Rehydration and restoration of intervertebral discs with polyelectrolytes

• US 20070150060A1
• Filed: 12/27/2005
• Published: 06/28/2007
• Est. Priority Date: 12/27/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai
• Granted Patent: US 8,506,633 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• 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

Abstract

The embodiments provide a method for treating an intervertebral disc having a nucleus pulposus and an annulus fibrosis, using one or more polyelectrolyte materials. Additionally, the embodiments provide a method for bulking up an intervertebral disc having a nucleus pulposus and an annulus fibrosis, using one or more polyelectrolyte materials. The methods comprise introducing an amount of the polyelectrolyte materials into the intervertebral disc space without removing nucleus pulposus or annulus fibrosis material.

Claims

1. A method for treating an intervertebral disc having a nucleus pulposus and an annulus fibrosis, using one or more polyelectrolyte materials, comprising introducing the polyelectrolyte materials into the intervertebral disc space without removing nucleus pulposus or annulus fibrosis material, thereby rehydrating the intervertebral disc space.

2. The method of claim 1, wherein the intervertebral disc is rehydrated until equilibrium swelling is attained.

3. The method of claim 1, wherein the intervertebral disc is at least partially collapsed, and treating the intervertebral disc increases the intervertebral disc'"'"'s height.

4. The method of claim 1, wherein the intervertebral disc is experiencing progressive disc collapse, and treating the intervertebral disc decreases the rate of disc collapse.

5. The method of claim 1, wherein the intervertebral disc is experiencing progressive disc collapse, and treating the intervertebral disc maintains the intervertebral disc'"'"'s height.

6. The method of claim 1, wherein the polyelectrolyte materials are not more than about 15% crosslinked.

7. The method of claim 6, wherein the polyelectrolyte materials are not more than about 5% crosslinked.

8. The method of claim 1, wherein the polyelectrolyte materials are capable of attracting an amount of fluid at least about ten times the weight of the polyelectrolyte materials in their dry form under atmospheric pressure.

9. The method of claim 8, wherein the polyelectrolyte materials are capable of attracting an amount of fluid at least about twenty times the weight of the polyelectrolyte materials in their dry form under atmospheric pressure.

10. The method of claim 1, wherein the polyelectrolyte materials are in one or more forms selected from the group consisting of beads, fibers, flakes, granules, microspheres, nano-particles, particles, pellets, platelets, powder, randomly shaped particles, rods, chunks, and pieces.

11. The method of claim 1, additionally comprising introducing fluids into the intervertebral disc.

12. The method of claim 1, additionally comprising introducing one or more additives into the intervertebral disc.

13. The method of claim 12, wherein the additives are selected from the group consisting of analgesic compounds, anesthetics, antibacterial compounds, antibiotics, antibodies, antifungal compounds, anti-inflammatories, antiparasitic compounds, antiviral compounds, anticancer compounds, carbohydrates, cells, crosslinking agents, cytokines, drugs, genetic agents, enzyme inhibitors, hormones, steroids, glucocorticosteroids, growth factors, immunoglobulins, immunomodulators, lipoproteins, minerals, neuroleptics, nutritional supplements, oligonucleotides, organic polymers, peptides, polysaccharides, proteins, proteoglycans, radiocontrast media, toxins, tumoricidal compounds, tumorstatic compounds, and vitamins.

14. The method of claim 1, wherein introducing the polyelectrolyte materials into the intervertebral disc space comprises:

mixing the polyelectrolyte materials with a medium to make the polyelectrolyte materials flowable; and

using a delivery device to inject the flowable polyelectrolyte materials into the disc space.

15. The method of claim 1, wherein introducing the polyelectrolyte materials into the intervertebral disc space comprises:

loading the polyelectrolyte materials into a delivery device; and

using a plunger to force the polyelectrolyte materials from the delivery device into the disc space.

16. The method of claim 1, wherein introducing the polyelectrolyte materials into the intervertebral disc comprises:

inserting an inflatable member into the disc space; and

using a delivery device to inject the polyelectrolyte materials into the inflatable member.

17. The method of claim 16, wherein the inflatable member is a balloon.

18. The method of claim 17, wherein the balloon is made of a polymer selected from the group consisting of polyethylene terephthalates, polyolefins, polyurethanes, nylon, polyvinyl chloride, silicone, polyetheretherketone, polylactide, polyglycolide, poly(lactide-co-glycolide), poly(dioxanone), poly(ε

-caprolactone), poly(hydroxylbutyrate), poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene fumarate.

