IP Library Granted Patent US 10,349,898
Granted Patent B2
US 10,349,898 · App. 15/195,037 · Granted Jul 16, 2019

Automated CCHD screening and detection

Inventors: Ammar Al-Ali (San Juan Capistrano, CA); Bilal Muhsin (San Clemente, CA)
Assignee: MASIMO CORPORATION
A61B5/7275A61B5/0205A61B5/02028A61B5/0295A61B5/14551A61B5/14552A61B5/684A61B5/6825A61B5/6829A61B5/7221A61B5/7278A61B5/7282A61B5/743A61B5/024A61B5/0816A61B2503/04
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Quick Facts
Patent No.
US 10,349,898
App. No.
15/195,037
Granted
Jul 16, 2019
Kind
B2
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 (53)

1. 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 for a first period of time;

gathering second physiological data from a second site on a patient's body for a second period of time;

processing said first physiological data and said second physiological data, wherein said processing comprises at least:

selecting at least a first sub-portion of at least one of said first physiological data or said second physiological data based on one or more confidence criteria;

selecting at least a second sub-portion of an other of said first physiological data or said second physiological data; and

comparing the first sub-portion to the second sub-portion to determine a difference; and

outputting the difference, the difference used to determine the existence of a critical congenital heart defect.

2. The computer-implemented method of claim 1 , wherein the physiological data includes at least one of: blood oxygenation data, plethysmograph data, pulse rate data, respiration data, or perfusion index data.

3. The computer-implemented method of claim 1 , 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.

4. The computer-implemented method of claim 3 , wherein the difference is the computed average, over a third period of time, of the difference between the pre-ductal blood oxygen saturation measurement and the post-ductal blood oxygen saturation measurement.

5. The system of claim 4 , wherein the third 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, or a respiration cycle.

6. The computer-implemented method of claim 1 , 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.

7. The computer-implemented method of claim 1 , 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, or the difference.

8. The computer-implemented method of claim 1 , wherein the one or more confidence criteria include at least one of: a correlation between a feature of the first physiological data and a feature of the second physiological data, a signal strength, a perfusion index, or a respiration cycle.

9. 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 for a first period of time and a second site for a second period of time with the noninvasive sensor,

wherein at least a first sub-portion of blood oxygen saturation data from at least one of the first site or the second site is selected based on one or more confidence criteria,

wherein at least a second sub-portion blood oxygen saturation data from an other of the first site or the second site is selected,

wherein the first sub-portion is compared to the second sub-portion to compute a delta, and

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

10. The system of claim 9 , 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.

11. The system of claim 9 , wherein the pulse oximeter comprises a display.

12. The system of claim 10 , wherein the blood oxygen saturation data related to the patient is shown on the display.

13. The system of claim 10 , wherein the existence of a critical congenital heart defect is indicated on the display by at least one of: a number, a color, or a symbol.

14. The system of claim 10 , wherein a caregiver is instructed, through the display, where to place the noninvasive sensor, and whether to re-perform either of the measurements.

15. The system of claim 9 , wherein the computed delta is an average over a third period of time of the difference between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site.

16. The system of claim 15 , wherein the third 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, or a respiration cycle.

17. The system of claim 9 , 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.

18. The system of claim 9 , wherein the one or more confidence criteria include at least one of: a correlation between a feature of the first physiological data and a feature of the second physiological data, a signal strength, a perfusion index, or a respiration cycle.

19. 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 for a period of time with two or more of the plurality of noninvasive sensors,

wherein at least a first sub-portion of blood oxygen saturation data from at least one of the first site or the second site is selected based on one or more confidence criteria,

wherein at least a second sub-portion of blood oxygen saturation data from an other of the first site or the second site is selected,

wherein the first sub-portion is compared to the second sub-portion to compute a delta, and

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

20. The system of claim 19 , 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.

21. The system of claim 19 , wherein the computed delta is an average over a second period of time of the difference between the blood oxygen saturation at the first site and the blood oxygen saturation at the second site.

22. The system of claim 21 , wherein the second 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, or a respiration cycle.

23. The system of claim 19 , wherein the one or more confidence criteria include at least one of: a correlation between a feature of the first physiological data and a feature of the second physiological data, a signal strength, a perfusion index, or a respiration cycle.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 28, 2016
From: AL-ALI, AMMAR; MUHSIN, BILAL
To: MASIMO CORPORATION
Reel/Frame 039884/0116 →
Continuity (4)
Division 13733782 · Jan 3, 2013
Provisional Application 61583143 · Jan 4, 2012
Provisional Application 61703132 · Sep 19, 2012
Related Publication 20170007134A1 · Jan 12, 2017
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