CA2411944A1 - The combination of antimicrobial agents and bacterial interference to coat medical devices - Google Patents

The combination of antimicrobial agents and bacterial interference to coat medical devices Download PDF

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Publication number
CA2411944A1
CA2411944A1 CA002411944A CA2411944A CA2411944A1 CA 2411944 A1 CA2411944 A1 CA 2411944A1 CA 002411944 A CA002411944 A CA 002411944A CA 2411944 A CA2411944 A CA 2411944A CA 2411944 A1 CA2411944 A1 CA 2411944A1
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CA
Canada
Prior art keywords
pathogenic
bacterium
coating layer
antimicrobial agent
bacterial
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Granted
Application number
CA002411944A
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French (fr)
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CA2411944C (en
Inventor
Rabih O. Darouiche
Richard A. Hull
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Baylor College of Medicine
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Individual
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Publication of CA2411944A1 publication Critical patent/CA2411944A1/en
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Publication of CA2411944C publication Critical patent/CA2411944C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/005—Ingredients of undetermined constitution or reaction products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/30—Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A61L2300/608—Coatings having two or more layers
    • A61L2300/61—Coatings having two or more layers containing two or more active agents in different layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices

Abstract

This invention relates to a method for coating a medical device comprising t he steps of applying to at least a portion of the surface of said medical devic e, an antimicrobial coating layer and a non-pathogenic bacterial coating layer, wherein the antimicrobial and non-pathogenic bacterial coating layers inhibi t 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 include s at least one of the following: viable whole cells, non-viable whole cells, o r 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 prio r to implantation in a mammal.

Claims (31)

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.
2. 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.
3. 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.
4. The method of claim 2, wherein said antimicrobial agent is selected from the group of antiseptics consisting of .alpha.-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.
5. 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, Gandnerella vaginalis, and Acinetobacter species.
6. The method of claim 5, wherein said non-pathogenic gram-negative bacterium is Pseudomonas aeruginosa.
7. 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.
8. The method of claim 7, wherein said Enterobacteriacea is Escherichia coli 83972 or mutants thereof.
9. 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.
10. The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises viable whole cells of the non-pathogenic gram-negative bacterium.
11. 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.
12. 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-pathogenc gram-negative bacterium.
13. The method of claim 1, wherein said non-pathogenic bacterial coating layer further comprises at least two non-pathogenic gram-negative bacteria.
14. 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 animicrobial 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 non-pathogenic gram-positive bacterium in an effective concentration to inhibit the growth of pathogenic bacterial and fungal organisms, wherein said non-pathogenic gram-positive bacterium is resistant to said antimicrobial agent.
15. The method of claim 14, wherein said non-pathogenic gram-positive bacterium is selected from the group consisting of Staphylococcus aureus, coagulase-negative staphylococci, streptococci, enterococci, corynebacteria, and Bacillus species.
16. The method of claim 14, 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.
17. The method of claim 14, wherein said non-pathogenic bacterial coating layer further comprises viable whole cells of the non-pathogenic gram-positive bacterium.
18. The method of claim 14, wherein said non-pathogenic bacterial coating layer further comprises non-viable whole cells or cellular structures or extracts of the non-pathogenic gram-positive bacterium.
19. The method of claim 14, 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-positive bacterium.
20. The method of claim 14, wherein said non-pathogenic bacterial coating layer further comprises at least two non-pathogenic gram-positive bacteria.
21. The method of claim 14, wherein said non-pathogenic bacterial coating layer further comprises at least one non-pathogenic gram-positive bacterium and at least one non-pathogenic gram-negative bacterium.
22. 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 fungal coating layer, wherein said fungal coating layer comprises a fungus in an effective concentration to inhibit the growth of pathogenic bacterial and fungal organisms, wherein said fungus is resistant to said antimicrobial agent.
23. The method of claim 22, wherein said fungus is Candida.
24. The method for preventing a urinary tract infection comprising the steps of:
pretreating a patient with antibiotics for five to seven days;
inoculating said patient with a culture of non-pathogenic bacterium; and applying to at least a portion of the surface of a urinary catheter, an antimicrobial coating layer having an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical devices.
25. A kit comprising compositions to coat the surfaces of medical devices prior to implantation into a mammal comprising an antimicrobial agent and a culture from a non-pathogenic bacterium, wherein said non-pathogenic bacterium has been genetically modified to enhance the adherence of the bacterium to the implant surface.
26. The kit of claim 25, wherein the compositions are in the same container.
27. The kit of claim 25, wherein the compositions are in different containers.
28. A kit comprising compositions to coat the surfaces of medical devices prior to implantation into a mammal comprising an antimicrobial agent and a culture from a non-pathogenic bacterium, wherein said non-pathogenic bacterium has been genetically modified to decrease the sensitivity of the bacterium to antimicrobial agents.
29. A lit comprising compositions to coat the surfaces of medical devices prior to implantation into a mammal comprising an antimicrobial agent acid a culture from a non-pathogenic bacterium, wherein said non-pathogenic bacterium has been genetically modified to increase the stability of the bacterium at room temperature.
30. A kit comprising compositions to coat the surfaces of medical devices prior to implantation into a mammal comprising an antimicrobial agent and a culture from a non-pathogenic bacterium, wherein said non-pathogenic bacterium has been lyophilized and reconstituted prior to application to the surface of the implant.
31. A lit comprising a medical device pre-coated with an antimicrobial agent and compositions to coat said medical device prior to implantation into a mammal comprising a culture from a non-pathogenic bacterium.
CA2411944A 2000-06-09 2001-06-08 The combination of antimicrobial agents and bacterial interference to coat medical devices Expired - Fee Related CA2411944C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US21071500P 2000-06-09 2000-06-09
US60/210.715 2000-06-09
PCT/US2001/018596 WO2001095876A1 (en) 2000-06-09 2001-06-08 The combination of antimicrobial agents and bacterial interference to coat medical devices

Publications (2)

Publication Number Publication Date
CA2411944A1 true CA2411944A1 (en) 2001-12-20
CA2411944C CA2411944C (en) 2010-12-14

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US (3) US6719991B2 (en)
EP (1) EP1303256B1 (en)
AT (1) ATE419880T1 (en)
AU (1) AU2001271292A1 (en)
CA (1) CA2411944C (en)
DE (1) DE60137334D1 (en)
WO (1) WO2001095876A1 (en)

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