19. The method of claim 17, wherein the balloon is in a shape selected from the group consisting of conical, spherical, square, long conical, long spherical, long square, tapered, stepped, dog bone, and offset.

20. The method of claim 16, wherein the inflatable member is permeable, semi-permeable, or impermeable.

21. A method for bulking up an intervertebral disc having a nucleus pulposus and an annulus fibrosis, using one or more polyelectrolyte materials, comprising introducing the polyelectrolyte materials into the intervertebral disc space without removing nucleus pulposus or annulus fibrosis material, thereby accomplishing at least one of an increase in the disc height, an increase in the disc volume, and an increase in the intra-discal pressure.

22. The method of claim 21, wherein the intervertebral disc is rehydrated until equilibrium swelling is attained.

23. The method of claim 21, wherein introducing the polyelectrolyte materials accomplishes at least an increase in intervertebral disc height.

24. The method of claim 21, wherein the intervertebral disc is experiencing progressive disc collapse, and bulking up the intervertebral disc decreases the rate of disc collapse.

25. The method of claim 21, wherein the intervertebral disc is experiencing disc progressive collapse, and bulking up the intervertebral disc maintains the intervertebral disc'"'"'s height.

26. The method of claim 21, wherein the polyelectrolyte materials are not more than about 15% crosslinked.

27. The method of claim 26, wherein the polyelectrolyte materials are not more than about 5% crosslinked.

28. The method of claim 21, wherein the polyelectrolyte materials are capable of attracting an amount of fluid at least about ten times the weight of the polyelectrolyte materials in their dry form under atmospheric pressure.

29. The method of claim 28, wherein the polyelectrolyte materials are capable of attracting an amount of fluid at least about twenty times the weight of the polyelectrolyte materials in their dry form under atmospheric pressure.

30. The method of claim 21, wherein the polyelectrolyte materials are in one or more forms selected from the group consisting of beads, fibers, flakes, granules, microspheres, nano-particles, particles, pellets, platelets, powder, randomly shaped particles, rods, chunks, and pieces.

31. The method of claim 21, further comprising introducing fluids into the intervertebral disc.

32. The method of claim 21, further comprising introducing one or more additives into the intervertebral disc space.

33. The method of claim 32, wherein the additives are selected from the group consisting of analgesic compounds, anesthetics, antibacterial compounds, antibiotics, antibodies, antifungal compounds, anti-inflammatories, antiparasitic compounds, antiviral compounds, anticancer compounds, carbohydrates, cells, crosslinking agents, cytokines, drugs, genetic agents, enzyme inhibitors, hormones, steroids, glucocorticosteroids, growth factors, immunoglobulins, immunomodulators, lipoproteins, minerals, neuroleptics, nutritional supplements, oligonucleotides, organic polymers, peptides, polysaccharides, proteins, proteoglycans, radiocontrast media, toxins, tumoricidal compounds, tumorstatic compounds, and vitamins.

34. The method of claim 21, wherein introducing the polyelectrolyte materials into the intervertebral disc space comprises:

mixing the polyelectrolyte materials with a medium to make the polyelectrolyte materials flowable; and

using a delivery device to inject the flowable polyelectrolyte materials into the disc space.

35. The method of claim 21, wherein introducing the polyelectrolyte materials into the intervertebral disc space comprises:

loading the polyelectrolyte materials into a delivery device; and

using a plunger to force the polyelectrolyte materials from the delivery device into the disc space.

36. The method of claim 21, wherein introducing the polyelectrolyte materials into the intervertebral disc comprises:

inserting an inflatable member into the disc space; and

using a delivery device to inject the polyelectrolyte materials into the inflatable member.

37. The method of claim 36, wherein the inflatable member is a balloon.

38. The method of claim 37, wherein the balloon is made of a polymer selected from the group consisting of polyethylene terephthalates, polyolefins, polyurethanes, nylon, polyvinyl chloride, silicone, polyetheretherketone, polylactide, polyglycolide, poly(lactide-co-glycolide), poly(dioxanone), poly(ε

-caprolactone), poly(hydroxylbutyrate), poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene fumarate.

39. The method of claim 37, wherein the balloon is in a shape selected from the group consisting of conical, spherical, square, long conical, long spherical, long square, tapered, stepped, dog bone, and offset.

40. The method of claim 36, wherein the inflatable member is permeable, semi-permeable, or impermeable.