Method and device for predicting the fertile phase of women

• US 6,592,529 B2
• Filed: 07/31/2001
• Issued: 07/15/2003
• Est. Priority Date: 07/31/2001
• Status: Expired due to Fees

• Current Assignee: HealthWatchSystems, Inc. (Novation Holdings, Inc.)
• Original Assignee: Pheromone Sciences Corp.
• Inventors: Marett, Douglas M.
• Primary Examiner(s): Hindenburg, Max F.
• Application Number:
  US09/917,739
• Publication Number:
  US 20030028122A1
• Time in Patent Office: 714 Days
• Field of Search: 600/551, 600/587, 600/591
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266

Abstract

A method and device to predict ovulation in a female human by measuring changes in the concentration of a number of ions in eccrine sweat is disclosed. The concentration, or changes in concentration, of one or more ions are determined throughout the day and analyzed against predetermined patterns in order to predict ovulation one to five days in advance. This permits the user to more accurately determine commencement of the fertile phase, which for female humans is generally considered to be about four days prior to ovulation to one day after ovulation. The concentration of the ions measured include sodium (Na+), potassium (K+), ammonium (NH₄+), calcium (Ca₂+), chloride (Cl−) and nitrate (NO₃−). To further increase the accuracy of the reading, a large number of readings can be obtained throughout a day and statistically analyzed to determine the change over time. In addition, the concentration of two or more ions can be obtained to increase accuracy. Ratiometric measurements between two or more ions can be determined to increase accuracy and account for ion accumulation on the skin. Ratiometric measurements between ammonium (NH₄+) and calcium (Ca₂+) have been found to provide more distinct patterns because the concentrations of these two ions change in opposite directions during the relevant period preceding ovulation.

Claims

1. A device for determining a fertile phase of a female human comprising:

(a) a sensor for sensing concentrations of at least two ions, comprising a first ion and a second ion, in the eccrine sweat of the female and generating output signals indicative of concentrations of the at least two ions in the eccrine sweat;

(b) a processor for controlling the sensor to sense the concentrations of at least two ions in the eccrine sweat substantially simultaneously and at least on a daily basis;

wherein the processor monitors the output signals from the sensor to identify a distinct change in a ratio of the concentration of the first ion with respect to the concentration of the second ion following an inversion which indicates the female human is in the fertile phase; and

wherein the first ion is selected from the group consisting of potassium (K+), nitrate (NO₃−

), ammonium (NH₄+) and calcium (Ca₂+) and the second ion is different from the first ion.

2. The device as claimed in claim 1, wherein the second ion is selected from the group consisting of sodium (Na+) and chloride (Cl−

).

3. The device as claimed in claim 1, wherein the first ion is selected from the group consisting of potassium (K+), nitrate (NO₃−

) and ammonium (NH₄+), and the second ion is selected from the group consisting of calcium (Ca₂+).

4. The device as claimed in claim 1, wherein the first ion is ammonium (NH₄+) and the second ion is calcium (Ca₂+).

5. The device as claimed in claim 3, wherein the at least two ions comprise a third ion selected from the group consisted of sodium (Na+) and chloride (Cl−

); and

wherein the processor monitors a first preliminary ratio of the concentration of the first ion with respect to the third ion, and, a second preliminary ratio of the concentration of the second ion with respect to the third ion, and, the processor then monitors a ratio of the first preliminary ratio to the second preliminary ratio to identify a distinct change in the ratio of the concentration of the first ion with respect to the second ion following an inversion indicating commencement of a fertile phase.

6. A device as claimed in claim 1, wherein the device further comprises a display for displaying characters indicating the female human is in the fertile phase.

7. A device as claimed in claim 1, further comprising a fastener for fastening the device to the female subject such that the sensor contacts the skin of the female at least six hours each day;

and

wherein the processor controls the sensor to sense the concentration of the at least two ions between eight to eighteen times each day to monitor a daily average of the concentrations.

8. A device as claimed in claim 1, wherein the fertile state of ovulation is predicted to occur within six days following the inversion.

19. A device as claimed in claim 2, wherein to identify a distinct change in the concentration of one of the least two ions following an inversion, the processor monitors the output signals to identify a surge of 25% followed by a drop of 40% in the ratio of the concentration of the first ion with respect to the second ion.

