Packaged antimicrobial medical device having improved shelf life and method of preparing same

Abstract

A packaged antimicrobial suture. The packaged antimicrobial suture includes an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial material reservoirs; at least one suture positioned within the inner package, the at least one suture comprising one or more surfaces; and an outer package having an inner surface, the outer package having the inner package positioned within; wherein the at least one suture, the inner package and the inner surface of the outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package. A method of making a packaged antimicrobial suture is also provided.

What is claimed: 
     
         1 . A method of making a packaged antimicrobial medical device, comprising:
 a) providing an inner package having at least an inner surface and an outer surface thereof;   b) positioning at least one medical device comprising one or more surfaces having an antimicrobial agent disposed thereon within the inner package;   c) providing means for introducing antimicrobial agent and stabilizing an amount or concentration on the medical device over a packaged antimicrobial medical device without such means; and   d) subjecting the medical device, at least the inner surface of the inner package and the means for introducing antimicrobial agent and stabilizing an amount or concentration on the medical device to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the means to the medical device and the inner surface of the inner package to substantially inhibit bacterial colonization on the medical device.   
     
     
         2 . The method of  claim 1 , wherein the inner package comprises a containment compartment and an outer cover, the outer cover comprising the means for improving shelf life. 
     
     
         3 . The method of  claim 2 , wherein the means for introducing antimicrobial agent and stabilizing an amount or concentration on the medical device comprises a plurality of patches. 
     
     
         4 . The method of  claim 3 , wherein each patch has a pair of antimicrobial agent reservoirs. 
     
     
         5 . The method of  claim 1 , wherein the medical device positioned within the inner package is substantially free of antimicrobial agent. 
     
     
         6 . The method of  claim 1 , wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof. 
     
     
         7 . The method of  claim 1 , wherein the effective amount of the antimicrobial agent transferred from the source of antimicrobial agent to the medical device and the inner package is transferred during an ethylene oxide sterilization process. 
     
     
         8 . The method of  claim 1 , wherein the step of subjecting the medical device and the inner surface of the package to conditions sufficient to transfer an effective amount of the antimicrobial agent comprises the steps of:
 placing the package and the medical device therein in a sterilization unit;   heating the sterilization unit to a first temperature;   adjusting the pressure in the sterilization unit to a first pressure value;   injecting steam into the sterilization unit to expose the package and the medical device to water vapor for a first period of time;   adjusting the pressure within the sterilization unit to a second pressure value;   introducing a chemical sterilization agent into the sterilization unit;   maintaining the chemical sterilization agent in the sterilization unit for a second period of time to render a sufficient number of microorganisms non-viable;   removing residual moisture and chemical sterilization agent from the medical device; and   drying the packaged antimicrobial medical device to a desired moisture level.   
     
     
         9 . The method of  claim 8 , wherein the step of introducing a chemical sterilization agent comprises introducing ethylene oxide gas into the sterilization unit. 
     
     
         10 . The method of  claim 1 , wherein the medical device is selected from a suture, a surgical mesh, a hernia plug, a brachy seed spacer, a suture clip, a suture anchor, an adhesion prevention mesh or film or a suture knot clip. 
     
     
         11 . The method of  claim 1 , wherein the package including the medical device is placed in a sealed environment and the antimicrobial agent source is contained in the sealed environment. 
     
     
         12 . The method of  claim 1 , wherein the package including the medical device is placed in a sealed environment and the antimicrobial agent source is subsequently introduced into the sealed environment. 
     
     
         13 . A packaged medical device having improved shelf life, comprising:
 a) an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs;   b) a medical device positioned within the inner package, the medical device comprising one or more surfaces;
 (i) an outer package having an inner surface, the outer package having the inner package positioned within;
 wherein the medical device, the inner package and the inner surface of the outer package are subjected to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner package, thereby substantially inhibiting bacterial colonization on the medical device, and 
 
   c) means for improving shelf life of the packaged antimicrobial medical device over a packaged antimicrobial medical device without such means.   
     
     
         14 . The packaged medical device of  claim 13 , wherein the inner package comprises a containment compartment and an outer cover, the outer cover comprising the means for improving shelf life. 
     
     
         15 . The packaged medical device of  claim 14 , wherein the means for improving shelf life comprises an adsorbent or absorbent material. 
     
     
         16 . The packaged medical device of  claim 15 , wherein the means for improving shelf life comprises a coating of an adsorbent or absorbent material. 
     
     
         17 . The packaged medical device of  claim 14 , wherein at least one antimicrobial agent reservoir comprises a non-woven polymeric fabric. 
     
     
         18 . The packaged medical device of  claim 14 , wherein the inner package comprises a containment compartment and an outer cover. 
     
     
         19 . The packaged medical device of  claim 18 , wherein the one or more patches are positioned about an outer periphery of an inner surface of the outer cover. 
     
     
         20 . The packaged medical device of  claim 19 , wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations of halogenated hydroxyl ethers and acyloxydiphenyl ethers. 
     
     
         21 . The packaged medical device of  claim 13 , wherein said improved shelf life is at least 6 months. 
     
     
         22 . The packaged medical device of  claim 13 , wherein said improved shelf life is at least one year. 
     
     
         23 . The packaged medical device of  claim 13 , wherein said improved shelf life is at least two years. 
     
     
         24 . A packaged medical device having improved shelf life, comprising:
 an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs:   a medical device positioned within the inner package, the medical device comprising one or more surfaces;   an outer package having an inner surface, the outer package having the inner package positioned within; wherein the medical device, the inner package and the inner surface of the outer package are subjected to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner package, thereby substantially inhibiting bacterial colonization on the medical device, and   means for buffering the antimicrobial agent and improving shelf life of the packaged antimicrobial medical device over a packaged antimicrobial medical device without such means.   
     
     
         25 . The packaged medical device of  claim 24 , wherein the antimicrobial agent is triclosan. 
     
     
         26 . The packaged medical device of  claim 24 , wherein said improved shelf life is at least one year. 
     
     
         27 . The packaged medical device of  claim 25 , wherein said improved shelf life is at least two years. 
     
     
         28 . A packaged medical device having improved shelf life, comprising:
 an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs:   a medical device positioned within the inner package, the medical device comprising one or more surfaces;   an outer package having an inner surface, the outer package having the inner package positioned within; wherein the medical device, the inner package and the inner surface of the outer package are subjected to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner package, thereby substantially inhibiting bacterial colonization on the medical device, and   means for moderating the rate of increase of triclosan on the medical device and improving the shelf life of the packaged antimicrobial medical device over a packaged antimicrobial medical device without such means.   
     
     
         29 . The packaged medical device of  claim 28 , wherein said improved shelf life is at least 6 months. 
     
     
         30 . The packaged medical device of  claim 28 , wherein said improved shelf life is at least one year. 
     
     
         31 . The packaged medical device of  claim 28 , wherein said improved shelf life is at least two years.