Treatment of the vertebral column

• US 20070213823A1
• Filed: 02/14/2006
• Published: 09/13/2007
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai
• Granted Patent: US 8,163,018 B2
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• 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 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• 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: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus

Abstract

A method is provided for treating a spinal condition. The method includes introducing a biological treatment into an area of a vertebral column, and mechanically unloading the treated area by applying a load-bearing device to the anterior region, the anterior column region, the posterior region, or the spinous process region of the vertebral column.

Claims

1. A method of treating a vertebral column comprising:

introducing a biological treatment into an area of a vertebral column; and

mechanically unloading the treated area by applying a load-bearing device to at least one region of the vertebral column.

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

3. The method of claim 2 wherein the biological treatment further comprises a biological additive.

4. The method of claim 3 wherein the biological additive comprises at least one of a biomaterial carrier, a therapeutic agent, a liquid and a lubricant.

5. The method of claim 3 wherein the biological additive is selected from autogenic collagen, allogenic collagen, xenogenic collagen, human recombinant collagen, gelatin, hyaluronic acid, fibrin, albumin, keratin, silk, elastin, 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.

6. The method of claim 3 wherein the biological additive is selected from nutrients, analgesics, antibiotics, anti-inflammatories, steroids, antiviricides, vitamins, amino acids and peptides.

7. The method of claim 6 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.

8. The method of claim 3 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.

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

cytokines;

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

anti-TNF alpha;

growth factors;

LIM mineralization proteins;

stem cell material, autogenic chondrocytes;

allogenic chondrocytes, autogenic chondrocytes with one of a retroviral viral vector or a plasmid viral vector;

allogenic chondrocytes with one of a retroviral viral vector or a plasmid viral vector; and

fibroblasts.

10. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from transforming growth factors, bone morphogenetic proteins, fibroblast growth factors, platelet derived growth factor (PDGF), insulin-like growth factor (ILGF);

human endothelial cell growth factor (ECGF);

epidermal growth factor (EGF);

nerve growth factor (NGF); and

vascular endothelial growth factor (VEGF).

11. The method of claim 10 wherein the biologically active component comprises at least one of a transforming growth factor selected from TGF-beta 1, TGF-beta 2, and TGF-beta 3, and a bone morphogenetic protein selected from BMP-2, BMP-3, BMP-4, BMP-6, BMP-7, and BMP-9.

12. 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.

13. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from cartilage derived morphogenetic protein (CDMP);

cartilage inducing factor (CIP);

proteoglycans;

hormones; and

matrix metalloproteinases (MMP) inhibitors.

14. The method of claim 1 wherein the biological treatment comprises a biologically active component selected from allogenic disc annulus material, xenogenic disc annulus material, 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.

15. The method of claim 1 wherein:

the biological treatment is introduced into at least one of a facet joint of the vertebral column and a disc space of the vertebral column; and

the mechanical unloading of the treated area comprises applying a load-bearing device to an anterior region of the vertebral column.

16. The method of claim 15 wherein the load-bearing device comprises at least one of a band, a plate, a sheet and a rod.

17. The method of claim 15 wherein the load-bearing device is formed from a biocompatible material selected from metals, polymers, ceramics, and tissue, and combinations thereof.

18. The method of claim 15 wherein the load-bearing device is formed from a metal selected from titanium, titanium alloys, nickel titanium, tantalum, stainless steel, and combinations thereof.

19. The method of claim 15 wherein the load-bearing 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.

20. The method of claim 1 wherein the load-bearing device is bioresorbable or partially resorbable.

21. The method of claim 1 wherein the biological treatment is non-load bearing.

22. The method of claim 1 wherein:

the biological treatment is introduced into the vertebral column in an area selected from a facet joint, a disc space, a vertebral body and an endplate; and

the mechanical unloading of the treated area comprises applying a load-bearing device to a spinous process region of the vertebral column.

23. The method of claim 22 wherein the load-bearing device is formed from at least one biocompatible material selected from metals, polymers, ceramics, and tissue, and combinations thereof.

24. The method of claim 23 wherein the load-bearing material device is formed from a metal selected from titanium, titanium alloys, nickel titanium, tantalum, stainless steel, and combinations thereof.

25. The method of claim 22 wherein:

the area of the vertebral column receiving the biological treatment comprises a facet joint;

the biological treatment comprises collagen, stem cells and TGF-beta 2; and

the load-bearing device is applied to the spinous process region adjacent to the facet joint receiving the biological treatment.

26. The method of claim 22 wherein:

the area of the vertebral column receiving the biological treatment comprises a facet joint;

the biological treatment comprises a polyvinyl alcohol hydrogel, chondrocytes and BMP-7(OP-1); and

the load-bearing device is applied to the spinous process region adjacent to the facet joint receiving the biological treatment.

27. The method of claim 22 wherein:

the area of the vertebral column receiving the biological treatment comprises a facet joint;

the biological treatment comprises a GAG, chondrocytes and PDGF; and

the load-bearing is applied to the spinous process region adjacent to the facet joint receiving the biological treatment.

28. A method for treating a motion segment of a spinal column comprising:

accessing a portion of a patient'"'"'s spinal column;

implanting a load-bearing device to at least partially mechanically unload an intact motion segment in the patient'"'"'s spine; and

injecting a biological treatment into the intact motion segment.

29. The method of claim 28 wherein the intact motion segment joint comprises at least one of an intact disc and an intact facet.

30. The method of claim 28 wherein the load-bearing device is implanted at a location in the spine that is spaced from the motion segment receiving the biological treatment.

31. The method of claim 28 wherein the load-bearing device is implanted at a location in the spine that is adjacent to the motion segment receiving the biological treatment.

32. The method of claim 28 wherein the biological treatment is non load-bearing.