Antibiotic solution for coating a medical device

Abstract

A semi-automated coating system for providing medical devices with antimicrobial coatings is disclosed. The semi-automated coating system extends the coating solution's usable life span by minimizing exposure to light, air and temperature extremes. Moreover, the disclosed semi-automated coating system minimizes operator and environmental exposure to the coating solutions. Methods for coating medical devices using the semi-automated coating system are also provided. The methods disclose techniques for preparing coating solutions, setting up the coating system and operating the device. Moreover, the systems and methods described herein minimize operator intervention with the coating processes and provide superior product consistency.

We claim:  
     
         1 . A semi-automated medical device coating system comprising: 
 a first vessel having a sealable cover, at least one mixing device and at least one heat transfer device;    a second vessel having a sealable cover, at least one mixing device and at least one heat transfer device, said second vessel in two-way fluid communication with said first vessel;    a fluid transfer system adapted to transfer fluids between said first and said second vessels;    a support adapted to suspend a device in said second vessel;    and a gas operated sparger in said second vessel adapted to transfer gas from an external gas supply into said second vessel.    
     
     
         2 . The semi-automated medical device coating system of  claim 1  wherein said coating system is a closed system substantially preventing exposure of said fluid to the ambient atmosphere or light.  
     
     
         3 . The semi-automated medical device coating system of  claim 1  further comprising a plurality of sensors cooperatively connected to said first vessel, said second vessel, said fluid transfer system, said heat transfer devices and said mixers, said sensors responsive to at least one microprocessor/controller.  
     
     
         4 . The semi-automated medical device coating system of  claim 1  further comprising at least one temperature controller responsive to said microprocessor/controller for heating and cooling said heat transfer device of said first and said second vessels.  
     
     
         5 . The semi-automated medical device coating system of  claim 1  wherein said fluid transfer system is at least one pump.  
     
     
         6 . The semi-automated medical device coating system of  claim 1  wherein said sparger is a spiral shaped device located within said second vessel.  
     
     
         7 . A semi-automated implantable medical device coating system comprising: 
 a containment platform having at least one temperature controller;    a holding vessel fixed to said containment platform having a first sealable closure, at least one mixer and a first heat transfer device in cooperation with said at least one temperature controller;    a processing vessel fixed to said containment platform having a second sealabe closure, a gas sparger, at least one mixer, a support for suspending said implantable medical device within said processing vessel and a second heat transfer device in cooperation with said at least one temperature controller;    a first fluid transfer system in cooperation with said containment platform adapted to transfer fluids between said holding vessel and said processing vessel;    a second fluid transfer system in cooperation with said containment platform adapted to transfer fluid between said processing vessel and a remote fluid reservoir and a waste reservoir;    a gas reservoir in cooperation with said gas sparger;    a plurality of valves in cooperation with said first and said second fluid transfer systems and said gas reservoir;    a plurality of sensors in cooperation with said holding vessel, said processing vessel, said first and said second sealable closure, said first and said second heat transfer device, said first and said second fluid transfer system, said plurality of valves and said at least one temperature controller;    a programmable controller responsive to said plurality of sensors.    
     
     
         8 . The semi-automated implantable medical device coating system of  claim 7  wherein said programmable controller is adapted to regulate the contents, temperatures, fluid levels, and gas flow within said holding vessel and said processing vessel.  
     
     
         9 . The semi-automated implantable medical device coating system of  claim 7  wherein said programmable controller is adapted to open and close said plurality of valves.  
     
     
         10 . The semi-automated implantable medical device coating system of  claim 7  wherein said programmable controller is adapted to act as a fail-safe monitor responsive to said plurality of sensors.  
     
     
         11 . A method for coating a medical device comprising: 
 providing a first sealed vessel having a coating solution disposed therein;    providing a second sealed vessel adapted to receive said coating solution from said first vessel, said second vessel having at least one medical device to be coated disposed therein;    heating said coating solution and said second vessel;    transferring at least a portion of said coating solution to said second vessel;    cooling said first vessel and said coating solution remaining therein;    holding said second vessel and said coating solution disposed therein at a predetermined temperature for a first predetermined time;    transferring said coating solution from said second vessel to said first vessel at the conclusion of said first predetermined time;    transferring a wash solution from a wash solution reservoir into said second vessel;    washing said medical device in said wash solution for a second predetermined time;    removing said wash solution from said second vessel;    drying said medical device.    
     
     
         12 . The method for coating a medical device of  claim 11  further comprising: 
 mixing said coating solution in said first and said second vessels.  
 
