Implants for treatment of symptomatic or degenerated intervertebral discs

• US 8,920,828 B2
• Filed: 11/29/2006
• Issued: 12/30/2014
• 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): Driscoll, Lora E Barnhart
• Application Number:
  US11/605,728
• Publication Number:
  US 20070122446A1
• Time in Patent Office: 2,953 Days
• US Class Current: 424/426
• 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 one or more 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. For devices containing multiple active agents, the configuration of the device be chosen to provide for the sequential or simultaneous release of each of the active agents. The elongate solid body can include a sheath comprising a first active agent and a core comprising a second active agent.

Claims

1. An intervertebral disc implant comprising a first layer including a first active agent and a second layer including a second active agent therapeutically different than the first active agent, wherein the first and second active agents are in solid form and wherein the second layer is configured to delay exposure to the first layer from an in vivo environment of the soft tissue of the nucleus pulposus.

2. The implant of claim 1, wherein the implant is a solid body.

3. The implant of claim 1, wherein the second active agent is a chemonucleolysis agent and wherein the first active agent is a growth factor.

4. The implant of claim 3, wherein the growth factor is selected from the group consisting of a transforming growth factor-beta protein, a bone morphogenetic protein, a fibroblast growth factor, a platelet-derived growth factor, and an insulin-like growth factor.

5. The implant of claim 2, wherein the solid body is an elongate solid body.

6. The implant of claim 2, wherein the solid body is an elongate solid body having a circular cross section.

7. The implant of claim 5, wherein the elongate solid body has a tapered or rounded end.

8. The implant of claim 1, wherein the implant is a microsphere, wherein the microsphere includes the first layer of a core comprising the first active agent and the second layer of a shell comprising the second active agent.

9. The implant of claim 8, wherein the first active agent is a growth factor and the second active agent is a chemonucleolysis agent.

10. The implant of claim 5, wherein the elongate solid body includes the first layer of a core comprising the first active agent and the second layer of a sheath comprising the second active agent.

11. The implant of claim 10, wherein the second active agent is chymopapain.

12. The implant of claim 10, wherein the core further comprises a first binder and wherein the sheath further comprises a second binder.

13. The implant of claim 12, wherein the first and second binders are both bioresorbable polymers.

14. The implant of claim 13, wherein the first binder is less bioresorbable than the second binder.

15. The implant of claim 13, wherein the first active agent is a growth factor and wherein the second active agent is a chemonucleolysis agent.

16. The implant of claim 15, wherein the second active agent is chymopapain.

17. The implant of claim 1, wherein the implant comprises three or more different active agents.

18. The implant of claim 5, wherein the elongate solid body includes the first layer of a core comprising the first active agent, the second layer of an inner sheath comprising the second active agent, and a third layer of an outer sheath comprising a third active agent different than the first and second active agents.

19. The implant of claim 18, wherein the first active agent is a growth factor, the second active agent is a chemonucleolysis agent and the third active agent is a pain medication.

20. The implant of claim 18, wherein the core comprises a first binder, the inner sheath comprises a second binder, and the outer sheath comprises a third binder.

21. The implant of claim 10, comprising a plurality of adjacent layers within the core each comprising a different active agent.

22. The implant of claim 2, further comprising a hydrogel coating.

23. The implant of claim 2, 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 5, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 5 mm.

27. The implant of claim 5, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 3 mm.

28. The implant of claim 5, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 1 mm.