Device and method for determining a fertile phase of a woman by ascertaining a CO;partial pressure in a respiratory gas of the woman

• US 9,392,997 B2
• Filed: 05/25/2011
• Issued: 07/19/2016
• Est. Priority Date: 05/25/2010
• Status: Active Grant

• Current Assignee: MAM Baby AG
• Original Assignee: Carbomed Medical Solutions GmbH & Co., KG
• Inventors: Krammer, Gert
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/699,504
• Publication Number:
  US 20130178717A1
• Time in Patent Office: 1,882 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/09 using an element rotated by the flow toys actuated by air current A63H33/40
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

The invention relates to a device (1) for determining a fertile phase of a woman by ascertaining a CO₂ partial pressure in a respiratory gas of the woman in several consecutive breaths, comprising an inlet for receiving the respiratory gas, and an outlet, a sample chamber (2), into which the respiratory gas can be conducted, a measuring module (3) with a measuring element (4) with which a CO₂ concentration in the respiratory gas in the sample chamber (2) can be measured, optionally a pressure sensor (5) for measuring an air pressure, a processor (7) for processing measured data obtained by means of the measuring module (3) and the pressure sensor (5), and at least one output unit (9) for outputting a result of the measured data. So that the method can be carried out by a woman herself quickly and nevertheless with high precision, it is provided according to the invention that the device (1) is embodied as a hand-held device and an algorithm is stored in the processor (7), with which with a measurement based on several immediately consecutive breaths a predetermined reproducibility criterion regarding an end expiratory CO₂ partial pressure of the respiratory gas can be tested, wherein, if the reproducibility criterion is met, the at least one output unit (9) outputs and/or signals and/or displays whether a fertile phase applies. Furthermore, the invention relates to a method for determining a fertile phase of a woman by ascertaining an end expiratory CO₂ partial pressure in a respiratory gas and comparison of the measured data thus obtained with measured data in the follicle phase outside the fertile phase.

Claims

1. A device for determining a fertile phase of a woman by ascertaining a CO₂ partial pressure in a respiratory gas of the woman in several consecutive breaths, comprising:

an inlet for receiving the respiratory gas,

an outlet, a sample chamber, into which the respiratory gas is conducted,

a measuring module with a measuring element with which a CO₂ concentration in the respiratory gas in the sample chamber is measurable,

a processor for processing measured data obtained by the measuring module, and

at least one output unit for outputting a result of the measured data,

wherein the device is embodied as a hand-held device and an algorithm is stored in the processor, with which with a measurement based on several immediately consecutive breaths a predetermined reproducibility criterion regarding an end expiratory CO₂ partial pressure of the respiratory gas is testable,

wherein, if the reproducibility criterion is met, the at least one output unit outputs and/or signals and/or displays whether a fertile phase applies,

wherein the predetermined reproducibility criterion is met when the measured data based on several immediately consecutive breaths are within a predetermined tolerance range; and

wherein the algorithm based on the measured data of a cycle calculates a base line for the end expiratory CO₂ partial pressure in a follicle phase outside the fertile phase.

2. The device according to claim 1, wherein the algorithm takes into consideration measured data of the end expiratory CO₂ partial pressure of several preceding cycles with an interpretation of the measured data.

3. The device according to claim 1, wherein if several measurements are carried out on one day, the algorithm calculates a sliding daily average.

4. The device according to claim 1, wherein when the reproducibility criterion is met, a color code and/or an acoustic signal is emitted with the output device.

5. The device according to claim 1, wherein a temperature sensor is provided in the sample chamber.

6. The device according to claim 5, further comprising a moisture sensor provided in the sample chamber.

7. The device according to claim 1, wherein the measuring module comprises a measuring element that operates with IR radiation of one or more wavelengths.

8. The device according to claim 1, wherein the measuring module comprises a photoacoustic IR spectroscope.

9. The device according to claim 1, wherein the measuring module comprises an electrochemical sensor for measuring the CO₂ concentration.

10. The device according to claim 1, wherein the measuring module comprises an acoustic sensor for measuring the CO₂ concentration.

11. The device according to claim 1, wherein the measuring module comprises a solids sensor for measuring the CO₂ concentration on the basis of an ion conductivity.

12. The device according to claim 1, wherein a device for thermostatting the sample chamber is provided.

13. The device according to claim 1, wherein a pump is provided, with which a certain volume of the respiratory gas is conducted out of a space lying between the inlet and the sample chamber into the sample chamber.

14. The device according to claim 1, wherein the device comprises a mouthpiece.

15. The device according to claim 1, wherein in the sample chamber a further measuring element is provided with which a breathing rate is measurable.

16. The device according to claim 15 wherein the measuring element comprises a heated resistance element or a propeller.

17. The device according to claim 1, further comprising a pressure sensor for measuring an air pressure, wherein the processor additionally processes measured data obtained by the pressure sensor.

30. The method according to claim 18, wherein the method is performed using the device according to claim 1.

18. A method for determining a fertile phase of a woman by ascertaining an end expiratory CO₂ partial pressure in a respiratory gas of the woman and comparison of measured data thus obtained with measured data in a follicle phase outside the fertile phase, wherein with a measurement in a sample chamber based on several immediately consecutive breaths a reproducibility criterion predetermined with respect to the end expiratory CO₂ partial pressure of the respiratory gas is tested and at least one output unit outputs a signal when the reproducibility criterion for a predetermined number of breaths has been achieved and it is output and/or signaled and/or displayed by the output unit whether a fertile phase applies,

wherein the reproducibility criterion is met when the measured data based on the predetermined number of consecutive breaths are within a predetermined tolerance range;

and

wherein a base line for the end expiratory CO₂ partial pressure in the follicle phase outside the fertile phase is calculated based on the measured data of a cycle.

19. The method according to claim 18, wherein the measured data of several preceding cycles are taken into consideration in an interpretation of the measured data.

20. The method according to claim 18, wherein if several measurements are carried out on one day, a sliding daily average is calculated.

21. The method according to claim 18, wherein when the reproducibility criterion has been met, an acoustic signal and/or a color coded image is outputted.

22. The method according to claim 18, further comprising ascertaining a CO₂ concentration, wherein the ascertainment of the CO₂ concentration is carried out by an IR measuring method.

23. The method according to claim 18, wherein a water vapor partial pressure is calculated from a temperature measurement in the sample chamber and/or from a temperature measurement and a measurement of an air humidity in the sample chamber and is taken into consideration as a correction variable.

24. The method according to claim 23, wherein the method for determining the fertile phase of the woman comprises a basal temperature determination.

25. The method according to claim 18, wherein a measured result is combined with a measured result of a further method for determining a fertile phase of the woman.

26. The method according to claim 18, wherein the measured data of several preceding cycles are stored and is retrievable.

27. The method according to claim 18, wherein before a first measurement and/or between measurements, a calibration is carried out using known gas concentrations.

28. The method according to claim 18, wherein in the sample chamber with a further measuring element a breathing rate is measured and is taken into consideration as a variable in meeting the reproducibility criterion.

29. The method according to claim 28, wherein the further measuring element comprises a heated resistance element or a propeller.