Method and apparatus for determination of chemical species in perspiration

• US 5,441,048 A
• Filed: 12/11/1992
• Issued: 08/15/1995
• Est. Priority Date: 09/08/1988
• Status: Expired due to Fees

• Current Assignee: Sudormed Incorporated
• Original Assignee: Sudor Partners
• Inventors: Schoendorfer, Donald W.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/989,204
• Time in Patent Office: 977 Days
• Field of Search: 128/632, 128/636, 128/637, 128/760, 128/771, 604/312
• US Class Current: 600/346
• 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 system for determining the presence of an analyte in perspiration of a subject mammal comprising:

a) a dermal patch to be worn on the skin of a subject mammal, said patch comprising;

i) an absorbent material for collecting components of perspiration which diffuse through the skin of said subject, 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, wherein said absorbent material comprises a material which can be dissolved into a solution with a solvent such that said solvent and the dissolved absorbent material in solution do not interfere with the analysis of said components of perspiration; and

ii) adhesive on said patch for removably securing said first side of said absorbent material in fluid communication with the skin of said subject; and

b) a solvent which can dissolve said absorbent material of said dermal patch into solution, wherein said solvent does not interfere with the analysis of said components of perspiration.

2. The system of claim 1, wherein said patch additionally comprises a fluid permeable support layer adjacent said first side of said absorbent material in fluid communication with said subject'"'"'s skin when said patch is worn on said subject'"'"'s skin, wherein said support layer comprises a rate-limited structure that limits the rate of diffusion of perspiration through said support layer, said support layer being located between said absorbent material and the subject'"'"'s skin when said patch is on the subject'"'"'s skin.

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

6. The system 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 of said outer protective layer is adjacent said second side of said absorbent material, and wherein said adhesive is located on said first side of said outer protective layer.

7. The system of claim 6, wherein said patch further comprises a pooling area between said outer protective layer and the skin of said subject when said patch is on said subject'"'"'s skin and a fluid, said absorbent material being in fluid communication with said pooling area only through said fluid permeable support layer, said fluid permeable support layer being adjacent said first side of said absorbent material in fluid communication with said subject'"'"'s skin when said patch is worn on said subject'"'"'s skin.

8. The system 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 system of claim 1, wherein said absorbent material contains a component of said perspiration of said subject, and wherein said component is a drug of abuse.

10. The system of claim 9, wherein said drug of abuse is cocaine.

11. The system of claim 2, wherein said rate-limited structure of said support layer allows the passage of perspiration through said support layer at a rate lower than the insensible rate of perspiration through the skin of said subject.

12. A method of detecting metabolites of an analyte contained in perspiration of a subject mammal, wherein said analyte appears in a chemically modified form in a body fluid of said subject other than perspiration, comprising:

a) passing said analyte through the skin of said mammal in the perspiration of said mammal;

b) collecting said analyte on a dermal patch worn on the skin of said subject mammal, said patch comprising;

i) an absorbent material for collecting components of perspiration which diffuse through the skin of said subject, 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; and

ii) adhesive on said patch for removably securing said first side of said absorbent material in fluid communication with the skin of said subject;

c) chemically modifying said analyte after said analyte has been collected on said absorbent material in order to convert said analyte into the chemically modified form of said analyte which appears in said body fluid of said subject other than perspiration; and

d) detecting said chemically modified form of said analyte.

13. The method of claim 12, additionally comprising the step of freeing said analyte from said absorbent material after said analyte has been collected on said absorbent material.

14. The method of claim 13, wherein the freeing step comprises eluting said analyte from said absorbent material with a solvent.

15. The method of claim 13, wherein said absorbent material is dissolvable by said solvent into a solution such that the dissolved material and solution do not interfere with the detection of said analyte, and said freeing step involves dissolving said absorbent material and thereby eluting said analyte.

16. The method of claim 12, wherein said step of chemically modifying comprises exposing said analyte to a solution having an alkaline pH.

17. The method of claim 12, further comprising heating said analyte during said step of chemically modifying.

18. The method of claim 12, wherein said analyte is cocaine.

19. The method of claim 12, wherein said step of chemically modifying comprises incubating said analyte with an enzyme capable of hydrolyzing said analyte.

20. The method of claim 12, wherein said step of chemically modifying said analyte comprises reacting said analyte with a cholinesterase enzyme.

21. The method of claim 12, wherein said step of chemically modifying said analyte comprises converting said analyte into a form of said analyte which appears in the urine of said subject.

22. The method of claim 12, wherein said step of chemically modifying said analyte comprises converting said analyte into a form of said analyte which appears in the blood of said subject.

23. The method of claim 12, additionally comprising the step of concentrating said analyte on said dermal patch after collecting perspiration containing said analyte on said patch, wherein said perspiration collects in said absorbent material of said patch, and wherein said concentrating step is performed by passing water from said perspiration in said absorbent material through a gas permeable outer protective layer, said outer protective layer having a first and second side, wherein said first side of said outer protective layer is adjacent said second side of said absorbent material, and wherein said adhesive is located on said first side of said outer protective layer.

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

a) placing a dermal patch on the skin of said subject, said patch comprising;

i) an absorbent material for collecting components of perspiration which diffuse through the skin of said subject, 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, wherein said absorbent material comprises a material which can be dissolved such that the dissolved absorbent material does not interfere with the analysis of said components of perspiration; and

ii) adhesive on said patch for removably securing said first side of said absorbent material in fluid communication with the skin of said subject;

b) accumulating perspiration containing said analyte from said subject on said patch;

c) dissolving said absorbent material of said patch containing said analyte into a solution, wherein said solution does not interfere with the analysis of said components of perspiration; and

d) detecting said analyte in said solution.

25. The method of claim 24, wherein said detecting step additionally comprises chemically modifying said analyte and detecting a 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 wherein said dissolving step comprises contacting said absorbent material with a solvent, said solvent being selected from the group consisting of an acid and a base.

27. The method of claim 24, wherein said absorbent material is polystyrene and wherein said dissolving step comprises contacting said absorbent material with a solvent, said solvent being 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, additionally comprising the step of concentrating said analyte on said dermal patch after accumulating perspiration containing said analyte on said patch, wherein said perspiration accumulates in said absorbent material of said patch, and wherein said concentrating step is performed by passing water from said perspiration in said absorbent material through a gas permeable outer protective layer, said outer protective layer having a first and second side, wherein said first side of said outer protective layer is adjacent said second side of said absorbent material, and wherein said adhesive is located on said first side of said outer protective layer.