PREFORMED DRUG-ELUTING DEVICE TO BE AFFIXED TO AN ANTERIOR SPINAL PLATE

• US 20100266657A1
• Filed: 10/30/2009
• Published: 10/21/2010
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H., McKay, William F., Xia, Jusong, Metcalf, Newton H. JR., Amery, Drew, Kerr, Nikolas F.
• Granted Patent: US 9,078,712 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/8042 the additional component being a cover over the screw head
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• 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: A61P 19/00 Drugs for skeletal disorders

Abstract

A drug-eluting device comprising a drug-eluting matrix containing at least one elutable drug, a method of manufacturing a preformed drug-eluting device, and an implant kit comprising the same.

Claims

1. A drug-eluting device comprising a drug-eluting biocompatible matrix containing at least one elutable drug and at least one substance that facilitates non-irritating motion of the device across adjacent tissue, said device configured to fit an anterior spinal plate comprising at least one affixation feature for providing affixation of the device to said anterior spinal plate.

2. The drug-eluting device of claim 1, wherein the affixation feature is selected from the group consisting of drug-eluting matrix fabricated from a shape-memory material, drug-eluting matrix fabricated from a heat-shrinkable material, tabs, sutures, staples, pins, screws, biocompatible adhesive, snap-fit element(s), press-fit elements(s), structure engageable with mating structure on the said anterior spinal plate plate and combinations thereof.

3. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises at least one semi-synthetic or fully synthetic polymer.

4. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises a bioresorbable polymer.

5. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises a hydrogel 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.

6. The drug-eluting device of claim 1, wherein the elutable drug comprises at least one antibacterial, antifungal, anti-inflammatory, analgesic, soft tissue growth inhibitors or combination thereof.

7. The drug-eluting device of claim 6, wherein the elutable drug is rifampin in combination with minocycline and/or clindamycin.

8. The drug-eluting device of claim 7, wherein rifampin is present in an amount of between about 0.03 wt % and about 0.7 wt % and clindamycin is present in an amount of between about 0.1 wt % and about 0.2 wt %.

9. The drug-eluting device of claim 7, 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 %.

10. The drug-eluting device of claim 9, wherein the drug-eluting biocompatible matrix comprises a silicone elastomer.

11. The drug-eluting device of claim 7, 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 %.

12. The drug-eluting device of claim 1, 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 %.

13. The drug-eluting device of claim 12, wherein the biocompatible matrix comprises a silicone elastomer.

14. A method of manufacturing a preformed drug-eluting device of claim 1, the method comprising:

forming a drug-eluting biocompatible matrix from a silicone elastomeric material into an hollow cylindrical shape having a top end, a bottom end and a wall extending between the top end and the bottom end, wherein the wall has an interior face and an exterior face;

creating a solution containing rifampin and clindamycin dissolved in a solvent selected from the group consisting of methylene chloride, xylene, chloroform and combinations thereof at concentration between about 0.1 to about 0.8 grams per deciliter;

immersing the drug-eluting biocompatible matrix in the solution;

removing the drug-eluting biocompatible matrix from the solution; and

removing the solvent from the drug-eluting biocompatible matrix to produce a preformed drug-eluting device.

15. The method of manufacturing a preformed drug-eluting device of claim 14, the further comprising:

creating a solution containing rifampin and clindamycin dissolved in a solvent wherein the rifampin is present in an amount of between about 0.03 wt % and about 0.07 wt % and the clindamycin is present in an amount of between about 0.1 wt % and about 0.2 wt %.

16. The method of manufacturing a preformed drug-eluting device of claim 15, the further comprising:

removing the solvent from the drug-eluting biocompatible matrix by purging the drug-eluting biocompatible matrix with nitrogen and subjecting the drug-eluting biocompatible matrix to a vacuum to drive off the solvent.

17. An implant kit comprising:

an anterior spinal plate; and

,

at least one preformed drug-eluting device of claim 1.

18. A drug-eluting device comprising a drug-eluting biocompatible matrix containing at least one elutable drug and at least one substance that facilitates non-irritating motion of the device across adjacent tissue, said device configured to fit a spinal rod comprising at least one affixation feature for providing affixation of the device to said spinal rod.

19. The drug-eluting device of claim 18 wherein the affixation feature is selected from the group consisting of drug-eluting matrix fabricated from a shape-memory material, drug-eluting matrix fabricated from a heat-shrinkable material, tabs, sutures, staples, pins, screws, biocompatible adhesive, snap-fit element(s), press-fit elements(s), structure engageable with mating structure on the said anterior spinal plate plate and combinations thereof.

20. The drug-eluting device of claim 18, 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 % and the drug-eluting biocompatible matrix comprises a silicone elastomer.