Arterial imaging / assessment systems and methods, and related user interface based-workflows
Patent Information
- Application Number
- JP2024174357
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-03-17
- Filing Date
- 2024-10-03
- Publication Date
- 2025-05-20
Smart Images

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Abstract
Description
[Technical field]
[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application is based on U.S. Provisional Patent Application No. 62 / 819,595, filed March 17, 2019. This application claims priority to and the benefit of the same. The entire disclosure of this U.S. provisional patent application is hereby incorporated by reference. No. 6,399,421, which is incorporated herein by reference in its entirety. [Background technology]
[0002] Interventional cardiologists use catheters to plan, guide, and evaluate treatment. Various diagnostic tools are incorporated during the procedure. Similarly, such vascular imaging may be used in the setting of bypass surgery or stent placement. It is used by physicians to diagnose, locate and treat vascular disease during interventions such as endoscopic procedures. Intravascular imaging techniques such as optical coherence tomography (OCT) are also As an alternative to fluoroscopy to obtain high-resolution data on the vascular status of a given subject, It is a valuable tool that can be used alone or in combination with fluoroscopy.
[0003] Intravascular optical coherence tomography peers into the walls of coronary arteries and produces images for examination Coherent light, interference, and catheter-based imaging modality. Using interferometry and micro-optics, OCT allows for video-rate in vivo cross-sectional imaging of diseased blood vessels. It can provide imaging with micrometer-level resolution. Using 3D imaging to view subsurface structures at high resolution allows for minimally invasive imaging of internal tissues and organs. This level of detail possible with OCT makes OCT particularly useful. This allows the user to not only monitor the progression of coronary artery disease, but also to diagnose it. Non-invasive imaging modalities also assess stenosis, calcium, and other features or regions of interest. It can be used together with OCT or separately to achieve this.
[0004] Calcium plaque in blood vessels is the main cause of heart disease. Calcium deposits cause the diameter of blood vessels to decrease. This leads to narrowing of the blood vessels and hardening of the blood vessel walls, which significantly reduces the function of the blood vessels. Therefore, calcium plaque is one of the main targets of cardiovascular intervention.
[0005] Imaging of portions of arteries provides a useful diagnostic tool for physicians and others. For example, intravascular imaging of the coronary arteries can reveal the location of narrowing or stenosis. Cardiologists are choosing between invasive coronary artery bypass surgery and angioplasty or stent surgery. This will help patients choose between minimally invasive catheter-based procedures such as endoscopic delivery and catheter-based delivery. Although a popular option, stent delivery has its own associated risks.
[0006] A stent is a tubular structure that is often made of mesh. It can be inserted into blood vessels and expanded to address stenotic conditions that limit blood flow. The implant is typically made of a metal or polymer scaffold. The stents can be placed at the site of the stenosis via a catheter. During a vascular procedure, the stent is delivered through a catheter over a guidewire to the site of the stenosis, A stent can be expanded using a balloon. Typically, a stent is used to fill the lumen of a narrowed blood vessel. It is expanded using a preset pressure to enlarge the lumen. Summary of the Invention [Problem to be solved by the invention]
[0007] There are several factors that influence patient outcome when placing a stent. In some procedures, the stent corresponds to the diameter of the adjacent healthy vessel segment. Excessive expansion of the stent can cause severe damage to the blood vessel. Lifting, dissection, disarticulation, and intra-mural hemorrhage It may cause emorrhage. On the other hand, if a certain part of the stent comes into contact with the vessel wall, the vessel may not expand properly. If the stent cannot be expanded, the risk of thrombosis may increase. In some cases, flow cannot be restored. Apparently, after the stent is placed, Stent overexpansion and stent underexpansion can lead to a variety of problems. It's possible.
[0008] Another challenge with stent placement and related procedures is the use of angiography systems. In such cases, visualization of the placement of the stent relative to the wall of the vessel is difficult to achieve by inspection. All of the imaging modalities and tools available to the clinician can provide useful information. However, it does not provide the clinician with much information when diagnosing or treating in catheterization. Care must be taken to avoid this. Workflows using imaging modalities and other diagnostic tools The challenge now is to establish the law in a balanced and forward-looking manner.
[0009] Additionally, you will be able to review images in the catheterization lab and operate various screens and systems. There are many conflicting time constraints in the design of a stent. The rest of the coronary landscape is not an easy task. Tools and workflows for treatment and confirmation, as well as detection systems and related methods All to enhance the success of cardiac procedures and a better understanding of the condition of the cardiac system of a given subject. This is a difficult problem for which there is great interest in practical solutions.
[0010] The present disclosure addresses these and other challenges. [Means for solving the problem]
[0011] In one aspect, the present disclosure relates to a method for displaying a representation of an artery, the method comprising: Using these processors, we have a step-by-step process to detect EEL-based metrics on a frame-by-frame basis. a frame including a group of scan lines; and, using said one or more processors, determining an EEL diameter or other EEL base. and calculating a metric of the artery using the one or more processors. Detecting calcium at a position along the segment and displaying the calcium concentration on a user-defined display. a step of displaying a user interface, the user interface being a first panel and wherein the display is in electrical communication with an intravascular imaging system. The method further comprises: the first panel being characterized by one or more EEL-based metrics or EEL-direct metrics. Also included is a longitudinal cross-sectional view of a representation of a blood vessel depicting a first indicia corresponding to a diameter. .
[0012] In one embodiment, the method includes measuring one or more regions of an artery in which calcium is detected. and displaying a second indicia corresponding to the region. The method further comprises: providing the user interface to guide stent planning or stenosis assessment; Measurement of the luminal boundary, minimum luminal area, or angular extent of detected calcium. In one embodiment, the method further comprises: In response to the detection of the stent struts, an index corresponding to the stent is generated over a range of frames. It displays the stent expansion metric and stent malapposition. and indicating one or both of the following: In an embodiment, the method further comprises: detecting the lumen boundary by detecting a region on each scan line. In one embodiment, the method includes identifying the tissue as luminal border tissue. The method includes determining a thickness value of one or more instances of detected calcium; and displaying the value to an end user.
[0013] In one embodiment, the method further comprises adding a second panel to the user interface. and displaying a second panel including a different view of the artery representation. In an embodiment, the method further comprises displaying a second panel in the user interface. and the second panel includes a first cross-sectional view of a location along the longitudinal section. In one embodiment, the method further comprises displaying the percent diameter stenosis on the user interface. This also includes
[0014] In one embodiment, the method further comprises: providing a proximal datum and a distal datum to the user interface. In one embodiment, the method includes displaying the proximal reference diameter on a display interface. In one embodiment, the method further comprises displaying the diameter value of the distal reference and the diameter value of the distal reference. indicating a minimum luminal area of a subset of the longitudinal sections between the proximal datum and the distal datum. the minimum lumen area is determined by a group of frames in the subset of the longitudinal sections. The scan lines of the group of frames are calculated for each frame. In one embodiment, the method includes overlaying a stent on the first longitudinal cross-sectional view. In one embodiment, the method includes: It also includes displaying the angle or circumference measurement of calcium detected at the location.
[0015] In one embodiment, the method comprises: and identifying or detecting one or more regions or features of interest in the collected image data. The region of interest or the feature of interest may be: a calcified plaque or other vascular Calcium in vein calcification; lumen, arterial wall, lumen, luminal border, EEL, intima, media , side branches, stent struts, tissue type, and other arterial features. In one embodiment, the image data includes OCT, IVUS, OFDI, etc. The image data includes scan lines acquired using an intravascular / diagnostic system such as a The frames may also include frames generated using an intravascular imaging probe or other imaging modalities. This can be done.
[0016] In one embodiment, the method includes: displaying at least one representation of the region of interest in a graphical user interface. and various graphical user interfaces including one or more of the features of interest. The one or more regions or features of interest may be displayed to a user simultaneously. In one embodiment, the artery is automatically detected. The representation of a segment may be identified using indicia, overlays, or other visual elements. The graphical user simultaneously selects some of the features of interest or regions of interest. a two-dimensional cross-sectional view of the artery displayed on a user interface; a two-dimensional longitudinal cross-sectional view of the image, or a combination thereof. The interface guides end users in treating subjects in a catheterization lab or another environment. To guide users through the process, the workflow is arranged or grouped into a series of steps and information presentations. In one embodiment, the feature of interest or the region of interest is a region of the intima, media, Groups including membrane, adventitia, lumen, EEL, IEL plaque, calcium, and calcium plaque are selected.
[0017] Display one or more arc lengths of a region of interest, such as detected instances of calcium. In one embodiment, the discrete regions of calcium detection can be Color, shape, and other graphics are combined to show one angle measurement of the total angle. A variety of indicia and graphics that can include graphical elements or overlays In various embodiments, the imaging / diagnostic system may be operated using The graphical user interface generated together with the operations and controls is Computer directed or computer assisted morphological workflow, computer Computer-directed or computer-assisted stent sizing / sizing workflow, computer Computer-directed or computer-assisted stent deployment / deployment workflow, computer-directed or The present invention relates to computer-assisted review / comparison workflows, combinations thereof, and the A set of graphical elements organized into groups that correspond to other workflows as disclosed. In some embodiments, the user interface may include The workflow is based on one or more panels, one or more indicia, and A graphical user interface is used that includes dynamically detected features and regions of interest. The various workflows are generated and displayed using cross-sectional and longitudinal views. Transverse and longitudinal section views showing the lumen and calcium arc and EEL detection for etc., including representations of two-dimensional and / or three-dimensional views of the arteries.
[0018] In one aspect, the present disclosure relates to a method for displaying a representation of an artery, the method comprising: storing the intra-image data set in a memory device of the diagnostic imaging system; The intravascular image dataset is generated in response to intravascular imaging of a segment of an artery. The method also includes automatically detecting a luminal boundary of the segment on a frame-by-frame basis. The method includes automatically detecting the external elastic lamina (EEL) of the segment on a frame-by-frame basis. The method also includes a step of selecting a stent sizer that configures a graphical user interface. and displaying available workflows for the task, said graphical user interface The source includes a first representation of the artery in a first frame and a second representation of the artery in a second frame. and a second representation of the artery, wherein a first EEL thickness and a first lumen thickness are determined with respect to the first representation. and a second EEL thickness and a second lumen thickness are displayed for the second representation.
[0019] In one embodiment, the method further comprises: Where the EEL is specified for each respective expression using one or more indicia In one embodiment, the method further comprises: The third interface further includes a third representation of the artery in a third frame, The EEL thickness and the third lumen thickness are displayed for the third representation, and the third frame is The user can select and change the settings through the graphical user interface. In one embodiment, the method further comprises: The second frame may be selected from a frame between the first frame and the second frame. wherein the graphical user interface displays a longitudinal cross-sectional representation of the artery. and further comprising: the longitudinal cross-sectional representation displaying the first frame and the second frame with respect to In one embodiment, the method further comprises: wherein the lumen area is symmetrical about the longitudinal cross-sectional axis of said representation.
[0020] In one embodiment, the method further comprises the steps of: and displaying the detected EEL for a plurality of frames using one or more indicia. In one embodiment, the method further comprises: The first frame is a proximal reference frame and the second frame is a distal reference frame. In one embodiment, the method further comprises: a first portion of the representation of the system is identified using a first indicia, and the distal reference frame The second part of the expression may be identified using a second indicia. In an embodiment, the method further comprises the step of: and a longitudinal cross-sectional representation of the member, the longitudinal cross-sectional representation being characterized by using the first indicia. In one embodiment, the method further includes displaying a portion of a first axis that is identified by the The method further comprises: the graphical user interface displaying the motion in a third frame. a third representation of the vein, said third representation being identified using said first indicia; The method further includes displaying the portion of the first axis.
[0021] In one embodiment, the method further comprises the step of: , a graphical element, and an overlay. In an embodiment, the method includes detecting calcium at a position along the segment. and displaying the total calcium angle for one or more frames in said graphical user interface. and displaying the interface. In one embodiment, the method further comprises: The user inputs a selection of a stent landing zone for a longitudinal cross-sectional representation of the segment. In one embodiment, the method further comprises receiving from the user displaying the calculated stent length in response to selecting the stenting zone; and displaying a minimum luminal diameter (MLD) for the longitudinal cross-sectional representation. In one embodiment, the method further comprises: The method further includes displaying an option to select an instance deployment workflow. In one embodiment, the method further comprises the step of selecting a review workflow after stent deployment. The review workflow further includes a representation of the stented artery and and one or more indicators of stent expansion percentage and stent malapposition.
