# US 2021/0241455 A1 · Systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking

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- Number: US 2021/0241455 A1
- Document ID: US20210241455A1
- Status: Published application
- Kind: A1
- Application number: 17/214,593
- Filed: 2021-03-26
- Published: 2021-08-05
- Earliest claimed: 2020-01-07
- Assignees: Cleerly, Inc.
- Applicants: Cleerly, Inc.
- Inventors: JAMES K. MIN; JAMES P. EARLS; HUGO MIGUEL RODRIGUES MARQUES
- Web page: https://patentgrep.com/patent/US20210241455A1

## CPC

- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 5/0066: {Optical coherence imaging}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7267: {involving training the classification device}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/7475: {User input or interface means, e.g. keyboard, pointing device, joystick}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/037: {Emission tomography}
- A61B 6/463: {characterised by displaying multiple images or images and diagnostic data on one display}
- A61B 6/467: {characterised by special input means}
- A61B 6/481: {involving the use of contrast agents}
- A61B 6/5205: {involving processing of raw data to produce diagnostic data}
- A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data}
- A61B 6/583: {using calibration phantoms}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/14: Echotomography
- A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)}
- A61K 49/04: X-ray contrast preparations
- G06F 18/10: Pre-processing; Data cleansing
- G06F 18/22: Matching criteria, e.g. proximity measures
- G06F 18/2413: based on distances to training or reference patterns
- G06T 7/0012: {Biomedical image inspection}
- G06V 10/20: Image preprocessing
- G06V 10/245: {by locating a pattern; Special marks for positioning}
- G06V 10/761: {Proximity, similarity or dissimilarity measures}
- G06V 10/764: using classification, e.g. of video objects
- G06V 10/82: using neural networks
- A61B 5/004: {adapted for image acquisition of a particular organ or body part (A61B5/0082 takes precedence; arrangements for optical scanning A61B5/0062)}
- A61B 5/1076: {for measuring dimensions inside body cavities, e.g. using catheters (A61B3/1005 takes precedence)}
- A61B 8/587: {Calibration phantoms}
- G06T 2207/10081: Computed x-ray tomography [CT]
- G06T 2207/10088: Magnetic resonance imaging [MRI]
- G06T 2207/10101: Optical tomography; Optical coherence tomography [OCT]
- G06T 2207/10104: Positron emission tomography [PET]
- G06T 2207/10108: Single photon emission computed tomography [SPECT]
- G06T 2207/10116: X-ray image
- G06T 2207/10132: Ultrasound image
- G06T 2207/20081: Training; Learning
- G06T 2207/20084: Artificial neural networks [ANN]
- G06T 2207/20101: Interactive definition of point of interest, landmark or seed
- G06T 2207/30048: Heart; Cardiac
- G06T 2207/30101: Blood vessel; Artery; Vein; Vascular
- G06V 10/247: {by affine transforms, e.g. correction due to perspective effects; Quadrilaterals, e.g. trapezoids}
- G06V 2201/03: Recognition of patterns in medical or anatomical images
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- G06V: IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The disclosure herein relates to systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking. In some embodiments, the systems, devices, and methods described herein are configured to analyze non-invasive medical images of a subject to automatically and/or dynamically identify one or more features, such as plaque and vessels, and/or derive one or more quantified plaque parameters, such as radiodensity, radiodensity composition, volume, radiodensity heterogeneity, geometry, location, and/or the like. In some embodiments, the systems, devices, and methods described herein are further configured to generate one or more assessments of plaque-based diseases from raw medical images using one or more of the identified features and/or quantified parameters.

