CA2432915A1 - Antimicrobial medical devices - Google Patents

Antimicrobial medical devices Download PDF

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Publication number
CA2432915A1
CA2432915A1 CA002432915A CA2432915A CA2432915A1 CA 2432915 A1 CA2432915 A1 CA 2432915A1 CA 002432915 A CA002432915 A CA 002432915A CA 2432915 A CA2432915 A CA 2432915A CA 2432915 A1 CA2432915 A1 CA 2432915A1
Authority
CA
Canada
Prior art keywords
medical article
volume
water
chlorhexidine
percent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002432915A
Other languages
French (fr)
Other versions
CA2432915C (en
Inventor
Shanta M. Modak
Lester A. Sampath
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Columbia University of New York
Original Assignee
The Trustees Of Columbia University In The City Of New York
Shanta M. Modak
Lester A. Sampath
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Trustees Of Columbia University In The City Of New York, Shanta M. Modak, Lester A. Sampath filed Critical The Trustees Of Columbia University In The City Of New York
Priority to CA2784754A priority Critical patent/CA2784754C/en
Publication of CA2432915A1 publication Critical patent/CA2432915A1/en
Application granted granted Critical
Publication of CA2432915C publication Critical patent/CA2432915C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D175/00—Coating compositions based on polyureas or polyurethanes; Coating compositions based on derivatives of such polymers
    • C09D175/04—Polyurethanes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—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
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—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
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
    • A61L2300/206—Biguanides, e.g. chlorohexidine
    • 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

Abstract

The present invention relates to medical devices treated with a solution comprising a combination of chlorhexidine free base and a water-soluble chlorhexidine salt, in a ratio that facilitates chlorhexidine uptake by the devices and hence improves antimicrobial effectiveness.

Claims (22)

