Energy-assisted transdermal collection patch for accelerated analyte collection and method of use

• US 5,465,713 A
• Filed: 07/20/1993
• Issued: 11/14/1995
• 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:
  US08/094,787
• Time in Patent Office: 847 Days
• Field of Search: 128/632, 128/636, 128/637, 128/760, 128/771, 604/312
• US Class Current: 600/346
• 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

A dermal patch including a means for generating heat on the surface of the skin of a subject wearing the patch. The temperature of the surface of the skin under the patch is raised to about 115° F., and perspiration is collected in the patch over the course of about an hour. The patch is then analyzed to determine the presence of an analyte in the patch.

Claims

1. A method of collecting an analyte contained in the perspiration of a mammal using a dermal patch, comprising the steps of:

a. placing a dermal patch on the skin of a mammal, wherein said patch comprises an absorbent material for collecting analytes contained in the perspiration of said mammal;

b. generating heat by means of a chemical composition in order to heat the skin of said mammal underneath said dermal patch, wherein perspiration flows through the skin of said mammal

c. collecting an analyte present in the perspiration of said mammal in said absorbent material of said patch;

d. removing said patch after a sufficient period of time has elapsed following the initial application of heat to the skin of said mammal to allow said analyte to be detected in said patch by an assay for said analyte; and

e. detecting the presence of said analyte in said patch.

2. The method of claim 1, wherein step (b) further comprises exposing a chemical composition to oxygen, wherein said chemical composition reacts exothermically in the presence of oxygen.

3. The method of claim 1, wherein step (b) comprises heating the skin of said mammal to between about 100°

F. and 150°

F.

4. The method of claim 3, wherein step (b) comprises heating the skin of said mammal to between about 105°

F. and 115°

F.

5. The method of claim 1, wherein step (d) comprises removing said patch after between 1 and 2 hours.

6. The method of claim 2, wherein step (d) comprises removing said patch after about 1 hour.

7. The method of claim 1, wherein step (d) comprises removing said patch after less than 1 hour.

8. The method of claim 1, wherein step (e) comprises detecting the presence of cocaine in said patch.

9. The method of claim 1, wherein step (a) comprises placing said dermal patch on the palm of one of said mammal'"'"'s hands.

10. The method of claim 1, wherein step (a) comprises placing said dermal patch on the sole of one of said mammal'"'"'s feet.

11. The method of claim 1, wherein step (a) comprises placing said dermal patch on facial skin of said mammal.

12. A single use dermal patch for detecting an analyte contained in the perspiration of a subject mammal, said patch comprising:

an outer protective layer having an adhesive applied to one side of said layer, wherein said adhesive secures said outer protective layer to the skin of a subject mammal when said patch is worn on the subject'"'"'s skin;

an absorbent material for collecting analytes contained in the perspiration of said subject, wherein said absorbent material is secured to the side of said outer protective layer to which said adhesive is applied, said absorbent material being in fluid communication with the skin of said subject when said patch is worn on the subject'"'"'s skin; and

a heat-generating chemical composition, wherein said composition is secured to said outer protective layer or to said absorbent material of said patch, said composition being capable of reaching temperatures in excess of 105°

F. when reacted.

13. The patch of claim 12, wherein said composition is one which reacts exothermically when exposed to air.

14. The patch of claim 12, wherein said composition comprises iron, a metal chloride or metal sulfate, activated carbon, and water.

15. The patch of claim 12, wherein said composition is further contained in a porous bag in said patch.

16. The patch of claim 12, wherein said chemical composition surrounds said absorbent material of said patch.

17. The patch of claim 12, wherein said outer protective layer comprises a layer of 1625 Tegaderm wound dressing.

18. The patch of claim 12, wherein said outer protective layer is rectangular.

19. The patch of claim 12, wherein said absorbent material is rectangular.

20. A packaged patch, comprising the patch of claim 12 and a package for said patch, wherein said package is made from a material that is resistant to the influx of air, and wherein said patch is encased in said package.