Preformed drug-eluting device to be affixed to an anterior spinal plate

• US 9,078,712 B2
• Filed: 10/30/2009
• Issued: 07/14/2015
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Xia, Jusong, Trieu, Hai H., McKay, William F., Metcalf, Newton H. Jr., Kerr, Nikolas F., Amery, Drew
• Primary Examiner(s): Pallay, Michael B
• Application Number:
  US12/610,020
• Publication Number:
  US 20100266657A1
• Time in Patent Office: 2,083 Days
• Field of Search: 424/423
• 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
• 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:

an open cell drug-eluting matrix containing at least one elutable drug and at least one anti-adhesion substance that facilitates non-irritating motion of the device across adjacent tissue; and

an anterior spinal plate comprising at least one affixation feature for providing affixation of the drug-eluting matrix to said anterior spinal plate,

wherein said drug-eluting matrix is configured to engage a surface of said anterior spinal plate and comprises rifampin and minocycline, wherein the rifampin and minocycline are configured to be eluted from said drug-eluting matrix towards said surface of said anterior spinal plate, and

wherein said anterior spinal plate and said drug-eluting matrix are provided as two separately sterilized components, said anterior spinal plate being sterilized using an autoclave and said drug-eluting matrix being sterilized using sterilizing radiation or sterilant gas.

2. The drug-eluting device of claim 1, wherein the affixation feature is a cavity and said drug-eluting matrix comprises an extension that is configured to be press fit into said cavity.

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 biocompatible matrix comprises a silicone elastomer.

5. The drug-eluting device of claim 1, wherein the drug-eluting matrix is configured such that the rifampin and the minocycline pass directly to the surface of the anterior spinal plate.

6. The drug-eluting device of claim 1, wherein the drug-eluting matrix is configured to have a gradient such that the drug-eluting matrix has a greater concentration of rifampin and minocycline adjacent a surface of the drug-eluting matrix that engages the surface of the anterior spinal plate.

7. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises 0.03 wt % of rifampin and 0.09 wt % of minocycline post-sterilization.

8. The drug-eluting device of claim 1, wherein the rifampin is present in an amount of between about 0.05 wt % and about 0.06 wt %.

9. The drug-eluting device of claim 1, wherein the drug-eluting matrix is a planar sheet comprising multiple layers.

10. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises a first layer including the rifampin and a second layer comprising the minocycline.

11. The drug-eluting device of claim 1, wherein the drug-eluting matrix comprises a plurality of drug-eluting matrices.

12. The drug-eluting device of claim 1, wherein said anterior spinal plate is fabricated from a bioresorbable polymer.

13. The drug-eluting device of claim 1, wherein said open cell drug-eluting matrix comprises polyurethane foam.

14. The drug-eluting device of claim 1, wherein at least one of said rifampin and said minocycline are incorporated into said drug-eluting matrix in both an encapsulated form in which said rifampin and/or said minocycline are encased in a dissolvable bead or liposome and in a free form that comprises a liquid carrier.

15. The drug-eluting device of claim 1, wherein said affixation feature is a cavity that extends through opposite top and bottom surfaces of said anterior spinal plate and said drug-eluting matrix comprises an extension that is configured to be press fit into said cavity, said top and bottom surfaces each being planar and free of any projections extending outwardly therefrom.

16. An implant kit comprising:

an anterior spinal plate; and

,

at least one preformed drug-eluting device comprising an open cell drug-eluting matrix and at least one anti-adhesion substance, said drug-eluting matrix comprising rifampin and minocycline,

wherein said anterior spinal plate and said at least one preformed drug-eluting device are provided as two separately sterilized components, said anterior spinal plate being sterilized using an autoclave and said at least one preformed drug-eluting device being sterilized using sterilizing radiation or sterilant gas.

17. The implant kit of claim 16, further comprising a plurality of drug-eluting matrices each comprising rifampin and minocycline, wherein each of said plurality of drug-eluting matrices includes a different amount of rifampin and minocycline and wherein each of said plurality of drug-eluting matrices are sterilized using sterilizing radiation or sterilant gas and are provided separately.

18. A system comprising:

a spinal rod; and

a hollow drug-eluting device having a cylindrical shape defining a sleeve configured to have said spinal rod positioned therein, said device comprising an open cell drug-eluting biocompatible matrix containing at least one elutable drug and at least one anti-adhesion substance that facilitates non-irritating motion of the device across adjacent tissue, said device comprising a lengthwise slit extending through an inner surface and an outer surface of said device, said inner surface of said device being configured to engage an outer surface of said spinal rod, said device comprising at least one affixation feature for providing affixation of the device to said spinal rod,

wherein said spinal rod and said device are provided as two separately sterilized components, said spinal rod being sterilized using an autoclave and said device being sterilized using sterilizing radiation or sterilant gas.

19. The system of claim 18 wherein the affixation feature is press-fit elements(s).

20. The system of claim 18, wherein said spinal rod is cylindrical and is free of any openings extending through said spinal rod.