WO2002087446A1

WO2002087446A1 - Method and device for determining the hormonal status of females

Info

Publication number: WO2002087446A1
Application number: PCT/AT2002/000123
Authority: WO
Inventors: Thomas Walla
Original assignee: Nova Technical Research Gmbh
Priority date: 2001-04-25
Filing date: 2002-04-24
Publication date: 2002-11-07
Also published as: ATA6742001A; AT411215B

Abstract

The invention relates to a method for determining the hormonal status of females, in particular the moment of ovulation. In the vagina, the following are measured continuously, or at given, regular intervals: the ion concentration of the cervical mucous, by means of the conductance (σ) of the latter; optionally the pH value (P) of the vaginal secretion and the vaginal temperature. The extremes such as the minimum and maximum value and also the reversal points are calculated from these measured values. The measurement data is saved and the current status of the vaginal tract is calculated from the saved data, based on a mathematical model. The method uses a sensor capsule (1). Said sensor capsule (1), (which can be introduced into the vagina), consists of a capsule-type, hermetically sealed container (2), comprising at least one sensor (3) for measuring the conductivity (σ) of the cervical mucous. The sensor capsule (1) also has an additional sensor (4) for registering the vaginal secretion, e. g. for measuring the pH value (P). In addition, said sensor capsule (1) has a further sensor (5), which records the vaginal temperature (T).

Description

Method and device for determining female hormone status

The invention relates to a method for determining the female hormone status, in particular the time of ovulation, and a device for carrying out this method.

It is known that the hormone-controlled time of ovulation is associated with a slight increase in body temperature. This temperature increase is used to determine the time of ovulation. But because the increase in body temperature can also be triggered by other processes in the body, such as due to a slight cooling, this method alone is not reliable.

Furthermore, it is from the literature e.g. Gitsch / Janisch "Gynecology" knows that the hormonal control of the time of ovulation also causes a strong change in the cervical mucus and vaginal secretions. These changes ensure optimal conditions for fertilization. The volume and the consistency of the cervical mucus change. For example, the Concentration of sodium or potassium ions The pH value of vaginal secretions changes from strongly acidic towards neutral.

It is also known from US Pat. No. 6,080,118 A to determine the time of ovulation on a characteristic sensor carrier using biosensors which are not described in more detail. The sensor carrier is similar to a spoon that protrudes from the vaginal tract and can only be used for a short-term measurement of parameters. In this publication, a number of parameters to be measured are listed within the vaginal secretion, such as estrogen, progesterone or gonadotropin content, but without showing how these parameters are to be determined and measured in the body with the biosensors. In addition, from today's perspective, it is inconceivable that given the extremely low content of the hormones mentioned in the vaginal secretions, they can be detected at all.

At the moment there is only one known and really reliable method for determining the time of ovulation and that is the daily blood draw to determine the hormone values over the period in question - this is usually between the 8th and 17th day of the woman's cycle.

This blood analysis is time-consuming and expensive and is uncomfortable for the patients.

The object of the invention is therefore to create a method of the type mentioned at the outset which on the one hand avoids the above disadvantages and on the other hand ensures a reliable determination of ovulation.

The object is achieved by the invention.

The method according to the invention is characterized in that the ion concentration of the cervical mucus is measured in the vagina continuously or in certain regular time intervals via the conductance and that the extremes, such as maximum value and minimum value, are determined from the measured values. With the invention, it is possible for the first time to determine the time of ovulation precisely to the hour, for example.

Exact knowledge of ovulation is of course no guarantee of a desired pregnancy, but an indispensable prerequisite and, in the opinion of experts, could solve the problem in many cases, such as with the increasingly common hypospermia of men. Regarding contraception, gynecologists confirm a strong interest in natural methods, which should be just as reliable as the pill. Knowledge of the time of ovulation is also essential for this purpose.

Although the absolute amount of sodium and potassium in the cevical mucus does not change, the decrease in viscosity increases, among other things. the sodium or potassium ion concentration. This process can be explained by increasing the water content in the mucus, which means that more ions can dissolve. At the time of ovulation, the ion concentration reaches the highest value.

This means that both the minimum viscosity and the maximum ion concentration are used to determine the time of ovulation. Measuring the change in viscosity is relatively complicated and time-consuming. It is much easier to record the change in ion concentration, which is determined via the associated change in electrical conductivity.

