Method and apparatus for predicting and detecting ovulation
First Claim
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1. A method for determining the onset of ovulation in a female subject comprising:
- a. providing an oral sensor;
b. connecting the oral sensor to an electrical circuit comprising;
(i) frequency generating oscillator means;
(ii) frequency measurement means;
(iii) data processing and control means;
(iv) data storage means; and
(v) data display means;
c. contacting the oral sensor on a first day with the subject'"'"'s saliva until a stable frequency is indicated by the frequency measurement means;
d. recording the first day'"'"'s frequency measurement;
e. repeating steps (c) and (d) on a subsequent day to obtain a second frequency measurement;
f. calculating the difference in frequency, df, between the first and the second day'"'"'s frequencies;
g. recording the df calculated in step (f);
h. repeating steps (e) through (g) on each successive day of the subject'"'"'s menstrual cycle to establish an historic baseline of the df value for each of the days;
i. applying the baseline df values to an algorithm corresponding to predetermined patterns of df values for menstrual cycles;
j. recording the baseline data from step (i) in the data storage means corresponding to the subject'"'"'s historical menstrual cycle;
k. repeating steps (c) through (h) for each day in a subsequent menstrual cycle of the same subject and recording the data in the data storage means in association with the subsequent cycle;
l. comparing the data obtained in step (k) with the data obtained in step (j) to determine the subject'"'"'s fertility state; and
m. displaying data from the data storage means on the data display means corresponding to the subject'"'"'s fertility state in the menstrual cycle.
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Abstract
An apparatus and method for monitoring, predicting and detecting ovulation during the menstrual cycle of a female subject is based upon daily changes in frequency of an oscillator circuit when a capacitive oral sensor is placed in contact with the subject'"'"'s saliva. An oral sensor that forms a component in the oscillator circuit contained in a hand-held, portable device includes a pre-programmed integrated circuit device with data processing and control capacities, data storage and display means for measuring, recording and processing historical baseline data and relative frequency changes within the subject'"'"'s current menstrual cycle.
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Citations
41 Claims
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1. A method for determining the onset of ovulation in a female subject comprising:
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a. providing an oral sensor;
b. connecting the oral sensor to an electrical circuit comprising;
(i) frequency generating oscillator means;
(ii) frequency measurement means;
(iii) data processing and control means;
(iv) data storage means; and
(v) data display means;
c. contacting the oral sensor on a first day with the subject'"'"'s saliva until a stable frequency is indicated by the frequency measurement means;
d. recording the first day'"'"'s frequency measurement;
e. repeating steps (c) and (d) on a subsequent day to obtain a second frequency measurement;
f. calculating the difference in frequency, df, between the first and the second day'"'"'s frequencies;
g. recording the df calculated in step (f);
h. repeating steps (e) through (g) on each successive day of the subject'"'"'s menstrual cycle to establish an historic baseline of the df value for each of the days;
i. applying the baseline df values to an algorithm corresponding to predetermined patterns of df values for menstrual cycles;
j. recording the baseline data from step (i) in the data storage means corresponding to the subject'"'"'s historical menstrual cycle;
k. repeating steps (c) through (h) for each day in a subsequent menstrual cycle of the same subject and recording the data in the data storage means in association with the subsequent cycle;
l. comparing the data obtained in step (k) with the data obtained in step (j) to determine the subject'"'"'s fertility state; and
m. displaying data from the data storage means on the data display means corresponding to the subject'"'"'s fertility state in the menstrual cycle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
a. measuring the frequency of the circuit after the oral sensor is connected to the circuit; b. comparing the measured frequency to a predetermined frequency or frequency range; and
c. generating a signal corresponding to the condition of oral sensor.
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9. The method of claim 1 which includes the further step of processing the df data utilizing at least one algorithm contained in the data processing and control means.
