System and method for displaying stent strut coverage in a vessel

Abstract

To provide a method and a device used for planning stent delivery or generating and displaying diagnostic information of interest for other purposes.SOLUTION: A stent can be visualized using intravascular data and subsequently displayed as stent struts or portions of a stent as a part of a graphic user interface. In one embodiment, the method includes steps to distinguish stented region(s) from background noise using an amalgamation of angular stent strut information for a given neighborhood of frames. The GUI can include views of a blood vessel generated using distance measurements and demarcating the actual stented region(s), which provides visualization of the stented region. The disclosure also relates to display of intravascular diagnostic information such as indicators. An indicator can be generated and displayed with images generated using an intravascular data collection system.SELECTED DRAWING: None

Description

[Technical Field]

[0001] [Related Applications] This application is a continuation of U.S. Provisional Patent Application No. 62 / 162,795, filed May 17, 2015. No. 62 / 196,997, filed June 25, 2015; U.S. Provisional Patent Application No. 62 / 322,578, filed April 14, 2016, and This application claims priority to and benefits from U.S. patent application Ser. No. 14 / 975,516, filed Dec. 18, 2004. No. 6,239,999, the disclosures of which are incorporated herein by reference in their entireties.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to intravascular measurement and feature detection and related diagnostic methods and devices. [Background technology]

[0003] Coronary artery disease is one of the leading causes of death worldwide. The ability to see and treat can be of life-saving importance. Optical Coherence Tomography (OCT) uses light to peer into the coronary artery wall and capture the image for examination. Coherent light, interferometry, is a catheter-based imaging modality that produces Utilizing micro-optics, OCT allows for video-rate in vivo sectioning of diseased blood vessels. It can provide layer imaging with micrometer-level resolution. High-resolution viewing of subsurface structures using the This level of imaging possible with OCT makes OCT particularly useful. The details allow clinicians to not only monitor the progression of coronary artery disease, but also diagnose it. OCT images provide high-resolution visualization of coronary artery morphology and are useful for diagnostic and stent delivery planning. alone or in conjunction with other information such as angiographic data to aid in the planning of the procedure, etc. It can be used in combination with other sources of data.

[0004] OCT imaging of a patient's body parts provides a useful diagnostic tool for doctors and others For example, imaging of coronary arteries with intravascular OCT reveals the location of narrowing or stenosis. This information is used by cardiologists to determine whether invasive coronary artery bypass surgery is necessary or not. Less invasive catheterization, such as angioplasty or stent delivery It helps people choose between steroid-based treatments, which are popular options, but Tent delivery has its own associated risks.

[0005] A stent is a tubular structure, often made of mesh. It can be inserted into a vessel and expanded to address a restrictive stenosis. Catheters are typically made of metal or polymer scaffolds. During cardiovascular procedures, stents can be deployed at the site of a stenosis via a catheter. The catheter is delivered to the stenotic site via a guidewire and a balloon is used. Typically, a stent widens the lumen of a narrowed blood vessel. The angiography system uses a preset pressure to expand the vessel. The stent device, intravascular ultrasound system, and OCT system are used in combination or alone. It can be used to facilitate rehab planning and stent deployment.

[0006] There are several factors that influence patient outcomes when deploying a stent. In some procedures, the stent should be expanded to a diameter that corresponds to the diameter of the adjacent healthy vessel segment. Overexpansion of the stent may cause significant damage to the vessel, predisposing it to dissection, disarticulation, and intramural hemorrhage. Insufficient expansion of the stent may inappropriately dilate the vessel. If portions of the stent do not contact the vessel wall, the risk of thrombosis may increase. An under-expanded or incompletely expanded stent Crimping A malapposed stent may not be able to restore normal flow. Once a stent is placed, stent malapposition and inadequate stent expansion may result in a variety of problems.

[0007] There are other challenges associated with stent placement and related procedures. Visualization of stent deployment against the vessel wall is difficult to achieve by inspection. Additionally, angiographic images were manually reviewed to determine stent position on an image-by-image basis. Doing so is also error-prone.

[0008] In addition, after the stent is deployed, a stent is placed in the stent chamber to ensure it is properly deployed. However, clinicians may image the treatment site to determine if the area is cleared. Background noise caused by blood cells that are not present in the OCT image data In some cases, stent struts may appear in the stent, making accurate detection of the stent difficult. Sometimes the clinician can identify the stented area, but the user Requiring intervention by the user results in significant variability and is subject to user error. In addition, different stents have different geometries and They may have mesh patterns, which can complicate their evaluation. do.