[0022] In a second aspect, the present disclosure relates to a method for displaying an artery, the method comprising: storing the data set in a memory device of the diagnostic imaging system, The image dataset is generated in response to intravascular imaging of a segment of an artery. The method includes measuring, by frame, one or more regions of calcium relative to the luminal border of the segment. The method also includes automatically detecting the detected calcium in one or more frames. The method also includes calculating an angular or circumferential measurement of the frame. The method also includes calculating a calcium thickness of the detected calcium. The method also includes generating a first representation of the artery in the one or more frames. the calcium thickness of the detected calcium in a first frame of the frame and the angle measurement or the circumferential measurement. The method also includes displaying the first representation of the artery. The method also includes displaying indicia indicative of the angular measurement or the circumferential measurement.
[0023] In one embodiment, the method further comprises generating a second representation of the artery. the second representation includes a longitudinal cross-sectional representation of the artery; and and displaying indicia corresponding to the detection of the. The method automatically detects the external elastic lamina (EEL) of the segment on a frame-by-frame basis. and displaying indicia corresponding to the EEL for each frame of the longitudinal cross-sectional representation. The present invention further includes the following.
[0024] Multiple image datasets are used to assess morphology, pre-treatment, stent planning / sizing Various workflows and procedures organized around stent placement, placement, and review of procedures The basic graphical user interface displays the score, measurements, total angle, maximum thickness, E EL, Lumen, Side Branch, Calcium, Calcium Angle, Frame, Image and Displayed Motion The proximal end of the arterial segment or frame, the distal end of the imaged and displayed arterial segment or frame. frame, selected frame, flag, bookmark, proximal fiducial, distal fiducial, luminal border Angiographic images and images displayed with respect to image data acquired in or about an artery and co-registration indicia, first pullback, second pullback pullback, nth pullback, EEL diameter, EEL measurement, EEL metric, cal The score generated using the smear angle and EEL thickness, stent expansion percentage, Tent apposition, stent malapposition, total calcium angle, minimum luminal surface area Product, minimum lumen diameter, lumen thickness, stenosis, stent expansion threshold, stent adhesion threshold, calcium threshold value, calcium 0 degrees to about 360 degrees, circumferential calcium arc, etc. The combination can be displayed.
[0025] In part, the present disclosure relates to a system for identifying a region of interest within a blood vessel, such as an artery, the system comprising: The system includes a processor in communication with a memory that, when executed, generates an image of the blood vessel. Acquiring image data and sorting scan lines, frames, pixels, and combinations thereof Detecting or segmenting image data such as a region of interest and identifying features of the region of interest and one or more graphic user interfaces that are organized and displayed as part of the diagnosis and treatment. and displaying a vessel representation using the interface. In one embodiment, the image data is a plurality of scanlines. In an embodiment, the image data is a polar image.
[0026] In part, one embodiment of the present disclosure includes an intravascular data collection system and one or more A software-based graphic user interface and A software module that performs one or more detection and display processes. In one embodiment, intravascular data is collected while angiographic data is simultaneously collected. Thus, cross-sectional views and / or longitudinal views of one or more of the arteries may be collected at the same time. The representation of can be co-registered with the angiography data. The present disclosure relates to angiography or optical coherence tomography (or other intravascular image data) Calcification information of blood vessels and other detected calcium-related information related to one or more of the above. Regarding display.
[0027] In various embodiments, a proximal frame, a distal frame, and a frame therebetween The frame is positioned and the detected calcium is displayed using the first indicia. In some embodiments, the calcium arc and calcium angle are shown together with The detected calcium angle or arc value, including the sum, may also be numerically and / or indicatively The EEL detection is also displayed using a visual or graphical element, and the thickness associated with this detection is also displayed. In various embodiments, the proximal frame and the distal frame are displayed using measurements. The frames can be the first frame and the second frame, or vice versa. The frame disposed between the first frame and the second frame may be It may be a third / intermediate frame, such as a user-selected frame. As shown in the figure, the Fr. followed by a number indicates OCT, IVUS, etc. , OFDI, or other pullback generating imaging modalities. Indicates the system number.
[0028] One general aspect is the treatment workflow, planning workflow, As part of a review workflow or other workflow, lumen detection may be performed to determine the lumen boundary, Detecting calcium and EEL and displaying lumen detection for one or more arterial representations In one embodiment, the detected lumen boundary data is obtained on an image-by-image basis. Other embodiments of this aspect include a plurality of sensors each configured to perform the actions of the method. A corresponding computer system, device, and one or more computer storage devices that Includes recorded computer programs.
[0029] Implementations may include one or more of the following features. In one embodiment and inputting the detected lumen boundary data includes inputting a region of interest and a region of interest in the image data. The described technique reduces the latency of classifying features of interest. , a method or process, or computer software on a computer-accessible medium Various machine learning techniques, image processing based techniques, and other image analysis techniques can be used. The analytical techniques disclosed herein can be used to detect and segment features and regions of interest. The process can be performed automatically.
[0030] One general aspect is a data collection and / or imaging and region / feature characterization system. The system also includes a housing. The system is adapted to receive polar data, ultrasonic data, optical data, and Receive one or more of the following image data: image data, X-ray image data, and intravascular image data. The intravascular system also includes a frame grabber for receiving the signal from the intravascular system. The intravascular system also includes a power supply. The system also includes one or more electronic memory storage devices in electrical communication with the power supply. The internal system is executable on a processor and is connected to the one or more electronic memory storage devices. The intravascular system also includes one or more image processing software modules stored on the device. The system also includes a computing device including a first processor, A power supply device is 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 provided in the housing. Either placed in a housing or connected to the housing through one or more ports, buses, or networks. In one embodiment, a given machine learning system The MLS (Multi-Layer Learning System) and its trained neural network are Ant / Server embodiment, Edge computing embodiment, or Service embodiment It is operated remotely through the cloud or software.
[0031] In one embodiment, the system further comprises: The system also includes one or more software programs stored in the one or more functions. Machine learning system with neural network including machine learning software module The intravascular system also includes one or more AI processors, The machine learning software module above is executable on the one or more AI processors. One or more AI processors, a bus, an AI processor memory, and image data are stored in the and an interface for transmitting and receiving data to and from a first processor, The system is in electronic communication with the power supply and is connected to the machine learning system, the computing device, The chair and the one or more electronic memory storage devices are disposed within the housing. In one embodiment, the bus is a PCIe bus. corresponding computers each configured to perform the actions of the method. A system, an apparatus, a computer program recorded on one or more computer storage devices program, AI processor, dedicated ASIC, circuitry and circuitry components. In an embodiment, the bus is connected to the AI processor and to on-board memory and diagnostics. Connect the processor / imaging system.
[0032] Implementations can include one or more of the following features: The housing includes an optical connector. Hearence Tomography Imaging System, OFDI System, Tomography System, CT Scan , an X-ray or an intravascular ultrasound imaging system. The image processing software module detects the region of interest or feature of interest as it is displayed to the end user. Tissue classification overlay software to label features and lumen detection software module Adjust the view of the graphical user interface, organized by workflow. and logic for detecting the presence or absence of said one or more machine learning software components. The modules are neural network interface, lumen contour prediction, and side branch prediction. Calcium detection; EEL detection; and user interface and input processing software. The module and the MLS interface to control and set the parameters of the neural network interface software module, MLS memory manager software, and pre-processing software and a stent strut prediction software module. a stent prediction software module; and a guidewire prediction software module; an interface module for exchanging data with an imaging system and a given computer instruction; or a workflow logic diagram showing any of the above for computer-assisted workflows. and one or more of the following: , a method or process, or computer software on a computer-accessible medium The software may include
[0033] In part, this disclosure uses machine learning (ML) methods and systems. and adapted to evaluate image data from a patient in real time or substantially real time. In various embodiments, the present invention relates to a computer-based method and system for detecting intravascular A set of image data such as data pullback is fed to a convolutional neural network Classification is done virtually in real time using a trained neural network In various embodiments, the image data set may include between about 400 frames and about 600 frames. In addition, a rotating probe is used to capture OCT, IVUS image data, Considering the acquisition of the 3D and other imaging data, we deal with two coordinate systems related to them. This disclosure addresses these challenges and the need to provide a single Rapid patient access so stent insertion and other procedures can be performed between sessions and numerous other challenges related to solving imaging and diagnostic problems. The workflow disclosed herein is as follows: a patient is in the cath lab and undergoes one of the procedures for a given procedure. can be used for treatment / diagnosis, deployment, review, or other workflows as part of Reduce operator fatigue during these procedures and provide controlled information to facilitate decision making. Segmentation of an image into a number of features or regions of interest. The instruction workflow allows for stent planning, bypass surgery, and Inform evaluation of endovascular surgery, atherectomy, debulking of the stent zone, and other surgical options , by providing clinicians with diagnostic information to assess changes in a patient’s condition over time. This reduces the time spent between initial diagnostic procedures and subsequent treatment procedures.
[0034] In part, the present disclosure uses an imaging processing pipeline to identify tissue types and other Features, stent, EEL, calcium, calcium angle, EEL, EEL thickness, guide wire and detecting regions of interest within blood vessels, which may include ears and other features, properties and materials of the blood vessels. In addition, neural networks are used to analyze calcium, lumen, media, intima, and lipid and other regions or features of interest, such as those disclosed herein. The present invention relates to a method for identifying a region of interest in a blood vessel.
[0035] In one embodiment, a segmentation in one or more masks, images, or outputs is performed. and / or the tissue type or tissue characteristic, region of interest, selected for detection and expression. The features of interest, classes or types or vascular features include the following: cholesterol, roll, fiber, lipid pool, lipid, fibrofatty, calcification, calcium nodule, calcium plate rate, intima, thrombus, foam cells, proteoglycans, and other such agents disclosed herein. The various systems disclosed herein may include one or more of the following: controller, FPGA, AI processor and other components as disclosed herein. Operable to perform all of the methods and processes disclosed herein using .
[0036] The method disclosed herein comprises: detecting the one or more regions or features of interest in each polar image; The method may further include classifying the samples as a type or class. The type or class may be intima, media, adventitia, lumen, EEL, IEL plaque, , calcium, calcium plaque. The image data used with the systems and methods disclosed herein may include, but is not limited to, carpets. Quickview image, scanline, pixel, 2D image, 3D image, angiogram image, blood vessel Endoscopic images, CT scan images, X-ray images, and images of arteries, veins, organs, or other components of the circulatory system The features, regions, channels, classes, etc. are then trained on them. The detection can be performed using a neural network trained on the
[0037] While the present disclosure is directed to various aspects and embodiments, the various Aspects and embodiments may be integrated, combined, or combined. as a system or, where appropriate, partially as separate components, devices and systems. It is understood that the present invention can also be used together as described above. Each embodiment may incorporate each of the above aspects to varying degrees as appropriate for a given implementation. can be incorporated into the
[0038] 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 not intended to limit the present disclosure. , the scope of which is defined only by the claims.
