Antimicrobial Needle Coating For Extended Infusion

• US 20070299409A1
• Filed: 11/09/2005
• Published: 12/27/2007
• Est. Priority Date: 11/09/2004
• Status: Abandoned Application

• Current Assignee: Angiotech Pharmaceuticals Incorporated
• Original Assignee: Angiotech Pharmaceuticals Incorporated
• Inventors: Gravett, David, Lydon, Margaret, Whitbourne, Richard
• Application Number:
  US11/667,311
• Publication Number:
  US 20070299409A1
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer

Abstract

The present invention relates to bioabsorbable polymeric coatings with antimicrobial agents that provide coated surfaces that resist protein absorption and infectious formation on coated surfaces of medical devices that are inserted or implanted in patients, and kits thereof with an antimicrobial disc.

Claims

1. A medical device comprising a percutaneously insertable surface, the insertable surface comprising a surface layer comprising at least one anti-infective agent and at least one bioerodable polymer, wherein the surface layer extends the patency of the device when inserted into a patient.

2. The device of claim 1, wherein the surface layer is a coating.

3. The device of claim 2, wherein the device is coated with a composition comprising at least one anti-infective agent and at least one anti-protein absorption bioerodable polymer.

4. The device of claim 1, wherein the surface layer is deciduous.

9. The device of claim 1, wherein the medical device is selected from the group consisting of a needle, an infusion set or device, a peripheral venous catheter or needle, an indwelling infusion needle, a butterfly needle, a subcutaneous access device, an insulin pump needle, a patient controlled analgesia (PCA) pump needle, an arterial catheter, a central venous catheter, a dialysis catheter, a peritoneal dialysis catheter, a nephrostomy catheter, a percutaneous cystostomy catheter, an indwelling paracentesis or pleurocentesis catheter or drain, a percutaneous nephrostomy, a cystostomy tube, a spinal or epidural catheter, and a sensor.

14. The device of claim 1, wherein the device is a blood glucose monitor.

15. The device of claim 1, wherein the polymer is biocompatible and bioabsorbable.

16. The device of claim 1, wherein the device surface resists protein encapsulation.

17. The device of claim 1, wherein the bioerodable polymer comprises a water soluble polymer or a dispersible polymer.

18. The device of claim 1, wherein the bioerodable polymer comprises one or more polymers selected from the group consisting of polyethylene glycol, polyethylene oxide, acrylic acid or a salt or a copolymer thereof, acrylic emulsion copolymer, a polymer or copolymer of polylactic acid, a polymer or copolymer of polyglycolic acid, polyacrylamide, polyvinylpyrrolidone, polyurethane, water-soluble cellulose polymer, and methylcellulose.

20. The device of claim 1, wherein the surface layer comprises about 50% to about 99.9% bioerodable polymer.

21. The device of claim 1, wherein the surface layer comprises about 70% to about 99% bioerodable polymer.

22. The device of claim 1, wherein the bioerodable polymer is higher molecular weight polyethylene glycol (PEG).

23. The device of claim 22, wherein the polyethylene glycol (PEG) has a molecular weight of at least about 3500.

24. The device of claim 22, wherein the polyethylene glycol (PEG) has a molecular weight of at about 3500 to 35,000.

28. The device of claim 1, wherein the surface layer further comprises a non-bioabsorbable polymer.

29. The device of claim 28, wherein the non-bioabsorbable polymer comprises one or more polymers selected from the group consisting of acrylates, urethanes, polycarbonates, polyamides, polyesters and polyimides, styrene isobutylene, styrene polymers, cellulose esters, polystyrene, and alkylated polyvinylpyrrolidone.

30. The device of claim 1, wherein the surface layer further comprises a biostable polymer.

31. The device of claim 30, wherein the biostable polymer comprises one or more polymers selected from the group consisting of cellulose ester polymers and copolymers, polyurethanes, polyvinyl chloride, polyamides, acrylate polymers and copolymers, ethylenevinylacetate copolymers, vinylpyrrolidoneethylacetate copolymers, acetal polymers and copolymers, silicone polymers and copolymers, polyesters, polyimides and copolymers and polyetherimides.

32. The device of claim 1, wherein the surface layer comprises at least about 1 to 50% nitrocellulose.

42. The device of claim 1, wherein the surface layer further comprises bactericides, antibiotics, antivirals, antiseptics, antineoplastics, anticancer compounds, antifungals, anti-yeast, and/or anti-scarring agents.

43. The device of claim 1, wherein the surface layer comprises paclitaxel or rapamycin or an analog or derivative thereof.

46. The device of claim 1, wherein the surface layer further comprises a corticosteroid.

49. The device of claim 1, wherein the surface layer further comprises a non-steroidal anti-inflammatory drug (NSAID).

51. The device of claim 1, wherein the surface layer comprises two or more coating layers.

5-8. -8. (canceled)

10-13. -13. (canceled)

19. (canceled)

25-27. -27. (canceled)

33-41. -41. (canceled)

44-45. -45. (canceled)

47-48. -48. (canceled)

50. (canceled)

52-55. -55. (canceled)

56. A coating composition comprising at least one anti-infective agent and at least one bioerodable polymer, wherein the coating composition, when applied to a percutaneously insertable surface of an insertable or implantable medical device, provides a surface layer that substantially extends the patency of the device when inserted into a patient.

57-74. -74. (canceled)

75. A kit for reducing protein absorption and infection arising from insertion of a medical device through a body surface comprising:

an insertable medical device having a percutaneously insertable surface,

means for providing the insertable surface with an anti-infective, anti-protein absorption coating, wherein the coating comprises at least one anti-infective agent and at least one polymer; and

a disc comprising at least one anti-infective agent, said disc being adapted to surround and abut said percutaneously insertable surface when the device is inserted in a subject and a portion of said percutaneously insertable surface projects from an external bodily surface of the subject, and said disc is in contact with said external bodily surface of the subject.

83. The kit of claim 75, wherein the device is selected from the group consisting of a needle, an infusion set or device, a peripheral venous catheter or needle, an indwelling infusion needle, a butterfly needle, a subcutaneous access device, an insulin pump, a patient controlled analgesia (PCA) pump, an arterial catheter, a central venous catheter, a dialysis catheter, a peritoneal dialysis catheter, a nephrostomy catheter, a percutaneous cystostomy catheter, an indwelling paracentesis or pleurocentesis catheter or drain, a percutaneous nephrostomy, a cystostomy tube, a spinal or epidural catheter, and a sensor.

76-82. -82. (canceled)

84-119. -119. (canceled)