SYSTEMS AND METHODS FOR APPLYING A NOVEL ANTIMICROBIAL COATING MATERIAL TO A MEDICAL DEVICE

• US 20130255061A1
• Filed: 04/03/2012
• Published: 10/03/2013
• Est. Priority Date: 04/03/2012
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Burkholz, Jonathan Karl, Hoang, Minh Quang
• Application Number:
  US13/438,559
• Publication Number:
  US 20130255061A1
• Time in Patent Office: Days
• US Class Current: 29/458
• CPC Class Codes: A01N 25/00 Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application , e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
• CPC Class Codes: A01N 25/02 containing liquids as carriers, diluents or solvents
• CPC Class Codes: A01N 25/24 containing ingredients to enhance the sticking of the active ingredients
• CPC Class Codes: A01N 31/02 Acyclic compounds
• CPC Class Codes: A01N 31/08 Oxygen or sulfur directly attached to an aromatic ring system
• CPC Class Codes: A01N 31/16 with two or more oxygen or sulfur atoms directly attached to the same aromatic ring system
• CPC Class Codes: A01N 43/54 1,3-Diazines; Hydrogenated 1,3-diazines
• CPC Class Codes: A01N 47/44 Guanidine; Derivatives thereof
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/055 the aromatic ring being substituted by halogen
• CPC Class Codes: A61K 31/085 having an ether linkage to aromatic ring nuclear carbon
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2/232 layered or coated
• CPC Class Codes: A61L 2/235 cellular, porous or foamed
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 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 39/162 : with antiseptic agent incorporated within the connector
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y10T 29/49885 : with coating before or during assembling

Abstract

An antimicrobial composition, generally comprising a biocidal agent, such as chlorhexidine gluconate, a lubricant, such as a modified siloxane, and a solvent, such as an alcohol and/or water. The biocidal agent acts as a highly effective biocide while the lubricant reduces friction between various components of a medical device during assembly. The antimicrobial composition may be applied to an internal component of the medical device prior to assembly. The process of assembling the medical device results in antimicrobial composition being distributed to various internal structures and geometries of the medical device as the coated, internal component is assembled into the interior of the medical device. Air is then used to further distribute excess antimicrobial agent to the remaining surfaces downstream from the installed, internal component. In some embodiments, additional air is passed through the assembled medical device to assist in removing the carrier solvent from the medical device via evaporation.

Claims

1. An antimicrobial compound, comprising:

a non-alcohol, biocidal agent;

a lubricant; and

a carrier solvent comprising an alcohol, the carrier solvent being capable of dissolving the biocidal agent and the lubricant.

2. The antimicrobial compound of claim 1, wherein the lubricant comprises a low viscosity siloxane.

3. The antimicrobial compound of claim 1, wherein the alcohol solvent comprises an alcohol selected from the group consisting of ethanol, isopropanol, propanol, butanol and combinations thereof.

4. The antimicrobial compound of claim 1, wherein the alcohol solvent is selected from the group consisting of lower alcohols from about 1 to about 6 carbon atoms.

5. The antimicrobial compound of claim 4, wherein the lower alcohol comprises a mixture of isopropanol and ethanol in a ration from about 1:

10 to about 1;

1.

6. The antimicrobial compound of claim 1, wherein the alcohol solvent comprises from about 70% to about 99.8% of the antimicrobial compound, by weight.

7. The antimicrobial compound of claim 1, wherein the non-alcohol, biocide agent is selected from the group consisting of phenol, quaternary ammonium, guanidine, pyridinium, benzalkonium, centrimide, hexetidine, benzethonium chloride, cetylpyridinium chloride, dequalium acetate, dequalinium chloride, chloroxylenol, chlorhexidine, chlorhexidine gluconate, chlorhexidine hydrochloride, Triclosan, chlorhexidine dihydrochloride, chlorhexidine diacetate and combinations thereof.

8. The antimicrobial compound of claim 1, wherein the non-alcohol, biocidal agent comprises from about 0.01% to about 1.0% of the antimicrobial compound, by weight.

9. The antimicrobial compound of claim 8, wherein the non-alcohol, biocidal agent comprises from about 0.01% to about 0.5% of the antimicrobial compound, by weight.

10. The antimicrobial compound of claim 1, wherein the lubricant comprises a surface tension of about 20 mN/m.

11. A method for assembling a medical device, comprising:

providing a medical device having an internal lumen;

providing a septum having an outer surface;

coating the outer surface of the septum with an excess of an antimicrobial compound, the antimicrobial compound comprising;

a non-alcohol, biocidal agent;

a lubricant; and

a carrier solvent comprising an alcohol, the carrier solvent being capable of dissolving the biocidal agent and the lubricant;

inserting the coated septum into the internal lumen of the medical device;

distributing the excess antimicrobial compound to the internal lumen by advancing and seating the coated septum within the internal lumen;

further distributing the excess antimicrobial compound within the internal lumen by blowing air through the internal lumen and the seated septum; and

blowing additional air through the internal lumen and the seated septum to evaporate the carrier solvent of the antimicrobial compound thereby immobilizing the lubricant and the non-alcohol, biocidal agent within the internal lumen.

12. The method of claim 11, wherein the medical device is a catheter assembly.

13. The method of claim 11, wherein the lubricant comprises a low viscosity siloxane.

14. The method of claim 11, wherein the alcohol solvent comprises an alcohol selected from the group consisting of ethanol, isopropanol, propanol, butanol and combinations thereof.

15. The method of claim 11, wherein the non-alcohol, biocide agent is selected from the group consisting of phenol, quaternary ammonium, guanidine, pyridinium, benzalkonium, centrimide, hexetidine, benzethonium chloride, cetylpyridinium chloride, dequalium acetate, dequalinium chloride, chloroxylenol, chlorhexidine, chlorhexidine gluconate, chlorhexidine hydrochloride, Triclosan, chlorhexidine dihydrochloride, chlorhexidine diacetate and combinations thereof.

16. The method of claim 11, wherein the alcohol solvent is selected from the group consisting of lower alcohols from about 1 to about 6 carbon atoms.

17. The method of claim 16, wherein the lower alcohol comprises a mixture of isopropanol and ethanol in a ration from about 1:

10 to about 1;

1.

18. The method of claim 11, wherein the non-alcohol, biocidal agent comprises from about 0.01% to about 1.0% of the antimicrobial compound, by weight.

19. An antimicrobial composition, comprising:

a non-alcohol, biocidal agent comprising chlorhexidine gluconate, wherein the chlorhexidine gluconate comprises about 0.01% to about 0.5% of the antimicrobial composition, by weight;

a lubricant comprising a low viscosity siloxane; and

a carrier solvent comprising an alcohol, the carrier solvent being capable of dissolving the biocidal agent and the lubricant, the alcohol comprising a mixture of isopropanol and ethanol in a ration from about 1;

10 to about 1;

1.

20. The antimicrobial composition of claim 19, further comprising a second non-alcohol biocidal agent selected from the group consisting of phenol, quaternary ammonium, guanidine, pyridinium, benzalkonium, centrimide, hexetidine, benzethonium chloride, cetylpyridinium chloride, dequalium acetate, dequalinium chloride, chloroxylenol, chlorhexidine, chlorhexidine hydrochloride, Triclosan, chlorhexidine dihydrochloride, chlorhexidine diacetate and combinations thereof.