[0009] The present disclosure addresses these and other challenges. Summary of the Invention [Means for solving the problem]

[0010] In part, this disclosure relates to angiographic and intravascular data acquisition systems, such as OCT and / or IVUS, that can be used to generate and display diagnostic information of interest for planning stent delivery or for other purposes. This disclosure also relates to the generation of various indicators and their integration into the display of image data. As one example, Crimping Longitudinal indicators such as apposition bars may be used alone or in conjunction with stent strut indicators for diagnostic processes such as stent planning and overlaid on an angiography frame co-registered with an endovascular data set such as a set of OCT scan lines or an image generated therewith.

[0011] In part, this disclosure relates to a system and method for displaying to a user of an intravascular data collection system, and in one embodiment on an angiography system, the results of data analysis applied to an intravascular data set. ... Crimping The present invention describes a user interface and a graphical user interface (GUI) that provides graphical data representations that can be applied to one or more generated vascular images or angiographic images so that regions of interest, such as areas of interest and others, can be easily found and understood on OCT and angiographic images.

[0012] In part, this disclosure relates to a data acquisition system, such as an intravascular data acquisition system, suitable for use in a cath lab, such as an optical coherence tomography system. In part, this disclosure relates to a data acquisition system including a processor adapted to display intravascular image data. The displayed image data includes data or images generated based on depth measurements. In one embodiment, the image data is generated using optical coherence tomography. The system may also display, for one or more stents in a vessel, data regarding stent malapposition in a longitudinal mode on a stent strut-by-stent strut basis, or information regarding stented, unstented, or stented areas of potential interest. Crimping A user interface for displaying intravascular information may be displayed, such as a bar with areas corresponding to levels.

[0013] One or more indicators, such as longitudinal indicators, may be generated in response to the stent detection process and lumen boundary detection, as one non-limiting example, and may be displayed on the angiography, OCT, and IVUS images. These may be viewed by a user to plan stent delivery and to adjust stent delivery by reviewing the co-registered OCT and angiography images along with the associated indicators of interest. In part, the systems and methods described herein relate to methods for avoiding or reducing the possibility of data misinterpretation by replacing regions of missing data with indicators such as hashing, colored regions, or other visual indicators. In this way, end users are notified when data is missing rather than misinterpreting black regions as shadows or side branches. Thus, regions of missing data are coded with indicators that prevent the regions from being misinterpreted as side branches, stents, or other features of interest to the diagnostician. In one embodiment, the method may include displaying indicia of stent struts on a graphical user interface and indicia indicating one or more regions in the intravascular image where data was unavailable for display. In one embodiment, Crimping The bar is independent of the intravascular view and therefore can be used when there are no images containing indicators or stents. Crimping In one embodiment, the present disclosure provides a method for determining whether a stented region is aligned with a bar. Crimping With respect to the bar, the stented region includes a located stent strut; Crimping The bar is rotationally agnostic or persistent.

[0014] In part, this disclosure relates to, for example, an optical coherence tomography probe or an intravascular ultrasound probe. In the context of intravascular data sets acquired using a probe such as a stent, detection and shadow detection.

[0015] In part, the present disclosure provides a method for detecting metal stent struts within a shadow cast in OCT image data. The present invention relates to a system and method for accurately determining the offset or location of a stent. The method of traction detection includes the steps of accessing multiple frames of intravascular imaging data ( accessing), and multiple frames are optical coherency tomography (OCT) scan lines. Including, steps, impact areas corresponding to candidate stent struts a step of identifying candidate strut shadow scan lines; Identifying scan lines corresponding to candidate stent strut shadow regions, and analyzing the shadow scan lines to identify the location of the stent struts. That's fine.

[0016] The method of stent strut detection also involves storing multiple frames of intravascular imaging data. storing a stent within a first group of frames of the plurality of frames; detecting struts, one or more shadow regions within the first group of frames; detecting one or more of the shadow regions as detected stent segments; adjacent to the trough, the step, the area where the given shadow area is due to the guidewire or side branch The candidate stent strut shadow area is determined on a shadow area basis to determine whether it is a contributing area. generating a set of candidate stent strut shadow regions, each of the candidate stent strut shadow regions including a shadow boundary; , step, and scan lines to identify candidate stent strut shadow regions within the shadow boundary. Step 10.