[0039] 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) are available upon request. , and will be provided by the U.S. Patent and Trademark Office upon payment of the necessary fee. [Brief description of the drawings]
[0040] [Figure 1] FIG. 1 is a schematic diagram of a diagnostic system suitable for imaging arteries, automatically detecting features and regions of interest in the resulting image data, and displaying an enhanced instruction workflow to streamline procedures in a catheter lab, in accordance with an exemplary embodiment of the present disclosure. [Figure 2A] FIG. 2 illustrates an exemplary user interface suitable for evaluating image data acquired and stored in a memory such as in the system of FIG. 1 having various features of interest such as calcium detection, total calcium angle, proximal and distal frames, and other features as shown, in accordance with an exemplary embodiment of the present disclosure. [Figure 2B] FIG. 2 illustrates an exemplary user interface suitable for evaluating image data acquired and stored in a memory such as in the system of FIG. 1 having various features of interest such as calcium detection, total calcium angle, EEL detection for multiple frames, proximal and distal frames, and other features as shown, in accordance with an exemplary embodiment of the present disclosure. [Figure 2C] 13A-13C illustrate example user interfaces of longitudinal cross-sectional views of an artery in which some of the EEL regions are below thresholds in various regions, according to example embodiments of the present disclosure. [Figure 2D] FIG. 13 illustrates an example user interface of a morphology workflow in which various panels are arranged as part of the user interface to indicate various bookmarks and orientations of the artery in a cross-sectional representation of the artery relative to a longitudinal cross-sectional representation of the artery, in accordance with an exemplary embodiment of the present disclosure. [Figure 2E]FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a morphology workflow in which calcium and EEL detection and associated measurements are shown. [Figure 2F] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a morphology workflow in which calcium and EEL detection and associated measurements are shown. [Figure 3A] FIG. 13 illustrates an exemplary graphical user interface suitable for implementing a stent sizing workflow for selecting a stent and other stent parameters such as stent length for a representation of an artery suitable for evaluating a stent landing zone, according to an exemplary embodiment of the present disclosure. [Figure 3B] FIG. 13 illustrates an exemplary graphical user interface suitable for implementing a stent sizing workflow for selecting a stent and other stent parameters such as stent length for a representation of an artery suitable for evaluating a stent landing zone, according to an exemplary embodiment of the present disclosure. [Figure 3C] FIG. 13 illustrates an exemplary graphical user interface suitable for implementing a stent sizing workflow for selecting a stent and other stent parameters such as stent length for a representation of an artery suitable for evaluating a stent landing zone, according to an exemplary embodiment of the present disclosure. [Figure 3D] FIG. 13 illustrates an exemplary graphical user interface suitable for implementing a stent sizing workflow for selecting a stent and other stent parameters such as stent length for a representation of an artery suitable for evaluating a stent landing zone, according to an exemplary embodiment of the present disclosure. [Figure 4A] FIG. 1 illustrates an exemplary registration interface suitable for configuring and demonstrating endovascular and angiographic coregistration in support of a stent placement workflow, according to an exemplary embodiment of the present disclosure. [Figure 4B]1A-1C illustrate an exemplary graphical user interface suitable for implementing a stent placement workflow, according to an exemplary embodiment of the present disclosure. [Figure 4C] 1A-1C illustrate an exemplary graphical user interface suitable for implementing a stent placement workflow, according to an exemplary embodiment of the present disclosure. [Figure 5A] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 5B] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 5C] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 5D] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 6] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 7A] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 7B]FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. [Figure 8] FIG. 1 illustrates an exemplary graphical user interface suitable for implementing a review workflow in which additional procedures, such as additional ballooning or additional stent repositioning, may be performed to improve patient outcomes, in accordance with an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] The present disclosure relates in part to collecting artery-related data, detected parameters, or images. In one embodiment, the present invention relates to a diagnostic system for acquiring and / or storing in electronic memory the The system provides automated detection, various aspects of this detection that facilitate various diagnostic purposes. Facilitates the determination of metrics and / or through various graphical user interfaces These purposes include, but are not limited to, the sizing (size selection), stent placement, balloon sizing, balloon placement , review of concurrent or prior treatment or diagnostic procedures and other diagnostic tools, measurements and calculations The user interface and associated diagnostic system may include X-ray imaging, C T-scan, angiography (blood vessel) system, fluoroscopy system, ultrasound system, optical coherence CT systems, intravascular imaging systems, combinations of these, and other It includes received data from various imaging modalities, such as imaging modalities and diagnostic modalities. and / or can be linked to this received data.
[0042] In one aspect, the present disclosure provides a method for streamlining catheter lab procedures and providing a method for treating cardiac Various works that make information easily accessible to users such as specialists or other clinicians Each workflow has its own indices such as color, hatching, dotted lines, and overlays. A (or mark), calcium, EEL, lumen, lumen, as disclosed herein Different views, such as cross-sectional or longitudinal views, can be used to highlight various interesting detections such as boundaries. Representations of arteries or arterial segments modified as identified between views. In some embodiments, the representation of the artery, such as a longitudinal cross-sectional view, is symmetric about an axis. In various embodiments, colors are used in different ways to highlight features of interest among the various representations. It is used as an indicia such as orange as shown in the drawings.
[0043] A variety of data acquisition and analysis systems are available to obtain information about the coronary system. Data obtained using a device from a vessel or intravascular measurements related to these data Data derived from clinical or extravascular measurements are analyzed or compiled to assist researchers and clinicians. In addition, the automatic detection of intravascular features according to the morphological workflow can be performed. Operator review and pretreatment options and procedures according to sizing and planning workflow Evaluate stent size selection and landing zone according to deployment workflow Select and evaluate the arterial segment as part of the selection and ensure the patient is still in the catheter lab. To evaluate stent expansion and malapposition during the procedure and improve final stent placement and expansion. Facilitates review of stent deployment to allow for further ballooning or other procedures To achieve this, various computer-directed or computer-assisted workflows are defined. It can be generated and displayed in a specified manner.
[0044] Optical coherence tomography (OCT) uses an interferometer and an imaging modality for obtaining distance measurements for a blood vessel or an object disposed within the blood vessel. In various embodiments, optical frequency domain imaging (OFDI) is used. Intravascular Imaging (IVIM) can also be used as an intravascular imaging modality. Intravascular Ultrasound (IVUS) can also be used as a probe to image blood vessels. Angiography and fluoroscopy systems may also be capable of making diagnostic decisions. The patient will be photographed so that various possible treatment options, such as stent placement, can be performed. These and other imaging systems are often used to image the patient externally. or can be used to capture raw data from the inside, , can contain various types of image data.
[0045] The present disclosure generally relates to a method for collecting intravascular data, such as acquiring image data related to a blood vessel using an intravascular data collection device. Any intravascular data that can be used to generate and receive signals containing diagnostic information. These devices can be applied to optical or ultrasonic probes. imaging devices such as probes, pressure sensor devices, and other components of the blood vessels or cardiovascular system. This may include, but is not limited to, other devices suitable for collecting data relating to It is not intended to be a one-size-fits-all approach. It is intended to evaluate various user interface representations and associated workflows. Before proceeding, an exemplary system for implementing the methods and arterial assessment tools disclosed herein will be reviewed. It is useful to discuss this issue.
[0046] Figure 1 shows the imaging of an artery and the automated detection of features and regions of interest in the acquired image data. Enhanced indication workflow and workflow visualization to streamline procedures in the catheterization lab FIG. 1 is a schematic diagram of a suitable diagnostic system 5. The system 5 is capable of detecting various intravascular imaging modalities and Supports non-intravascular imaging modalities to generate arterial image data and provide evidence The system provides a variety of diagnostic procedures and treatment options using a variety of base measurements and their efficient display. This paper presents a workflow that makes it easy to support
[0047] The system 5 is suitable for viewing and evaluating visual representations of arterial information. The interface is controlled by the user using a mouse, joystick, or other control device. and can be operated using one or more processors and memory storage elements. The imaging device may include one or more movable elements that can automatically acquire and / or process image data. The resulting morphological results can be displayed as part of a streamlined workflow .
[0048] In the stent delivery planning procedure, the level and location of apposition, Users can refer to OCT and annotated angiograms to assess stent placement as part of their delivery plan. These system features and methods are shown in FIG. This can be implemented using system 5.
[0049] FIG. 1 illustrates a method for collecting data or detecting a characteristic of a subject 4 or detecting a state of a subject 4. Various data collection subsystems adapted to detect or otherwise diagnose the subject 4. In one embodiment, the subject sits on a table, It is placed on a suitable support 44, such as a bed, or a chair, or other suitable support. Typically, subject 4 is a human or other animal having a particular region of interest 25 .
[0050] The data acquisition system 5 may be a nuclear magnetic resonance, x-ray, computer-assisted tomography, or other suitable Non-invasive imaging systems, including non-invasive imaging techniques, are also included. As a non-limiting example, angiograms suitable for producing cines may be used. Shown is a system 20. The angiography system 20 may include a fluoroscopy system. The angiography system 20 may be configured to perform one or more imaging techniques, such as, for example, OCT or IVUS. The probe 3 is adapted to image blood vessels in the region 25 of the subject 4 using angiography in Typically, the form of a frame of image data is taken while the pullback procedure is being performed using to non-invasively image a subject 4 such that a frame of angiographic data is generated at It is composed.
[0051] The angiography system 20 communicates with an angiography data storage and image management system 22. The angiography data storage and image management system 22 is, in one embodiment, In one embodiment, the collection Data processing associated with the collected angiographic signals is performed directly on the detector of the angiography system 20. Images from the system 20 are stored in an angiography data storage and image manager 22. The information is stored and managed in the form.
[0052] In one embodiment, the system server 50 or the workstation 85 In one embodiment, the entire system 20 is The system 20 also detects such radiation passing through the subject 4. The data processing system 22 then uses the signals from the angiography system 20 to Then, one or more regions of subject 4, including region 25, are imaged.
[0053] As shown in this particular example, the region of interest 25 may be a portion of the vascular system, such as a particular blood vessel, or the peripheral vascular system. This subset can be imaged using OCT. A catheter-based data collection probe 30 is introduced into the subject 4, e.g., to measure coronary The probe 30 is placed in the lumen of a particular blood vessel, such as a vein. FR probes, IVUS probes, probes that combine two or more of the above features Various types of data collection probes, such as endovascular probes, and other probes suitable for imaging within blood vessels. The probe 30 typically includes a probe tip, one or more radiating The probe tip includes a radiopaque marker, an optical fiber, and a torque wire. Optical beam directors, acoustic beam directors, pressure detector sensors, other transducers or detectors , and combinations of the above.
[0054] In the case of a probe having an optical beam director, the optical fiber 28 may The torque wire is used to provide optical communication with the probe. The torque wire defines a hole through which the optical fiber is disposed. In FIG. 1, the optical fiber 28 is shown without the torque wire surrounding it. The probe 30 may also include a sheath, such as a polymer sheath (not shown), which may form part of a catheter. In the context of an OCT system, the optical Fiber 28 is connected to a patient interface unit (PIU) as shown. It is optically connected to the ace unit 35.
[0055] The patient interface unit 35 receives the end of the probe 30 and provides an optical connection thereto. Typically, the data collection probe 30 is used The PIU35 is appropriately configured based on the type of data collection probe being used. For example, the combination of OCT and IVUS data collection probes. The alignment requires OCT and IVUS type PIUs. The PIU 35 is typically The wire, sheath, and optical fiber 28 disposed therein may be removed as part of a pullback procedure. In addition to being pulled back, the probe tip also includes a motor suitable for pulling back. The portion is also typically rotated by the PIU 35. Thus, the blood vessels of the subject 4 are The probe 30 can also image coronary flow prediction. Characteristics such as fractional flow reserve (FFR) or other pressure measurements The present invention can be used to measure certain parameters.
[0056] The PIU 35 is then connected to one or more intravascular data acquisition systems 40. The data acquisition system 40 may be an OCT system, an IVUS system, another imaging system, and combinations of the above. For example, probe 30 may be an OCT probe. The system 40 in this context includes a sample arm of an interferometer, a reference arm of an interferometer, and a nce arm), a photodiode, a control system, and a patient interface unit. Similarly, as another example, in the context of an IVUS system, intravascular data The acquisition system 40 includes ultrasonic signal generating and processing circuitry, noise filters, a rotatable gear In one embodiment, the actuator may include a joint, a motor, and an interface unit. In the angiography system 20, the data acquisition system 40 collects an angiography video frame. configured to synchronize the time stamp and the OCT image frame time stamp; It has a shared clock or other timing signal.
[0057] In addition to the invasive or non-invasive image data collection systems and devices of FIG. Various other types of data may be collected regarding the subject's area 25 and other parameters of interest for the subject. For example, the data collection probe 30 may include one or more wires, such as a pressure wire. The pressure wires can be used to facilitate the addition of OCT or ultrasound components. The pressure readings can be used to segment blood vessels in the region 25 of the subject 4. The information can be obtained according to the following:
[0058] Such readings may be relayed through a wired or wireless connection. As shown in the flow reserve ratio (FFR) data collection system, the wireless transceiver 48 Receives pressure readings from probe 30 and transmits them to the system to measure vascular and generating FFR measurements at one or more locations along the one or more displays 82. , 83 also describes the various workflows disclosed herein, calcium angle, EEL detection, calcium Calcium detection, proximal frame, distal frame, and associated graphical user interface Interface, EEL-based metrics, stent / no stent decisions, scores, debulking and other procedures Recommendations,Evidence-based recommendations informed by automatic detection of regions of interest and features,vascular Contrast data frame, OCT frame, image data, stent planning interface, morphology Structure interface, review interface, stent deployment interface, OCT and 1 illustrates a user interface for angiography data and other controls and features of interest. Two example workflows, Workflow A and Workflow B, can be used to: The flows can be displayed on displays 82, 83. These workflows are Examples of the present invention include, but are not limited to, graphical user interfaces, panels, arterial images, arterial representations, Cardiac features, regions of interest, and other measurements and graphical representations disclosed or depicted herein. It can contain any of the elements, and can contain any subset of them. This can be done.
