Dermal patch detecting long-term alcohol consumption and method of use

• US 5,899,856 A
• Filed: 11/12/1996
• Issued: 05/04/1999
• Est. Priority Date: 09/08/1988
• Status: Expired due to Fees

• Current Assignee: Sudormed Incorporated
• Original Assignee: Sudormed Incorporated
• Inventors: Miller, William R., Schoendorfer, Donald W.
• Primary Examiner(s): Peterson, Kenneth E.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US08/747,304
• Time in Patent Office: 903 Days
• Field of Search: 600/362, 600/363, 600/304, 600/366, 600/346, 600/573, 600/575, 600/584, 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 10/0064 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 5/4266 sweat secretion
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 33/4972 Determining alcohol content for vehicle safety devices B60K28/06

Abstract

A non-occlusive dermal patch for collecting vapor phase perspiration from a subject'"'"'s skin and retaining an analyte such as ethanol in the perspiration is disclosed. A method of collecting vapor phase perspiration containing an analyte such as ethanol over a period up to several days and detecting the analyte to determine the wearer'"'"'s consumption of the analyte during the period when the patch was worn is disclosed.

Claims

1. A dermal patch for determining the presence of an analyte in perspiration of a subject mammal, comprising:

an adsorbent material for collecting perspiration in vapor phase from a subject'"'"'s skin and retaining a vapor phase analyte present in said collected vapor phase perspiration, said adsorbent material having a first side and a second side and an outer perimeter, wherein said first side is adapted to be in fluid communication with the subject'"'"'s skin;

a first gas permeable film having a first side and a second side and an outer perimeter, wherein said first side of the gas permeable film is adjacent to said second side of said adsorbent material and wherein said first gas permeable film has a first moisture vapor transmission rate (MVTR) whereby perspiration expressed through the subject'"'"'s skin is permitted to escape in vapor phase from said patch through said first gas permeable film; and

a second gas permeable film having a first side and a second side and an outer perimeter, wherein said first side of the second gas permeable film is adapted to be in fluid communication with the subject'"'"'s skin and said second side of the second gas permeable film is located adjacent to said first side of said adsorbent material, and wherein said second gas permeable film has a second MVTR that is no more than about equal to said first MVTR.

2. The dermal patch of claim 1, further comprising an adhesive layer on said first side of said first gas permeable film, said adhesive layer for attaching said patch to the subject'"'"'s skin.

3. The dermal patch of claim 1, further comprising an adhesive layer on said first side of said second gas permeable film, said adhesive layer for attaching said patch to the subject'"'"'s skin.

4. The dermal patch of claim 1, further comprising a release liner having a first side and a second side, wherein said release liner is located between said first gas permeable film and said adsorbent material such that said first side of said release liner is adjacent to said first side of said first gas permeable film and said second side of said release liner is adjacent to said second side of said adsorbent material.

5. The dermal patch of claim 1, further comprising an outer protective liner located proximate to said second side of said first gas permeable film, to said first side of said second gas permeable film, or both.

6. The dermal patch of claim 1, wherein said adsorbent material comprises activated carbon in an inert matrix.

7. The dermal patch of claim 1, wherein the analyte retained in said adsorbent material comprises ethanol.

8. The dermal patch of claim 1, wherein said first or second gas permeable film comprises polyurethane.

9. The dermal patch of claim 1, further comprising a pouch for containing the dermal patch before use, after use or both.

10. The dermal patch of claim 1, further comprising indicia incorporated into the dermal patch for identifying the dermal patch.

11. A dermal patch to be worn on the skin of a subject mammal for determining the presence of ethanol in the subject'"'"'s perspiration, comprising:

a carbon-containing adsorption pad for collecting vapor phase perspiration from a subject'"'"'s skin and retaining vapor phase ethanol present in said collected perspiration, said adsorption pad having a first side and a second side, wherein said first side is adapted to be in fluid communication with the subject'"'"'s skin;

a first gas permeable film having a first side and a second side and an outer perimeter, wherein said first side of the gas permeable film is located adjacent to said second side of said carbon-containing adsorption pad, and wherein said first gas permeable film has a first moisture vapor transmission rate (MVTR); and

a second gas permeable film having a first side and a second side and an outer perimeter, wherein said first side of the second gas permeable film is adapted to be in fluid communication with the subject'"'"'s skin and said second side of the second gas permeable film is located adjacent to said first side of said adsorption pad, and wherein said second gas permeable film has a second MVTR that is no more than about equal to said first MVTR.

12. The dermal patch of claim 11, further comprising an adhesive layer on said first side of said gas permeable film, said adhesive layer for attaching said patch to the subject'"'"'s skin.

13. The dermal patch of claim 11, further comprising an adhesive layer on said first side of said second gas permeable film, said adhesive layer for attaching said patch to the subject'"'"'s skin.

14. The dermal patch of claim 11, wherein said first or second gas permeable film comprises polyurethane.

15. The dermal patch of claim 11, wherein said first and second gas permeable films comprise polyurethane.

16. The dermal patch of claim 11, further comprising a release liner having a first side and a second side, wherein said release liner is located between said first gas permeable film and said adsorption pad such that said first side of said release liner is adjacent to said first side of said first gas permeable film and said second side of said release liner is adjacent to said second side of said adsorption pad.

17. The dermal patch of claim 11, wherein said adsorption pad comprises activated charcoal in an inert matrix.

18. The dermal patch of claim I 1, further comprising a pouch for containing the dermal patch before use, after use or both.

