Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1996-08-02
1998-05-19
Bockelman, Mark
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
A61M 535, A61M 2500
Patent
active
057529418
DESCRIPTION:
BRIEF SUMMARY
This invention relates to central venous polyurethane catheters with a thin hydrophilic coating loaded with an antibiotic of the ramoplanin group, the method for their preparation and their use in preventing development of catheter related infections in patients.
The catheters of this invention are useful to prevent bacterial adherence and colonization and, therefore, to lower the risk of vascular infections in catheterized patients.
Infections of central venous lines represent a challenging problem in modern medicine (1-4). Contamination of the catheter by skin flora during insertion is thought to be one of the major routes in the development of catheter infections. Gram-positive bacteria like Staphylococcus aureus and coagulase negative staphylococci (CNS) are the predominant causative organisms.
Catheter infections may lead to severe complications for a patient, and, even if they are not life-threatening, they may contribute to a prolongation of hospital stay and to an increase in therapy costs. Most of the catheter infections can be managed by removing the catheter if clinical signs of infection occur; this is normal clinical routine procedure in patients having short peripheral venous lines.
In cases of difficulties for venous access, however, and especially in patients with a long-term central venous catheter, keeping the catheter in place despite the infection is desired. In many cases, however, antibiotic therapy is not able to eliminate bacteria from the catheter.
The failure of antibiotic therapy is mainly due to the existence of a slime barrier (biofilm) which hinders the antibiotic in penetrating and in reaching the adherent bacterial cells.
It was discovered by many investigators that the MIC- or MBC-values of antibiotics for bacteria embedded in a biofilm are much higher than those for bacteria in suspension (5, 6, 7).
An alternative strategy to treat and especially to prevent catheter infections is the coating or loading of medical devices with antimicrobial substances (8-10). The release of the antimicrobial substance (e.g. an antibiotic) from the catheter surface or from the interior leads to a high local drug concentration which should be sufficiently high to reach the MIC and MBC of bacteria in biofilms. Furthermore, local antimicrobial action shortly after catheter insertion would probably inhibit the production of a biofilm by the bacteria. There are already a number of investigations on the coating or loading of catheter materials with antimicrobial substances, mainly with antibiotics (11-15, 16). Such systems show in part good in vitro performances; in a few cases there have already been clinical trials with antimicrobial-coated catheters (11, 17).
Development of resistance to commonly used antibiotics, for instance, due to resistant Staphylococcus aureus strains (see M. E. Reverdy et al., "Evolution de la resistance aux antibiotiques et aux antiseptiques de souches hospitalieres de Staphylococcus aureus isolees de 1980 a 1991" published in Pathologie Biologie, 1993, Vol. 41, No. 9 897-904), is a further factor which makes difficult the management of infections in hospitals and favors any possible employment of antibiotics not yet utilized in the clinical practice.
The main object of this invention is to provide a central venous polyurethane catheter with a thin hydrophilic layer on the surfaces loaded with an antibiotic of the ramoplanin group or any mixture thereof, in a concentration sufficient to inhibit the bacterial colonization of the catheter after its insertion into the patient. The catheters of this invention can be maintained in place for the desired period without incurring severe complications for the catheterized patient.
According to in vitro experiments described by B. Jansen et al. (18), it has been found that teicoplanin has appropriate biological and physico-chemical characteristics to allow absorption on the thin hydrophilic layer coating the surfaces of certain central venous polyurethane catheters. The release of antibacterially active concentrations of the subs
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Denaro Maurizio
Goldstein Beth P.
Romano Gabriella
Williams Rosamund Jean
Bockelman Mark
Gruppo Lepetit S.p.A.
Sadula Jennifer R.
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