CARDIAC HEALTH ASSESSMENT SYSTEMS AND METHODS
20210378537 · 2021-12-09
Assignee
Inventors
Cpc classification
G16H50/20
PHYSICS
A61B2560/0431
HUMAN NECESSITIES
G16H10/60
PHYSICS
G16H50/30
PHYSICS
A61B5/349
HUMAN NECESSITIES
A61B5/02055
HUMAN NECESSITIES
A61B5/6898
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/11
HUMAN NECESSITIES
G16H10/60
PHYSICS
Abstract
A cardiac health assessment system and method for use with a handheld electronic device. The cardiac health assessment system includes an electronic device case (EDC), a plurality of electrodes, and a circuit board. The EDC secures the handheld electronic device. The electrodes include a first ECG electrode, a second ECG electrode, and a third electrode. The first ECG electrode is placed on an outer surface of the EDC. The second ECG electrode and the third electrode are placed on each side of the EDC to facilitate a thumb and fingers of a user to be placed on the handheld electronic device. The electrodes capture data indicative of the cardiac health of the user. The circuit board includes a microphonic sensor, an Inertial Measurement Unit (IMU) sensor, and a microcontroller. The microphonic sensor and IMU sensor capture cardiac health data. The microcontroller transmits cardiac health data to the handheld electronic device.
Claims
1. A cardiac health assessment system for use with a handheld electronic device, the cardiac health assessment system comprising: a handheld electronic device having a processor configured to transmit data indicative of cardiac function from the handheld electronic device to one or more computing devices over a network for remote diagnostic analysis using machine learning; an electronic device case (EDC) having a shape adapted to position the handheld electronic device within the EDC; a plurality of electrodes comprising: a first ECG electrode placed on an outer surface of the EDC; and a second ECG electrode and a third electrode placed on the sides of the EDC to facilitate a thumb and fingers of a user to be placed on the EDC having the shape that is adapted to secure the handheld electronic device, wherein the plurality of electrodes are configured to capture data indicative of the cardiac health of a user; and a circuit board configured within the EDC and electrically connected with the plurality of electrodes, where the circuit board comprises: a microphonic sensor to capture cardiac audio signals indicative of the cardiac health of the user; a diaphragm to enhance the cardiac audio signals captured by the microphonic sensor; Inertial Measurement Unit (IMU) sensor to capture seismic and auscultation signals indicative of the cardiac health of the user, wherein the IMU sensor includes an IMU sensor signal-enhancing material to amplify seismic d auscultation signals; and a microcontroller to transmit cardiac health data received from the plurality of electrodes, the microphonic sensor, and the IMU sensor to at least one of the handheld electronic device and a computing device, wherein the computing device is configured to: receive, in one or more temporal windows, a representation of one or more of the IMU sensor, the plurality of electrodes, and the microphonic sensor signal recorded by the EDC; detect features of the IMU sensor, the plurality of electrodes and the microphonic sensor from at least one or more portions of the received representations falling within each of the one or more temporal windows; identify patterns of the features of respective sensors and electrodes from within the one or more portions based on at least a trained classification model or a regression model; calculate, based on the identified patterns, a probability of whether the one or more portions correspond to a problem with the cardia health of the user; and estimate, based on the identified patterns, one or more of the following: an intracardiac pressure of the user and left ventricular ejection fraction of the user.
2. The cardiac health assessment system according to claim 1, wherein the handheld electronic device having a shape adapted to position the handheld electronic device within the EDC includes a display screen for displaying cardiac diagnostic information derived from the cardiac health data received from the microcontroller.
3. The cardiac health assessment system according to claim 1, wherein the EDC is configured to capture cardiac health data of the user when positioned against the chest of the user.
4. The cardiac health assessment system according to claim 1, wherein the processor executes a plurality of instructions pertaining to a cardiac monitoring application, and wherein the processor is configured to show on the display one or more commands allowing the user to position the EDC against the chest of the user.
5. The cardiac health assessment system according to claim 1, wherein a classification model is trained using the cardiac health data received from the plurality of electrodes, the microphonic sensor, and the IMU sensor for aiding in the detection of abnormal heart activity arising from cardiac health conditions comprising coronary artery disease and heart arrhythmias.
