Device and Method for Determining a Comparison Value of Biodata and for Recording Biodata

• US 20090240119A1
• Filed: 04/04/2007
• Published: 09/24/2009
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Loewenstein Medical Technology S.A.
• Original Assignee: Loewenstein Medical Technology S.A.
• Inventors: Schöller, Bernd, Sommermeyer, Dirk, Schwaibold, Matthias
• Granted Patent: US 9,801,589 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

The method and the device are used for evaluating recorded measurement data. In particular, the use of the method and of the device makes it possible to detect the individual risk of a living being in respect of certain disease states and, if appropriate, to automatically evaluate correspondingly recognized risks in a device control. Measurement data in respect of heart-specific and/or circulation-specific parameters or respiration-specific parameters of a patient are preferably recorded and evaluated. The measurement data are determined over a defined period of time and the measurement data are evaluated taking into account the time information. A particularly effective implementation of the method can be based on pattern recognition in which individual patterns and/or sequence patterns are evaluated.

Claims

1. A device for determining a reference value of biophysical data (body parameters) of an individual for determining an individual risk, said device consisting of at least one sensor for the noninvasive measurement of at least two signals, which are selected from the following group:

CWF (continuous wave fluctuation), SpO2, heart rate, and PTT (pulse transit time), and an evaluation unit connected to the sensor, where the evaluation unit has at least one analyzer, which determines signal ranges that can be defined by signal analysis, wherein a comparator coordinates the signal ranges, taking additional parameters into account, such as existing biophysical data of the individual and/or static data sets, and that the result can be output as an index value.

2. A device in accordance with claim 1, wherein the parameters of the biophysical data of the individual include . . . , such as medication, age, sex, diagnostic data, and the like.

3. A device in accordance with claim 1, wherein the static data sets can be compiled from groups of individuals, such as medication, age, sex, diagnostic data and the like.

4. A device in accordance with claim 1, wherein the comparator can be connected to peripheral devices, such as computers, printers, and display devices.

5. A device in accordance with claim 1, wherein the evaluation unit is designed for determining a CWP (continuous wave parameter) from at least one detected test signal.

6. A device in accordance with claim 5, wherein the evaluation unit is designed for determining a CWF (continuous wave fluctuation) from at least one detected test signal.

7. A device in accordance with claim 1, wherein the evaluation unit is designed for determining a CWF from the CWP.

8. A device in accordance with claim 1, wherein the evaluation unit is designed for determining the CWF both from at least one detected test signal and the CWP.

17. A device in accordance with claim 1, wherein a classifier compares at least one CWF datum and/or quantities derived from it with stored data in order to identify physiological/pathophysiological events from this information.

18. A device in accordance with claim 1, wherein a classifier compares at least one CWF datum and/or quantities derived from it with other test signals and/or CWP'"'"'s in order to identify physiological/pathophysiological events from this information.

19. A device in accordance with claim 1, wherein at least some of the results of the analyzer and/or at least some of the results of the classifier are output basically immediately, acoustically, and/or graphically.

20. A device in accordance with claim 1, wherein, to identify physiological events, at least two signals that are temporally related are evaluated.

21. A device in accordance with claim 1, wherein supplementary modules can be adapted for measuring other signals.

22. A device in accordance with claim 1, wherein at least one interface is installed in the basic module and/or in supplementary modules, where this interface allows data to be read out and/or other devices, especially therapeutic devices, to be controlled.

23. A device in accordance with claim 1, wherein supplementary sensor devices can be adapted for measuring other signals.

24. A device in accordance with claim 1, wherein sensor devices are selected from the group comprising:

EKG, EMG, EOG, EEG, pulse oximetry, blood pressure, impedance measurement, ultrasound, Doppler, CO2, respiratory flow, snoring, mouth, thorax, abdomen, and position sensors.

25. A device in accordance with claim 1, wherein a module that is designed to determine other biophysical data can be added.

