Method for the evaluation of implantable materials

Abstract

A method for the evaluation of a material to determine whether the material is susceptible to bacterial contamination or colonization comprising providing bacteria which are modified to produce a first detectable signal, exposing the material being evaluated to the bacteria and determining whether the first signal is present determining whether the first signal is present on the material or within the material.

1 . A method for evaluating an implantable material to determine whether the implantable material is susceptible to bacterial contamination or colonization when implanted into a living animal or human comprising: 
 a) providing bacteria which are modified to produce a first detectable signal;    b) exposing the implantable material being evaluated to the modified bacteria by introducing the modified bacteria into a living animal or human; and    c) determining in vivo whether the first signal is present on the implantable material or within the implantable material;    where absence of the first signal on the implantable material or within the implantable material indicates that the implantable material is not susceptible to bacterial contamination or colonization and where presence of the first signal on the implantable material or within the implantable material indicates that the implantable material is susceptible to bacterial contamination or colonization; 
 where the implantable material is non-living.  
   
   
   
       2 . The method of  claim 1 , additionally comprising quantifying the susceptibility of the implantable material to bacterial contamination or colonization by quantifying the amount of the first signal on the implantable material or within the implantable material; 
 where increasing amounts of the first signal on the implantable material or within the implantable material indicates increasing susceptibility of the implantable material to bacterial contamination or colonization.    
   
   
       3 . The method of  claim 2 , where exposing the implantable material being evaluated to the modified bacteria comprises using the implantable material as wound closure material in an animal or human.  
   
   
       4 . The method of  claim 1 , where the bacteria are modified to produce a second detectable signal, and where the method additionally comprises determining whether the second signal is present on the implantable material or within the implantable material; 
 where absence of the second signal on the implantable material or within the implantable material indicates that the implantable material is not susceptible to bacterial contamination or colonization and where presence of the second signal on the implantable material or within the implantable material indicates that the implantable material is susceptible to bacterial contamination or colonization.    
   
   
       5 . The method of  claim 1 , where the first signal is light emission in the visible spectrum.  
   
   
       6 . The method of  claim 4 , where the second signal is light emission in the visible spectrum.  
   
   
       7 . The method of  claim 1 , where the bacteria are modified to incorporate a functional green fluorescent protein.  
   
   
       8 . The method of  claim 1 , where the bacteria are modified to incorporate a functional luciferase.  
   
   
       9 . The method of  claim 1 , where the bacteria are modified to incorporate both a functional green fluorescent protein and a functional luciferase.