19. The dermal patch of claim I 1, further comprising indicia for identifying the dermal patch.

20. A dermal patch for determining the presence of an analyte in perspiration of a subject mammal, comprising:

a first adsorption pad for collecting perspiration in vapor phase from a subject'"'"'s skin and retaining a vapor phase analyte present in said vapor phase perspiration, said adsorption pad having a first side and a second side and an outer perimeter, wherein said first side is adapted to be in fluid communication with the subject'"'"'s skin;

a second adsorption pad for collecting said vapor phase analyte from a subject'"'"'s environment and retaining said analyte, said second adsorption pad having a first side and a second side and an outer perimeter, wherein said second side is adapted to be in fluid communication with the subject'"'"'s environment;

a first gas permeable film having a first side and a second side and an outer perimeter, wherein said first side of the first gas permeable film is adjacent to a second side of at least one adsorption pad, wherein said second side of said first gas permeable film is adapted to be in fluid communication with the subject'"'"'s environment, and wherein perspiration expressed through the subject'"'"'s skin is permitted to escape in vapor phase from said patch through said first gas permeable film;

a second gas permeable film having a first and second side and an outer perimeter, wherein said first side of the second gas permeable film is adapted to be in fluid communication with the subject'"'"'s skin, wherein said second side of the second gas permeable film is located adjacent to a first side of at least one adsorption pad, and wherein said first side of said second gas permeable film is adapted to be in fluid communication with the subject'"'"'s skin; and

a separator layer located between said first adsorption pad and said second adsorption pad.

21. The dermal patch of claim 20, wherein said separator layer has a first side and a second side, and wherein said first side of said separator layer is located proximate to said second side of said first adsorption pad and said second side of said separator layer is located proximate to said first side of said second adsorption pad.

22. The dermal patch of claim 20, wherein said first adsorption pad is located proximate to said second adsorption pad in a side-by-side arrangement such that a portion of the perimeter of said first adsorption pad is proximate to a portion of the perimeter of said second adsorption pad and said separator layer is located adjacent to the perimeter and the first side of said second adsorption pad, thereby separating the proximate portions of the perimeters of said first and second adsorption pads and separating said second adsorption pad from said second gas permeable film.

23. The dermal patch of claim 20, further comprising an outer protective liner located adjacent to the first side of said second gas permeable film.

24. The dermal patch of claim 20, further comprising an outer protective liner located adjacent to the second side of said first gas permeable film.

25. The dermal patch of claim 20, wherein said analyte comprises ethanol.

26. The dermal patch of claim 20, further comprising a pouch for containing the dermal patch before use, after use or both.

27. The dermal patch of claim 20, further comprising indicia incorporated into the dermal patch for identifying the dermal patch.

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

removably attaching a dermal patch to a subject'"'"'s skin, wherein said dermal patch comprises a carbon-containing material capable of adsorbing a vapor phase analyte contained in the subject'"'"'s perspiration, a first gas permeable film and a second gas permeable film, wherein said carbon-containing material is located between said first and second gas permeable films and is adapted to be in fluid communication with the subject'"'"'s skin when said dermal patch is placed on the subject'"'"'s skin, and wherein said first gas permeable film has first and second sides and wherein the second side of the first gas permeable skin faces away from the subject'"'"'s skin when the dermal patch is attached to the subject'"'"'s skin and;

wherein said first gas permeable film permits vapor phase perspiration to escape from said dermal patch;

passing vapor phase perspiration containing said analyte expressed from the subject'"'"'s skin through said carbon-containing material for a period of time sufficient to adsorb said analyte;

removing said dermal patch after a period of time sufficient to adsorb said analyte has elapsed; and

determining the amount of analyte adsorbed in said carbon-containing material.

29. The method of claim 28, wherein the removing step occurs about one hour to about ten days after the attaching step.

30. The method of claim 28, wherein the determining step includes extracting said analyte from said carbon-containing material to produce an extract.

31. The method of claim 30, wherein said analyte comprises ethanol which is extracted from said carbon-containing material with water.

32. The method of claim 30, further including a step of measuring said analyte in said extract by gas chromatography.

33. The method of claim 28, further including a step of examining the dermal patch for evidence of tampering or of partial or complete removal of the dermal patch before the removing step.

34. The method of claim 28, wherein the attaching step includes attaching a dermal patch to skin on the subject'"'"'s arm, the back, the chest or any combination thereof.

35. The method of claim 28, wherein said analyte comprises ethanol.

36. The method of claim 28, wherein said dermal patch further includes a second carbon-containing material that is adapted to be in fluid communication with said vapor phase analyte in the subject'"'"'s skin, and the method further includes the steps of:

collecting said vapor phase analyte in the subject'"'"'s skin during the period when vapor phase perspiration containing said analyte is passed through said carbon-containing material; and

determining the amount of said analyte adsorbed in said second carbon-containing material.

37. The method of claim 36, further including the step of comparing the amount of analyte in the second carbon-containing material with the amount of analyte in said carbon-containing material through which vapor phase perspiration passed to determine an amount of said analyte in the subject'"'"'s perspiration during the period when vapor phase perspiration containing said analyte passed through said carbon-containing material.

38. A method of indicating alcohol consumption by a patient, comprising the steps of:

identifying a patient to be monitored for alcohol consumption;

providing a non-occlusive dermal patch having an activated charcoal layer therein;

securing the dermal patch to the skin of the patient for a period in excess of about one day;

permitting moisture in perspiration to escape from the patient and through the dermal patch during said period;

removing the dermal patch from the skin of the patient; and

measuring ethanol or a metabolite of ethanol contained in the activated charcoal layer.

39. The method of claim 38, wherein the period is up to about ten days.

40. The method of claim 38, wherein the metabolite of ethanol comprises acetaldehyde.