Biological fusion in the vertebral column

• US 20070213717A1
• Filed: 02/14/2006
• Published: 09/13/2007
• Est. Priority Date: 02/14/2006
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Sherman, Michael, Trieu, Hai
• Application Number:
  US11/354,312
• Publication Number:
  US 20070213717A1
• Time in Patent Office: Days
• US Class Current: 606/255
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• 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 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61L 2300/214 Amino acids
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/408 Virucides, spermicides
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Methods are provided for treating a spinal condition. One method includes promoting fusion of an area of a vertebral column by introducing a biological treatment into the area to be fused. Another method includes causing damage in the area to be fused so as to induce a healing response. Other methods include applying a mechanical device to the vertebral column to provide stability to the area undergoing fusion.

Claims

1. A method of causing fusion across a facet joint of a vertebral column comprising:

injecting a biological treatment into the facet joint to promote fusion across the facet joint.

2. The method of claim 1 further comprising:

causing damage to at least a portion of the facet joint sufficient to induce a healing response in the facet joint.

3. The method of claim 1 further comprising applying a mechanical device to the vertebral column.

4. The method of claim 3 further comprising:

causing damage to at least a portion of the facet joint sufficient to induce a healing response in the facet joint.

5. The method of claim 3 wherein the mechanical device is applied to a posterior region of the vertebral column.

6. The method of claim 3 wherein the mechanical device is formed from a biocompatible material selected from metals, polymers, ceramics, and tissue, and combinations thereof.

7. The method of claim 6 wherein the mechanical device is formed from a metal selected from titanium, titanium alloys, nickel titanium, tantalum, stainless steel, and combinations thereof.

8. The method of claim 6 wherein the mechanical device is formed from a material selected from polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), PEEK-carbon composite, polyetherimide, polyimide, polysulfone, polyethylene, polyester, polylactide, copolymers of poly L-lactide and poly D-lactide, polyorthoester, tyrosine polycarbonate, polyurethane, silicone, polyolefin rubber, and combinations thereof.

9. The method of claim 3 wherein the mechanical device is bioresorbable or partially resorbable.

10. The method of claim 1 wherein the biological treatment comprises a biologically active component.

11. The method of claim 10 wherein the biological treatment further comprises a biological additive.

12. The method of claim 11 wherein the biological additive comprises at least one of a biomaterial carrier, a therapeutic agent, a liquid and a lubricant.

13. The method of claim 11 wherein the biological additive is selected from autogenic collagen, allogenic collagen, xenogenic collagen, human recombinant collagen, gelatin, hyaluronic acid, fibrin, albumin, keratin, silk, elastin, calcium phosphate, calcium sulfate, glycosaminoglycans (GAGs), polyethylene glycol (PEG), polyethylene oxide (PEO), polyvinyl alcohol (PVA) hydrogel, polyvinyl pyrrolidone (PVP), co-polymers of PVA and PVP, polysaccharides, platelet gel, peptides, carboxymethyl cellulose, modified starches and celluloses.

14. The method of claim 11 wherein the biological additive is selected from analgesics, antibiotics, anti-inflammatories, steroids, antiviricides, vitamins, amino acids and peptides.

15. The method of claim 14 wherein the biological additive comprises at least one of:

an analgesic selected from codeine, prodrugs, morphine, hydromorphone, propoxyphene, hydrocodone, oxycodone, meperidine, methadone, and fentanyl; and

an antibiotic selected from erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracyclines, viomycin, chloromycetin, streptomycins, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.

16. The method of claim 11 wherein the biological additive is selected from water, saline, radio-contrast media, hyaluronic acid, a salt of hyaluronic acid, sodium hyaluronate, glucosaminoglycan, dermatan sulfate, heparin sulfate, chondroitin sulfate, keratin sulfate, synovial fluid, a component of synovial fluid, vitronectin and rooster comb hyaluronate.

17. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from anti-cytokines;

anti-interleukin-1 components (anti-IL-1);

anti-TNF alpha;

growth factors;

LIM mineralization proteins;

stem cell material, osteoblasts and cells containing a viral vector for osteoinductivity.

18. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from bone morphogenetic proteins, platelet derived growth factor (PDGF), insulin-like growth factor (ILGF), human endothelial cell growth factor (ECGF), nerve growth factor (NGF), and vascular endothelial growth factor (VEGF).

19. The method of claim 18 wherein the biologically active component comprises at least one bone morphogenetic protein selected from BMP-2, BMP-3, BMP-4, BMP-6, BMP-7, and BMP-9.

20. The method of claim 1 wherein the biological treatment comprises stem cell material selected from dedifferentiated stem cells, undifferentiated stem cells, mesenchymal stem cells, marrow-extracted stem cell material and adipose-derived stem cell material.

21. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from biologic tissues, activated tissue grafts, engineered cells comprising a nucleic acid for encoding a protein or variant thereof, and a recombinant human bone morphogenetic protein.

