# US 2023/0147336 A1 · Systems, methods, and devices for medical image analysis, diagnosis, risk stratification, decision making and/or disease tracking

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- Number: US 2023/0147336 A1
- Document ID: US20230147336A1
- Status: Published application
- Kind: A1
- Application number: 18/148,712
- Filed: 2022-12-30
- Published: 2023-05-11
- 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/US20230147336A1

## 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 system for tracking post-treatment progression of coronary artery disease (CAD) based on medical image analysis of a medical image of a subject to facilitate determination of continued treatment for CAD for the 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 distribution of density values corresponding to one or more regions of plaque in one or more regions of one or more coronary arteries of a subject, wherein the first distribution of density values is generated from analyzing a first medical image of the subject comprising the one or more regions of the one or more coronary arteries, the first medical image of the subject obtained at a first point in time;
access a second medical image of the subject, the second medical image of the subject obtained at a second point in time after treatment or deferring treatment the subject with a treatment for CAD, the treatment comprising one or more of pharmaceutical treatment, lifestyle change, or surgery, the second point in time being later than the first point in time, the second medical image of the subject comprising the one or more regions of the one or more coronary arteries of the subject;
identify the one or more regions of the one or more coronary arteries of the subject from the first medical image in the second medical image;
analyze the second medical image to generate a second distribution of density values corresponding to the one or more regions of plaque in the one or more regions of the one or more coronary arteries of the subject;
determine a post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque, wherein an increase in density values above a first predetermined threshold is indicative of progression of CAD, wherein an increase in density values above a second predetermined threshold is indicative of progression of CAD, and wherein an increase in density values above a third predetermined threshold is indicative of stabilization of CAD; and
generate a graphical representation comprising the determined post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque, wherein the graphical representation is configured to facilitate determination of a state of CAD progression, regression, or stabilization based at least in part on the determined change in post-treatment total plaque volume, non-calcified plaque volume, and calcified plaque volume, and wherein the determination of the state of CAD progression, regression, or stabilization is configured to facilitate determination of continued treatment for CAD for the subject.

### Claim 2 (depends on 1)

The system of claim 1, wherein the density values comprise radiodensity values.

### Claim 3 (depends on 1)

The system of claim 1, wherein the density values comprise material density values.

### Claim 4 (depends on 1)

The system of claim 1, wherein the graphical representation comprises one or more of a post-treatment increase in density values above the first predetermined threshold, a post-treatment increase in density values above the second predetermined threshold, and a post-treatment increase in density values above the third predetermined threshold.

### Claim 5 (depends on 4)

The system of claim 4, wherein the post-treatment increase in density values above the first predetermined threshold, the post-treatment increase in density values above the second predetermined threshold, and the post-treatment increase in density values above the third predetermined threshold comprises a difference in absolute volume.

### Claim 6 (depends on 1)

The system of claim 1, wherein the post-treatment increase in density values above the first predetermined threshold, the post-treatment increase in density values above the second predetermined threshold, and the post-treatment increase in density values above the third predetermined threshold comprises a percentage difference.

### Claim 7 (depends on 1)

The system of claim 1, wherein the graphical representation comprises simultaneous display of a post-treatment increase in density values above the first predetermined threshold, a post-treatment increase in density values above the second predetermined threshold, and a post-treatment increase in density values above the third predetermined threshold.

### Claim 8 (depends on 1)

The system of claim 1, wherein the system is further caused to generate a patient-specific report based at least in part on the determined post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque.

### Claim 9 (depends on 1)

The system of claim 1, wherein the post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque is determined on one or more of a patient, vessel, segment, or lesion level.

### Claim 10 (depends on 1)

The system of claim 1, wherein post-treatment stabilization of density values above the first predetermined threshold between the first point in time and the second point in time is indicative of stabilization of CAD.

### Claim 11 (depends on 1)

The system of claim 1, wherein post-treatment increase in density values above the third predetermined threshold and decrease in density values above the second predetermined threshold between the first point in time and the second point in time is indicative of stabilization of CAD.

### Claim 12 (depends on 1)

The system of claim 1, further comprising generating the continued treatment for CAD for the subject based at least in part on the determined post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque.

### Claim 13 (depends on 1)

The system of claim 1, wherein the graphical representation is configured to be used to assess the treatment for the subject.

### Claim 14 (depends on 1)

The system of claim 1, wherein the system is further caused to:
access a first assessment of ischemia of the one or more regions of the one or more coronary arteries at the first point in time, wherein the first assessment of ischemia is generated based at least in part on the first medical image;
analyze the second medical image to generate an assessment of ischemia of the one or more regions of the one or more coronary arteries at the second point in time;
determine a post-treatment change between the first assessment of ischemia and the second assessment of ischemia; and
generate a graphical representation of the determined post-treatment change between the first assessment of ischemia and the second assessment of ischemia.

### Claim 15 (depends on 14)

The system of claim 14, wherein the assessment of ischemia at the first point in time is generated based at least in part on the first set of quantified plaque parameters.

### Claim 16 (depends on 1)

The system of claim 1, wherein the system is further caused to:
access a first comparison of the first distribution of density values corresponding to the one or more regions of plaque to one or more reference distributions of density values;
generate a second comparison of the second distribution of density values corresponding to the one or more regions of plaque to the one or more reference distributions of density values;
determine a post-treatment change between the first comparison and the second comparison; and
generate a graphical representation of the determined post-treatment change between the first comparison and the second comparison.

### Claim 17 (depends on 1)

The system of claim 1, wherein the medical image is obtained using coronary computed tomography angiography (CCTA).