[0059] An intravascular image, such as a frame of intravascular data generated using the data collection probe 30. The data is sent to a data acquisition and processing system 40 connected to the probe via the PIU 35. The non-invasive image data generated using the image management system 22 can be One or more servers, such as a registration server 50 and a workstation 85. The data may be transmitted to a server or workstation, stored therein, and processed thereby. A computer board configured to capture angiographic image data from the system 22. Video frame grabber devices (video frame acquisition devices) 55 such as It can be used in the embodiment.
[0060] In one embodiment, the server 50 is stored in a memory 70 and operated by a processor 80. One or more coregistration software modules executed by 67. The server may be a trained computer suitable for implementing various embodiments of the present disclosure. In one embodiment, the neural network 52 includes a graphic The AI processor such as the AI processing unit 53 is included in the server 50 and electrically connected to the memory 70. The computing device server 50 is a processor-based computer. It may include other typical components for a database server. One or more databases, such as database 90, store the generated image data, subject parameters, and a database generated by one or more of the system devices or components shown in FIG. other information received by the database 90 or sent to the database 90. It can be configured as follows.
[0061] The database 90 is stored in the memory of the workstation 85 while the server 50, this is just one example configuration. The software module 67 may be executed on a processor of the workstation 85. and the database 90 may be located in the memory of the server 50. The use of a device or system for executing software modules is provided as an example. The hardware and software described herein may be used in various combinations. The software acquires frames of image data, processes such image data, and The image data can be used to align the images.
[0062] Unless otherwise specified herein, software module 67 may be referred to as pre-processing software. A, transform, matrix, and process image data or in response to patient triggers, other software The base component 67 facilitates coregistration of different types of image data. or otherwise perform annotation of image data to generate ground truth. Software, such as other software-based components used to implement the present disclosure, It may include other software, modules, and functions suitable for implementing various embodiments. These modules include Workflow, Morphological Workflow, Reviewer Workflow, Sizing workflow, Deployment workflow, Computer directed workflow - using computer-assisted workflows, scanline-based or image-based methods Lumen detection, workflow, indicia generation, calcium angle and arc generation, scanning Stent detection, indicator generation, and stent placement using line-based or image-based methods Cohesive bar generation for endoscopic planning, proximal and distal color coding and indicia generation, luminal border detection, stage Includes: endodontic extension, lumen profile, target lumen profile, side branch and missing data. It is possible to do so.
[0063] The database 90 is generated by the angiography system 20 and is Receive and store angiographic image data 92, such as image data acquired by the server 50. The database 90 can store OCT image data, IVUS image data, or O Intravascular image data, such as FDI image data or OCT image data generated by the OCT system 40 Other non-endovascular arterial image data 95 such as image data, frame acquisition unit 50 of server 50 The information acquired by 55 can be received and stored.
[0064] In addition, the subject 4 may be connected to one or more monitors, such as monitor 49, via one or more electrodes. The monitor 49 may be electrically connected to a monitor related to, but not limited to, cardiac function. , an electrocardiogram monitor that generates data indicative of various states of the subject, such as systole and diastole It is possible.
[0065] The use or lack of use of directional arrows in a given diagram indicates the way in which information can flow. For example, the connections shown in Figure 1 may be For a given connector, such as an arrow or line, shown as The flow may be in one or more directions or in only one direction, as appropriate for the application. The connection may be any suitable data transmission connection, such as an optical connection, a wired connection, a power connection, a wireless connection, or an electrical connection. A transmission connection may be included.
[0066] One or more software modules may be implemented in an angiography system, such as system 22 shown in FIG. The frame of angiographic data may be processed by the processor. However, the software, its components, or software-based or process-based Various software modules that may include one or more steps of the method are , may be used in given embodiments of the present disclosure.
[0067] The present disclosure relates in part to a processor-based method for analyzing intravascular data collected by an intravascular probe. Intravascular data acquisition systems and related systems that can be converted or analyzed by the The results of such analysis and transformation may include identifying features of interest or Parallel processing of image processing software modules for image segmentation and detection of regions of interest Pipeline classifies elements in medical images and detects instances of features and regions of interest Machine learning systems with neural networks for and a display that communicates with the segmentation and detection system. In one embodiment, OCT, IVUS, X-ray, A given imaging system, such as a base imaging system, is in electronic communication with the MLS and is The modified version of the image data acquired using the imaging system is referred to as such image data. can be displayed during the same session in which they were acquired. UMedVision1, CUMedVision2, VGGNet, multi-stage multi-recursion Input fully convolutional network (M 2 FCN:Multi-stage Multi-recursive-input Fully Convolutional Network, Coarse-to-Fine Stacked d) Fully Convolutional Nets, Deep Active Learning Framework, ResNet, Combinations of these, as well as other neural networks suitable for image segmentation, Various neural networks, including network and software-based machine learning frameworks The architecture can be used for image segmentation.
[0068] In one embodiment, the MLS is configured to generate the workflows disclosed herein in a timely manner. Perform the necessary machine learning operations so you can get results quickly to support A dedicated hardware system to handle the application and training process. The specialized hardware system of a given MLS embodiment includes an AI / ML program. The machine learning system may include a plurality of processors, such as a processor for image composition. Tissues, tissue types, and other regions of interest are detected and based on type or another parameter, The image is segmented or processed so that it can be characterized. This can be accomplished by training a classifier. The lumen, intima, media and plaque are detected, with boundaries corresponding to these different tissues. It is identified as such.
[0069] The present disclosure provides one or more memory devices including a memory with an increased amount of memory allocated per processor. The present invention relates to an advanced machine learning system including the AI processor. , is designed to support multi-channel segmentation techniques. Various channels can be selected for different areas of interest and characteristics. For example, In one embodiment, the first channel, the second channel, the third channel and the fourth channel These channels are involved in the regulation of luminal, calcium, EEL, and other areas of interest. Each class / type is assigned to a different area or feature. It can also be associated with the channel in which it is used to facilitate segmentation.
[0070] In one embodiment, calcium is classified with respect to the arterial wall tissue surrounding the lumen. Luminal border detection can provide the outer boundary of calcium within the tissue of the arterial wall. In some embodiments, the plaque type is classified as calcified. In addition, calcium, plaque and other detectable changes in a given artery section can be detected. Given that the presence of such features may indicate the presence of constriction from stenosis or the like, another aspect of the present disclosure is The feature quickly and automatically obtains one or more scores associated with a given plaque or stenosis. This can help end users make decisions more easily. For example, a given score determined using image data and its machine learning-based analysis may be Whether immediate action is not recommended or whether the stenosis should be stented; or This can help determine whether other procedures, such as atherectomy or bypass, are necessary. This can be done as part of a workflow described herein, such as a morphology workflow. or as part of a stent planning and sizing workflow. Also larger calcium angle and EEL thickness.
[0071] In healthy patients, arteries are made up of various membranes arranged in a coherent structure, including the tunica intima, tunica media, and tunica adventitia. As a result of the atherosclerotic process, the intima becomes pathologically thickened and fibrous. , proteoglycans, lipids and calcium, as well as macrophages and other inflammatory cells. These tissue types may include plaques composed of different types of tissue, including Establish a set of training data for one or more of the machine learning systems listed. When imaged using the various imaging systems that can be used to capture The plaques considered to be the most pathologically significant are linear plaques with underlying lipid pools. The different types of atherosclerotic plaques are called vulnerable plaques, which are composed of a fibrous capsule. For example, foam cells usually have ribosomal lipids at the shoulder of a large lipid pool. The shape information is currently In one embodiment, the neural network is used for qualitative evaluation of OCT images. The study was trained to identify fibrous capsules and / or fibrous capsules with underlying lipid pools. In various embodiments, calcium is referred to herein without limitation. This includes, but is not limited to, calcified plaque and other calcium-containing tissues.
[0072] If the patient is still catheterized and has received a stent or other treatment option While the patient is being prepared for surgery, the patient is quickly put through an imaging procedure to obtain arterial images and After that, the images can be processed using machine learning systems, resulting in significant time savings and Improved patient outcomes are achieved.
[0073] The tunica media and its outer edge, called the External Elastic Lamina or EEL. is used by physicians to size their stents during intervention. Finding and measuring the diameter of partially diseased tissue is time-consuming and difficult. This also requires training in image interpretation. Automatic detection and measurement of EEL diameter may be faced at the time of diagnosis or otherwise when evaluating patients for treatment options. One example of such a diameter measurement is the lumen diameter or The end user may specify different lumen distances and EEL diameters or different EEL distances for these arterial measurements and and review to select stent size based on potential landing zone. This is shown in Figures 3A to 3D as part of a stent sizing workflow that can be performed.
[0074] 2A and 2B are diagrams illustrating a method for displaying an image and a representation of one or more features of a blood vessel, such as an artery. 2A is an exemplary graphical user interface of a suitable diagnostic system. The user interface 10 of FIG. 1 and the user interface 15 of FIG. 2B are respectively A partial cross-sectional view 17, 19 is shown on the right, and a longitudinal cross-sectional view 21 of each artery is shown on the right. , 23 are shown at the bottom of the interface. are examples of arterial representations, whether in a single frame or across multiple frames. It is.
[0075] The illustrated longitudinal representations or images 21, 23 etc. are labeled proximal on the left and Also included on the right side is the label D in the distal direction. In one embodiment, the longitudinal section mode of the vessel is The measured values are derived from collected imaging data or other data, such as measurements of a given artery that is being evaluated. In one embodiment, an actual image of the arterial segment is displayed. In some cases, data are presented with respect to longitudinal or other views (see legend 31). These views, including those shown in Figure 1, may be smoothed, vectorized, or simplified, or visual data may be removed. A reduced representation is also generated.
[0076] In one embodiment, a device such as a probe P is placed in an artery as shown in FIG. In addition, various views, such as longitudinal and transverse, are stored as individual frames of image data. The frame 120 for the pullback of the probe P is shown in FIG. 17, the frame 120 is shown at the bottom in a longitudinal cross-sectional view. Various scales and measurement standards are also presented, such as the standard 36 corresponding to the scale of Other scales and metrics that relate or track arterial features and dimensions may also be used. The diagnostic system may include one or more computer-based imaging systems. and may include a specialized subsystem for detecting vascular features. Cut.
[0077] The user interface disclosed herein includes a variety of menus, such as menu 12 and other menus. Includes various menus, panels, interfaces, controls, and combinations thereof. In one embodiment, the various screens / user interfaces are Construction, sizing (such as stent sizing or other arterial metrics), deployment (device deployment) or procedure deployment, etc.), co-registration, review of current or prior procedures or other diagnostic data Accessible through menu 12 for patient metrics, supported imaging modalities, etc. In various embodiments, during the stent planning workflow, The user may decide to side stent based on the EEL measurement and / or the lumen diameter measurement. This can be done by selecting the desired stent from the graphical user interface shown in Figures 3A to 3D. The following is shown in the interface:
[0078] Detecting and displaying any suitable morphological and structural features of an image of a blood vessel or other representation of a blood vessel In one embodiment, the features detected relate to arteries. The systems and methods described herein may include a method for detecting calcium and one or more arterial layers. Various representations and metrics or measurements related thereto can be displayed. Some exemplary methods for detecting and displaying calcium in blood vessels are described in detail in the US Pat. No. 6,333,625. The patent application, filed on the 14th of this month, is entitled "SYSTEMS AND METHODS TO DETECT AND DISPLAY ENDOVASCULAR This is described in more detail in U.S. Patent No. 9,940,723 entitled "Method and Method of Carrying Out the Invention FEATURES." The disclosure of this U.S. patent is incorporated herein by reference in its entirety. do.
[0079] In general, the exemplary user interfaces 10, 15 are configured to display morphological information. It consists of, but is not limited to, other information, along with various indicia, overlays, and visualization elements. Both interfaces 10 and 15 can display one or more segments. The calcium detected in the artery in each frame is shown. The upper right portion of the 10th and 15th sections was identified as a morphological feature where calcium 65 was highlighted. Legend 31 indicates which controls can be toggled on and off for various interfaces. and / or Orange color corresponds to above-threshold detected areas associated with exceeded calcium detection levels The colors of the stenotic ducts, side branches (SB) and lumen (L) are shown, and other parameters are Also shown with indicia such as symbols and colors or hatching or other visual elements. It is possible.
