System for classifying arterial image regions and their features and method of operation thereof - Patents.com

Abstract

In part, this disclosure relates to methods and systems suitable for evaluating image data from patients in real time or substantially real time using machine learning (ML) methods and systems. Systems and methods are provided that use machine learning techniques applied to specific problems related to intravascular images with polar representations to improve diagnostic tools for end users, such as cardiologists and imaging professionals. Furthermore, given the use of rotating probes to acquire OCT, IVUS image data, and other imaging data, dealing with the two associated coordinate systems poses challenges. This disclosure addresses these challenges and numerous other challenges related to solving the problem of rapidly imaging and diagnosing patients so that stent placement and other procedures can be performed during a single session in a cath lab.

Description

[Technical field]

[0001] In part, this application relates to imaging arteries and segmenting and characterizing their component parts. Specifically, in some embodiments, this application relates to the application of machine learning to characterizing and / or classifying arterial tissue and associated arterial regions and features of interest.

[0002] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 791,876, filed January 13, 2019, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Optical coherence tomography (OCT) is an interference imaging technique that has widespread applications in ophthalmology, cardiology, gastroenterology, and other medical fields. The ability to view subsurface structures with high resolution through a small diameter fiber optic probe makes OCT particularly useful for minimally invasive imaging of internal tissues and organs. OCT systems can generate images at up to 100 frames per second, allowing imaging of coronary arteries in beating heart arteries within seconds. OCT can be performed in both the time domain (time domain OCT, TD-OCT) and the frequency domain (Fourier domain OCT or optical frequency domain imaging, OFDI). OCT can be used with a variety of other imaging techniques, such as intravascular ultrasound (IVUS), angiography, fluoroscopy, X-ray based imaging systems, and other imaging techniques.

[0004] OCT imaging of each part of a patient's body provides a useful tool for doctors to determine the best type and course of treatment. For example, imaging of coronary arteries with intravascular OCT can reveal the location of stenosis, the presence of vulnerable plaque, or the type of atherosclerotic plaque. This information helps cardiologists choose which treatment will best benefit the patient: medical therapy (e.g., cholesterol-lowering medication), catheter-based treatments such as angioplasty and stenting, or invasive surgical procedures such as coronary artery bypass surgery. In addition to its applications in clinical medicine, OCT is also very useful in drug development in animal studies and clinical trials.

[0005] Normal arteries have a consistent layered structure consisting of the intima, media and adventitia. As a result of the atherosclerotic process, the intima can thicken pathologically and contain plaques composed of various types of tissue, including fibrous matter, proteoglycans, lipids and calcium, as well as macrophages and other inflammatory cells. These tissue types have different optical properties that can be measured by manual measurements and imaging techniques. The plaques considered to be the most pathologically significant are the so-called vulnerable plaques, which have a fibrous cap with an underlying lipid pool.

[0006] In a typical OCT imaging system, a catheter-mounted optical probe is carefully maneuvered to an internal point of interest, such as a coronary vessel. A light beam is then transmitted and the backscattered signal is received through coherent detection using an interferometer. As the probe is scanned through a given line or area, many lines of data can be collected. An image (2D or 3D) is then reconstructed using known techniques. This image is then visually analyzed by a cardiologist to assess pathological features such as vessel wall thickening and plaque composition. Summary of the Invention [Problem to be solved by the invention]

[0007] Since tissue types are identified by their appearance on the screen, errors may occur in the analysis because certain information (such as tissue type) is not easily visible. Various other components or regions of interest regarding arteries, organs, or other body parts of a given patient that are difficult to accurately classify by visual inspection appear in virtually all medical fields. Thus, there is a need for a system and method for detecting various targets in image data and representing these targets to an end user. The present disclosure addresses these and other challenges. [Means for solving the problem]

[0008] A system of one or more computers can be configured to perform specific operations or actions by having installed thereon software, firmware, hardware, or a combination thereof that causes the system to perform actions during operation. One or more computer programs can be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform actions. One general aspect includes a method of assessing coronary arteries using one or more machine learning systems (MLS).

[0009] In one embodiment, the disclosure relates to various method steps, including obtaining a set of image data including frames of polar images, annotating one or more regions or features of interest in each polar image of the set of image data such that each annotated region or feature is a ground truth annotation, training a neural network of a machine learning system using the set of annotated polar images, where each of a plurality of regions in each polar image is identified by a class, inputting the polar image data to the trained neural network, and displaying a predicted output image including color-coded regions, each color corresponding to a class.

[0010] In one embodiment, the system includes one or more AI processors with associated memory, and one or more trained software-based neural networks execute on the one or more AI processors. The machine learning system may include a convolutional neural network. The method may include obtaining a set of image data, such as arterial image data. In one embodiment, the image data includes intravascular image data. In one embodiment, the image data includes polar images. The method may include annotating one or more regions or features of interest in each polar image of the set of images, such that each annotated region or feature is a ground truth annotation. The ground truth annotations may be stored in memory as a set of ground truth masks. The method may include training a neural network of the machine learning system using the set of annotated polar images, such as through the set of ground truth masks. In one embodiment, one ground truth mask includes a region of interest that corresponds to a particular feature or channel.

[0011] Thus, a first region of the ground truth mask can correspond to a first feature and a second region of the ground truth mask can correspond to a second feature. This correspondence can be applied to M features and P regions, with each feature corresponding to one or more regions. As an example, two or more regions of calcium, lumen, and intima can be part of one ground truth mask and their classification by class or type is calcium, lumen, and intima with each region so classified / segmented. In one embodiment, the ground truth mask is used to train a neural network to detect / predict which regions in input image data from a user correspond to a particular feature or channel. In one embodiment, the method includes inputting image data, such as polar image data, and / or a ground truth mask into the neural network to train the neural network. The neural network is trained for one or more epochs until it can effectively detect multiple features / channels within an error threshold. In one embodiment, the method includes inputting image data, such as polar image data, into a trained neural network and displaying a predicted output image from the machine learning system. In one embodiment, a ground truth image mask is generated in response to annotating a representation of the image in a user interface. In various embodiments, the polar image is annotated in such a user interface. The neural network is implemented in one or more software applications, such as PyTorch, LibTorch, etc., as disclosed herein. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0012] Implementations may include one or more of the following processes or steps: In one embodiment, each image includes a plurality of image data elements relating to the coronary artery. In one embodiment, the annotating is performed using a graphical user interface including user controls for selecting a group of pixels or a two-dimensional boundary that defines a feature of interest. In one embodiment, the training of the neural network is repeated until the output of a cost function is below a threshold, the cost function comparing a predicted output of a machine learning system (MLS) to a ground truth input. In various embodiments, a cross-entropy evaluation is used to measure an error associated with a cost function. The method may further include classifying the one or more regions or features of interest of each polar image as a type or class. In one embodiment, the type or class is selected from the group including intima, media, adventitia, lumen, EEL, IEL, plaque, calcium, calcium plaque. In one embodiment, the image data used with the systems and methods disclosed herein includes carpet view images, scan lines, pixels, 2D images, 3D images, angiogram images, intravascular images, CT scan images, X-ray images, and other images of arteries, veins, organs, or other parts of the circulatory system. The features, regions, channels, classes, etc. can be detected using neural networks trained on them.

[0013] In one embodiment, the feature, region, type and / or class include one or more of a side branch, a lumen, a guidewire, a stent strut, a stent, a jailed stent, a bioresorbable vascular scaffold (BVS), a drug eluting stent (DES), a blooming artifact, a pressure wire, a guidewire, lipid, atherosclerotic plaque, a stenosis, calcium, calcified plaque, calcium containing tissue, a lesion, fat, a malapose stent, an under-inflated stent, an over-inflated stent, a radiopaque marker, a branching angle of an arterial tree, a calibration element of a probe, a doped membrane, an optical scattering particle, a sheath, a doped sheath, a fiducial alignment point, a diameter measure, a calcium arc measure, a thickness of a region or feature of interest, a radial measure, a guide catheter, a shaded area, a guidewire segment, a length, a thickness, and others as disclosed herein.

[0014] In one embodiment, each data element, each image, and each output is stored in a machine-readable memory in electronic communication with the machine learning system. In one embodiment, the set of annotated polar images includes images that include one or more imaging artifacts or unwanted imaging conditions. In one embodiment, the one or more imaging artifacts or unwanted imaging conditions are selected from the group including incomplete clearing of the artery prior to intravascular imaging of the artery, insufficient contrast, insufficient contrast solution, light intensity below the average level for intravascular imaging, contrast cloud, non-uniform rotational distortion (NURD), blooming artifacts, jailed side branches, and reflections from imaging probe components. In one embodiment, the methods and systems disclosed herein are operable or perform identifying in the predicted output images one or more arc-based metrics, measures of similarity of both Ca and EEL, detected EEL diameter, and detected Ca depth. In one embodiment, the neural network is a convolutional neural network and the number of input channels of the first node or layer is 4. In one embodiment, the method and system disclosed herein is operable or performs: generating a carpet view using line projection; and filtering the carpet view to reduce noise in the predicted output image.

[0015] In one embodiment, each of the above (and other examples disclosed herein of identifiable elements in input image data) is a data channel that may be used as a region of interest (ROI) or feature of interest (FOI) to train the MLS and be detectable by the trained MLS. In one embodiment, each of the above has an associated mask or data channel, or is an element in an image mask, such as a ground truth mask or output mask. In one embodiment, an output mask includes multiple regions, different regions corresponding to different channels, such that a multi-channel segmentation representation is generated for the input data. In one embodiment, a first frame of image data is processed using the neural network of the MLS to generate a first output mask corresponding to the first frame of image data, and the first mask is modified such that regions / features of interest are identified using indicia such as color coding, hatching, etc. Thus, the first output mask includes the input image data with an overlay, modifications to the image data or mask regions that identify its class / type, or other indicia regarding regions of pixels that are classified as pixels of a particular feature, class, etc.

[0016] In one embodiment, the predicted output image includes one or more indicia indicating the boundaries of the predicted or classified features. The method further includes converting the predicted output image from a polar form to a Cartesian form. Thus, the output polar image mask with indicia corresponding to the detected ROI / FOI can be converted to a Cartesian image, and the indicia are converted and represented in the Cartesian image. In various embodiments, annotation and processing of the Cartesian image is avoided to generate a ground truth image / mask and training of the neural network, and instead the ground truth polar image is processed and used to train a given neural network. In one embodiment, carpet view masks, and subsets thereof, can be used. In one embodiment, the carpet view has a first axis corresponding to frame number and a second axis corresponding to scanline number.

[0017] In one embodiment, the neural network is a conformal neural network. In one embodiment, the MLS includes an AI processor, the AI ​​processor including one or more parallel processing elements. In one embodiment, the AI ​​processor includes n parallel processing elements and further includes a dedicated AI processor memory. In one embodiment, the dedicated AI processor memory ranges from about 8 GB to about 64 GB. In one embodiment, the dedicated AI processor memory ranges from about 64 GB to about 128 GB. In one embodiment, the AI ​​processor is a graphics processing unit. In one embodiment, the parallel processing elements are selected from the group including a Compute Unified Device Architecture (CUDA) core processor, a core processor, a tensor core processor, and a stream processor. In one embodiment, the AI ​​processor is operated locally through an edge network appliance or a server. In one embodiment, an AI processor such as a graphical processing unit containing 8GB or more of dedicated memory along with 32GB or more of on-board RAM is used as part of the computing device located within the housing of the data collection / imaging system.

[0018] In one embodiment, the method further comprises reducing the processing time of the MLS when classifying user image data by flattening the image data before inputting it into the neural network. This can be applied to patient image data when classifying, detecting and / or identifying features / regions of interest during a training phase. The method further comprises reducing the processing time of the MLS when classifying user image data by resizing or excluding regions of the image before inputting it into the neural network. The method further comprises performing one, two or three circular shifts on one or more of the polar images. The method further comprises performing a left-right flip on one or more of the polar images. The method further comprises performing lumen detection using an image processing method or machine learning method to generate a set of detected lumen boundary data. The method further comprises generating one or more image masks for each region or feature of interest identified in the patient image. Implementations of the described techniques can include hardware, methods or processes, or computer software on a computer accessible medium. The methods and systems can include various buses and interface components.

[0019] One general aspect includes performing lumen detection to detect a lumen boundary. In one embodiment, detected lumen boundary data, such as on an image-by-image basis, is also input into the neural network along with polar image data of the patient. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0020] Implementations may include one or more of the following features: In one embodiment, inputting the detected lumen boundary data reduces the latency of classifying regions and features of interest in the patient's polar image data. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium. In one embodiment, each input image for training or processing patient data is converted into multiple versions, which are generated by left-right flip and circular shift. This provides an expanded data set, which reduces errors and increases the accuracy of the neural network / MLS. In various embodiments, references to MLS include neural network and vice versa.

[0021] One general aspect includes a data collection and / or imaging and region / feature characterization system. The system also includes a housing. The system also includes a frame grabber that receives one or more of image data, such as polar data, ultrasound data, optical image data, x-ray image data, and intravascular image data. The intravascular system also includes a power supply. The intravascular system also includes one or more electronic memory storage devices in electrical communication with the power supply. The intravascular system also includes one or more image processing software modules executable on a processor and stored in the one or more electronic memory storage devices. The intravascular system also includes a computing device including a first processor, the computing device in electronic communication with the power supply and the first processor. In one embodiment, one or more AI processors and dedicated AI processor memory are located in the housing or connected to the housing through one or more ports, buses, or networks. In one embodiment, the MLS and its trained neural network are operated remotely, such as through a client / server implementation, an edge computing implementation, or a cloud or software as a service implementation.

[0022] In one embodiment, the system also includes one or more software programs stored in the one or more electronic memory storage devices. The system also includes a machine learning system comprising a neural network including one or more machine learning software modules. The endovascular system also includes one or more AI processors, the one or more machine learning software modules being executable on the one or more AI processors, a bus, an AI processor memory, and an interface for transmitting and receiving image data to and from the first processor, the machine learning system being in electronic communication with the power supply, and the machine learning system, the computing device, and the one or more electronic memory storage devices being disposed within the housing. In one embodiment, the bus is a PCIe bus. Other embodiments of this aspect include corresponding computer systems, apparatus, computer programs recorded on one or more computer storage devices, AI processors, special purpose ASICs, circuitry, and circuitry components, each configured to perform the actions of the method. In one embodiment, the bus connects the AI ​​processor and on-board memory and a processor of a diagnostic / imaging system.

[0023] Implementations may include one or more of the following features: The housing is a housing for an optical coherence tomography imaging system or an intravascular ultrasound imaging system. The one or more image processing software modules include one or more of software for converting a polar intravascular image to a Cartesian image, software for converting a Cartesian intravascular image to a polar image, tissue classification overlay software for labeling regions or features of interest when displayed to an end user, a lumen detection software module, an image flattening pre-processing software module, an image resizing software module, image annotation software with a GUI for labeling or marking training images with ground truth data, a pre-processing software module, and a circular shift software module. The one or more machine learning software modules include one or more of a neural network interface, a lumen contour prediction, a side branch prediction, an image resizing module, a user interface and input processing software module, an MLS interface software module that controls and sets parameters of the neural network, an MLS memory manager software, a pre-processing software module, a stent strut prediction software module, a jailed stent prediction software module, a guidewire prediction software module, and an interface module that exchanges data with an imaging system. Implementations of the described techniques may include hardware, methods or processes, or computer software on a computer accessible medium.

[0024] In part, the present disclosure relates to computer-based methods and systems suitable for evaluating image data from a patient in real-time or substantially real-time using machine learning (ML) methods and systems. In various embodiments, a set of image data, such as a pullback of endovascular data, is classified in substantially real-time using a trained neural network, such as a convolutional neural network. In various embodiments, the set of image data includes between about 400 frames and about 600 frames and is obtained from a memory or by imaging the patient using an imaging system. In one embodiment, the set of image data includes between about 400 frames and about 600 frames is classified. In one embodiment, the substantially real-time is in the range of between about 1 second and about 60 seconds. In one embodiment, the substantially real-time is in the range of between about 1 second and about 30 seconds. In one embodiment, the substantially real-time is in the range of between about 1 second and about 20 seconds. In one embodiment, the substantially real-time is in the range of between about 1 second and about 15 seconds. In one embodiment, substantially real-time is in the range of about 1 second to about 10 seconds. In one embodiment, substantially real-time is less than about 10 seconds. In part, the present disclosure is directed to improving diagnostic tools for end users, such as cardiologists and imaging professionals, using machine learning techniques applied to specific problems related to intravascular images having Cartesian and polar representations. Furthermore, considering the use of rotating probes to acquire OCT, IVUS image data, and other imaging data, dealing with the two coordinate systems associated therewith poses challenges. The present disclosure addresses these challenges and numerous others related to solving the problem of rapidly imaging and diagnosing patients so that stent placement and other procedures can be applied during a single session in a cath lab.The ability to segment an image into multiple features or regions of interest reduces the time a patient spends during initial diagnostic and subsequent treatment procedures by providing clinicians with diagnostic information to inform evaluation of stent planning, bypass, atherectomy, and other surgical options, and to evaluate changes in a patient's condition over time.

[0025] In one embodiment, MLS system training is performed using polar images or polar image data elements that have been annotated by an expert. The annotated polar images are used to train the MLS. The MLS processes new polar images from the patient to generate an output of classified image regions that are still in polar format. After using the trained MLS for prediction and inference, the prediction output in polar format from the MLS is converted to Cartesian format and the image with classified tissue regions (lumen, intima, side branch, guidewire, stent, plaque, calcium, etc.) is displayed in Cartesian format. In one embodiment, the coordinates can be reversed and the image is in Cartesian format when annotated and is finally converted to polar format after processing and prediction by a given MLS.

[0026] In various embodiments, probability and texture maps are generated that provide user interface feedback for various workflows. Additionally, the probability and texture maps can be combined, compared, convolved, and otherwise used to generate output results that classify regions and features of interest using a trained neural network. In various embodiments, a given neural network is preferably trained using annotated polar images.

[0027] In part, the present disclosure relates to user interface designs that facilitate improved information and time management using one or more tissue map representations based on characterized tissue of body lumens, such as coronary arteries. In various embodiments, the various detected ROIs / FOIs can be co-registered with angiography data and displayed using one or more user interfaces as part of an imaging system or other diagnostic system.

[0028] In part, the disclosure relates to a method for using an imaging processing pipeline to detect regions of interest within blood vessels that may include tissue type and other features such as side branches, stents, guidewires and other features, vascular properties and materials, and using neural networks to identify regions of interest within said blood vessels to detect other ROI / FOI such as calcium, lumen, media, intima, lipids, and others as disclosed herein.

[0029] In one embodiment, the tissue types or tissue characteristics, regions of interest (ROIs), features of interest, classes or types, or vascular features selected for segmentation and / or detection and representation in one or more masks, images, or outputs include a tissue map that includes one or more of the following: cholesterol, fibrous, lipid pools, lipids, fibrofatty, calcifications, calcium nodules, calcium plates, intima, thrombus, foam cells, proteoglycans, and others as disclosed herein. The various systems disclosed herein are operable to perform all of the methods and processes disclosed herein using dedicated circuitry, controllers, FPGAs, AI processors, and other components as disclosed herein.

[0030] While the present disclosure is directed to various aspects and embodiments, it is understood that these various aspects and embodiments disclosed herein can be integrated, combined, and used together as combined systems or as partially separate components, devices, and systems as appropriate. Thus, each embodiment disclosed herein can incorporate each of the above aspects to varying degrees as appropriate for a given implementation.

[0031] The figures are not necessarily to scale, emphasis instead generally being placed upon illustrative principles. The figures are to be considered in all respects illustrative and are not intended to limit the present disclosure, the scope of which is defined only by the claims.

