Antimicrobial device and method

A method of infusing antimicrobials into the body of implantable and long in-dwelling medical devices containing a body of elastomer material comprising the steps of:

• completely contacting the surfaces of the body of elastomer with a solution comprising a swelling agent as a solvent and at least one antimicrobial agent as a solute dissolved therein, said elastomer and said at least one antimicrobial agent selected so that the rate of diffusion of the antimicrobial agent out of the medical device will remain the same or be retarded by the effects of autoclaving.
• maintaining contact between the solution and the surfaces for a sufficient period of time for the solution to completely penetrate and swell and to enlarge the normal intermolecular spaces of the body of material and to diffuse the solution into the enlarged intermolecular spaces provided by the swelling;
• evaporating the solvent from the solution and to thereby deposit and retain the antimicrobial agent within the intermolecular spaces of the body of elastomer while causing the body of material to return substantially to its original physical shape and condition with substantially normal intermolecular spaces;
• and
• rinsing the surfaces of the treated body of material and autoclaving the treated body of material prior to use.

A medical device for use in the human body and comprising:

• a body of silicone elastomer having a matrix of polymeric molecules;
• two antimicrobial agents substantially uniformly dispersed throughout said body of polymeric material and providing a substantially uniform molecular dispersion of said antimicrobial agents within the normal intermolecular spaces of said body of silicone elastomer;
• and
• said body of silicone elastomer and said antimicrobial agents therein effectively providing a solid solution of molecules of polymeric material and molecules of antimicrobial agent having a concentration and concentration distribution of antimicrobial agent such as to cause solid state diffusion of the molecules of the antimicrobial agent toward and through the intermolecular spaces of the body of polymeric material for sufficient period of time to provide effective protection against infection after implant in the human body, the rate of said solid diffusion having remained the same or been retarded by autoclaving such device.