Method for treating medical devices using glycerol and an antimicrobial agent

Abstract

A non-metallic medical device treated with a antimicrobial agents is provided. Different combinations of antimicrobial agents can be used for different types of non-metallic medical devices depending on the types of infections related to each device. The combination of different antimicrobial substances has a synergistic effect against certain bacteria and fungi. An antimicrobial agent can be used to treat a non-metallic medical device by mixing the antimicrobial agent with an acid solution and glycerol and exposing the non-metallic medical device to the resulting mixture such that an enough of the antimicrobial agent binds to a portion of the non-metallic medical device to inhibit the growth of bacterial and fungal organisms.

What I claim is:  
     
         1 . A method of treating a non-metallic medical device with an antimicrobial agent comprising the steps of: 
 mixing at least an antimicrobial agent, an acid solution, and glycerol to form an antimicrobial composition; and    applying the antimicrobial composition to at least a portion of the non-metallic medical device under conditions wherein an effective concentration of the antimicrobial composition binds to the non-metallic medical device.    
     
     
         2 . The method of  claim 1 , wherein the antimicrobial composition is formed by mixing the antimicrobial agents and the acid solution and then adding glycerol.  
     
     
         3 . The method according to  claim 1 , wherein the antimicrobial agent is selected from the group of combinations consisting of chlorhexidine and methylisothiazolone; chlorhexidine and α-terpineol; thymol and chloroxylenol; thymol and methylisothiazolone; chlorhexidine and cetylpyridinium chloride; chlorhexidine and chloroxylenol; chlorhexidine, methylisothiazolone and thymol; methylisothiazolone and α-terpineol; minocycline and rifampin; and chlorhexidine, methylisothiazolone and α-terpineol.  
     
     
         4 . The method according to  claim 1 , wherein the antimicrobial agent is comprised of a minocycline and rifampin.  
     
     
         5 . The method according to  claim 1 , wherein a portion of the non-metallic medical device is made from material selected from the group consisting of rubber, plastic, nylon, silicone, polyurethane, polyethylene, polyvinyl chloride, polytetrafluoroethylene tetraphthalate, polyethylene tetraphthalate, polytetrafluoroethylene, latex, and materials sealed with gelatin, collagen or alumin.  
     
     
         6 . The method according to  claim 1 , wherein the non-metallic medical device is a catheter selected from the group consisting of peripherally insertable central venous catheter, dialysis catheter, long term tunneled central venous catheter, peripheral venous catheter, short-term central venous catheter, arterial catheter, pulmonary artery Swan-Ganz catheter, urinary catheter, long term non-tunneled central venous catheters, peritoneal catheters, and ventricular catheters.  
     
     
         7 . The method according to  claim 1 , wherein the non-metallic medical device is selected from the group consisting of long term urinary devices, tissue bonding urinary devices, penile prostheses, vascular grafts, extravascular grafts, urinary stints, vascular catheter ports, wound drain tubes, hydrocephalus shunts, pacemaker systems, artificial urinary sphincters, vascular dialators, extravascular dialators, vascular stints, extravascular stints, small joint replacements, temporary joint replacements, urinary dilators, heart valves, orthopedic implants, heart assist devices, stents, penial implants, mammary implants, and dental devices.  
     
     
         8 . The method according to  claim 1 , wherein the acid solution is comprised of short chain monocarboxylic acid and ortho-phosphoric acid.  
     
     
         9 . The method according to  claim 8 , wherein the volume ratio for monocarboxylic acid to ortho-phosphoric acid to glycerol is about 79:8:13.  
     
     
         10 . The method according to  claim 8 , wherein the short chain monocarboxylic acid is selected from the group consisting of formic acid, acetic acid, and propionic acid.  
     
     
         11 . The method according to  claim 1 , wherein the antimicrobial composition has a temperature that reaches between 2° C. to 75° C. during the applying step.  
     
