Treatment of the vertebral column

• US 20070227547A1
• Filed: 02/14/2006
• Published: 10/04/2007
• Est. Priority Date: 02/14/2006
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai
• Application Number:
  US11/354,314
• Publication Number:
  US 20070227547A1
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/7061 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 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 35/33 Fibroblasts
• CPC Class Codes: A61K 35/545 Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells
• CPC Class Codes: A61K 38/1841 Transforming growth factor [TGF]
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: A61K 38/30 Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 insulin-like growth factor binding protein A61K38/1754
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord

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 at least one area of a vertebral column selected from a facet joint, a disc space, a vertebral body and an endplate; and

at least partially mechanically unloading the treated area by applying a load-bearing device to at least a posterior 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 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 and polyolefin rubber, and combinations thereof.

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

17. The method of claim 1 wherein the load-bearing device comprises at least one of a fixation system, a dampener system, an annulus repair system, and an annulus replacement system.

18. The method of claim 17 wherein the load-bearing device comprises a fixation system comprising at least one of hooks, rods and screws.

19. The method of claim 1 wherein the load-bearing device comprises at least one of plates, sheets and rods.

20. The method of claim 1 wherein the load-bearing device is formed from a biocompatible material selected from metals, polymers, ceramics, and tissue, and combinations thereof.

21. The method of claim 1 wherein:

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

22. The method of claim 1 wherein:

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

the biological treatment comprises collagen, stem cells and BMP-6; and

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

23. The method of claim 1 wherein:

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

the biological treatment comprises a polyvinyl alcohol hydrogel containing chondrocytes and TGF-beta 2; and

the load-bearing device comprises a fixation system comprising at least one rod and at least one screw applied to the posterior region adjacent to the facet joint receiving the biological treatment.

24. The method of claim 1 wherein:

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

the biological treatment comprises a polyethylene glycol gel containing fibroblasts and TGF-beta; and

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

25. The method of claim 1 wherein:

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

the biological treatment comprises a porcine-based collagen containing anti-TNF alpha and ILGF; and

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

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

27. 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 spinal column, wherein the intact motion segment comprises a facet joint; and

injecting a biological treatment into the facet joint.

28. The method of claim 27 wherein the load-bearing device is implanted at a location in the spine that is spaced from the motion segment receiving the biological treatment.

29. The method of claim 27 wherein the load-bearing device is implanted at a location in the spine that is adjacent to the motion segment receiving the biological treatment.

30. The method of claim 27 wherein the biological treatment is non-load-bearing.