Method and apparatus for determination of chemical species in perspiration

• US 5,638,815 A
• Filed: 05/31/1995
• Issued: 06/17/1997
• 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:
  US08/454,850
• Time in Patent Office: 748 Days
• Field of Search: 128/632, 128/636, 128/637, 128/770, 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 dermal patch to be worn on the skin of a subject mammal for quantitatively determining the presence and amount of an analyte in said subject'"'"'s perspiration, comprising:

a fluid permeable support layer having a first and second side, and being adapted to be in fluid communication with the subject'"'"'s skin when said first side is proximate to the subject'"'"'s skin, wherein said support layer comprises a rate-limited structure that limits the rate of diffusion of perspiration through said support layer; and

an absorbent material located adjacent to said second side of said support layer and in fluid communication with said support layer for collecting non-aqueous components of perspiration which diffuse through said support layer.

2. The patch of claim 1, wherein said patch additionally comprises a gas permeable outer layer having a first and second side and an outer perimeter, said first side of the permeable outer layer being adjacent to said absorbent material and spaced apart from said second side of said support layer, wherein water and other fluids expressed through the skin of said subject are permitted to escape from said absorbent material through said gas permeable outer layer in their vapor phase.

3. The patch of claim 2, further comprising a pooling area located proximate to said first side of said gas permeable outer layer and formed by a portion of said gas permeable outer layer that is unattached to the subject'"'"'s skin when said first side of said support layer is proximate to the subject'"'"'s skin for collecting excess perspiration that is not diffused across said support layer, wherein said absorbent material is in fluid communication with said pooling area only through said support layer.

4. The patch of claim 2, wherein said gas permeable outer layer further includes an adhesive composition applied to the outer perimeter of said gas permeable outer layer on the first side of said gas permeable outer layer, said adhesive composition for attaching said patch to the skin of said subject.

5. The patch of claim 1, wherein said rate-limited structure is selected from the group consisting of a polycarbonate microporous membrane and a membrane made from nylon 6/6.

6. The patch of claim 1, wherein said absorbent material is paper.

7. The patch of claim 1, wherein said rate-limited structure limits the rate of diffusion of perspiration across said support layer to less than the insensible rate of perspiration through the skin of said subject.

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 8, wherein said binding partner is an antibody.

10. The patch of claim 1, wherein said absorbent material can be dissolved into a solution such that the dissolved material and solution do not interfere with the analysis of said analyte.

11. A method of quantitatively determining the presence of an analyte contained in the perspiration of a subject mammal, comprising the steps of:

a. placing a patch on the skin of a mammal, wherein said patch comprises an absorbent material capable of concentrating non-aqueous components of the perspiration of said mammal and a rate-limited structure having a known area, wherein said rate-limited structure is positioned adjacent to said absorbent material and proximate to the skin of said mammal when said patch is placed on the skin;

b. passing perspiration of said mammal containing an analyte through said structure at a known rate to said absorbent material;

c. removing said patch after a sufficient test period of time has elapsed so that said analyte can be detected by an assay for said analyte;

d. recording the amount of time the patch was worn in order to determine the total amount of perspiration which passed across said structure;

e. determining the amount of said analyte contained in the patch; and

f. relating the amount of analyte determined in step (e) to the amount of perspiration determined in step (d) in order to determine the average amount of the analyte in said mammal'"'"'s perspiration.

12. The method of claim 11, wherein said structure is selected from the group consisting of a polycarbonate microporous membrane and a membrane made from nylon 6/6.

13. The method of claim 11, wherein said absorbent material is paper.

14. The method of claim 13, wherein a binding partner for said analyte is attached to said absorbent material.

15. The method of claim 14, wherein said binding partner is an antibody.