Estrogen or estradiol need determination by vaginal or urethral acidity determination

• US 20010021816A1
• Filed: 04/20/2001
• Published: 09/13/2001
• Est. Priority Date: 08/25/1994
• Status: Active Grant

• Current Assignee: Femteck LLC
• Original Assignee: James C. Caillouette
• Inventors: Caillouette, James C.
• Granted Patent: US 6,544,196 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• 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 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4294 vaginal secretions
• 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 determining need for human estrogen replacement therapy or estrogen or estradiol dose change, the steps include determining local acidity proximate a moist wall surface of the vagina, or urethra, as differing from desired threshold level (pH 4.5), and administering sufficient estrogen or estradiol to result in change in acidity toward such level.

Claims

1. In the method of determining need for estrogen replacement therapy or estrogen or estradiol dose change, the steps that include:

a) determining local acidity proximate a moist wall surface of the vagina or urethra, as differing from desired threshold level, and in the substantial absence of bacterial vaginosis,

b) and administering sufficient estrogen or estradiol to result in change in said acidity toward said level.

2. The method of

claim 1

wherein said administering of sufficient estrogen or estradiol is effected on a periodic basis, and in increasing amounts, and said determination of local acidity is repeated, whereby said local acidity is ultimately determined to have reached said desired level.

3. The method of

claim 1

wherein said determining of local acidity includes employing an acidity indicator, and effecting contact of said indicator with said wall surface of the vagina or urethra.

4. The method of

claim 3

, wherein said indicator includes one of the following:

i) NITRAZINE®

paper

ii) phenaphthazine on a carrier

iii) a material or materials exhibiting different colorations as a function of pH level.

5. The method of

claim 1

wherein said threshold level is approximately 4.2 pH.

6. The method of

claim 3

including providing a strip of material carrying said acidity indicator, and said determining of local acidity includes first contacting said strip with the wall surface of the vagina, or urethra, and then observing said indicator on the strip.

7. The method of

claim 6

wherein said indicator comprises a material or materials exhibiting colorations or other indications corresponding to pH levels of moisture of the wall surface of the vagina, or urethra, said colorations being different for different pH levels.

8. The method of

claim 3

including providing an elongated applicator on which said indicator is mounted, and manipulating said applicator to bring said indicator into said contact with the vaginal or urethral wall surface.

9. The method of

claim 8

including providing said indicator in the form of a strip of material or materials mounted on an end portion of the applicator.

10. The method of

claim 6

including manually manipulating said strip of material into contact with the wall surface of the vagina, or urethra.

11. In the method of determining need for human estrogen or estradiol change, the steps that include:

a) providing a pH detection means on a carrier stick,

b) providing a protective porous layer adjacent said pH detection means,

c) manipulating the stick to obtain pH detection of vaginal or urethral moisture, and including allowing vaginal or urethral moisture to penetrate said porous layer for contact with said pH detection means,

d) visually observing said detection means,

e) and determining from said observed pH detection means a need for a change in estrogen or estradiol level to be administered to a human female,

f) said method carried out in the absence of bacterial vaginosis.

12. The method of

claim 11

including, after said step c), removing said porous layer from adjacency to said pH detection means to allow said visually observing of said detection means.

13. The method of

claim 11

including providing said pH detection means to include at least one of the following:

i) a pH indicating strip

ii) a color comparison measurement means.

14. In the method of determining need for human estrogen or estradiol change, the steps that include:

a) first determining local acidity proximate a moist wall surface of the vagina, or urethra, said determining employed as an indicator of the presence or absence of bacterial vaginosis,

b) and, after a vaginosis condition has been treated and eliminated, then again determining local acidity proximate a moist wall surface of the vagina or urethra, as differing from desired threshold level,

c) and administering sufficient estrogen or estradiol to result in change in said acidity toward said threshold level.

15. The method of

claim 14

wherein said administering of estrogen or estradiol is effected periodically and orally.

16. The method of

claim 14

wherein said administering of sufficient estrogen or estradiol is effected on a periodic basis, and in increasing or decreasing amounts, and said determination of local acidity is repeated, whereby said local acidity is ultimately determined to have reached said desired level.

17. The method of

claim 14

wherein said determining of local acidity includes employing an acidity indicator, and effecting contact of said indicator with said wall surface of the vagina or urethra.

18. The method of

claim 17

wherein said indicator includes one of the following:

i) NITRAZINE®

paper

ii) phenaphthazine on a carrier

iii) a material or materials exhibiting different colorations or indications as a function of pH level.

19. The method of

claim 14

wherein said threshold level is approximately 4.2 to 4.5 pH.

20. An apparatus for measuring pH of vaginal or urethral moisture for determination of need for change in estrogen or estradiol dosage, comprising in combination:

a) an elongated carrier,

b) pH indicating means on the carrier, at one end portion thereof, and sized for application to a zone adjacent the wall of the vagina or urethra.

21. An apparatus for measuring pH of vaginal or urethral moisture for determination of need for a change in estrogen or estradiol dosage, comprising in combination:

a) an elongated carrier,

b) pH indicating first means in the form of a strip on the carrier, at one end portion thereof,

c) color comparison pH measurement second means on the carrier, spaced from said one end portion thereof,

d) the carrier projecting freely from said first and second means for manual manipulation to first obtain pH indication of vaginal or urethral moisture at said one end of the carrier, and to enable interpretation of that indication by color comparison with said second means,

e) the carrier then being disposable to dispose of both said first and second means in one disposal step,

f) there being a protective porous layer extending adjacent at least one of the following;

x₁) said strip

x₂) said color comparison measurement means.

