# US 2021/0241913 A1 · Machine learning system for assessing heart valves and surrounding cardiovascular tracts

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- Number: US 2021/0241913 A1
- Document ID: US20210241913A1
- Status: Published application
- Kind: A1
- Application number: 17/238,684
- Filed: 2021-04-23
- Published: 2021-08-05
- Earliest claimed: 2013-10-23
- Assignees: Stenomics, Inc.
- Applicants: Stenomics, Inc.
- Inventors: Michael A. SINGER
- Web page: https://patentgrep.com/patent/US20210241913A1

## CPC

- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 5/7253: {characterised by using transforms}
- A61B 5/7267: {involving training the classification device}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- G06F 17/11: for solving equations {, e.g. nonlinear equations, general mathematical optimization problems (optimization specially adapted for a specific administrative, business or logistic context G06Q10/04)}
- G06N 5/04: Inference or reasoning models
- G16H 50/50: for simulation or modelling of medical disorders
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06N: COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

A machine learning system for evaluating at least one characteristic of a heart valve, an inflow tract, an outflow tract or a combination thereof may include a training mode and a production mode. The training mode may be configured to train a computer and construct a transformation function to predict an unknown anatomical characteristic and/or an unknown physiological characteristic of a heart valve, inflow tract and/or outflow tract, using a known anatomical characteristic and/or a known physiological characteristic the heart valve, inflow tract and/or outflow tract. The production mode may be configured to use the transformation function to predict the unknown anatomical characteristic and/or the unknown physiological characteristic of the heart valve, inflow tract and/or outflow tract, based on the known anatomical characteristic and/or the known physiological characteristic of the heart valve, inflow tract and/or outflow tract.

## Claims

### Claim 1

A computer-implemented method for evaluating at least one characteristic of a heart valve, an inflow tract, an outflow tract or a combination thereof the method comprising:
(a) predicting, with a transformation function on a computer, at least one of an unknown anatomical characteristic or an unknown physiological characteristic of at least one of a heart valve, an inflow tract or an outflow tract, using at least one of a known anatomical characteristic or a known physiological characteristic of the at least one heart valve, inflow tract or outflow tract, wherein said at least one of said heart valve, said inflow tract, and said outflow tract includes at least one of said heart valve, a heart ventricle, and a heart atrium; and
(b) using a production mode of a system on the computer to direct the transformation function and one or more feature vectors, to predict at least one of unknown anatomical characteristic or unknown physiological characteristic of at least one production heart valve, production inflow tract or production outflow tract, based on at least one of patient specific patient known anatomical characteristic or patient known physiological characteristic of the at least one production heart valve, production inflow tract or production outflow tract, wherein said at least one of said production heart valve, said production inflow tract, said production outflow tract includes at least one of said production heart valve, a production heart ventricle, and a production heart atrium, to generate at least one or more quantities of interest.

### Claim 2 (depends on 1)

A method as in claim 1 further maintaining, in said at least one or more feature vectors on the computer, the at least one patient known anatomical characteristic or patient known physiological characteristic of the at least one production heart valve, production inflow tract or production outflow tract.

### Claim 3 (depends on 2)

A method as in claim 2 further comprising using the computer to calculate an approximate blood flow through the at least one production heart valve, production inflow tract or production outflow tract.

### Claim 4 (depends on 2)

A method as in claim 2, further comprising using the computer to store in at least one of said one or more feature vectors quantities associated with an approximate blood flow through the at least one production heart valve, production inflow tract or production outflow tract.

### Claim 5 (depends on 2)

A method as in claim 2, further comprising using the computer to perturb the at least one patient known anatomical characteristic or patient known physiological characteristic of the at least one production heart valve, production inflow tract or production outflow tract stored in the at least one of said one or more feature vectors.

### Claim 6 (depends on 5)

A method as in claim 5, further comprising using the computer to calculate a new approximate blood flow through the at least one production heart valve, production inflow tract or production outflow tract with the perturbed at least one known patient anatomical characteristic or patient known physiological characteristic.

### Claim 7 (depends on 5)

A method as in claim 5, further comprising using the computer to store quantities associated with a new approximate blood flow through the perturbed at least one production heart valve, production inflow tract or production outflow tract in said one or more feature vectors.

