Implantable devices for chemonucleolysis of intervertebral discs

• US 9,061,064 B2
• Filed: 11/29/2006
• Issued: 06/23/2015
• Est. Priority Date: 08/06/2003
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H.
• Primary Examiner(s): Skowronek, Karlheinz R
• Assistant Examiner(s): Fischer, Joseph
• Application Number:
  US11/605,815
• Publication Number:
  US 20070128575A1
• Time in Patent Office: 3,128 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/254 Enzymes, proenzymes
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Devices for the treatment of intervertebral discs are described. The devices, when implanted into the nucleus pulposus of an intervertebral disc, provide for the controlled release of active agents into the disc. The active agent can be a chemonucleolytic agent such as chymopapain. The device can also comprise one or more binders. The device can be an elongate solid body having a tapered or rounded insertion end. Alternatively, the device can include a plurality of particles.

Claims

1. An intervertebral disc implant comprising a chemonucleolysis agent in solid powder form, a plurality of particles and a binder, wherein the implant has a solid body throughout the cross-section of the implant and when placed into the nucleus pulposus of an intervertebral disc, the implant having a sheath comprising the chemonucleolysis agent incorporated into the sheath, the implant sustainably releases the chemonucleolysis agent into the nuclear disc tissue surrounding the implant to proteolytically degrade the tissue, the chemonucleolysis agent comprises chymopapain and is incorporated into the particles.

2. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 0.1 to 500 μ

m.

3. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 0.5 to 250 μ

m.

4. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 1 to 100 μ

m.

5. The intervertebral disc implant of claim 1, wherein the chemonucleolysis agent further comprises collagenase, chondroitinase-ABC and human proteolytic enzymes.

6. The intervertebral disc implant of claim 1, wherein the solid body is an elongate solid body.

7. The intervertebral disc implant of claim 1, wherein the solid body is an elongate solid body having a tapered or rounded end.

8. The intervertebral disc implant of claim 1, wherein the solid body is a microsphere.

9. The intervertebral disc implant of claim 1, wherein the solid body has a profile shape selected from the group consisting of the profile shapes depicted in FIGS. 16A, 16B, 16C, 16D, 16E, 16F, 16G, 16H, 16I, 16J, 16K, 16L, 16M, 16N and 16O.

10. The intervertebral disc implant of claim 1, wherein the solid body has a circular cross section.

11. The intervertebral disc implant of claim 1, wherein the implant comprises up to 90% by volume of the binder.

12. The intervertebral disc implant of claim 1, wherein the implant comprises from 25 to 75% by volume of the binder.

13. The intervertebral disc implant of claim 1, wherein the binder is a polymer.

14. The intervertebral disc implant of claim 1, wherein the binder is a non-resorbable polymer, a bioresorbable polymer, or a naturally occurring polymer.

15. The intervertebral disc implant of claim 1, wherein the binder is a non-resorbable polymer selected from the group consisting of polyurethanes, polysiloxanes, polymethyl methacrylate, polyethylene, polyvinyl alcohol, polyvinyl pyrrolidone, poly(2-hydroxy ethyl methacrylate), polyacrylic acid, poly(ethylene-co-vinyl acetate), polyethylene glycol, polymethacrylic acid, and polyacrylamide.

16. The intervertebral disc implant of claim 1, wherein the binder is a bioresorbable polymer selected from the group consisting of polylactides, polyglycolides, polylactide-co-glycolides, polyanhydrides, and polyorthoesters.

17. The intervertebral disc implant of claim 1, wherein the binder is a naturally occurring polymer selected from the group consisting of polysaccharides, collagens, silk, elastin, keratin, albumin, and fibrin.

18. The intervertebral disc implant of claim 1, wherein the implant further comprises a second active agent different than the chemonucleolysis agent.

19. The intervertebral disc implant of claim 18, wherein the second active agent is a pain medication or a growth factor.

20. The intervertebral disc implant of claim 18, wherein the second active agent is a pain medication selected from the group consisting of codeine, propoxyphene, hydrocodone, and oxycodone.

21. The intervertebral disc implant of claim 18, wherein the second active agent is a growth factor selected from the group consisting of a transforming growth factor-B protein, a bone morphogenetic protein, a fibroblast growth factor, a platelet-derived growth factor, and an insulin-like growth factor.

22. The implant of claim 1, wherein the solid body further comprises a hydrogel coating.

23. The implant of claim 1, further comprising an x-ray marker.

24. The implant of claim 23, wherein the x-ray marker is a bead or a thread.

25. The implant of claim 23, wherein the x-ray marker comprises barium sulfate, platinum or tantalum.

26. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 5 mm.

27. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 3 mm.

28. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 1 mm.

29. The implant of claim 1, wherein the implant erodes upon resorption.