26. A device in accordance with claim 1, wherein a module that is designed to determine other respiratory parameters, such as respiratory flow, PTT, movement signals, and respiratory effort, can be added.

27. A device in accordance with claim 1, wherein a module that is designed to determine other cardiological parameters, such as EKG and heart rate, can be added.

28. A device in accordance with claim 1, wherein a data input device is provided for inputting patient data, for example, age, sex, and state of health.

29. A device in accordance with claim 1, wherein a display device and/or an output device is provided for the display and/or output of analytical results.

30. A device in accordance with claim 1, wherein means are provided for fastening the device on the body of an individual.

9. A method for determining an individual risk for an individual, especially a cardiovascular risk, comprising the following steps:

determination of measurement data of at least one heart-specific and/or circulation-specific and/or respiration-specific parameter of the user, selected from the group comprising;

continuous wave fluctuation (CWF), SpO2, SaO2, pulse rate, heart rate, pulse transit time (PTT), and blood pressure by means of at least one noninvasive sensor device;

determination of the measurement data over a period of at least one minute;

determination of measurement data with a synchronized time recording;

bringing together the time information and the measurement data information;

analysis of the measurement data with the time information being taken into account;

carrying out the analysis as a pattern recognition, in which, at least in intervals, the course of the measurement with respect to time of at least one parameter can be detected and is evaluated with respect to a typical individual pattern and/or progressive pattern;

analysis as to whether identified individual patterns and/or patterns of development are comparable in a user-specific way with definable threshold values; and

analysis as to whether identified threshold value deviations of the user-specific individual patterns and/or patterns of development are quantified and/or can be qualified.

10. A method in accordance with claim 9, wherein at least one user-specific risk index value that is representative of a heart-specific and/or circulation-specific and/or respiration-specific parameter of the user can be determined from the quantification and/or qualification of the threshold value deviations.

13. A method in accordance with claim 10, wherein a CWF is computed from at least one test signal.

14. A method in accordance with claim 10, wherein a CWF is computed from at least one test signal and the CWP.

15. A method in accordance with claim 10, wherein the CWF is evaluated for device control.

11. A method for evaluating at least one test signal detected with the use of at least one sensor, wherein a CWP (continuous wave parameter) is computed from the test signal.

12. A method in accordance with claim 11, wherein a CWF (continuous wave fluctuation) is computed from the CWP.

16. A device for determining and analyzing biophysical data of an individual, which consists of a basic module with a power supply, a memory unit, and at least one sensor device for the noninvasive measurement of at least one test signal that represents cardiac activity and/or respiratory activity, which is selected from the following group:

pulse rate, plethysmogram, oxygen saturation, respiratory signal, and heart signal, and an analyzer connected to the sensor device for extracting at least one CWP (continuous wave parameter) from the test signal, and/or a device for determining at least one CWF (continuous wave fluctuation), wherein the CWF (continuous wave fluctuation) is determined from the CWP and/or the test signal.

31. A device for determining and analyzing biophysical data of an individual, which consists of at least one sensor device for the noninvasive measurement of at least two signals, such as a plethysmogram and CWF (continuous wave fluctuation) signals derived from it, SpO2 and pulse rate, and an analyzer connected to the sensor device for analyzing transient and/or periodically recurring patterns of the measured signals, which analyzer has at least one module for the evaluation of information that is related to the frequency or amplitude of the signals or the parameters derived from them.

32. A method for determining and analyzing biophysical data of an individual, in which at least one sensor device is used for the noninvasive measurement of at least two signals, especially two signals selected from the group comprising a plethysmogram with CWF (continuous wave fluctuation) signals derived from it, SpO2 signals and pulse rate, and in which an analyzer connected to the sensor device determines transient and/or periodically recurring patterns of the measured signals, wherein, with respect to the results of the evaluation, that information which is related to the frequency and/or amplitude of the signals or parameters derived from them is further processed.