[0017] The methods of the present invention may include additional steps or features. For example, the methods may include non-step The candidate stent straps are identified by eliminating the shadow regions corresponding to the stent features. The non-stent features may include, for example, identifying shadow areas corresponding to guides. The branch may be selected from the group consisting of a wire, a side branch, and combinations thereof.

[0018] The method removes candidate strut shadow scan lines that contain spillage from lumen pixels. The method may include the step of summing the signal responses over the candidate strut shadow scan lines. By doing so, each of the candidate strut shadow scan lines or a portion or sample of a scan line The method may include the substep of determining a projection over the The method may include the substep of identifying up to three maxima in

[0019] The method ranks the maxima based on peak signal strength and calculates the peak score. The ranking substep may include the substep of generating a ranking. The local maxima with higher peak signal strength receive higher peak scores. ) may be ranked.

[0020] The method may include the substep of ranking the maxima based on their proximity to the vessel wall to generate a proximity score. The ranking substep may be an ordinal ranking, with maxima closer to the vessel wall receiving a higher proximity score. The method may include the step of assigning a malapposition score to each maxima. The malapposition score may be binary, with malapposition scores being assigned to each maxima. Crimping A local maximum may receive a score of zero.

[0021] The method includes summing the peak score, the proximity score, and the incomplete contact score. The local maximum with the highest total score may be designated as the location of the stent strut. can be.

[0022] The method includes the steps of identifying a plurality of shadow regions corresponding to candidate stent struts; Identifying scan lines corresponding to stent strut shadow regions and and identifying the location of the stent strut within the strut shadow region. The method performs a cross-frame analysis to identify multiple optical coherences. The designated stent struts were aligned across the optical computed tomography (OCT) imaging frames. A step of validating may also be included.

[0023] In part, this disclosure relates to an intravascular data acquisition system, an angiography system, and the aforementioned the exchange of data between two or more of the The one or more indicators may be, for example, an intravascular data acquisition system. Overlay such indicators with images generated using or in other ways Indicators may be generated and displayed by combining One or more indicators or graphical elements suitable for showing diagnostic information. Such indicators may include longitudinal, transverse, and other indicator types. The indicators are used to guide the user during stent delivery planning and other operations. The present disclosure may also be used, for example, in optical coherence tomography probes or intravascular ultrasound. In the context of intravascular data sets obtained using probes such as ultrasound probes, Regarding stent detection and shadow detection.

[0024] This disclosure relates, in part, to computer-based visualization of stent placement within a blood vessel. The stent is visualized using OCT data and one or more graphics As part of the user interface (GUI), the stent struts or In particular, the present invention provides a method for extracting background noise from the image. Provide a computer algorithm to identify the stented region(s). UI is generated using OCT distance measurements and the actual stented area(s). The view may include one or more views of the vessel, which may define the boundaries of the stented vessel. Provides visualization of the area where the

[0025] In one embodiment, the present disclosure provides a method for stenting one or more stents upon pullback. In one embodiment, the present invention relates to automated detection of the region where the CT or IVUS is placed. or other intravascular modalities are used to collect data during pullback. In some embodiments, the present disclosure provides one or more stents at a given pullback. Automated detection of struts and removal of false positive strut detections from frames that are not part of the stent One objective of some implementations described herein is to without it being possible to determine the start and end frames of one or more stents at a given pullback. The algorithm automatically detects which frames belong to the stent. To determine which are outside the stent region, a threshold angle metric is used. It uses frame-by-frame strut detection.

[0026] Multi-frame processing algorithms are used to process a single frame. Based on the struts detected during the step, one or more struts are selected in the pullback. In this step, the cross-frame information is automatically detected. To identify sets of frames belonging to the stent and eliminate false positives in non-stented areas In one embodiment, the method includes determining the placement of a guide catheter. The method includes removing detections in the guide catheter frame determined after the detection.

