Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1994-04-18
1996-03-12
Dudash, Diana
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
424423, 604265, 427 21, 427 224, 427 228, 427 23, B05D 300, B05D 136, A61F 200, A61M 532
Patent
active
054984165
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a process for the protection of protheses, implants and/or catheters, of temporary or permanent implantable material, against bacterial colonization and infection, as well as equipment permitting obtaining this protection.
BACKGROUND OF THE INVENTION
The impregnation of catheters by quinolines has been described in numerous publications.
The publication EP-A-0 328 421 relates to a known method of antibacterial securement by a matrix of polymeric resin, first dissolved in an organic solvent. It is this resin which will then be secured on the polymer. This mode of securement is indirect.
The publication EP-A-0 207 624 relates to methods of preparation of an anti-infection polymer in a direct manner, comprising different stages. First, an immersion of the polymer in a solution of antimicrobial agents dissolved in an organic solvent, then, the immersion of the polymer in an organic solvent which can contain metallic salts, finally the immersion of the polymer in an organic solvent containing antimicrobials. It is dried after this immersion.
The publication EP-A-0 379 269 relates to the incorporation of chlorhexidine in a polymer during its manufacture. This technique uses a heating as well as a quaternary ammonium compound of the type of tridodecyl methyl ammonium chloride (TDMAC) so as to permit ultimate securement of the antibiotic. It is thus an indirect utilization. On the other hand, the doctor who wishes to use this type of technique must dip the polymer in the antimicrobial just before its use because there is no possibility of preserving the polymer treated with the antibiotic.
The publication EP-A-0 141 628 relates to the use of chlorhexidine and therefore of its cationic functions for the direct securement on latex. In this document, there is no question of securing an antimicrobial or an antibacterial.
The publication GB-A-2 093 348 uses, to secure the antimicrobial or the antibacterial, plaster of Paris.
Finally, the publication WO-A-8 904 674 relates to the securement of an antimicrobial on a biodegradable polymer.
SUMMARY OF THE INVENTION
Contrary to most of these publications, the present invention uses first a biguanide which will be secured on a polymer such as a catheter, a prothesis or a suture strand, so as to permit thereafter, and only thereafter, the securement of the antimicrobial. This successive effect is not taught in any of the above-mentioned publications.
On the other hand, this sequence permits not having to use either a solvent or a resin and thus afterward to have a much more simple operation which permits the conservation of the medical objects which have been treated and the sterilization by ethylene oxide, which assures ease of use for the surgeon who will have at his disposal a sterile material ready to use.
The adhesion of these antibacterial agents on the medical materials being difficult, there is as a result a protection insufficient to avoid consecutive bacterial infections upon use of the prothesis.
The impregnation of catheters by biguanides is also described in Japanese patent application 60-036064. These protections are nevertheless insufficient and can give rise to toxicological problems upon leaching out of the biguanides.
Despite the researches undertaken, the cases of infection in the presence of foreign material are greatly increasing.
Infections brought on by the implantation of protheses can be particularly of endocardital origin and require difficult treatments which may even be impossible. The failure of these treatments leads most often to the loss of material; there is a high social cost and a substantial risk for the patient.
The present invention permits overcoming the problems of securement and toxicity of the antibacterial substance, and thus gives rise to improved efficacy.
DETAILED DESCRIPTION OF THE INVENTION
There has been discovered a protective process according to which the prothesis is successively impregnated, which is not proposed by the publications mentioned above:
1) by a
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Carsenti-Etesse Helene J.
Dellamonica Pierre L.
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