[0032] The patent file or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a schematic diagram of a system suitable for training a neural network, such as a network that uses ground truth masks obtained on arterial image data, such as image frames, to generate predicted outputs that classify particular features or regions of interest, in accordance with an exemplary embodiment of the present disclosure. [Figure 1A] FIG. 1 is a schematic diagram of a machine learning system suitable for use with image data, such as image data acquired of arteries, during a training phase, in accordance with an exemplary embodiment of the present disclosure. [Figure 1B] FIG. 1 is a schematic diagram of a machine learning system suitable for use with user image data, such as image data acquired of arteries, to detect, predict, and / or classify features of interest in the user image data, according to an exemplary embodiment of the present disclosure. [Figure 1C]FIG. 1 is a schematic diagram of a machine learning system suitable for use with user image data showing input polar image data, such as OCT image data, that is processed to generate ground truth image data used to train an MLS, and predicted image data obtained using a trained MLS, according to an exemplary embodiment of the present disclosure. [Figure 1D] FIG. 1 is a schematic diagram of a machine learning system suitable for use with user image data to generate classified or characterized features or regions of interest for the user image data, according to an exemplary embodiment of the present disclosure. [Figure 1E] FIG. 1 is a schematic diagram of a machine learning system suitable for use with user image data that generates classified or characterized features or regions of interest for the user image data, including a lumen detection system and a pre-processing system, according to an exemplary embodiment of the present disclosure. [Figure 1F] 1 is an example process flow of a training process and a subsequent prediction process of certain example embodiments of the present disclosure. [Figure 1G] FIG. 1 illustrates image data obtained from imaging a patient given an exemplary embodiment of the present disclosure, and three output probability maps corresponding to detecting the media, calcium, and lumen as separate channels. [Diagram 2] FIG. 1 illustrates a multi-layer neural network architecture suitable for training and generating prediction results using ground truth annotations, according to an exemplary embodiment of the present disclosure. [Figure 2A] FIG. 1 is a schematic diagram showing a set of outputs from an MLS including indicia corresponding to various color-coded classes, and their use to obtain projections to generate a carpet view and optionally a tissue map, in accordance with an exemplary embodiment of the present disclosure. [Figure 2B] 1 is a plot of an MLS system showing loss function values ​​for testing data and training data, according to an example embodiment of the present disclosure. [Figure 2C] 1 is a plot of an MLS system showing mismatch percentage values ​​for test data and training data, according to an exemplary embodiment of the present disclosure. [Figure 2D] 1A-1C show intravascular polar images of a patient's artery, polar images annotated or augmented with classified ground truth regions, and polar images with features and / or regions of interest classified using MLS, according to exemplary embodiments of the present disclosure. [Figure 2E] 1A-1D show, from left to right, polar image data of an artery, a polar image annotated with ground truth lumen data, lumen detection results performed with MLS with a 2D neural net, and lumen detection results performed with MLS with a 3D neural net, in accordance with an exemplary embodiment of the present disclosure. [Figure 2F] 1A-1D show, from left to right, polar image data of an artery, a polar image annotated with ground truth lumen data, lumen detection results performed with MLS with a 2D neural net, and lumen detection results performed with MLS with a 3D neural net, in accordance with an exemplary embodiment of the present disclosure. [Figure 2G] 1A-1D show, from left to right, polar image data of an artery, a polar image annotated with ground truth lumen data, lumen detection results performed with MLS with a 2D neural net, and lumen detection results performed with MLS with a 3D neural net, in accordance with an exemplary embodiment of the present disclosure. [Figure 2H] 1A-1D show, from left to right, polar image data of an artery, a polar image annotated with ground truth lumen data, lumen detection results performed with MLS with a 2D neural net, and lumen detection results performed with MLS with a 3D neural net, in accordance with an exemplary embodiment of the present disclosure. [Figure 3A] FIG. 1 illustrates a graphical user interface of an MLS system suitable for navigating and annotating image data for training an MLS or a component thereof, according to an exemplary embodiment of the present disclosure. [Figure 3B]FIG. 13 illustrates a polar frame of image data from an imaging probe pullback through an artery, annotated using a graphic user interface-based training tool for MLS, according to an exemplary embodiment of the present disclosure. [Figure 3C] FIG. 1 is a schematic diagram of a Cartesian format of a segmented arterial image in which tissue regions are classified by a predictive operation of MLS, according to an exemplary embodiment of the present disclosure. [Figure 3D] FIG. 13 illustrates an output image from MLS converted to Cartesian form showing the input image and a semantic segmentation of the image showing the MLS classified media region or mask, lumen region or mask, and Ca region or mask, according to an exemplary embodiment of the present disclosure. [Figure 3E] FIG. 13 illustrates an output image from MLS converted to Cartesian form showing the input image and a semantic segmentation of the image showing the MLS classified media region or mask, lumen region or mask, and Ca region or mask, according to an exemplary embodiment of the present disclosure. [Figure 4A] FIG. 1 illustrates an example imaging diagnostic system that includes one or more machine learning systems that are or can be integrated with an imaging system, or that are or can be otherwise combined with an imaging system. [Figure 4B] FIG. 1 illustrates an example imaging diagnostic system that includes one or more machine learning systems that are or can be integrated with an imaging system, or that are or can be otherwise combined with an imaging system. [Figure 4C] FIG. 1 illustrates an example imaging diagnostic system that includes one or more machine learning systems that are or can be integrated with an imaging system, or that are or can be otherwise combined with an imaging system. [Figure 5A] FIG. 1 is a schematic diagram of a system suitable for performing guided atherectomy using an optical imaging system, such as an OCT imaging system, according to an exemplary embodiment of the present disclosure. [Figure 5B]1 is a schematic diagram of a method suitable for performing guided atherectomy using an optical imaging system, such as an OCT imaging system, according to an exemplary embodiment of the present disclosure. [Figure 5C] FIG. 1 illustrates an OCT image segmented to highlight calcium plaque regions using an MLS system, such as a deep learning-based system, according to an exemplary embodiment of the present disclosure. [Figure 5D] FIG. 1 illustrates an OCT image segmented to highlight calcium plaque regions using an MLS system, such as a deep learning-based system, according to an exemplary embodiment of the present disclosure. [Figure 5E] 1A-1C show user interface representations of calcium plaque in 3D, cross-sectional and longitudinal sections, according to exemplary embodiments of the present disclosure. [Figure 5F] FIG. 1 illustrates a calcium map generated on an angiography system using angiography co-registration, according to an exemplary embodiment of the present disclosure. [Figure 5G] FIG. 1 illustrates an annotated Cartesian OCT image according to an exemplary embodiment of the present disclosure. [Figure 5H] FIG. 1 illustrates an annotated Cartesian OCT image according to an exemplary embodiment of the present disclosure. [Figure 5I] FIG. 1 illustrates an expanded Cartesian OCT image identifying various layers of an artery, according to an exemplary embodiment of the present disclosure. [Figure 5J] FIG. 5D illustrates a histology image of the artery of FIG. 5C with various layers of the artery identified as part of a ground truth or training set review suitable for annotating image data for use with a given MLS embodiment, according to an exemplary embodiment of the present disclosure. [Figure 6A] 13A-13C show Cartesian OCT images and predicted output of MLS identifying lumen, media, and Ca plaque, and exemplary diameter measurements, respectively, according to an exemplary embodiment of the present disclosure. [Figure 6B]13A-13C show Cartesian OCT images and predicted output of MLS identifying lumen, media, and Ca plaque, and exemplary diameter measurements, respectively, according to an exemplary embodiment of the present disclosure. [Figure 6C] 13A-13C show additional OCT images, a ground truth mask, and an output mask showing tissue classification and prediction using MLS, according to an exemplary embodiment of the present disclosure. [Figure 6D] 13A-13C show additional OCT images, a ground truth mask, and an output mask showing tissue classification and prediction using MLS, according to an exemplary embodiment of the present disclosure. [Figure 6E] 13A-13C show additional OCT images, a ground truth mask, and an output mask showing tissue classification and prediction using MLS, according to an exemplary embodiment of the present disclosure. [Figure 6F] 13A-13C show additional OCT images, a ground truth mask, and an output mask showing tissue classification and prediction using MLS, according to an exemplary embodiment of the present disclosure. [Figure 7A] FIG. 2 illustrates an exemplary original OCT image in Cartesian form as acquired using a combined imaging MLS-based system, according to an exemplary embodiment of the present disclosure. [Figure 7B] FIG. 2 illustrates a grayscale polar image, according to an exemplary embodiment of the present disclosure. [Figure 7C] FIG. 1 illustrates a ground truth mask according to an exemplary embodiment of the present disclosure. [Figure 7D] FIG. 7B illustrates an example of an annotation using a trained MLS, and a deep learning output of an MLS embodiment generated using the image of FIG. 7B as input for training and prediction, according to an exemplary embodiment of the present disclosure. [Figure 8A] FIG. 1 illustrates pre-processing operations on a polar OCT image before annotation with expert or ground truth data, according to an exemplary embodiment of the present disclosure. [Figure 8B] 1A-1C illustrate various exemplary polar image masks for detecting lumen, media, and calcium, according to exemplary embodiments of the present disclosure. [Figure 8C] 1A-1C illustrate various exemplary polar image masks for detecting lumen, media, and calcium, according to exemplary embodiments of the present disclosure. [Figure 8D] 1A-1C illustrate various exemplary polar image masks for detecting lumen, media, and calcium, according to exemplary embodiments of the present disclosure. [Figure 9A] 1A-1C are diagrams illustrating polar OCT images illustrating a circular shift and left-right flip applied to the original OCT polar image as part of a pre-processing step, according to an exemplary embodiment of the present disclosure. [Figure 9B] 1A-1C are diagrams illustrating polar OCT images illustrating a circular shift and left-right flip applied to the original OCT polar image as part of a pre-processing step, according to an exemplary embodiment of the present disclosure. [Figure 9C] 1A-1C are diagrams illustrating polar OCT images illustrating a circular shift and left-right flip applied to the original OCT polar image as part of a pre-processing step, according to an exemplary embodiment of the present disclosure. [Figure 10A] FIG. 1 illustrates an image showing ground truth annotated images and predicted outputs, according to an exemplary embodiment of the present disclosure. [Figure 10B] FIG. 1 illustrates an image showing ground truth annotated images and predicted outputs, according to an exemplary embodiment of the present disclosure. [Figure 11A] 1A-1C are images illustrating various pre-processing steps developed to increase MLS processing speed and reduce patient wait times, according to exemplary embodiments of the present disclosure. [Figure 11B] 1A-1C are images illustrating various pre-processing steps developed to increase MLS processing speed and reduce patient wait times, according to exemplary embodiments of the present disclosure. [Figure 11C] 1A-1C are images illustrating various pre-processing steps developed to increase MLS processing speed and reduce patient wait times, according to exemplary embodiments of the present disclosure. [Figure 11D] 1A-1C are images illustrating various pre-processing steps developed to increase MLS processing speed and reduce patient wait times, according to exemplary embodiments of the present disclosure. [Figure 12A] 1 is a flowchart of exemplary processing steps in which raw image data is fed and processed along with annotation using ground truth data, according to an exemplary embodiment of the present disclosure. [Figure 12B] 1 is a flowchart of exemplary processing steps in which raw image data is fed and processed along with annotation using ground truth data, according to an exemplary embodiment of the present disclosure. [Figure 13A] 1A-1C illustrate exemplary user interfaces of diagnostic tools that support stent planning through virtual stent placement incorporating tissue classification using MLS systems and methods, according to exemplary embodiments of the present disclosure. [Figure 13B] 1A-1C illustrate exemplary user interfaces of diagnostic tools that support stent planning through virtual stent placement incorporating tissue classification using MLS systems and methods, according to exemplary embodiments of the present disclosure. [Figure 14] 1A-1C show representations of an artery including various cross sections of the boundary from an OCT scan of a subject's artery and generation of a tissue map using various sets of image data acquired during pullback, according to an exemplary embodiment of the present disclosure. [Figure 15] 1A-1C show schematic representations of an artery acquired using one or more imaging modalities and various cut planes suitable for generating a tissue map, according to an exemplary embodiment of the present disclosure. [Figure 16] FIG. 13 illustrates various tissue map representations generated using OCT imaging pullback of an artery with various indicia integrated into a user interface displaying the various tissue maps to support diagnostic and treatment planning such as stent placement and atherectomy, according to an exemplary embodiment of the present disclosure. [Figure 17] FIG. 13 illustrates various tissue map representations generated using OCT imaging pullback of an artery with various indicia integrated into a user interface displaying the various tissue maps to support diagnostic and treatment planning such as stent placement and atherectomy, according to an exemplary embodiment of the present disclosure. [Figure 18] FIG. 13 illustrates various tissue map representations generated using OCT imaging pullback of an artery with various indicia integrated into a user interface displaying the various tissue maps to support diagnostic and treatment planning such as stent placement and atherectomy, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Various data collection and analysis systems are available to obtain information about the coronary artery system. Data obtained from blood vessels using devices or derived from intravascular or extravascular measurements related to blood vessels can be analyzed or displayed to assist researchers and clinicians. Optical coherence tomography (OCT) is an imaging modality that uses interferometry to obtain distance measurements related to blood vessels or objects placed within blood vessels. Intravascular ultrasound (IVUS) can also be used with a probe to image portions of blood vessels. Angiography and fluoroscopy systems are also often used to image patients so that diagnostic decisions can be made and various possible treatment options such as stent placement can be performed. These and other imaging systems can be used to image patients externally or internally to obtain raw data, which can include various types of image data. The present disclosure relates to various machine learning system embodiments, including one or more networks, such as neural networks, that provide improved classification of components of medical imaging data. An exemplary MLS-based system is illustrated with respect to Figures 1, 1A, 1B, 1C, 1D, 1E, 4A, 4B, and other figures disclosed and illustrated herein.

[0035] Of particular interest is image data acquired of body lumens, such as coronary arteries. Moreover, given the benefits of intravascular imaging for diagnosis, flow measurement, stent planning, and the like, obtaining timely image analysis and tissue matching and classification using MLS systems is of great value. These systems often require significant amounts of time to perform image processing tasks. Thus, it is a feature of various embodiments of the present disclosure to reduce the time required to process a set of patient image data using an MLS system.

[0036] In general, the present disclosure may be applied to any intravascular data collection device that may be used to generate and receive signals containing diagnostic information, such as image data, about the blood vessel in which the intravascular data collection device is used. These devices may include, but are not limited to, imaging devices, such as optical or ultrasound probes, pressure sensor devices, and other devices suitable for collecting data about blood vessels or other components of the cardiovascular system.

[0037] 1 includes a system suitable for performing various steps of the present disclosure, such as annotating and generating a ground truth mask, collecting image data for classification using a trained neural network, and displaying such prediction results to a user. Various user interface features are described herein for viewing and evaluating the visual representation of the arterial information. These user interfaces may include one or more moving elements that a user may control using a mouse, joystick, or other control device and may be operated using one or more processors and memory storage elements.

[0038] During the stent delivery planning procedure, the user can refer to the OCT and the annotated angiogram to further expand or move the stent as part of the delivery plan. These system features and methods can be implemented using system 3 shown in FIG.

[0039] 1 shows a system 3 including various data acquisition subsystems suitable for collecting data or detecting characteristics of a subject 4 or sensing a condition of the subject 4 or otherwise diagnosing the subject 4. In one embodiment, the subject is positioned on a suitable support 19, such as a table, bed, or chair, or other suitable support. Typically, the subject 4 is a human or another animal having a particular region of interest 25.

[0040] The data acquisition system 3 includes a non-invasive imaging system, such as nuclear magnetic resonance, x-ray, computer-aided tomography, or other suitable non-invasive imaging technique. As shown as a non-limiting example of such a non-invasive imaging system, an angiography system 20 is shown suitable for generating cines. The angiography system 20 may include a fluoroscopy system. The angiography system 20 is configured to non-invasively image the subject 4 while a pullback procedure is performed using the probe 30 such that blood vessels in the region 25 of the subject 4 are imaged using angiography in one or more imaging techniques, such as OCT or IVUS, and frames of angiography data, typically in the form of frames of image data, are generated.

[0041] The angiography system 20 is in communication with an angiography data storage and image management system 22, which in one embodiment may be implemented as a workstation or a server. In one embodiment, data processing related to the collected angiography signals is performed directly on the detector of the angiography system 20. Images from the system 20 are stored and managed by the angiography data storage and image management system 22.

[0042] In one embodiment, a system server 50 or workstation 85 handles the functionality of system 22. In one embodiment, the entire system 20 generates electromagnetic radiation, such as x-rays. System 20 also receives such radiation after it passes through subject 4. Data processing system 22 then uses signals from angiography system 20 to image one or more regions of subject 4, including region 25.

[0043] As shown in this particular example, the region of interest 25 is a subset of the vasculature, such as a particular blood vessel, or peripheral vasculature. This subset can be imaged using OCT. A catheter-based data collection probe 30 is introduced into the subject 4 and positioned within the lumen of a particular blood vessel, such as a coronary artery. The probe 30 can be various types of data collection probes, such as, for example, an OCT probe, an FFR probe, an IVUS probe, a probe combining features of two or more of the above, and other probes suitable for imaging within a blood vessel. The probe 30 typically includes a probe tip, one or more radiopaque markers, an optical fiber, and a torque wire. In addition, the probe tip includes one or more data collection subsystems, such as an optical beam director, an acoustic beam director, a pressure detector sensor, other transducers or detectors, and combinations of the above.

[0044] In the case of a probe including an optical beam director, the optical fiber 33 is in optical communication with the probe using the beam director. The torque wire defines a bore in which the optical fiber is disposed. In FIG. 1, the optical fiber 33 is shown without a torque wire surrounding it. In addition, the probe 30 also includes a sheath, such as a polymer sheath (not shown), that forms part of a catheter. In the context of an OCT system, the optical fiber 33, which is part of the sample arm of the interferometer, is optically coupled to a patient interface unit (PIU) 35 as shown.

[0045] The patient interface unit 35 includes a probe connector suitable for receiving and optically coupling to the end of the probe 30. Typically, the data collection probe 30 is disposable. The PIU 35 includes appropriate joints and elements based on the type of data collection probe used. For example, a combination of OCT and IVUS data collection probes requires an OCT and IVUS PIU. The PIU 35 also typically includes a motor suitable for pulling back the torque wire, sheath, and optical fiber 33 disposed therein as part of a pull-back procedure. In addition to being pulled back, the probe tip is also typically rotated by the PIU 35. Thus, the blood vessels of the subject 4 can be imaged longitudinally or through a cross-section. The probe 30 can also be used to measure certain parameters such as fractional flow reserve (FFR) or other pressure measurements.

[0046] The PIU 35 is then connected to one or more intravascular data collection systems 40. The intravascular data collection system 40 can be an OCT system, an IVUS system, another imaging system, and combinations of the above. For example, the system 40 in the context of the probe 30 being an OCT probe can include an interferometer sample arm, an interferometer reference arm, a photodiode, a control system, and a patient interface unit. Similarly, as another example, in the context of an IVUS system, the intravascular data collection system 40 can include ultrasound signal generation and processing circuitry, noise filters, a rotatable joint, a motor, and an interface unit. In one embodiment, the data collection system 40 and the angiography system 20 have a shared clock or other timing signal configured to synchronize angiography video frame timestamps and OCT image frame timestamps.

[0047] In addition to the invasive and non-invasive image data collection systems and devices of FIG. 1, various other types of data can be collected regarding the region 25 of the subject and other parameters of interest of the subject. For example, the data collection probe 30 can include one or more pressure sensors, such as, for example, a pressure wire. Pressure wires can be used without the addition of an OCT or ultrasound component. Pressure readings can be taken along a segment of a blood vessel within the region 25 of the subject 4.

[0048] Such readings may be relayed by a wired connection or via a wireless connection. As shown in the fractional flow reserve FFR data collection system, the wireless transceiver 48 is configured to receive pressure readings from the probe 30 and transmit them to the system to generate FFR measurements for one or more locations along the measured blood vessel. One or more displays 82, 83 may also be used to show angiography frames of data, OCT frames, user interfaces for the OCT and angiography data, as well as other controls and features of interest.

[0049] Intravascular image data, such as frames of intravascular data generated using the data collection probe 30, may be sent via the PIU 35 to a data acquisition and processing system 40 coupled to the probe. Noninvasive image data generated using the angiography system 20 may be transmitted to, stored on, and processed by one or more servers or workstations, such as the co-registration server 50 or workstation 85. A video frame grabber device 55, such as a computer board configured to capture angiography image data from the system 22, may be used in various embodiments.

[0050] In one embodiment, the server 50 includes one or more co-registration software modules 67 stored in memory 70 and executed by the processor 80. The server can include a trained neural network 52 suitable for implementing various embodiments of the present disclosure. In one embodiment, an AI processor, such as a graphical processing unit 53, is included in the server 50 and is in electrical communication with the memory 70. The computing device / server 50 can include other typical components for a processor-based computing server. Alternatively, one or more databases, such as database 90, can be configured to receive image data generated, subject parameters, and other information generated by one or more of the system devices or components shown in FIG. 1 and received by or transferred to the database 90.

[0051] While the database 90 is shown connected to the server 50 while being stored in the memory of the workstation 85, this is but one exemplary configuration. For example, the software module 67 can execute on a processor of the workstation 85 and the database 90 can be located in the memory of the server 50. The use of a device or system to execute the various software modules is provided as an example. In various combinations, the hardware and software described herein can be used to acquire frames of image data, process such image data, and register such image data. The various software modules can also include tissue map generation software suitable for generating one or more tissue maps indicative of one or more regions of interest (ROI) and / or detected or characterized tissue or arterial material, such as calcium.