### Claim 8 (depends on 7)

A method as in claim 7, further comprising using the computer to repeat said perturbing and said storing to create at least one of (a) one or more feature vectors and (b) one or more quantity vectors.

### Claim 9 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to apply the transformation function to the one or more feature vectors.

### Claim 10 (depends on 9)

A method as in claim 9, further comprising the production mode using the computer to generate the one or more quantities of interest.

### Claim 11 (depends on 10)

A method as in claim 10, further comprising the production mode using the computer to store the one or more quantities of interest.

### Claim 12 (depends on 11)

A method as in claim 11, further comprising the production mode using the computer to process the quantities of interest to provide data for use in at least one of evaluation, diagnosis, prognosis, risk, treatment and treatment planning related to at least one of the production heart valve, production inflow tract, and production outflow tract.

### Claim 13 (depends on 12)

A method as in claim 12 further comprising using said data to at least one of (1) guide clinical decision-making, (2) provide predictive information about disease progression, (3) provide information for risk stratification, (4) patient monitoring, (5) conducting sensitivity analyses, (6) evaluating an anatomic scenario, (7) evaluating a physiologic scenario, (8) evaluating a hemodynamic scenario, (9) estimating response to therapy, and (10) developing understanding of cardiac health.

### Claim 14 (depends on 1)

A method as in claim 1 wherein said computer-implemented method includes a computed tomography device.

### Claim 15 (depends on 1)

A method as in claim 1 wherein said computer-implemented method includes a magnetic resonance imaging device.

### Claim 16 (depends on 1)

A method as in claim 1 wherein said computer-implemented method includes an ultrasound imaging device.

### Claim 17 (depends on 1)

A method as in claim 1 wherein said system comprises a Doppler device.

### Claim 18 (depends on 1)

A method as in claim 1 wherein said system comprises an electrophysiologic device.

### Claim 19 (depends on 1)

A method as in claim 1 wherein said system comprises clinical instruments.

### Claim 20 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to process the quantities of interest to provide data for use in at least one of evaluation, diagnosis, prognosis, risk, treatment and treatment planning related to at least one of the production heart valve, production inflow tract, and production outflow tract.

### Claim 21 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to provide data for use in at least one of the construction and execution of a computer-based model of at least one of cardiac anatomy and physiology.

### Claim 22 (depends on 1)

A method as in claim 1 further comprising:
(a) using a training mode of a system on the computer to train said computer and construct said transformation function based upon a plurality of images to predict said at least one of said unknown anatomical characteristic or said unknown physiological characteristic of at least one of said heart valve, said inflow tract or said outflow tract, using at least one of said known anatomical characteristic or said known physiological characteristic of the at least one heart valve, inflow tract or outflow tract;
(b) wherein said known anatomical characteristic or said known physiological characteristic of the at least one heart valve, inflow tract or outflow tract includes at least one of size, shape, and flow characteristics.

### Claim 23 (depends on 22)

A method as in claim 22 wherein said transformation function is based upon at least one morphological simplification that exploits underlying geometric features.

### Claim 24 (depends on 22)

A method as in claim 22 wherein said known anatomical characteristic or said known physiological characteristic of the at least one heart valve, inflow tract or outflow tract characterizes calcification.

### Claim 25 (depends on 24)

A method as in claim 24 wherein said characterizes calcification includes location of calcification.

### Claim 26 (depends on 24)

A method as in claim 24 wherein said characterizes calcification includes extent of calcification.

### Claim 27 (depends on 24)

A method as in claim 24 wherein said characterizes calcification includes size of calcification.

### Claim 28 (depends on 24)

A method as in claim 24 wherein said characterizes calcification includes degree of calcification.

### Claim 29 (depends on 22)

A method as in claim 22, further comprising the training mode using the computer to store in said at least one of said one or more feature vectors which are representative of the at least one known anatomical characteristic or known physiological characteristic of the at least one heart valve, inflow tract or outflow tract.

### Claim 30 (depends on 29)

A method as in claim 29, further comprising the training mode using the computer to calculate an approximate blood flow through the at least one heart valve, inflow tract or outflow tract.

