THERAPEUTIC DRUG ELUTING IMPLANT COVER AND METHOD OF MAKING THE SAME

• US 20100247600A1
• Filed: 10/30/2009
• Published: 09/30/2010
• Est. Priority Date: 03/24/2009
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Amery, Drew, Trieu, Hai H., McKay, William F., Xia, Jusong, Metcalf, Newton H. JR., Kerr, Nikolas F.
• Application Number:
  US12/610,005
• Publication Number:
  US 20100247600A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

A drug-eluting implant cover fabricated from a drug-eluting biocompatible matrix containing at least one elutable drug, a drug-eluting implant cover kit containing at least one drug-eluting implant cover, and a method of manufacturing the same.

Claims

1. A drug-eluting implant cover comprising:

a pre-formed snap-to-fit implant cover fabricated from a drug-eluting biocompatible matrix comprising at least one elutable drug wherein said drug-eluting biocompatible matrix is configured for therapeutically delivering said at least one elutable drug to a surgical area and to facilitate non-irritating motion across adjacent tissue.

2. The drug-eluting implant cover of claim 1 wherein said drug-eluting biocompatible matrix is made of or coated with a friction-reducing material in order to reduce irritation of adjacent tissue with motion across said tissue.

3. The drug-eluting implant cover of claim 2 wherein said friction-reducing material is selected from the group consisting of silicone, hydrogel, xerogel, polyethylene, lotions, lubricants, oils, greases and combinations thereof so as to facilitate non-irritating motion across soft tissue.

4. The drug-eluting implant cover of claim 3, wherein said hydrogel is selected from the group consisting of a polyvinyl alcohol, a polyacrylic acid, a polyarylamide, a poly(acrylonitrile-acrylic acid), a polyurethane, a polyethylene glycol, a poly(N-vinyl-2-pyrrolidone), a gelatin, a collagen, a polysaccharide, a cellulose, and combinations thereof.

5. The drug-eluting implant cover of claim 1, wherein said drug-eluting biocompatible matrix comprises a film-forming polymer.

6. The drug-eluting implant cover of claim 5, wherein said film-forming polymer is selected from the group consisting of bioresorbable polymer, hydrogel, polylactide, polyglycolide, copolymers of polylactide, polyglycolide, polycaprolactone, polyorthoester, silicone, polyurethane, silicone-polyurethane copolymers, polyethylene, polypropylene, polyester, polyaryletherketone, polyimide, polyetherimide, polyamide, polysulfone and combinations thereof.

7. The drug-eluting implant cover of claim 6, wherein said hydrogel is selected from the group consisting of a polyvinyl alcohol, a polyacrylic acid, a polyarylamide, a poly(acrylonitrile-acrylic acid), a polyurethane, a polyethylene glycol, a poly(N-vinyl-2-pyrrolidone), a gelatin, a collagen, a polysaccharide, a cellulose, and combinations thereof.

8. The drug-eluting implant cover of claim 1, wherein said elutable drug is selected from the group consisting of at least one antibiotic agent, antiseptic agent, analgesic, bone growth promoting substance, anti-inflammatant, anti-arrhythmics, anti-coagulants, antifungal agent, growth inhibitors, growth stimulators, steroid, anti-adhesion agent, growth factor, wound-healing accelerator, immuno-suppressant, bone morphogenic protein, soft tissue growth inhibitors and combinations thereof.

9. The drug-eluting implant cover of claim 1, wherein the elutable drug is rifampin in combination with minocycline and/or clindamycin.

10. The drug-eluting implant cover of claim 9, wherein rifampin is present in an amount of between about 0.03 wt % and about 0.07 wt % and clindamycin is present in an amount of between about 0.1 wt % and about 0.2 wt %.

11. The drug-eluting implant cover of claim 10, wherein rifampin is present at between about 0.05 wt % and about 0.06 wt % and clindamycin is present between about 0.1 wt % and about 0.2 wt %.

12. The drug-eluting implant cover of claim 10, wherein the drug-eluting biocompatible matrix comprises a silicone elastomer.

13. The drug-eluting device of claim 9, wherein minocycline is present in an amount between about 0.02 wt % and about 0.8 wt % and rifampin is present in an amount between about 0.03 wt % and about 1.0 wt %.

14. The drug-eluting device of claim 9, wherein minocycline is present in an amount between about 0.1 wt % and about 0.3 wt % and rifampin is present in an amount between about 0.1 wt % and about 0.4 wt %.

15. The drug-eluting device of claim 13, wherein the biocompatible matrix comprises a silicone elastomer.

16. The drug-eluting implant cover of claim 1, wherein said implant cover is configured to fit an implant selected from the group consisting of a spinal stabilization implant, spinal dynamic implant, spinal rod, spinal plate, anterior spinal plate, spinal rod component of a spinal fixation system, spinal fixation system, spinal interbody fusion device, bone screw, pedicle screw, crosslink component, spinal hook, interspinous process spacer, bone rod and sub-assembly components thereof.

17. The drug-eluting implant cover of claim 1, wherein said drug-eluting biocompatible matrix has a thickness of between about 0.1 mm and about 5 mm.

18. A drug-eluting implant cover kit comprising at least one snap-to-fit implant cover of claim 1 in a sterile container.

19. The drug-eluting implant cover kit of claim 18, wherein said at least one elutable drug comprises a combination of minocycline and rifampin or a combination of clindamycin and rifampin.

20. The drug-eluting implant cover kit of claim 19, wherein the elutable drug comprises a combination of clindamycin and rifampin and rifampin is present at between about 0.05 wt % and about 0.06 wt % and clindamycin is present between about 0.1 wt % and about 0.2 wt % and the drug-eluting biocompatible matrix comprises a silicone elastomer.