SPINAL FUSION METHODS AND DEVICES

• US 20090298776A1
• Filed: 08/07/2009
• Published: 12/03/2009
• Est. Priority Date: 10/24/2000
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Application Number:
  US12/537,682
• Publication Number:
  US 20090298776A1
• Time in Patent Office: Days
• US Class Current: 514/1.1
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• 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 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease

Abstract

Methods, devices and compositions for fusing adjacent vertebrae, and otherwise localizing bone growth, are provided. In one form of the invention, a method for fusing adjacent vertebrae includes preparing a disc space for receipt of an intervertebral disc implant in an interwertebral disc space between adjacent vertebrae, inserting the implant into the intervertebral disc space and providing an osteoinductive composition that includes an osteoinductive factor in a pharmaceutically acceptable carrier. The carrier is advantageously substantially impermeable to efflux of the osteoinductive factor and is released as the carrier is resorbed or biodegraded. Preferred carriers include a hardened, resorbable carrier, such as a calcium phosphate cement that retains at least about 50% of the osteoinductive factors greater than about 2 days. Preferred osteoinductive factors are growth factors and include bone morphogenctic proteins and LIM mineralization proteins. In alternative forms of the invention, the method may be performed without utilization of a load-bearing spinal implant by disposing the osteoinductive composition in the disc space. The method is advantageously performed on lumbar vertebrae by a posterior approach. Intervertebral fusion devices and methods for their preparation are also provided.

Claims

1-10. -10. (canceled)

11. An osteoinductive composition for generating a bone mass in a patient, the osteoinductive composition comprising bone morphogenetic protein 2 within a biodegradable carrier comprising calcium phosphate the biodegradable carrier being substantially impermeable to efflux of said bone morphogenetic protein 2 so that the formed bone mass is confined to a volume of the carrier, wherein the bone morphogenetic protein 2 is present in an amount of 0.5 mg/ml to 4 mg/ml of the calcium phosphate and the bone morphogenetic protein 2 is released from the biodegradable carrier as the biodegradable carrier degrades.

12. An osteoinductive composition of claim 11, wherein said composition further comprises collagen.

13. An osteoinductive composition of claim 11, wherein said calcium phosphate comprises tricalcium phosphate.

14. An osteoinductive composition of claim 13, wherein said composition further comprises hydroxyapatite.

15. An osteoinductive composition of claim 11, wherein said bone morphogenetic protein 2 is recombinant human bone morphogenetic protein 2.

16. An osteoinductive composition claim 11, wherein said biodegradable carrier has a closed pore structure.

17. An osteoinductive composition claim 11, wherein said calcium phosphate is a cement and comprises tricalcium phosphate or hydroxyapatite or combinations thereof.

18. An osteoinductive composition of claim 11, wherein said osteoinductive composition further comprises an osteoinductive factor selected from the group consisting of LIM mineralization protein, transforming growth factors, insulin-like growth factors, epidermal growth factors, platelet-derived growth factors and fibroblast growth factors.

21. An osteoinductive composition of claim 11, wherein said composition is inserted into a disc space.

22. An osteoinductive composition of claim 11, wherein said composition has a chamber for receipt of said bone morphogenetic protein 2.

24. An osteoinductive composition of claim 11, wherein less than about 50% by weight of the bone morphogenetic protein 2 is released from the carrier after about 2 days post implantation.

25. An osteoinductive composition of claim 11, wherein less than about 50% by weight of the bone morphogenetic protein 2 is released from the carrier after about 7 days post implantation.

19-20. -20. (canceled)

23. (canceled)

26-37. -37. (canceled)