Detection of menopause status and treatment thereof

• US 7,101,342 B1
• Filed: 05/24/2004
• Issued: 09/05/2006
• Est. Priority Date: 05/24/2004
• Status: Expired due to Fees

• Current Assignee: Femteck LLC
• Original Assignee: Femteck LLC
• Inventors: Caillouette, James C.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/851,017
• Time in Patent Office: 834 Days
• Field of Search: 600569-573, 600/562, 600/584, 600/551, 600/591, 600/547, 600/587, 604/1, 335/11, 335/12, 337/55, 33758-760, 514/177, 607/138
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0032 based on measurement of pH-value

Abstract

The method of treating a human female menopausal condition, the steps that include determining need for increasing estrogen level in the blood, from a lower level associated with reduced ovarian estrogen production, the determining including measuring vaginal moisture or urethral fluid pH level, at repeated time intervals over a series of days. A test for FSH level in the blood, during those days, may be made for detection of high level FSH in conjunction with high pH level at the vagina to establish need for estrogen therapy, on a confirmatory basis.

Claims

1. In the method of treating a human female menopausal condition, the steps that include:

a) determining need for increasing estrogen level in the blood, from a lower level associated with reduced ovarian estrogen production,

b) said determining including measuring vaginal moisture or urethral fluid pH level, at repeated time intervals over a series of days,

c) said determining including providing an elongated probe having an enlarged handle at one end and an enlarged, peripherally generally circular test region at the opposite end of the probe, and a moisture acidity indicator substantially centrally exposed to the exterior, within said test region and at one side of the probe, the indicator characterized as having characteristic coloring that corresponds to moisture acidity,

d) there being an elongated stem between said test region and said handle, said stem having flat opposite sides and elongated opposite edges of constant thickness diverging toward the substantially circular outer periphery of said test region, said indicator having a substantially circular outer periphery substantially uniformly spaced inwardly of said test region outer periphery whereby the indicator outer periphery is everywhere substantially concentric to the test region substantially circular outer periphery.

2. The method of claim 1 including periodically administering estrogen or estradiol to the patient, to be transported in the blood.

3. The method of claim 2 where said administering is repeated to reduce the measured vaginal moisture pH level to about 4.5, or to significantly reduce menopausal symptoms.

4. The method of claim 1 which further includes periodically observing one or more menopausal symptoms needing reduction, including:

i) insomnia

ii) emotional instability

iii) body hot flashes

iv) vaginal dryness.

5. The method of claim 1 wherein said measuring of vaginal moisture pH level includes determining local acidity proximate a moist wall surface of the vagina, by employment of said acidity indicator.

6. The method of claim 5, 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.

7. The method of claim 5 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.

8. The method of claim 5 wherein said indicator comprises a material or materials exhibiting colorations corresponding to pH levels of moisture of the wall surface of the vagina, said colorations being different for different pH levels.

9. The method of claim 5 including manipulating said probe to bring said indicator into said contact with the vaginal wall surface.

10. The method of claim 8 including providing a pH measurement calorimeter, and positioning said colorimeter to extend for ready comparison with coloration of said material or materials of the indicator.

11. The method of claim 2 wherein said measuring is repeated at time intervals such that vaginal moisture pH level is ultimately determined to have reached a desired level corresponding to reduced observed menopausal symptoms, in a human patient.

12. The method of claim 1 wherein said determining also includes measuring FSH level in the patient'"'"'s blood, for correlating an increasing FSH level with an increase in said pH level, as an indicator of said need for estrogen increase.

13. The method of claim 12 wherein said FSH measuring is periodic to indicate a timewise increasing FSH level, including said correlating step.

14. The method of claim 13 including administering estrogen to the patient as a result of said correlation, and at a relatively low dosage level corresponding generally to healthy ovarian estrogen production level.

15. The method of determining need for estrogen administration to a human patient that includes:

a) measuring a timewise increasing vaginal moisture pH level,

b) measuring a timewise increasing FSH level in the blood,

c) correlating the a) and b) measurements over time to determine co-existence of relatively high pH and FSH levels,

d) and administering estrogen to the patient as a result of said co-existence correlating, and initially at a relatively low dosage level,

e) said step a) measuring including providing an elongated probe having an enlarged handle at one end and an enlarged, peripherally generally circular test region at the opposite end of the probe, and a moisture acidity indicator substantially centrally exposed to the exterior, within said test region and at one side of the probe,

f) there being an elongated stem between said test region and said handle, said stem diverging toward the generally circular outer periphery of said test region, said indicator having a generally circular periphery substantially uniformly spaced inwardly of said outer periphery,

g) said indicator periphery and the outer periphery of the test region being substantially concentric.