1. An antimicrobial medical article prepared by treating a polymeric medical article, for an effective period of time, with a solution consisting essentially of one or more solvents and a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt, wherein the weight/weight ratio of chlorhexidine free base and the water-soluble chlorhexidine salt in the solution is between 1:1 to 1:5.
2. The antimicrobial medical article of claim 1, wherein the ratio is 1:1.
3. The antimicrobial medical article of claim 1, wherein the solvent is selected from the group consisting of water, alcohol, tetrahydrofuran, dimethylsulfoxide, dimethylformamide, N-methyl-2-pyrrolidone, and mixtures thereof.
4. The antimicrobial medical article of claim 3, wherein the solvent is a mixture of between 10 and 30 percent (volume/volume) tetrahydrofuran and 70 and 90 percent (volume/volume) ethanol.
5. The antimicrobial medical article of claim 7, wherein the solvent is a mixture of 20 percent (volume/volume) tetrahydrofuran and 80 percent (volume/volume) ethanol.
6. The antimicrobial medical article of claim 3, wherein the solvent is a mixture of between 75 and 95 percent (volume/volume) tetrahydrofuran and 5 and 25 percent (volume/volume) methanol.
7. The antimicrobial medical article of claim 6, wherein the solvent is a mixture of about 85 percent (volume/volume) tetrahydrofuran and 1 S
percent (volume/volume) methanol.
8. The antimicrobial medical article of claim 1, wherein the article is a hydrophilic polymeric medical article.
9. The antimicrobial medical article of claim 8, wherein the article is a catheter.
10. The catheter of claim 9, wherein the catheter has a lumen which is treated, for an effective period of time, with the solution consisting essentially of one or more solvents and the mixture of chlorhexidine free base and water-soluble chlorhexidine salt.
11. The medical article of claim 8, wherein the water-soluble chlorhexidine salt is chlorhexidine diacetate.
12. The catheter of claim 9, wherein the water-soluble chlorhexidine salt is chlorhexidine diacetate.
13. The catheter of claim 10, wherein the water-soluble chlorhexidine salt is chlorhexidine diacetate.
14. The antimicrobial medical article of claim 1, wherein the article is a hydrophobic polymeric medical article.
15. The antimicrobial medical article of claim 14, wherein the article is expanded polytetrafluoroethylene.
16. The antimicrobial medical article of claim 14, wherein the article is a polytetrafluoroethylene soft tissue patch.
17. An antimicrobial medical article prepared by treating a polymeric medical article, for an effective period of time, with a solution consisting essentially of (1) one or more solvents;
(2) a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt; and (3) one or more of (i) an organic acid, at a concentration of between 0.1 and 5 percent; (ii) an anti-inflammatory agent, at a concentration of between 0.1 and 5 percent; or (iii) a hydrogel at a concentration of between 0.5 to 10 percent, wherein the weight/weight ratio of chlorhexidine free base and the water-soluble chlorhexidine salt in the solution is between 1:1 to 1:5.
18. The antimicrobial medical article of claim 17, wherein the concentration of organic acid in the solution is between 0.1 and 2 percent.
19. The antimicrobial medical article of claim 17, wherein the concentration of anti-inflammatory agent is between 0.1 and 1 percent.
20. The antimicrobial medical article of claim 17, wherein the concentration of hydrogel in the solution is between 1 and 5 percent.
21. A method of preparing a medical article comprising the steps of (i) placing the medical article in a solution consisting essentially of (a) a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, dimethylsulfoxide, dimethylformamide, N-methyl-2-pyrrolidone, and mixtures thereof; and (b) a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt, wherein the weight/weight ratio of chlorhexidine free base and water-soluble chlorhexidine salt in the solution is between 1:1 to 1:5;
(ii) soaking the medical article in the solution for an effective period of time to allow the medical article to swell;
(iii) removing the medical article from the solution; and (iv) drying the medical article.
22. A method of preparing a catheter having a lumen comprising the steps of (i) exposing the lumen of the catheter to a solution consisting essentially of (a) a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, dimethylsulfoxide, dimethylformamide, N-methyl-2-pyrrolidone, and mixtures thereof; and (b) a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt, wherein the weight/weight ratio of chlorhexidine free base and water-soluble chlorhexidine salt in the solution is between 1:1 to 1:5;
(ii) filling the lumen of the catheter with the solution for an effective period of time to allow the lumen of the catheter to swell;
(iii) removing the solution from the lumen of the catheter; and (iv) drying the catheter.
CA2432915A 2000-12-22 2001-12-21 Antimicrobial medical devices Expired - Lifetime CA2432915C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2784754A CA2784754C (en) 2000-12-22 2001-12-21 Antimicrobial medical devices comprising chlorhexidine

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/746,670 US7329412B2 (en) 2000-12-22 2000-12-22 Antimicrobial medical devices containing chlorhexidine free base and salt
US09/746,670 2000-12-22
PCT/US2001/049205 WO2002051464A2 (en) 2000-12-22 2001-12-21 Antimicrobial medical devices

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2784754A Division CA2784754C (en) 2000-12-22 2001-12-21 Antimicrobial medical devices comprising chlorhexidine

Publications (2)

Publication Number Publication Date
CA2432915A1 true CA2432915A1 (en) 2002-07-04
CA2432915C CA2432915C (en) 2012-10-23

Family

ID=25001831

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2784754A Expired - Lifetime CA2784754C (en) 2000-12-22 2001-12-21 Antimicrobial medical devices comprising chlorhexidine
CA2432915A Expired - Lifetime CA2432915C (en) 2000-12-22 2001-12-21 Antimicrobial medical devices

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2784754A Expired - Lifetime CA2784754C (en) 2000-12-22 2001-12-21 Antimicrobial medical devices comprising chlorhexidine

Country Status (9)

Country Link
US (5) US7329412B2 (en)
EP (1) EP1343547B1 (en)
JP (1) JP2004523267A (en)
AT (1) ATE428456T1 (en)
AU (1) AU2002231069B2 (en)
CA (2) CA2784754C (en)
DE (1) DE60138412D1 (en)
ES (1) ES2327492T3 (en)
WO (1) WO2002051464A2 (en)

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