[0080] Calcium plaque in the arteries is correlated with heart disease and is the subject of stenting. This can sometimes present a challenge. Calcium deposits can lead to narrowing of the blood vessel diameter and hardening of the blood vessel walls. This leads to a significant decrease in vascular function. Calcium plaques therefore It is one of the main targets of cardiac vascular intervention. The user interfaces disclosed herein for thickness and calcium angle are The user navigates through calcified areas and receives information about stent insertion for those areas. or to stent areas with thinner calcium regions. Or choose a debulking procedure such as atherectomy or other tissue or material removal process. Provides end users with diagnostic information that allows them to choose their implementation.
[0081] In one embodiment, the present disclosure provides a method for treating the external elastic layer (EEL) of an artery. er), or measurements or metrics obtained or generated using the detection area of the EEL. The present invention relates to a graphical user interface suitable for displaying a check. In some embodiments, the detection area of the EEL or the measurement or calculation of the EEL diameter or radius is The calculated values are displayed on the representation of the artery as a dotted or dashed line. A user interface displaying one or more of the parameters and calcium parameters. Examples are shown in Figures 2A, 2B, 2C, 2, 4, 5A, 5B, and 6. In these figures, dotted lines are used to indicate such parameters. The legend used herein for Ca, EEL, etc. is consistent with the legends presented in other figures. In various embodiments, the same applies to such figures, where applicable, even if the figures are not included. As can be seen from the given diagram, calcium, stent expansion level, or stent failure The color orange is shown in the figure to indicate perfect contact.
[0082] FIG. 2C shows that some of the EEL regions are below the threshold, as shown in regions J and K. 1 shows an exemplary user interface of a longitudinal cross-sectional view of a vein. In addition, calcium C The region of a is also indicated by the orange region. There are no dashed lines in regions J and K. This means that plaques may extend beyond these regions and EELs may not be detected. These results indicate that the EDTA-induced toxicities were not detected at or below the threshold level for delineating the EEL. In this manner, the user interface 38 allows the end user to select a landing zone. In addition, areas with different dashed spacing can be easily identified. L is shown, which shows how the EEL varies along the length of the artery. How other thresholds can be set for the These changes are meaningful based on the variation of the EEL. It can be used to guide decision making.
[0083] In one embodiment, the diagnostic system and associated user interface include Users can use touch screens, joysticks, trackballs, mice, keyboards, The system can be interacted with through a variety of input devices, including a combination of and methods include calcium, EEL, EEL metric, EEL diameter, EEL radius, EEL Derived values, landing zone, stent landing zone, balloon landing zone , target zone, stenosis, lesion, fiducial frame, marker band, stent malapposition Area of, threshold, deviation or difference from threshold, stent expansion metric, malapposition threshold, stent Detect and display tent expansion threshold, calcium arc length, calcium angle measurements, and circumference measurements; It is about manipulation, transformation and visualization.
[0084] The user interface displays one or more images or views of the artery from various viewing angles and cross-sectional views. In one embodiment, the location of the EEL, the diameter of the EEL, or Other EEL-based parameters can be angular measurements, or as shown in Figures 2A and 2B. The total angle in degrees is shown in terms of the detected calcium arc. The arc, angle, or circumferential extent of calcium detected for a given cross-section of the artery is expressed as a function of the This can be shown as arc length or angular extent or via other metrics. Detected calcium (Ca) 65 with an angle range of A degrees to B degrees is shown. In addition, another calcium arc, A1-B1, is also shown. The total angle of calcium is The sum of arcs 31 and 31b. Specifically, in FIG. 2A, this total angle is shown as 76 degrees. In addition, the maximum MT thickness detected for calcium 65 (Ca) is also shown. In this example, the MT is approximately 0.37 mm. The detected calcium is expressed as the EEL parameter A longitudinal cross-sectional view 21 is also shown.
[0085] In FIG. 2B, two regions of calcium are shown in interface portion 19. The first The first calcium region has an angular range of A degrees to B degrees, and the second calcium region has an angular range of C degrees. In one embodiment, two different total Ca angles can be shown: In FIG. 2B, the sum of the range of angles A to B and the range of angles C to D is a total angle of 33 The maximum thickness of the calcium region, MT, located between A and B, is also shown. and has a value of about 0.54 mm. In various embodiments, the angle is greater than 180 degrees. The calcium angle is a set of parameters that are used to help users make informed decisions. The endovascular treatment is identified as suitable for debulking or stent insertion based on endovascular thickness.
[0086] In one embodiment, a landing zone for deploying a particular stent or balloon. When selecting, the diagnostic user interface described herein may display additional vascular preparation information. Provide end users with information on which areas are required or areas to avoid for landing zones. FIG. 2C shows areas J and K where landing zones should be avoided. The region L of the artery representation 38 is determined by EEL-based values, such as diameter values, that vary across the region. is shown based on the change in dotted line label.
[0087] FIG. 2D shows how the various panels depict variations in the cross-sectional representation of the artery relative to the longitudinal cross-sectional representation of the artery. Various bookmarks and arterial orientations are placed as part of the user interface. FIG. 2D is an exemplary user interface of the morphology workflow. The near and far reference frames are aligned using indicia, in this case yellow Y and blue B. The upper parts of the distal and proximal reference frames are yellow and the lower parts are blue. This orientation of the feature is also used in Figure 3B. The proximal and distal frames are used to determine which part of the artery is in relation to the proximal and distal reference frames. The upper panel of the graphical user interface holds the Y and B orientation of the frame. Also, as part of this morphological workflow, a full 184 degree The calcium angle and maximum calcium thickness MT of 0.54 mm are also shown. Various flags in the code move the user back and forth between pre-specified frames of interest. It is a bookmark that allows you to
[0088] 3A-3D, the system of FIG. 1 may be used with an MLS or other detection system. Automatic EEL and lumen measurements, such as EEL diameter and lumen diameter detected using the system The value will inform which stent size to consider and which type of stent to use. MLS-mediated calcium detection can be used to treat lesions and improve outcomes by stenting. It provides information on treatment options, such as atherectomy rather than endoscopic surgery. Cium detection is a consideration when selecting any atherectomy procedure and when using a given vendor's stent, Input parameters for selecting stent type, stent model, stent length, and stent thickness Interaction with the graphical user interface is done by the user. The camera can be moved and the various dimensions of the imaged artery can be changed. Having greater flexibility when selecting a tent and when the stent is deployed Supports workflow that allows
[0089] In one embodiment, the dotted line in one or more views, such as the longitudinal cross-sectional view, is the EEL line. Shows diameters by frame, by vessel segment, or by subsets and combinations thereof Detecting EELs in the cloud is a complex task that requires image processing, machine learning, artificial intelligence, neural networks, and other techniques as disclosed herein.
[0090] In some arteries, once plaque has developed or is in place, it , which may push out or surround the EEL. As a result, some implementations Detecting EELs or meeting or exceeding the EEL diameter threshold in morphology. The dotted lines corresponding to the EEL threshold metric, such as the threshold metric that is exceeded, are dotted or Regions with and without other indicia of EEL detection were identified for a given segment of the artery. This is because the EEL is covered by the plaque location. Either the EEL-based parameters are hidden or the EEL-based parameters are hidden for a given region, one frame, multiple frames, or multiple The EEL may be obscured in another way so as to be undetectable for several frames or segments. The area is considered to be a poor candidate for a landing zone for a stent or balloon due to its Therefore, indices such as the dotted line indicating EEL parameter detection Breaks in the design can indicate areas to be avoided from a landing zone / deployment perspective. The use of three frames, including a user-selectable frame, creates a timeline that facilitates decision making. One or more markers in the longitudinal mode are indicated by 153. It can be varied to change the center frame.
[0091] In one embodiment, orange indicia associated with calcium detection. is the amount of calcium detected or a given circumferential percentage of calcium detected is a particular threshold of calcium, such as a certain threshold thickness, that is met over an arc length or angular span. is detected. A value that meets a threshold or a different threshold is met. When the calcium threshold requirement is met, one or more indicia associated with the calcium threshold requirement are Any suitable indicia, such as hatching, color, animation, etc., can be used to display the , arteries suitable for display with respect to the disclosed user interfaces and subsets thereof. In one embodiment, a particular feature may be used. Various thresholds and interfaces for detecting features, and how and when to detect those features The display is specified by the end user via the input user interface. In other embodiments, the thresholds can be preset, or the user can select various preset values. It may also be provided for the user's selection.
[0092] FIG. 3A shows the graphical user interface of the stent sizing workflow. The upper part of the interface shows the frame of the artery at the proximal fiducial 151. Or a particular view or slice and a selected frame 153 (lower longitudinal view 165) and the distal reference frame 155 At the top of this FIG. 3A are three views corresponding to views 1 and 2.
[0093] The view in the lower part of FIG. 3A shows the combined C in luminal profile view. The proximal datum 151 and the distal datum 155 indicate one or more luminal points through the lumen L. The lumen L is shown with a dotted line above it. These values obtained from the measurement of these lines are , applied to a measured or detected EEL location, point, or pixel, and the measured EEL diameter or average EEL diameter. Some exemplary EEL diameter measurements are , approximately 3.8 mm (proximal) and approximately 3.4 mm (distal).
[0094] FIG. 4A illustrates an exemplary coregistration interface 200. In an embodiment, angiographic data, such as an angiographic image, is acquired and OCT, I Other imaging modalities such as VUS, X-ray, etc. may also be used. Angiographic data may be used to compare other data. It can be used to co-register with other imaging modalities such as CT, IVUS, etc. The path of the pullback is shown using the intra-arterial pathway. The start 207 of the cloud can also be shown.
[0095] Figure 4B has a live blood vessel on the left, which is visualized using OCT, IVUS, and X-ray. The angiogram was positioned next to the right reference angiogram, which was co-registered with another imaging modality such as 1 shows a user interface 153 for displaying the dual live and reference angiographic information. The module alignment allows the user to perform angiography co-registered with OCT or other imaging modalities. This helps visualize the arteries that are in the vicinity of the graft. This provides a fiducial co-registration that informs live angiograms. The data can be used to help deploy a stent or balloon. FIG. 4C shows an existing deployed stent DST and the stent During the endovascular planning workflow or another workflow, A workflow interface in which the image data was used to select and plan stent deployment. Two landing zones, LZ1 and LZ2, from the source are visible on the angiogram. 1 shows an angiogram image co-registered with an OCT image as shown in FIG.
[0096] Various endpoints of the landing zone may be shown on the angiogram as endpoints S and T. These points allow for a morphometric mapping between the arterial representations, either in the image or in the centerline. Link, map, or otherwise share angiographic data with other related data. The following points are mapped or tracked together so that they can be aligned: These are used to select the stent landing zone as part of the deployment process. In addition, different stent lengths can be selected as part of the stent deployment planning stage. In order to select or try, a distance measurement, such as distance Y mm, can be evaluated.
[0097] FIG. 5B is a user interface showing a review mode of stent placement on an arterial representation. In one embodiment, the representation or indicia of the stent is It may be depicted or otherwise depicted or overlaid with respect to.
[0098] In one embodiment, the stent is a mesh or graph having cross-hatching. The landing zones S and T of the stent are visualized as various The EEL diameter is shown at the frame or segment location 180. The minimum stent expansion of 73% is shown. The horizontal colored lines indicate the The stent expansion of the frame or location 180 corresponds to the stent expansion. 83% stent expansion at the point along the line and at that location / frame 180 Also shown at top right is another view showing a luminal area of approximately 9.09 mm. The torso-strut SS is also shown in the upper right view. Right-side color coding as shown in the angiogram The lengths shown correspond to the stent expansion metrics shown below. The malapposition frames are colored. Identified by dividing vertical lines.
[0099] In one embodiment, a thin horizontal orange line is implemented as an extension of the target. In one embodiment, the indicator is orange or another color. The data is used to indicate expansion failure or expansion against the expansion threshold or expansion metric. Orange vertical lines or other color-coded lines or indicia indicate thresholds. In one embodiment, the vertical bars represent a frame with stent malapposition. is a frame with other indicia such as color that may not fit perfectly. Examples of this type of expression that can be used in a face are shown in Figures 5A, 5B, and 6 ( The lower longitudinal section view is depicted in FIG. 5A and FIG. 7B. The approximate distance between the stent struts is used to display vertical lines corresponding to the instances of the stent struts. The 300 μm threshold for incomplete apposition is also shown. Various stent struts ST are shown. Stent struts shown with UMs are malapposed and / or have poor expansion. This shows a good area and is a candidate for re-ballooning before the patient leaves the cath lab. The ability to inspect and correct a deployment is a key feature of a review workflow.
