# US 6,719,991 B2 · Combination of antimicrobial agents and bacterial interference to coat medical devices

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- Number: US 6,719,991 B2
- Document ID: US6719991B2
- Status: Granted
- Kind: B2
- Application number: 09/877,898
- Filed: 2001-06-08
- Published: 2002-03-14
- Granted: 2004-04-13
- Earliest claimed: 2000-06-09
- Assignees: Baylor College of Medicine
- Inventors: Rabih O. Darouiche; Richard Hull
- Web page: https://patentgrep.com/patent/US6719991B2

## CPC

- A61L 29/08: Materials for coatings
- A61L 29/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 2300/30: Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- A61L 2300/45: Mixtures of two or more drugs, e.g. synergistic mixtures
- A61L 2300/61: containing two or more active agents in different layers
- A61L 2420/02: Methods for coating medical devices
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

This invention relates to a method for coating a medical device comprising the steps of applying to at least a portion of the surface of said medical device, an antimicrobial coating layer and a non-pathogenic bacterial coating layer, wherein the antimicrobial and non-pathogenic bacterial coating layers inhibit the growth of pathogenic bacterial and fungal organisms. The non-pathogenic bacterium used in the bacterial coating layer is resistant to the antimicrobial agent. Furthermore, the non-pathogenic bacterium layer includes at least one of the following: viable whole cells, non-viable whole cells, or cellular structures or extracts. The antimicrobial agent and non-pathogenic bacterium are used to develop a kit comprising these compositions in one container or in separate containers. The kit is used to coat a catheter prior to implantation in a mammal.

## Claims

### Claim 1

A method for coating a medical device comprising the steps of:
applying to at least a portion of the surface of said medical device, an antimicrobial coating layer, wherein said antimicrobial coating layer comprises an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical devices; and
applying to at least a portion of the surface of said medical device, a non-pathogenic bacterial coating layer, wherein said non-pathogenic bacterial coating layer comprises a non-pathogenic gram-negative bacterium in an effective concentration to inhibit the growth of pathogenic bacterial and fungal organisms, wherein said non-pathogenic gram-negative bacterium is resistant to said antimicrobial agent.

### Claim 2 (depends on 1)

The method of claim 1, wherein said antimicrobial agent is selected from the group consisting of an antibiotic, an antiseptic, a disinfectant and a combination thereof.

### Claim 3 (depends on 2)

The method of claim 2, wherein said antimicrobial agent is selected from the group of antibiotics consisting of penicillins, cephalosporins, carbepenems, other beta-lactams antibiotics, aminoglycosides, macrolides, lincosamides, glycopeptides, tetracylines, chloramphenicol, quinolones, fucidins, sulfonamides, trimethoprims, rifamycins, oxalines, streptogramins, lipopeptides, ketolides, polyenes, azoles, and echinocandins.

### Claim 4 (depends on 2)

The method of claim 2, wherein said antimicrobial agent is selected from the group of antiseptics consisting of (α-terpineol, methylisothiazolone, cetylpyridinium chloride, chloroxyleneol, hexachlorophene, chlorhexidine and other cationic biguanides, methylene chloride, iodine and iodophores, triclosan, taurinamides, nitrofurantoin, methenamine, aldehydes, azylic acid, silver, benzyl peroxide, alcohols, and carboxylic acids and salts.

### Claim 5 (depends on 1)

The method of claim 1, wherein said non-pathogenic gram-negative bacterium is selected from the group consisting of Enterobacteriacea, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Burkholderia cepacia, Gardnerella vaginalis, and Acinetobacter species.

### Claim 6 (depends on 5)

The method of claim 5, wherein said non-pathogenic gram-negative bacterium is Pseudomonas aeruginosa.

### Claim 7 (depends on 5)

The method of claim 5, wherein said non-pathogenic gram-negative bacterium is selected from the group of Enterobacteriacea consisting of Escherichia, Shigella, Edwardsiella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Hafnia, Serratia, Proteus, Morganella, Providencia, Yersinia, Erwinia, Buttlauxella, Cedecea, Ewingella, Kluyvera, Tatumella and Rahnella.

### Claim 8 (depends on 7)

The method of claim 7, wherein said Enterobacteriacea is Escherichia coli 83972 or mutants thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein said non-pathogenic gram-negative bacterium is a bacterium which adheres to urinary catheters selected from the group consisting of Providencia, Proteus, Pseudomonas aeruginosa and Escherichia coli.

### Claim 10 (depends on 1)

The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises viable whole cells of the non-pathogenic gram-negative bacterium.

### Claim 11 (depends on 1)

The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises non-viable whole cells or cellular structures or extracts of the non-pathogenic gram-negative bacterium.

### Claim 12 (depends on 1)

The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises at least one or more viable whole cells, non-viable whole cells or cellular structures or extracts of the non-pathogenic gram-negative bacterium.

### Claim 13 (depends on 1)

The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises at least two non-pathogenic gram-negative bacteria.