[0052] Unless otherwise specified herein, software modules 67 may include software such as pre-processing software, transformations, matrices, and other software-based components used to process image data or in response to patient triggers to facilitate co-registration of different types of image data by other software-based components 67 or otherwise perform annotation of the image data to generate ground truth, as well as other software, modules, and functions suitable for implementing various embodiments of the present disclosure. These modules may include lumen detection using scanline or image-based techniques, stent detection using scanline or image-based techniques, indicator generation, apposition bar generation for stent planning, guidewire shadow indicator to prevent confusion due to mismatches, side branches, and missing data, etc.

[0053] The database 90 may be configured to receive and store angiography image data 92, such as image data generated by the angiography system 20 and acquired by the frame grabber 55 of the server 50. The database 90 may be configured to receive and store OCT image data 95, such as image data generated by the OCT system 40 and acquired by the frame grabber 55 of the server 50.

[0054] Additionally, subject 4 may be electrically coupled via one or more electrodes to one or more monitors, such as monitor 49. Monitor 49 may include, without limitation, an electrocardiogram monitor configured to generate data related to cardiac function and indicative of various states of the subject, such as systole and diastole.

[0055] The use, or lack thereof, of directional arrows in a given diagram is not intended to limit or dictate the direction in which information may flow. For a given connector, such as the arrows and lines shown connecting elements shown in FIG. 1, information may flow in one or more directions or in only one direction, as appropriate for a given embodiment. The connections may include various suitable data transmission connections, such as optical connections, wired connections, power connections, wireless connections, or electrical connections.

[0056] One or more software modules may be used to process frames of angiography data received from an angiography system, such as system 20 shown in Figure 1. A variety of software modules, which may include, without limitation, software, components thereof, or one or more steps of a software-based or processor-implemented method, may be used in a given embodiment of the present disclosure.

[0057] In part, the present disclosure relates to an intravascular data collection system and associated methods in which intravascular data collected by an intravascular probe may be transformed or analyzed by a processor-based system. The results of such analysis and transformation may be displayed to an end user in various representations, such as a display in communication with a given MLS having a neural network that classifies components of a medical image. In one embodiment, a given imaging system, such as an OCT, IVUS, or X-ray based imaging system, may be in electronic communication with the MLS to display modified versions of image data acquired using a given type of imaging system during the same session in which such image data was acquired. V-net, U-net, CUMedVision1, CUMedVision2, VGGNet, Multi-Stage Multi-Recurrent Input Fully Convolutional Network (M 2Various neural network architectures can be used for image segmentation, such as Multi-stage Multi-recursive-input Fully Convolutional Network (FCN), Coarse-to-Fine Stacked Fully Convolutional Nets, deep active learning frameworks, ResNet, combinations thereof, and other neural networks and software-based machine learning frameworks suitable for image segmentation.

[0058] In one embodiment, the MLS includes a specialized hardware system that handles the necessary machine learning operations and its training process so that results can be obtained based on rapid processing, such as within about 2 seconds to about 30 seconds. In one embodiment, results are obtained in less than about 45 seconds. The specialized hardware system of a given MLS embodiment can include multiple processors, such as AI / ML processors. This machine learning system can be implemented by training a classifier to segment the image or perform processing on the image such that the constituent tissues, tissue types, and other regions of interest of the image are detected and characterized based on type or another parameter. In one embodiment, the lumen, intima, media, and plaque are detected and identified as having boundaries corresponding to these different tissues. Training a given MLS / neural network involves teaching the network using known inputs and known outputs.

[0059] The present disclosure relates to an advanced machine learning system that includes one or more AI processors that include memory with an increased amount of memory allocated per processor. The advanced machine learning system is designed to support multi-channel segmentation techniques. Different channels can be selected for different regions of interest and characteristics of a given implementation. For example, in one embodiment, a first channel, a second channel, a third channel, and a fourth channel are designated, with each of these channels associated with one each of the lumen, intima, media, and plaque. Other classes / types can also be associated with different channels to facilitate segmentation.

[0060] In one embodiment, the plaque type is classified. In some embodiments, the plaque type can be classified as calcified. Additionally, given that the presence of plaque and other detectable features in a given arterial section may indicate the presence of a constriction from a stenosis or the like, another feature of the present disclosure is that one or more scores associated with a given plaque or stenosis can be quickly and automatically obtained to help facilitate a decision made by an end user. For example, a given score determined using image data and machine learning-based analysis thereof can help determine whether emergency action is not recommended or whether the stenosis should be stented or whether other procedures such as atherectomy or bypass are warranted.

[0061] In healthy patients, arteries have various layers arranged in a coherent structure including the intima, media and adventitia. As a result of the atherosclerotic process, the intima may thicken pathologically and contain plaques composed of different types of tissue including fibrous matter, proteoglycans, lipids and calcium, as well as macrophages and other inflammatory cells. These tissue types have different characteristics when imaged using various imaging systems that can be used to establish a set of training data for one or more of the machine learning systems of the present disclosure. The plaques considered to be the most pathologically significant are the so-called vulnerable plaques, which consist of a fibrous cap with an underlying lipid pool. Different atherosclerotic plaques have different geometries. For example, foam cells usually form ribbon-like features at the shoulders of a large lipid pool, the tunica media appears annular around the vessel, etc. Shape information is currently used for the qualitative evaluation of OCT images. In one embodiment, a neural net is trained to identify fibrous caps and / or fibrous caps with an underlying lipid pool. In various embodiments, references herein to calcium include, but are not limited to, calcified plaque and other calcium-containing tissues.

[0062] The ability to quickly perform an imaging procedure on a patient to obtain images of the arteries while the patient is still catheterized and ready to receive a stent or other treatment option, and then use a machine learning system to process the images, results in significant time savings and improved patient outcomes.

[0063] The tunica media and its outer edge, called the external elastic lamina, are used by physicians to size their stents during interventions. Locating the tunica media and measuring the diameter of partially diseased tissue is time-consuming and difficult. It also requires image interpretation training. Automated detection and measurement of EEL diameter addresses these technical challenges faced when evaluating patients for treatment options at the time of diagnosis or otherwise. An example of such a diameter measurement is shown in FIG. 6B. FIG. 3C shows a series of labeled masks and ROI masks in a Cartesian view of the artery.

[0064] The ROIs are generally shown as examples and may correspond to calcium or another feature of interest such as a region containing a side branch or stent strut. Each region or feature, corresponding to the lumen L, intima I, plaque Q, adventitia ADV, imaging probe P, media M, etc., may be generated by MLS using a trained NN such as a CNN. The image 365 of FIG. 3C may be used as a diagnostic tool to help guide and inform the clinician. In various embodiments, the detection of the various features in FIG. 3C may be displayed using one or more user interfaces and co-registered with the angiography data as shown in FIG. 5F. In some embodiments, one or more features, regions, types, classes, predicted results are co-registered with the angiography data. In FIG. 5F, calcium plaque detected in the OCT is mapped / co-registered to the angiography image for review and planning. In some embodiments, tissue maps and other image data representations are used to support diagnosis and treatment recommendations. In one embodiment, each identified feature or class, such as ADV, EEL, IEL, L, P, I, Q, etc., can be generated as a mask or a prediction mask using one or more of the trained neural networks disclosed herein. Indicia corresponding to the output results can be shown using color-coded and other indicia.

[0065] In one embodiment, the annotated mask regions corresponding to sets or groups of pixels define a ground truth mask used to train one or more neural networks as disclosed herein. Once the neural network is trained, a prediction or detection mask is generated that includes sets of pixels corresponding to regions of the user data and an identifier of the feature or class of the region, such as lumen, calcium, EEL, or another class or feature as disclosed herein. In one embodiment, prediction results are generated for each class, and then all of the prediction results for a given image data input, such as an input frame of OCT, IVUS, or other image data, are compared pixel by pixel to generate a final prediction result for all classes. In one embodiment, the prediction results are displayed as an output image mask with regions corresponding to particular classes indicated as such by indicia, such as color, and one or more legends summarizing which indicia map to which classes.

[0066] Plaque detection and plaque type classification helps the physician choose his / her intervention strategy. The physician may choose to perform atherectomy if the calcium burden is too high, or may choose to land the stent in different zones depending on the underlying plaque composition. Automating the process of plaque identification and characterization facilitates the physician's image interpretation and improves the physician's workflow.

[0067] The MLS disclosed herein can be implemented using various neural networks and can be integrated with various imaging diagnostic systems. In one embodiment, the system and method is implemented using a deep learning framework. In various embodiments, the MLS includes one or more of neural networks, rule engines, fuzzy logic systems, comparators, image processing modules such as flattening modules, shifting modules, resizing modules such as heuristic systems, pattern matching systems, and pattern recognition systems, software implementations thereof.

[0068] In one embodiment, the MLS uses a neural network (NN), such as a convolutional neural network (CNN). The CNN includes multiple nodes or neurons and can receive and output image data, data derived from the image data, and / or modifications to the image data, and / or classification information regarding image data components or segments. In one embodiment, the CNN performs semantic image segmentation. In one embodiment, semantic segmentation using a given MLS embodiment can be used to detect whether an image has calcium and EEL, and identify pixels that have calcium and EEL. This can help physicians solve various problems related to selecting treatment options and guiding specific treatments. In one embodiment, the MLS uses a 3D CNN, such as PyTorch 3D CNN or V-NET. The neural networks described herein can be implemented using a variety of frameworks, including PyTorch, the Microsoft Cognitive Toolkit (CNTK), TensorRT, TensorFlow, and other similar proprietary and open source ML frameworks and tools.

[0069] In one embodiment, the tool selected for data annotation allows the user to select, move, and / or border pixels. Such an exemplary user interface tool 305 is shown in FIG. 3A and FIG. 3B. The use of a GUI supports annotation consistency from frame to frame (especially in the 3D case). When a standardized tool such as a GUI-based annotation tool is used, the tool's constraints and set of actions for annotating support consistent training data. This is in contrast to having different users annotate images by hand and then scan or process images. In one embodiment, a useful feature of the GUI is the ability to copy data from previous frames to subsequent frames. Additionally, in one embodiment, points are annotated at the poles, eliminating the Cartesian to polar transformation during preprocessing.

[0070] In one embodiment, the input to the MLS includes a training set of about 450 expert annotated images, where the tissue type of each image pixel is annotated by one or more expert users. In one embodiment, this training set can be pre-processed by a training set of another MLS to perform lumen detection before using the image data as a training set. Thus, in one embodiment, a first set of training data is pre-processed using one or more pre-processing techniques. These pre-processing techniques can include lumen detection using an MLS pre-trained using a training set with annotated lumen regions or segments. Pre-processing techniques can also be selected to speed up the prediction speed of the trained network during training and / or backward propagation of the network. Thus, pre-processing techniques may include image data flattening, circular shift processes, circular shift processes, excluding portions of image data such as depth data below the noise floor, data removal which may be done every other time such that every other scan line of an image is removed or every other column is removed, pixel filtering which may remove noise and increase uniformity of the region, and other pre-processing steps.

[0071] In one embodiment, the training set includes about 400 to about 600 image data elements ("image data elements"), such as individual images, or groups, clusters, or subsets of images, scanlines, or pixels. In one embodiment, the training set includes about 500 to about 700 images or image data elements. In one embodiment, the training set includes about 700 to about 800 images or image data elements. In one embodiment, the training set includes about 800 to about 900 images or image data elements. In one embodiment, the training set includes about 900 to about 1000 images or image data elements. In one embodiment, the training set includes about 1000 to about 1100 images or image data elements. In one embodiment, the training set includes about 1000 to about 5000 images or image data elements.

[0072] In one embodiment, a given CNN used with a particular MLS includes multiple nodes or neurons. Such a network can include various layers, including hidden layers. Elements of the network can have weights, filter values, or bias values ​​that change over time as the network is trained to learn about input image data, such as OCT, IVUS, angiograms, CT scans, or other image data. In one embodiment, the network used in a given MLS implementation includes multiple filters that change over time in response to a training set that includes polar and / or Cartesian image data inputs.

[0073] In one embodiment, a CNN interface, which may include one or more graphical user interface components, is used to facilitate batch input of image data. A given image is an example of image data. Image data may also include scanlines from endovascular pullbacks and other sources of medical imaging data suitable for segmentation and classification. In one embodiment, each image constituting the ground truth image data is classified into different parts, classes or types, and such data is used to support training the network to detect such parts, classes or types when operating on new patient image data. In one embodiment, the ground truth and training set are masks generated while the MLS is operating for regions or features of interest that are subject to classification and generation of the trained MLS to predict or detect regions or features of interest automatically without human intervention in various embodiments. Human or machine learning can be used to generate the training set / ground truth. Each of these can be implemented as a mask and a data channel. Each data channel is color-coded in various embodiments.

[0074] As shown in FIG. 1A, a schematic diagram of a system 5 for performing a training phase of MLS suitable for classifying tissues and other data types of a given set of medical image data is shown. Various features, regions, types, and / or classes of tissues in an image as well as regions, pixels, contours, and boundaries can be tagged or identified to the image data to obtain annotated image data such as a ground truth mask. Furthermore, the above can be used to train a neural network so that the network can operate on the image data and generate an output of image data having indicia suitable for classifying and visualizing the features, regions, types, and / or classes of tissues as well as regions, pixels, contours, and boundaries using the trained network. A given ground truth match can include a region corresponding to a particular channel or feature, or a group of regions corresponding to a particular channel or feature. A given region includes a set of pixels in a given ground truth mask. In one embodiment, the ground truth mask can be annotated to include regions or features corresponding to a particular type or class such as calcium, plaque, EEL border, and various other classes, types, and classifications disclosed herein.

[0075] In one embodiment, data augmentation is performed by increasing the density of the image dataset by performing one or more transformations on the image data, the annotated image data, and / or the ground truth mask. These transformations may include one or more of circular shift, left flip, right flip, flattening, resizing, cropping, filtering, binarization, and normalization. When the image data is OCT data, IVUS data, or other data acquired using one or more rotational elements, data augmentation is performed subject to avoiding transformations that are inconsistent with the imaging being performed.

[0076] In one embodiment, the MLS includes a CNN that includes one or more inputs and receives image data and generates an output based on the MLS performing processing on the image data. In one embodiment, the MLS and / or the CNN includes a deep learning classifier. In one embodiment, about 400 to about 2000 image data elements, such as an OCT image, an IVUS image, or an angiogram image, are annotated by an expert or a first MLS is provided to the MLS as image data. The image data includes image data elements and ground truth annotations for such data elements obtained from one or more experts and / or the first MLS for image pre-processing such as lumen detection. In one embodiment, the pixels (or a subset thereof) of each image data element are annotated by an expert of the first MLS.

[0077] Thus, the image data, including image data elements and ground truth annotations to the image data elements, constitute a training set that is provided as input to the MLS. In one embodiment, the training set is input to the MLS, which includes a CNN and / or deep learning classifier. As shown in FIG. 1A, image data / image data elements and ground truth annotations are input to the MLS. The output from the MLS is compared to the ground truth annotations and / or image data elements combined with the ground truth annotations to generate an error value. In one embodiment, the error value is the output of a cost function. In one embodiment, the error value is a training error value. Various metrics, scores, and tests can be used to evaluate the change and convergence of the training error over time to an acceptable threshold. In various embodiments, Dice, Jaccard, cosine similarity, and overlap distance, metrics, scores, or coefficients can be outputs, inputs, or components of the cost function. Further details regarding the cost function are described herein. The system of FIG. 1A, as well as other systems disclosed herein, can include various pre-processing steps to further improve training and / or processing times.

[0078] FIG. 1F is an exemplary method 80 of the present disclosure including a training process and subsequent prediction process suitable for use with various regions / features of interest, such as lumen, calcium, media, and intima. In one embodiment, the trained neural network is trained using ground truth annotations including calcium, intima, lumen, and media. In one embodiment, the trained neural network is trained using ground truth annotations consisting of calcium, intima, lumen, and media, or ground truth annotations specifically directed to one or more of these. The method includes acquiring image data, which may include polar image data, such as endovascular data (step 100). Initially, a set of ground truth data, such as a ground truth mask, is established by reviewing and annotating the set of image data. In one embodiment, the method includes annotating one or more regions or features of interest in each polar image of the set of images, such that each annotated region or feature becomes a ground truth annotation (step 102). Pixels corresponding to the ground truth annotations may be stored in persistent electronic memory, such as the database of FIG. 1. All of the data and annotations described herein may be stored in a database or other data structure acceptable to the neural network and image processing software modules of a given imaging system.

[0079] In one embodiment, ground truth annotation can be done using a user interface as shown and discussed in more detail herein, such as with respect to FIG. 3A. In one embodiment, the annotations can include a set of regions or features of interest identified by a user along with the boundaries or pixels that make up the regions or features, stored as a ground truth mask. In one embodiment, the mask includes an overlay of pixels that is combined with an original image, such as a polar image. In one embodiment, the mask includes an address / list of pixels that correspond to a particular ground truth annotation or prediction result.

[0080] Training a neural network of a machine learning system using the set of annotated polar images is performed (step 104). The training can be performed using ground truth masks and image data that is annotated to obtain these ground truth masks. The ground truth masks can be augmented using circular flip, right flip, left flip, and other augmentation transformations applicable to rotational imaging modalities. In part, the disclosure relates to augmented polar images where one ground truth mask is modified to increase the number of ground truth masks. In one embodiment, lumen detection is performed as an initial detection step, where the ground truth mask includes a lumen boundary or lumen features or lumen regions. In one embodiment, training is performed until one or more metrics, such as a cost function or other measure of error, are reduced to an acceptable level. As the error is reduced, the detection / prediction accuracy of the MLS improves.

[0081] Once the MLS is trained, the neural network is fed with image data to generate a set of image data with prediction, detection, classification, etc. of various features / regions of interest (step 105). K probability masks are generated for each of the K classes / types (step 106). An example of a probability map output / probability mask when K is 3 for three different classes is shown in FIG. 1G. Specifically, FIG. 1G shows image data obtained from imaging a patient and three output probability maps / probability masks of different classes. The output masks / maps correspond to the detection of tunica media M, calcium Ca, and lumen L as separate channels given an exemplary embodiment of the present disclosure. As shown, for each channel, the detected class is shown in red. Thus, in FIG. 1G, tunica media M is shown in red in the tunica media channel, the two detected calcium regions Ca are shown in red in the calcium channel, and lumen L is shown in red in the lumen channel. Other indicia can be used to color-code or represent the various detected / predicted classes corresponding to the regions / features of interest. In one embodiment, each class or type of feature of interest is assigned an associated channel for tracking the masks, maps, and final output that have predictions regarding the classification of each portion of the image on which the network was trained.

[0082] K is 4 where calcium, media, lumen, and intima are the classes / types for which the neural network is trained to classify features / regions. In one embodiment, the output of the neural network includes K probability maps such that there is one probability map for each class / type. The method can include generating a final prediction output for each frame of input image data (step 107). In one embodiment, each of the K probability maps for each of the K different classes / types is compared and evaluated pixel by pixel such that each pixel of a given image frame is evaluated, and a final prediction result is assigned to each pixel. In this manner, each frame of image data is processed and a final prediction output is generated. In one embodiment, the final prediction result is a prediction output mask that includes one or more indicia corresponding to the type / class. In one embodiment, the method includes displaying the final prediction output image from the neural network / machine learning system along with the class / type indicia (step 108).

[0083] In one embodiment, various indicia are used to color-code or otherwise visualize the segmentation between different regions and features of interest identified using the trained MLS. In one embodiment, the output image data is displayed, modified to include the features / regions of interest identified / predicted using the neural network / machine learning system. The above steps can be performed using one or more of the computer-based and AI processor-based systems disclosed herein.

[0084] Various neural network architectures can be used with the embodiments disclosed herein, such as V-net, U-net, CUMedVision1, CUMedVision2, VGGNet, multi-stage multi-recurrent input fully convolutional network (M 2FCN), coarse-to-fine stacked fully convolutional nets, deep active learning frameworks, ResNet, combinations thereof, and other neural networks and software-based machine learning frameworks may be suitable for performing feature / region of interest image segmentation and classification as disclosed herein. FIG. 2 is an example of a convolutional neural network architecture suitable for training using annotated ground truth masks and generating a probability map suitable for evaluating prediction output and showing classified image data with classified regions / features of interest. The multi-layer neural network architecture 115 of FIG. 2 is suitable for training using ground truth annotations and generating prediction results. The neural network architecture of FIG. 2 may be trained using ground truth masks of various types / classes (calcium, lumen, media, intima, and numerous other groups as disclosed herein). The network 115 may be any of the network architectures disclosed herein or modified versions thereof or combinations thereof. In one embodiment, the network 115 is a convolutional network.