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10. An oral sensor for use in an oscillator circuit, the oral sensor comprising a laminated article formed from:
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a. an electrically conductive first layer;
b. a non-conductive second layer;
c. an electrically conductive third layer;
d. a non-conductive fourth layer; and
e. an electrically conductive fifth layer, where the third and fourth layers are perforated and the third and fifth layers are in electrical contact with each other through the perforations in the fourth layer, and the second and fourth layers contact each other through the perforations in the third layer. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method of monitoring the menstrual cycle in a female mammal subject comprising:
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a. providing a capacitive oral sensor;
b. contacting the capacitive oral sensor with the mammal'"'"'s saliva on a daily basis;
c. measuring a change in frequency associated with the oral sensor during step (b);
d. calculating any change in frequency between each subsequent daily measurement and the previous day'"'"'s measurement; and
e. utilizing the calculated daily changes in frequency to predict ovulation during the subject'"'"'s menstrual cycle. - View Dependent Claims (31, 32)
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33. A method of diagnosing the onset of the fertile period of a female mammal subject comprising:
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a. monitoring the concentration of electrolytes in solution by measuring changes in capacitance/permeability of a capacitive oral sensor that is in contact with said bodily fluid; and
b. providing an indicator for responding to the changes in capacitance of said capacitive oral sensor, whereby the response of said indicator is diagnostic of the onset of the fertile period of said female.
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34. A capacitive oral sensor comprising:
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a. a non-conductive element separating first and second conducting elements to form a capacitor-like component; and
b. terminals associated with said capacitor-like element connectable to an electric circuit that is responsive to the capacitance of said oral sensor, wherein the capacitance of said oral sensor varies as a function of the concentration of electrolytes which contact the oral sensor.
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35. An apparatus for monitoring the changes of electrolyte concentration in a liquid medium comprising:
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a. an oral sensor introducible into the medium, said oral sensor'"'"'s capacitance varying with the concentration of electrolyte;
b. means for detecting any changes in the capacitance of said oral sensor; and
c. means for indicating the result of said change in capacitance.
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36. A diagnostic system for determining the onset of ovulation in a female subject, comprising;
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a. a digital processor;
b. a capacitive oral sensor;
c. a connector for electrically connecting the oral sensor to said processor, said oral sensor causing a change in frequency response when in contact with an electrolyte; and
d. a display for indicating the onset of ovulation. - View Dependent Claims (37, 38, 41)
a. an electrically conductive first layer;
b. a non-conductive second layer;
c. an electrically conductive third layer;
d. a non-conductive fourth layer; and
e. an electrically conductive fifth layer, where the third and fourth layers are perforated and the third and fifth layers are in electrical contact with each other through the perforations in the fourth layer, and the second and fourth layers contact each other through the perforations in the third layer.
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41. The method of claim 38 where the indication is a visual indicia selected from the group consisting of text, graphic display, tabular display and combinations thereof.
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39. A method of predicting ovulation in a female human subject, which subject has experienced the onset of menstruation in her fertility cycle, the method comprising:
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a. providing a first capacitive oral sensor;
b. providing an oscillator circuit having a known frequency characteristic;
c. incorporating the first oral sensor in the oscillator circuit;
d. measuring on a first test day a first frequency of the oscillator circuit that incorporates the oral sensor;
e. recording the first frequency;
f. contacting the capacitive oral sensor with subject'"'"'s saliva for a period of time that is sufficient to obtain a stable second frequency response in the oscillator circuit;
g. recording the second frequency;
h. calculating the value and direction of the change in frequency between the first and second recorded frequencies;
i. recording the results of step (h) as df;
j. removing the first capacitative oral sensor from the oscillator circuit;
k. providing a second unused capacitive oral sensor;
l. incorporating the second oral sensor in the oscillator circuit;
m. repeating steps (d) through (i) above, on a second and subsequent test days 3 through n, where n is the total number of days in the subject'"'"'s menstrual cycle, and recording the results in step (i) as (df)2 through (df)n; and
repeating steps (j) through (l) after the second and subsequent test days; and
n. providing and indication of the onset of ovulation as a function of the maximum value of an increase in the change of frequency following the onset of menstruation, which maximum increase in the change of frequency is followed by a nadir and subsequent sharp increase in the rate of change in frequency. - View Dependent Claims (40)
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Specification