## Claims

### Claim 1

A computer-implemented method of characterizing a change in coronary calcium based on image analysis of one or more medical images of a coronary region of a subject, the method comprising:
accessing, by a computer system, a first coronary calcium level of the subject and a first set of plaque parameters associated with the coronary region of the subject, the first coronary calcium level and the first set of parameters obtained at a first point in time, wherein the first set of plaque parameters comprises a ratio or function of volume or surface area, heterogeneity index, geometry, and radiodensity of one or more regions of plaque within the coronary region of the subject at the first point in time;
generating, by the computer system, a first weighted measure of the accessed first set of plaque parameters;
accessing, by the computer system, a second coronary calcium level of the subject and one or more medical images of the coronary region of the subject, the second coronary calcium level and the one or more medical images obtained at a second point in time, wherein the one or more medical images of the coronary region of the subject comprises the one or more regions of plaque;
determining, by the computer system, a change in coronary calcium level of the subject between the first point in time and the second point in time by comparing the first coronary calcium level and the second coronary calcium level;
identifying, by the computer system, the one or more regions of plaque from the one or more medical images;
determining, by the computer system, a second set of plaque parameters associated with the coronary region of the subject by analyzing the one or more regions of plaque from the one or more medical images, wherein the second set of plaque parameters comprises a ratio or function of volume or surface area, heterogeneity index, geometry, and radiodensity of the one or more regions of plaque at the second point in time;
generating, by the computer system, a second weighted measure of the determined second set of plaque parameters;
analyzing, by the computer system, a change between the first weighted measure of the accessed first set of plaque parameters and the second weighted measure of the determined second set of plaque parameters; and
characterizing, by the computer system, the change in coronary calcium level of the subject between the first point in time and the second point in time as one of positive, neutral, or negative based at least in part on the analyzed change between the first weighted measure of the accessed first set of plaque parameters and the second weighted measure of the determined second set of plaque parameters,
wherein the computer system comprises a computer processor and an electronic storage medium.

### Claim 2 (depends on 1)

The computer-implemented method of claim 1, further comprising generating, by the computer system, a proposed treatment for the subject based at least in part on the characterized change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 3 (depends on 1)

The computer-implemented method of claim 1, wherein the first set of plaque parameters further comprises location of the one or more regions of plaque within the coronary region of the subject at the first point in time, and wherein the second set of plaque parameters further comprises location of the one or more regions of plaque within the coronary region of the subject at the second point in time.

### Claim 4 (depends on 1)

The computer-implemented method of claim 1, wherein a decrease in a ratio of volume to surface area of the one or more regions of plaque between the first point in time and the second point in time is indicative of a positive characterization of the change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 5 (depends on 1)

The computer-implemented method of claim 1, wherein a decrease in the heterogeneity index of the one or more regions of plaque between the first point in time and the second point in time is indicative of a positive characterization of the change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 6 (depends on 1)

The computer-implemented method of claim 1, wherein the heterogeneity index of the one or more regions of plaque is determined by generating a spatial mapping of radiodensity values within the one or more regions of plaque.

### Claim 7 (depends on 1)

The computer-implemented method of claim 1, wherein the heterogeneity index of the one or more regions of plaque is determined by generating a three-dimensional histogram of radiodensity values within a geometric shape of the one or more regions of plaque.

### Claim 8 (depends on 1)

The computer-implemented method of claim 1, wherein the heterogeneity index of the one or more regions of plaque is determined by generating a mathematical transform of radiodensity values within a geometric shape of the one or more regions of plaque.

### Claim 9 (depends on 1)

The computer-implemented method of claim 1, further comprising determining, by the computer system, a change in a ratio or function of volume and radiodensity of the one or more regions of plaque between the first point in time and the second point in time, wherein the change in coronary calcium level of the subject is further characterized based at least in part the determined change in the ratio or function of volume and radiodensity of one or more regions between the first point in time and the second point in time.

### Claim 10 (depends on 1)

The computer-implemented method of claim 1, wherein the change in coronary calcium level of the subject is characterized for one or more of a vessel, segment, or region of plaque within the coronary region of the subject.

### Claim 11 (depends on 1)

The computer-implemented method of claim 1, wherein the change in coronary calcium level of the subject is characterized for a vessel segment within the coronary region of the subject.

### Claim 12 (depends on 1)

The computer-implemented method of claim 1, wherein the change in coronary calcium level of the subject is characterized for one of the one or more regions of plaque within the coronary region of the subject.

### Claim 13 (depends on 1)

The computer-implemented method of claim 1, wherein the first set of plaque parameters and the second set of plaque parameters further comprise a diffuseness of the one or more regions of plaque.

### Claim 14 (depends on 1)

The computer-implemented method of claim 1, further comprising:
analyzing, by the computer system, the one or more medical images of the coronary region of the subject to identify one or more new regions of plaque, wherein the one or more regions of plaque do not comprise the one or more new regions of plaque; and
characterizing, by the computer system, the change in coronary calcium level of the subject between the first point in time and the second point in time further based at least in part on the analysis to identify one or more new regions of plaque, wherein identification of one or more new regions of plaque is indicative of a negative characterization of the change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 15 (depends on 1)

The computer-implemented method of claim 1, wherein the second coronary calcium level of the subject is determined by analyzing, by the computer system, the one or more medical images of the coronary region of the subject.

