AUTOMATED CCHD SCREENING AND DETECTION

• US 20190274635A1
• Filed: 05/29/2019
• Published: 09/12/2019
• 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 11,179,111 B2
• Time in Patent Office: Days
• 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. (canceled)

2. A method of determining a likelihood of a critical congenital heart defect using a pulse oximeter, the method comprising:

displaying, on a display of a pulse oximeter, instructions to a caregiver to position a noninvasive sensor at a first measurement site and at a second measurement site on a patient, wherein the noninvasive sensor is configured to output signals responsive to attenuation of light at measurement sites on the patient to the pulse oximeter;

receiving the output signals indicative of measures of blood oxygenation levels at the first measurement site and the second measurement site;

displaying, on the display of the pulse oximeter, an indication to the caregiver of a success or failure of obtaining the measures of blood oxygenation levels at the first measurement site and/or the second measurement site;

processing, by one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine a likelihood that the patient has a critical congenital heart defect, wherein said processing comprises at least aligning of at least portions of the measure of blood oxygenation level at the first measurement site and the measure of blood oxygenation level at the second measurement site; and

displaying, on the display of the pulse oximeter, an indication to the caregiver of the likelihood that the patient has the critical congenital heart defect.

3. The method of claim 2 further comprising:

displaying, on the display of the pulse oximeter, instructions to the caregiver to proceed with an additional screening for the critical congenital heart defect after a period of time.

4. The method of claim 2, wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect comprises:

displaying, on the display of the pulse oximeter, an indication of a difference between the measures of blood oxygenation levels at the first and second measurement sites.

5. The method of claim 4, wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect further comprises:

displaying, on the display of the pulse oximeter, an indication of the measure of blood oxygenation level at the first measurement site and an indication of the measure of blood oxygenation level at the second measurement site.

6. The method of claim 5, wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect further comprises:

displaying, on the display of the pulse oximeter, respective measures of perfusion index associated with each of the measures of blood oxygenation level.

7. The method of claim 6, wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect further comprises:

displaying, on the display of the pulse oximeter, an indication of a confidence in the likelihood that the patient has the critical congenital heart defect.

8. The method of claim 2 further comprising:

displaying, on the display of the pulse oximeter, an indication of a progress of obtaining the measure of blood oxygenation level at the first measurement site.

9. The method of claim 2 further comprising:

displaying, on the display of the pulse oximeter, an indication of a progress of obtaining the measure of blood oxygenation level at the second measurement site.

10. The method of claim 2, wherein the first measurement site comprises a right hand of the patient.

11. The method of claim 10, wherein the second measurement site comprises at least one of a foot or left hand of the patient.

12. The method of claim 2, wherein:

the output signals indicative of the measure of blood oxygenation level at the first measurement site are received during a first duration of time, and comprise a first waveform responsive to a pre-ductal oxygen saturation of the patient;

the output signals indicative of the measure of blood oxygenation level at the second measurement site are received during a second duration of time, and comprise a second waveform responsive to a post-ductal oxygen saturation of the patient; and

processing, by the one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine the likelihood that the patient has a critical congenital heart defect comprises;

electronically determining, by the one or more hardware processors, one or more waveform features in the first waveform responsive to the pre-ductal oxygen saturation;

electronically determining, by the one or more hardware processors, one or more of the one or more waveform features in the second waveform responsive to the post-ductal oxygen saturation;

electronically aligning, by the one or more hardware processors, one or more of the one or more waveform features from the first waveform with one or more of the one or more waveform features from the second waveform;

electronically determining, by the one or more hardware processors, a pre-ductal value of the first waveform at a first time; and

electronically determining, by the one or more hardware processors, a post-ductal value of the second waveform at the first time taking into account the aligning,

wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect comprises;

in response to determining the pre-ductal value and the post-ductal value differ by a predetermined threshold, outputting display indicia to the display indicating a likelihood that the patient has the critical congenital heart defect.

13. The method of claim 12, wherein said first time comprises a third duration of time, and wherein determining said pre-ductal value and said post-ductal value differ by the predetermined threshold comprises:

calculating an average difference between said pre-ductal value and said post-ductal value over the third duration of time.

14. The method of claim 13, wherein said first duration of time and said second duration of time each comprise at least sixty seconds.

15. The method of claim 14, wherein said third duration of time comprises at least thirty seconds.

16. The method of claim 12, wherein said one or more waveform features from said first waveform comprise at least one of:

a trough, a peak, a natural high cycle of oxygen saturation, a natural low cycle of oxygen saturation, or a cyclical variation.

17. The method of claim 12, wherein processing, by the one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine the likelihood that the patient has a critical congenital heart defect further comprises:

discarding a waveform when a quality of said output signals is outside of a pre-determined range.

18. The method of claim 12, wherein processing, by the one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine the likelihood that the patient has a critical congenital heart defect further comprises:

receiving said signal outputs to obtain a third waveform responsive to a blood perfusion level of the patient, wherein a waveform is discarded when the blood perfusion level associated with the waveform is outside of a pre-determined range.

19. A pulse oximetry based system configured to determine a likelihood of a critical congenital heart defect, the system comprising:

a noninvasive sensor configured to output signals responsive to an attenuation of light at measurement sites on a patient; and

a pulse oximeter in communication with the noninvasive sensor to drive light sources of said noninvasive sensor and to receive said output signals, said pulse oximeter including one or more hardware processors configured to;

display, on a display of the pulse oximeter, instructions to a caregiver to position the noninvasive sensor at a first measurement site and at a second measurement site on a patient;

receive the output signals indicative of measures of blood oxygenation levels at the first measurement site and the second measurement site;

display, on the display of the pulse oximeter, an indication to the caregiver of a success or failure of obtaining the measures of blood oxygenation levels at the first measurement site and/or the second measurement site;

process, by the one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine a likelihood that the patient has a critical congenital heart defect, wherein said processing comprises at least aligning of at least portions of the measure of blood oxygenation level at the first measurement site and the measure of blood oxygenation level at the second measurement site; and

display, on the display of the pulse oximeter, an indication to the caregiver of the likelihood that the patient has the critical congenital heart defect.

20. The system of claim 19, wherein:

the output signals indicative of the measure of blood oxygenation level at the first measurement site are received during a first duration of time, and comprise a first waveform responsive to a pre-ductal oxygen saturation of the patient;

the output signals indicative of the measure of blood oxygenation level at the second measurement site are received during a second duration of time, and comprise a second waveform responsive to a post-ductal oxygen saturation of the patient; and

processing, by the one or more hardware processors of the pulse oximeter, the measures of blood oxygenation levels at the first measurement site and the second measurement site to determine the likelihood that the patient has a critical congenital heart defect comprises;

electronically determining, by the one or more hardware processors, one or more waveform features in the first waveform responsive to the pre-ductal oxygen saturation;

electronically determining, by the one or more hardware processors, one or more of the one or more waveform features in the second waveform responsive to the post-ductal oxygen saturation;

electronically aligning, by the one or more hardware processors, one or more of the one or more waveform features from the first waveform with one or more of the one or more waveform features from the second waveform;

electronically determining, by the one or more hardware processors, a pre-ductal value of the first waveform at a first time; and

electronically determining, by the one or more hardware processors, a post-ductal value of the second waveform at the first time taking into account the aligning,

wherein displaying the indication of the likelihood that the patient has the critical congenital heart defect comprises;

in response to determining the pre-ductal value and the post-ductal value differ by a predetermined threshold, outputting display indicia to the display indicating a likelihood that the patient has the critical congenital heart defect.