Method and apparatus for determination of chemical species in body fluid

• US 5,676,144 A
• Filed: 06/07/1995
• Issued: 10/14/1997
• 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:
  US08/483,504
• Time in Patent Office: 860 Days
• Field of Search: 128/632, 128/636, 128/759, 128/760, 128/771, 604/312
• 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 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• 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: 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
• 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: A61F 7/032 : using oxygen from the air, e.g. pocket-stoves
• CPC Class Codes: B01L 3/505 : flexible containers not provided for above
• CPC Class Codes: G01N 33/54386 : Analytical elements

Abstract

Disclosed is a method and apparatus for the non-invasive determination of one or more preselected analytes in a body fluid expressed through the skin. The fluid is collected in a dermal concentration patch and concentrated by driving off a portion of the substantial water fraction under the influence of body heat. The analyte is optimally complexed with an immobilized specific binding partner and an indicium of the presence of the analyte is visually expressed. The patch may comprise a plurality of test zones for screening for a plurality of analytes. Additional positive and negative control zones are also disclosed. The patch may comprise a feature to detect tampering with the patch to produce false negative results, especially when used in screens for drugs of abuse. In addition to being useful as a drug of abuse screen, the patch is useful for diagnostic purposes.

Claims

1. A dermal concentration patch for determining the presence of a photosensitive analyte in a subject mammal'"'"'s perspiration, comprising:

a concentration layer having a first side and a second side;

an attenuation layer disposed over the second side of the concentration layer for attenuating the amount of light reaching the concentration layer; and

an adhesive membrane on at least one of the concentration layer or attenuation layer for securing the first side of the concentration layer in fluid communication with the subject'"'"'s skin,

wherein water vapor is permitted to escape through the concentration layer and the attenuation layer and outside of the concentration patch.

2. The concentration patch of claim 1, wherein the light attenuation layer comprises black paper.

3. The concentration patch of claim 1 wherein the attenuation layer comprises a light reflective material.

4. The concentration patch of claim 3, wherein the attenuation layer comprises a metallic surface.

5. The concentration patch of claim 4, wherein the attenuation layer comprises aluminum foil perforated with a plurality of holes.

6. The concentration patch of claim 1 wherein the attenuation layer comprises a material capable of substantially absorbing incoming light energy.

7. The concentration patch of claim 6, wherein the attenuation layer comprises a dark surface.

8. The concentration patch of claim 1 wherein said concentration layer additionally comprises a specific binding partner for said analyte.

9. The concentration patch of claim 8, wherein said specific binding partner is an antibody.

10. A dermal concentration patch for determining the presence of a photosensitive analyte in a subject mammal'"'"'s perspiration, comprising:

a water permeable support layer having a first side and a second side; and

a vapor permeable attenuation layer on the second side of the support layer for attenuating the amount of light reaching the support layer, the attenuation layer having an adhesive thereon for securing the first side of the support layer in fluid communication with the subject'"'"'s skin,

wherein water is permitted to escape through the support layer and outside of the concentration patch.

11. A dermal concentration patch for determining the presence of a photosensitive analyte in a subject mammal'"'"'s perspiration, comprising:

a concentration zone for collecting and storing said photosensitive analyte, wherein said concentration zone has a first side and a second side, wherein said first side is capable of being placed in fluid communication with the subject'"'"'s skin;

an adhesive layer having a first side and a second side, wherein said first side is proximate to said second side of said concentration zone, for removably securing the first side of said concentration zone in fluid communication with the subject'"'"'s skin; and

an attenuation layer having a first side and a second side, wherein said first side is proximate to said second side of said adhesive layer, for attenuating the transmission of light into said concentration zone,

wherein the concentration zone and the attenuation layer allow passage of aqueous components of sweat to outside of the concentration patch.

12. A method of determining the presence of a photosensitive analyte in perspiration of a subject mammal, comprising the steps of:

securing a dermal patch having a concentration zone to the subject'"'"'s skin, wherein said concentration zone is in fluid communication with the subject'"'"'s skin;

collecting perspiration containing said photosensitive analyte from said subject'"'"'s skin in said concentration zone;

attenuating the amount of photoradiation reaching said concentration zone during said collecting step, thereby protecting said photosensitive analyte from excessive photoradiation exposure;

concentrating said photosensitive analyte in said concentration zone by allowing aqueous components of perspiration to pass through and escape from said dermal patch; and

determining the presence of said photosensitive analyte in said subject'"'"'s perspiration.

13. The method of claim 12, wherein said attenuating step is accomplished by placing a substantially nontransmissive layer over the concentration zone of said dermal patch.

14. The method of claim 12, wherein said dermal patch comprises an adhesive layer, and wherein said securing step comprises adhering said adhesive layer to said subject'"'"'s skin.

15. The method of claim 14, wherein said attenuating step comprises placing a reflective material proximate to said adhesive layer of said dermal patch.

16. The method of claim 13, wherein said substantially nontransmissive layer is a metallic material.

17. The method of claim 12, wherein said attenuating step comprises placing a material capable of substantially absorbing light proximate to said concentration zone of said dermal patch.

18. The method of claim 14, wherein said attenuating step comprises placing a material capable of substantially absorbing light proximate to said adhesive layer of said dermal patch.