### Claim 18 (depends on 1)

The system of claim 1, wherein the medical image comprises a non-contrast CT image.

### Claim 19 (depends on 1)

The system of claim 1, wherein the medical image is obtained using an imaging modality comprising one or more of CT, x-ray, ultrasound, echocardiography, MR imaging, optical coherence tomography (OCT), nuclear medicine imaging, positron-emission tomography (PET), single photon emission computed tomography (SPECT), or near-field infrared spectroscopy (NIRS).

### Claim 20 (depends on 1)

The system of claim 1, wherein the second distribution of density values corresponding to the one or more regions of plaque is generated using a machine learning algorithm.

### Claim 21

A computer-implemented method for tracking post-treatment progression of coronary artery disease (CAD) based on medical image analysis of a medical image of a subject to facilitate determination of continued treatment for CAD for the subject, the method comprising:
accessing, by a computer system, a first distribution of density values corresponding to one or more regions of plaque in one or more regions of one or more coronary arteries of a subject, wherein the first distribution of density values corresponding to one or more regions of plaque is generated from analyzing a first medical image of the subject comprising the one or more regions of the one or more coronary arteries, the first medical image of the subject obtained at a first point in time;
accessing, by the computer system, a second medical image of the subject, the second medical image of the subject obtained at a second point in time after treatment or deferring treatment of the subject with a treatment for CAD, the treatment comprising one or more of pharmaceutical treatment, lifestyle change, or surgery, the second point in time being later than the first point in time, the second medical image of the subject comprising the one or more regions of the one or more coronary arteries of the subject;
identifying, by the computer system, the one or more regions of the one or more coronary arteries of the subject from the first medical image in the second medical image;
analyzing, by the computer system, the second medical image to generate a second distribution of density values corresponding to the one or more regions of plaque in the one or more regions of the one or more coronary arteries of the subject;
determining, by the computer system, a post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque, wherein an increase in density values above a first predetermined threshold is indicative of progression of CAD, wherein an increase in density values above a second predetermined threshold is indicative of progression of CAD, and wherein an increase in density values above a third predetermined threshold is indicative of stabilization of CAD; and
generating, by the computer system, a graphical representation comprising the determined post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque, wherein the graphical representation is configured to facilitate determination of a state of CAD progression, regression, or stabilization based at least in part on the determined change in post-treatment total plaque volume, non-calcified plaque volume, and calcified plaque volume, and wherein the determination of the state of CAD progression, regression, or stabilization is configured to facilitate determination of continued treatment for CAD for the subject
wherein the computer system comprises a computer processor and an electronic storage medium.

### Claim 22 (depends on 21)

The computer-implemented method of claim 21, wherein the graphical representation comprises one or more of a post-treatment increase in density values above the first predetermined threshold, a post-treatment increase in density values above the second predetermined threshold, and a post-treatment increase in density values above the third predetermined threshold.

### Claim 23 (depends on 22)

The computer-implemented method of claim 22, wherein the post-treatment increase in density values above the first predetermined threshold, the post-treatment increase in density values above the second predetermined threshold, and the post-treatment increase in density values above the third predetermined threshold comprises a difference in absolute volume.

### Claim 24 (depends on 22)

The computer-implemented method of claim 22, wherein the post-treatment increase in density values above the first predetermined threshold, the post-treatment increase in density values above the second predetermined threshold, and the post-treatment increase in density values above the third predetermined threshold comprises a percentage difference.

### Claim 25 (depends on 21)

The computer-implemented method of claim 21, wherein the graphical representation comprises simultaneous display of a post-treatment increase in density values above the first predetermined threshold, a post-treatment increase in density values above the second predetermined threshold, and a post-treatment increase in density values above the third predetermined threshold.

### Claim 26 (depends on 21)

The computer-implemented method of claim 21, further comprising generating, by the computer system, a patient-specific report based at least in part on the determined post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque.

### Claim 27 (depends on 21)

The computer-implemented method of claim 21, wherein the post-treatment change between the first distribution of density values corresponding to the one or more regions of plaque and the second distribution of density values corresponding to the one or more regions of plaque is determined on one or more of a patient, vessel, segment, or lesion level.

### Claim 28 (depends on 21)

The computer-implemented method of claim 21, wherein stabilization of density values above the first predetermined threshold between the first point in time and the second point in time is indicative of CAD stabilization, and wherein increase in density values above the third predetermined threshold and decrease in density values above the second predetermined threshold between the first point in time and the second point in time is indicative of CAD stabilization.

### Claim 29 (depends on 21)

The computer-implemented method of claim 21, further comprising:
accessing, by the computer system, a first assessment of ischemia of the one or more regions of the one or more coronary arteries at the first point in time, wherein the first assessment of ischemia is generated based at least in part on the first medical image;
analyzing, by the computer system, the second medical image to generate an assessment of ischemia of the one or more regions of the one or more coronary arteries at the second point in time;
determining, by the computer system, a post-treatment change between the first assessment of ischemia and the second assessment of ischemia; and
generating, by the computer system, a graphical representation of the determined post-treatment change between the first assessment of ischemia and the second assessment of ischemia.

### Claim 30 (depends on 21)

The computer-implemented method of claim 21, further comprising:
accessing, by the computer system, a first comparison of the first distribution of density values corresponding to the one or more regions of plaque to one or more reference distributions of density values;
generating, by the computer system, a second comparison of the second distribution of density values corresponding to the one or more regions of plaque to the one or more reference distributions of density values;
determining, by the computer system, a post-treatment change between the first comparison and the second comparison; and
generating, by the computer system, a graphical representation of the determined post-treatment change between the first comparison and the second comparison.