AUTOMATED CCHD SCREENING AND DETECTION

• US 20130190581A1
• Filed: 01/03/2013
• Published: 07/25/2013
• Est. Priority Date: 01/04/2012
• Status: Active Grant

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Corporation
• Inventors: Al-Ali, Ammar, Muhsin, Bilal
• Granted Patent: US 9,392,945 B2
• Time in Patent Office: Days
• US Class Current: 600/324
• CPC Class Codes: A61B 2503/04 Babies, e.g. for SIDS detection
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• 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: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

Automated critical congenital heart defect (“CCHD”) screening systems and processes are described. A caregiver may be guided to use a single or dual sensor pulse oximeter to obtain pre- and post-ductal blood oxygenation measurements. A delta of the measurements indicates the possible existence or nonexistence of a CCHD. Errors in the measurements are reduced by a configurable measurement confidence threshold based on, for example, a perfusion index. Measurement data may be stored and retrieved from a remote data processing center for repeated screenings.

Claims

1. A method of detecting a critical congenital heart defect, the method comprising:

instructing a caregiver, using a pulse oximeter display, to measure a pre-ductal blood oxygenation level for a first period of time using the pulse oximeter;

instructing the caregiver, using the pulse oximeter display, to measure a post-ductal blood oxygenation level for a second period of time using the pulse oximeter;

automatically determining, on the pulse oximeter, a first timeframe within the first period of time, and a second timeframe within the second period of time, during which the measured pre-ductal blood oxygenation level is correlated with the measured post-ductal blood oxygenation level;

automatically calculating, on the pulse oximeter, a saturation difference between the measured pre-ductal blood oxygenation level during the first timeframe and the measured post-ductal blood oxygenation level during the second timeframe;

automatically detecting, on the pulse oximeter, a critical congenital heart defect based at least in part on the calculated saturation difference; and

displaying an indication of the critical congenital heart defect on the display of the pulse oximeter.

2. The method of claim 1, wherein the calculated saturation difference comprises an average of the difference over the first timeframe and the second timeframe.

3. The method of claim 1, wherein the first period of time and the second period of time are each sixty seconds.

4. The method of claim 1, wherein the first timeframe and the second timeframe are each thirty seconds.

5. The method of claim 1, wherein the correlation is determined based on at least one of:

natural high and low cycles of oxygen saturation, respiration, pulse rate, and perfusion index.

6. The method of claim 1, wherein a noninvasive sensor measures the pre-ductal blood oxygenation level and the post-ductal blood oxygenation level.

7. The method of claim 6, wherein a measured blood oxygenation level is discarded when the sensor signal quality related to the measurement is outside of a preset range.

8. The method of claim 6, wherein the sensor further measures a perfusion index, and wherein a measured blood oxygenation level is discarded when the measured perfusion index associated with the measurement is outside of a preset range.

9. The method of claim 1, further comprising:

retrieving from a remote data processing center a previous saturation difference; and

comparing the previous saturation difference with the calculated saturation difference.

10. A computer-implemented method for determining the existence of a critical congenital heart defect, the computer-implemented method comprising:

under control of one or more computing devices configured with specific computer executable instructions,

gathering first physiological data from a first site on a patient'"'"'s body;

gathering second physiological data from a second site on a patient'"'"'s body;

processing said first physiological data and said second physiological data; and

outputting a difference between said first physiological data and said second physiological data, the difference used to determine the existence of a critical congenital heart defect.

11. The computer-implemented method of claim 10, wherein the physiological data includes at least one of:

blood oxygenation data, plethysmograph data, pulse rate data, respiration data, and perfusion index data.

12. The computer-implemented method of claim 10, wherein the physiological data gathered from the first site comprises a pre-ductal blood oxygen saturation measurement, and the physiological data gathered from the second site comprises a post-ductal blood oxygen saturation measurement.

