Body moisture test apparatus and method

• US 6,402,705 B1
• Filed: 11/08/1999
• Issued: 06/11/2002
• Est. Priority Date: 08/25/1994
• Status: Expired due to Fees

• Current Assignee: Femteck LLC
• Original Assignee: James C. Caillouette
• Inventors: Caillouette, James C.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/436,332
• Time in Patent Office: 946 Days
• Field of Search: 600/572, 600/574, 600/584, 335/11, 335/12
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0048 for taking amniotic fluid samples
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4283 gastrointestinal secretions, e.g. bile production
• CPC Class Codes: A61B 5/4294 vaginal secretions
• CPC Class Codes: A61B 5/4318 Evaluation of the lower reproductive system A61B5/4343 takes precedence
• CPC Class Codes: A61B 5/4337 of the vagina
• CPC Class Codes: A63F 2011/0018 integrated in the game board
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

In the method of measuring pH of vaginal or other tissue moisture, the steps that include providing an indicator that exhibits a characteristic color when contacted with the moisture, the color being a function of moisture pH; obtaining a vaginal or other tissue moisture sample and transferring moisture from the sample to an indicator, outside the body, whereby the indicator then exhibits a characteristic color, which is a function of pH of the moisture; and providing a color comparison measurement means, and comparing the indicator characteristic color with color comparison measurement means. Also provided are test kit structures to enable performance of such pH measurement, as used for estrogen need determination and the presence or absence of amniotic fluid; and also to determine presence of amines produced by pathogenic bacteria, or flagellates (trichomonas).

Claims

1. In the method of measuring pH of vaginal or other body tissue moisture, the steps that include

a) providing an indicator that exhibits a characteristic color when contacted with vaginal or other tissue moisture, said color being a function of moisture pH,

b) obtaining a vaginal or vaginal tissue moisture sample by providing a vaginal or vaginal tissue moisture receiver supported on a carrier, and manipulating the carrier to insert the receiver into the vagina and therein obtain said sample on the receiver, and thereafter withdrawing the receiver from the vagina and transferring that moisture from the sample to said indicator, outside the body, whereby the indicator then exhibits said characteristic color, which is a function of pH of said moisture,

c) providing a color comparison measurement means, and comparing said indicator characteristic color with said color comparison measurement means.

2. The method of claim 1 including providing a vaginal or other moisture receiver supported on a carrier, and manipulating the carrier to obtain said sample on the receiver.

3. The method of claim 1 including providing a package which includes structure carrying said indicator and said color comparison measurement means.

4. The method of claim 2 including providing a package which includes structure supporting said indicator and said carrier for the receiver, and including the step of removing the carrier from the package for use in obtaining said moisture sample on the receiver.

5. The method of claim 3 wherein said color comparison measurement means is provided to extend proximate said indicator, in or on the package.

6. The method of claim 5 wherein said color comparison measurement means is provided to include portions of varying color that are arranged in at least one of the following ways:

ii) in a generally linear sequence,

iii) in a sequence to at least partially surround the indicator.

7. The method of claim 5 wherein said color comparison measurement means is provided in the form of swatches of varying color that extend in a sequence about and proximate the indicator for side by side comparison with the color of the indicator.

8. The combination of claim 5 wherein the indicator includes multiple sections, and said color comparison measurement means is provided in the form of swatches of varying color that extend about and proximate each indicator section, for side-by-side comparison with the color of each indicator section.

9. The combination of claim 5 wherein the indicator includes multiple sections, and said color comparison measurement means includes color swatches, at least one swatch located proximate each indicator.

10. The method of claim 4 wherein the carrier is provided in the form of a stick, and the receiver is supported proximate an end of the stick, the receiver provided in the form of a swab, and a shoulder provided on the stick to limit depth of insertion of the swab, into the vagina.

11. The method of claim 4 wherein said indicator is provided in the form of a strip.

12. The method of claim 4 including providing a second indicator supported by the package, said second indictor including a reactant or reactants characterized as changing color when contacted with moisture containing amine, and including transferring moisture from the sample to said second indicator, outside the body, whereby a change in color at the second indicator indicates the presence of amine from pathogenic bacteria or flagelates or protozoa in said moisture.

13. The method of claim 12 wherein said second indicator is selected from the group consisting of Bromocresol Green, Bromocresol Purple, Nitrazine Yellow, Bromophenol Blue, and equivalents.

14. The method of claim 12 wherein said amine is selected from the group putrecine and cadavarine.

15. The method of claim 12 wherein said reactant includes an alkali substance selected from the group that consists essentially of potassium hydroxide, sodium aluminate, magnesium hydroxide, sodium hypochlorite and sodium carbonate.

16. The method of claim 1 including repeating said method at intervals and over a time period sufficient to detect changes in vaginal or other tissue moisture pH levels indicative of need for estrogen therapy.

17. The method of claim 1 wherein said moisture sample includes amniotic fluid.

18. The method of claim 17 wherein said moisture sample is collected in fluid form outside the body.

19. The method of claim 1 wherein said indicator is dipped into contact with the sample of collected moisture.

20. The method of claim 18 including providing a support for said indicator, and manipulating said support to bring said indicator and fluid into wetting contact.

21. The method of claim 20 wherein the support is provided in one of the following forms:

a) a stick

b) a card

c) a receptacle.

22. The method of claim 17 including providing a pH color comparison chart, and comparing the indicator color with colors on said chart.

23. The method of claim 2, including adhering the receiver to the carrier, prior to said step b).

24. The method of claim 1 including locating said indicator in a predetermined position, proximate the color comparison measurement means.

25. The method of testing for uterine membrane rupture accompanied by release of amniotic fluid, from the body, that includes

a) providing a pH indicator, the indicator characterized as changing color as a function of fluid pH,

b) contacting said pH indicator with that fluid that has been obtained from within the vagina or urethra, or from vaginal tissue or urethral tissue within the vagina or urethra, and transported to the exterior of the vagina or urethra, for transfer to the indicator,

c) and observing the color of the indicator to determine occurrence of a color change indicative of the pressure of amniotic fluid or of another body fluid such as urine.

26. The method of claim 25 including providing a support for said indicator, and manipulating said support to bring said indicator and fluid into wetting contact.

27. The method of claim 26 wherein the support is provided in one of the following forms:

a) a stick

b) a card

c) a receptacle.

28. The method of claim 25 including providing a pH indicator color comparison chart, and comparing the indicator color with colors on said chart.

29. The method of claim 25 wherein said observing includes determining if the indicator color change is indicative of a pH at or close to 7.0, indicative of the presence of amniotic fluid.

30. The method of claim 25 wherein said observing includes determining:

i) if the indicator color change is indicative of a pH at or close to 7.0, indicative of the presence of amniotic fluid, or

ii) if the indicator color change is indicative of a pH at or close to 4.5, indicating presence of urine.

31. The method of claim 26 including adhering the indicator to the support prior to said step b).