### Claim 16 (depends on 1)

The computer-implemented method of claim 1, wherein the one or more medical images of the coronary region of the subject comprises an image obtained from a non-contrast Computed Tomography (CT) scan.

### Claim 17 (depends on 1)

The computer-implemented method of claim 1, wherein the one or more medical images of the coronary region of the subject comprises an image obtained from a contrast-enhanced CT scan.

### Claim 18 (depends on 1)

The computer-implemented method of claim 1, wherein a positive characterization of the change in coronary in coronary calcium score is indicative of plaque stabilization.

### Claim 19 (depends on 1)

The computer-implemented method of claim 1, wherein the change in coronary calcium level of the subject is characterized by a machine learning algorithm utilized by the computer system.

### Claim 20 (depends on 1)

The computer-implemented method of claim 1, wherein the first weighted measure is generated by weighting the accessed first set of plaque parameters logarithmically or algebraically.

### Claim 21

A system for characterizing a change in coronary calcium based on image analysis of one or more medical images of a coronary region of a subject, the system comprising:
one or more computer readable storage devices configured to store a plurality of computer executable instructions; and
one or more hardware computer processors in communication with the one or more computer readable storage devices and configured to execute the plurality of computer executable instructions in order to cause the system to:
access a first coronary calcium level of the subject and a first set of plaque parameters associated with the coronary region of the subject, the first coronary calcium level and the first set of parameters obtained at a first point in time, wherein the first set of plaque parameters comprises a ratio or function of volume or surface area, heterogeneity index, geometry, and radiodensity of one or more regions of plaque within the coronary region of the subject at the first point in time;
generate a first weighted measure of the accessed first set of plaque parameters;
access a second coronary calcium level of the subject and one or more medical images of the coronary region of the subject, the second coronary calcium level and the one or more medical images obtained at a second point in time, wherein the one or more medical images of the coronary region of the subject comprises the one or more regions of plaque;
determine a change in coronary calcium level of the subject between the first point in time and the second point in time by comparing the first coronary calcium level and the second coronary calcium level;
identify the one or more regions of plaque from the one or more medical images;
determine a second set of plaque parameters associated with the coronary region of the subject by analyzing the one or more regions of plaque from the one or more medical images, wherein the second set of plaque parameters comprises a ratio or function of volume or surface area, heterogeneity index, geometry, and radiodensity of the one or more regions of plaque at the second point in time;
generate a second weighted measure of the determined second set of plaque parameters;
analyzes a change between the first weighted measure of the accessed first set of plaque parameters and the second weighted measure of the determined second set of plaque parameters; and
characterize the change in coronary calcium level of the subject between the first point in time and the second point in time as one of positive, neutral, or negative based at least in part on the analyzed change between the first weighted measure of the accessed first set of plaque parameters and the second weighted measure of the determined second set of plaque parameters.

### Claim 22 (depends on 21)

The system of claim 21, wherein the system is further caused to generate a proposed treatment for the subject based at least in part on the characterized change in coronary calcium level of the subject between the first point in time and the second point in time

### Claim 23 (depends on 21)

The system of claim 21, wherein a decrease in a ratio of volume to surface area of the one or more regions of plaque between the first point in time and the second point in time is indicative of a positive characterization of the change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 24 (depends on 21)

The system of claim 21, wherein a decrease in the heterogeneity index of the one or more regions of plaque between the first point in time and the second point in time is indicative of a positive characterization of the change in coronary calcium level of the subject between the first point in time and the second point in time.

### Claim 25 (depends on 21)

The system of claim 21, wherein the heterogeneity index of the one or more regions of plaque is determined by generating a spatial mapping of radiodensity values within the one or more regions of plaque.

### Claim 26 (depends on 21)

The system of claim 21, wherein the heterogeneity index of the one or more regions of plaque is determined by generating a three-dimensional histogram of radiodensity values within a geometric shape of the one or more regions of plaque.

### Claim 27 (depends on 21)

The system of claim 21, wherein the system is further caused to determine a change in a ratio or function of volume and radiodensity of the one or more regions of plaque between the first point in time and the second point in time, wherein the change in coronary calcium level of the subject is further characterized based at least in part the determined change in the ratio or function of volume and radiodensity of one or more regions between the first point in time and the second point in time.

### Claim 28 (depends on 21)

The system of claim 21, wherein the change in coronary calcium level of the subject is characterized by a machine learning algorithm.

### Claim 29 (depends on 21)

The system of claim 21, wherein a positive characterization of the change in coronary in coronary calcium score is indicative of plaque stabilization.