13. The computer-implemented method of claim 12, wherein the difference is the computed average, over a period of time, of the difference between the pre-ductal blood oxygen saturation measurement and the post-ductal blood oxygen saturation measurement.

14. The system of claim 13, wherein the period of time is based on at least one of:

a correlation between the pre-ductal blood oxygen saturation measurement and the post-ductal blood oxygen saturation measurement, a signal strength of a noninvasive sensor used to gather pre- and post-ductal blood oxygen saturation measurements, a perfusion index, and a respiration cycle.

15. The computer-implemented method of claim 10, further comprising:

under control of the one or more computing devices configured with specific computer executable instructions,

communicating with a remote data processing center, the remote data processing center configured to store and communicate physiological data;

retrieving one or more previously acquired differences associated with the patient; and

comparing the one or more previously acquired differences with the difference to determine the existence of a critical congenital heart defect.

16. The computer-implemented method of claim 10, further comprising:

under control of the one or more computing devices configured with specific computer executable instructions,

displaying to a caregiver at least one of;

the first physiological data, the second physiological data, and the difference.

17. A system configured to indicate the existence of a critical congenital heart defect, the system comprising:

a noninvasive sensor configured to gather blood oxygen saturation data related to a patient; and

a pulse oximeter in communication with the noninvasive sensor, the pulse oximeter configured to process the blood oxygen saturation data,

wherein blood oxygen saturation data related to the patient is gathered from a first site and a second site with the noninvasive sensor,

wherein the blood oxygen saturation data gathered from the first site and the blood oxygen saturation data gathered from the second site are compared and a delta is computed,

wherein the computed delta indicates the existence or nonexistence of a critical congenital heart defect.

18. The system of claim 17, wherein the blood oxygen saturation data gathered from the first site comprises a pre-ductal measurement, and the blood oxygen saturation data gathered from the second site comprises a post-ductal measurement.

19. The system of claim 17, wherein the pulse oximeter comprises a display.

20. The system of claim 18, wherein the blood oxygen saturation data related to the patient is shown on the display.

21. The system of claim 18, wherein the existence of a critical congenital heart defect is indicated on the display by at least one of:

a number, a color, and a symbol.

22. The system of claim 18, wherein a caregiver is instructed, through the display, where to place the noninvasive sensor, and whether to re-perform either of the measurements.

23. The system of claim 17, wherein the computed delta is an average over a period of time of the difference between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site.

24. The system of claim 23, wherein the period of time is selected based on at least one of:

a correlation between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site, a signal strength of the noninvasive sensor, a perfusion index, and a respiration cycle.

25. The system of claim 17, further comprising:

a remote data processing center in communication with the pulse oximeter, the remote data processing center configured to store and communicate blood oxygen saturation data,

wherein one or more previously calculated deltas associated with the patient are retrieved by the pulse oximeter and compared to the current calculated delta, indicating the existence of a critical congenital heart defect.

26. A system configured to indicate the existence of a critical congenital heart defect, the system comprising:

a plurality of noninvasive sensors configured to gather blood oxygen saturation data related to a patient; and

a pulse oximeter in communication with the plurality of noninvasive sensors, the pulse oximeter configured to process the blood oxygen saturation data,

wherein blood oxygen saturation data related to the patient is gathered from at least a first site and a second site simultaneously with two or more of the plurality of noninvasive sensors,

wherein the blood oxygen saturation data gathered from the first site and the blood oxygen saturation data gathered from the second site are compared and a delta is computed,

wherein the computed delta indicates the existence or nonexistence of a critical congenital heart defect.

27. The system of claim 26, wherein the blood oxygen saturation data gathered from the first site comprises a pre-ductal measurement, and the blood oxygen saturation data gathered from the second site comprises a post-ductal measurement.

28. The system of claim 26, wherein the computed delta is an average over a period of time of the difference between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site.

29. The system of claim 28, wherein the period of time is selected based on at least one of:

a correlation between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site, a signal strength of the noninvasive sensor, a perfusion index, and a respiration cycle.