[0027] In one embodiment, a one-dimensional plot of angular coverage is obtained from the non-stented area. It is used as a proxy or threshold to filter the stented region. If the frame does not have the expected configuration, the angular coverage will be low. The 1D plot is a single adjacent It is used to amalgamate data from adjacent frames into a local neighborhood. In one embodiment, all of the struts within the multiframe neighborhood are covered. The angles are calculated for each detected stratus in each frame. In a multi-frame algorithm (such as this one), the Angular positions for pairs of struts interlaced over a given neighborhood In one embodiment, the method comprises: The struts are combined to create a superframe, and then the steel on the superframe is Perform coverage analysis / filtering on the target.

[0028] In one embodiment, even if struts from neighboring frames around frame k have a maximum angle Even though they are used to calculate gap and angle coverage metrics, , is assigned to frame k because it is the neighborhood window centered In one embodiment, the angular metric threshold is on a frame-by-frame basis, and the neighborhood is the frame before the current frame and the current The frame immediately following the frame currently being reviewed. The number of neighboring frames on either side of may include multiple frames without any restrictions.

[0029] In one embodiment, angles are measured for each strut detected in each frame. In the implementation of the multi-frame algorithm, the frames are assembled over a fixed neighborhood. The angular positions for the paired strut sets are used. The frame neighborhood is processed against an angular metric threshold as described herein; Then, a threshold is used to filter the signal in the stented area. In one embodiment, the neighborhood includes two frames. In one embodiment, the neighborhood includes three frames. In another embodiment, the neighborhood includes two or more frames. Includes the upper frame.

[0030] In one embodiment, the present disclosure provides a method for detecting a stented region in a blood vessel. a non-transient encoding with a plurality of processor-executable instructions for executing A machine-readable storage medium for performing the steps described and illustrated herein. Contains processor instructions for

[0031] The present invention relates, in part, to a method for detecting stented regions in a blood vessel. The method includes receiving optical coherence tomography data about a stented vessel. and the optical coherence tomography data includes a plurality of image frames. Storing the optical coherence tomography data in the storage device of the intravascular data acquisition system Storing step: Analyzing multiple image frames and performing computations on a frame-by-frame basis identifying stent struts on a per frame basis; The angular gap amalgamated across adjacent image frames. To generate the data, the angular offset of the identified stent struts is delimited. and demarcating any two adjacent frames in the neighboring frames. determining a maximum angular gap between the struts.

[0032] The method may include one or more of the following features: If the maximum angular gap is less than the threshold angular gap, the stent-containing frame classifying the frame as a t-containing frame. stomach.

[0033] The method further comprises: selecting adjacent frames that encompass a maximum angular gap that is less than a threshold angular gap; By identifying clusters of stents, the stent-containing zones are identified. It may also include a

[0034] The method includes the steps of determining a centroid value for the stented vessel; Computing the maximum angular gap with respect to the vessel centroid for frame k The maximum angular gap θ for a given frame k may be max,k teeth,( According to Equation 1, the angular gap metric Ψ for frame k is k Calculate Angle gap metrics closer to 1 indicate that the frame is indicates that it contains.

number

[0035] The method may involve determining whether the angle gap metric is greater than or equal to a threshold angle gap (e.g., from about 0.25 to about 0. classifying the frame as a stent-containing frame if the It may include.

[0036] The method includes calculating an angular gap for frame k and at least one neighboring frame k+1. The method may include calculating a parameter metric for consecutive nearby frames. The method may include iteratively calculating an angular gap metric for each of the plurality of angles.

[0037] The method sequentially classifies multiple frames in the optical coherence tomography data. repeating one or more of the steps of the method to (also) classify The method may include: determining whether the angular gap metric for a given frame is greater than or equal to a threshold value; If the angular gap is greater than The method may include steps of: In the deployed area, an aggregating stent containing frame is placed. The method may include a step of determining whether frames adjacent to the first frame have a gap greater than a threshold angle. The first end of the stented region is terminated when the first end has a lower angular gap metric than the first end. The method may include a terminating step.

[0038] The method is to determine whether the frames adjacent to the last frame have an angular gap lower than the threshold angular gap. terminating the second end of the stented region if the second end has a metric. The present disclosure also relates, in part, to a method for stenting a stented vessel. The present invention relates to a method for detecting a region of a blood vessel using an intravascular imaging system. storing one or more intravascular image data sets, each intravascular data set The set includes multiple frames. Step 1: Using an intravascular imaging system, storing one or more intravascular image data sets, wherein each intravascular data set A set includes multiple frames; a neighborhood is defined, and the neighborhood is a set of frames. step k, which includes frame k and one or more frames in the vicinity of frame k. by combining all of the struts detected on all frames in the neighborhood. , determining an angular gap for frame k; and The angular coverage metric Ψ with respect to frame k is calculated using k generating a It may include.

