Spinal fusion methods and devices

• US 20040034428A1
• Filed: 07/25/2003
• Published: 02/19/2004
• Est. Priority Date: 10/24/2000
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F
• Granted Patent: US 8,226,729 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• 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 intervertebral 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 morphogenetic 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. A method for spinal treatment comprising:

preparing a treatment site in a disc space or proximal to one or more vertebrae for receipt of an osteoinductive composition; and

disposing an osteoinductive composition combined with a degradable carrier into the treatment site, wherein the carrier is substantially impermeable to efflux of said osteoinductive composition, and whereby bone formation is substantially confined to the volume of the carrier disposed in the treatment site.

2. The method of claim 1, wherein said osteoinductive composition comprises a growth factor.

3. The method of claim 2, wherein said growth factor is a bone morphogenetic protein.

4. The method of claim 3, wherein said bone morphogenetic protein is a recombinant human protein.

5. The method of claim 4, wherein said bone morphogenetic protein is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, heterodimers thereof and combinations thereof.

6. The method of claim 4, wherein said recombinant protein is selected from rhBMP-2, rhBMP-7, heterodimers thereof and combinations thereof.

7. The method of claim 2, wherein said osteoinductive composition comprises an osteoinductive factor selected from the group consisting of LIM mineralization protein, growth and differentiation factors, cartilage-derived morphogenic proteins, transforming growth factors, insulin-like growth factors, epidermal growth factors, platelet-derived growth factors and fibroblast growth factors.

8. The method of claim 1, wherein said degradable carrier is a calcium-phosphate containing carrier.

9. The method of claim 1, wherein said degradable carrier is a cement.

10. The method of claim 9, wherein said cement is a calcium phosphate cement.

11. A method for fusing adjacent vertebrae in a patient by a posterior or transforaminal fusion approach, comprising:

preparing a disc space for receipt of an intervertebral disc implant in an intervertebral space between adjacent vertebrae, said implant configured to retain an osteoinductive composition, wherein said preparing is by a posterior or transforaminal approach that exposes a hematoma site or scar tissue site susceptible to contact by a diffusible osteoinductive factor; and

providing an osteoinductive composition combined with a degradable carrier substantially impermeable to efflux of said osteoinductive composition, wherein the osteoinductive composition is released from the carrier as the carrier degrades, and whereby bone formation is substantially avoided at said hematoma site or scar tissue site.

12. The method of claim 11, wherein said implant has a chamber for retaining said osteoinductive composition.

13. The method of claim 11, wherein said osteoinductive composition comprises a growth factor.

14. The method of claim 13, wherein said growth factor is a bone morphogenetic protein.

15. The method of claim 14, wherein said bone morphogenetic protein is a recombinant human protein.

16. The method of claim 14, wherein said bone morphogenetic protein is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, heterodimers thereof and combinations thereof.

17. The method of claim 15, wherein said recombinant protein is selected from rhBMP-2 , rhBMP-7, heterodimers thereof and combinations thereof.

18. The method of claim 13, wherein said osteoinductive composition comprises an osteoinductive factor selected from the group consisting of LIM mineralization protein, growth and differentiation factors, cartilage-derived morphogenic proteins, transforming growth factors, insulin-like growth factors, epidermal growth factors, platelet-derived growth factors and fibroblast growth factors.

19. The method of claim 11, wherein said degradable carrier is a calcium-phosphate containing carrier.

20. The method of claim 19, wherein said carrier comprises a calcium phosphate cement.

21. The method of claim 11, comprising inserting an implant into said disc space.

22. The method of claim 21, wherein said implant has a chamber for receipt said osteoinductive composition.

23. The method of claim 21, wherein said implant is biodegradable or resorbable.

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

25. The method of claim 24, wherein less than about 50% by weight of the osteoinductive composition is released from the carrier after about 7 days post implantation.

26. A method of treating spinal defects comprising:

identifying a patent in need of treatment and having a predisposition or preexisting condition for bone overgrowth at a site proximal to a desired treatment site;

preparing the desired treatment site;

implanting an osteoinductive composition combined with a degradable carrier substantially impermeable to efflux of the osteoinductive composition, whereby bone formation is substantially confined to the treatment site.

29. The method of claim 26, wherein said osteoinductive composition comprises a growth factor.

30. The method of claim 29, wherein the growth factor is a bone morphogenetic protein.

31. The method of claim 30, wherein said bone morphogenetic protein is a recombinant human protein.

32. The method of claim 30, wherein said bone morphogenetic protein is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, heterodimers thereof and combinations thereof.

33. The method of claim 31, wherein said recombinant human protein is selected from rhBMP-2, rhBMP-7, heterodimers thereof and combinations thereof.

34. The method of claim 29, wherein said growth factor is 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.

35. The method of claim 26, wherein less than about 50% by weight of the osteoinductive composition is released from the carrier after about 2 days post implantation.

36. The method of claim 35, wherein less than about 50% by weight of the osteoinductive composition is released from the carrier after about 7 days post implantation.

37. The method of claim 26 wherein the osteoinductive composition and carrier are provided in a spacer.

27. The method of claim 27 wherein said degradable carrier is a calcium-phosphate containing carrier.

28. The method of claim 27, wherein said degradable carrier is a calcium phosphate cement.