Non-Invasive Colorimetric-Based Infection Detector And Infection Detecting Bandage

• US 20100178203A1
• Filed: 01/15/2009
• Published: 07/15/2010
• Est. Priority Date: 01/15/2009
• Status: Active Grant

• Current Assignee: Polestar Technologies Inc.
• Original Assignee: Polestar Technologies Inc.
• Inventors: Kane, James A., Ricci, Melissa, Shashidhar, Ranganathan
• Granted Patent: US 8,628,728 B2
• Time in Patent Office: Days
• US Class Current: 422/56
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

A non-invasive, calorimetric infection detector is provided, comprised of a substrate, and one or more indicator compositions disposed upon or incorporated therein. These indicator compositions exhibit a persistent change color when exposed to gaseous oxides of nitrogen and acids formed therefrom, providing a means of detecting NO production in a wound, which has been found to occur at a high level at the onset of infection in a wound. In addition, a bandage is provided, comprised of the detector, as well as a porous portion, and preferably a hydrophobic barrier layer to protect the detector from contamination by water and other fluids draining from the wound. The non-invasive, calorimetric infection detector, and bandage containing same, can be utilized to provide a convenient, easily utilized colorimetric means of detecting the onset of wound infection, thereby enabling caregivers to effectively and timely treat infections.

Claims

1. A non-invasive, colorimetric infection detector comprising:

(a) a substrate; and

(b) an indicator composition capable of sensing gaseous oxides of nitrogen and acids formed therefrom, said indicator composition disposed on, encapsulated within, or covalently linked with the substrate,

wherein the detector, when disposed in proximity to a wound, detects gaseous oxides of nitrogen and acids formed therefrom emanating from the wound upon onset of infection therein, and exhibits a color change in response thereto.

2. The non-invasive, colorimetric infection detector of claim 1, wherein the color change exhibited by the indicator composition is persistent for 1 or more hours.

3. The non-invasive, colorimetric infection detector of claim 1, wherein the substrate is a solid, liquid or gel.

4. The non-invasive, calorimetric infection detector of claim 3, wherein the substrate is a gas permeable hydrophilic substrate.

5. The non-invasive, colorimetric infection detector of claim 4, wherein the gas permeable hydrophilic substrate has a water content of from about 5% to about 95% by weight.

6. The non-invasive, colorimetric infection detector of claim 5, wherein the substrate is a gas permeable hydrophilic substrate has a water content of from about 20% to about 95% by weight, said detector further comprising:

(c) a hydrophobic barrier layer disposed adjacent to or attached to the substrate.

7. The non-invasive, colorimetric infection detector of claim 3, wherein the substrate is a gas impermeable porous solid substrate comprised of one or more of aerogels, xerogels, and zeolites.

8. The non-invasive, colorimetric infection detector of claim 3, wherein the substrate is comprised of one or more of polyurethane, silicone, nylon, polysulfone, cellulose, alkyl cellulose, cellulose acetate, cellulose xanthate, carboxyalkyl cellulose, hydroxyalkyl cellulose, mineral oil, glycerin, petrolatum, gelatin, polyester, polyolefin, polystyrene, polycarbonate, poly ether ether ketone (PEEK), Teflon®

, fluoropolymer, polyacrylamide, polyacrylate, poly(N-vinylpyrrolidone), poly(vinyl alcohol), poly(vinyl acetate), poly(vinyl chloride) (PVC), poly(alkyl oxide), poly(alkylene oxide), poly(methacrylonitrile), poly(lactic acid), poly(maleic acid), poly(lactide/glycolide) copolymer, poly(ethylene glycol)/poly(lactic acid) block polymer, poly[(−

)3-hydroxybutryic acid], chitin, chitosan, keratin, alginate, esterified hyaluronans, collagen, maleates, phthalates, adipates, sebacates and citrates,

9. The non-invasive, colorimetric infection detector of claim 8, wherein the indicator composition comprises from between about 0.1 to about 40% by weight of the detector.

10. The non-invasive, calorimetric infection detector of claim 1, wherein the indicator composition has a pKa in the range of from about 1 to about 6.5.