According to a special feature of the invention, the vaginal secretion is recorded in the vagina continuously or in certain regular periods and optionally analyzed and, for example, the pH value is determined, and the extremes, such as maximum value and minimum value, are determined from the measured values. For the pH value measurement of the vaginal secretion, a measuring range from approximately pH 3.7 to pH 4.5 before ovulation up to a value of approximately pH 7.0 at the time of ovulation is to be assumed. Changes in the vaginal milieu could also be ascertained via the vaginal secretion. For example, fungal diseases could be identified in this way.

According to a further special feature of the invention, the vaginal temperature becomes continuous or in certain regular ones

Periods are measured and the extremes, such as maximum value and minimum value, and the turning points are determined from the measured values. Due to the possible individual fluctuation range of the values, the measurement of only one parameter - which correlates with the hormone status of the woman - could be one have limited meaningfulness with regard to the exact time of ovulation. In order to eliminate this uncertainty, the change in the pH value of the vaginal secretion and the vaginal temperature may also be measured.

According to one embodiment of the invention, the measurement data are stored and the current status of the vaginal tract is calculated from the stored data based on a mathematical model. The ACTUAL values of the three parameters, namely temperature, pH value and conductivity index, determined by sensors in regular time intervals are stored in an EE memory and these reference values are used to calculate the exact time of ovulation. This calculation process is based on an imaging model that represents the correlation of the individual measured values or parameters with the hormone course of the woman during the cycle.

However, the object of the invention is also achieved independently of this by a device for carrying out the method.

The device according to the invention for carrying out the method is characterized in that a capsule-like, hermetically sealed container which can be inserted into the vagina and which has at least one sensor for measuring the conductance of the cervical mucus is provided. Such a container can advantageously be placed in the externally accessible hollow organ with a non-invasive procedure. A miniaturized and body-compatible sensor complements the ovulation monitoring system. Such a container can be used without medical help and guarantees the greatest possible comfort without impairing freedom of movement.

According to a further embodiment of the invention, the container has at least one sensor for detecting and possibly analyzing the vaginal secretion, for example for determining the pH value of the vaginal secretion. to measure the pH of the vaginal secretions. Such sensors are inexpensive and can also be guaranteed by their functionality Developing countries. Such sensors could also detect changes in the vaginal milieu.

According to a development of the invention, the container has at least one sensor for measuring the vaginal temperature. The use of such a sensor ensures an exact determination of the time of ovulation.

According to a further embodiment of the invention, at least one memory for storing the measurement data is provided in the container. As already mentioned, the ACTUAL values of the three parameters, namely temperature, pH value and conductivity index, which are determined by the sensors at regular intervals, are stored in an EE memory and these reference values are used to calculate the exact time of ovulation. Such memories can advantageously be operated without problems over a long operating time.

According to an advantageous embodiment of the invention, a computer is connected to the memory. It has already been shown that the calculation process is based on an imaging, mathematical model which represents the correlation of the individual measured values with the hormone course of the woman during the cycle. Such calculations can be carried out easily with today's computers.

According to a further development according to the invention, the unidirectional or bidirectional data transmission of the measured and calculated values from and / or to the container to an external data reading and / or processing system takes place either inductively or with contact. In this way, the function of the system can advantageously be optimally ensured.

According to a special embodiment of the invention, the energy supply takes the form of a rechargeable battery integrated in the hermetically sealed container. Such mini batteries are economical and inexpensive in the Integrate manufacturing process of the system. Furthermore, these batteries also have a long service life, which has an advantageous effect.

According to a special embodiment of the invention, the energy supply is preferably inductive from an external power source. Advantages can also be attributed to this variant. A purely passive solution to the energy supply prevents any irreversible damage.

According to a special feature of the invention, the container is surrounded by a plastic carrier, the plastic carrier consisting at least of a soft, sponge-like outer part and a hard inner part. This embodiment of the invention ensures the well-being of the patient on the one hand and the optimal placement of the device in the hollow organ on the other.

According to a further embodiment of the invention, the hard inner part has bores or through openings for the defined drainage of the cervical mucus and possible other body fluids. This ensures that there is no falsification of the measurement data due to slime residues from previous measurements.

According to a further feature of the invention, a plastic carrier for devices, apparatus, objects or the like which can be inserted into body openings is provided, which is characterized in that a hard inner part is provided surrounding the device, the apparatus or the object, which is provided with a is provided with a soft, sponge-like outer part coming into contact with the human body surface. Such a plastic carrier avoids all imaginable health risks. The prerequisite for this is, of course, that body-compatible materials are used. Furthermore, plastic carriers of this type can be produced economically and inexpensively.