6. The cardiac health assessment system according to claim 1, wherein the EDC further comprises a heat-sensing camera to detect variations in chest skin surface temperature resulting from variations in cardiac volume.
7. The cardiac health assessment system according to claim 1, wherein the diaphragm further comprises an enhancer unit to amplify low-frequency auscultation signals pertaining to the cardiac audio signals.
8. The cardiac health assessment system according to claim 1, wherein the EDC further comprises a battery configured to supply electrical power to the circuit board.
9. The cardiac health assessment system according to claim 1, wherein the EDC further comprises a camera and a lens configured to envelop at least a portion of the camera.
10. The cardiac health assessment system according to claim 1 further comprising a second computing device wirelessly connected to the handheld electronic device and having a wireless transceiver configured to establish communication with the handheld electronic device for communicating cardiac health data there-between, wherein the second computing device is configured to: detect using a classification model an abnormal heart activity arising from a plurality of parameters comprising one or more of: hypertension, aortic stenosis, aortic regurgitation, mitral stenosis and mitral regurgitation; and estimate using a regression model one or more of: an intracardiac pressure and a left ventricular ejection fraction.
11. A cardiac health assessment method for use with a handheld electronic device, the cardiac health assessment method comprising steps of: securing, by an electronic device case (EDC), the handheld electronic device; capturing, by a plurality of electrodes, a microphonic sensor, and an Inertial Measurement Unit (IMU) sensor, cardiac health data of a user, wherein the plurality of electrodes comprises a first ECG electrode placed on an outer surface of the electronic device case (EDC), and a second ECG electrode and a third electrode are placed on each side of the electronic device case (EDC) to facilitate a thumb and fingers of a user to be placed on the handheld electronic device; transmitting, by a microcontroller, the cardiac health data received from the plurality of electrodes, the microphonic sensor, and the IMU sensor to at least one of the handheld electronic device and a computing device; and displaying, by a display screen, cardiac diagnostic information derived from the cardiac health data received from the microcontroller
12. The cardiac health assessment method according to claim 11, wherein the electronic device case (EDC) is positioned against the chest of the user to capture cardiac health data.
13. The cardiac health assessment method according to claim 11, wherein the handheld electronic device comprises a processor to execute a plurality of instructions pertaining to a cardiac monitoring application, wherein the processor is configured to display one or more commands to position the electronic device case (EDC) against the chest of the user.
14. The cardiac health assessment method according to claim 11, wherein the classification model is trained to detect abnormal heart activity arising from cardiac health conditions comprising coronary artery disease and heart arrhythmias.
15. The cardiac health assessment method according to claim 11, wherein the electronic device case (EDC) comprises a heat-sensing camera to detect variations in chest skin surface temperature resulting from variations in cardiac volume.
16. The cardiac health assessment method according to claim 11, wherein the diaphragm comprises an enhancer unit to amplify low-frequency auscultation signals pertaining to the cardiac audio signals.
17. The cardiac health assessment method according to claim 11, wherein the electronic device case (EDC) comprises a battery configured to supply electrical power to the circuit board.
18. The cardiac health assessment method according to claim 11, wherein the electronic device case (EDC) comprises a lens configured to envelop the camera of the handheld electronic device.
19. The cardiac health assessment method according to claim 11, wherein the computing device is a server configured to: train a classification model to detect an abnormal heart activity arising from a plurality of parameters comprising hypertension, aortic stenosis, aortic regurgitation, mitral stenosis and/or mitral regurgitation; and train a regression model to estimate intracardiac pressure and/or left ventricular ejection fraction.
20. The cardiac health assessment method according to claim 11, wherein the user simultaneously makes a long, continuous and/or droning sound throughout the recording.
21. The cardiac health assessment system according to claim 9, wherein the lens is configured to block external environmental light when the handheld electronic device shines light on the skin of the user, wherein the lens is used to record one or more images of the user's skin, and wherein the one or more images of the user's skin are analyzed with machine learning to provide insights into the cardiac health of the user.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The accompanying drawings illustrate the embodiments of systems, methods, and other aspects of the disclosure. Any person with ordinary skills in the art will appreciate that the illustrated element boundaries (e.g., boxes, groups of boxes, or other shapes) in the figures represent an example of the boundaries. In some examples, one element may be designed as multiple elements, or multiple elements may be designed as one element. In some examples, an element shown as an internal component of one element may be implemented as an external component in another and vice versa. Furthermore, the elements may not be drawn to scale.