[0085] Neural network 115 includes input 111 and output 117. Output 117 is K probability maps for each image data input when K classes are specified for classifying features and regions of interest. The K probability maps are evaluated using a scoring or weighting system where the output probability maps are compared for each frame of image data 111 and used to ascertain which pixels have a higher relative probability of being one of the K classes. The evaluation results in a final predicted output showing the various K classes and associated features and regions, along with indicia and legends distinguishing the classes.

[0086] The various nodes are N1-N9 shown in the network 115 with associated sets of operations and transformations "OP" that can be applied to the channels of image data. In various embodiments of the network 115, the number of channels T is typically 16 or more. To streamline the processing speed of the network 115, applicants set T to 4, finding that T=4 is suitable for training the network to classify and evaluate arterial image data. Thus, in various embodiments, T channels correspond to 4 channels, 2T channels, 4T channels, 8T channels, and 16T channels correspond to 8 channels, 16 channels, 32 channels, and 64 channels. These various channels are set at each layer / hidden layer of the network to specify how instances of input data should be processed with respect to various functions OP of the various nodes of the network. In one embodiment, the network 115 is trained with ground truth masks using functions / operators such as adaptive learning algorithms. In one embodiment, a gradient descent based method is used to train the network 115 with annotated ground truth masks.

[0087] The various nodes of the network 115 include a set of operations and conversions OP in nine nodes N1-N9, as indicated by OP1, OP2, OP3, OP4, OP5, OP6, OP7, OP8, and OP9. Other nodes and layers can be added between nodes N2, N3 and nodes N7, N8, as indicated by network elements 128a, 128b. The left side of the network 115, including nodes N1, N2, N3, and N4, and the input arrow from node N4 to N5, performs one or more downsampling / downconversion operations DC. In contrast, the right side of the network 115, including the output arrow from node N5 to N6 and nodes N6-N9, this part of the network performs one or more upsampling / upconversion operations UC between the nodes. In one embodiment, this neural network architecture includes an encoder that captures contextual information and a symmetric decoder path that allows for accurate localization.

[0088] The left part of the network 115 is a downsampling encoder part where convolution blocks and downsampling operations are used to encode the input image into a feature representation at different levels. The right part of the network includes upsampling convolution and concatenation operations. The right part of the network operates to output an image with the same dimensions as the input image. In one embodiment, the network architecture has four instances of downsampling or upsampling operations, and therefore the dimensions of the input image need to be divided by 16 to avoid dimensional mismatch. In this specification, the image data has pixel dimensions of M×N.

[0089] In one embodiment, the M×N dimensions are 912×512, although other specified dimensions may be used. In one embodiment, images other than the specified M×N size are padded or cropped to match the specified dimensions. In various embodiments, the OP operations and functions OP1-OP9 performed at each node are selected from the group consisting of convolution, deconvolution, additive process, concatenation process, upconversion process, downconversion process, Softmax process, and PReLu process. In one embodiment, Softmax process and Parametric Rectified Linear Unit (PReLu) process are performed between one or more nodes as a layer that converts network parameters transmitted between nodes from the input image data into probabilities for inclusion in the output probability map. In one embodiment, the output of the neural network includes a probability assignment layer, such as may be configured using a Softmax function. Probabilities according to another grouping, such as per pixel, per scanline, or per mask region based on a set of trained classes, also referred to as types or labels, are provided as a plurality of outputs 117 for each of the K classes. In one embodiment, each node may act as a layer, and a layer may be defined by two horizontal nodes and arrows between them. In one embodiment, transfers between nodes, as indicated by arrows 130a-130d from the left side of the network to the right side of the network, correspond to combining or concatenating one or more channels from the left side of the architecture to the right side of the architecture.

[0090] In one embodiment, the network architecture of FIG. 2 is configured to characterize three or more types / classes of pixel labels, such as calcium, media, lumen, and other classes and types of corresponding imaged features and regions of interest. In one embodiment, network 115 reduces the channel count such that T is 4, and the processing speed of the network is substantially real-time for about 400 to about 600 frames of image data for all of the T channels shown. Given the goal of reducing waiting dwell time in the cath lab during imaging and other procedures, complex neural networks, such as networks with T greater than 4, will have longer inference times when generating predicted outcomes / probabilities, but will also cause other problems in the training process, such as overfitting. In various embodiments, setting T to 4 in network 115 of FIG. 2 results in reduced inference times and improved accuracy of the network. In one embodiment, when T is equal to 4, the channels in FIG. 2 are 4, 8, 16, 32, and 64, corresponding to the T, 2T, 4T, 8T, and 16T channels shown.

[0091] In one embodiment, each horizontal layer, such as a given node or two nodes linked by a forwarding operation 130a-130d, is a convolutional layer performing convolution operations, such as one or more of OP1-OP9 and / or vertical DC operations between nodes. These layers extract or learn some features of the input ground truth data. For the convolutional layer on the left side, different strides can be set for each node. The given stride provides control over downsizing of the image during the convolution operation. For example, if the image size is 256×256, the output size after convolution is 128×128 (256 / stride). The deconvolution on the right side of the network performs upscaling for each of the various UC operations.

[0092] FIG. 2A is a schematic diagram showing a set of outputs from an MLS including indicia corresponding to various color-coded classes Ca (red), lumen (blue), and media (green), and their use to obtain an axial projection to generate a carpet view and optionally a tissue map, in accordance with an exemplary embodiment of the present disclosure.

[0093] In various embodiments, the neural network architecture can be a 2D network or a 3D network, and thus is operable to process 2D and 3D data. In one embodiment, a 3D pullback of F frames, each frame being a 2D polar image, is displayed using a carpet view representation. In various embodiments, a filter can be applied to the 2D carpet view to remove noise or other unwanted features that would increase processing time compared to using a 3D operator. Further details regarding the use of the carpet view are provided with respect to FIG. 2A.

[0094] After the tunica media and calcium detection process, each frame in polar space has a corresponding frame / mask of the regions of interest / features of tunica media M and calcium Ca. These frames / masks can include lumen L and other classes used to train the neural network for ROI / FOI detection. A set of four output image masks / frames 190 is shown as an example. In various embodiments, this set of frames contains about 400 to about 600 frames. A color code indicia is used and shown in the frames and images in FIG. 2A with blue for lumen, red for calcium, and green for tunica media. The output image mask can cover the entire pullback when OCT or IVUS data is used. In one embodiment, all of the frames of the tunica media and calcium masks, which in this example also include the lumen, are projected along an axis, such as the x-axis or y-axis, as an OR operation to obtain the lines of the mask. The lines resulting from the projection operation are shown as four lines 193. One can see the color coding of the pixels in the projected lines with green for tunica media and red for calcium. In one embodiment, all lines are combined into one binary media mask and binary calcium mask based on left to right proximal to distal frame order.

[0095] This combination of line projections 193 is shown as carpet view 195. Optionally, in some embodiments, the carpet view or line projections 193 are used to create a tissue map 198 as shown. The outermost ring of the tissue map corresponds to the proximal direction, while the innermost ring indicates the distal direction. In one embodiment, the tissue map 198 is created by performing a polar transform on the carpet view. The carpet view essentially contains 3D data including all frames from the pullback. In one embodiment, a binary morphological reconstruct filter is applied to the media and calcium carpet view image 198 to clean out noise and small structures. In one embodiment, such carpet view filtering step on the carpet view based on the predicted output frame / mask from the neural network advantageously removes small detection areas in the carpet view image, while large detection areas remain unchanged.

[0096] In one embodiment, the processed carpet view image can be applied to the media mask and calcium mask through a convolution process, an additive process, or a comparison process, etc., to remove noise in the 3D polar space. By limiting the operations on the 2D carpet view to 2D filters, the processing time is improved relative to operations on the 3D data space using 3D operators. The various processes and operations shown in FIG. 2A can be implemented using computer-based systems and software modules, such as image processing pipelines and neural network-based feature / region detection and classification. In one embodiment, the method of detecting ROI / FOIs, such as calcium, media, lumen, and intima, using a trained neural network includes performing one or more of side branch detection, guidewire detection, and stent detection using an image processing pipeline instead of using a trained neural network to increase the processing rate of the set of image frames acquired during the OCT pullback.

[0097] In one embodiment, the carpet view is a 3D representation of the image frames of the intravascular pullback. The intravascular image data acquired during the pullback procedure using the probe can be displayed to the user by creating a representation of the scan lines by unfolding cross-sectional or polar views along the longitudinal plane. The carpet view is a two-dimensional data representation. In one embodiment, the carpet view shows a cross-sectional OCT image, but unfolded or unfolded similar to unfolding a wrapped cylinder of a carpit.

[0098] The carpet view can be used to display groups of polar image data or underlying components thereof in one or more ways. For example, in one embodiment, the carpet view reduces the radial offset dimension of a 3D endovascular data set to a single intensity. In this way, the data can be represented in (Z, θ) coordinates. In one embodiment, a line projection can be used to generate the carpet view. In one embodiment, a method for reducing the radial offset dimension is to sum the intensity values ​​between the near offset estimate and the far offset estimate. This summation of intensity values ​​produces a detectable increase in contrast for some specific regions in the carpet view / OCT image. These can be used to improve resolution and remove noise from the output prediction mask displayed using one or more panels of a graphical user interface such as those shown in Figures 5E and 13A-B.

[0099] In one embodiment, the carpet view or OCT data can be used to generate a carpet view mask. A carpet view mask of the endovascular data can be generated to facilitate filtering of noise and artifacts from the final predicted output displayed via a user interface such as that shown in Figures 5E and 13A-B. A process of binarization performed on the carpet view image is advantageous. In one embodiment, the carpet view mask is used as input for a subsequent endovascular image processing stage where unwanted pixel fragments or other noise are removed.

[0100] In one embodiment, a carpet view is a two-dimensional data set generated from a pulled-back scanline in which the offset dimension along the scanline is removed or reduced. In a carpet view, shadow areas have low intensity values ​​and tissue has high intensity values. Carpet views are typically grayscale images, but in some embodiments, a color version can be displayed.

[0101] In one embodiment, training and experiments were performed using three or more AI processors, such as graphical processing units. In one embodiment, the training code was implemented in Python using the PyTorch framework. Before inputting the OCT images and masks into the neural network for training, all images were normalized to the range of (0.0 to 1.0). All images and masks were randomized in order and further divided into two parts. The first part is 90% of the entire dataset used in training the model. During the training session, the images and masks were randomly shifted vertically between (-256, +256) to extend the training samples for each epoch. The second part was used to evaluate the performance of the trained model after each epoch. In one embodiment, the cross-entropy loss was calculated over the model output using a Softmax function operable per pixel. The training and testing results are shown in Figures 2B and 2C. The loss function refers to the actual cross-entropy loss calculated from the predictions and ground truth, as shown in Figure 2B. The mismatch percentage is the percentage of misclassified pixels in each image compared to the ground truth. Both Figures 2B and 2C show that the training process converged well after 300 epochs, with no overfitting issues.

[0102] As mentioned herein, lumen detection is performed on ground truth data image data and user image data where features / regions of interest need to be detected / classified. In some embodiments, lumen detection is performed by analyzing scan lines for discontinuities such as start and stop pairs. In other embodiments, lumen detection is performed using a 2D or 3D neural network trained with annotated images such as a ground truth mask with identified lumen boundaries. FIG. 2E shows polar image data of an artery 230 with identified lumen L and tissue T. FIG. 2F shows polar image data 233 annotated with ground truth lumen data and a mask with lumen L and tissue T corresponding to two different regions / channels of interest. FIG. 2G shows output image data 235 resulting from lumen detection performed using MLS with 2D neural net. FIG. 2H shows output image data 240 resulting from lumen detection performed using MLS with 3D neural net.

[0103] 3A and 3B show a user interface of a system suitable for navigating frames of image data and annotating the image data to generate ground truth. FIG. 3B shows a polar image 350 in which a region 357 is defined as ground truth point-wise, such as through the movement of boundary points 360a, 360b, 360c with pixels away from the center of the region. In one embodiment, various drawing editing tools can be used to annotate the raw image data. These annotated images can be used to generate a ground truth mask, with the classes or features of the annotated regions defined using the interface 305 of FIG. 3A and stored in memory. In FIG. 3A, 271 frames of the intravascular imaging pullback are available for annotation. Frame 146 has been selected for annotation to provide ground truth data for training the MLS. The user-selected region for annotation in FIG. 3B corresponds to the tunica media as indicated by the class identifier selected in FIG. 3A. In this manner, any feature / class can be selected for labeling, which is stored in memory along with the annotation. The annotations include pixel boundaries / regions that define masks that are matched to particular classes or features, such as, but not limited to, lumen, media, calcium, and can include any class, feature, or region disclosed herein.

[0104] As an example, Figure 2C shows a plot suitable for evaluating the change in training error over time (from 0 epochs to over 600 epochs). In Figure 2C, the x-axis shows the training epoch number and the y-axis shows the Dice coefficient, which is a measure of error. The blue and orange curves show the performance of the network on the training and test data.

[0105] In one embodiment, training data, such as ground truth data, is provided as input to the MLS CNN along with image data elements, which may include various image formats, such as raw grayscale images. The MLS is run for a period of epochs until the training error is reduced, minimized, or otherwise below a threshold. In one embodiment, this period ranges from about 100 epochs to about 1000 epochs.

[0106] In one embodiment, the training data, including raw images and ground truth annotations, are all in polar coordinates. The ground truth annotations can be augmented with existing software algorithms that perform lumen detection. The lumen detection output from this software is combined with expert user annotations of media, plaque, and plaque type to generate the ground truth image. In one embodiment, the input to the MLS is the ground truth image and the output is the classified image. When the classified image is the same as the ground truth image, the error is approximately 0.

[0107] FIG. 1B illustrates the use of the MLS 15 after training the MLS 15 using one or more of the training processes described herein or otherwise suitable for use with the MLS and CNN. Once trained, a given MLS / CNN can process raw images and output image segmentations including classified or characterized tissues. In one embodiment, polar images from the pullback of an intravascular imaging probe are processed by the trained MLS to generate classified images. The system of FIG. 1B can include various pre-processing steps / operations 16 that further improve training and / or processing times. In one embodiment, the pre-processing includes a normalization step. In one embodiment, the normalization step includes normalizing the intensity of one or more or all of the image data, ground truth annotations, masks, frames, scanlines, neural network output, and other intensity-based data such that the intensities are normalized within a range such as about 0 to about 1 or another applicable range.

[0108] An example of an unclassified / uncharacterized OCT image in polar format corresponding to an image of a cross section of a coronary artery is shown in the first image of FIG. 2D. The second image of FIG. 2D is the polar image plus a ground truth mask showing the ROI / FOIs of the media, Ca, and lumen. The third image of FIG. 2D is a polar OCT image with inference or prediction results shown in color-coded indicia with the media in green, calcium in red, and lumen in blue. An example of user image data acquired using an optical coherence tomography image classified or characterized by a trained MLS is shown in, for example, FIG. 3D and FIG. 3E. Comparing FIG. 3D with FIG. 3C, it is clear that both images are Cartesian images. In one embodiment, MLS training and prediction are performed on a polar image, and after classification is performed, the polar view is converted to a Cartesian view, and annotations generated by the trained MLS are displayed on the image using color coding or other suitable indicia or visualization. As shown in FIG. 3D, the inner lumen region is shown in blue, the calcium containing plaque region at the 9 o'clock position is shown in red, and the media region is roughly indicated as the thin curved region on the right side of the image extending past the midpoint between the top and bottom of the lumen.

[0109] A given cost function provides a metric to evaluate the output of a machine learning system by comparing the ground truth input / training set with the expected output when processing patient data. The goodness of fit between the training data and the output data can be measured using the cost function. The output of the cost function can be a value corresponding to an error metric. This output is a comparison metric such as difference or distance that summarizes how successful the machine learning system or neural network or other operating components thereof is in terms of accurate predictions given the predicted results and ground truth used to train the system. If the output result of the cost function is 0, then the system is operating perfectly valid. Thus, iterative modifications to the system can be used to reduce the cost or error function of the system and improve its prediction accuracy.

[0110] In addition, a pixel-wise cost function is specified to measure the distance between the prediction and the ground truth or another suitable metric or score. In one embodiment, backpropagation is to update each of the network-based value weights derived from the cost function. In one embodiment, partial derivatives of the cost function are used to update the weights during backpropagation. This weight update process has the advantage that the actual prediction result is closer to the ground truth. This has the advantage of reducing or minimizing the error of each output neuron / node of the neural network. In one embodiment, the neural network is a convolutional neural network (CNN).

[0111] FIG. 1C is a schematic diagram of a machine learning system 30 including a trained neural network 34, such as a network trained with an augmented dataset of annotated ground truth masks. As shown, input image data, such as OCT polar image data in the illustrated example, is processed by the trained neural network 34. The input polar OCT images are processed to generate predicted values / prediction outputs in the form of polar images including color-coded indicia corresponding to various arterial features / regions, such as the tunica media (green), calcium (red), and lumen (blue) as shown. Also shown is an example of a ground truth image in the form of an annotated ground truth image mask used to train the MLS neural network 34. In various embodiments, the output of the MLS system includes one or more of an arc-based metric / measure of similarity of both Ca and EEL, detected EEL diameter, and detected Ca depth. In some embodiments, these values ​​are measured on the image data after classifying the EEL, tunica media, calcium, lumen, and other regions and features of interest.

[0112] With continued reference to FIG. 1C, once the MLS is trained, backpropagation can be performed from time 0 to a backpropagation time BPT. Thus, predictions corresponding to annotated images or masks are generated by inputting raw images from a patient, such as OCT pullbacks, into the MLS and propagating the data through the network to generate predicted outputs. In one embodiment, the BPT time ranges from greater than 0 seconds to about 60 seconds. In one embodiment, the BPT time is less than about 180 seconds. In one embodiment, the BPT time is less than about 90 seconds. In one embodiment, the BPT time is substantially real-time as disclosed herein in various examples. Various neural networks 34 can be used to implement the systems and methods disclosed herein. These networks can include various hidden layers, functions, operators, and operatively combined operators for multiple channels. In one embodiment, a channel corresponds to input image data, such as a set of pixels from a given frame or a subset of pixels from a given frame.

[0113] FIG. 1D illustrates the MLS 55a operating with the image processing components of the imaging system to generate results that are sent to the imaging system. In one embodiment, the image processing is OCT image processing. The MLS performs AI detection using a neural network. This can be done using an AIP / GPU. Processing time T1 ranges from about 20 seconds to about 40 seconds in one embodiment. In one embodiment, the AIP is a GeForce GPU of the 1080 family or higher. AI detection can be configured to detect the lumen, calcium, EEL, and any of the ROIs / FOIs disclosed herein. The system 65a of FIG. 1E separates lumen detection as a separate processing stage with processing time T3. Lumen AI detection can be done using one or more AIPs / GPUs. The system of FIG. 1E also includes various pre-processing steps that reduce downstream processing time when the patient is in the cath lab, with tissue detection / prediction being done while the patient is being prepared for the procedure. Pre-processing can have processing time. In one embodiment, the pre-processing includes a data flattening step.

[0114] Finally, AI detection can be performed on the lumen detection and pre-processed image data. The AI ​​detection process can take a period T4. In one embodiment, T3 ranges from about 1 second to about 5 seconds. In one embodiment, T4 ranges from about 5 seconds to about 12 seconds. In one embodiment, the total processing time T2 ranges from about 8 seconds to about 20 seconds. In one embodiment, T2 is from about 5 seconds to about 15 seconds.

[0115] In one embodiment, the MLS and method steps and operations performed may include semantic image segmentation utilizing an end-to-end trained neural network to process OCT images. The training data includes approximately 900 OCT images with manually labeled regions of interest in polar space, each region of interest corresponding to a given ground truth. Each given ground truth may be mapped to a channel detected in the image data using the trained network. In one embodiment, various input images and their corresponding channel-specific masks are used to train the network using one or more algorithms. In one embodiment, a stochastic gradient descent optimization algorithm is used.

[0116] In part, the present disclosure relates to methods for classifying tissues and their various constituent layers and materials (each of the exemplary tissue types or tissue properties listed above) and changes therein over time. Exemplary output Cartesian images of a patient's artery classified by MLS and one or more associated methods are shown in images B and D of Figures 3D and 3E.