According to a development of the above invention, the hard inner part has bores or through openings for the defined outflow of Body fluids. As already mentioned, the device can remain inside the hollow organ for a long time and carry out continuous measurements.

The invention is explained in more detail with reference to exemplary embodiments which are shown in the drawing.

Show it:

1 to 3 in diagrams the relationships between the measurement data recorded over a period of time

4 is an oblique view of the ovulation monitoring system and

Fig. 5 is an oblique view of the plastic carrier.

As an introduction, it should be noted that in the differently described embodiments, the same parts are provided with the same reference numerals or the same component names, and the disclosures contained in the entire description can be applied analogously to the same parts with the same reference numerals or the same component names. The location information selected in the description, e.g. above, below, laterally, etc. refer to the figure described and illustrated immediately and are to be transferred to the new position in the event of a change of position.

According to the diagrams in FIGS. 1 to 3, the relationships in the body for determining the female hormone status - provided there are no diseases - are explained in more detail. The period t between the 8th and 17th day of the woman's cycle is shown.

According to the diagram in FIG. 1, the body temperature T is plotted over the period t. It can be clearly seen that just before the ovulation time X, which is entered on the 14th day of the woman's cycle, the lowest temperature T, that is the temperature minimum, is given. According to the diagram in FIG. 2, the pH value P of the vaginal secretion is plotted over the period t. It can be seen in the diagram that the pH value changes from strongly acidic, that is from about 3.7 to 4, to neutral, that is to say in the range from 7.0, the maximum of this measured value curve being given at the time of ovulation X.

According to the diagram in FIG. 3, the conductivity σ of the cervical mucus, which reflects the ion concentration of the electrolytes, is plotted over the period t. It can be seen that the measured value minimum is again at

Ovulation point X is reached. This process can be explained by increasing the water content in the mucus, which means that more ions can dissolve. At the time of ovulation, the ion concentration peaks.

This means that both the viscosity minimum and the ion concentration maximum could be used to determine the time of ovulation. Measuring the change in viscosity appears to be relatively complicated and time-consuming. It is much easier to measure and record the change in ion concentration, which is determined by the change in electrical conductivity.

If the conductance or the conductivity σ of the cervical mucus is measured continuously or in certain regular periods, the minimum value can be determined. This minimum value at the given time corresponds to the time of ovulation.

The ion concentration in the cervical mucus shows a maximum at the time of ovulation, which is easy to measure by changing the conductivity, so that an exact determination of the time of ovulation is expected. However, due to the possible individual fluctuation range of the values, the measurement of only one parameter - which correlates with the hormone status of the woman - could be of limited relevance in relation to have the exact time of ovulation. In order to remedy this uncertainty, the change in the pH value of the vaginal secretion and the vaginal temperature can also be measured.

The individual measurement data are saved and the current status of the vaginal tract is calculated from the saved data, based on a mathematical model.

4, a sensor capsule 1 is used to carry out this method. This sensor capsule 1 - which can be inserted into the vagina - consists of a capsule-like, hermetically sealed container 2 which has at least one sensor 3 for measuring the conductivity σ of the cervical mucus. This sensor 3 is preferably arranged at the tip of the sensor capsule 1. Furthermore, the sensor capsule 1 has a further sensor 4 for measuring the pH value P of the vaginal secretion. This sensor 4 can be provided on the side, in the front part of the sensor capsule 1 facing the interior of the body. This ensures that the outflowing vaginal secretions flow via this sensor 4 to record the necessary measurement data. In addition, the sensor capsule 1 has a further sensor 5, which is used to detect the vaginal temperature T.

The ACTUAL values determined by sensors 3, 4 and 5 at the defined time intervals are stored in a memory 6, in particular in an EE memory. Evaluation electronics, for example in the form of a computer 7, are connected to this memory 6. The measurement data, i.e. the actual values, are used to calculate the exact time of ovulation. The calculation process is based on a model to be mapped - correlation of the individual measured values with the hormone course of the woman during the cycle. As is known per se, the control of female sexual function and the distribution of the necessary substances is based on an extremely complex control loop between the hypothalamus, adenohypophysis and the ovaries. As already mentioned, the vaginal milieu could also be detected via the sensor 4. Changes in the vaginal milieu caused by fungal diseases could be detected. Other or further measurement data that can be derived from the vaginal milieu could also be determined via the sensor 4, which is used to record the vaginal secretion.