22. A method of promoting fusion in a joint between adjacent vertebrae comprising:

accessing a joint between adjacent vertebrae in a vertebral column; and

introducing a biological treatment into the joint between the adjacent vertebrae to promote fusion across the joint.

23. The method of claim 22 wherein introducing the biological treatment into the joint comprises injecting the biological treatment into the joint.

24. The method of claim 23 wherein injecting the biological treatment into the joint comprises at least one of a percutaneous injection and injection through a needle.

25. The method of claim 23 wherein fusion is promoted across at least one of a facet joint and adjacent vertebral bodies.

26. The method of claim 22 further comprising applying a mechanical device to the vertebral column.

27. The method of claim 26 wherein the mechanical device is applied to at least one of an anterior region, a posterior region, and a spinous process region of the vertebral column.

28. The method of claim 22 wherein the biological treatment comprises a biologically active component.

29. The method of claim 28 wherein the biological treatment further comprises a biological additive.

30. The method of claim 29 wherein the biological additive comprises at least one of a biomaterial carrier, a therapeutic agent, a liquid and a lubricant.

31. The method of claim 30 wherein the biological additive is selected from autogenic collagen, allogenic collagen, xenogenic collagen, human recombinant collagen, gelatin, hyaluronic acid, fibrin, albumin, keratin, silk, elastin, calcium phosphate, calcium sulfate, glycosaminoglycans (GAGs), polyethylene glycol (PEG), polyethylene oxide (PEO), polyvinyl alcohol (PVA) hydrogel, polyvinyl pyrrolidone (PVP), co-polymers of PVA and PVP, polysaccharides, platelet gel, peptides, carboxymethyl cellulose, modified starches and celluloses.

32. The method of claim 30 wherein the biological additive is selected from analgesics, antibiotics, anti-inflammatories, steroids, antiviricides, vitamins, amino acids and peptides.

33. The method of claim 32 wherein the biological additive comprises at least one of:

an analgesic selected from codeine, prodrugs, morphine, hydromorphone, propoxyphene, hydrocodone, oxycodone, meperidine, methadone, and fentanyl; and

an antibiotic selected from erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracyclines, viomycin, chloromycetin, streptomycins, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.

34. The method of claim 30 wherein the biological additive is selected from water, saline, radio-contrast media, hyaluronic acid, a salt of hyaluronic acid, sodium hyaluronate, glucosaminoglycan, dermatan sulfate, heparin sulfate, chondroitin sulfate, keratin sulfate, synovial fluid, a component of synovial fluid, vitronectin and rooster comb hyaluronate.

35. The method of claim 22 wherein the biological treatment comprises a biologically active component selected from anti-cytokines;

anti-interleukin-1 components (anti-IL-1);

anti-TNF alpha;

growth factors;

LIM mineralization proteins;

stem cell material, osteoblasts and cells containing a viral vector for osteoinductivity.

36. The method of claim 22 wherein the biological treatment comprises a biologically active component selected from bone morphogenetic proteins, platelet derived growth factor (PDGF), insulin-like growth factor (ILGF), human endothelial cell growth factor (ECGF), nerve growth factor (NGF), and vascular endothelial growth factor (VEGF).

37. The method of claim 36 wherein the biologically active component comprises at least one bone morphogenetic protein selected from BMP-2, BMP-3, BMP-4, BMP-6, BMP-7, and BMP-9.

38. The method of claim 22 wherein the biological treatment comprises stem cell material selected from dedifferentiated stem cells, undifferentiated stem cells, mesenchymal stem cells, marrow-extracted stem cell material and adipose-derived stem cell material.

39. The method of claim 22 wherein the biological treatment comprises a biologically active component selected from biologic tissues, activated tissue grafts, engineered cells comprising a nucleic acid for encoding a protein or variant thereof, and a recombinant human bone morphogenetic protein.

40. A method of fusing a motion segment of a spinal column comprising:

applying a biological treatment to an intact motion segment of the spinal column to promote fusion within the intact motion segment.

41. The method of claim 40 wherein the intact motion segment joint comprises at least one of an intact facet joint and intact adjacent vertebrae.

42. The method of claim 41 further comprising injecting the biological treatment into the intact facet joint.

43. The method of claim 41 wherein the intact adjacent vertebrae comprise at least one of intact adjacent vertebral bodies and intact adjacent endplates, and further comprising injecting the biological treatment into at least one of the intact adjacent vertebral bodies or the intact adjacent endplates.

44. The method of claim 40 further comprising applying a mechanical device to the spinal column.

45. The method of claim 44 wherein the mechanical device is applied to the spinal column percutaneously.

46. The method of claim 40 wherein the mechanical device is applied to at least one of an anterior region, a posterior region and a spinous process region of the spinal column.

47. The method of claim 40 wherein the biological treatment is injected into the intact motion segment through a vertebral annulus between adjacent vertebrae of the intact motion segment.

48. The method of claim 40 wherein the biological treatment is injected into the intact motion segment through a bony portion of the intact motion segment.

49. The method of claim 40 further comprising:

causing damage to at least a portion of the intact motion segment sufficient to induce a healing response in the intact motion segment.