Dermal substance collection method

• US 4,819,645 A
• Filed: 11/04/1987
• Issued: 04/11/1989
• Est. Priority Date: 02/11/1985
• Status: Expired due to Fees

• Current Assignee: The United States of America As Represented By The Secretary of Agriculture
• Original Assignee: The United States Of America As Represented By The Secretary Of The Army
• Inventors: Peck, Carl C.
• Primary Examiner(s): Coven, Edward M.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/116,763
• Time in Patent Office: 524 Days
• Field of Search: 128/760, 128/767, 128/632, 128/637, 604/290
• US Class Current: 600/362
• 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 5/4283 gastrointestinal secretions, e.g. bile production
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02

Abstract

A dermal substance collection device (DSCD) is described which provides ms for the non-invasive, instantaneous and continuous monitoring of chemical substances which are present in a detectable amount in either or both interstitial fluid or sweat or which are on or in the skin. The transdermal substance collection device of this invention is comprised of three essential components: (1) a substance binding reservoir, wettable by (2) a liquid transfer medium which allows for liquid bridge transfer of a soluble substance from the skin surface to the binding reservoir by virtue of its wettability by the liquid, and (3) an occlusive cover.

Claims

1. A method for the non-invasive, immediate and continuous collection of a chemical substance from a dermal surface, said method comprising the steps of

I. applying to the skin to collect said chemical substance from said surface a dermal surface a dermal substance collection device (DSCD) comprised of:

(a) a binding reservoir material for binding with said dermal substance to prevent back transfer loss of said dermal substance from said collection device to the dermal surfaces;

(b) a liquid bridge transfer medium which allows the instantaneous and continuous transfer of said dermal substance from the dermal surface to said binding reservoir material, said binding reservoir material being maintained in a wet-state by said liquid bridge transfer medium; and

(c) a cover means for occlusively containing said binding reservoir material and said liquid bridge transfer medium and for occlusively maintaining said liquid bridge transfer medium in continuous contact with the dermal surface upon application of said collection device to the dermal surface;

II. maintaining the DSCD in a substantially air tight relation with the skin surface over the collection period;

III. removing the binding reservoir material from the DSCD; and

IV. analyzing the chemical substance collected in the binding reservoir.

2. A method according to claim 1 wherein the dermal substance collection device has a circular shape and a substantially flat profile relative to the dermal surface upon adhesive application thereto.

3. A method according to claim 1 wherein the dermal substance collection device has an immobilized liquid transfer medium approximately 1 millimeter to 7 centimeters in diameter and 1 millimeter to 0.5 centimeters in thickness.

4. A method according to claim 1 wherein the dermal substance collection device has a strippable backing.

5. A method according to claim 1 wherein said liquid bridge transfer medium is immobilized.

6. A method according to claim 5 wherein said binding reservoir is selected from the group consisting of activated charcoal, ion-exchange resin, immobilized antibody, silica, zeolite and molecular sieve.

7. A method according to claim 5 wherein said occlusive cover means is comprised of an outer adhesive layer and an inner metallic foil layer contiguous to said immobilized liquid bridge transfer medium.

8. A method according to claim 18 wherein said occlusive cover means further comprises a transfer medium-surrounding closed-cell foam layer contiguous to said foil layer.

9. A method according to claim 5 wherein said immobilized liquid bridge transfer medium comprises a protruding surface relative to the occlusive cover means and the dermal surface-interface to maintain positive pressure contact between said transfer medium and said dermal surface.

10. A method according to claim 5 wherein said binding reservoir material is dispersed in said immobilized liquid bridge transfer medium.

11. A method according to claim 10 wherein said binding reservoir material is activated charcoal and said immobilized liquid bridge transfer medium is an aqueous gel.

12. A method according to claim 11 wherein said aqueous gel comprises an osmotically active substance.

13. A method according to claim 12 wherein said aqueous gel consists essentially of an osmotically active aqueous solution and an agarose gelling agent.

14. A method according to claim 13 wherein said osmotically active aqueous solution contains sodium chloride present in an amount up to saturation of said aqueous gel.

15. A method according to claim 14 wherein the amount of agarose is 0.5 to 30% by weight of the aqueous sodium chloride solution and the amount of activated charcoal is 0.5 to 30% by weight of the aqueous gel.

16. A method according to claim 15 wherein the amount of agarose is about 3 weight-percent of the sodium chloride solution and the amount of activated charcoal is about 5 weight-percent of the aqueous gel.

17. A method according to claim 11 wherein said aqueous gel comprises an agarose gelling agent.

18. A method according to claim 11 wherein said aqueous gel comprises a polyvinyl alcohol polymer gelling agent.

19. A method according to claim 18 wherein the penetration enhancing agent is selected from the group consisting of n,n-diethyl-m-toluamide, 1-dodecylazacycloheptane-2-one, and dimethyl sulfoxide.

20. A method according to claim 7 wherein said aqueous gel comprises a penetration enhancing agent.