Anterior spinal plate with preformed drug-eluting device affixed thereto

• US 9,414,864 B2
• Filed: 04/15/2009
• Issued: 08/16/2016
• 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.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/409,089
• Publication Number:
  US 20100268282A1
• Time in Patent Office: 2,680 Days
• Field of Search: 606/70, 606/280, 606/295, 606/298
• US Class Current: 1/1
• 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

Abstract

An anterior spinal plate has affixed to at least a portion of a surface thereof at least one preformed drug-eluting device fabricated from a drug-eluting matrix containing at least one elutable drug.

Claims

1. A drug-eluting device comprising a drug-eluting biocompatible matrix comprising a layer of a bioresorbable polymer and at least one antibacterial elutable drug comprising clindamycin at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix in combination with rifampin at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix, and minocycline at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix, said device comprising at least one locking element configured to attach with an anterior spinal plate, wherein the matrix comprises a non-bioresorbable layer disposed in between the plate and the bioresorbable layer and each layer comprises distinct zones of concentration within the matrix with the drugs clindamycin, rifampin and minocycline.

2. The drug-eluting device of claim 1, wherein said at least one locking element includes an elastomeric material configured to engage a surface of the anterior spinal plate in a snug fit arrangement.

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 3, wherein the semi-synthetic or fully synthetic polymer is selected from the group consisting of silicone, polyurethane, silicone-polyurethane copolymers, polyethylene, polypropylene, polyester, polyaryletherketone, polyimide, polyetherimide, polyamide, polysulfone and combinations thereof.

5. The drug-eluting device of claim 1, wherein the bioresorbable polymer is selected from the group consisting of hydrogel, polylactide, polyglycolide, copolymers of polylactide and polyglycolide, polycaprolactone, polyorthoester and combinations thereof.

6. The drug-eluting device of claim 1, wherein said locking element is selected from the group consisting of tabs, sutures, staples, anchors, pins, screws, flexible or elastic structures configured to snap-fit or pressure-fit the drug-eluting device to the anterior spinal plate.

7. The drug-eluting device of claim 1, wherein at least a portion of a surface of the drug-eluting device comprises a layer of biocompatible adhesive positioned to securely attach the drug-eluting device to at least a portion of a tissue exposed surface of the anterior spinal plate.

8. The drug-eluting device of claim 7, wherein the biocompatible adhesive comprises at least one material selected from the group consisting of cyanoacrylate, epoxy, silicone, acrylics, polyvinyl alcohol, polyurethane, polysaccharide, albumin, collagen and combinations thereof.

9. The drug-eluting device of claim 1, wherein the drug-eluting device is configured to be attached to the anterior spinal plate having one or more screws used for securing the anterior spinal plate to spinal bone.

10. 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.

11. The drug-eluting device of claim 1, wherein the bioresorbable polymer comprises polycaprolactone.

12. The drug-eluting device of claim 1, wherein the at least one elutable drug is encased in liposomes for delayed release of the at least one elutable drug.

13. The drug-eluting device of claim 1, wherein the antibacterial consists of clindamycin, rifampin and minocycline.

14. A spinal implant kit comprising:

a) an anterior spinal plate; and

, b) at least one preformed drug-eluting device fabricated from a drug-eluting matrix comprising a layer of a bioresorbable polymer and at least one antibacterial elutable drug comprising clindamycin at a level of from 1 to about 20 weight percent of the drug-eluting matrix in combination with rifampin at a level of from 1 to about 20 weight percent of the drug-eluting matrix, and minocycline at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix, said device comprising at least one locking element configured to attach with said anterior spinal plate, wherein the matrix comprises a non-bioresorbable layer disposed in between the plate and the bioresorbable layer and each layer comprises distinct zones of concentration within the matrix with the drugs clindamycin, rifampin and minocycline.

15. A method for surgically installing an anterior spinal plate in a body which comprises surgically installing an anterior spinal plate in the body of a patient and affixing to at least a portion of a surface of the plate at least one preformed drug-eluting device fabricated from a drug-eluting biocompatible matrix comprising a layer of a bioresorbable polymer and at least one antibacterial elutable drug comprising clindamycin at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix in combination with rifampin at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix, and minocycline at a level of from 1 to about 20 weight percent of the drug-eluting biocompatible matrix, said device comprising at least one locking element configured to attach with said anterior spinal plate, wherein the matrix comprises a non-bioresorbable layer disposed in between the plate and the bioresorbable layer and each layer comprises distinct zones of concentration within the matrix with the drugs clindamycin, rifampin and minocycline, the affixing step being carried out prior to, during or following the installing step.

16. The method of claim 15, wherein the preformed drug-eluting device is affixed to the anterior spinal plate by biocompatible adhesive, one or more screws, pressure fit or is a stretchable structure that is engagedly fitted to some portion of the plate.

17. The method of claim 16, wherein the biocompatible adhesive is present on at least a portion of a surface of the drug-eluting device to be contacted with a surface of the anterior spinal plate.