Treatment of the vertebral column

• US 7,520,888 B2
• Filed: 02/14/2006
• Issued: 04/21/2009
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US11/353,520
• Publication Number:
  US 20070213824A1
• Time in Patent Office: 1,162 Days
• Field of Search: 623 1711- 1716, 606/61, 606/248, 606/279
• US Class Current: 606/279
• 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:

gaining surgical access to a disc space of a vertebral column including introducing a sheath to provide an access path to the disc space;

resecting at least a portion of the disc space of the vertebral column by introducing a tissue removal device through the sheath to the disc space and moving at least an end portion of the tissue removal device through a removal path to remove the portion of the disc space;

removing the tissue removal device from the sheath;

introducing a non-load bearing biological treatment into the resected portion of the disc space of the vertebral column by introducing the non-load bearing biological treatment through a treatment delivery device extending through the sheath and into the disc space and moving at least an end portion of the delivery device through a delivery path while the non-loading bearing biological treatment is emitted from the end portion of the delivery device;

removing the delivery device and the sheath;

gaining surgical access to an undamaged, load bearing spinous process region of the vertebral column spaced from the disc space; and

mechanically unloading the disc space of the vertebral column by applying a load bearing spinal device to at least the spinous process 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 comprises allogenic collagen, stem cells and PDGF; and

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

16. The method of claim 1 wherein:

the biological treatment comprises a polyvinyl alcohol hydrogel, chondrocytes, TGF-beta 1 and TGF-beta 2; and

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

17. The method of claim 1 wherein:

the biological treatment comprises a polyethylene glycoal gel, fibroblasts and PDGF; and

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

18. The method of claim 1 wherein:

the biological treatment comprises a porcine-based collagen, chondrocytes, and BMP-12; and

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

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

20. The method of claim 1, wherein the tissue removal device comprises a needle.

21. The method of claim 1, wherein the sheath comprises a dilator.

22. The method of claim 1, further comprising inserting the sheath over a guide needle.

23. The method of claim 1, wherein introducing the sheath comprises inserting the sheath over a guide needle.

24. The method of claim 23, wherein the guide needle is a steerable guide needle and wherein the steerable guide needle comprises at least the end portion of the delivery device.