     
     
         13 . The method for coating a medical device of  claim 11  further comprising: 
 aerating said medical device in said second vessel prior to transferring said wash solution into said second vessel.  
 
     
     
         14 . The method for coating a medical device of  claim 11  further comprising: 
 injecting a gas into said second vessel using a gas sparger for aerating, washing and drying said medical device.  
 
     
     
         15 . The method for coating a medical device of  claim 14  further comprising: 
 providing a first velocity gas sparge for washing and a higher second velocity gas sparge for aerating and drying said medial device.  
 
     
     
         16 . The method for coating a medical device of  claim 11  further comprising: 
 automating said method for coating a medical device by providing and programming a microprocessor/controller adapted to receive information from at least one sensor and transmitting information necessary to control said method for coating a medical device.  
 
     
     
         17 . The method for coating a medical device of  claim 11  wherein said coating solution is an antimicrobial solution.  
     
     
         18 . The method for coating a medical device of  claim 17  wherein said antimicrobial solution is an antiseptic solution.  
     
     
         19 . The method for coating a medical device of  claim 17  wherein said antimicrobial solution is an antibiotic solution.  
     
     
         20 . The method for coating a medical device of  claim 19  wherein said antibiotic solution comprises minocycline, rifampin and at least one solvent.  
     
     
         21 . The method for coating a medical device of  claim 20  wherein said at least one solvent is selected from the group consisting of: butyl acetate, methyl alcohol, amyl acetate, benzene, carbon tetrachloride, chloroform, dimethyl ether, ethylene dichloride, hexane, 2-ethyl hexanol, hexyl ether, methyl ethyl ketone, methyl isobutyl ketone, methylene chloride, perchloroethylene, Stoddard reagent, toluene, thrichloroethylene, xylene and combinations thereof.  
     
     
         22 . The method for coating a medical device of  claim 11  wherein said medical device is selected from the group consisting of: urinary catheters, vascular catheters, surgical slings, artificial joints, penial implants, ocular implants, stents, sutures, and heart valves.  
     
     
         23 . An antibiotic solution for coating a medical device consisting essentially of rifampin, minocycline and at least one solvent.  
     
     
         24 . An antibiotic solution for coating a medical device of  claim 23  wherein said at least one solvent is selected from the group consisting of: butyl acetate, methyl alcohol, amyl acetate, benzene, carbon tetrachloride, chloroform, dimethyl ether, ethylene dichloride, hexane, 2-ethyl hexanol, hexyl ether, methyl ethyl ketone, methyl isobutyl ketone, methylene chloride, perchloroethylene, Stoddard reagent, toluene, thrichloroethylene, xylene and combinations thereof.  
     
     
         25 . A semi-automated medical device coating system comprising: 
 a coating solution holding vessel;    a processing vessel for coating medical devices separate form said coating solution vessel;    a coating solution transfer system;    a heat transfer system for heating and cooling said holding vessel and said processing vessel either simultaneously or separately;    a mixer associated with said holding vessel and said mixing vessel;    at least one remote sensor;    at least one microprocessor/controller for receiving data from said at least one remote sensor and for transmitting information to said coating solution transfer system and said heat transfer system;    a product suspension device for holding said medical device in place during coating;    a wash solution reservoir;    a wash solution transfer system;    at least one valve; and    at least one vent.    
     
     
         26 . A method for coating a medical device comprising: 
 heating a coating solution having an antimicrobial substance suspended in said solution;    subjecting said medical device to said heated coating solution for a specified period of time;    removing said heated coating solution from said medical device;    leaving a sufficient amount of said antimicrobial substance on said medical device so as to inhibit infection in a patient receiving said medical device; and,    performing at least each of the above activities through a closed system and without intervention by a human.    
     
     
         27 . A medical device coating system comprising: 
 a first receptacle, said receptacle comprised of a material capable of holding an antimicrobial substance without introducing contamination;    a second receptacle in fluid communication with said first receptacle;    said fluid communication being substantially closed to ambient air at least during flow of fluid;    said second receptacle sized and shaped to receive at least one medical device;    an electronic controller to govern flow between said first receptacle and said second receptacle.    
     
     
         28 . A medical device coating system comprising: 
 a first receptacle, said receptacle comprised of a material capable of holding an antimicrobial substance without introducing contamination;    a second receptacle in fluid communication with said first receptacle; 
 said fluid communication being substantially closed to ambient air at lest during flow of fluid;  
 said first receptacle and said second receptacle being continually maintained under an inert gas;  
 said second receptacle sized and shaped to receive at least one medical device; and  
   an electronic controller to govern flow between said first receptacle and said second receptacle.