Process for the protection of prostheses and of temporarily or permanently implantable material against bacterial colonization and infection

• US 5,498,416 A
• Filed: 04/18/1994
• Issued: 03/12/1996
• Est. Priority Date: 07/18/1991
• Status: Expired due to Fees

• Current Assignee: Helene J. Carsenti-Etesse, Pierre L. Dellamonica
• Original Assignee: Helene J. Carsenti-Etesse, Pierre L. Dellamonica
• Inventors: Dellamonica, Pierre L., Carsenti-Etesse, Helene J.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/182,090
• Time in Patent Office: 694 Days
• Field of Search: 427/2.1, 427/2.12, 427/2.28, 427/2.3, 427/2.31, 424/422, 424/423, 604/265
• US Class Current: 424/422
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A method for protecting prostheses and temporarily or permanently implantable materials from bacterial colonization and infection, wherein the material is successively impregnated with: (a) a biguanide solution having the general formula (I) ##STR1## wherein R₁ is an alkyl, aminoalkyl, optionally substituted phenyl, naphthyl or cyano radical, R₂ is a hydrogen atom or an alkyl radical and n is an integer from 1-6, with the proviso that the alkyl radicals and portions are linear or branched and contain 1-4 carbon atoms; and (b) a solution of an antibacterial agent which may be gradually redistributed in an aqueous medium; whereafter the material thereby impregnated is dried.

Claims

1. In a process for the protection of prostheses, implants and/or catheters, of temporary or permanent implantable materials, against bacterial colonization and infection in which there is applied to a material to be protected, a solution of an antibacterial agent capable of being progressively released into aqueous medium, the improvement which comprises:

successively impregnating said material to ensure the adhesion of the antibacterial agent to the material to be protected;

a) with a solution in aqueous or organic solvent of a biguanide of the general formula;

##STR2## in which R₁ represents an alkyl radical, aminoalkyl, phenyl possibly substituted (with a halogen atom or a hydroxy, alkyl, alkoxy or carboxy radical), naphthyl or cyano, R₂ represents a hydrogen atom or an alkyl radical and n is a whole number from 1 to 6, wherein the alkyl portions and radicals are a straight chain or branched and contain 1 to 4 carbon atoms, then

b) with the solution of antibacterial agent capable of being progressively released into aqueous medium, and drying the thus-impregnated material.

2. Process according to claim 1, wherein the material to be protected is dried between impregnation with the biguanide solution and impregnation with the solution of antibacterial agent.

3. Process according to claim 1, wherein the material to be protected, after impregnation with the biguanide solution, is not washed prior to impregnation with the antibacterial agent solution.

4. Process according to claim 1, wherein the biguanide is chlorhexidine, alexidine or hexamethylene bis [aminohexyl biguanide] -1, 1'"'"'.

5. Process according to claim 1, wherein the antibacterial agent is selected from the group consisting of quinolines, β

-lactams, fusidic acid, phosphomycine, teicoplanine, aztreoname and imipeneme.

6. Process according to claim 1, wherein the antibacterial agent is pefloxacine.

7. Process according to claim 1, wherein the biguanide solution contains 20 to 100 g/l of biguanide.

8. Process according to claim 1, wherein the solution of antibacterial agent contains 1 to 100 g/l of antibacterial agent.

9. An infection-resistant device capable of progressively releasing in aqueous medium an amount of an antibacterial substance fixed to the device, said amount being effective to prevent bacterial contamination of the device, said device comprising a first coating from a solution in aqueous or organic solvent of a biguanide of the general formula:

##STR3## in which R₁ represents an alkyl radical, aminoalkyl, phenyl possibly substituted (with a halogen atom or a hydroxy, alkyl, alkoxy or carboxy radical), naphthyl or cyano, R₂ represents a hydrogen atom or an alkyl radical and n is a whole number from 1 to 6, wherein the alkyl portions and radicals are a straight chain or branched and contain 1 to 4 carbon atoms, and a second coating from a solution of the antibacterial substance, said second coating overlying said first coating, and said first coating ensuring adhesion of the antibacterial substance to the device.