Antimicrobial coating for dermally invasive devices

• US 8,821,455 B2
• Filed: 07/07/2010
• Issued: 09/02/2014
• Est. Priority Date: 07/09/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Burkholz, Jonathan Karl, Hoang, Minh Quang
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/831,880
• Publication Number:
  US 20110009831A1
• Time in Patent Office: 1,518 Days
• Field of Search: 604265-269
• US Class Current: 604/265
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/442 Colorants, dyes
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/02 Local antiseptics
• CPC Class Codes: A61P 31/04 Antibacterial agents

Abstract

An antimicrobial coating applied to a transdermal surface of a catheter device. An antimicrobial coating applied to catheter device such that when the catheter device is fully inserted, the antimicrobial coating is interposed between the catheter device and the dermal layers of the patient.

Claims

1. An antimicrobial catheter device, comprising:

a catheter having a tip end, a base end, and an extended portion extending therebetween, the catheter further having an outer surface including a transdermal surface and an intravascular surface; and

an antimicrobial agent in the form of a manipulatably adjustable, putty-like matrix applied to the transdermal surface of the outer surface of the catheter, wherein following insertion of the catheter into a patient, a first portion of the antimicrobial agent remains applied to the transdermal surface and is in contact with dermal layers of the patient, and a second portion of the antimicrobial agent is removed from the transdermal surface and deposited external to and surrounding an insertion site into which the catheter is inserted, thereby forming a manually moldable mass of antimicrobial agent proximate to the insertion site.

2. The device of claim 1, wherein the antimicrobial agent comprises:

a polymer component;

a fugitive solvent component;

an alcohol component; and

a biocidal agent.

3. The device of claim 2, wherein the polymer component comprises a cationic polymer component.

4. The device of claim 2, wherein the polymer component is insoluble in water.

5. The device of claim 4, wherein the polymer component is at least one of cellulosic polymer, chitosan, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate, polyurethane.

6. The device of claim 2, wherein the polymer component is water soluble.

7. The device of claim 2, wherein the biocidal agent is present in an amount from approximately 0.01% (w/v) to approximately 10.0% (w/v).

8. The device of claim 2, wherein the biocidal agent is present in an amount from approximately 0.01% (w/v) to approximately 5.0% (w/v).

9. The device of claim 2, wherein the polymer component is present in an amount from approximately 0.001% (w/v) to approximately 5.0% (w/v).

10. The device of claim 2, wherein the biocidal agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, benzalkonium chloride.

11. The device of claim 2, wherein the alcohol component comprises a lower alcohol having between one and six carbon atoms.

12. The device of claim 2, wherein the alcohol component is present within the antimicrobial agent in an amount approximately equal to 20% (w/v).

13. The device of claim 2, wherein the alcohol component comprises a mixture of isopropyl alcohol and ethanol and is present within the antimicrobial agent in an amount from approximately 40% (w/v) to approximately 95% (w/v).

14. The device of claim 2, wherein the fugitive solvent comprises an organic solvent that is present within the antimicrobial agent in an amount from approximately 20% (w/v) to approximately 95% (w/v).

15. The device of claim 2, wherein the polymer component comprises a cationic polymer.

16. The device of claim 1, wherein the antimicrobial agent comprises:

ethanol;

isopropyl alcohol;

chlorhexidine gluconate;

triclosan;

chlorhexidine diacetate;

chloroxylenol;

ethyl cellulose;

tetrahydrofuran, methyl ethyl ketone, or hexane;

water; and

cationic cellulosic polymer.

17. The device of claim 16, wherein the ethanol is present within the antimicrobial agent in an amount of 70% (w/v).

18. The device of claim 16, wherein the chlorhexidine gluconate is present within the antimicrobial agent in an amount of 4% (w/v).

19. The device of claim 16, wherein the chloroxylenol is present within the antimicrobial agent in an amount of 0.1% (w/v).

20. The device of claim 16, wherein the antimicrobial agent comprises a biocompatible bacteria-indicator dye.

21. An antimicrobial catheter device, comprising:

a catheter having a tip end, a base end, and an extended portion extending therebetween, the catheter further having an outer surface including a transdermal surface and an intravascular surface; and

an antimicrobial agent applied to the transdermal surface of the outer surface of the catheter, wherein following insertion of the catheter into a patient, at least a portion of the antimicrobial agent remains applied to the transdermal surface and is in contact with dermal layers of the patient;

wherein the antimicrobial agent comprises;

ethanol;

isopropyl alcohol;

chlorhexidine gluconate;

triclosan;

chlorhexidine diacetate;

chloroxylenol;

ethyl cellulose;

tetrahydrofuran, methyl ethyl ketone, or hexane;

water; and

cationic cellulosic polymer.