Method and apparatus for determination of chemical species in perspiration

• US 5,817,011 A
• Filed: 02/03/1997
• Issued: 10/06/1998
• Est. Priority Date: 09/08/1988
• Status: Expired due to Fees

• Current Assignee: Sudormed Incorporated
• Original Assignee: Sudormed Incorporated
• Inventors: Schoendorfer, Donald W.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/794,284
• Time in Patent Office: 610 Days
• Field of Search: 128/632, 128/636, 128/637, 128/760, 128/771, 604/312, 600/362, 600/573, 600/584, 600/367
• US Class Current: 600/362
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61F 2013/00195 electric warmer
• CPC Class Codes: A61F 2013/00434 Epicutaneous test
• CPC Class Codes: A61F 2013/00608 with reinforcing layers
• CPC Class Codes: A61F 2013/00642 soluble, e.g. in water
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 2013/00655 adhesive wound bandages with alginate A61F2013/00229; plasters with a double adhesive layer A61F2013/00421; with cyano-acrylic adhesive A61F2013/00459; plasters for treating burn with hydrogel A61F2013/00523; with adhesive connecting means A61F2013/00561; adhesive for plasters, with hydrogel A61F2013/00676; for use on mucosae A61F2013/00714; for use on wounds A61F2013/00719; wound humidity control with hydrocolloids or superabsorbers A61F2013/00748; with absorbent adhesives A61F2013/00757; with fumed silica A61F2013/00787; with viscoelastic oil-elastomer gel A61F2013/00893; with permeable adhesive layers A61F2013/00761; different adhesion of different adhesive layers A61F2013/00804; changing the adhesion force with strain value A61F2013/00838
• CPC Class Codes: A61F 2013/00731 with absorbing pads
• CPC Class Codes: A61F 2013/00863 with pores
• CPC Class Codes: A61F 2013/00902 : containing means
• CPC Class Codes: A61F 2013/8411 : in controlling solution Ph
• CPC Class Codes: A61F 2013/842 : with active charcoal
• CPC Class Codes: A61F 2013/8473 : for diagnostic purposes
• CPC Class Codes: A61F 2013/8491 : including test methods
• CPC Class Codes: A61M 35/006 : using sponges, foams, absorbent pads or swabs as spreading means
• CPC Class Codes: B01L 3/505 : flexible containers not provided for above
• CPC Class Codes: G01N 33/54386 : Analytical elements

Abstract

A dermal patch to be worn on the skin for increasing the concentration of an analyte expressed through the skin in perspiration to a conveniently measurable level. Included are patches and methods of using such patches to determine the quantity of an analyte in a given volume of perspiration, to determine a subject'"'"'s sensitivity to an allergen, to allow an analyte to be detected with conventional detection systems, and to dissolve the structural components of a patch to facilitate analyte detection.

Claims

1. A dermal patch to be worn on the skin of a subject mammal for determining the presence of an analyte in said subject'"'"'s perspiration, said patch comprising an absorbent material, said absorbent material having a first and second side, said first side of said absorbent material being adapted to be in fluid communication with the skin of said subject for collecting non-aqueous components of perspiration which diffuse through the skin of said subject, and an adhesive means for securing said patch to the skin of the subject, wherein said absorbent material can be dissolved with a solvent into a solution such that the dissolved absorbent material and solution do not interfere with the analysis of said components of perspiration.

2. The patch of claim 1, additionally comprising a fluid permeable support layer, said support layer having a first and second side, wherein said first side is adapted to be in fluid communication with said subject'"'"'s skin and said second side is located proximate to said first side of said absorbent material.

3. The patch of claim 1, wherein said absorbent material is selected from the group consisting of protein, nylon 6/6, phenolic, polyurethane (TP), and polyester (PBT), and said solvent is selected from the group consisting of an acid and a base.

4. The patch of claim 1, wherein said absorbent material is polystyrene and said solvent is selected from the group consisting of chlorinated hydrocarbons, aromatic hydrocarbons, esters, ketones, essential oils of high terpene content, and turpentine.

5. The patch of claim 4, wherein said solvent is selected from the group consisting of cyclohexanone, dichloroethylene, and methylenedichloride.

6. The patch of claim 1, additionally comprising a gas permeable outer protective layer, said outer protective layer having a first and second side, wherein said first side is located proximate to said second side of said absorbent material.

7. The patch of claim 6, further comprising a pooling area located proximate to said first side of said outer protective layer, wherein said pooling area is formed by a portion of said outer protective layer that extends beyond said absorbent material.

8. The patch of claim 1, wherein said absorbent material is provided with a specific binding partner for an analyte present in the perspiration of said subject.

9. The patch of claim 1, wherein said absorbent material is provided with a specific binding partner for a drug of abuse.

10. The patch of claim 9, wherein said specific binding partner binds cocaine.

11. The patch of claim 1, further comprising an allergenic material contained within or on a surface of said patch and adapted to be in fluid communication with the skin of said subject.

12. The patch of claim 1, further comprising a rate-limited structure located proximate to said absorbent material and adapted to be in fluid communication with the skin of said subject, wherein said structure allows the passage of perspiration through said structure at a rate lower than the insensible rate of perspiration through the skin of said subject.

