Method and composition for producing catheters with antibacterial property

• US 7,597,903 B2
• Filed: 12/02/2002
• Issued: 10/06/2009
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: Shenkar College Of Engineering And Design
• Original Assignee: Shenkar College Of Engineering And Design
• Inventors: Rosinskaya, Cecilia, Weinberg, Amotz
• Primary Examiner(s): Woodward; M P
• Assistant Examiner(s): Berrios; Jennifer A
• Application Number:
  US10/307,501
• Publication Number:
  US 20040106912A1
• Time in Patent Office: 2,500 Days
• Field of Search: 424/1, 514/1
• US Class Current: 424/426
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/208 Quaternary ammonium compounds
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

A medical device and a method for imparting antibacterial properties to the device, made from hydrophobic polymer, particularly to urinary latex catheters comprises treatment of the device by spreading, dipping or spraying and consequent drying with natural biodegradable polymers (A), composition including a cross-linking agent (B) for partial cross-linking the mentioned polymer and an anti-microbial agent compatible with A and B. The polymer may be from a group of polysachharides, for example polyglucosamine-chitosan. For partial cross-linking of the polymer substances having aldehyde groups such as glucose or evolving aldehydes such as hexamethylenetetramine or their mixtures are used. The polymer is able to form on the surface of the medical device a thin film that swells in wet or moisturized state once inserted into the body. In the swollen state it will gradually release an anti-microbial agent.

Claims

1. A medical device coated with a slow-release antibacterial composition, the slow-release antibacterial composition comprising a mixture of chitosan and dextrose, thereby forming a polymeric network wherein the concentration of said dextrose is between 0.5 and 5.0% of dry chitosan;

and

a cationic antibacterial agent which is chlorhexidine or benzalkonium chloride, compatible with said chitosan and said dextrose, wherein said cationic antibacterial agent is embedded in said polymeric net-work;

wherein said slow-release antibacterial composition swells upon being contacted with body fluids and releases said cationic antibacterial agent.

2. The medical device as claimed in claim 1, wherein said medical device is a urinary catheter.

3. The medical device as claimed in claim 1, wherein said chitosan has a molecular weight at the range of 10⁴ to 10⁶ and a degree of deacetylation at the range of 75% to 87%.

4. The medical device of claim 1, wherein the said chitosan is used at concentration in a solution in the range of between 1.5 to 4.5 (w/w) %.

5. The medical device as claimed in claim 1, wherein said chlorhexidine is in the form of chlorhexidine diacetate and/or chlorhexidine digluconate.

6. The medical device of claim 5, wherein said chlorhexidine is in the form of chlorhexidine digluconate or chlorhexidine diacetate and is present at a range of concentrations of between 2.0 to 10.0 g/kg of slow-release antibacterial composition.

7. A method for coating a medical device according to claim 1 comprising the steps:

preparing an aqueous solution of a biodegradable chitosan, wherein the chitosan is dissolved in water solution of acetic acid at concentrations between 1.0 to 1.5%;

adding dextrose, and chiorhexidine or benzalkonium chloride, compatible with said chitosan and said dextrose;

applying said aqueous solution to said medical device; and

drying said medical device.

8. The medical device as claimed in claim 1, wherein said dextrose is used at range of concentrations between 0.5 to 2.0% of weight of dry chitosan.

9. The medical device as claimed in claim 1, wherein said cationic antibacterial agent is benzalkonium choride.

10. The medical device as claimed in claim 9, wherein the concentration of said benzalkonium choride is at a range of concentrations between 5.0 to 20.0 g/kg of the slow-release antibacterial composition.

11. The medical device of claim 6, wherein the said chlorhexidine diacetate is used at range of concentrations between 3.0 to 6.0 g/kg of the slow-release antibacterial composition.

12. The medical device of claim 6, wherein the chlorhexidine digluconate is used at range of concentrations between 3.0 to 6.0 g/kg of the slow-release antibacterial composition.