[0117] Figures 2E-H show polar images of an artery, polar images annotated using ground truth lumen data, and lumen detection results performed using MLS with a 2D neural net and MLS with a 3D neural net.

[0118] The various layers of a coronary artery are shown. An internal region P corresponding to a shadow or reflection from an intravascular imaging probe P is shown in the lumen of the blood vessel L. In particular, the present disclosure relates to detecting and identifying tissue types and regions and / or features of interest for an artery and displaying indicia or other visualizations of such tissue types. This prediction or inference from the MLS shown in the tissue-characterized / classified arterial image helps the end user to facilitate diagnostic and treatment decision-making. Some non-limiting examples of tissue types that can be detected using the methods and systems disclosed herein include the internal region through which blood flows, the lumen, the tunica intima, the tunica media, the external elastic lamina (EEL) (also called the external elastic membrane), the internal elastic lamina (IEL), the tunica adventitia, plaque, calcium or calcified tissue, etc. The tunica media is bounded by the IEL and the EEL. The tunica intima is bounded by the lumen and the IEL.

[0119] The present disclosure relates to various embodiments that use one or more machine learning or artificial intelligence (AI) systems to detect or segment an image of an artery or other structure into various constituent tissue types or regions of interest. In part, the machine learning system is designed to be installed or combined with an imaging system such as an intravascular imaging system, an ultrasound system, or an X-ray system such as an angiography system or a fluoroscopy system. In one embodiment, the disclosure relates to using MLS to characterize tissue to detect one or more of the lumen, EEL, tunica media, and calcium / calcium plaque. Further details regarding these arterial layers and calcium plaque are shown in Figures 5G-5J.

[0120] In one embodiment, the image data, which may be raw image data from one or more imaging systems (OCT, IVUS, angiography, x-ray, fluoroscopy, etc.), the ground truth annotations are all in one or more coordinate systems. The ground truth, ROI, FOI, and predicted results may each correspond to a channel and may have an associated image mask within a given training image or patient image. Processing data in polar coordinate format, such as OCT data, is challenging for a variety of systems.

[0121] Timely processing of image data using MLS is a practical necessity, given the real-time requirements associated with generating a classified set of image data immediately after acquiring such image data from a patient who still has a catheter inserted. To enable the use of machine learning and AI techniques, various pre-processing or MLS design options can be implemented to facilitate data processing times in the range of about 1 second to about 20 seconds.

[0122] In general, the systems and methods disclosed herein provide various automated diagnostic tools to help physicians determine whether to treat a given patient and, if so, which lesions / stenoses to treat. In one embodiment, the system provides guidance to treat the most critical lesions based on physiology. In addition, details about the plaque type and other MLS detected features can be used to select the shortest stent that provides maximum flow restoration. In addition, a virtual stenting procedure can be performed that provides interactive planning that allows the stent to be adapted for placement in a known artery by tissue classification and other measurements as disclosed herein.

[0123] The systems and methods disclosed herein provide guidance to allow clinicians to evaluate various stent landing zones. This can be supported by virtual stenting with virtual flow reserve values ​​that aid in lesion landing zone selection. Co-registration with angiography and OCT data further supports this. With the use of MLS detection, normal frames (frames with healthy tissue) have more adequate media / EEL coverage. Thus, MLS as implemented herein solves the problem of guiding stent planning and helping to improve patient outcomes.

[0124] Furthermore, automated EEL measurements obtained using the MLS described herein inform which stent size should be considered and which type of stent should be used. Calcium detection via MLS provides information on lesion pre-treatment and treatment options, such as choosing atherectomy over stenting. Additionally, calcium detection provides an input parameter when deciding between calcium detection aids in the decision of BVS vs. DES.

[0125] 4A-4C are exemplary imaging diagnostic systems including one or more machine learning systems that are or can be integrated with an imaging system or that are otherwise combined or can be combined with an imaging system. Exemplary imaging systems can include OCT, IVUS, angiography, fluoroscopic x-ray based imaging systems, etc.

[0126] Referring to FIG. 4A, an imaging system 410 is shown including a data collection / imaging probe 407 and an MLS system 442 suitable for use as an intravascular diagnostic / data collection system. The system 442 can include an AIP, such as one or more GPUs, serial or parallel, and an AI memory AIM. This system can be used to implement one or more of the AI / ML based techniques, systems, and methods described herein. The system 410 can be used as a stent planning system to suggest stent placement options and provide a graphical user interface for simulated or virtual stent planning based on flow measurements such as VFR, IFR, FFR, etc. Some exemplary graphical user interface components of such a system are shown in FIG. 13A and FIG. 13B. FIG. 13B shows an artery cross-section with measured and predicted VFR values. Additionally, a mask has been generated using a trained neural network to indicate calcium (Ca / red), media (M / green), and lumen (L / blue). The simulated stent is also shown in a longitudinal section of the artery representation in the user interface shown in FIG. 13B.

[0127] In various embodiments, the intravascular probe 407 can be used to image an artery in the presence of an X-ray imaging system, such as an angiogram. Other imaging systems, such as CT scans, MRIs, X-ray based imaging systems, and other 2D and 3D imaging systems, can be used to generate image data and / or the image data can be stored in one or more memory storage devices. The probe 407 in various embodiments can include other imaging modalities, such as OCT, intravascular ultrasound (IVUS), etc. The probe 407 is in optical communication with an intravascular diagnostic / data acquisition system 410. An OCT optical system or subsystem 431, which connects to the probe 407 via optical fiber 414, includes a light source, such as a laser, an interferometer with a sample arm and a reference arm, various optical paths, a clock generator, photodiodes, and other OCT system components.

[0128] The system 410 further includes one or more diagnostic software tools or modules 412 for MLS-based image detection. This software can be stored as non-transitory instructions on one or more memory devices, such as memory device 445, and can be executed by one or more computing devices, such as computing device 440 or MLS 442. The MLS, in one embodiment, includes one or more AI processors AIP and dedicated memory AIM. The stent planning software tool can include one or more vascular profiles, such as a target profile generated by a user, a comparator, or other comparison software routine that compares pre-stent and post-stent profiles or other profiles. In general, the software 412 can process a set of endovascular data and perform various method steps described herein, such as those described with respect to Figures 1F, 2, 2A, 2B, 4B, 4C, 12A, and 12B, and other method steps depicted and disclosed herein. In one embodiment, the software 412 is stored in the AIM and executable by the AIP.

[0129] The software 412 is designed to process endovascular data sets and other vascular data from other detectors or data sources, such as an intravascular probe or angiography system. In one embodiment, the vascular data can be recorded during a pullback procedure and stored in an electronic memory device. The training, pre-processing, and ground truth mask generation, detected / predicted tissue classification, neural nets, and other features and software components can be executed on the AIP or computing device 440. The software includes various MLS training, pre-processing, and prediction modules, as shown. These can include a lumen contour prediction module 412A, a side branch prediction module 412B, a resizing module 412C, an image flattening module 412D, a lumen flattening module, a stent strut prediction module 412E, a user interface and input processing module 412F, a pre-processing module 412G, an MLS interface module 412H, an MLS memory manager module 412I, a GUI training module 412J that annotates image data and generates ground truth masks, an intensity normalization module 412K, and the like.

[0130] In one embodiment, the software modules are designed to process the endovascular data to characterize the tissue and identify regions of interest such as calcium regions, taper regions, lipid pools, and other tissue features. The software 412 can also compare coronary flow reserve, vascular resistance ratio (VRR), and other measured and calculated endovascular data collection parameters. To the extent that such parameters change from the stented to non-stented state, such parameters can be used to generate one or more metrics.

[0131] In one embodiment, an OCT system 431 can be used. This system includes an optical receiver, such as a balanced photodiode-based system, that receives light returned by the probe 407. A computing device 440, such as a computer, processor, ASIC, or other device that is part of the system 410 or included as another subsystem in electrical or optical communication with the system 410, receives electronic signals from the probe 407. The computing device 440 in various embodiments includes local memory, buses, and other components suitable for processing data and utilizing software 444, such as image data processing configured for stent visualization and stent malapposition detection. In one embodiment, a PCIe bus or other high bandwidth, low latency bus is used to connect the various components of a given imaging system, MLS, or combination system including both.

[0132] The stent deployment planning tools 412 may be part of or exchange data with the software 444. These tools may be used to place a virtual stent in the luminal area where the probe 407 is positioned against the vessel wall. Figure 13B shows an exemplary region of a pullback segment where one or more virtual stents may be deployed and displayed on the user interface.

[0133] As shown in FIG. 4A, a display 446 can also be part of the system 410 for showing information 447, such as cross-sectional and longitudinal views of the vessel, generated using the collected endovascular data. Once the endovascular data is acquired using the probe 407 and stored in the memory 445, the endovascular data can be processed to generate and display information 447, or a subset thereof, such as cross-sectional, longitudinal, and / or three-dimensional views of the vessel along the length of the pullback region. Two-dimensional or three-dimensional image masks can be used to show or store ground truth data and predicted results. These views can be depicted as part of a user interface, as shown in subsequent figures and described below. Images of the vessel generated using distance measurements acquired from the system 410, when processed using the tools and software modules described herein, provide information about the vessel, including lumen contour, vessel diameter, vessel cross-sectional area, landing zone, and virtual stent bounded by the landing zone. In one embodiment, the MLS 442 includes one or more computing devices and one or more software programs or modules. There are various devices, components, systems, and subsystems disclosed herein that are operable to perform the tasks, methods, steps, processes, and other features described herein with respect to each of them.

[0134] The MLS 442 may include one or more AI processors and / or GPUs and / or processing cores and / or stream processors and dedicated memory to perform the MLS training and prediction / inference when processing patient image data, such as image data elements. Further details of an MLS-based system are shown in FIG. 4B.

[0135] As shown in FIG. 4B, a combined imaging and MLS system 450 is shown. The system includes a display 420 that can support annotating raw image data with points and contours to store ground truth data for training the MLS. The display can be connected to the MLS 425 or the imaging subsystem 430. The MLS 425 and imaging system 430 have a data transfer interface 465. In one embodiment, the MLS 425 includes one or more buses / motherboards 468 that provide communication channels and connections for the various AIPs, memory, and other components. In one embodiment, the MLS 425 includes several AI processors (AIPs). These can be arranged in a server configuration. As shown, the three AI processors AIP1, AIP2, and AIP3 communicate serially, parallel, or a combination thereof. The MLS and imaging system are arranged in a housing in one embodiment. The housing includes a cooling system CS that manages the high temperatures generated by the AIPs. In one embodiment, the AIP includes one or more graphics processing units (GPUs). In one embodiment, the housing includes a temperature sensor TS that regulates a cooling system CS to ensure continued operation of the AIP within the housing. In one embodiment, the one or more AIPs are networked to the imaging system and / or MLS to transfer data for processing outside of the housing.

[0136] In one embodiment, the system includes a motherboard that connects to the AI ​​processor. The motherboard is located within a housing of the system. The housing can be a cart that includes wheels to move the housing and its imaging MLS system components around the cath lab or another location. The system includes a probe interface unit 470 that includes a coupler for an optical imaging probe, such as an OCT probe or an IVUS probe. This PIU is also referred to as a dock in one embodiment.

[0137] In various embodiments, the trained neural network is executed on an AI / ML processor, such as a graphics processor / graphics processing unit, located within the housing of the imaging / data acquisition system. The AI / ML processor includes N parallel processors. In one embodiment, N ranges from about 2000 to about 2500. In one embodiment, N ranges from about 2000 to about 3000. In one embodiment, N ranges from about 3000 to about 4000. In one embodiment, N ranges from about 4000 to about 5000. In one embodiment, N ranges from about 5000 to about 6000. Multiple parallel processors can be grouped on individual hardware elements called compute units. In one embodiment, the compute units range from about 20 to about 80 compute units for a given AI processor. Each compute unit can have multiple parallel processors. In one embodiment, a Compute Unified Device Architecture (CUDA) is used with CUDA cores ranging from about 2000 to about 10000 cores. In one embodiment, a Compute Unified Device Architecture (CUDA) is used with CUDA cores ranging from about 2000 to about 2500 cores. Examples of suitable parallel processors include, but are not limited to, CUDA and tensor core processors from Nvidia and stream processors from AMD. In one embodiment, about 200 to about 300 tensor cores are included in the AI ​​processor / graphics processor used.

[0138] In one embodiment, the AI ​​processor memory (AIM) is greater than about 8 GB. In one embodiment, the AI ​​processor memory is greater than about 16 GB. In one embodiment, the AI ​​processor memory is greater than about 32 GB. In one embodiment, the AI ​​processor memory is greater than about 64 GB. In one embodiment, the AI ​​processor memory is greater than about 128 GB. In one embodiment, the AI ​​processor memory is in the range of about 4 GB to about 256 GB. In one embodiment, the AI ​​processor memory is in the range of about 8 GB to about 128 GB. In one embodiment, the AI ​​processor memory is in the range of about 16 GB to about 64 GB. In one embodiment, the AI ​​processor memory is in the range of about 8 GB to about 32 GB. In one embodiment, the AI ​​processor memory is in the range of about 32 GB to about 64 GB. In one embodiment, one or more of the electronic memory storage devices include an NVMe™ interface to increase processing speed and reduce data analysis time for MLS operations when the patient is in the cath lab. In one embodiment, 16 GB or more of on-board RAM is used on the imaging / data acquisition system motherboard. In one embodiment, 32 GB or more of on-board RAM is used on the imaging / data acquisition system motherboard.

[0139] In one embodiment, the AI ​​processor memory is in the range of about 1 GB to about 2 GB. In one embodiment, the AI ​​processor memory is in the range of about 2 GB to about 4 GB. In one embodiment, the AI ​​processor memory is in the range of about 4 GB to about 6 GB. In one embodiment, the AI ​​processor memory is in the range of about 6 GB to about 8 GB. In one embodiment, the AI ​​processor memory is in the range of about 8 GB to about 10 GB. In one embodiment, the AI ​​processor memory is in the range of about 10 GB to about 12 GB. In one embodiment, the AI ​​processor memory is in the range of about 12 GB to about 14 GB. In one embodiment, the AI ​​processor memory is in the range of about 14 GB to about 16 GB.

[0140] FIG. 4C illustrates a system 475 having software modules suitable for processing image data using two alternative process flows for identifying / segmenting features / regions of interest on the image data. In one embodiment, the image data is arterial image data, such as polar OCT image data, but other image data from various image sources can also be used. In the upper process flow option, artificial intelligence based lumen detection 487 is performed, such as by using a NN trained on the lumen boundary / mask as ground truth. This AI lumen detection runs on an AI processor, such as a GPU, or other processor with dedicated memory. The image data, along with a mask or other representation of the detected lumen boundary for a frame of image data, is processed with a NN that uses forward and back propagation to segment / classify the image and generate the classes, features of interest, regions of interest, and other detections / predictions the NN was trained on. This results in a prediction result 495, such as an output predicted image mask.

[0141] In contrast, in other embodiments, other detections / predictions are made in various sequences and orders before using the results of any initial detections, such as side branch 479, guidewire 481, and lumen 482, along with the arterial image data as input to the MLS for processing the arterial data and pre-detection using the trained MLS. In this manner, MLS-based detections / predictions of a given set of pixel classes, FOIs, ROIs, etc. are determined with respect to the image data and a pre-set of detections. The pre-detections of side branches, guidewires, lumens, etc. can be stored as image masks. In one embodiment, the MLS is trained on a ground truth image dataset that includes pre-detections performed, such as side branches, guidewires, and lumens, in the illustrated exemplary embodiment.

[0142] In part, the disclosure relates to an automated method using a substantially real-time guided method to detect tissue such as calcified tissue or calcium including calcium plaques or other regions of interest, identify associated nodules / regions of interest for atherectomy, and perform atherectomy using a laser. In various embodiments, an OCT imaging probe is in optical communication with an imaging laser such as a swept source laser. As a result, there is an optical path that extends through the probe to a light directing element such as a unitary lens, a GRIN lens, or a beam director where light is received from the imaging laser. The light is transmitted through one of the optical elements to the tissue, and the light from the tissue is received and returned to the OCT imaging system. In the OCT imaging system, this light interferes with the light generated by the imaging laser.

[0143] FIG. 5A is a schematic diagram of an exemplary system for performing OCT-guided atherectomy. FIG. 5B is then a schematic diagram of an exemplary method for performing OCT-guided atherectomy. FIG. 5A shows a system 500 for detecting features of interest using an OCT system 505 that includes one or more MLS systems that include feature detection software such as a trained NN. An imaging probe 510 includes an optical fiber that is part of a sample arm of an interferometer. A reference arm of the interferometer is included in or in communication with the OCT system 500. A patient interface unit 470 includes a rotary coupler or other mechanism that couples the imaging probe and its optical fiber to the OCT system 505.

[0144] One or more optical switches 520 can be in optical communication with the PIU 470. The optical switches 520 can be controlled by controller software or a controller. The OCT system then includes an imaging laser 527 and includes or communicates with an ablation laser. The control software or controller 535 enables the optical switches to switch between an imaging laser for OCT imaging and an ablation laser for target ablation using a GRIN lens, beam director, microlens, or other optical element that directs light to the probe 510. The MLS and its detection software, such as calcium detection software 525, can then be used to identify regions of interest that contain calcium or other material for which ablation is the preferred treatment option.

[0145] In part, this disclosure relates to calcium detection using an MLS system, such as a deep learning based artificial intelligence system operating in conjunction with OCT software or other imaging software. The MLS highlights areas where calcium plaques or other ablation targets are present. The deep learning network / MLS was trained using 450-1000 annotated OCT images with calcium regions marked by expert users. This trained network is then fed raw OCT images that are segmented to the pixel level through the deep learning network.

[0146] In one embodiment, calcium detection using a trained MLS system, such as a deep learning-based artificial intelligence working with OCT software, is an aspect of the present disclosure. The MLS highlights areas where calcium plaques or other displaceable tissues are present. The deep learning network was trained using 450 annotated OCT images with calcium regions marked by expert users. The trained network was fed raw OCT images that were segmented to the pixel level through the deep learning network.

[0147] 5C and 5D show OCT images segmented to highlight calcium plaque regions using the MLS system. FIG. 5E is a user interface displaying detected regions of calcium, such as calcified plaques, in 3D, transverse and longitudinal cross-sectional views. FIG. 5F is then a calcium map created for the angiography data by co-registering the OCT data with the angiography data and displaying a frame containing calcium with respect to the angiography data. This maps the calcium plaques detected in the OCT onto the angiography graphical user interface for review and planning. The calcium regions detected in the OCT pullback are also mapped onto the angiography data for review by the physician. The physician then identifies calcium nodule regions of interest that are candidates for atherectomy or ablation procedures.

[0148] As outlined in FIG. 5B, a method 560 of detecting and eliminating tissue of interest using an OCT imaging probe is described. Initially, a first OCT pullback is performed (563). Using an initial set of OCT data, calcium detection is performed (565) using an MLS embodiment or another method of detecting calcium. The OCT data is collected during an angiographic imaging session. The resulting OCT and angiographic images are co-registered (573). A calcium map is generated (575) as shown in FIG. 5D. The clinician then reviews the image data and calcium detection to identify plaques that are grounds for ablation (577). Once the area of ​​atherectomy is identified, a second OCT pullback is performed (579). During this time between acquisitions, calcium detection 581 is also performed. The imaging / ablation system uses the calcium map and the target calcium nodules to align the atherectomy high powered laser as part of software-based control 583. The system also performs real-time calcium detection to correct for any changes in registration between the first OCT pullback image and the current image. This is facilitated by narrowing the range of the search window of frames that need to be considered. In one embodiment, once the catheter tip reaches the target calcium plaque nodule, a high-power ablation laser is turned on (584), providing a short burst of energy to vaporize and debulk the calcium nodule. The ablation procedure is user controlled in various embodiments to perform an atherectomy 587.

[0149] 5G and 5H show annotated Cartesian OCT images according to an exemplary embodiment of the present disclosure. These figures show the location of the imaging probe P within the lumen, the vessel wall W, the adventitia AD, and details regarding calcium plaque and calcium angle. In one embodiment, MLS can be used to detect and output calcium angle measurements. FIG. 5I shows a magnified Cartesian OCT image identifying various layers of the artery according to an exemplary embodiment of the present disclosure.

[0150] Figure 5J shows a histology image of the artery of Figure 5C with various layers of the artery identified as part of a review of a ground truth or training set suitable for annotating image data for use with a given MLS embodiment, according to an exemplary embodiment of the present disclosure. Figures 5G and 5H show cross-sectional images of the artery acquired by using an intravascular probe P shown in an in-vivo environment for a blood vessel B having a vessel wall VW defining a lumen L. The oval / circular reflection and shading of the blood vessel B also includes a side branch SB.

