Patient attached patch and method of making

• US 4,329,999 A
• Filed: 03/03/1980
• Issued: 05/18/1982
• Est. Priority Date: 03/03/1980
• Status: Expired due to Term

• Current Assignee: Michael Phillips
• Original Assignee: Michael Phillips
• Inventors: Phillips, Michael
• Primary Examiner(s): Weston, Caleb
• Application Number:
  US06/126,882
• Time in Patent Office: 806 Days
• Field of Search: 156/250, 156/256, 156/263, 156/514, 156/247, 156/249, 128/632, 128/637, 128/760, 128/762, 128/112, 128/113, 128/290 P, 128/296
• US Class Current: 600/573
• 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 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/1062 Prior to assembly
• CPC Class Codes: Y10T 156/1074 Separate cutting of separate sheets or webs

Abstract

A patch which is attached to a patient to collect sweat is formed. The patch collects sweat from a patient in a non-intrusive manner which produces very accurate and precise results to determine the amount of drug and/or alcohol use by such patient.

Claims

1. A method of forming a test patch for use in clinical studies including the steps of:

cutting a first portion of material;

defining a hole in said portion of material;

placing a strip of adhesive tape on said first portion of material to cover said hole;

heat shaping said strip covered first portion and forcing the adhesive surface of the adhesive tape through said hole;

placing an absorbent pad on the adhesive surface forced through said hole;

forcing said pad covered adhesive surface back through said hole so that said pad is located within a chamber defined by said adhesive strip;

cutting a second portion of material;

cutting a third portion of material;

folding said third portion of material;

attaching said folded portion of material to said second portion of material;

applying a length of adhesive tape to said second and third portions of material;

defining an access hole through said length of adhesive tape and said second portion of material;

removing said chamber containing adhesive tape from said first portion of material; and

applying said chamber containing adhesive tape to said second portion of material so that said access hole is aligned with said chamber to form a combined portion of material.

2. The method defined in claim 1 wherein said first portion of material is cut into a square shape.

3. The method defined in claim 1 wherein said first portion of material is formed of polystyrene.

4. The method defined in claim 2 wherein said hole is defined at the center of said first portion of material.

5. The method defined in claim 1 wherein the hole in said first portion of material is circular and is approximately 13/16 inches in diameter.

6. The method defined in claim 1 wherein said strip of adhesive tape is formed of surgical tape.

7. The method defined in claim 1 wherein said heat shaping step includes placing said strip covered first portion of material in a template.

8. The method defined in claim 7 wherein said heat shaping step includes directing a blast of hot air onto said template located strip covered first portion of material.

9. The method defined in claim 8 wherein said heat shaping step includes maintaining said template located strip covered first portion of material in situ for at least forty-eight hours.

10. The method defined in claim 1 wherein said second portion of material is cut into a square shape.

11. The method defined in claim 1 wherein said second portion of material is formed of a polystyrene material.

12. The method defined in claim 10 wherein said third portion of material is formed of a strip of vinyl film.

13. The method defined in claim 12 wherein said third portion of material is folded longitudinally.

14. The method defined in claim 1 wherein said folded third portion of material is attached to said second portion of material near the edge of said second portion of material.

15. The method defined in claim 1 wherein said length of adhesive tape is formed of surgical tape.

16. The method defined in claim 1 wherein said access hole is defined near the center of said length of adhesive tape.

17. The method defined in claim 1 wherein said access hole is about 9/16 inches in diameter.

18. The method defined in claim 1 wherein said access hole is defined by stamping.

19. The method defined in claim 1 further including stamping a disc from said combined portion of material.

20. The method defined in claim 19 wherein said disc is about 15/8 inches in diameter.

21. The method defined in claim 1 further including forming said absorbent pad using steps including:

layering a plurality of sheets of absorbent material one on top of the other;

wetting said layered sheets;

placing cylinders on said wet material;

placing a weighting element on top of said cylinders;

heating said weighted layered sheets;

removing portions of said heated layered sheets; and

wetting said portions.

22. The method defined in claim 21 wherein said sheets are formed of felted polyester absorbent material.

23. The method defined in claim 22 wherein said material is 11/2 denier, polyester fiber, non-woven needle loomed with a 0.8% hydrophilic finish.

24. The method defined in claim 21 further including a step of providing a container and said sheets are layered in said container.

25. The method defined in claim 24 wherein said container is formed of aluminum foil.

26. The method defined in claim 21 wherein said sheets are wetted with a saturated solution of sodium chloride in water.

27. The method defined in claim 21 wherein said cylinders have aluminum caps thereon.

28. The method defined in claim 21 wherein said cylinders are about 13/16 inches in diameter.

29. The method defined in claim 21 wherein said weighting element is formed of a sheet of steel.

30. The method defined in claim 21 wherein said heating step is performed at about 80°

C. for about 15-20 hours.

31. The method defined in claim 21 wherein said removed portions are punched out.

32. The method defined in claim 21 wherein said removed portions are discs about 13/16 inches in diameter.

33. The method defined in claim 21 wherein said removed portions are wetted with a solution containing Nystatin, sodium fluoride and reduced methylene blue.

34. The method defined in claim 33 wherein wetting of said removed portions is performed in a glass dessicator under CO₂.

35. The method defined in claim 34 further including a step of dessicating said wetted removed portions to dryness at room temperature.

36. The method defined in claim 35 further including a step of accelerating drying of said wetted removed portions using a vacuum dryer.

37. A test patch formed according to the method defined in claim 1.

38. A test patch as defined in claim 37 wherein said first portion of material is formed of polystyrene.

39. A test patch as defined in claim 37 wherein said hole is defined at the center of said first portion of material.

40. A test patch as defined in claim 37 wherein the hole in said first portion of material is circular and is approximately 13/16 inches in diameter.

41. A test patch as defined in claim 37 wherein said strip of adhesive tape is formed of surgical tape.

42. A test patch as defined in claim 37 wherein said second portion of material is cut into a square shape.

43. A test patch as defined in claim 37 wherein said second portion of material is formed of a polystyrene material.

44. A test patch as defined in claim 37 wherein said third portion of material is formed of a strip of vinyl film.

45. A test patch as defined in claim 37 wherein said length of adhesive tape is formed of surgical tape.

46. A test patch as defined in claim 37 wherein said access hole is defined near the center of said length of adhesive tape.

47. A test patch as defined in claim 37 wherein said access hole is about 9/16 inches in diameter.

48. A test patch as defined in claim 37 wherein said absorbent pad includes a plurality of sheets of absorbent material layered one on the other, and wetting solution wetting said layers.

49. A test patch as defined in claim 48 wherein said sheets are formed of felted polyester absorbent material.

50. A test patch as defined in claim 48 wherein said material is 11/2 denier, polyester fiber, non-woven needle loomed with a 0.8% hydrophilic finish.

51. A test patch as defined in claim 48 wherein said wetting solution includes a solution of sodium chloride in water.

52. A test patch as defined in claim 48 wherein said wetting solution includes a solution containing Nystatin, sodium fluoride and reduced methylene blue.