11. The non-invasive, colorimetric infection detector of claim 1, wherein the indicator composition comprises one or more of phenolsulfonephthaleins, triphenylmethanes, azo dyes, nitrophenols, and styryl dyes.

12. The non-invasive, calorimetric infection detector of claim 11, wherein the indicator composition comprises one or more of thymol blue, xylenol blue, m-cresol purple, cresol red, phenol red, methyl violet, methyl green, methyl red, methyl yellow, crystal violet, leuchomalachite green, anilinoazoparabenzene sulfonic acid derivatives, anilinoazobenzene derivatives, anilinoazoparatoluene derivatives, α

-naphthylaminoazoparabenzene sulfonic acid derivatives, α

-naphthylaminoazobenzene derivatives, α

-naphthylaminoazotoluene derivatives, 2,4-dinitrophenol and 2,5-dinitrophenol, quinaldine red (2-(4-dimethylaminostyryl)-ethylquinolinium iodide) and p-ethoxy quinaldine-p-ethoxy quinoline.

13. The non-invasive, calorimetric infection detector of claim 1, further comprising an adhesive or elastic attachment means in communication with the substrate, said attachment means operable to attach the sensor to a patient.

14. A non-invasive, colorimetric infection detecting bandage comprising:

(a) an indicator substrate;

(b) an indicator composition capable of sensing oxides of nitrogen and acids formed therefrom when disposed on, encapsulated within, or covalently linked to the indicator substrate; and

(c) an adhesive portion in communication with the indicator substrate, said adhesive portion capable of adhering the bandage to a patient,

wherein, when the bandage is adhered on or in proximity to a wound, the indicator composition detects gaseous oxides of nitrogen and acids formed therefrom emanating from the wound, and exhibits a color change in response thereto so as to detect onset of infection and/or sepsis.

15. The non-invasive, colorimetric infection detecting bandage of claim 14, wherein the indicator substrate is a cloth or film layer comprised of polymers.

16. The non-invasive, colorimetric infection detecting bandage of claim 15, wherein the polymers are comprised of one or more of polyurethane, silicone rubber, nylon, polysulfone, cellulose, alkyl cellulose, cellulose acetate, cellulose xanthate, cotton, polyester, polyolefin, silica, gelatin, polystyrene, polycarbonate, poly ether ether ketone (PEEK), Teflon®

, fluoropolymer, polyacrylamide, polyacrylate, poly(methacryonitrile), poly(lactic acid), poly(maleic acid), poly(lactide/glycolide) copolymer, poly(ethylene glycol)/poly(lactic acid) block polymer, poly[(−

)3-hydroxybutryic acid], keratin, polyvinyl chloride, esterified hyaluronans, latex rubber, polyolefin blends, styrenics, polyolefin/styrenic blends, metallocene polymers, acrylonitrile butadiene styrene (ABS), styrene butadiene styrene (SBS), fluoroelastomers, polyisoprene, and polychloroprene, maleates, phthalates, adipates, sebacates and citrates.

17. The non-invasive, colorimetric infection detecting bandage of claim 14, wherein the indicator composition has a pKa in the range of from about 1 to about 6.5.

18. The non-invasive, colorimetric infection detecting bandage of claim 14, wherein the indicator composition is comprised of one or more of phenolsulfonephthaleins, triphenylmethanes, azo dyes, nitrophenols, and styryl dyes.

19. The non-invasive, colorimetric infection detecting bandage of claim 14, wherein the indicator composition is comprised of one or more of thymol blue, xylenol blue, m-cresol purple, cresol red, phenol red, methyl violet, methyl green, methyl red, methyl yellow, crystal violet, leuchomalachite green, anilinoazoparabenzene sulfonic acid derivatives, anilinoazobenzene derivatives, anilinoazoparatoluene derivatives, α

-naphthylaminoazoparabenzene sulfonic acid derivatives, α

-naphthylaminoazobenzene derivatives, α

-naphthylaminoazotoluene derivatives, 2,4-dinitrophenol and 2,5-dinitrophenol, quinaldine red (2-(4-dimethylaminostyryl)-ethylquinolinium iodide) and p-ethoxy quinaldine-p-ethoxy quinoline.

