Apparatus with reagents for detection of medical conditions

• US 6,203,496 B1
• Filed: 08/12/1999
• Issued: 03/20/2001
• Est. Priority Date: 08/12/1999
• Status: Expired due to Fees

• Current Assignee: Michael R. Gael, Sidney Gael, William Gael
• Original Assignee: Michael R. Gael, Sidney Gael, William Gael
• Inventors: Gael, Sidney, Gael, William, Gael, Michael R.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US09/372,876
• Time in Patent Office: 586 Days
• Field of Search: 600/362, 600/573, 600/584, 600/309, 602/52, 604/358, 604/362
• US Class Current: 600/362
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: C12Q 2334/30 Naphthol derivatives, e.g. alpha-naphthyl-esters, i.e. alpha-NE, beta-naphthyl-esters, i.e. beta-NE
• CPC Class Codes: C12Q 2334/70 the product, e.g. phenol, naphthol being diazotised in situ, e.g. with Fast Red
• CPC Class Codes: G01N 2333/805 Haemoglobins; Myoglobins
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/64 involving ketones
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

Disclosed is a disposable diaper that has one or more chemical reagents provided in the absorbent region of the diaper, which comes into contact with urine when a patient wearing the diaper urinates. These chemical reagents change color when they contact urine containing abnormal levels of substances, such as leukocytes, blood, glucose, nitrites, protein, ketones, bilirubin, or urobilinogen; which substances may indicate the presence of a medical abnormality. Such a color change provides a visible indication of an abnormality in the urine and thus a possible incipient medical condition, such as a urinary tract infection, diabetes mellitus, hematuria, or the like. Such a color change is easily assessed by personnel having limited medical training, allowing such personnel to screen patients for these medical conditions and refer them to the appropriate medical personnel.

Claims

1. A method for detecting and monitoring a medical condition in a mammal, comprising the steps of:

positioning an absorbent apparatus on the mammal so as to receive urine from the mammal, the apparatus having at least one reagent configured to indicate, by a visual color change, the presence of the medical condition, wherein the medical condition is selected from the group consisting of (a) urinary tract infection, (b) hematuria, (c) glycosuria, (d) biliary abnormality, (e) ketonuria, and (f) proteinuria; and

determining from the color of the reagent whether an abnormal level of a substance indicating the presence of said medical condition is present in the urine received on the apparatus.

2. The method of claim 1, wherein the apparatus is a diaper.

3. The method of claim 1, wherein the apparatus is a panty liner.

4. The method of claim 1, wherein the apparatus is a pad.

5. The method of claim 1, wherein said medical condition is a urinary tract infection.

6. The method of claim 5, wherein said substance is selected from the group consisting of leukocytes and nitrites.

7. The method of claim 5, wherein the reagent is selected from the group consisting of naphthyl ester, diazonium salt, arsenilic acid, and tetrahydrobenzo (h) quinolin.

8. The method of claim 1, wherein said medical condition is hematuria, and said substance is red blood cells.

9. The method of claim 8, wherein the reagent is cumene-hydroperoxide tetramethylbenzidine.

10. The method of claim 1, wherein said medical condition is glycosuria and said substance is glucose.

11. The method of claim 10, wherein the reagent is selected from the group consisting of glucose oxidase, peroxidase, and potassium iodide.

12. The method of claim 1, wherein the condition is proteinuria and the substance is a protein.

13. The method of claim 12, wherein the reagent is tetrabromphenol blue.

14. The method of claim 1, wherein the medical condition is ketonuria and the substance is ketones.

15. The method of claim 14, wherein the reagent is sodium nitroprusside.

16. The method of claim 1, wherein the medical condition is a biliary abnormality and the substance is selected from the group consisting of bilirubin and urobilinogen.

17. The method of claim 16, wherein the reagent is selected from the group consisting of dichloroaniline diazonium salt and diethylaminobenzaldehyde.

18. A method for detecting and monitoring a medical condition in an adult mammal, comprising the steps of:

positioning an absorbent apparatus on the mammal so as to receive urine from the mammal, the apparatus having at least one reagent configured to indicate, by a visual color change, the presence of the medical condition when in contact with urine;

collecting urine on the apparatus such that the urine contacts the reagent;

determining from the color of the reagent whether an abnormal level of a substance indicating the presence of said medical condition is present in the urine received on the apparatus.

19. The method of claim 18, wherein the apparatus is a diaper.

20. The method of claim 18, wherein the apparatus is a panty liner.

21. The method of claim 18, wherein the apparatus is a pad.

22. An apparatus for determining the presence of a medical condition in a mammal, said apparatus configured to be positioned on the mammal to receive urine from the mammal, said apparatus comprising:

a liquid-impermeable outside sheet;

a liquid-absorbent layer;

at least one reagent on or in said liquid-absorbent layer, said reagent being configured to detect, in urine, an abnormal level of a substance associated with a medical abnormality after said reagent contacts said urine, said detection occurring by a visible color change, said medical condition being selected from the group consisting of;

(a) urinary tract infection, (b) hematuria, (c) glycosuria, (d) biliary abnormality, (e) ketonuria, and (f) proteinuria.

23. The apparatus of claim 22, wherein the liquid-absorbent layer further comprises paper.

24. The apparatus of claim 22, wherein the liquid-absorbent layer further comprises cloth.

25. The apparatus of claim 22, wherein the apparatus is a diaper.

26. The apparatus of claim 22, wherein the apparatus is a panty liner.

27. The apparatus of claim 22, wherein the apparatus is a pad.

28. The apparatus of claim 22, wherein said medical condition is a urinary tract infection, and wherein the reagent is selected from the group consisting of naphthyl ester, diazonium salt, arsenilic acid, and tetrahydrobenzo (h) quinolin.

29. The apparatus of claim 22, wherein said medical condition is hematuria, and the reagent is cumene-hydroperoxide tetramethylbenzidine.

30. The apparatus of claim 22, wherein said medical condition is glycosuria and the reagent is selected from the group consisting of glucose oxidase, peroxidase, and potassium iodide.

31. The apparatus of claim 22, wherein the condition is proteinuria and the reagent is tetrabromphenol blue.

32. The apparatus of claim 22, wherein the medical condition is ketonuria and the reagent is sodium nitroprusside.

33. The apparatus of claim 22, wherein the medical condition is a biliary abnormality and the reagent is selected from the group consisting of dichloroaniline diazonium salt and diethylaminobenzaldehyde.