[0039] The angular coverage metric is of the form (2), where θ max,k is adjacent This is the largest angular gap between the struts.

number

[0040] The method determines whether the angular coverage metric for a given frame is greater than a threshold angular gap. and sequentially classifying the frame as a stent-containing frame if the The present disclosure also provides, in part, a method for detecting one or more stented regions. PROGRAMMABLE PROCESSOR-BASED COMPUTER APPARATUS FOR AN INTRAVASCULAR IMAGING SYSTEM FOR IMAGING - Patent application The programmable processor-based computing device is capable of processing intravascular imaging data. one or more data access channels for receiving data; and one or more a processor and associated memory in electrical communication with one or more data access channels; It may include.

[0041] In one embodiment, the processor uses an intravascular imaging system to and storing one or more intravascular image datasets, each of the intravascular datasets comprising multiple frames. defines a neighborhood, where the neighborhood is frame k and one or more neighbors of frame k. the frame above; combine all of the struts detected on all nearby frames. Determine the angular gap for frame k by Using the metric, we compute the angular coverage metric Ψ for frame k. k and given If the angular coverage metric for the frame of is greater than the threshold angular gap , classify the frame as a stent-containing frame.

[0042] In one embodiment, the present disclosure provides a method for providing a stent with a stent strut having a length that spans the entire length of the stent. Maximum stent failure, defined as the widest separation between the surface and the vessel wall. The minimization of this distance is particularly relevant for drug-eluting stents. In order to fix the stent firmly to the blood vessel wall and prevent the blood vessel from collapsing, This is necessary to ensure that sufficient radial support is provided to the

[0043] In one embodiment, the present disclosure provides a method for providing a stent with a stent strut having a length that spans the entire length of the stent. The maximum stent malapposition distance, defined as the widest gap between the surface and the vessel wall, was measured. Minimizing this distance is especially important for drug-eluting stents because The stent must be firmly fixed to the vessel wall and have sufficient radial extension to prevent the vessel from collapsing. This is necessary to ensure that the government provides support for the

[0044] In part, the present disclosure relates to a method for removing the upper panel of a stent that is not properly placed within a lumen of interest. The present invention relates to a computer interface with a three-dimensional representation of a stent. Areas of poor adhesion may be indicated as hatched areas or with other markings. Thus, in one embodiment, the methods of the present invention and features described herein include A computer-based user interface that allows viewing of OCT in multiple panels. Furthermore, stent malapposition may be demonstrated in three dimensions. In addition, in the case of simulated stent placement, the user is required to implant a stent in a real patient. Before placing the stent, areas of malapposition were removed to simulate correct stent placement. Tents may be rearranged.

[0045] The method includes displaying the identified stent struts on a graphical user interface. The present disclosure may also include a step of causing a processor to perform the aforementioned steps when executed. The present invention also includes a computer-readable medium including non-transitory instructions for causing the computer to perform any of the following:

[0046] However, the present invention relates to different aspects and embodiments, and is not limited to the specific embodiments disclosed herein. The different aspects and embodiments may be combined in whole or in part as needed. It is understood that the embodiments disclosed herein may be combined. These may be incorporated into each aspect to varying degrees as appropriate for the implementation of the invention. Aspects and embodiments are described using the term "means for," but as used herein All aspects, embodiments and other concepts disclosed are intended to be illustrative and not restrictive, even if specific "means" language is used in writing. Means-plus-function claims are not used in any specific part of the description. It is understood that the present invention may serve as a support for the [Brief explanation of the drawings]

[0047] The drawings are not necessarily to scale, emphasis instead being placed generally on illustrative principles. The drawings are to be considered in all respects as illustrative and not restrictive. No other term is intended, the scope of which is defined solely by the claims.

[0048] [Figure 1] FIG. 1 shows a schematic diagram of an intravascular imaging and data collection system according to one exemplary embodiment of the present disclosure.

[0049] [Figure 2A] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, and an angiography system for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2B] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, and an angiography system for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2C] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, and an angiography system for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2D] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, and an angiography system for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2E] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, and an angiography system for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure.

