# US 5,944,662 A · Method and apparatus of determination of chemical species in perspiration

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- Number: US 5,944,662 A
- Document ID: US5944662A
- Status: Granted
- Kind: A
- Application number: 09/073,612
- Filed: 1998-05-06
- Granted: 1999-08-31
- Earliest claimed: 1988-09-08
- Assignees: Sudormed, Inc.
- Inventors: Donald W. Schoendorfer
- Web page: https://patentgrep.com/patent/US5944662A

## CPC

- A61B 10/0064: {for taking sweat or sebum samples (measuring sweat production A61B5/4266)}
- A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons
- A61B 5/14521: {using means for promoting sweat production, e.g. heating the skin (measuring sweat secretion A61B5/4266)}
- A61B 5/411: {Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance}
- A61B 5/415: {the glands, e.g. tonsils, adenoids or thymus}
- A61B 5/418: {lymph vessels, ducts or nodes}
- A61B 5/4266: {sweat secretion}
- A61B 5/6833: {Adhesive patches}
- A61B 10/0035: {Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches}
- A61M 35/006: {using sponges, foams, absorbent pads or swabs as spreading means}
- B01L 3/505: {Flexible containers without fluid transport within}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 10/0051: {for taking saliva or sputum samples (devices for receiving spittle A61J9/00)}
- A61B 2010/0009: {Testing for drug or alcohol abuse}
- A61F 2013/00195: {electric warmer}
- A61F 2013/00434: {Epicutaneous test}
- A61F 2013/00608: {with reinforcing layers}
- A61F 2013/00642: {soluble, e.g. in water}
- A61F 2013/00646: {Medication patches, e.g. transcutaneous}
- A61F 2013/00655: {adhesive}
- A61F 2013/00731: {with absorbing pads}
- A61F 2013/00863: {with pores}
- A61F 2013/00902: {containing means}
- A61F 2013/8411: {in controlling solution Ph}
- A61F 2013/842: {with active charcoal}
- A61F 2013/8473: {for diagnostic purposes}
- A61F 2013/8491: {including test methods}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 4)

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

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 7)

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.

### Claim 10 (depends on 7)

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.

### Claim 11 (depends on 1)

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

### Claim 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.

### Claim 13 (depends on 12)

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.

### Claim 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.

### Claim 15 (depends on 14)

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.