9. A device for determining the fertility status of a female mammal comprising:

(a) a sensing means for substantially simultaneously sensing at least two ions comprising a first ion and a second ion different from the first ion, said first ion selected from the group consisting of potassium (K+), ammonium (NH₄+), calcium (Ca₂+) and nitrate (NO₃), in the eccrine sweat of the female mammal and generating output signals indicative of the concentration of the at least two ions in the eccrine sweat;

(b) processor means for controlling the sensing means to sense the at least two ions, including substantially simultaneously sensing the first ion and the second ion, in the eccrine sweat at least on a daily basis; and

wherein the processor means monitors the output signals stored in the storage means to identify a distinct change in a concentration of the first ion with respect to the second ion following an inversion which indicates the female mammal is in the fertile phase.

10. A device as claimed in claim 9, wherein the female mammal is a female human and the distinct change is a change of at least 40% following the inversion.

11. A device as claimed in claim 9, wherein the device further comprises a display means for indicating the female mammal is in the fertile phase.

12. A device as claimed in claim 9, wherein the sensing means utilizes a solid state sensor.

13. The device defined in claim 9, wherein the female mammal is a female human and the processor causes the sensing means to sense the concentration of the at least two ions at least six readings per day and statistically analyzes the at least six readings to provide an average of the concentration of the first ion with respect to the second ion for the day;

and

wherein the processor means monitors the average of the concentration of one of the ions to identify a distinct change in the concentration of the first ion with respect to the second ion following an inversion which indicates the female human is in the fertile phase.

14. The device as defined in claim 9, further comprising:

storage means for storing information regarding previous reproductive cycles of the female; and

wherein the processor utilizes the information to predict an expected duration of the reproductive cycle and disregard output signals obtained for an initial portion of a reproductive cycle of the female mammal immediately following menstruation.

15. The device as defined in claim 14, wherein the initial portion which is disregarded is prior to 19 days before an estimated end of the reproductive cycle.

16. The device as claimed in claim 15, wherein the processor monitors a ratio of the concentration of the first ion to the second ion to identify a distinct change in the concentration of the first ion with respect to the second ion following an inversion which indicates the female human is in the fertile phase.

17. The device as claimed in claim 16, wherein the first ion is selected from the group consisting of potassium (K+), nitrate (NO₃−

), ammonium (NH₄+) and calcium (Ca₂+), and, a second ion is selected from the group consisting of sodium (Na+) and chloride (Cl−

).

18. A device as claimed in claim 9, wherein the female mammal is a female human and ovulation is ascertained to occur within six days following the inversion.

20. A method for determining a fertile phase of a female human comprising the steps of:

(a) sensing concentration of at least two ions, comprising a first ion and a second ion, in eccrine sweat of the female human substantially simultaneously and at least on a daily basis;

(b) generating output signals indicative of concentrations of the at least two ions in the eccrine sweat;

(c) monitoring the output signals indicative of the concentration of at least the first ion or the second ion to identify a distinct change in a ratio of the concentration of the first ion to the concentration of the second ion to identify a distinct change in the concentration of the first ion with respect to the second ion following an inversion which indicates the female human is in the fertile phase;

wherein the first ion is selected from the group consisting of potassium (K+), nitrate (NO₃−

), ammonium (NH₄+) and calcium (Ca₂+) and the second ion is different from the first ion.

21. The method as defined in claim 20, wherein step (c) further comprises the step of:

(i) monitoring the output signals to identify a surge of at least 25% followed by a drop of at least 40% in the concentration of one of the at least two ions indicating the female human is in the fertile phase.

22. The method as defined in claim 20, wherein the second ion is selected from the group consisting of sodium (Na+) and chloride (Cl−

).

23. The method as defined in claim 20, wherein the first ion is selected from the group consisting of nitrate (NO₃−

) and ammonium (NH₄+), and the second ion is selected from the group consisting of calcium (Ca₂+).

24. The method as defined in claim 20, comprising the further steps of:

sensing concentrations of the least two ions substantially simultaneously and at least six times a day;

generating output signals indicative of concentrations of the at least two ions in the eccrine sweat;

processing the output signals to provide a daily average of the at least two ions;

monitoring the daily averages of the output signals to identify a distinct change in the two ratios following an inversion which indicates the female human is in the fertile phase.

25. The method as defined in claim 20 further comprising the steps of:

storing information regarding previous reproductive cycles of the female;

predicting, based on the stored information regarding previous reproductive cycles of the female, an expected duration of the reproductive cycle and disregarding output signals prior to 19 days before an estimated end of the expected duration of the reproductive cycle.