Surgery – Diagnostic testing – Monitoring fertility cycle
Reexamination Certificate
2000-10-19
2002-04-02
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Monitoring fertility cycle
Reexamination Certificate
active
06364844
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
This invention relates generally to the field of determining and/or monitoring physiological conditions in mammals, and in particular relates to electronically sensing, predicting and confirming that such physiological conditions exist in female mammals. The invention also particularly relates to an improved means and method for predicting and confirming ovulation in human females that offers enhanced features and advantages over prior methods, such as substantial automation, greater reliability, more accurate results and enhanced ease of use, enabling a correspondingly greater acceptance as the method of choice for fertility prediction, and birth control, by consumers and organizations.
2. Background Art
The problem of determining the precise point when ovulation in mammals has occurred is of ever-increasing interest throughout the world, both in the animal husbandry industry and with respect to humans. It is especially important for human couples suffering from infertility to determine if and when ovulation occurs, to maximize the potential for pregnancy. At ovulation, an egg is released from the ovary. This egg remains viable approximately 12-24 hours. Conception occurs when an egg, present in the fallopian tube, is fertilized by a sperm. However, the egg is present in the fallopian tube typically for only a few hours, usually from 3-10. Meanwhile, sperm remains viable in a female for up to 48 hours. Thus, if a woman wishes to become pregnant it is necessary for the sperm and egg to interact within the 12-24 hours following ovulation.
Meanwhile, for other couples who desire to practice family planning or minimize the potential for pregnancy by monitoring the female ovulation cycle, it is possible to determine that portion of the month where conception is physically impossible. Thus, both infertility and birth control may be impacted by the ovulation cycle.
There are many types of tests known in the art that can be conducted for the purpose of predicting the time of ovulation. For example, one well-known test is designed to predict ovulation by comparing the pH in a woman's saliva with that of her vagina over the course of time. By comparing the changes in the pH levels of a woman's body, it is scientifically possible to predict when ovulation will occur. Such a test employs a device similar to a digital pH meter, which permits a determination of the pH of a solution. Similarly, tests are well known for measuring the level of luteinizing hormone in various body fluids, as a predictor of ovulation occurrence. These tests typically either include a urine test or a blood test. Luteinizing hormone is a hormone of protein-carbohydrate composition that is obtained from the interior lobe of the pituitary gland, and that in the female, stimulates the development of corpora lutea, and together with follicle stimulating hormone, the secretion of progesterone. The luteinizing hormonal level in the blood peaks just before ovulation and drops after ovulation.
Other methodologies of the prior art rely on the concept that it is possible to predict when ovulation has occurred, based on the well-known basal body temperature increase in a female (up to 1 degree Fahrenheit) shortly after the time of ovulation. Still another methodology involves “ferning” of the cervical mucus. The optimal time for conception is thought to be when the cervical mucus is at its maximum density. Medical personnel, in conjunction with a pelvic exam, can examine mucus which has been deposited on a slide under a microscope to determine the amount of “ferning.” Whereas the normal amount of “ferning” ranges from 1-3, optimal conditions for conception exist when the value associated with “ferning” is 4+.
Attempting to conduct all of the tests described above is both time consuming, relatively expensive, and requires the assistance of medical professionals. However, to verify that optimum conditions exist, in the usual case all of the above tests should be performed and should test positive.
The need for a simple but reliable method of predicting and confirming ovulation, which can be conveniently carried out in the privacy of the home, has been a recognized need for many decades. Because of religious, philosophic, or health considerations, the preferred method of birth control for many is by periodic abstinence, also known as the “rhythm method.” This method involves the identification of the fertile period using an available method, or more often simply by a guess based on the length of the menstrual cycle, and then avoiding coitus during this period. Ovulation is assumed to occur mid-cycle, and the period of abstinence is adjusted accordingly. This technique has proven highly unreliable at best. The unreliability of the rhythm method is largely due to the inability to accurately predict and confirm ovulation. Thus, a clear need exists for a natural family planning method, acceptable under existing cultural and religious mores, which offers improved reliability without the need for intervention by medical professionals.
To address some of the foregoing issues, a more reliable procedure, known as the sympto-thermal method, involves a subjective evaluation of both basal body temperature and cervical mucus to determine the fertile period. However, this method requires intensive user training, and relatively high variability of results and failure rates were and are still unavoidable.
In this procedure, changes in cervical mucus are combined with basal body temperature (“BBT”) to identify the onset and end of the fertile period. There are several disadvantages with this approach, among them being the need for immobility before taking the BBT, daily monitoring of the cervix and vagina, and subjective interpretation of vaginal mucus quality and of the BBT trend. The technique is difficult to learn, with one to six months of careful training and supervision being required to attain proficiency. Another relatively serious problem with this particular methodology is the variation of the relation between the basal body temperature and the peak mucus symptom, known as spinnbarkheit. Furthermore, BBT correlates with ovulation in only about 70% of female cycles, since monophasic (non-indicative) BBT patterns are frequently seen in ovulatory cycles. Thus, when use of this methodology has been attempted for birth control, failure rates of up to 34% have been recorded. Although computerized interpretation of data is now available for the sympto-thermal method, for example as disclosed in U.S. Pat. No. 4,151,831, issued May 1, 1979, to Lester, the disadvantages obviously inherent in the physiological parameters used in the method are still limiting factors.
Other methods well known in the art are more invasive of the body, but can be good indicators of the time of ovulation. The identification of a preovulatory rise in estrogens followed by a peak in luteinizing hormone (LH) concentration, as determined by radioimmunoassay, is a good indication of imminent ovulation. Frequently, several samples of blood, drawn at mid-cycle, are analyzed for luteinizing hormone concentration. These techniques are expensive, involve invasive drawing of blood from the subject, and require several visits to a hospital or medical laboratory having the appropriate analytical facilities.
The process of ovulation has also been monitored and detected using ultrasonography. However, this procedure is time-consuming and expensive for the subject, as daily visits to a center equipped with the sophisticated instrumentation used for the procedure are necessary. Several scans are required to pinpoint ovulation by observing follicular development and subsequent ovum release. While accurate identification of ovulation is possible with this technique, it is of little value as a self-monitoring method for purposes of enhancing or reducing fertility.
Several methods of predicting ovulation based on biochemical changes in various body fluids such as vaginal secretions, saliva, or urine have been proposed. The m
Regas Jennine
Regas Philip George Chelf
Hindenburg Max
Wilcox James L.
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