13. A method of detecting a metabolite of an analyte contained in the perspiration of a subject mammal, comprising:

a) applying a dermal patch including an absorbent material to the skin of said subject, whereby said absorbent material is in fluid communication with the skin of said subject;

b) collecting an analyte in the perspiration of said subject in said absorbent material;

c) chemically modifying said analyte which has been collected on said absorbent material, thereby producing a metabolite of said analyte; and

d) detecting said metabolite of said analyte.

14. The method of claim 13, additionally comprising the step of freeing said analyte from said absorbent material after said analyte has been collected on said absorbent material.

15. The method of claim 14, wherein the freeing step comprises eluting said analyte from said absorbent material with a solvent.

16. The method of claim 14, wherein said absorbent material is dissolvable by a solvent and the freeing step comprises dissolving said absorbent material with said solvent into a solution containing said analyte, such that the dissolved material and solution do not interfere with the detection of said analyte.

17. The method of claim 13, wherein said step of chemically modifying comprises exposing said analyte to a solution having an alkaline pH.

18. The method of claim 13, further comprising heating said analyte during said step of chemically modifying.

19. The method of claim 13, wherein said analyte is cocaine, and wherein step (d) comprises detecting BE.

20. The method of claim 13, wherein said step of chemically modifying comprises incubating said analyte with an enzyme capable of hydrolyzing said analyte.

21. The method of claim 13, wherein said patch further comprises a specific binding partner for said analyte.

22. The method of claim 21, wherein said specific binding partner is an antibody.

23. The method of claim 21, wherein said binding partner is an antigen.

24. A method for determining the presence of an analyte in perspiration of a subject mammal, comprising the steps of:

applying a dermal patch to the skin of said subject;

accumulating perspiration containing said analyte from said subject with said dermal patch, wherein said patch comprises an absorbent material for accumulating said analyte, and wherein said absorbent material can be dissolved by a solvent into a solution;

dissolving said absorbent material containing said analyte with a solvent, wherein said solvent does not interfere with the detection of said analyte; and

detecting said analyte in said solution.

25. The method of claim 24, wherein said detecting step additionally comprises chemically modifying said analyte to form a metabolite of said analyte and then detecting said metabolite of said analyte in order to detect the presence of said analyte.

26. The method of claim 24, wherein said absorbent material is selected from the group consisting of protein, nylon 6/6, phenolic, polyurethane (TP), and polyester (PBT), and said solvent is selected from the group consisting of an acid and a base.

27. The method of claim 24, wherein said absorbent material is polystyrene and said solvent is selected from the group consisting of chlorinated hydrocarbons, aromatic hydrocarbons, esters, ketones, essential oils of high terpene content, and turpentine.

28. The method of claim 27, wherein said solvent is selected from the group consisting of cyclohexanone, dichloroethylene, and methylenedichloride.

29. The method of claim 24, wherein said patch further comprises a specific binding partner for said analyte.

30. The method of claim 29, wherein said specific binding partner is an antibody.

31. The method of claim 29, wherein said specific binding partner is an antigen.

32. A dermal patch to be worn on the skin of a subject mammal for determining the presence of an analyte in said subject'"'"'s perspiration, said patch comprising an absorbent material, said absorbent material being free of activated charcoal and having a first and second side, said first side of said absorbent material being adapted to be in fluid communication with the skin of said subject for collecting non-aqueous components of perspiration which diffuse through the skin of said subject, and an adhesive means for securing said patch to the skin of the subject, wherein said absorbent material can be dissolved completely with a solvent into a solution such that the dissolved absorbent material and solution do not interfere with the analysis of said components of perspiration.

33. The patch of claim 32, additionally comprising a fluid permeable support layer, said support layer having a first and second side, wherein said first side is adapted to be in fluid communication with said subject'"'"'s skin and said second side is located proximate to said first side of said absorbent material.

34. The patch of claim 32, wherein said absorbent material is selected from the group consisting of protein, nylon 6/6, phenolic, polyurethane (TP), and polyester (PBT), and said solvent is selected from the group consisting of an acid and a base.

35. The patch of claim 32, wherein said absorbent material is polystyrene and said solvent is selected from the group consisting of chlorinated hydrocarbons, aromatic hydrocarbons, esters, ketones, essential oils of high terpene content, and turpentine.

36. The patch of claim 35, wherein said solvent is selected from the group consisting of cyclohexanone, dichloroethylene, and methylenedichloride.

37. The patch of claim 32, additionally comprising a gas permeable outer protective layer, said outer protective layer having a first side and a second side, wherein said first side is located proximate to said second side of said absorbent material.

38. The patch of claim 37, further comprising a pooling area located proximate to said first side of said gas permeable outer protective layer and formed by a portion of said gas permeable outer protective layer that extends beyond said absorbent material.

39. The patch of claim 32, wherein said absorbent material is provided with a specific binding partner for an analyte present in the perspiration of said subject.

40. The patch of claim 32, wherein said absorbent material is provided with a specific binding partner for a drug of abuse.

41. The patch of claim 40, wherein said specific binding partner binds to cocaine.

42. The patch of claim 32, further comprising an allergenic material contained within or on a surface of said absorbent material and adapted to be in fluid communication with the skin of said subject.

43. The patch of claim 32, further comprising a rate-limited structure located proximate to said absorbent material and adapted to be in fluid communication with the skin of said subject, wherein said rate-limited structure allows the passage of perspiration through said structure at a rate lower than the insensible rate of perspiration through the skin of said subject.