22. The apparatus of

claim 21

wherein said strip is adhered to said one end of the carrier, and said second means extends lengthwise along the carrier, away from said first means.

23. The apparatus of

claim 21

including a smooth surfaced protective tip facing endwise at said one end of the carrier.

24. The apparatus of

claim 21

wherein said porous layer has a portion thereof adhered to the carrier.

25. The apparatus of

claim 23

wherein said tip has bulb shape.

26. The apparatus of

claim 22

wherein said second means has color gradations in a series sequence on the carrier.

27. The apparatus of

claim 22

wherein said first means comprises a NITRAZINE®

strip.

28. The apparatus of

claim 27

wherein said NITRAZINE®

strip is wound about the carrier at said one end thereof.

29. The apparatus of

claim 26

wherein there are pH numerical indications on the carrier, in close association with said color gradations.

30. The apparatus of

claim 21

wherein said porous layer terminates at a location characterized in that a substantial length of the strip remains freely and openly exposed outwardly.

31. The apparatus of

claim 23

including a protective plastic sleeve extending about a portion of said carrier in endwise alignment with said strip, said sleeve carrying said tip.

32. In apparatus for detecting pH of vaginal or urethral moisture, the combination comprising

a) an elongated carrier,

b) pH detecting means on the carrier, at one end portion thereof,

c) and a protective porous layer extending adjacent said pH detecting means.

33. The combination of

claim 32

wherein said protective porous layer has a portion thereof attached to the carrier.

34. The combination of

claim 32

wherein said pH detecting means includes at least one of the following:

i) a pH indicating strip

ii) a color comparison measurement means.

35. The combination of

claim 32

including a smooth surfaced protective tip facing endwise at said one end of the carrier, in alignment with said porous layer.

36. In the method of employing detected pH of vaginal or urethral moisture in estrogen therapy, the steps that include:

a) providing an acidity sensing means on a carrier,

b) providing a protective porous layer adjacent said sensing means,

c) manipulating the carrier proximate vaginal or urethral moisture, and including allowing vaginal or urethral moisture to penetrate said porous layer for contact with said sensing means,

d) and detecting a vaginal or urethral moisture produced change in said sensing means, for determining need for a change in estrogen or estradiol dosage.

37. In apparatus for detecting pH of vaginal or urethral moisture, the combination comprising:

a) an elongated carrier stick having a substantially flat side, and opposite end portions,

b) a pH detecting means in the form of a phenapthazine pH paper strip adhered to said flat side on one end portion of the stick, said strip being flat and elongated in the direction of stick elongation,

c) and the opposite end portion of the stick defining a handle which has a textured surface.

38. The combination of

claim 37

wherein said strip is substantially flat and at the same side of the stick as said textured surface.

39. The combination of

claim 37

wherein said strip and said texturing each have about 1.5 inches length, and are spaced apart, lengthwise of the stick.

40. In combination:

a) a support package,

b) a carrier and a pH detection means on the carrier, the carrier removably supported by the package,

c) color comparison measurement elements carried by the package to allow their comparison with said pH detection means after exposure of said detection means to vaginal or urethral moisture the pH of which is to be determined, for determining need for a change in estrogen or estradiol administration.

41. The method of determining validity of pH of body moisture or fluid, which includes:

a) determining pH of vaginal moisture or fluid, by employment of a first indicator,

b) also determining pH of urethral moisture or fluid, by employment of a second indicator,

c) and visually observing at least one of said indicators, in determining need for a change in estrogen or estradiol and administration.

42. The method for measuring pH of vaginal or urethral moisture for determining need for a change in estrogen or estradiol dosage, that includes providing an elongated carrier, providing a pH indicating detector on the carrier, providing color comparison measurement means, providing a longitudinally elongated receptacle for said carrier and detector, said color comparison measurement means provided in association with the receptacle, there being a longitudinal window along which said color comparison measurement means is displayed in the form of bands, and manipulating said detector within the receptacle and along the window for visual color comparison with said bands, after exposure of said detector to vaginal or urethral moisture.

43. The method of

claim 42

wherein said bands are provided in two longitudinal rows, at laterally opposite sides of said window.

44. The method of

claim 43

wherein said detector is provided to have a lateral dimension greater than width of the window, and said bands are provided to extend proximate the window, and said detector is displaced longitudinally in proximate adjacency to the bands at opposite sides of the window.

45. The combination that comprises a package including an elongated carrier, a pH indicating detector on the carrier, color comparison measurement elements, said package also including a longitudinally elongated receptacle for said detector, said color comparison elements positioned in association with the receptacle, there being a longitudinal window along which said color comparison elements are displayed, whereby the detector may be manipulated within the receptacle and along the window for visual color comparison with said elements, after exposure of the detector to vaginal or urethral moisture.

46. The combination of

claim 45

wherein said elements extend in two longitudinal rows, at laterally opposite sides of said window.

47. The combination of

claim 46

wherein said detector has lateral dimension matching or exceeding the width of the window and said elements extend into proximity to the window, whereby the detector may be displaced longitudinally in proximate adjacency to successive of said elements at opposite sides of the window.