[0151] 6A and 6B show a Cartesian OCT image and predicted output of MLS identifying lumen (blue indicia), media (green indicia), and Ca / Ca plaque (red indicia), and an example diameter measurement of 3.31 mm obtained using an MLS-based system with a neural network (NN) trained according to one or more embodiments disclosed herein. FIGs. 6C and 6D show an original Cartesian OCT image and a polar image generated using scanlines collected using an imaging probe. FIG. 6E shows ground truth masks of Ca, lumen, intima, and media. FIG. 6F shows predicted results output from the deep learning MLS of the present disclosure.

[0152] FIG. 7A shows an example original OCT image in Cartesian format as acquired using a combined imaging MLS-based system. The imaging probe is shown in the top right quarter of the image. The dark luminal region is in the center. FIG. 7B shows a grayscale polar image corresponding to the Cartesian image of FIG. 7A. FIGS. 7C and 7D show ground truth masks and deep learning outputs of an MLS embodiment generated using the image of FIG. 7B as input for annotation, training and prediction using a trained MLS. Each mask or detection corresponds to a channel. In part, the present disclosure relates to a multi-channel MLS designed for use in tissue classification using image masks corresponding to ground truth and predicted results.

[0153] In one embodiment, semantic segmentation is performed on multiple channels corresponding to multiple arterial features such as tissue type, calcium, side branch, lumen, guidewire, intima, media, calcium, fibrosis, stent, stent struts, stenosis, and other arterial features. Ground truth of various features is used to train a convolutional neural network. In one embodiment, two neural networks are used, a first neural network is used for lumen detection and a second neural network is used to detect other arterial features after lumen detection is performed by the first neural network. In one embodiment, either the first network or the second network, or both networks are convolutional neural networks. In some embodiments, lumen detection is performed on the image data prior to detecting other features of interest such as calcium, media, intima, and other features disclosed herein. Lumen detection can be performed using a variety of systems and methods, including those disclosed in U.S. Patent No. 9,138,147, entitled "Lumen morphology image reconstruction based on the scan line data of OCT," filed September 22, 2010, the detailed contents of which are incorporated herein by reference in their entirety.

[0154] In one embodiment, a first neural network and a first image processing pipeline are used. It is advantageous to reduce the waiting dwell time during which catheters are inserted during an imaging session, and therefore it is desirable to reduce the time to generate output from the region of interest / feature classification system. Thus, in some embodiments, the neural network is trained using frames of image data that have been annotated with M and / or more than M types of classes of features / regions of interest. In some embodiments, M is in the range of 2-3. In some embodiments, M is in the range of 2-4. In some embodiments, M is in the range of 2-5. In some embodiments, M is in the range of 2-6. In some embodiments, M is in the range of 2-7. In some embodiments, M is in the range of 2-8. In some embodiments, M is in the range of 2-9. In some embodiments, M is in the range of 2-10. In some embodiments, M is in the range of 3-4. In some embodiments, M is in the range of 3-5. In one embodiment, M is 3 and the types / classes used to train the neural network are calcium, lumen, and media. The ground truth annotations / ground truth masks used to train the neural network include masks having groups of annotated regions, where at least three of the annotated regions in one ground truth mask include a media annotation, a calcium annotation, and a lumen annotation. In various embodiments, any collection of types and classes of features / regions of interest can include any of the types and classes disclosed herein.

[0155] In various embodiments, the use of image processing pipelines with trained neural networks supports expedited processing of image data through each of these. Additionally, training a neural network to predict features / regions of interest with annotations of all possible detectable features in an image results in one or more of excessive network training time, excessive network complexity, and excessive processing time when using the network to predict outcomes.

[0156] 8A illustrates a pre-processing operation on a polar OCT image 800 before it is annotated with expert / ground truth data. As shown, as part of the pre-processing step, depth pixels that do not encode or capture useful imaging data or detectable tissue or ROI or FOI are effectively filtered out by reducing or constraining the depth dimension to generate reduced image data elements 805 that can be used for iterative dilation or direct annotation with expert truth data. In one embodiment, multiple data augmentation processes are used to convert an image or image data element into multiple versions of it, such as through circular shifts, left-right flips, and other image-based transformations.

[0157] For example, if the original image is circularly shifted by multiple phases such as 90 degrees, 180 degrees, and 270 degrees, the new versions and the original image or image data elements constitute four versions. Each of these four versions can be flipped left and right to obtain eight versions or augmentations. Furthermore, each of these can be annotated with ground truth annotations by using a user interface software such as that shown in Figures 3A and 3B where a user can select a set of pixels, pixel region boundaries, and other geometric elements to annotate the image data with ground truth information such as classifications of calcium, lumen, side branch, etc. (810). Furthermore, these can also be evaluated by the trained MLS to measure the detection accuracy using a cost function or other metric. The average of the results or statistical analysis of the multiple versions / augments can be used to improve the detection accuracy.

[0158] 8B-8D show various exemplary image masks for detecting lumen, media, and calcium, according to exemplary embodiments of the present disclosure. Various image masks can be used, such as lumen, intima, media, calcium, fibrous, and any ROI or FOI masks disclosed herein. The masks are binary masks in one embodiment. Additionally, in one embodiment, each mask can be used to reflect ground truth detection. In some embodiments, a given ground truth mask includes one or more regions that correspond to ground truth classes, such as calcium, lumen, intima, and other regions of the mask that do not correspond to one or more of the classes. In one embodiment, the ground truth mask includes a first set of pixels that correspond to one or more classes and a second set of pixels that do not correspond to one or more classes. The ground truth masks can be used to train a neural network for a given MLS, such as the neural networks shown in FIG. 1C and FIG. 2. In one embodiment, resizing and other steps, such as flattening as described herein, are performed before generating an expanded or additional version of a given raw image. A given mask can include a subset of pixels corresponding to a particular channel, where the channel corresponds to a feature of interest such as calcium, intima, etc. as disclosed herein. The mask can identify pixels of a given channel that are used to train a ground truth or as a result of using a trained MLS to process image data to obtain an output. In one embodiment, multiple masks are one-to-one associated with multiple channels, and processing of a given image assigns pixels to a given channel, such as a given region of interest in the mask. In one embodiment, the ground truth annotations include multiple channels of information. For example, a given ground truth annotation / mask for training a neural network includes calcium region, media region, lumen region, and intima region.

[0159] 9A-9C are polar OCT images illustrating a circular shift and left and right flips applied to an original OCT polar image as part of a pre-processing step performed prior to training the MLS neural network. In FIGS. 9A-9C, various pre-processing steps are performed on image data, such as raw polar OCT images. As a result of these processing steps or transformations, one raw polar image is transformed into seven additional modifications or versions. This data augmentation process can be implemented in a variety of ways. FIG. 9B illustrates a circular shift of the original image of FIG. 9A. FIG. 9C illustrates a left and right flip of the shift transformed image of FIG. 9B. Such a given augmentation can produce eight modifications of an image of a single frame. This includes one original and three circular shifts (each 90 degrees). A left and right flip of each of these four copies results in a total of eight. These operations, additional operations, or a subset of them, can be used to pre-process data for training MLS and / or prediction using MLS.

[0160] 10A and 10B are images showing a ground truth annotated image and a predicted output, respectively. The blue ground truth mask inside FIG. 10A is partitioned by the lighter tunica media layer. The yellow layer can be coded as another channel or classification, such as lipid LP. The orange area corresponds to calcium. In some embodiments, it is desirable to implement a penalty or constraint system to avoid "false positives". In FIG. 10B, a background channel "B" is shown. This can be used to effectively prevent background from being misclassified as one of the other interest classes or types, if the background is identified in the predicted results. In various embodiments, the channel can be established using features corresponding to imaging artifacts, background, non-uniform rotation distortion effects, etc., that can be generated using the ground truth annotations. Thus, in some embodiments, a neural network can be trained to identify artifacts, imaging system errors, false positives, and other imaging phenomena that are desirable to remove from or prevent from appearing in a given user interface representation of imaging data. A mask showing the predicted results is displayed in FIG. 10B.

[0161] 11A-11D are images showing various pre-processing steps developed to increase MLS processing speed and reduce patient wait time. As shown in FIG. 11A, the OCT image with ground truth shown through a color-coded mask (green for media, red for Ca, and blue for lumen) reveals that along the vertical 976 pixels there are regions such as region 300 along the depth dimension that lack useful data. These images can be flattened as shown in FIG. 11B. The white lumen outline in the central and upper regions of the polar image has been flattened to an approximately straight line in FIG. 11B. This flattening allows the MLS / NN to process regions of the image in the transformed state that are more likely to contain relevant tissue data. Similarly, in FIG. 11C, a half-resolution resizing is performed such as by omitting A lines (scan lines) to generate a central image. Additionally, the image is further resized by omitting or excluding depth pixels in the image to obtain the pre-processed image on the right side of FIG. 11C. These steps improve MLS operation and can be performed in real-time or substantially real-time when the patient is catheterized after the OCT or IVUS images. In this way, these processes can save time and improve patient outcomes. FIG. 11D shows a flattened OCT image 244 and the same flattened OCT image with inference or prediction results in the form of an image mask showing calcium plaque regions in red, lumen regions in blue, and media regions in green. Flattening can be performed as a pre-processing step in some embodiments. This polar image can be converted to Cartesian form and displayed to the end user in a diagram similar to the Cartesian image of FIG. 6B.

[0162] 12A and 12B are flow charts of exemplary processing steps in which raw image data is sent and processed with annotations using ground truth data. In FIG. 12A, one or more of steps A1-A8 can be performed using one or more computing device-based systems disclosed herein. As shown in FIG. 12A, according to one embodiment, the system and method can perform one or more of the following: The imaging system and / or MLS can perform multi-point annotation of image data or image data elements via a computing device or AIP. An annotation GUI facilitates placing and connecting points to define boundaries that can be converted into an image mask that effectively labels a given tissue type in the image. The method can include detecting / updating lumen detections such as lumen boundaries or contours. The method can include transferring annotations, lumen detections, raw image data or data elements from one system, such as the imaging system, to an interface or intermediate system that provides input to the MLS / neural network. In one embodiment, resizing the image data elements is performed to remove non-useful image data to improve processing time. In one embodiment, the method includes generating a binary mask for tissue labeling / annotation. Further, the data can be formatted as an array or into another format for input. Finally, the input data, which can include the image mask and the resized raw image data or data elements, is input to the MLS / NN for processing, such as training or prediction.

[0163] FIG. 12B is another embodiment and includes various steps that may be performed by various systems disclosed herein. In FIG. 12B, one or more of steps A1-A8 may be performed using one or more computing device-based systems disclosed herein. These steps may include one or more of the following: One or more system components, such as an imaging system (OCT, IVUS, X-ray, Anglo, etc.), acquire a raw image data set. Various pre-processing steps may be performed. Flattening of luminal and / or image regions of the raw image and mask image with ground truth data may be performed. In one embodiment, every other scanline is removed. In one embodiment, the luminal contour or boundary is flattened to highlight meaningful ROI / FOI data as shown in FIG. 11B and FIG. 11D. In other embodiments, the image may be circular shifted, flipped left / right, or transformed in a different way. This may increase the entries in a given training set or may produce different versions of the MLS / NN that operate so that the results of the ML can be monitored and tested.

[0164] Scanlines / data / pixels can be clipped, omitted, or removed from the raw and annotated mask images to adjust the rows (in polar or Cartesian format). For example, as shown in FIG. 11A, pixels corresponding to depth in the vertical axis can be removed to resize the images as shown in FIG. 11B and FIG. 11C. In addition, it may be useful to add scanlines / data / pixels to standardize columns of the raw and annotated mask images for MLS / NN processing. The method may include formatting the raw and mask image data as needed and inputting them into the MLS / Neural Network for predictive analysis or additional training.

[0165] 13A and 13B show exemplary user interfaces of a diagnostic tool supporting stent planning through virtual stent placement incorporating tissue classification. These user interfaces help depict MLS analysis that can identify the most important lesion based on physiology and / or the shortest stent that provides the greatest flow restoration. In one embodiment, a virtual stent VS can be positioned relative to the lumen representation to perform interactive virtual stent placement, as shown by the white stent area formed from semicircles. Interactive virtual stent placement allows the stent to be aligned with the lesion. The user can obtain predicted and current VFR values. The MLA diagram in the bottom panel showing the percent diameter stenosis and minimum lumen area also shows the VFRp and VFR values ​​that change based on the stenosis and / or virtual stent selection. The angiogram image shown in the top right panel is co-registered with Cartesian or polar views or longitudinal sections of the artery in the other panels. In FIG. 13B, the predicted VFRp and current VFR are shown for a virtual stent VS and Cartesian arterial image masked or characterized with various indicia corresponding to the lumen, calcium plaque and media ROI / FOI.

[0166] The methods and systems disclosed herein provide diagnostic planning tools for the user. For example, the methods and systems include tools that can automatically place a virtual stent in the artery on image data from the pullback. Further details of such diagnostic graphic user interface based tools can be seen in Figures 13A and 13B. An exemplary user interface from a combined imaging and machine learning system suitable for such diagnostic planning is shown in Figures 13A and 13B. Furthermore, the automated placement of such a stent includes processes, user interfaces, and related software-based features that display such a stent in an optimal location and with the appropriate stent size identified for the end user.

[0167] The present disclosure includes various embodiments of stent planning software that place a stent in an optimal location or a location that otherwise optimizes some specific parameter. In one embodiment, the parameters optimized to facilitate stent planning include the flow rate that can be achieved by deploying a stent of a particular length. Proximal and distal landing zone locations of the stent as well as the size of the stent are provided to the end user. These are determined by optimizing the improvement in flow rate that can be achieved using a set of possible stents and stent deployment locations.

[0168] In one embodiment, training data is created using ground truth expert guidance or guidance from MLS for lumen detection, etc. The training data is divided into masks. In one embodiment, the masks are one or more individual channels. They are used to train a training set. When the training set is passed through the neural network, each of those channels essentially contributes to different weights and filters of the network. In this way, the NN adapts / changes in response to the masks / training data. Then, when patient sample data is input into the trained network, the raw image data is tagged or labeled with different channels, all of which correspond to different features used in the training set, such as images of lumen, intima, media, adventitia, EEL, IEL, plaque, calcium, calcium plaque, stents, guidewires, etc.

[0169] In general, the MLS system disclosed herein relates to a multi-channel segmentation process where each tissue type, each region of interest, each arterial layer, etc. is processed as a separate data channel with its own image mask to generate a training set and predicted output.

[0170] One exemplary approach to assess flow restoration as a result of stent deployment may be that described in U.S. Patent Application Serial No. 14 / 115,527, entitled "METHOD AND APPARATUS FOR AUTOMATED DETERMINATION OF A LUMEN CONTOUR OF A STENTED BLOOD VESSEL," the contents of which are incorporated herein by reference in their entirety. Other approaches, including those not listed herein, may also be used. To understand some aspects of flow changes and behavior within an artery, it is helpful to consider the features shown in Figures 13A and 13B, which illustrate stenosis and various characteristics related to the selection and positioning of a virtual stent based on identified landing zone and stent length(s).

[0171] In various aspects, the present disclosure relates to training one or more of a machine learning system, a neural network, and a convolutional neural network using polar images of coronary arteries. In various aspects, the present disclosure relates to training one or more of a machine learning system, a neural network, and a convolutional neural network using ground truth annotations made on polar images of coronary arteries. In various aspects, the present disclosure relates to training one or more of a machine learning system, a neural network, and a convolutional neural network using ground truth annotations made on polar images of coronary arteries where various tissue types and features of interest are annotated in a training set.

[0172] In various aspects, the present disclosure relates to training one or more of a machine learning system, a neural network, and a convolutional neural network using ground truth annotations made on Cartesian or non-polar images of coronary arteries where various tissue types and features / regions of interest are annotated in a training set. In various aspects, the present disclosure relates to using trained machine learning systems, neural networks, and / or convolutional neural networks, and combinations thereof, to classify / characterize input patient data in polar or non-polar or Cartesian format and identify various tissue types and features / regions of interest using ground truth annotations made on polar images of coronary arteries where various tissue types and features of interest are annotated in a training set.

[0173] The present disclosure relates to using ground truth tissue types and features / regions of interest to classify, identify, and / or characterize various tissue types and features / regions of interest in patient image data and image data elements. In various embodiments, aspects, and / or one or more MLS embodiments, the tissue types and features of interest (FOI) / regions of interest (ROI) may be multiple coronary arteries, a single coronary artery, an OCT image, an IVUS image, an X-ray image, an ultrasound image, an angiogram image, a graph or plot of an arterial tree, a side branch, a lumen, a guidewire, a stent, a jailed stent, a bioresorbable vascular scaffold (BVS), a drug eluting stent (DES), fibrous, blooming artifact, a pressure wire, lipid, calcium, atherosclerotic plaque, stenosis, plaque, calcium, calcified plaque, calcium containing tissue, lesion, fat, a malapose stent, an underinflated stent, an overinflated stent, a inflated) stents, radiopaque markers, branching angles of the arterial tree, calibration elements such as PET doped membranes, sheaths, doped sheaths, fiducial registration points, diameter changes of the artery, radial changes of the artery, flow measurements obtained using the imaging data, FFR values ​​of the images, bifurcation models, combinations of the above, Cartesian images of classifications or types of the above, polar images, non-polar images or portions thereof, and one or more of: Cartesian images, polar images, non-polar images.

[0174] In one embodiment, the probe includes a probe tip that includes or is in optical communication with an optical fiber. The optical fiber and tip of the probe are disposed within one or more sheaths, such as a catheter sheath. The probe tip can include various elements, such as an angled beam director or lens cap and transducers of other imaging modalities. The optical fiber of the probe 407 can also include a torque wire disposed around the fiber. The probe transmits light into the lumen L and receives light scattered from the vessel wall VW.

[0175] In one embodiment, the optical fiber is part of the sample arm of the interferometer. A data collection probe 407, such as an OCT probe, can be used to collect depth information suitable for imaging a sample, such as a blood vessel. A set of frames of image data, such as polar or Cartesian images, are shown in 3D, respectively. The figures are generated based on optical signals transmitted and received by such a probe 407. Cross-sectional images of the blood vessel are formed by collecting scan lines as the probe rotates (see Cartesian images shown in Figures 3D, 3E, 6A, 6B). Cross-sectional images, such as images 6A and 6B, are Cartesian images. Figures 7B and 8A show examples of polar views or polar formats of medical images. Cartesian and polar images can be referred to as frames in various embodiments.

[0176] OCT images, such as the cross-sectional images of FIGS. 3B, 3C, and 3D, are typically acquired one scanline at a time. A sequence of samples along a ray emanating from the catheter center to the maximum imaging depth is referred to as a scanline in one embodiment. In one embodiment, the smallest data unit in an OCT image is referred to as a sample. A sequence of samples along a ray emanating from the probe center to the maximum imaging depth is referred to as a scanline. OCT images are typically acquired one scanline at a time. A cross-sectional image can be formed from a set of scanlines collected as the probe rotates. Additionally, to image a segment of an artery or other vessel, the catheter is moved longitudinally while rotating. In this manner, the probe acquires a set of cross-sectional images in a spiral pattern. The images result from various scanlines associated with a slice of the vessel or artery of interest. The scanlines are arranged with angles between them like the spokes of a wheel. The scanlines are acquired in a polar format in one embodiment.

[0177] [User interface features for mapping organizational characteristics] In part, the present disclosure is directed to a medical diagnostic system including image navigation, user interface design, time saving enhancements and other design considerations. The above features improve time and information management issues during time critical medical procedures such as those performed in a cath lab. The present disclosure describes a method for converting the results of tissue characterization into a tissue map display. Tissue characterization can be performed using a variety of techniques including pathology research efforts, artificial intelligence techniques, machine learning techniques, attenuation and backscattering based techniques, and image processing detection and enhancement techniques that may exist, be in development, or be developed.

[0178] Embodiments of tissue maps disclosed herein provide a user interface that enhances the viewing of image data including various characterized tissues and boundaries and their relative locations for one or more portions of a subject, such as arteries, blood vessels, or other body lumens. Physicians, researchers, engineers, and other end users, when given a set of images with characterized regions of tissue, can arrive at planning decisions based on diagnostic information and make informed decisions more quickly and in a more informed situation than would otherwise be possible.

