Method and applicator for the perioperative disinfection of medical instruments to be inserted through non-natural openings

Abstract

The invention relates to means and methods for the disinfection of an insertion channel to prevent in particular catheter sepsis, which significantly reduces the carry-over of germs even out of deeper skin layers by means of medical instruments, such as catheters, to be introduced into non-natural openings and also permits the decontamination of perioperatively contaminated medical instruments. The disinfection of the insertion channel is achieved by means of a method for the perioperative coating of a medical instrument to be inserted into an invasively produced opening before use, comprising the application of a viscous or foam-like composition containing at least one anti-infective compound, preferably a gel having octenidine, by means of an applicator, such that when said gel is used, the composition is also specifically effective in the first millimeters of the insertion channel. Furthermore, an immediate disinfecting action is provided over the entire coated surface.

We claim: 
     
         1 . A method for the perioperative disinfection of a medical instrument to be inserted into an invasively generated body opening, preferably a vascular catheter, and/or an injection channel generated by inserting a medical instrument into the body, comprising the application of a viscous or foam-like composition containing at least one anti-infectious compound upon the medical instrument prior to use, wherein the composition is embodied to adhere on the medical instrument like a film after being brought into contact with the medical instrument, and that at least a portion of the composition adhering like a film reaches at least to the epidermis upon insertion of the medical instrument into the body. 
     
     
         2 . The method according to  claim 1 , wherein the composition is a gel. 
     
     
         3 . The method according to  claim 1 , with the anti-infectious composition being applied via an applicator. 
     
     
         4 . The method according to  claim 1 , with the medical instrument being a vascular catheter, an endoscope, a drainage, a peritoneal catheter, a pin, a trocar, or an electrode. 
     
     
         5 . The method according to  claim 1 , with the anti-infectious compound being selected from a group consisting of octenidine and chlorhexidine or a combination thereof. 
     
     
         6 . The method according to  claim 5 , with the composition further comprising an anti-infectious compound selected from the group consisting of hydrogen peroxide, povidon-iodine, cetylpyridinium chloride, cetylpyridinium bromide, 2-phenoxy ethanol, triclosan, polyhexanide, ethyl alcohol, isopropanol, bacitracin, gramicidin, fusidinic acid, polymyxine B, neomycin, gentamycin, erythromycin, chloramphenicol, lincosamide, minocycline, rifampin, doxycycline, or a gyrase inhibitor, or a combination thereof. 
     
     
         7 . The method according to  claim 2 , with the composition being PAA, preferably carbomer, or PVA gel, with the PAA portion ranging from 0.1 to 2% by weight and the PVA-portion ranging from 0.1 to 20% by weight. 
     
     
         8 . The method according to  claim 1 , with the composition further comprising polyvinyl pyrrolidone from 0.1 to 5% by weight. 
     
     
         9 . The method according to  claim 5 , with the composition comprising octenidine from 0.01 to 0.2%. 
     
     
         10 . The method according to  claim 1 , with the medical instrument to be inserted into an invasively generated body opening being intended for an extended stay in the body. 
     
     
         11 . A composition comprising at least one anti-infectious compound, wherein the composition is embodied to adhere like a film on the medical instrument upon being brought into contact with a medical instrument to be inserted preoperatively into an invasively generated body opening, and that at least a portion of the composition adhering like a film reaches at least the epidermis upon inserting the medical instrument into the body. 
     
     
         12 . A method of use of a composition described in  claim 1  for the perioperative disinfection or for washing medical instruments to be inserted into invasively generated body openings or as an anti-adhesive or lubricant on medical instruments to be inserted into invasively generated body openings or for disinfecting an insertion channel generated by inserting a medical instrument into the body. 
     
     
         13 . A medical instrument to be inserted into invasively generated body openings, from the group comprised of a vascular catheter, endoscope, pin, trocar, or electrode, with a preferably viscous or foam-like composition comprising an anti-infectious compound, such compound selected from the group comprised of chlorhexidine and octenidine, wherein the composition is embodied to adhere on the medical instrument like a film upon being brought into contact with it and that the film-like adhesive composition, upon inserting the medical instrument, reaches into the body at least to the epidermis. 
     
     
         14 . A method for the production of at least one composition comprising an anti-infectious compound for the perioperative disinfection of a medical instrument to be inserted into an invasively generated body opening or for the disinfection of an insertion channel generated by the insertion of a medical instrument into the body, comprising the steps of:
 (a) producing a gel, preferably a PAA, or PVA gel in H 2 O with a pH ranging from 5 to 8,   (b) dissolving an anti-infectious substance selected from octenidine and chlorhexidine in polyvinyl pyrrolidone, and   (c) mixing the gel of (a) with the solution of (b) so that the PAA is present in the gel at a range from 0.1 and 2% by weight and PVA at a range from 0.1 and 20% by weight, the anti-infectious substance at a concentration from 0.01 to 2% by weight, and the polyvinyl pyrrolidone at a concentration from 0.1 to 5% by weight.   
     
     
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         28 . (canceled) 
     
     
         29 . A method of use of an applicator for the perioperative disinfection of a medical instrument to be inserted into invasively generated body openings, with the applicator being embodied such that a viscous or foam-like, anti-infectious composition can be applied on a surface of the medical instrument by a relative motion between the applicator and said medical instrument, wherein the applicator, preferably located in the rear in the direction of motion, comprises a retention device for the anti-infectious compound, with the applicator being formed as an essentially hollow embodied reservoir with a conically tapering section located at the rear in the direction of motion for applying a composition comprising at least one anti-infectious compound as described in  claim 1  upon a medical instrument to be inserted into invasively generated body openings prior to use. 
     
     
         30 . The method of use according to  claim 29 , wherein the anti-infectious compound is the compound described in  claim 1 .