Furthermore, an external data reading and / or processing system - not shown - is provided. The one-way or bidirectional data transmission of the measured and calculated values from and / or to the container 2 to an external data reading and / or processing system takes place either inductively or with contact. The energy supply in the sensor capsule 1 can take place via an integrated rechargeable battery. However, it is quite conceivable that the energy supply takes place inductively from an external power source.

The values of the time of ovulation calculated in this way can also be read out by the user via a display of the charger belonging to the sensor capsule 1. The sensor capsule 1 measures and records the three measured variables regularly, for example approximately every 60 minutes, and converts the values into a parameter field representing the cycle course of the user by means of a corresponding model. The doctor can read out the data on the computer, which are sent to the PC via the integrated interface of the charger. This gives the opportunity to non-invasively detect the critical values before, during and after ovulation and to recognize any faults.

In order to position the sensor capsule 1 exactly in the vaginal tract and to ensure a corresponding wearing comfort for the user during the measurement, a sensor system carrier according to FIG. 5 is provided. This objective is achieved through the selection of the optimal shape, the suitable materials and the corresponding technologies. The sensor capsule 1 or the container 2 is surrounded by a plastic carrier 8, the plastic carrier 8 consisting at least of a soft, sponge-like outer part 10 and a hard inner part 9. The hard inner part 9 has bores 11 or through openings for the defined drainage of the cervical mucus and possible other body fluids.

Of course, this plastic carrier 8 according to FIG. 5 could also serve as a carrier for other devices, apparatus or objects.

For the sake of order, it should finally be pointed out that, for a better understanding of the structure, the parts or their components have been partially shown to scale and / or enlarged and / or reduced.

Claims

claims

1. A method for determining the female hormone status, in particular the time of ovulation, characterized in that in the vagina continuously or in certain, regular periods over the

Conductivity (σ) the ion concentration of the cervical mucus is measured and that the extremes, such as maximum value and minimum value, are determined from the measured values.

2. The method according to claim 1, characterized in that in the vagina continuously or in certain, regular periods, the vaginal secretions are recorded and optionally analyzed and, for example, the pH (P) is determined and that from the measured values, the extremes, such as maximum and minimum values , be determined.

3. The method according to claim 1 or 2, characterized in that the vaginal temperature (T) is measured continuously or in certain regular time intervals, that the extremes, such as maximum value and minimum value, and the turning points are determined from the measured values.

4. The method according to at least one of claims 1 to 3, characterized in that the measurement data are stored and that the current status of the vaginal tract is calculated from the stored data based on a mathematical model.

5. Device for performing the method according to at least one of claims 1 to 4, characterized in that an insertable into the vagina, capsule-like hermetically sealed container (2) is provided, the at least one sensor (3) for measuring the conductivity (σ) of the cervical mucus.

6. Device according to claim 5, characterized in that the container (2) at least one sensor (4) for detecting and possibly analyzing the Has vaginal secretions, for example for determining the pH (P) of the vaginal secretions.

7. Device according to claim 5 or 6, characterized in that the container (2) at least one sensor (5) for measuring the vaginal temperature

(T).

8. Device according to at least one of claims 5 to 7, characterized in that in the container (2) at least one memory (6) is provided for storing the measurement data.

9. Device according to at least one of claims 5 to 8, characterized in that a computer (7) is connected to the memory (6).

10. The device according to at least one of claims 5 to 9, characterized in that the one-way or bidirectional data transmission of the measured and calculated values from and / or to the container (2) to an external data reading and / or processing system is either inductive or contact ,

11. The device according to at least one of claims 5 to 10, characterized in that the energy supply takes the form of a rechargeable battery integrated in the hermetically sealed container (2).

12. The device according to at least one of claims 5 to 10, characterized in that the energy supply is preferably carried out inductively from an external power source.

13. The device according to at least one of claims 5 to 12, characterized in that the container (2) is surrounded with a plastic carrier (8), the plastic carrier (8) at least from a soft, sponge-like outer part (10) and a hard inner part (9) exists.

14. Device according to claim 13, characterized in that the hard inner part (9) has bores (11) or through openings for the defined outflow of the cervical mucus and possible other body fluids.

15. Plastic carrier for insertable devices, apparatus, objects or the like in the body openings according to claim 13 or 14, characterized in that a device, the apparatus or the object surrounding hard inner part (9) is provided, which with a the soft, spongy outer part (10) coming into contact with the human body surface is provided.

16. Plastic carrier according to claim 15, characterized in that the hard inner part (9) has bores (11) or through openings for the defined outflow of body fluids.