     
         12 . The method according to  claim 1 , wherein the antimicrobial composition has a temperature that reaches about 45° C. during the applying step.  
     
     
         13 . The method according to  claim 8 , wherein the acid solution further comprises potassium chloride.  
     
     
         14 . The method according to  claim 1 , wherein the antimicrobial composition is applied by exposing the non-metallic medical device to the antimicrobial composition for about 10 minutes to about 18 hours.  
     
     
         15 . The method according to  claim 1 , wherein the antimicrobial composition is applied by exposing the non-metallic medical device to the antimicrobial composition for about 60 minutes.  
     
     
         16 . The method according to  claim 1 , further comprising the step of: 
 removing excess antimicrobial composition from the non-metallic medical device after applying the antimicrobial composition; and drying the non-metallic medical device after removing the excess antimicrobial composition.    
     
     
         17 . The method according to  claim 16 , wherein the excess antimicrobial composition is removed with gaseous material.  
     
     
         18 . The method according to  claim 17 , wherein the gaseous material is nitrogen.  
     
     
         19 . The method according to  claim 16 , wherein the drying step lasts for about 16 hours.  
     
     
         20 . The method according to  claim 16 , further comprising the step of flushing the non-metallic medical device with water after the drying step.  
     
     
         21 . The method according to  claim 20 , further comprising drying the non-metallic medical device after flushing the non-metallic medical device with water.  
     
     
         22 . The method according to  claim 20 , further comprising drying the non-metallic medical device from about 10 hours to about 24 hours after flushing the non-metallic medical device with water.  
     
     
         23 . The method according to  claim 1 , wherein the antimicrobial agent is applied by dipping the non-metallic medical device into the antimicrobial composition.  
     
     
         24 . An implantable medical device comprising: a body; one or more non-metallic surfaces on said body, glycerol, and an antimicrobial agent, wherein the glycerol and an effective concentration of the antimicrobial agent coat the one or more non-metallic surfaces.  
     
     
         25 . The device of  claim 24 , wherein the antimicrobial agent is selected from the group consisting of: chlorhexidine and methylisothiazolone; chlorhexidine and α-terpineol; thymol and chloroxylenol; thymol and methylisothiazolone; chlorhexidine and cetylpyridinium chloride; chlorhexidine and chloroxylenol; chlorhexidine, methylisothiazolone and thymol; methylisothiazolone and a-terpineol; minocycline and rifampin; and chlorhexidine, methylisothiazolone and a-terpineol.  
     
     
         26 . The device of  claim 24 , wherein the antimicrobial agent is comprised of a minocycline and rifampin.  
     
     
         27 . The device of  claim 24 , where in the non-metallic material is selected from the group consisting of rubber, plastic, nylon, silicone, polyurethane, polyethylene, polyvinyl chloride, polytetrafluoroethylene tetraphthalate, polyethylene tetraphthalate, polytetrafluoroethylene, latex, and materials sealed with gelatin, collagen or alumin.  
     
     
         28 . The device of  claim 24 , wherein the non-metallic medical device is a catheter selected from the group consisting of peripherally insertable central venous catheter, dialysis catheter, long term tunneled central venous catheter, peripheral venous catheter, short-term central venous catheter, arterial catheter, pulmonary artery Swan-Ganz catheter, urinary catheter, long term non-tunneled central venous catheters, peritoneal catheters, and ventricular catheters.  
     
     
         29 . The device of  claim 24 , wherein the non-metallic medical device is selected from the group consisting of long term urinary devices, tissue bonding urinary devices, penile prostheses, vascular grafts, extravascular grafts, urinary stints, vascular catheter ports, wound drain tubes, hydrocephalus shunts, pacemaker systems, artificial urinary sphincters, vascular dialators, extravascular dialators, vascular stints, extravascular stints, small joint replacements, temporary joint replacements, urinary dilators, heart valves, orthopedic implants, heart assist devices, stents, penial implants, mammary implants, and dental devices.