[0179] Tissue characterization generally includes one or more methods for determining the type of tissue or other tissue characteristics for a given set of patient tissues. Thus, when an artery is imaged and multiple images form a set of image data, the tissues in each image can be characterized to determine at a high level whether they are of a particular type, such as fat, muscle, etc., as well as at a more detailed level, such as calcification, intima, EEL, and other types as disclosed herein or otherwise present in the subject being imaged. Typically, one or more detection processes are used to detect the type of tissue of interest in a region of the image. After another detection process, such as a machine learning inference process or an image processing pipeline-based process, detects calcium and media in the image data, a calcium plaque mask and a media mask are available for the set of image frames. A ring-like structure can be obtained by projecting each mask along an A-line as discussed above with respect to FIG. 2A. 16-18 show various tissue map representations generated using an arterial OCT imaging pullback with various indicia integrated into a user interface displaying the various tissue maps to support diagnosis and treatment planning such as stent placement and atherectomy, according to exemplary embodiments of the present disclosure.

[0180] In Figs. 14, 15, 16, 17, and 18, each ring on the plane represents one frame of tissue characterization results from 3D pullback OCT data. In Fig. 14, a three-dimensional representation of an artery 1405 is shown with regions of calcium detected using guidewire GW, MLS, or another technique, and three cross-sectional boundaries R1, R2, and R3, which are projected onto a plane as shown to generate a tissue map TM. Another version of the tissue map is also shown in Figs. 2A and 16-17. Fig. 15 shows a schematic representation of various cut planes / rings / boundaries R1-Rn shown along a 3D artery representation 1425 extending in the proximal and distal directions. In one embodiment, imaging data such as OCT, IVUS, x-ray, or other imaging modalities can be used to generate such a 3D representation of an artery 1425.

[0181] Intravascular Optical Coherence Tomography (OCT) images provide high resolution visualization of coronary artery morphology. In part, this disclosure relates to automated detection and / or classification of intracoronary plaque (calcium, lipid, fibrosis, and thrombus). Internal and external calcification boundaries are also detected and displayed in one embodiment. The detection and classification process can improve interpretation of OCT images and provide targeted information to diagnosticians. In part, this disclosure relates to systems and methods that display to a user the results of data analysis applied to an intravascular data set in a manner that is clear, easy to interpret, and aids in the subject's diagnosis, such as the tissue map TM and the examples shown in Figures 14-18.

[0182] In part, this disclosure describes a graphical user interface (GUI) that provides a user interface and a graphical data representation that may generate an overall tissue map from a set of imaging data of a given artery or another body lumen (intestine, esophagus, etc.). The tissue map is responsive to user selections, such as user selection of a particular region of the tissue map. In response to a user clicking or otherwise selecting a tissue map region, a user interface software module of an applicable imaging system may redirect the information displayed to the user such that an underlying image or frame of image data specific to the user selection may be displayed.

[0183] In this way, rather than scrolling through a long series of images or frames of image data, a tissue map is presented to the user. Interaction and selection on the tissue map reduces diagnosis and analysis by quickly directing the end user to areas of interest, such as calcium plaque or lipids in an artery. Furthermore, this can facilitate stent planning while the patient is catheterized on a table and blood flow is temporarily stopped to image a section of the vessel. In this way, faster decisions can be made to improve patient outcomes. Selecting stent landing zones is also improved by avoiding calcified regions where proper stent expansion is limited by the presence of calcium or another undesirable arterial condition. Favourable and unfavourable areas of the artery can be flagged as suitable or unsuitable stent landing zones using colour, graphics, visual cues, or other indicia or user interface features such as animation or other cues.

[0184] In part, the disclosure relates to a data collection system, such as an intravascular data collection system suitable for use in a cath lab, such as an optical coherence tomography system. In part, the disclosure relates to a data collection system including a processor suitable for displaying intravascular image data. The displayed image data includes data or images generated based on depth measurements. In one embodiment, the image data is generated using optical coherence tomography. The system can also display a user interface that displays intravascular information, such as data regarding intravascular plaque.

[0185] In part, the diagnostic systems, methods, navigation tools, and tissue maps and related features disclosed herein provide improvements in the form of better tools for interpretation and decision making based on plaque composition, lesion characteristics, tissue type, and related tissue and vascular information after one or more tissue characterization processes and image data detection and analysis software modules are operational. The tissue map interface and characterized tissue data organized from the underlying image data acquired during a scan of a given subject demonstrate a variety of improved image views. For example, for OCT and other intravascular imaging modalities, a given tissue map can provide a volumetric view of the full imaging probe pullback in a single image.

[0186] In this case, the imaging probe is pulled back through the vessel as it rotates to acquire imaging data. The end user can use the given tissue map to quickly realize the arc extend and thickness of calcium plaque and healthy landing zones for stent implementation. Furthermore, other details regarding the tissue type can be evaluated. Additionally, to the extent that the given tissue map reveals excessive amounts of calcium or other undesirable tissue conditions, this information can facilitate the end user to select alternative treatment options such as bypass or atherectomy. The given tissue map can be generated using a variety of methods. The given methods can vary based on the source of image data acquired from scanning the patient with the imaging system.

[0187] At the pre-intervention assessment stage, the physician can access the plaque composition. As shown in the tissue map display 1425 of FIG. 16, pixels with green color G indicate areas where the tunica media was detected in the tissue characterization, while red color indicates the presence of calcium plaque Ca. The colors mentioned in a given tissue map user interface may vary and in some instances may be replaced by hatching or by using other indicia.

[0188] The dotted lines in the tissue map are shown to provide a match with the rings R1, R2, and R3 in FIG. 14 along the length of the artery representation. In one embodiment, a given tissue map can indicate the spread of calcium plaque. The intensity values ​​correspond to the thickness of the calcium plaque in millimeters as indicated by the symbols ranging from about 0.5 mm to about 1.5 mm. Any class or type of ROI / FOI detected using the methods disclosed herein can be displayed using a tissue map representation such as tissue map 1425. In addition, other information such as fibrous and lipid containing plaque can also be added to the tissue map as shown in the exemplary tissue map in FIG. 18. At the stent deployment stage, the physician can easily identify the landing zone from this plot. The intensity of the green color indicates the thickness of the media, but can be changed to indicate the distance between the two end points of the EEL that are 180 degrees apart. This can then be used for useful information regarding stent size.

[0189] FIG 17 shows the tissue map of FIG 16 with cross-sectional frames R1, R2, and R3 shown with the tunica media M, lumen L, and calcium Ca identified. In one embodiment, these regions of interest are color coded with the lumen as blue, calcium as red, and the tunica media as green. FIG 18 then shows a tissue map 1490 with indicia of the guidewire GW (gray), tunica media M (green), calcium Ca (red), lipid LP (blue), and side branch SB (boundary indicated). These various representations can be used to support various workflows and diagnoses.

[0190] In part, the disclosure relates to a diagnostic system to which one or more imaging and tissue detection methodologies are applied, and an interface of the diagnostic system that facilitates navigating the vessel representation. For a given vessel or other body lumen, such as a coronary artery, one or more tissue types or other regions of interest can be identified using various techniques. In particular, calcium nodules, such as calcified regions within a vessel, calcified tissue, and other calcium-related tissues can be represented. One or more tissue map representations can be generated and used to display the characterized tissues and regions of interest to a user. Characterized tissues and / or regions of interest suitable for detection and inclusion on one or more tissue maps can include one or more of the following: lipid regions, luminal regions, stent struts, side branches, guidewires, external elastic lamina (EEL), internal elastic lamina (IEL), boundaries and associated volumes, and other arterial features and tissue types as disclosed herein.

[0191] In part, the present disclosure relates to a user interface design that facilitates improved information and time management using one or more tissue map representations based on characterized tissue of a body lumen, such as a coronary artery. In the various tissue maps illustrated, moving towards the page is moving distally to the location where the OCT imaging probe was positioned and pulled back. The length of the pullback is between R1 and RN, where RN is the frame count of the pullback. The lowest ring count is the most proximal. In one embodiment, the highest ring count is the most distal. This can be seen in the ring arrangement of FIG.

[0192] The present disclosure is based in part on the discovery that calcium and other tissue in blood vessels can be detected and characterized image data for blood vessels can be obtained, such as OCT image data, IVUS image data, CT scan image data, MRI image data, angiography image data, and other image data sources. In some imaging modalities, calcified regions appear as discrete dark shapes. This is true in OCT images, which show calcium as darker regions against the lighter vascular tissue background of the OCT image.

[0193] In part, the present disclosure relates to a method for identifying regions of interest within a blood vessel that may include tissue types and other features, such as lumens, side branches, stents, guidewires, and other features, properties and materials of the blood vessel.

[0194] In one embodiment, the representation of the vessel subjected to a tissue type analysis and / or tissue type segmentation represents one or more of a two-dimensional cross-sectional rendering of the vessel or a three-dimensional longitudinal rendering of the vessel. In one embodiment, the representation of the vessel or the characterised image data of the underlying tissue acquired for the vessel is converted into a tissue map. In one embodiment, various colours, shapes, hatches, masks, borders and other graphical elements or overlays are used to identify or segment the detected tissue types and / or regions of interest in the tissue map.

[0195] In part, the disclosure relates to a system for identifying a region of interest in a blood vessel, the system including a processor in communication with a memory that includes instructions that, when executed, cause the processor to acquire image data of the blood vessel and apply a plurality of filters to the image data to generate a characteristic or type, such as a tissue type. In one embodiment, the image data is a plurality of scanlines. In one embodiment, the image data is x-ray based data. In one embodiment, the image data is a polar image. In one embodiment, one or more polar images are sampled. The samples are combined to generate a tissue-characterized representation of the blood vessel. The tissue-characterized representation of the blood vessel is in polar form. A tissue map is obtained in one embodiment by converting the polar tissue-characterized representation to a Cartesian representation. In one embodiment, the tissue map is a series of rings, circles, or ellipses arranged in sequence along a proximal to distal axis.

[0196] In part, one embodiment of the present disclosure relates to an endovascular data collection system and one or more software-based graphic user interfaces and software modules that perform one or more detection and display processes as described herein. In one embodiment, endovascular data is collected while angiographic data is simultaneously collected. In other embodiments, angiography, CT scan, X-ray-based imaging, photography, or other imaging modalities are used to obtain imaging data that is used to generate a tissue map.

[0197] In part, the present disclosure relates to systems and methods for treatment evaluation, including stent planning and surgical options, by visualizing a subject's blood vessel, such as one or more coronary arteries. Image data can be acquired using an intravascular data collection probe. The probe can be pulled back through the blood vessel and data can be collected about the blood vessel. Such pullback and associated data collection is used to plan stent deployment or evaluate a deployed stent. The intravascular data resulting from the pullback can be used in a variety of ways, such as for visualization of various vessel regions, features, and stents deployed therewith. Image data used to generate a tissue map can be co-registered with corresponding angiographic data. Thus, a user can select a region of the tissue map and see the underlying image data used to generate the map (OCT, IVUS, X-ray, etc.), as well as the angiographic data with highlighting or other indicia indicating the region of the selected blood vessel on the tissue map.

[0198] Stents can be visualized in terms of side branches in various embodiments of the present disclosure. This is an important feature since it is usually the case that it is desirable to avoid stenting side branches during stent deployment. In this manner, the tissue map can indicate side branches and frames containing side branches can be flagged as unsuitable for use as a stent landing zone. The systems and methods described herein facilitate visualization of stent landing zones for different types of tissues and regions of interest. The tissue map can be co-registered with the angiography data based on detection of these features in the collected endovascular data in various user interfaces as well as representations of stent struts and side branches.

[0199] In part, this disclosure relates to intravascular data collection systems such as OCT, IVUS, and other imaging modalities, and the generation and visualization of diagnostic information such as stent landing zones, side branches, regions of interest, and characterized tissue regions within a vessel as part of a tissue map. Graphical elements suitable for indicating such diagnostic information of interest serve as user selection elements in the tissue map to facilitate navigation to the underlying images summarized in the tissue map.

[0200] Also disclosed herein are systems and methods for visualizing stents, tissue types, tissue volumes, and tissue boundaries. One or more software modules can be used to detect side branch locations, lumen contours, and stent strut positions, generate vessel representations, generate tissue maps, and control navigation of imaging based on user selections of the tissue maps. The systems and methods disclosed herein also include automated measurement systems and related features that can measure angles, thicknesses, volumes, widths, frame counts, and relative tissue-lumen proximity of various tissue types, including calcium, lipid, fibrous, etc.

[0201] In various embodiments, such measurement tools can be used to measure the above parameters and any geometric properties of a given region of interest of a particular tissue type. These measurements can be used to generate various ratings or scores suitable for review by an end user. For example, if calcium burden in a particular region of a blood vessel appears on the tissue map, but overall there is only a small amount of superficial calcium, measurements in this regard can help guide the user and not rule out such regions as candidate landing zones.

[0202] It is understood that for clarity, the present disclosure describes various aspects of the embodiments of the applicant's teachings while omitting some specific specific details wherever it is convenient or appropriate to do so. For example, the discussion of similar or similar features in alternative embodiments may be somewhat shortened. Known ideas or concepts may not be discussed in any detail for the sake of brevity. Those skilled in the art will recognize that some embodiments of the applicant's teachings may not require some of the specifically described details in every implementation described herein merely to provide a thorough understanding of the embodiment. Similarly, it is clear that the described embodiments can be modified or altered in accordance with common general knowledge without departing from the scope of the present disclosure. The detailed description of the embodiments should not be considered as limiting the scope of the applicant's teachings in any way.

[0203] The term "about" or "substantially the same" as used herein refers to variations in quantities that may occur, for example, through real-world measurement or handling procedures, through accidental errors in these procedures, through differences / faults in the manufacture of electrical elements, through electrical losses, as well as variations that would be recognized as equivalent by a person skilled in the art, unless such variations encompass known values ​​practiced by the prior art. Typically, the term "about" means greater than or less than the stated value or range of values ​​by 1 / 10 of the stated value, e.g., ±10%. For example, applying a voltage of about +3V DC to an element can mean a voltage of +2.7V DC to +3.3V DC. Similarly, when values ​​are said to be "substantially the same," the values ​​may differ by up to 5%. The quantitative values ​​recited in the claims, whether modified by the terms "about" or "substantially the same," include variations in quantities equivalent to the recited values, e.g., values ​​that may occur but would be recognized as equivalent by a person skilled in the art.

[0204] Non-Limiting Software Features and Embodiments of the MLS and Tissue Characterization / Classification Systems and Methods The following description is intended to provide an overview of device hardware and other operating components suitable for carrying out the methods of the present disclosure described herein. This description is not intended to limit the applicable environments or the scope of the present disclosure. Similarly, the hardware and other operating components may be suitable as part of the apparatus described above. The present disclosure may be practiced with other system configurations, including personal computers, multiprocessor systems, microprocessor-based or programmable electronic devices, network PCs, minicomputers, mainframe computers, and the like. The present disclosure may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network, such as in different rooms of a catheterization lab or cath lab.

[0205] Some portions of the detailed descriptions are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations may be used by those skilled in the art of computers and software. In one embodiment, an algorithm is herein generally conceived to be a self-consistent sequence of operations leading to a desired result. The operations performed as method steps or otherwise described herein are operations requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, transformed, compared, and otherwise manipulated.

[0206] Unless otherwise specified as will be apparent from the discussion below, throughout this specification, discussion utilizing terms such as "processing" or "calculation" or "classification" or "characterization" or "correlation" or "detection" or "evaluation" or "convolution" or "deconvolution" or "classification" or "segmentation" or "training" or "annotation" or "alignment" or "measurement" or "calculation" or "comparison" or "generation" or "detection" or "determination" or "display" or "Boolean logic" or other set of related operations, etc., will be understood to refer to the operations and processes of a trained MLS, computer system, AI processor, GPU, or electronic device that manipulates and converts data represented as physical (electronic) quantities in the registers and memory of a computer system or electronic device to other data similarly represented as physical quantities in electronic memory or registers or other such information storage, transmission or display devices.

[0207] The present disclosure also relates in some embodiments to an apparatus for performing the operations herein. The apparatus may be specially constructed for the required purposes, or the apparatus may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Various circuits and components thereof may be used to perform some of the data collection and transformation and processing described herein.

[0208] The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems can be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the required method steps. The required structure for a variety of these systems will appear from the description below. In addition, the present disclosure is not described with reference to any particular programming language, and various embodiments may therefore be implemented using a variety of programming languages.

[0209] The embodiments of the present disclosure may be embodied in many different forms, including but not limited to computer program logic for use with a processor (e.g., a microprocessor, microcontroller, digital signal processor, or general purpose computer), programmable logic for use with a programmable logic device (e.g., a field programmable gate array (FPGA) or other programmable logic device), discrete components, integrated circuit mechanisms (e.g., an application specific integrated circuit (ASIC)), or any other means including any combination thereof. In an exemplary embodiment of the present disclosure, some or all of the processing of data collected using the OCT probe, 2D imaging or 3D imaging system, and processor-based system is implemented as a set of computer program instructions, which are converted into a computer executable format, themselves stored on a computer readable medium, and executed by a microprocessor under the control of an operating system. Thus, the query responses and input data are converted into processor understandable instructions suitable for generating training sets, image masks, and other inputs and outputs as disclosed herein. Computer program logic implementing all or a portion of the functionality described herein above may be embodied in a variety of forms, including but in no way limited to source code form, computer executable form, and various intermediate forms (e.g., forms generated by an assembler, compiler, linker, or locator). Source code may include a series of computer program instructions implemented in any of a variety of programming languages ​​(e.g., object code, assembly language, or high-level languages ​​such as Python, Perl, Go, FORTRAN, C, C++, JAVA, or HTML) for use with a variety of operating systems or operating environments. Source code may define and use various data structures and communication messages.The source code may be in a computer-executable form (eg, via an interpreter) or the source code may be converted (eg, via a translator, assembler, or compiler) into a computer-executable form.

[0210] The various embodiments described herein, or components or portions thereof, can be implemented in many different embodiments of software, firmware, and / or hardware, or modules thereof. The software code or specialized control hardware used to implement some of the embodiments does not limit the invention. For example, the embodiments described herein above can be implemented in computer software using any suitable computer programming language, such as, for example, .NET, SQL, or MySQL, using conventional or object-oriented techniques.

[0211] Programming languages ​​for computer software and other computer-implemented instructions may be translated into machine code by a compiler or assembler prior to execution and / or directly at run-time by an interpreter. Examples of assembly languages ​​include ARM, MIPS, and x86, examples of high-level languages ​​include Ada, BASIC, C, C++, C#, COBOL, Fortran, LUA, Clojure, Java, Lisp, Pascal, and Object Pascal, and examples of scripting languages ​​include Bourne script, JavaScript, Python, Ruby, PHP, and Perl.

[0212] The operation and behavior of the embodiments are described without specific reference to actual software code or dedicated hardware components. The absence of such specific reference is feasible because it is clearly understood that those skilled in the art can design software and control hardware to implement the embodiments of the present disclosure based on the description herein with no undue experimentation and with only moderate effort.

[0213] Various machine learning systems and related neural networks can be used, such as deep learning neural networks, 3D neural networks, convolutional neural networks, 2D neural networks, N-layer neural networks, feedforward neural networks, feedforward networks, feedbackward networks, radial basis function neural networks, Kohonen self-organizing neural networks, recurrent neural networks (RNNs), modular neural networks, deep learning networks, artificial intelligence based systems and frameworks, and combinations thereof.

[0214] The software of the various machine learning systems described herein and other computer functions described herein can be implemented in computer software using any suitable computer programming language, such as .NET, C, C++, Python, C#, Matlab programming modules and tools, and using conventional, functional, or object-oriented techniques. For example, the various machine learning systems can be implemented using software modules stored or otherwise retained in a computer-readable medium, such as RAM, ROM, secondary storage, etc. One or more processing cores (e.g., CPU, GPU, and / or AI accelerator cores) of the machine learning system can then execute the software modules to perform the functions of the respective machine learning system (e.g., network 107, encoders 111-114, learning coach 110, etc.).

[0215] The computer program may be fixed in any form (e.g., source code form, computer executable form, or intermediate form) permanently or temporarily on a tangible storage medium such as a semiconductor memory device (e.g., RAM, ROM, PROM, EEPROM, or flash programmable RAM), a magnetic memory device (e.g., diskette or fixed disk), an optical memory device (e.g., CD-ROM), a PC card (e.g., PCMCIA card), or other memory device. The computer program may be fixed in any form on a signal that is transmittable to a computer using any of a variety of communication technologies, including, but in no way limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. The computer program may be distributed in any form on a removable storage medium (e.g., shrink wrapped software) with accompanying printed or electronic documentation, may be preloaded on a computer system (e.g., system ROM or fixed disk), or may be distributed from a server or electronic bulletin board over a communication system (e.g., the Internet or World Wide Web).

