Estrogen or estradiol need determination by vaginal acidity determination

• US 5,735,801 A
• Filed: 08/19/1996
• Issued: 04/07/1998
• Est. Priority Date: 08/25/1994
• Status: Expired due to Term

• Current Assignee: Femteck LLC
• Original Assignee: James C. Caillouette
• Inventors: Caillouette, James C.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/699,251
• Time in Patent Office: 596 Days
• Field of Search: 128/749, 128/759, 128/760, 128/771
• US Class Current: 600/572
• 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 5/14507 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 5/4294 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, 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, as differing from desired threshold level, and in the substantial absence of bacterial vaginosis, or vaginitis,

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

c) said administering of sufficient estrogen or estradiol or estrogenic substance being effected on a periodic basis, and said determination of local acidity being repeated, whereby said local acidity is ultimately determined to have reached said desired level.

2. 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.

3. The method of claim 2, 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.

4. The method of claim 1 wherein said threshold level is approximately 4.2 pH.

5. The method of claim 2 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, and then observing said indicator on the strip.

6. The method of claim 5 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, said colorations being different for different pH levels.

7. The method of claim 2 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 wall surface.

8. The method of claim 7 including providing said indicator in the form of a strip of material or materials mounted on an end portion of the applicator.

9. The method of claim 5 including manually manipulating said strip of material into contact with the wall surface of the vagina.

10. In the method of determining need for estrogen or estradiol or estrogenic substance change, in a human, 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 moisture, and including allowing vaginal 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 or estrogenic substance level to be administered to a human female,

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

11. The method of claim 10 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.

12. The method of claim 10 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.

13. In the method of determining need for estrogen or estradiol or estrogenic substance change, the steps that include:

a) first determining local acidity proximate a moist wall surface of the vagina, 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, as differing from desired threshold level,

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

14. The method of claim 13 wherein said administering of estrogen or estradiol or estrogenic substance is effected on a periodic basis.

15. The method of claim 13 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.

16. The method of claim 13 wherein said determining of local acidity includes employing an acidity indicator, and effecting contact of said indicator with said wall surface of the vagina.

17. The method of claim 16 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.

18. The method of claim 13 wherein said threshold level is approximately 4.2 to 4.5 pH.

19. In the method of employing detected pH of vaginal 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 moisture, and including allowing vaginal moisture to penetrate said porous layer for contact with said sensing means,

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

e) and periodically administering sufficient estrogen or estradiol or estrogenic substance along with repeated detecting of vaginal moisture produced change in said sensing means to reduce said need to a desired level, said detecting taking place at intervals of up to about two weeks.

20. The method of claim 19 wherein said carrier is a stick, and including providing a smooth surfaced protective tip facing endwise at one end of the stick.

21. The method of claim 19 wherein said protective porous layer is provided to extend about a portion of said acidity sensing means.

22. The method of claim 19 wherein said carrier is a stick, and said protective porous layer is provided to extend about the stick, and over said acidity sensing means.

23. The method of claim 22 wherein said layer is provided in the form of a sleeve.

24. The method of claim 23 including providing a smooth surfaced protective tip facing endwise at one end of the stick, and in proximity to said sleeve.