US2021369874A1PendingUtilityA1

Composition for detecting biofilms on viable tissues

Assignee: CONVATEC TECHNOLOGIES INCPriority: Nov 30, 2010Filed: Aug 10, 2021Published: Dec 2, 2021
Est. expiryNov 30, 2030(~4.3 yrs left)· nominal 20-yr term from priority
C12Q 1/04G01N 33/582G01N 33/569G01N 33/533A61K 49/0041
64
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Claims

Abstract

A staining composition for use in making biofilm detectable on viable tissue wherein the composition preferentially stains the biofilm and comprises a staining agent in a quantity effective to stain said biofilm and render it detectable.

Claims

exact text as granted — not AI-modified
1 . A staining composition for use in making biofilm detectable on viable tissue that preferentially stains the biofilm rather than the viable tissue, the composition comprising:
 a staining agent to stain the biofilm and render the biofilm detectable,   wherein the composition is a non-gelled composition, and   wherein the composition is in the form of a lyophilized wafer or a soluble film.   
     
     
         2 . The composition of  claim 1 , further comprising a preservative in the form of methyl-paraben. 
     
     
         3 . The composition of  claim 1 , further comprising EDTA. 
     
     
         4 . The composition of  claim 3 , wherein the composition comprises from 0.1% to 2.0% by weight EDTA. 
     
     
         5 . The composition of  claim 1 , further comprising a surfactant. 
     
     
         6 . The composition of  claim 5 , wherein the composition comprises from 0.1% to 2.0% by weight of the surfactant. 
     
     
         7 . The composition of  claim 1 , further comprising:
 from 0.1% to 2.0% by weight EDTA;   from 0.1% to 2.0% by weight of a surfactant; and   a preservative in the form of methyl-paraben.   
     
     
         8 . The composition of  claim 1 , further comprising a humectant. 
     
     
         9 . The composition of  claim 1 , wherein the composition comprises from 0.0001% to 1% by weight of the staining agent in the form of Rose Bengal. 
     
     
         10 . The composition of  claim 1 , wherein the staining agent is configured to absorb light of wavelengths from 380 nm to 720 nm. 
     
     
         11 . A kit of parts for use in the detection of biofilms on viable tissue, the kit comprising:
 a composition including a staining agent, wherein the composition is in the form of a soluble film or a lyophilized wafer, and wherein the composition is a non-gelled composition; and   a light source to cause the staining agent to fluoresce.   
     
     
         12 . The kit of  claim 11 , wherein the composition comprises a preservative in the form of methyl-paraben. 
     
     
         13 . The kit of  claim 12 , wherein the composition includes from 0.1% to 2.0% by weight EDTA. 
     
     
         14 . The kit of  claim 13 , wherein the composition includes from 0.1% to 2.0% by weight of a surfactant, and wherein the staining agent is Rose Bengal. 
     
     
         15 . The kit of  claim 11 , further comprising:
 spectacles or lenses for use in detecting a biofilm, wherein the spectacles or lenses are configured to exclude all wavelengths of light except those at which the staining agent fluoresces in use of the kit; and   a wound irrigation solution.   
     
     
         16 . A method of detecting a biofilm in a wound, the method comprising:
 obtaining a non-gelled composition including a staining agent which preferentially stains biofilms, wherein the non-gelled composition is in the form of a soluble film or a lyophilized wafer; and   applying the non-gelled composition to viable tissue.   
     
     
         17 . The method of  claim 16 , further comprising terminally sterilizing the non-gelled composition using ethylene oxide. 
     
     
         18 . The method of  claim 16 , wherein the non-gelled composition comprises from 0.1% to 2.0% by weight EDTA, and wherein the non-gelled composition comprises from 0.1% to 2.0% by weight of a surfactant. 
     
     
         19 . The method of  claim 16 , wherein the non-gelled composition comprises a preservative in the form of methyl-paraben, and wherein the staining agent is Rose Bengal. 
     
     
         20 . The method of  claim 16 , wherein applying the non-gelled composition to viable tissue comprises:
 contacting the viable tissue with the soluble film or the lyophilized wafer having a thickness of at least 0.1 centimeter; and   leaving the soluble film or the lyophilized wafer in place for at least 2 minutes to permit dissolution of the film or the wafer.

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