Beaded wound spacer device

• US 8,685,421 B2
• Filed: 07/06/2007
• Issued: 04/01/2014
• Est. Priority Date: 07/07/2006
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Kloke, Tim M., Keough, Steven J., Lockwood, Nathan, Gardner, Margaret R., Hergenrother, Robert W., Chappa, Ralph A.
• Primary Examiner(s): Epps-Smith, Janet
• Assistant Examiner(s): Buckley, Audrea
• Application Number:
  US11/774,495
• Publication Number:
  US 20080188819A1
• Time in Patent Office: 2,461 Days
• Field of Search: 424/404
• US Class Current: 424/404
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/62 Encapsulated active agents, e.g. emulsified droplets
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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 31/04 Antibacterial agents

Abstract

A wound spacer device comprising multiple beads connected by non-absorbable suture material is disclosed. The device can be applied, for example, by a first responder to an injured individual, or can be applied by a trauma treatment facility, such as a Level 2 medical unit. In typical embodiments the device allows for site-specific controlled elution of an antimicrobial agent, such as Tobramycin, including defined elution over a period of time, such as 48 or 72 hours.

Claims

1. A removable wound spacer packing device, said wound spacer packing device comprising:

a plurality of beads arranged along a flexible textured polyamide connector material, each of said beads comprising;

a polyamide core;

a first layer outside said core, said first layer containing a bioactive agent and a polymeric material derived from poly[vinylpyrrolidone], wherein said polymeric material is crosslinked to the core material;

a second layer outside said first layer, said second layer comprising poly(butylmethacrylate) and poly(ethylene-co-vinyl acetate), wherein the second layer outside the core is crosslinked to the first layer outside the core; and

a third layer outside said first layer, said third layer comprising poly(butylmethacrylate).

2. The removable wound spacer packing device of claim 1, wherein the second layer further comprises poly (vinylpyrrolidone).

3. The removable wound spacer packing device of claim 1, wherein the bioactive agent is selected from the group consisting of tobramycin, tobramycin sulfate, vancomycin, amikacin, gentamicin, kanamycin, neomycin, tigecycline, netilmicin, paromomycin, streptomycin, and apramycin and combinations thereof.

4. The removable wound spacer packing device of claim 1, wherein the bioactive agent comprises tobramycin sulfate.

5. The removable wound spacer packing device of claim 1, wherein the poly(ethylene-co-vinyl acetate) is selected from the group consisting of poly(ethylene-co-vinyl acetate) polymers having vinyl acetate concentrations of between about 10% and about 50% by weight.

6. The removable wound spacer packing device of claim 1, wherein the bioactive agent comprises a dose of about 500 to 2000 mcg per bead.

7. The removable wound spacer packing device of claim 1, wherein the bioactive agent has an elution profile such that at least 50 percent of the bioactive agent releases from the first, second, and third layers within 72 hours of placement within a wound.

8. The removable wound spacer packing device of claim 1, wherein the bioactive agent has an elution profile such that at least 65 percent of the bioactive agent releases from the first, second, and third layers within 72 hours of placement within a wound.

9. The removable wound spacer packing device of claim 1, wherein the beads are each molded to the connector material with sufficient strength so that the connector material will break under a tension load before the bond between the connector material and polyamide core breaks.

10. The removable wound spacer packing device of claim 1, wherein the cores of the plurality of beads contain barium sulfate.

11. The removable wound spacer packing device of claim 1, wherein only a portion of each bead of the plurality of beads contains barium sulfate.

12. The removable wound spacer packing device of claim 1, wherein the plurality of beads have an average spacing distance that is between 0.8 and 1.2 times the length of the average bead core diameter in contact with the connecting material.

13. The removable wound spacer packing device of claim 1, wherein the flexible polyamide connector material is coated with at least a first layer containing a bioactive agent and a polymeric material derived from poly[vinylpyrrolidone].

14. The removable wound spacer packing device of claim 1, wherein the flexible polyamide connector material is substantially free of silicone.

15. The removable wound spacer packing device of claim 1, wherein the connector material comprises flexile braided suture material.

16. The removable wound spacer packing device of claim 1, wherein the beads are non-spherical.

17. The removable wound spacer packing device of claim 1, wherein the beads have an average volume between 15 and 8,000 cubic millimeters.

18. The removable wound spacer packing device of claim 1, wherein the device volume is from 1 to 150 cubic centimeters.

19. A removable wound spacer packing device, said wound spacer packing device comprising:

a plurality of beads arranged along a flexible textured polyamide connector material, each of said polyamide beads comprising;

a polyamide core containing barium sulfate;

a first layer outside said core, said first layer containing a bioactive agent and a polymeric material derived from poly[vinylpyrrolidone] wherein said polymeric material is crosslinked to the core material;

a second layer outside said first layer, said second layer comprising a material derived from poly(butylmethacrylate), poly(ethylene-co-vinyl acetate) and poly (vinyl pyrrolidone), wherein the second layer outside the core is crosslinked to the first layer outside the core; and

a third layer outside said first layer, said third layer comprising poly(butylmethacrylate).

20. The removable wound spacer packing device of claim 19, wherein the bioactive agent is selected from the group consisting of tobramycin, tobramycin sulfate, vancomycin, amikacin, gentamicin, kanamycin, neomycin, tigecycline, netilmicin, paromomycin, streptomycin, and apramycin and combinations thereof.

21. The removable wound spacer packing device of claim 19, wherein the bioactive agent has an elution profile such that at least 65 percent of the bioactive agent elutes within 72 hours of placement within a wound.

22. The removable wound spacer packing device of claim 19, wherein the poly(ethylene-co-vinyl acetate) is selected from the group consisting of poly(ethylene-co-vinyl acetate) polymers having vinyl acetate concentrations of between about 10% and about 50% by weight.

23. The removable wound spacer packing device of claim 19, wherein the flexible polyamide connector material is coated with at least a first layer containing a bioactive agent and a polymeric material derived from poly[vinylpyrrolidone].

27. The removable wound spacer packing device of claim 19, wherein the textured suture material comprises braided suture material.

24. A kit for treating a wound, the kit comprising:

at least two removable wound spacer packing devices, each of said wound spacer packing devices comprising a plurality of beads arranged along a flexible textured polyamide connector material, each of said polyamide beads comprising;

a polyamide core containing barium sulfate;

a first layer outside said core, said first layer containing a bioactive agent and a polymeric material derived from poly[vinylpyrrolidone] wherein said polymeric material is crosslinked to the core material;

a second layer outside said first layer, said second layer comprising a material derived from poly(butylmethacrylate), poly(ethylene-co-vinyl acetate) and poly (vinyl pyrrolidone), wherein the second layer outside the core is crosslinked to the first layer outside the core; and

a third layer outside said first layer, said third layer comprising poly(butylmethacrylate); and

a retaining device for holding the at least two removable wound spacer packing devices during storage and prior to application to a wound.

25. The kit for treating a wound of claim 24, wherein at least one of the wound spacer packing devices contains the bioactive agent tobramycin sulfate.

26. The kit for treating a wound of claim 25, wherein at least one of the wound spacer packing devices contains a gram positive bioactive agent.

28. The removable wound spacer packing device of claim 24, wherein the textured suture material comprises braided suture material.