Method of coating medical devices with a combination of antiseptics and antiseptic coating therefor

• US 6,558,686 B1
• Filed: 11/08/1995
• Issued: 05/06/2003
• Est. Priority Date: 11/08/1995
• Status: Expired due to Term

• Current Assignee: Baylor College of Medicine (Baylor College), U.S. Government
• Original Assignee: Baylor College of Medicine (Baylor College)
• Inventors: Darouiche, Rabih O.
• Primary Examiner(s): Levy, Neil S.
• Application Number:
  US08/555,198
• Time in Patent Office: 2,736 Days
• Field of Search: 424/423, 600/30, 604/891.1, 604/8, 604/9, 623/1, 623/2, 623/11, 623/16, 523/122, 433/201.1
• US Class Current: 424/423
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• 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 25/34 Shaped forms, e.g. sheets, not provided for in any other sub-group of this main group
• CPC Class Codes: A01N 31/08 Oxygen or sulfur directly attached to an aromatic ring system
• CPC Class Codes: A01N 43/40 six-membered rings
• CPC Class Codes: A01N 43/80 five-membered rings with one nitrogen atom and either one oxygen atom or one sulfur atom in positions 1,2
• CPC Class Codes: A01N 47/44 Guanidine; Derivatives thereof
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A medical device of metallic or non-metallic material coated with a combination of antiseptics and a method for coating such an implant with a combination of antiseptics is provided. Different combinations of antiseptics can be used for different types of medical devices depending on the spectrum of organisms that cause the infections related to each device. The combination of different antiseptics has a synergistic effect against certain bacteria and fungi. The combination of antiseptic can be applied to the surface of a metallic device by dissolving the combination of antiseptics and a polymeric sticking agent in an acid solution to form an antiseptic solution, and applying the antiseptic solution, in an effective concentration to inhibit the growth of bacterial and fungal organisms, to at least a portion of the surfaces of the medical device. The antiseptic combination can be applied to the surface of and impregnate the material of a non-metallic implant by forming an antiseptic composition by dissolving the combination of antiseptics in an organic solvent and adding a penetrating agent to the composition, and applying the antiseptic composition to at least a portion of the medical implant under conditions where the antiseptic composition permeates the material of the medical implant.

Claims

1. An implantable medical device comprising:

a non-metallic medical device having at least one surface;

an antiseptic composition layer coating the at least one surface of the medical device, the antiseptic composition comprising a mixture of the combination of antiseptics, methanol, and butyl acetate, said antiseptic composition in an effective concentration to inhibit the growth of bacterial and fungal organisms; and

wherein said antiseptic composition penetrates the at least one surface of the non-metallic medical device.

2. The medical device of claim 1, wherein the combination of antiseptics is selected from the group of mixtures consisting of methylisothiazolone and thymol;

chlorhexidine, methylisothiazolone and thymol;

chlorhexidine, methylisothiazolone, and α

-terpineol;

chloroxylenol and thymol;

chlorhexidine and cetylpyridinium chloride; and

chlorhexidine and chloroxylenol.

3. The medical device of claim 1 wherein the combination of antiseptics comprises a mixture of thymol and either chloroxylenol or methylisothiazolone.

4. The medical device of claim 1 wherein the combination of antiseptics comprises a mixture of chlorhexidine, methylisothiazolone and α

-terpineol.

5. The medical device according to claim 4, further comprising a mixture of glacial acetic acid and formic acid.