### Claim 31 (depends on 29)

A method as in claim 29, further comprising the training mode using the computer to store quantities associated with an approximate blood flow through the at least one heart valve, inflow tract or outflow tract in at least one or more feature vectors.

### Claim 32 (depends on 29)

A method as in claim 29, further comprising the training mode using the computer to perturb the at least one known anatomical characteristic or known physiological characteristic of the at least one heart valve, inflow tract or outflow tract stored in at least one of said one or more feature vectors.

### Claim 33 (depends on 32)

A method as in claim 32, further comprising the training mode using the computer to calculate a new approximate blood flow through the at least one heart valve, inflow tract or outflow tract with the perturbed at least one known anatomical characteristic or known physiological characteristic.

### Claim 34 (depends on 33)

A method as in claim 33, further comprising the training mode using the computer to store quantities associated with a new approximate blood flow through the perturbed at least one heart valve, inflow tract or outflow tract.

### Claim 35 (depends on 34)

A method as in claim 34, further comprising the training mode using the computer to repeat said perturbing and said storing to create at least one of feature vectors and quantity vectors.

### Claim 36 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes hemodynamic data.

### Claim 37 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes patient data.

### Claim 38 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes the location of the at least one production heart valve, production inflow tract or production outflow tract.

### Claim 39 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes qualitative information of the at least one production heart valve, production inflow tract or production outflow tract.

### Claim 40 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes quantitative information of the at least one production heart valve, production inflow tract or production outflow tract for use in evaluating valvular anatomy.

### Claim 41 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to generate the one or more quantities of interest that includes quantitative information of the at least one production heart valve, production inflow tract or production outflow tract for use in evaluating physiology.

### Claim 42 (depends on 1)

A method as in claim 1 wherein said transformation function characterizes discretized surface elements.

### Claim 43 (depends on 1)

A method as in claim 1 wherein said transformation function characterizes discretized volume elements.

### Claim 44 (depends on 1)

A method as in claim 1 wherein any of said unknown anatomic characteristic is an unknown geometrical anatomic characteristic.

### Claim 45 (depends on 1)

A method as in claim 1 wherein said transformation is a multi-dimensional transformation function.

### Claim 46 (depends on 1)

A method as in claim 1 wherein said transformation is a one-dimensional transformation function.

### Claim 47 (depends on 1)

A method as in claim 1, further comprising using the computer to perform the following steps:
(a) receiving patient-specific data selected from the group consisting of anatomic data, physiologic data, and hemodynamic data;
(b) generating a digital model of the at least one production heart valve, production inflow tract or production outflow tract, based on the received data;
(c) discretizing the digital model;
(d) applying boundary conditions to at least one inflow portion and at least one outflow portion of the digital model; and
(e) initializing and solving mathematical equations of blood flow through the digital model.

### Claim 48 (depends on 47)

A method as in claim 47, further comprising the computer storing quantities and parameters that characterize at least one of an anatomic state or a physiologic state of the digital model and the blood flow.

### Claim 49 (depends on 47)

A method as in claim 47, further comprising the computer perturbing at least one of an anatomic parameter or a physiologic parameter that characterizes the digital model.

### Claim 50 (depends on 49)

A method as in claim 49, further comprising the computer at least one of re-discretizing or re-solving the mathematical equations with the at least one anatomic parameter or physiologic parameter.

### Claim 51 (depends on 50)

A method as in claim 50, further comprising the computer storing quantities and parameters that characterize at least one of the anatomic state or the physiologic state of the perturbed model and blood flow.

### Claim 52 (depends on 1)

A method as in claim 1, further comprising the production mode using the computer to receive one or more feature vectors.

### Claim 53 (depends on 52)

A method as in claim 52, further comprising the production mode using the computer to apply the transformation function to the feature vectors.

### Claim 54 (depends on 53)

A method as in claim 53, further comprising the production mode using the computer to generate one or more quantities of interest.

### Claim 55 (depends on 54)

A method as in claim 54, further comprising the production mode using the computer to process the quantities of interest to provide data for use in at least one of evaluation, diagnosis, prognosis, treatment or treatment planning related to a heart in which the at least one production heart valve, production inflow tract or production outflow tract resides.