[0100] In one embodiment, the image may correspond to a particular frame, location, region, segment, etc. a parameter associated with a characteristic or value that exceeds a threshold or threshold level for that value to indicate that the A given indicia, such as a threshold value, color, etc., is displayed on the user interface. It can be set as above a value / level or below a certain value / level. Therefore, it is possible to detect calcium, incomplete adhesion, poor stent expansion, and stent overexpansion. The overexpansion, EEL diameter, EEL radius, and other EEL-based parameters may be used alone or in conjunction with the present specification. In combination with other parameters, values, levels, etc. disclosed in the document or figure, Various indices such as frame colored regions, vertical lines, horizontal line hatching, and other indicia These various indicia can be used to indicate the shape and structure of the It may be used as part of the construction, stent sizing, stent deployment, or review phase. A given stage corresponds to a workflow in various embodiments.
[0101] In Figures 5A, 7A and 7B, the vertical colored lines or bars are aligned at a predetermined threshold or unity. Detected stent struts or stent cross sections that are incompletely attached relative to a user-specified threshold. In addition, horizontal colored lines or bars or expansion The expansion portion is detected as being underexpanded or overexpanded relative to a predetermined expansion threshold or a user-specified expansion threshold. 1 shows a frame of image data corresponding to an exposed stent strut or stent cross-section. Different indicia, such as different colors, can be used for stent underexpansion or overexpansion. In FIG. 6, the upper luminal view shows the colored area corresponding to calcium, while the lower In the inferior luminal view obtained from the pullback of the subsequent procedure, the stained areas indicate malapposition and stenting. Provides information about the placed stent with respect to stent expansion. Simplified interface Across the different views with different colors and indicia being used to , various indicia can be combined and / or standardized.
[0102] In addition, a given subject may be examined during a single session with a diagnostician / clinician or over one or more Multiple imaging sessions can be undertaken between multiple visits where amputation procedures are performed. For example, Then, perform an intravascular imaging session using OCT imaging, as shown in Figures 2A and 2B. Morphostructural evaluation was performed to demonstrate a combination of optimal EEL and calcium detection and thresholds. After the initial session, i.e., the first pullback, the stent is placed in place. A second pullback and subsequent imaging sessions can then be performed. These two different sessions allow for a normal flow of blood to the arteries, which usually occurs during each session. As a result, a length or segment of one session or pool is imaged. The session may include imaging data prior to a procedure such as stent insertion, but may not include subsequent sessions. The pullback or pullback includes image data after the stent has been deployed and expanded. Different lengths of the same artery can be acquired at different times.
[0103] FIG. 8 illustrates an additional review workflow interface in which a second pullback is compared. The first pullback is shown in the upper part of this interface as before. Stents that are deployed using other workflows are shown in the lower longitudinal section. The stent is shown in plan view. The minimum stent expansion is indicated. The MLA marker is also shown. Two corresponding cross-sectional frames are also shown on the left, which show the Stent struts are also shown. 2 and 2.76 mm 2 (Stent insertion The two measured lumen areas (before and after insertion) are also shown. Supports additional balloons before leaving the cath lab.
[0104] In one embodiment, the power supply is controlled by the underlying diagnostic system software. The receiving user interface may include two different pullbacks, such as a first pullback and a second pullback. In this way, the two data sets can be linked together. so that common areas of the arteries can be reviewed while being able to roll The two data sets can be synchronized. This allows for stenting, ballooning, and This makes it easier for end users to review the artery prior to stenting, atherectomy, etc. It becomes possible to see the results of placing a balloon or performing an atherectomy. If the two data sets, the first pullback and the second pullback, are not synchronized, It becomes difficult to capture slightly shifted or different content (frames of image data). It becomes difficult to track the location in the artery from the two pullbacks, and the error This can be seen in Figure 6. In one embodiment, once the link Then the scroll between the two images (like the two pullbacks) will stay linked / synchronized. The user can drag the frame to align the cross-sectional image, as shown in .
[0105] Lumen detection is disclosed in the "Lumen morphology image recognition" application filed on September 22, 2010. U.S. Patent No. 9,138,144 entitled "Structure based on the scan line data of OCT" This can be implemented using a variety of systems and methods, including those disclosed in US Pat. No. 6,397,363. The disclosure of this U.S. patent is incorporated herein by reference in its entirety. In addition, various other detection operations are disclosed in the application filed on January 13, 2020. "SYSTEMS AND METHODS FOR CLASSIFICATION OF ARTERIAL IMAGE REGIONS AND FEA No. 16 / 741,718, entitled "TURTURES THEREOF," which is hereby incorporated by reference. The present invention may be implemented using a variety of systems and methods, including those described in this application. The disclosure of the patent application is hereby incorporated by reference in its entirety. In addition, various other detection operations as well as stent analysis and target lumen profiling are performed. For details regarding the file, see “METHOD AND APPARATUS” filed on March 12, 2013. FOR AUTOMATED DETERMINATION OF A LUMEN CONTOUR OF A STENTED BLOOD VESSEL” No. 14 / 115,527, filed on Oct. 13, 2003. The disclosure of this U.S. patent application can be implemented using the systems and methods described herein. No. 6,399,945, which is incorporated herein by reference in its entirety.
[0106] One embodiment of the present disclosure includes, in part, an intravascular data collection system and one or more software A software-based graphic user interface as described herein It relates to a software module that performs one or more detection and display processes. In one embodiment, the intravascular data is collected while the angiographic data is simultaneously To be collected.
[0107] The present disclosure provides, in part, a method for evaluating the efficacy of a vascular endoscopic procedure by visualizing a subject's blood vessels, such as one or more coronary arteries. The present invention relates to a system and method for treatment evaluation, including tent planning and surgical options. The data can be acquired using an intravascular data collection probe. , a blood vessel can be pulled back through and data can be collected about it. Such pullbacks and associated data collection may be used to plan or assess the stent deployment. The resulting intravascular data from the pullback is used to evaluate various Various imaging techniques are available for visualization of different vascular regions, features, and stents deployed therewith. The image data, the arterial representation (a cross-sectional view of the imaged artery), , longitudinal view, and other views), and the detections shown for the arterial representation are The system can be co-registered with the endoscopic data. This allows the user to streamline the workflow. You can select an area of artery representation as part of the map (OCT, IVUS, X-ray, etc.) The underlying image data used to generate the arterial representation or binoculars can be seen. Angiographic display having highlighting or other indicia indicating the area of a selected vessel in the view. This can be done using the co-registration workflow. can.
[0108] The present disclosure relates in part to intravascular data collection, such as OCT, IVUS, and other imaging modalities. A collection system and computer-guided user interface layouts A set of workflows and parts of a given imaging diagnostic session in a catheterization lab. A stent landing zone in a blood vessel, shown as a series of operations as and generating and visualizing diagnostic information such as side branches, regions of interest, and characterized tissue regions. Suitable graphical elements for presenting diagnostic information of interest such as those listed above include comparisons, measurements, and It serves as a user selection element that allows for analysis and analysis. By concisely organizing and summarizing related information, the Displays are automatically generated, reducing the end user's overall information load and associated fatigue Helps.
[0109] Also described herein are systems for visualizing stents, tissue types, tissue volumes, and tissue boundaries. Systems and methods are also disclosed. The systems and methods disclosed herein are Angles, thicknesses, volumes, widths, frame cows for various tissue types including calcium, lipid, fibrous, etc. and an automated measurement system capable of measuring the relative proximity of tissue to a lumen and related In various embodiments, such a measurement tool includes features such as Ca, EEL, and The above parameters, such as the luminal thickness and the luminal thickness, together with any geometric characteristics of a given region of interest of a particular tissue type, These measurements can be used to measure the quality and usefulness of the product. This can be used to generate a variety of ratings or scores appropriate for the
[0110] Intravascular images or frames, such as cross-sectional images in the drawings, are typically captured one scan line at a time. The sample is captured along a ray that originates from the center of the catheter to the maximum imaging depth. In one embodiment, a sequence of pixels is called a scanline. The smallest data unit in an OCT image is called a sample. The sequence of samples along a ray that reaches a large imaging depth is called a scanline. T images are typically acquired one scan line at a time. Transverse images are acquired by The image can be formed from a set of scanlines collected as the image rotates. To image a segment of an artery or other vessel, the catheter is rotated and moved longitudinally. In this way, the probe takes a set of cross-sectional images in a spiral pattern. The images are acquired from various scan lines associated with a slice of the vessel or artery of interest. The scan lines are arranged with angles between them like the spokes of a wheel. The scanlines are acquired in polar format in one embodiment.
[0111] For clarity, this disclosure describes various aspects of embodiments of the applicant's teachings. However, some specific details are omitted wherever it is convenient or appropriate to do so. It will be understood that, for example, the discussion of the same or similar features in alternative embodiments may be construed as merely illustrative. Well-known ideas or concepts may be abbreviated for the sake of brevity. Those skilled in the art will appreciate that some implementations of the applicant's teachings may be readily understood to be within the scope of the present disclosure. The forms are set forth herein solely for the purpose of providing a thorough understanding of these embodiments. Some of the details specifically described in any of the embodiments described herein may be omitted. Similarly, the described embodiments are within the scope of the present disclosure. can accept modifications or variations in accordance with common general knowledge without departing from the scope of the It is clear that the detailed description of the embodiments does not in any way supersede the teachings of the applicant. It should not be construed as limiting the scope of the disclosure.
[0112] As used herein, the terms "about" and "substantially the same" refer to, for example, by handling measurements or procedures in the field; inadvertent errors in these procedures by; by differences / defects in the manufacture of electrical elements; by electrical losses Variations in quantities and the same as long as such variations do not include known values implemented by the prior art. Generally, the term "about" refers to a range of values that are within the scope of the present invention. Or the range of values, 1 / 10 greater or smaller than this specified value, for example ±1 For example, applying a voltage of about +3V DC to the element means that the It can mean applying a voltage of 2.7V DC to +3.3V DC. Where values are said to be "substantially the same", the values may differ by up to 5%. The terms "about" or "substantially" may be used in the claims, whether or not modified by the same term. The quantitative values recited in the specification are not intended to be limiting, and are not intended to be limiting unless otherwise specified. This includes any quantitative variations in such values that are recognized as equivalent by
[0113] [Arterial assessment using intravascular and other imaging modalities, workflow presentation] and sequencing, as well as non-limiting graphical user interface features, systems and methods. [Specific Software Features and Implementations] The following description is directed to device hardware suitable for carrying out the methods of the present disclosure described herein. This description is intended to provide an overview of the software and other operating components of the The hardware and and other operating components may be suitable as part of the apparatus described above. The indication is for personal computers, multiprocessor systems, and microprocessor-based Electronic devices or programmable electronic devices, network PCs, minicomputers , may be implemented using other system configurations, including mainframe computers, etc. The present disclosure relates to a system in which a task is performed by using communication networks in different catheter rooms or catheterization laboratories, etc. Distributed computing is performed by remote processing devices linked through a network. It may also be implemented in a mobile computing environment.
[0114] In one embodiment, the software module processes the endovascular data to: Characterize the tissue and identify related areas such as calcium regions, taper regions, lipid pools, and other tissue features. The software is designed to measure fractional flow reserve (FFR), vascular Vascular Resistance Ratio (VRR), and other measured and calculated intravascular data Data collection parameters can also be compared. Such parameters can be used to assess the stent insertion status. From the stent state to the non-stent state, such parameters can be used to determine one or more Tricks can be generated.
[0115] In one embodiment, an OCT system can be used. A receiver such as a balanced photodiode-based system that receives light returned by the probe. Any other device that is part of this system or in electrical or optical communication with this system. A computer, processor, ASIC, or other device included as a subsystem of or the like receives the electronic signals from the probe. The computing device in the Software for image data processing and configuration for stent visualization and stent malapposition detection In one embodiment, the PCI Express bus includes a PCI Express bus and other components suitable for utilizing the PCI Express bus. A bus, such as a 10Gb / s bus, may be used to communicate with a given imaging system, an MLS, or both. It is used to connect the various components of a combination system.