[0050] [Figure 3A] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 3B] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 4A] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 4B] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 5] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 6] 3A-6 illustrate various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure.

[0051] [Figure 7A] 7A and 7B show a three-dimensional representation of side branch markings generated using intravascular imaging data, such as OCT data, according to one exemplary embodiment of the present disclosure. [Figure 7B] 7A and 7B show a three-dimensional representation of side branch markings generated using intravascular imaging data, such as OCT data, according to one exemplary embodiment of the present disclosure.

[0052] [Figure 8A] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and their appropriate indicators, and an angiography system for the diagnostic process, according to one exemplary embodiment of the present disclosure. [Figure 8B] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and their appropriate indicators, and an angiography system for the diagnostic process, according to one exemplary embodiment of the present disclosure. [Figure 9A] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and their appropriate indicators, and an angiography system for the diagnostic process, according to one exemplary embodiment of the present disclosure. [Figure 9B] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and their appropriate indicators, and an angiography system for the diagnostic process, according to one exemplary embodiment of the present disclosure.

[0053] [Figure 10A] FIG. 10A illustrates an exemplary intravascular data collection system and associated intravascular data collection probe, as well as related image processing, detection and other software components, according to an exemplary embodiment of the present disclosure.

[0054] [Figure 10B] FIG. 10B is a cross-sectional OCT image of a stented vessel according to one exemplary embodiment of the present disclosure.

[0055] [Figure 11] FIG. 11 is a process flow diagram for detecting struts in OCT image data, according to one exemplary embodiment of the present disclosure.

[0056] [Figure 12] FIG. 12 is a scanline OCT image of a stented vessel in polar coordinates and logarithmic scale, according to one exemplary embodiment of the present disclosure.

[0057] [Figure 13] FIG. 13 is a graph illustrating the detection of multiple potential struts in a single shadow, according to one exemplary embodiment of the present disclosure.

[0058] [Figure 14A] FIG. 14A is a user interface representation of intravascular image data of a stented vessel region prior to removal of false-positive stent struts, according to one exemplary embodiment of the present disclosure.

[0059] [Figure 14B] FIG. 14B is a user interface representation of intravascular image data of a stented vessel region after removal of false-positive stent struts, according to an exemplary embodiment of the present disclosure.

[0060] [Figure 15A] 15A and 15B are schematic depictions of an automated stent detection algorithm that combines frames as part of an assessment of whether a frame is part of a stented region, according to one exemplary embodiment of the present disclosure. [Figure 15B] 15A and 15B are schematic depictions of an automated stent detection algorithm that combines frames as part of an assessment of whether a frame is part of a stented region, according to one exemplary embodiment of the present disclosure.

[0061] [Figure 16] FIG. 16 is a graph of an angular coverage plot demarcating the frame positions of two stents, according to one exemplary embodiment of the present disclosure.

[0062] [Figure 17] FIG. 17 is a flow chart illustrating a multi-frame stent region detection algorithm according to one exemplary embodiment of the present disclosure.

[0063] [Figure 18A] FIG. 18A is a user interface representation of intravascular image data of a stented vessel region prior to removal of false positive struts, according to one exemplary embodiment of the present disclosure.

[0064] [Figure 18B] FIG. 18B is a user interface representation of intravascular image data of a stented vessel region after removal of false positive struts, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0065] In part, this disclosure relates to intravascular data acquisition systems such as OCT, IVUS, and vascular imaging systems, and the exchange of data between two or more of the foregoing, and In one embodiment, the present invention relates to the generation and display of diagnostic information such as an OCT indicator. Intravascular data such as endovascular imaging are acquired while angiographic data are simultaneously acquired. An indicator consists of one or more one- or two-dimensional graphic elements and the color, gray, - Scales or scale gradations, hashes, symbols or other The information may include one or more associated indicia, such as a visual element.

[0066] The one or more indicators may be generated using, for example, an intravascular data acquisition system. You may overlay or otherwise combine such indicators with the image provided. The indicators may be generated and displayed by: Tracking of user selected landmarks, etc. A long, sharp object, such as one or more indicia or graphical elements suitable for indicating Includes longitudinal, transverse and other indicator types Stent strut indicators may also be used. A method for detecting such intravascular features is described herein, which allows a user to - To display on the interface and overlay indicators or marks etc. Angiographic data may also be used to display co-registered (co-reg) images. may be integrated and displayed with various common indicators as part of a singled display In one embodiment, shadows that may be misinterpreted as dissections, side branches, or other vascular features are removed. and other elements distinguish them and allow the use of image frames and data according to one embodiment. It may be shaded or otherwise altered to facilitate user review and analysis. Good too.

