Device and method for determining a comparison value of biodata and for recording biodata

• US 9,801,589 B2
• Filed: 04/04/2007
• Issued: 10/31/2017
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Loewenstein Medical Technology S.A.
• Original Assignee: Loewenstein Medical Technology S.A.
• Inventors: Schwaibold, Matthias, Sommermeyer, Dirk, Schller, Bernd
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US12/225,980
• Publication Number:
  US 20090240119A1
• Time in Patent Office: 3,863 Days
• Field of Search: 600513, 600508, 600509, 600300
• 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 of an individual for determining an individual risk, said device comprising:

at least one sensor for noninvasive measurement of at least three signals, which are CWF (continuous wave fluctuation), SpO2, heart rate; and

an evaluation unit connected to the sensor, where the evaluation unit has at least one analyzer adapted to determine signal ranges that are definable by signal analysis, wherein the evaluation unit includes a comparator adapted to coordinate the signal ranges by taking additional parameters into account, and to produce a result that is output as an index value, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the CWF signal contains information about fluctuations of the plethysmogram or the CWP'"'"'s derived from the plethysmogram, the signals being analyzed by pattern recognition and compared with stored values, the comparison providing a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.

2. A device in accordance with claim 1, wherein the additional parameters include existing biophysical data of the individual and/or static data sets.

3. A device in accordance with claim 2, wherein the static data sets are compiled from groups of individuals, and include medication, age, sex, and diagnostic data.

4. A device in accordance with claim 1, wherein the comparator is adapted to be connected to peripheral devices.

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

20. A device in accordance with claim 1, wherein the sensor device is 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.

21. A device in accordance with claim 1, further comprising a module adapted to determine other biophysical data.

22. A device in accordance with claim 1, further comprising a module adapted to determine other respiratory parameters.

23. A device in accordance with claim 1, further comprising a module adapted to determine other cardiological parameters.

24. A device in accordance with claim 1, further comprising a data input device adapted for inputting patient data.

25. A device in accordance with claim 1, further comprising a display device and/or an output device adopted to display and/or output analytical results.

26. A device in accordance with claim 1, further comprising a fastening assembly for fastening the device on a body of an individual.

29. A device in accordance with claim 2, wherein the additional parameters of the existing biophysical data of the individual include medication, medical history, age, sex, diagnostic data.

30. A device in accordance with claim 4, wherein the peripheral devices are selected from the group consisting of computers, printers and display devices.

6. A method for determining an individual risk for an individual, comprising the following steps:

determining measurement data of at least three heart-specific and/or circulation-specific and/or respiration-specific parameters of the user, selected from the group comprising;

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

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

determining measurement data with a synchronized time recording;

bringing together time information and the measurement data;

analyzing the measurement data with the time information being taken into account;

carrying out the analysis as a pattern recognition, including, at least in intervals, detecting a course of the measurement with respect to time of at least one parameter can be and evaluating the course with respect to a typical individual pattern and/or a progressive pattern to identify user-specific individual patterns and/or patterns of development;

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

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

wherein the measured data is determined using a pulse oximeter, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the signals are analyzed by pattern recognition and compared with stored values to provide a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.

7. A method in accordance with claim 6, including determining at least one user-specific risk index value that is representative of the heart-specific and/or circulation-specific and/or respiration-specific parameter of the user from the quantification and/or qualification of the threshold value deviations.

8. A method for evaluating at least one test signal, comprising the steps of:

detecting at least one test signal with at least one sensor; and

computing a CWP (continuous wave parameter) from the at least one test signal, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the CWF signal contains information about fluctuations of the plethysmogram or the CWP'"'"'s derived from the plethysmogram, the signals are analyzed by pattern recognition and compared with stored values to provide a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.

9. A method in accordance claim 8, including computing the CWF from at least one test signal.

10. A method in accordance with claim 8, including computing the CWF from the at least one test signal and the CWP.

11. A method in accordance with claim 9, including evaluating the CWF for controlling a device.

12. A device for determining and analyzing biophysical data of an individual, which device comprises a basic module with a power supply, a memory unit, and at least one sensor device for noninvasive measurement of at least three test signals 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 signals, and a device adapted 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, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the CWF signal contains information about fluctuations of the plethysmogram or the CWP'"'"'s derived from the plethysmogram, wherein the signals are analyzed by pattern recognition and compared with stored values to provide a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.

13. A device in accordance with claim 12, further comprising a classifier adapted to compare at least one CWF datum and/or quantities derived from the CWF datum with stored data for identifying physiological/pathophysiological events.

14. A device in accordance with claim 12, further comprising a classifier adapted to compare at least one CWF datum and/or quantities derived from the CWF datum with other test signals and/or CWP'"'"'s for identifying physiological/pathophysiological events.

15. A device in accordance with claim 13, 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.

16. A device in accordance with claim 12, wherein the analyzer is adapted to evaluate at least two signals that are temporally related to identify physiological events.

17. A device in accordance with claim 12, further comprising supplementary modules adapted for measuring other signals.

18. A device in accordance with claim 12, further comprising at least one interface installed in the basic module, where the interface is adapted to permit data to be read out and/or other devices to be controlled.

19. A device in accordance with claim 12, further comprising supplementary sensor devices adapted for measuring other signals.

27. A device for determining and analyzing biophysical data of an individual, comprising:

at least one sensor device for the noninvasive measurement of at least three signals, including a plethysmogram and CWF (continuous wave fluctuation) signals derived from the plethysmogram , 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 adapted for evaluation of information that is related to frequency or amplitude of the signals or parameters derived from the signals, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the CWF signal contains information about fluctuations of the plethysmogram or the CWP'"'"'s derived from the plethysmogram, the signals are analyzed by pattern recognition and compared with stored values to provide a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.

28. A method for determining and analyzing biophysical data of an individual, comprising the steps of:

noninvasively measuring at least three signals using at least one sensor device, the two signals being selected from the group comprising a plethysmogram with CWF (continuous wave fluctuation) signals derived from the plethysmogram, SpO2 signals and pulse rate;

determining transient and/or periodically recurring patterns of the measured signals with an analyzer connected to the sensor device; and

further processing, based on results from the analyzer, information which is related to frequency and/or amplitude of the signals or parameters derived from the signals, wherein the sensor is a pulse oximeter adapted to record a plethysmogram and SpO2, wherein the evaluation unit extracts CWP'"'"'s (continuous wave parameters) from the plethysmogram, the evaluation unit extracting the following as CWP'"'"'s;

pulse wave amplitude, a ratio of different integrals over different intervals of the plethysmogram, a quantity related to PTT (pulse transit time), the evaluation unit being adapted to compute a CWF (continuous wave fluctuation) signal from the CWP'"'"'s as a function of time, wherein the CWF signal contains information about fluctuations of the plethysmogram or the CWP'"'"'s derived from the plethysmogram, the signals are analyzed by pattern recognition and compared with stored values to provide a result that yields a patient-specific risk index that is suitable for predicting a risk of cardiovascular disease.