[0116] The stent deployment planning tool may be part of the software or may be integrated into the software. These tools can also exchange data with the vascular wall. This can be used to place a virtual stent in the affected luminal area. FIG. 3C illustrates a representation on a user interface in which one or more virtual stents can be deployed. FIG. 3C shows an example area of a segment of a pullback that may be shown. Candidate stenosis during sizing workflow co-registered to angiographic images The landing zone LZ is shown. The EEL diameter is 2.61 mm and the landing zone is 2.50 mm. Also shown is a cross-sectional representation of an arterial frame with a luminal diameter of 1.0 mm. Co-registration with vessels can be used to help inform tent selection. This helps the landing zone to be evaluated and modified. The upper part of the sizing and proximal reference frames is yellow, and the lower part is blue. As part of the design, a candidate landing zone (LZ) and a candidate stent length (23 mm) are provided by the user. Three frames are shown with a user selectable frame in the middle. In various embodiments, different EELs and lumen diameters are used for proximal and distal references. To allow for a detailed examination of the signal, the marker US can be moved to determine which frame is in the stain. Sizing allows you to change what is displayed in the central panel of the graphical interface. It also shows the bookmarks (BKMs) that users can set using the GUI. This allows the user to move between frames quickly. Another marker is also shown to indicate a frame with LD, and in another example, MLA, i.e. The minimum lumen area can be displayed.
[0117] Cross-sectional and longitudinal views of blood vessels generated using collected endovascular data A display showing the information can also be part of the system. Once acquired using a probe and stored in memory, this data can be processed to obtain the pullback region. or a subset thereof, cross-sectional views, longitudinal cross-sectional views, and / or 3D views of the vessel along its length. It is possible to generate and display information such as the original view. The disk can be used to display or store ground truth data and prediction results. These views are user-defined as described and illustrated in the following description and subsequent figures. It can be depicted as part of an interface.
[0118] A given set of user interfaces is displayed according to a workflow as disclosed herein. In various embodiments, the workflow can be organized in a catheterization lab. This will streamline operations at the hospital and allow for the patient to be seen before discharge or even after catheterization. The CT scanner has a preferred sequence that works to improve patient outcomes before leaving the CT scanner bench. In one embodiment, the workflow sequence is as follows: morphology, structure, The sequence is stent sizing, stent deployment, and review. The images of the blood vessels generated using the distance measurements include the lumen contour, the blood vessel diameter, and the blood vessel cross-sectional area. and the Landing Zone and the tools and software modules described herein. and a blood vessel including a virtual stent, the virtual stent being bounded by a landing zone when the virtual stent is processed as a blood vessel. In one embodiment, the MLS provides information about one or more computers. The present invention includes an operating device and one or more software programs or modules. The various devices, components, systems, and subsystems disclosed herein are For each of the tasks, methods, steps, processes and other features described herein, The device is operable to perform the
[0119] Some parts of the detailed description refer to operations on data bits within a computer memory. These algorithmic descriptions and symbolic representations are presented as , can be used by those skilled in the computer and software related fields. In embodiments of the present invention, an algorithm is defined herein generally as an operation that produces a desired result. The method steps are considered to be a self-consistent sequence of The operations performed as steps or otherwise described herein are physical manipulations of physical quantities. Typically, but not necessarily, these quantities are stored. Can be transferred, combined, transformed, compared, and otherwise manipulated. This takes the form of an electrical or magnetic signal.
[0120] As will become apparent from the discussion below, unless otherwise specified, throughout this specification: "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 "Ratio" "Compare," "Generate," "Detect," "Determine," "Indicate," "Boolean logic," or "Relate" A discussion using terms such as a set of operations or other similar terms may be used to describe a computer system or electronic device. The data represented as physical (electron) quantities in the registers and memory of electronic memory devices is called or register or other such information storage, transmission or display device trained to manipulate and convert data into other data represented as physical quantities in similar devices; The activation of the MLS, computer system, AI processor, GPU, or electronic device It is understood that the term refers to solutions and processes.
[0121] The present disclosure also provides, in some embodiments, a method for performing the operations herein. This apparatus may be specially constructed for the required purpose, or The apparatus is selectively activated by a computer program stored in the computer. or reconfigured general-purpose computers. The data collection and some of the conversion and processing described herein are performed using It can be executed.
[0122] The algorithms and displays presented herein essentially implement the principles of any particular computer. The present disclosure is not intended to be limiting, nor is it intended to be limiting, to any particular device, system, or equipment. It may therefore be used in conjunction with a program to perform the required method steps. In some cases it may prove convenient to build a more specialized device. The required structure for these systems will appear from the description below. It is not described with reference to any particular programming language, but rather may be implemented in various ways. The embodiments can thus be implemented using a variety of programming languages.
[0123] In one embodiment, semantic segmentation using a given MLS embodiment is performed. Using the quantification, the image is detected as having calcium and EEL, and the calcium Pixels with EELs and EMELs can be identified, allowing the physician to select treatment options. It helps to solve various problems regarding the selection of and guidance for specific treatments. In morphology, the output of the MLS system is an arc-based representation of similarity for both Ca and EEL. One or more of the following: metric / measurement, detected EEL diameter, and detected Ca depth. In some embodiments, these values include EEL, media, calcium, tubules, and the like. After classifying the cavities and other regions and features of interest, measurements are made on the image data. Tissue types that can be detected using the methods and systems disclosed herein include: Some non-limiting examples include the internal area through which blood flows, the lumen, the tunica intima, the tunica media, the external elastic lamina (ELA), EL) (also called external elastic membrane), internal elastic lamina (IEL), external The media includes the membrane, plaque, calcium or calcified tissue, etc. The media is divided into the IEL and EEL. The intima is bounded by the lumen and the IEL. Using machine learning or artificial intelligence (AI) systems to generate images of arteries or other structures Various implementations of detecting or segmenting images into various constituent tissue types or regions of interest are described. In part, the machine learning system is adapted to perform a variety of tasks, including intravascular imaging, ultrasound, and imaging. or an imaging system such as an X-ray system, such as an angiography system or a fluoroscopy system or can be combined with such an imaging system. In one embodiment, the present disclosure provides a method for characterizing tissue using MLS. and one or more of the lumen, EEL, media, and calcium / calcium plaque were examined. Relates to detecting.
[0124] Embodiments of the present disclosure include a processor (e.g., a microprocessor, a microcontroller, for use with a computer (such as a digital signal processor, Data-programmed logic, programmable logic devices (e.g., field programmed with FPGAs or other programmable logic devices For use with programmable logic, discrete components, integrated circuit mechanisms (e.g. (e.g., an application specific integrated circuit (ASIC)), or any other device, including any combination thereof. The present invention may be embodied in many different forms, including but not limited to, means. In an exemplary embodiment of the present disclosure, one or more imaging probes for pullback are provided. Intravascular imaging system, 2D imaging or 3D imaging system and processor-based Any or all of the processing of data collected using the system may be carried out using computer programs. The set of instructions is implemented as a set of program instructions that can be converted into a computer-executable form. The program is converted and stored in a computer readable medium, and the program is then used to control the operating system. The query response and the input data are then executed by the microprocessor under , training sets, image masks, and other inputs and outputs disclosed herein. The functions described above in this specification are converted into processor understandable instructions suitable for performing the functions described above in this specification. The computer program logic embodying all or part of the computer executable format, and various intermediate formats (e.g. assemblers, compilers, linkers, , or a format generated by a locator) The source code may be embodied in a variety of operating systems or For use with the Operating Environment, various programming languages (e.g. Object code, assembly language, or Python, Perl, Go, FORTR AN, C, C++, JAVA (registered trademark) or HTML) Source code may include a set of computer program instructions implemented in a program. The source code can specify and use various data structures and communication messages. may be in a computer-executable form (e.g., via an interpreter); source code is translated (e.g., via a translator, assembler, or compiler) It can be converted into a computer-executable format.
[0125] Various embodiments described herein, or components or portions thereof, may be implemented using software. Many different versions of software, firmware, and / or hardware, or modules thereof The present invention can be implemented in various embodiments. The software code or dedicated control hardware used in the present invention does not limit the present invention. For example, the embodiments described hereinabove are not, for example, conventional techniques or objects. Any suitable component such as .NET, SQL, or MySQL using object-oriented techniques. The present invention can be implemented in computer software using any suitable computer programming language. do.
[0126] Computer software and other computer-implemented instruction programming languages can be translated into machine code by a compiler or assembler before execution, and / or can be directly translated at run-time by the interpreter. Examples include ARM, MIPS, and x86; examples of high-level languages include Ada, BAS IC, C, C++, C#, COBOL, Fortran, LUA, Clojure, Ja Includes va, Lisp, Pascal, Object Pascal, and scripting languages Examples include Bourne script, JavaScript, Python, Ruby These include .y, PHP, and Perl.
[0127] The operation and behavior of the embodiments may be implemented using actual software code or dedicated hardware components. The absence of such specific reference is not material. It is possible, since one of ordinary skill in the art can easily and with only moderate effort and without undue experimentation, A software implementation of the present disclosure may be designed based on the description in the specification; This is because it is clearly understood that the hardware can be controlled.
[0128] Various machine learning systems, deep learning neural networks, 3D neural networks Neural Networks, Convolutional Neural Networks, 2D Neural Networks, N Layered neural network, feedforward neural network, feedforward Word Network, Feedback Word Network, Radial Basis Function Neural Network Network, Kohonen self-organizing neural network, recurrent neural network recurrent neural network (RNN), modular neural network, deep learning Learning networks, artificial intelligence-based systems and frameworks, and Related neural networks such as combinations of these.
[0129] Controllers, processors, computing devices, ASICs, FPGAs, and and / or combinations thereof, as well as other computer functions described herein. Software for the various diagnostic systems described herein that can be implemented using: Implemented in computer software using any suitable computer programming language. For example, various machine learning systems may be implemented using computer readable media, e.g. For example, software stored or otherwise maintained in RAM, ROM, secondary storage, etc. The present invention may be implemented using one or more processing cores (e.g., CPUs, GPU and / or AI accelerator cores) provide a set of workflow and graphic units It can generate user interfaces that can include joysticks, buttons, mice, and other The display may be responsive to user actions, such as from a user interface device.
[0130] Computer programs are stored in semiconductor memory devices (e.g. RAM, ROM, PRO M, EEPROM, or Flash programmable RAM), magnetic memory devices (e.g. diskette or fixed disk), optical memory devices (e.g., CD-ROM), P Tangible storage media such as C cards (e.g., PCMCIA cards) or other memory devices in any form (e.g., source code form, computer executable form, or intermediate form) Computer programs can be fixed permanently or temporarily in various communication technologies. The signal may be fixed in any form to a signal that can be transmitted to a computer using any of the techniques available. These communication technologies include analog technology, digital technology, optical technology, and wireless technology. (e.g. Bluetooth), networking technologies, and Internetworking These include, but are in no way limited to, computer programs. The document may be stored on a removable storage medium (e.g., a shrink-type You may distribute the software in any form, including as computer software (wrapped software), It can be preloaded into the system (e.g., system ROM or fixed disk) or From a server or bulletin board to a communication system (e.g., the Internet or World Wide Web) It can also be distributed via the internet.
[0131] Hardware logic (programs) implementing all or part of the functionality described herein. (including programmable logic used in conjunction with a programmable logic device) They can be designed using traditional manual methods, or through computer-aided design (CAD), Hardware description language (e.g., VHDL or AHDL), or PLD programming language Electronically, using various tools such as language (e.g., PALASM, ABEL, or CUPL) It can also be designed, captured, simulated, or documented.
[0132] Programmable logic is a semiconductor memory device (e.g., RAM, ROM, PRO M, EEPROM, or Flash programmable RAM), magnetic memory devices (e.g. a hard disk (e.g., diskette or fixed disk), an optical memory device (e.g., CD-ROM), or may be fixed, either permanently or temporarily, to a tangible storage medium such as another memory device. Programmable logic is a combination of analog, digital, optical, and wireless technologies. (e.g. Bluetooth), networking technologies, and Internet working using any of a variety of communication technologies, including but not limited to Programmable logic can be attached to a signal that can be transmitted to a computer. Removable storage media containing printed or electronic documentation (e.g. commercial software) The software may be distributed as part of a computer system (e.g., in system ROM or hard disk drive) or as part of a It can be preloaded onto a fixed disk or can be sent to a communication system from a server or bulletin board. It may also be distributed via (eg, the Internet or the World Wide Web).