[0067] Pertinent diagnostic information may include information about the stent, such as stent malapposition relative to the vessel wall or luminal boundary, user-selected OCT placement within the vessel and associated angiography frame positions, and other intravascular diagnostic information or other information generated to facilitate stent delivery planning. CrimpingThe system may include stent apposition information. The system includes a processor in communication with the graphical user interface and configured to send instructions to the graphical user interface. One or more software programs are used to perform one or more of the following: co-registering data such as image data, generating and displaying a longitudinal indicator showing stent placement relative to the determined lumen boundary, coding or labeling data-missing regions for the end user, transferring user-selected OCT placement information to the angiography display using one or more graphical elements to facilitate co-registration, and visually identifying the stent and simulated stent for planning purposes, and other matters described herein.

[0068] In part, this disclosure relates to graphical user interface (GUI) elements or indicators that are represented on a display for subject data, such as image data or other intravascular parameters measured for a subject. Any clinically useful parameter, such as one that varies longitudinally or transversely over the course of an optical coherence tomography pullback recording or IVUS or other intravascular or angiography system, may be evaluated and displayed as an indicator or indicia. Each indicator / indicia may be used by an interventional cardiologist to quickly view clinically useful information for the entire pullback recording in a single view without having to manually manipulate the image. The indicators may guide the user to specific points of interest within the vessel based on the parameter exceeding or falling below a clinically meaningful threshold. For example, by encoding the parameter value on a continuous color map or other scale using appropriate indicia, the varying degree of parameter severity may be easily summarized for the entire vessel in a single, easily interpretable view. These features are useful for various CrimpingIt is shown with bars, stent indicators and other indicators for angiographic and other intravascular data collection images.

[0069] FIG. 1 includes a system suitable for implementing some of these features. The top right panel shows the first user-selected configuration, US1, and the second user-selected configuration, US2. Angiographic display with various indicators including US2 and active frame AF These indicators are also shown on the bottom L-mode or longitudinal panel. US1 and US2 correspond to the vertical lines shown, and the active frame AF corresponds to the vertical line between them. The active frame is shown in cross section in the top right panel. The middle panel shows the values ​​in millimeters of US1 and US2 placement relative to the vessel placement. Figure 2B shows the calculated MLA along with the OCT data of Figure 1. 2 shows a magnified view of the angiographic image of FIG. 1. These user interfaces are may be 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 moving elements C1 and C2 are control devices and can be controlled by an interface. They can also be rotated or moved as part of the interface. 3B and others. In FIG. 3B, the control devices C1 and C2 also It is represented as a semicircle for the rat and as a line segment in the right panel.

[0070] FIG. 2C has regions R1 to R7. CrimpingThe bar / indicator bar 111 is shown as an indicator, which is shown in the top right angiographic view shown in more detail in FIG. 2D. The top right panel shows the angiographic view of the angiogram that crosses the threshold of interest. Crimping In L-mode, the stent struts are coded using indicia such as symbols or colors. Crimping Interest in the bar Crimping The region of the stent remains on the display even when the data set is rotated to draw the user's attention to areas important for stent planning and patient diagnosis. In this sense, the indicator can be persistent to direct the user's focus during planning or other procedures. Figure 2E shows an exemplary Crimping 1 shows additional details regarding the bar or indicator bar 111. The indicator bar 111 may be used for stent planning and review and may also be used to indicate the position of the stent struts. Crimping or may be used to indicate the region of the intravascular image where another metric is present. Indicator bar 111, in one embodiment, is persistent within the user interface view to alert the user to stent regions even if they are not visible based on the view selected by the user - 3D, cross-sectional, longitudinal, viewing angle, etc.

