Device and method for screening congenital heart disease

• US 10,667,700 B2
• Filed: 09/23/2014
• Issued: 06/02/2020
• Est. Priority Date: 07/06/2006
• Status: Active Grant

• Current Assignee: Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center (University of California)
• Original Assignee: Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center (University of California)
• Inventors: Chang, Ruey-Kang
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Toth, Karen E
• Application Number:
  US14/493,817
• Publication Number:
  US 20150011846A1
• Time in Patent Office: 2,079 Days
• CPC Class Codes: A61B 2503/045 Newborns, e.g. premature baby monitoring
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• 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 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/6841 by using templates
• 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 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61B 7/026 comprising more than one sound collector
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An apparatus including a main processing unit. The apparatus further including a precordial patch coupled to the main processing unit, the precordial patch having a plurality of sensors for detecting heart sounds and cardiac electrical signals (ECG). The apparatus further including a probe coupled to the main processing unit, the probe having a sensor for detecting oxygen saturation of blood circulating through a human. A method is further described including simultaneously measuring and analyzing heart sounds, cardiac electrical signals (ECG) and oxygen saturation of blood circulating through a human. The method further includes performing an algorithm to determine the presence of a significant congenital heart disease and displaying management recommendations based on results of the algorithm.

Claims

1. A method for detecting congenital heart disease based on a triple screen facilitated by an apparatus comprising a precordial patch configured to be secured to a newborn human subject, the precordial patch comprising dimensions for positioning the precordial patch within a precordium of a newborn human subject, the method being performed with a system comprising a display touch screen of a main processing unit and one or more processing units communicatively coupled with the display touch screen to perform the method, the method comprising:

receiving, with the one or more processing units, first information associated with a detected oxygen saturation, the first information being received from a first sensor associated with the precordial patch, the first information indicating whether the detected oxygen saturation is indicative of a normal heart, non-cyanotic congenital heart disease, overcirculated “

cyanotic”

congenital heart disease, or probable cyanotic congenital heart disease;

receiving, with the one or more processing units, responsive to the first information indicating the oxygen saturation is indicative of a normal heart, non--cyanotic congenital heart disease, or overcirculated “

cyanotic”

congenital heart disease, second information associated with a presence or absence of a detected heart murmur, the second information being received from a plurality of second sensors associated with the precordial patch;

receiving, with the one or more processing units, responsive to either (1) the first information indicating probable cyanotic congenital heart disease, (2) the second information indicating an absence of the detected heart murmur, or (3) the second information indicating presence of the detected heart murmur, third information associated with a presence or absence of detected abnormal electrical activity of a heart, the third information being received from a plurality of third sensors disposed at the precordial patch;

determining, with the one or more processing units, a presence of congenital heart disease based on (1) the detected oxygen saturation, (2) the presence or absence of a detected heart murmur, and (3) the presence or absence of detected abnormal electrical activity of the heart;

modifying, with the one or more processing units, a screening sensitivity of the determination of the presence of congenital heart disease for use in a current screening location, wherein high screening sensitivity results in an increased rate of congenital heart disease determinations and an increased rate of false positive determinations, and low screening sensitivity results in a decreased rate of congenital heart disease determinations and a decreased rate of false positive determinations; and

performing additional screenings with the one or more processing units for the presence of congenital heart disease with the modified screening sensitivity when screening at the current screening location.

2. The method of claim 1, wherein a given first sensor is configured to facilitate detecting oxygen saturation based on pulse oximetry.

3. The method of claim 1, wherein a given second sensor is configured to facilitate detecting heart murmurs based on a phonocardiogram.

4. The method of claim 1, wherein a given third sensor is configured to facilitate detecting abnormal electrical activity of a heart based on an electrocardiogram.

5. The method of claim 1, wherein one or more of the processing units are associated with the precordial patch, and wherein the determination of the presence of congenital heart disease is performed by one or more of the one or more processing units which are associated with the precordial patch.

6. The method of claim 1, wherein one or more of the processing units are disposed separately from the precordial patch and configured to be communicatively coupled with the precordial patch, and wherein the determination of the presence of congenital heart disease is performed by one or more of the one or more processing units which are disposed separately from the precordial patch and configured to be communicatively coupled with the precordial patch.

7. The method of claim 1, further comprising facilitating display of an outcome of the determination of the presence of congenital heart disease.

8. The method of claim 1, wherein the plurality of second sensors is disposed at a different region of the precordial patch than the plurality of third sensors.

9. The method of claim 1, further comprising determining a management recommendation based on the determination of the presence of congenital heart disease.

10. The method of claim 1, wherein the third information is received responsive to (2) the second information indicating an absence of the detected heart murmur, wherein the third information comprises information from a 6-lead third sensor, and wherein the third information further comprises information from a 12-lead third sensor responsive to the information from the 6-lead third sensor indicating abnormal electrical activity of the heart.

11. An apparatus configured For detecting congenital heart disease based on a triple screen, the apparatus comprising:

a precordial patch comprising dimensions for positioning the precordial patch within a precordium of a newborn human subject;

wherein the apparatus is configured to receive signals from a first sensor associated with the precordial patch, the first sensor being configured to facilitate detecting oxygen saturation based on puke oximetry, the detected oxygen saturation indicating a normal heart, non-cyanotic congenital heart disease, overcirculated “

cyanotic”

congenital heart disease, or probable cyanotic congenital heart disease;

wherein the apparatus is further configured to receive, responsive to the oxygen saturation indicating the oxygen saturation is indicative of a normal heart, non-cyanotic congenital heart disease, or overcirculated “

cyanotic”

congenital heart disease, signals from a plurality of second sensors associated with the precordial patch, a given second sensor being configured to provide a signal that facilitates detecting a heart murmur based on a phonocardiogram;

wherein the apparatus is further configured to receive, responsive to either (1) the oxygen saturation indicating probable cyanotic congenital heart disease, (2) an absence of the detected heart murmur, or (3) presence of the detected heart murmur, signals from a plurality of third sensors disposed at the precordial patch, a given third sensor being configured to facilitate detecting abnormal electrical activity of a heart based on an electrocardiogram;

one or more processing units configured to determine a presence of congenital heart disease based on (1) the detected oxygen saturation, (2) presence or absence of the detected heart murmur, and (3) a presence or absence of detected abnormal electrical activity of the heart;

wherein the apparatus is further configured to modify the screening sensitivity of the determination of the presence of congenital heart disease for use in a current screening location, wherein high screening sensitivity results in an increased rate of congenital heart disease determinations and an increased rate of fake positive determinations, and low screening sensitivity results in a decreased rate of congenital heart disease determinations and a decreased rate of fake positive determinations, and wherein the one or more processing units are configured to perform additional screenings for the presence of congenital heart disease with the modified screening sensitivity when screening at the current screening location;

and a display touch screen of a main processing unit configured for instructing a computing device to display management recommendations.

12. The apparatus of claim 11, wherein the one or more processing units are associated with the precordial patch.

13. The apparatus of claim 11, wherein the one or more processing units are disposed separately from the precordial patch and are configured to be communicatively coupled with the precordial patch.

14. The apparatus of claim 11, wherein the display touch screen of the main processing unit is configured to present an outcome of the determination of the presence of congenital heart disease.

15. The apparatus of claim 14, wherein the display touch screen of the main processing unit is associated with the precordial patch.

16. The apparatus of claim 14, wherein the display touch screen of the main processing unit is disposed separately from the precordial patch.

17. The apparatus of claim 11, wherein the plurality of second sensors is disposed at a different region of the precordial patch than the plurality of third sensors.

18. The apparatus of claim 11, wherein the one or more processing units are further configured to determine a management recommendation based on the determination of the presence of congenital heart disease.

19. The apparatus of claim 11, wherein the patch further comprises at least one indicator for an anatomical landmark.

20. The apparatus of claim 11, wherein the signals from the plurality of third sensors are received responsive to (2) an absence of the detected heart murmur, wherein the signals from the plurality of third sensors comprise signals from one or more 6-lead sensors, and wherein the signals from the plurality of third sensors further comprise signals from one or more 12-lead sensors responsive to the signals from the one or more 6-lead sensors indicating abnormal electrical activity of the heart.