperature ranging from about 40°

C. to about 70°

C.

43. The method of claim 33, wherein the bone particles are selected from the group consisting of nondemineralized bone, substantially fully demineralized bone, partially demineralized bone, superficially demineralized bone, and combinations thereof.

44. The method of claim 33, wherein the bone particles comprise demineralized bone particles.

45. The method of claim 33, wherein the bone particle comprise nondemineralized bone particles.

46. The method of claim 33, wherein the bone particles comprise a combination of demineralized bone particles and nondemineralized bone particles.