[0040] Various embodiments will hereinafter be described in accordance with the appended drawings, which are provided to illustrate, not limit, the scope, wherein similar designations denote similar elements, and in which:
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DETAILED DESCRIPTION
[0052] The present description is best understood with reference to the detailed figures and description set forth herein. Various embodiments of the present system and method have been discussed with reference to the figures. However, those skilled in the art will readily appreciate that the detailed description provided herein with respect to the figures are merely for explanatory purposes, as the present system and method may extend beyond the described embodiments. For instance, the teachings presented and the needs of a particular application may yield multiple alternative and suitable approaches to implement the functionality of any detail of the present systems and methods described herein. Therefore, any approach to implement the present system and method may extend beyond certain implementation choices in the following embodiments.
[0053] According to an embodiment herein, the methods of the present claimed subject matter may be implemented by performing or completing manually, automatically, and/or a combination of thereof. The term “method” refers to manners, means, techniques and procedures for accomplishing any task including, but not limited to, those manners, means, techniques, and procedures either known to the person skilled in the art or readily developed from existing manners, means, techniques and procedures by practitioners of the art to which the present invention belongs. The persons skilled in the art will envision many other possible variations within the scope of the present system and method described herein.
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[0056] The microcontroller transmits cardiac health data received from the plurality of electrodes 104, 106, and 108, the microphonic sensor 202, and the IMU sensor 206 to at least one of the handheld electronic device 112 and a computing device such as a server 306 (shown in
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[0058] In an embodiment, the server 306 trains a classification model to detect an abnormal heart activity arising from a plurality of parameters comprising hypertension, aortic stenosis, aortic regurgitation, mitral stenosis, and/or mitral regurgitation. The server 306 may further train a regression model to estimate intracardiac pressure and/or left ventricular ejection fraction. According to an embodiment herein, the server 306 is configured to train the classifier model and/or the regression model based on the identified data relationships in a secure database; receive a representation of the inertial measurement unit (IMU) sensor, and/or electrode and/or microphonic sensor signal recorded by the electronic device case (EDC) during temporal windows; detect the features of said sensors in at least some of the portions of the representation falling within each of the temporal windows; use the trained classifier model and/or regression model to identify patterns of said sensor features within the portions of said sensor signals; for each of the portions, calculate a probability of whether the portion of the representation within said sensor signals is associated with a patient experiencing cardiac health problems and/or estimating cardiac measurement values; and take an action based on the score.
[0059] In an embodiment, the processor is configured to transmit the data indicative of cardiac function from the handheld electronic device 112 to a server 306 over a network; and store the data in the server 306 for subsequent analysis by a clinician. Examples of the network could be a combination of a local area network and a wide area network, such as the Internet, through a physical or a wireless connection, for example, Bluetooth. In an embodiment, the processor is configured to transmit the data indicative of cardiac function from the handheld electronic device 112 to a clinician computing device 308 via the Internet, for remote diagnostic analysis using ML. In an embodiment, the clinician computing device 308 performs risk analysis and present in the mobile application of the handheld electronic device 112 in a suitable/presentable format. In an embodiment, the classification model is trained to detect abnormal heart activity arising from one or more cardiac health conditions comprising coronary artery disease and heart arrhythmias. In an embodiment, the microcontroller utilizes a pre-trained de-noising algorithm, for example using a machine learning library such as TensorFlow Lite.
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[0062] In an embodiment, the handheld electronic device comprises a processor to execute a plurality of instructions pertaining to a cardiac monitoring application, wherein the processor is configured to display one or more commands to position the electronic device case (EDC) against the chest of the user. In an embodiment, the server is configured to train a classification model to detect an abnormal heart activity arising from a plurality of parameters comprising hypertension, aortic stenosis, aortic regurgitation, mitral stenosis and/or mitral regurgitation; and train a regression model to estimate intracardiac pressure and/or left ventricular ejection fraction. In an embodiment, the classification model is trained to detect abnormal heart activity arising from coronary artery disease and/or heart arrhythmias.
[0063] The present cardiac health assessment system and method may include more than three different types of sensors employing different technologies as presented herein, which furthermore allows for robustness across different recording environments and patient cohorts. In one example of this, in a noisy environment, one might rely more heavily on visual or seismic sensors, whereas in a patient with darker skin where light is less able to penetrate adequately, one might rely more heavily on sensors pertaining to audio or electrophysiological sensors.