[0133] Various examples of suitable processing modules are discussed in more detail herein. As used herein, a module is a program that performs a particular data processing or data transmission task. Refers to software, hardware, or firmware suitable for implementing the In a preferred embodiment, the module is configured to receive instructions, or to transmit resistance changes, voltage changes, current changes, etc. ization, guidewire-based probe data, intravascular pressure data, ratio, calcium thickness, E Various types of data such as EL thickness, calcium angle, index and other subject information disclosed herein. Any software routines, programs, or other devices suitable for receiving, transforming, distributing, and processing such data. refers to other memory resident applications.
[0134] The computers and computer systems described herein acquire data: The software applications used to process, store and / or communicate The method may include operably linking a computer readable medium, such as a memory for storing Such memory may be used in conjunction with a computer or a Understand that a system can be internal, external, remote, or local. It is possible.
[0135] The storage medium may be non-transitory and may include a non-transitory device. Therefore, a non-transitory storage medium or device includes a tangible device. Tangible means that the device has a concrete physical shape, but the device itself can be It means that the physical state can be changed. So, for example, non-transient means , referring to the device remaining tangible despite this change in state.
[0136] In part, the present disclosure relates to a diagnostic system having one or more imaging and tissue detection methodologies applied thereto. The interface of this diagnostic system makes it easy to navigate the vascular representation. For a given blood vessel or other body lumen, such as a coronary artery, one or more tissue types or other Regions of interest can be identified using a variety of techniques, particularly to identify areas of interest such as calcified regions within blood vessels. May represent calcium nodules, calcified tissues and other calcium-related tissues. The arterial representation of the vascular system is then combined with the characterized tissue and Regions of interest can be generated and used to display to a user.
[0137] Features suitable for detection and inclusion on one or more graphical user interfaces The tagged tissue and / or region of interest can be used to identify and / or identify the area of interest when selecting or deploying a stent. For efficiency, the proximal segment, the distal segment, and the user-selected segment or segments are These graphical user interfaces can be displayed simultaneously, including The surfaces are automatically detected and one or more visual elements such as color, hatching, animation, etc. The features displayed to the user may be represented using elements or indicia. Features suitable for display and for displaying by means of one or more indicia include: That is, the lipid region, the luminal region, the stent struts, the side branches, the guidewire, the outer elastic layer (E The internal elastic lamina (EL), the internal elastic lamina (IEL), their associated boundaries and volumes, and the components disclosed herein. The various axes may include one or more of the following: , so that an axis in one view, such as a transverse view, coincides with the same axis in a longitudinal view. You can also color-code parts of them and use indicia to decorate them, like this: This is done, for example, in Figures 2D and 3B using the blue and yellow colored line / axis segments. It is shown that
[0138] In part, this disclosure relates to intravascular data collection, such as OCT, IVUS, and other imaging modalities. The collection system and stent in the vessel are used to identify landing zones, side branches, regions of interest, and characterize The present invention relates to the generation and visualization of diagnostic information, such as tissue regions that have been detected. Suitable graphical elements for showing information include user-selected elements in the workflow, such as markers. It serves the following function.
[0139] Also, systems and methods for visualizing stents, tissue types, tissue volumes, and tissue boundaries Also disclosed herein are methods for determining side branch location using one or more software modules. It detects the vascular occlusion, lumen contour, and stent strut position, generates a vessel representation, and provides a graphical user interface (GUI). Navigation to the image can be controlled based on user selection of the image. The disclosed systems and methods are capable of detecting calcium, lipids, fiber, and other biomarkers of various tissue types. Angle, arc, circumference, thickness, volume, width, frame count, relative proximity of tissue to lumen Also included are automated measurement systems capable of measuring the above and related features.
[0140] In various embodiments, such a measurement tool can be used to measure the above parameters and the specific tissue type. It can be used to measure any geometric property of a given region of interest of any type. These measurements generate various ratings or scores suitable for review by end users. For example, it can be used to detect calcium overload in specific areas of blood vessels. However, if there is only a small amount of surface calcium overall, the calcium burden is unclear. The measurements guide the user to exclude such areas as candidate landing zones. You can help them not to.
[0141] The aspects, embodiments, features, and examples of the present disclosure are considered to be illustrative in all respects and are not to be construed as limiting the present disclosure. is not intended to limit the scope of the present disclosure, the scope of which is defined only by the claims. Other embodiments, modifications, and uses are within the spirit and scope of the claimed disclosure. It will be apparent to one skilled in the art without departing from the scope of the present invention.
[0142] The use of headings and paragraphs in this application is not meant to limit the disclosure. may be applied to any aspect, embodiment, or feature of the present disclosure. Only patent claims using the phrase "means for" are to be interpreted under 35 U.S.C. ...112, 6 U.S.C. It is intended that the invention be In such cases, such claims should not be construed under 35 U.S.C. § 112. Any limitations from the specification shall be deemed to be construed as including no limitation unless such limitations are expressly included in the claims. Nor is it intended that any of the foregoing be read into the claims of this application.
[0143] Where values or ranges of values are given, the endpoints of each value and the ranges given and between them are The values will remain within the teachings of the present disclosure unless any different range is specifically stated. However, it can be increased or decreased by 20%.
[0144] Throughout this application, compositions are referred to as having, including, or comprising certain components. Where described or a process is described as having or including certain process steps When listed, the composition of the present teachings consists essentially of or includes the recited components. The process of the present teachings essentially consists of the process steps recited. It is contemplated that the method may consist of the process steps or be comprised of the process steps listed.
[0145] In this application, an element or component may be included in a recited list of elements or components. When referring to being selected from a list and / or a list of elements or components, the elements or components are selected from the list. It can be any one of the elements or components listed, and it can be any one of the elements or components listed. It should be understood that the compound may be selected from the group consisting of two or more of the components. Furthermore, the elements and / or features of the compositions, devices, or methods described herein may be: Any departure from the spirit and scope of the present teachings, whether express or implied, is intended to be within the scope of the present teachings. It should be understood that the various components may be combined in various ways without any need for a single component.
[0146] The terms "include", "includes", "including", The use of "have," "has," or "having" shall not be construed as being otherwise. Unless otherwise specified, the terms and conditions of the present application should generally be understood to be open-ended and non-limiting. .
[0147] Use of the singular herein includes the plural (and vice versa) unless otherwise specified. Further, unless the context clearly indicates otherwise, the singular forms "a" and "an" are used interchangeably. and "the" includes the plural. Additionally, use of the term "about" refers to a quantitative value. In the former cases, the present teachings also include the specific quantitative value itself, unless otherwise specified.
[0148] The order of steps or order for performing certain actions may be changed without departing from the spirit and scope of the present teachings. It should be understood that the number of steps is not critical, so long as the number of steps is not critical. The actions can be performed simultaneously.
[0149] Where a range or list of values is provided, the value between the upper and lower limits of that range or list of values Each intervening value is individually contemplated and is treated as if each value were specifically recited herein. Further, any smaller amounts between and including the upper and lower limits of a given range are encompassed within the present disclosure. Small ranges are contemplated and encompassed within the present disclosure. A list of example values or ranges is provided for any given It is not intended to exclude other values or ranges between and including the upper and lower limits of the range.
[0150] The figures and descriptions of the disclosure may be omitted for clarity, while other elements may be omitted to provide a clear understanding of the disclosure. It will be understood that the present invention has been simplified to show elements that are relevant for It will be appreciated, however, that these and other factors may be desirable. However, such elements are known in the art and may be incorporated herein by reference in their entirety. In order not to facilitate a better understanding, 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. Omitted details and modifications or alternative embodiments are within the knowledge of one of ordinary skill in the art. do.
[0151] In certain aspects of the present disclosure, to provide an element or structure, or to A single component may be replaced by multiple components to perform a given function. It is understood that multiple components may be replaced with a single component. Such substitutions may be used to implement certain embodiments of the present disclosure. Except where not possible, such substitutions are considered to be within the scope of the present disclosure.
[0152] The examples presented herein are intended to illustrate possible and specific embodiments of the present disclosure. It is intended that the examples be primarily for illustration of the present disclosure for those skilled in the art. No deviation from these figures or the specification can be made without departing from the spirit of this disclosure. There may be variations to the operations described in the document. For example, in certain cases: The method steps or actions may be performed or executed in a different order or can be added, deleted or modified.
Claims
1. receiving, by one or more processors, extraluminal image data of a blood vessel and endovascular data comprising a plurality of endovascular image frames; generating, by the one or more processors, a two-dimensional representation of the vessel based on the endovascular data, the two-dimensional representation being symmetric about a longest axis of the two-dimensional representation; determining, by the one or more processors, a first feature of interest based on the endovascular data; providing an output of the one or more processors: the extraluminal image data; at least one of the intravascular image frames including a first arc corresponding to the first feature of interest; and the two-dimensional representation including a first indicia corresponding to the first feature of interest. The method includes:
2. 2. The method of claim 1, wherein the first feature of interest is calcium and / or the external elastic lamina (EEL).
3. The method of claim 2 , wherein when the first feature of interest is calcium, the first arc extends along at least a portion of a circumference of at least one of the intravascular image frames.
4. When the first characteristic of interest is calcium, the one or more processors automatically detecting one or more calcium regions relative to a lumen boundary of the blood vessel for each of the intravascular image frames based on the intravascular data; determining, by the one or more processors, a measurement of an angle or circumference of the detected calcium for one or more intravascular image frames; The method of claim 2 further comprising:
5. The method of claim 4 , further comprising the one or more processors determining a calcium thickness of the detected calcium for the one or more intravascular image frames.
6. The method of claim 2 , wherein when the first feature of interest is an EEL, the first arc is output as an overlay on at least one of the intravascular image frames.
7. determining a second feature of interest based on the endovascular data, the at least one intravascular image frame further includes a second arc corresponding to the second feature of interest; the two-dimensional representation further includes second indicia corresponding to the second feature of interest; The method of claim 2.
8. 8. The method of claim 7, wherein the first feature of interest is calcium and the second feature of interest is the external elastic lamina (EEL).
9. receiving input related to the two-dimensional representation corresponding to a selection of an intravascular image frame; updating, by the one or more processors, an output of the at least one intravascular image frame to match the selected intravascular image frame; The method of claim 1 further comprising:
10. the one or more processors co-registering one or more stent landing candidate zones to the extraluminal image data; providing an output of at least one landing zone representation in the extraluminal image data; The method of claim 1 further comprising:
11. The method of claim 10 , further comprising the step of the one or more processors providing an output of the at least one landing zone representation in the two-dimensional representation.
12. The method of claim 1 , further comprising the one or more processors co-registering the first feature of interest with the two-dimensional representation of the vessel and the intravascular image frame.
13. receiving extraluminal image data of a blood vessel and endovascular data including a plurality of endovascular image frames; generating a two-dimensional representation of the vessel based on the endovascular data, the two-dimensional representation being symmetric about a longest axis of the two-dimensional representation; determining a first feature of interest based on the endovascular data; providing an output of the extraluminal image data, at least one of the intravascular image frames including a first arc corresponding to the first feature of interest, and the two-dimensional representation including a first indicia corresponding to the first feature of interest; A system having one or more processors that perform the steps of:
14. 14. The system of claim 13, wherein the first feature of interest is at least one of calcium and the external elastic lamina (EEL).
15. 15. The system of claim 14, wherein when the first feature of interest is calcium, the first arc extends along at least a portion of a circumference of at least one of the intravascular image frames.
16. When the first characteristic of interest is calcium, the one or more processors: automatically detecting, by the one or more processors, one or more calcium regions relative to a lumen boundary of the blood vessel for each of the intravascular image frames based on the intravascular data; determining, by the one or more processors, a measurement of the angle or circumference of the detected calcium for one or more intravascular image frames; The system of claim 14 , further comprising:
17. The system of claim 14 , wherein when the first feature of interest is an EEL, the first arc is output as an overlay on at least one of the intravascular image frames.
18. determining, by the one or more processors, a second feature of interest based on the endovascular data; the at least one intravascular image frame further includes a second arc corresponding to the second feature of interest; the two-dimensional representation further includes second indicia corresponding to the second feature of interest; The system of claim 14.
19. the one or more processors: co-registering one or more stent landing candidate zones to the extraluminal image data; providing an output of at least one landing zone representation of the extraluminal image data and / or the two-dimensional representation; The system of claim 13 , further comprising: