Medical devices and methods of making medical devices

Abstract

A medical device material impregnated with a combination of antimicrobial agents, the combination of antimicrobial agents comprising a first antimicrobial agent, the first antimicrobial agent being triclosan and at least a second antimicrobial agent, wherein the combination of antimicrobial agents provides the device material with antimicrobial activity and inhibition of resistant microbial mutations for of the order of, or greater than, 80 days.

1 . A method of making a medical device comprising:
 impregnating a first portion of the medical device with a first antimicrobial agent;   impregnating a second portion of the medical device with a second antimicrobial agent, the second portion being distinct from the first portion; and   treating one or both of the first and second portions so that the medical device has a portion that has both the first and second antimicrobial agents.   
     
     
         2 . The method of  claim 1 , wherein the first antimicrobial agent comprises triclosan. 
     
     
         3 . The method of  claim 1 , wherein the second antimicrobial agent is selected from the group consisting of rifamycin, lincomycin, trimethoprim, and derivatives thereof. 
     
     
         4 . The method of  claim 1 , wherein the impregnating steps occur with the first and second portions being separate from each other and the treating step occurs with the first and second portions being in contact with each other. 
     
     
         5 . The method of  claim 1 , wherein the first portion is impregnated with the first antimicrobial agent using a first technique and the second portion is impregnated with the second antimicrobial agent using a second, different technique. 
     
     
         6 . The method of  claim 5 , wherein the first technique comprises:
 impregnating the first portion with a solution of a swelling agent and the first antimicrobial agent, the first antimicrobial agent comprising triclosan;   allowing the solution of the swelling agent and triclosan to penetrate the first portion; and   removing the swelling agent from the first portion to leave triclosan impregnated in the first portion; and   wherein the second technique comprises impregnating the second antimicrobial agent into the second portion with a solution, emulsion or suspension of the second antimicrobial agent in a supercritical fluid.   
     
     
         7 . The method of  claim 6 , wherein the swelling agent is selected from the group consisting of hexane, toluene, xylene, chloroform, an ester, a ketone, methylene chloride, and combinations thereof. 
     
     
         8 . The method of  claim 1 , wherein at least one of the first portion and the second portion comprises a polymeric material. 
     
     
         9 . The method of  claim 9 , wherein the polymeric material is selected from the group consisting of a silicone elastomer, a polyalkene, polyethylene terephthalate, polyvinyl chloride, PTFE, silicone polyurethane copolymer, and polyurethane latex. 
     
     
         10 . The method of  claim 1 , wherein said treating comprises applying heat to at least part of at least one of the first and second portions. 
     
     
         11 . The method of  claim 1 , wherein said treating comprises autoclaving of the medical device. 
     
     
         12 . The method of  claim 11 , wherein the autoclaving is at about 121° C. and 1×10 5  N/m 2 . 
     
     
         13 . The method of  claim 1 , wherein said treating comprises applying ultrasound to the medical device. 
     
     
         14 . A medical device made by the method comprising:
 impregnating a first portion of the medical device with a first antimicrobial agent;   impregnating a second portion of the medical device with a second antimicrobial agent, the second portion being distinct from the first portion; and   treating one or both of the first and second portions so that the medical device has a portion that has both the first and second antimicrobial agents.   
     
     
         15 . The medical device of  claim 14 , wherein the medical device is selected from the group consisting of a wound guard, an external ventricular drainage device, an ommaya reservoir, an intraspinal pump, a central venous catheter, an ascites shunt, a pacemaker, a continuous ambulatory peritoneal catheter, a voice prosthesis, a vascular graft, a urinary catheter and an intraocular lens. 
     
     
         16 . The medical device of  claim 15 , wherein the central venous catheter is a totally implanted central venous catheter.