[0064] According to an embodiment herein, the present cardiac health assessment system and method provide an ability to operate the electronic device case (EDC) without a battery and through direct power from an electronic device improves on existing products of cardiac health assessment in several ways. Such a configuration allows for more space, and therefore larger and more powerful sensors may be used in the invention, further enhancing data collection quality and accuracy. The absence of a battery may furthermore reduce the amount of electrical interference inherent to the EDC's sensors. This allows for a more powerful device, removing the necessity of having multiple devices in order to be able to identify different cardiac conditions. Through having one device that is able to accurately analyze a number of the cardiac conditions instead of just a few, the patient experience is substantially improved, potentially increasing the patient's ease and willingness of carrying out monitoring on a regular basis.
[0065] The utilization of a handheld electronic device (HED) to use the EDC furthermore improves the accuracy of the EDC in one or more ways. Using the HED's internal accelerometer and microphone sensors, external data noise pertaining to both movement and sound can be measured. Such measurement can be of aid in the process of removing noise from the data so that the analysis can be made on data that is most relevant to conditions pertaining to cardiac health.
[0066] With increased electronic device usage globally, particularly with regard to smartphones, an EDC as presented herein is likely to substantially simplify the self-monitoring process for the patient. The present cardiac health assessment system and method are designed to always be carried with the patient, for example in the form as a protective case for a smartphone. Having one device instead of multiple for the purpose of cardiac self-monitoring likely reduces the propensity to misplace said device and having the ability to rely on the battery power of the electronic device further increases the likelihood of the device being charged at the right times. It further simplifies the ability to record at standardized time intervals. For example, a patient may use a handheld electronic device's internal alarm clock which might simultaneously remind and prompt the patient to do their cardiac health assessment recording using the EDC. Having the recording carried out at approximately the same time each day may further simplify the data analysis by being able to compare more similar recording environments. This may standardize the data collection process and consequently help reduce data noise.
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[0069] In some embodiments of the invention, the data collected through the EDC may be combined with data from a wearable electronic device. By combining data from other sources, such as a wearable sensor on the wrist of a patient, one may further enhance accuracy, for example by having the ability to calculate pulse transit time, and compare data between different parts of the body at the same time. Such combinations may further diversify the type of data and add robustness to the data collection process by combining a broader variety of sensor technologies such as but not limited to photoplethysmography. In some embodiments of the invention, the EDC may be equipped with a wireless charging station to allow for wireless charging of other devices/wearables. A battery-less wearable may be connected to the EDC and used to simultaneously record data, drawing power from the EDC.
[0070] Upon completing the data recording from the patient, the data may be analyzed in the connected electronic device or uploaded to a server for further analysis there. Said data analysis includes but is not limited to machine learning-based methods to classify whether or not certain cardiac conditions such as but not limited to, hypertension, reduced left ventricular ejection fraction, heart arrhythmias, aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation and/or coronary artery disease was present. The data analysis portion may furthermore be comprised of estimating cardiac pressure and the heart's left ventricular ejection fraction. The machine learning methods may include but are not limited to decision tree-based machine learning methods, artificial neural networks, convolutional neural networks, logistic regression, naive Bayes, nearest neighbor, support vector machines, and boosted tree learning methods.
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[0073] Unless otherwise defined, all terms (including technical and scientific terms) used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It is to be understood that the phrases or terms employed of the present invention is for the purpose of description and not of limitation. As will be appreciated by one of skill in the art, the present disclosure may be embodied as a device, system, and method or computer program product. Further, the present invention may take the form of a computer program product on a computer-readable storage medium having computer-usable program code embodied in the medium. The present systems and methods have been described above with reference to specific examples. However, other embodiments and examples than the above description are equally possible within the scope of the present invention. The scope of the disclosure may only be limited by the appended patent claims. Even though modifications and changes may be suggested by the persons skilled in the art, it is the intention of the inventors and applicants to embody within the patent warranted heron all the changes and modifications as reasonably and properly come within the scope of the contribution the inventors and applicants to the art. The scope of the embodiments of the present invention is ascertained with the claims to be submitted at the time of filing the complete specification.