Method and apparatus of determination of chemical species in perspiration

• US 5,944,662 A
• Filed: 05/06/1998
• Issued: 08/31/1999
• 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:
  US09/073,612
• Time in Patent Office: 482 Days
• Field of Search: 600/362, 600/556, 600/573, 600/584
• 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 sensitivity of said subject to an allergen, comprising:

a fluid permeable support layer having a first side, a second side and an outer perimeter;

an absorbent material located adjacent to said second side of said support layer and adapted to be in fluid communication with said support layer for collecting non-aqueous components of perspiration;

an allergen located in said absorbent material; and

a gas permeable layer having a first and second side and an outer perimeter said first side of the gas permeable layer being adjacent to said absorbent material, whereby water expressed through the subject'"'"'s skin is permitted to escape in vapor phase from said absorbent material through said gas permeable layer.

2. The patch of claim 1, additionally comprising an agent for increasing permeability of dermal capillaries located immediately below said patch, said agent being in fluid communication with the subject'"'"'s skin when said patch is worn on the subject'"'"'s skin.

3. 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 analysis of non-aqueous components of perspiration.

4. The patch of claim 1, further comprising a specific binding partner in said absorbent material for a non-aqueous component of perspiration.

5. The patch of claim 4, wherein said specific binding partner is an antibody.

6. The patch of claim 4, wherein said specific binding partner is an antigen.

7. The patch of claim 1, additionally comprising an outer protective layer having a first side, a second side and an outer perimeter, wherein said first side of said outer protective layer is proximate to said absorbent material and distal to said support layer.

8. The patch of claim 7, wherein said outer protective layer includes an adhesive composition applied to the outer perimeter of said outer protective layer on the first side of said outer protective layer, said adhesive composition for attaching said patch to the skin of said subject.

9. The patch of claim 7, further comprising a rate-limited structure adjacent to said absorbent material so as to be located between said absorbent material and the subject'"'"'s skin when the patch is worn.

10. The patch of claim 7, further comprising a pooling area for collecting excess perspiration that is not diffused across said support layer, wherein said pooling area is located proximate to an area of the outer protective layer which extends beyond the support layer and the absorbent material, and wherein said absorbent material is in fluid communication with said pooling area only through said support layer.

11. The patch of claim 1, wherein the support layer comprises a rate-limited structure.

12. A method of determining whether a subject mammal is allergic to a particular allergen, comprising:

placing a patch on a surface of the subject'"'"'s skin, wherein said patch comprises an absorbent material having an allergen located therein, such that said absorbent material is in fluid communication with the subject'"'"'s skin;

inducing the migration into said absorbent material of non-aqueous components of perspiration associated with an allergic reaction to said allergen; and

detecting said non-aqueous components to determine whether said subject has expressed an allergic response to said allergen.

13. The method of claim 12, wherein said absorbent material additionally comprises a composition for increasing permeability of dermal capillaries located immediately beneath said patch when said patch has been placed on the surface of the subject'"'"'s skin.

14. A method for determining whether a subject mammal is allergic to a particular allergen, comprising the steps of:

exposing the subject'"'"'s skin to said allergen;

accumulating perspiration from said subject'"'"'s skin proximate to an area of the subject'"'"'s skin exposed to said allergen; and

detecting an analyte in said perspiration, wherein said analyte is indicative of an allergic reaction to said allergen.

15. The method of claim 14, further comprising applying a composition to the subject'"'"'s skin to increase capillary permeability of the subject'"'"'s skin in the area of the subject'"'"'s skin exposed to said allergen.