[0216] Hardware logic (including programmable logic used in conjunction with a programmable logic device) implementing all or a portion of the functionality described herein above may be designed using conventional manual methods, or may be electronically designed, captured, simulated, or documented using a variety of tools, such as computer-aided design (CAD), hardware description languages ​​(e.g., VHDL or AHDL), or PLD programming languages ​​(e.g., PALASM, ABEL, or CUPL).

[0217] The programmable logic may be fixed, either permanently or temporarily, in a tangible storage medium, such as a semiconductor memory device (e.g., RAM, ROM, PROM, EEPROM, or flash programmable RAM), a magnetic memory device (e.g., a diskette or fixed disk), an optical memory device (e.g., a CD-ROM), or other memory device. The programmable logic may be fixed in signals transmittable to a computer using any of a variety of communication technologies, including, but in no way limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. The programmable logic may be distributed as a removable storage medium (e.g., packaged software) with accompanying printed or electronic documentation, may be preloaded into a computer system (e.g., a system ROM or fixed disk), or may be distributed over a communication system (e.g., the Internet or World Wide Web) from a server or electronic bulletin board.

[0218] Various examples of suitable processing modules are discussed in more detail below. As used herein, a module refers to software, hardware, or firmware suitable for performing a particular data processing or data transmission task. Typically, in preferred embodiments, a module refers to a software routine, program, or other memory resident application suitable for receiving, converting, distributing, and processing instructions or various types of data, such as resistance changes, voltage changes, current changes, guidewire-based probe data, intravascular pressure data, ratios, indices, and other information of interest.

[0219] The computers and computer systems described herein may include operatively associated computer-readable media, such as memory for storing software applications used in acquiring, processing, storing, and / or communicating data. It may be understood that such memory may be internal, external, remote, or local with respect to the computer or computer system to which it is operatively associated.

[0220] Memory may also include any means for storing software or other instructions, including, for example, without limitation, a hard disk, an optical disk, a floppy disk, a DVD (digital versatile disk), a CD (compact disk), a memory stick, flash memory, a ROM (read only memory), a RAM (random access memory), a DRAM (dynamic random access memory), a PROM (programmable ROM), an EEPROM (extended erasable programmable read only memory), and / or other similar computer readable medium.

[0221] Generally, computer-readable memory media applied in connection with the embodiments of the present disclosure described herein may include any memory medium capable of storing instructions executed by a programmable device. Where applicable, the method steps described herein may be embodied or executed as instructions stored on one or more computer-readable memory media. These instructions may be software embodied in various programming languages ​​such as C++, C, Java, and / or various other types of software programming languages ​​that may be applied to create instructions according to the embodiments of the present disclosure.

[0222] A storage medium can be non-transitory or can include a non-transitory device. Thus, a non-transitory storage medium or a non-transitory device can include a device that is tangible, meaning that the device has a concrete physical form, although it may change its physical state. Thus, for example, non-transitory refers to the device remaining tangible even with this change in state.

[0223] The aspects, embodiments, features, and examples of the present disclosure are considered in all respects to be illustrative and are not intended to be limiting of the disclosure, the scope of which is defined solely by the claims. Other embodiments, modifications, and uses will be apparent to those skilled in the art without departing from the spirit and scope of the disclosure as claimed.

[0224] The use of headings and paragraphs in this application is not meant to limit the disclosure. Each paragraph may apply to any aspect, embodiment, or feature of the disclosure. Only claims using the words "means for" are intended to be interpreted under 35 U.S.C. 112, paragraph 6. In the absence of a "means for" recitation in a claim, such claim should not be interpreted under 35 U.S.C. 112. No limitations from this specification are intended to be read into any claim unless such limitations are expressly included in the claim.

[0225] Where values ​​or ranges of values ​​are given, each value and the endpoints of the given ranges and values ​​therebetween can be increased or decreased by 20% while still remaining within the teachings of the present disclosure, unless any different range is specifically stated.

[0226] Throughout this application, when a composition is described as having, including, or comprising particular components, or a process is described as having, including, or comprising particular process steps, it is intended that the composition of the present teachings consists essentially of or consists of the recited components, and that the process of the present teachings consists essentially of or consists of the recited process steps.

[0227] When an element or component is referred to in this application as being included in and / or selected from a list of recited elements or components, it should be understood that the element or component can be any one of the recited elements or components and can be selected from a group consisting of two or more of the recited elements or components. Furthermore, it should be understood that the elements and / or features of the compositions, devices, or methods described herein, whether expressly or implicitly stated herein, can be combined in various ways without departing from the spirit and scope of the present teachings.

[0228] Use of the terms "include," "includes," "including," "have," "has," or "having" should generally be understood to be open-ended and non-limiting, unless otherwise specified.

[0229] The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. Furthermore, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, where the term "about" is used before a quantitative value, the present teachings also include the specific quantitative value itself unless specifically stated otherwise.

[0230] It should be understood that the order of steps or order for performing certain actions is immaterial so long as the present teachings remain operable. Moreover, two or more steps or actions may be conducted simultaneously.

[0231] When a range or list of values ​​is provided, each intervening value between the upper and lower limits of that range or list of values ​​is individually contemplated and encompassed within the disclosure as if each value were specifically recited herein. Additionally, smaller ranges between and including the upper and lower limits of a given range are contemplated and encompassed within the disclosure. A list of exemplary values ​​or ranges does not exclude other values ​​or ranges between and including the upper and lower limits of a given range.

[0232] It is understood that the figures and descriptions of the present disclosure have been simplified to show elements that are pertinent for a clear understanding of the present disclosure, while omitting other elements for clarity. Those skilled in the art will recognize, however, that these and other elements may be desirable. However, because such elements are known in the art, and because they do not facilitate a better understanding of the present disclosure, a discussion of such elements is not provided herein. It should be understood that the figures are presented for illustrative purposes, and not as structural diagrams. The omitted details and modifications or alternative embodiments are within the knowledge of those skilled in the art.

[0233] It will be understood that in certain aspects of the present disclosure, multiple components may be substituted for single components, and multiple components may be substituted for single components, to provide an element or structure or to perform a given function or functions. Except to the extent that such substitutions are not usable to practice a particular embodiment of the present disclosure, such substitutions are deemed to be within the scope of the present disclosure.

[0234] The examples presented herein are intended to illustrate possible and specific embodiments of the present disclosure. It can be understood that the examples are intended primarily for illustration of the present disclosure for those skilled in the art. There may be variations to these figures or the operations described herein without departing from the spirit of the present disclosure. For example, in certain cases, method steps or operations may be performed or executed in a different order, or operations may be added, deleted, or modified. In order to maintain the disclosure matters at the time of filing of the present application, the contents of claims 1 to 33 at the time of filing of the present application are added as follows. (Claim 1) acquiring a set of image data including a frame of polar images; annotating one or more regions or features of interest in each polar image of the set of image data, such that each annotated region or feature is a ground truth annotation; training a neural network of a machine learning system (MLS) using the set of annotated polar images, where each of a plurality of regions in each polar image is identified by a class; inputting polar image data into the trained neural network; displaying a predicted output image including color-coded regions, each color corresponding to a class; A method for evaluating a coronary artery, comprising: (Claim 2) The method of claim 1 , wherein each image includes multiple image data elements relating to the coronary arteries. (Claim 3) The method of claim 1 , wherein the annotating is performed using a graphical user interface that includes user controls for selecting a group of pixels or a two-dimensional boundary that defines the feature of interest. (Claim 4) 2. The method of claim 1, wherein training the neural network is repeated until an output of a cost function is below a threshold, the cost function comparing predicted outputs of MLS to ground truth inputs. (Claim 5) 2. The method of claim 1, further comprising classifying the one or more annotated regions or features of interest of each polar image as a type or class, and wherein training the neural network of the machine learning system further comprises classifying each annotated region with the type or class. (Claim 6) 6. The method of claim 5, wherein the type or class is selected from the group consisting of intima, media, adventitia, lumen, EEL, IEL, plaque, calcium, and calcium plaque. (Claim 7) 6. The method of claim 5, wherein the type or class is selected from the group consisting of side branch, lumen, guidewire, stent strut, stent, jailed stent, bioresorbable scaffold (BVS), drug eluting stent (DES), fibrous, blooming artifact, pressure wire, guidewire, lipid, atherosclerotic plaque, stenosis, calcium, calcified plaque, calcium containing tissue, lesion, fat, malapposing stent, underinflated stent, overinflated stent, radiopaque marker, branching angle of arterial tree, calibration element of probe, doped membrane, light scattering particle, sheath, doped sheath, fiducial alignment point, diameter measure, radial measure, guide catheter, shaded area, guidewire segment, length, and thickness. (Claim 8) The method of claim 1 , wherein each data element, each image, and each output is stored in a machine-readable memory in electronic communication with the MLS. (Claim 9) 2. The method of claim 1, further comprising identifying in the predicted output image one or more arc-based metrics, measures of similarity of both Ca and EEL, detected EEL diameter, and detected Ca depth. (Claim 10) 2. The method of claim 1, wherein the neural network is a convolutional neural network and the number of input channels of a first node or layer is four. (Claim 11) The method of claim 1 , wherein the predicted output image includes one or more indicia indicating boundaries of predicted or classified features. (Claim 12) The method of claim 1 , further comprising: generating a carpet view using line projection; and filtering the carpet view to reduce noise in the predicted output image. (Claim 13) The method of claim 1 , wherein the neural network is a conformal neural network. (Claim 14) The method of claim 1 , wherein the MLS comprises an AI processor, the AI ​​processor comprising one or more parallel processing elements. (Claim 15) The method of claim 14 , wherein the AI ​​processor comprises N parallel processing elements and further comprises a dedicated AI processor memory. (Claim 16) The method of claim 14 , wherein the AI ​​processor is a graphics processing unit. (Claim 17) The method of claim 14 , wherein the parallel processing elements are selected from the group consisting of CUDA core processors, tensor core processors, and stream processors. (Claim 18) The method of claim 15, wherein the dedicated AI processor memory is in the range of 8 GB to 64 GB. (Claim 19) The method of claim 15, wherein the dedicated AI processor memory is in the range of 64 GB to 128 GB. (Claim 20) 10. The method of claim 1, further comprising reducing MLS processing time when classifying user image data by flattening the image data before inputting it to the neural network. (Claim 21) 10. The method of claim 1, further comprising reducing MLS processing time when classifying user image data by resizing or excluding regions of the image before inputting it to the neural network. (Claim 22) The method of claim 1 , further comprising augmenting training data by performing one, two, or three circular shifts on one or more of the polar images. (Claim 23) The method of claim 1 , further comprising performing a left-right flip on one or more of the polar images. (Claim 24) 10. The method of claim 1, further comprising removing a subset of scanlines from a polar image of the patient prior to inputting the polar image data of the patient into the neural network. (Claim 25) The method of claim 1 , further comprising performing lumen detection using image processing or machine learning methods to generate a set of detected lumen boundary data. (Claim 26) 2. The method of claim 1, further comprising performing one or more of side branch detection, guidewire detection, and stent detection using an image processing pipeline that increases the processing rate of the set of image frames acquired during OCT pullback instead of using a trained neural network. (Claim 27) 26. The method of claim 25, wherein inputting the detected lumen boundary data reduces latency in classifying regions and features of interest in polar image data of a patient. (Claim 28) The method of claim 1 , further comprising generating one or more image masks for each region or feature of interest identified in the patient image. (Claim 29) 2. The method of claim 1, wherein each input image for training or processing patient data is converted into multiple versions, and the multiple versions are generated by left-right flip and circular shift. (Claim 30) Housing and a frame grabber for receiving one or more of x-ray image data and intravascular image data; A power supply device; one or more electronic memory storage devices in electrical communication with the power supply; one or more image processing software modules executable on a processor and stored in said one or more electronic memory storage devices; a computing device comprising a first processor, the computing device being in electronic communication with the power supply and the first processor; one or more software programs stored in said one or more electronic memory storage devices; a machine learning system (MLS) comprising a neural network including one or more machine learning software modules, the neural network being trained using ground truth annotations of polar images, the ground truth annotations including calcium and tunica media; one or more AI processors, wherein the one or more machine learning software modules are executable on the one or more AI processors, the one or more AI processors comprising dedicated memory; an interface for transmitting and receiving image data to and from the first processor; It is equipped with The machine learning system is in electronic communication with the power supply, the machine learning system, the computing device, and the one or more electronic memory storage devices are disposed within the housing, and the trained neural network is operable to classify the image data in substantially real-time. (Claim 31) 31. The system of claim 30, wherein the housing is a housing for an optical coherence tomography imaging system or an intravascular ultrasound imaging system, and the substantially real time is less than 10 seconds. (Claim 32) 31. The system of claim 30, wherein the one or more image processing software modules include one or more of: software for converting polar intravascular images to Cartesian images, software for converting Cartesian intravascular images to polar images, tissue classification overlay software that labels regions or features of interest when displayed to an end user, a lumen detection software module, an image flattening preprocessing software module, an image resizing software module, image annotation software having a GUI that labels or marks training images with ground truth data, a preprocessing software module, and a circular shift software module. (Claim 33) 31. The system of claim 30, wherein the one or more machine learning software modules include one or more of a neural network interface, a lumen contour prediction, a side branch prediction, an image resizing module, a user interface and input processing software module, an MLS interface software module that controls and sets parameters of the neural network, an MLS memory manager software, a pre-processing software module, a stent strut prediction software module, a jailed stent prediction software module, a guidewire prediction software module, and an interface module that exchanges data with an imaging system.

Claims

1. A method comprising: one or more processors acquiring a set of image data including a frame of polar images; annotating, by the one or more processors, one or more regions or features of interest in each polar image of the set of image data, such that each annotated region or feature of interest is a ground truth annotation; the one or more processors training a neural network of a machine learning system using the set of annotated polar images, where regions in each polar image are identified by classes; the one or more processors inputting polar image data into the trained neural network; the one or more processors generating a carpet view using line projection; the one or more processors display the carpet view and a predicted output image including color-coded regions, each color corresponding to a class; A method of operating a processor-based system for evaluating coronary arteries, comprising:

2. The method of claim 1 , wherein each image in the set of image data includes a plurality of image data elements relating to the coronary arteries.

3. The method of claim 1 , wherein the annotating is performed using a graphical user interface that includes user controls for selecting a group of pixels or a two-dimensional boundary that defines the feature of interest.

4. 10. The method of claim 1, wherein training the neural network is repeated until an output of a cost function is below a threshold, the cost function comparing a predicted output of the machine learning system to a ground truth input.

5. The method of claim 1, further comprising: the one or more processors classifying the one or more annotated regions or features of interest of each polar image as a type or class; and training the neural network of the machine learning system further comprises classifying each annotated region or feature of interest by the type or class.

6. 6. The method of claim 5, wherein the type or class is selected from the group consisting of intima, media, adventitia, lumen, external elastic lamina (EEL), internal elastic lamina (IEL), plaque, calcium, calcium plaque.

7. 6. The method of claim 5, wherein the type or class is selected from the group consisting of side branch, lumen, guidewire, stent strut, stent, jailed stent, bioresorbable scaffold (BVS), drug eluting stent (DES), fibrous, blooming artifact, pressure wire, lipid, atherosclerotic plaque, stenosis, calcium, calcified plaque, calcium containing tissue, lesion, fat, malapposing stent, under-inflated stent, over-inflated stent, radiopaque marker, branching angle of arterial tree, calibration element of probe, doped membrane, light scattering particle, sheath, doped sheath, fiducial alignment point, diameter measure, radial measure, guide catheter, shaded area, guidewire segment, length, and thickness.

8. The method of claim 2 , wherein each data element, each image, and each predicted output image is stored in a machine-readable memory in electronic communication with the machine learning system.

9. The method of claim 1, further comprising the one or more processors identifying, in the predicted output image, one or more arc-based metrics, similarity of both calcium (Ca) and external elastic lamina (EEL), detected external elastic lamina (EEL) diameter, and detected calcium (Ca) depth.

10. 2. The method of claim 1, wherein the neural network is a convolutional neural network and the number of input channels of a first node or layer is four.

11. The method of claim 1 , wherein the predicted output image includes one or more indicia indicating boundaries of predicted or classified features.

12. The method of claim 1 , further comprising filtering the carpet view to reduce noise in the predicted output image.

13. The method of claim 1 , wherein the polar image data input to the neural network is 2D data or 3D data.

14. The method of claim 1 , wherein the machine learning system comprises an artificial intelligence (AI) processor, the AI ​​processor comprising one or more parallel processing elements.

15. The method of claim 14 , wherein the AI ​​processor comprises N parallel processing elements, the AI ​​processor further comprising a dedicated AI processor memory.

16. The method of claim 14 , wherein the AI ​​processor is a graphics processing unit.

17. 15. The method of claim 14, wherein the N parallel processing elements are selected from the group consisting of a compute integrated device architecture core processor, a tensor core processor, and a stream processor.

18. The method of claim 15, wherein the dedicated AI processor memory ranges from 8 GB to 64 GB.

19. The method of claim 15, wherein the dedicated AI processor memory ranges from 64 GB to 128 GB.

20. The method of claim 1, further comprising the one or more processors reducing processing time of the machine learning system when classifying user image data by flattening the user image data before inputting it to the neural network.

21. The method of claim 1, further comprising: the one or more processors reducing processing time of the machine learning system when classifying user image data by resizing or excluding at least one region of one or more of the polar images before inputting them to the neural network.

22. The method of claim 1, further comprising the one or more processors expanding training data by performing one, two, or three circular shifts on one or more of the polar images.

23. The method of claim 1, further comprising the one or more processors performing a left-right flip on one or more of the polar images.

24. The method of claim 1, further comprising the one or more processors removing a subset of scanlines from a polar image of the patient before inputting the polar image data of the patient into the neural network.

25. The method of claim 1, further comprising the one or more processors performing lumen detection using image processing or machine learning methods and generating a set of detected lumen boundary data.

26. 26. The method of claim 25, wherein the detected lumen boundary data is further input to the neural network for training the neural network.

27. ​​The method of claim 1, further comprising the one or more processors generating one or more image masks for each region or feature of interest identified in one or more patient images.

28. 2. The method of claim 1, wherein each input image for training or processing patient data is converted into multiple versions, the multiple versions being generated by at least one of a left flip, a right flip, and a circular shift.

29. Housing and a frame grabber for receiving one or more of x-ray image data and intravascular image data; A power supply device; one or more electronic memory storage devices in electrical communication with the power supply; one or more image processing software modules executable on one or more processors and stored in said one or more electronic memory storage devices; a computing device comprising a first processor, the computing device being in electronic communication with the power supply and the first processor; one or more software programs stored in said one or more electronic memory storage devices; a machine learning system comprising a neural network including one or more machine learning software modules, the neural network being trained using ground truth annotations of polar images, the ground truth annotations including calcium and tunica media; one or more artificial intelligence (AI) processors, the one or more machine learning software modules being executable on the one or more AI processors, the one or more AI processors comprising dedicated memory; an interface for transmitting and receiving image data to and from the first processor; It is equipped with the machine learning system is in electronic communication with the power supply, the machine learning system, the computing device, and the one or more electronic memory storage devices are disposed within the housing, and the trained neural network is operable to classify the image data in substantially real-time; An intravascular imaging and tissue characterization system, wherein at least one of the first processor, the one or more software programs, or the one or more AI processors are configured to generate a carpet view using line projection.

30. 30. The system of claim 29, wherein the housing is an optical coherence tomography imaging system or an intravascular ultrasound imaging system and the substantially real time is less than 10 seconds.

31. 30. The system of claim 29, wherein the one or more image processing software modules include one or more of: software for converting polar intravascular images to Cartesian images; software for converting Cartesian intravascular images to polar images; tissue classification overlay software that labels regions or features of interest when displayed to an end user; a lumen detection software module; an image flattening pre-processing software module; an image resizing software module; image annotation software having a graphical user interface that labels or marks training images with ground truth data; a pre-processing software module; and a circular shift software module.

32. 30. The system of claim 29, wherein the one or more machine learning software modules include one or more of a neural network interface, a lumen contour prediction, a side branch prediction, an image resizing module, a user interface and input processing software module, a machine learning system interface software module that controls and sets parameters of the neural network, a machine learning system memory manager software, a pre-processing software module, a stent strut prediction software module, a jailed stent prediction software module, a guidewire prediction software module, and an interface module that exchanges data with an imaging system.

Images