20. The non-invasive, colorimetric infection detecting bandage of claim 14, further comprising a hydrophobic barrier layer disposed adjacent the indicator substrate, so as to face the wound and prevent absorption of fluids into the indicator substrate.

21. The non-invasive, calorimetric infection detecting bandage of claim 20, wherein the hydrophobic barrier layer is comprised of one or more of latex rubber, silicone rubber, polyolefin blends, styrenics, polyolefin/styrenic blends, nylons, polyurethanes, metallocene polymers, acrylonitrile butadiene styrene (ABS), styrene butadiene styrene (SBS), polyvinyl chloride (PVC), fluoroelastomers, polyisoprene, and polychloroprene.

22. An infection detecting bandage comprising:

(a) a porous portion which can be positioned on or adjacent a wound, said porous portion comprising a non-invasive calorimetric indicator composition which, when disposed in proximity to a wound, detects gaseous oxides of nitrogen and acids formed therefrom emanating from the wound upon onset of infection therein, and exhibits a color change in response thereto; and

(b) an adhesive or elastic portion attached to the porous portion, operable to adhere or dispose the bandage to an area of the wound.

23. The infection detecting bandage of claim 22, wherein the porous portion is a cloth or film comprised of one or more of polyurethane, silicone rubber, nylon, polysulfone, cellulose, alkyl cellulose, cellulose acetate, cellulose xanthate, carboxyalkyl cellulose, hydroxyalkyl cellulose, cotton, polyester, polyolefin, silica, polystyrene, polycarbonate, poly ether ether ketone (PEEK), Teflon®

, fluoropolymer, polyacrylamide, polyacrylate, poly(N-vinylpyrrolidone), poly(vinyl alcohol), poly(vinyl acetate), poly(alkyl oxide), poly(alkylene oxide), poly(methacrylonitrile), poly(lactic acid), poly(maleic acid), poly(lactide/glycolide) copolymer, poly(ethylene glycol)/poly(lactic acid) block polymer, poly[(−

)3-hydroxybutryic acid], gelatin, chitin, chitosan, keratin, alginate, esterified hyaluronans, collagen, PVC, esterified hyaluronans, latex rubber, polyolefin blends, styrenics, polyolefin/styrenic blends, metallocene polymers, acrylonitrile butadiene styrene (ABS), styrene butadiene styrene (SBS), fluoroelastomers, polyisoprene, and polychloroprene, mineral oil, glycerin, petrolatum, maleates, phthalates, adipates, sebacates and citrates.

24. The infection detecting bandage of claim 22, wherein the color change exhibited by the indicator composition is persistent for 1 or more hours.

25. The infection detecting bandage of claim 22, wherein the indicator composition has a pKa in the range of from about 1 to about 6.5.

26. The infection detecting bandage of claim 22, wherein the indicator composition is one or more of phenolsulfonephthaleins, triphenylmethanes, azo dyes, nitrophenols, and styryl dyes.

27. The infection detecting bandage of claim 26, wherein the indicator composition is one or more selected from the group consisting of thymol blue, xylenol blue, m-cresol purple, phenol red, cresol red, methyl violet, methyl green, methyl red, methyl yellow, crystal violet, leuchomalachite green, anilinoazoparabenzene sulfonic acid derivatives, anilinoazobenzene derivatives, anilinoazoparatoluene derivatives, α

-naphthylaminoazoparabenzene sulfonic acid derivatives, α

-naphthylaminoazobenzene derivatives, α

-naphthylaminoazotoluene derivatives, 2,4-dinitrophenol and 2,5-dinitrophenol, quinaldine red (2-(4-dimethylaminostyryl)-ethylquinolinium iodide) and p-ethoxy quinaldine-p-ethoxy quinoline.

28. The infection detecting bandage of claim 22, wherein the adhesive or elastic portion is comprised of one or more of polyacrylate, polymethacrylate, polyurethane, silicone, hydrogel, hydrocolloid, rosin, terpene, polyvinyl acrylate, polyvinyl alcohol, gum Arabic, latex, starch, mucilage, hydrolyzed keratin, casein, albumin, metallocene polymers, polychloroprene, cellulose, polyvinyl acetate.