[0071] With reference to FIG. 2C, two user-selected points of interest are shown as U1 and U2. R3 corresponds to the area of ​​malapposition of interest. R2 corresponds to the first stent. R6 corresponds to the second stent. R5 is the gap between them. To facilitate tent planning, the images are coregistered with angiographic data as shown in Figure 2D. The data collection elements of the probe DC are shown in the image. R1 and R7 are the points where the stent is located. U1 and U2 are the distal and proximal sections that are absent and correspond to the vessel lumen. To provide a frame of reference for the vessel segments labeled with U2, It can be used by users watching live angio. One or more displays may act as user-placed landmarks, e.g. , live angiography and OCT pullback data with previously acquired pullback frames. It may be used as a

[0072] Using these and other indicators, the images and indicators can serve as tools to guide stent delivery based on the data shown in Figures 2C and 2D. The indicators may also be provided with color-coded or otherwise coded markings of the stent struts in the transverse or longitudinal cross-sections to more specifically indicate when the stent needs to be expanded. In Figure 2E, the regions of first stent 222a and second stent 222b are Crimping The area 224 without a lumen or stent and the area of ​​malapposition 223 are also shown. This bar 111 may be displayed on any angiographic or OCT or IVUS image of interest. In one embodiment, Crimping The bar is independent or persistent with respect to the intravascular view, so that it can be seen when there is no image containing an indicator or stent. Crimping Various indicators and markings are generated using the systems of, for example, FIGS. 1 and 10A, such as stent detection, lumen detection, stent Crimping It may be generated based on measurements and various graphic overlays.

[0073] FIG. 3A shows the interface in longitudinal section or L-mode; Crimping Above threshold coded stent strut indicator CrimpingThe indicator bar 111 is shown in the center of the GUI, with stent-free areas 224 and malapposition areas 223 indicated. Lumen boundary data from OCT or IVUS may be used to determine if a threshold is exceeded for a given detected strut. Crimping The problem, Crimping In Figure 3B, an interface screen is shown above the L-mode display of the GUI screenshot shown, which provides a high-level view of the metal stent struts. Crimping 1 illustrates an example of an indicator that measures Crimping The indicators allow summary information regarding clinical parameters to be displayed without the need to manually manipulate or inspect the image data. Crimping The use of bars and other indicators and their co-registration with the angiogram provides many advantages to the user.

[0074] 3A, 3B, 4A, and 4B, some embodiments of the user interface include a stent strut. Crimping 1 depicts endovascular and angiographic data (if applicable) along with one exemplary indicator for other indicator-based data display. Crimping The bars are shown on the L-mode and angiographic images, 3D flow images, etc. Figure 4B shows an angiographic image with stent data showing threshold information along the outer boundary of the vessel. Crimping A longitudinal cross section of the indicator bar 111 is shown. Region 161a in the angiography portion of the user interface is also aligned with region 161b of the indicator bar 111. In one embodiment, the angiography image is Crimping It is aligned with or registered with the bar. Crimping One feature of bar 111 is that it is persistent in the user interface, so that if a stent is present in the 2D or 3D image but does not appear based on the cut plane or viewing angle, Crimping The bar persists, indicating the presence of a stent and any associated malapposition even though no 2D or 3D stent appears in the GUI, a useful feature for stent planning and diagnosis.

[0075] In FIG. 4A, the stent struts and the Crimping An indicator bar 111 indicating the area 157 is shown. Crimping These areas of interest 157, which indicate the stent struts themselves, may be grouped together, and may be color-coded or coded using other indicia that may be seen in the GUI. One example of grouping of stent strut codes with indicia and indicator bars is shown by regions 188 in Figures 3A, 3B, 5, and 6. In these regions 188, the indicator bars 111 indicate the stent struts' position relative to the vessel wall. Crimping , along with various markings corresponding to the stent and the series of struts. The detected lumen boundary is used to compare the stent placement against. Additional details regarding stent detection are included herein.

[0076] FIG. 5 shows another GUI with indicators or image data processing features that allow software to correct missing data, such as unclear data or data missing due to a guidewire shadow, and replace it with a gray mask or other indicator. To avoid user confusion with side branches, dissections, or missing data, indicators MD are used to indicate areas where data is missing. This has the advantage of preventing the user from mistaking missing data, dissection areas, or side branches. In one embodiment, areas where data is missing as a result of a shadow or for other reasons are displayed using a mark or indicator, such as a gray area, a colored area, hashing, or other visible marking. The central two-arrowhead arrow icon allows the view to be rotated. This user control: CrimpingThe identification of the guidewire by bar and color coding or other indicia, together with the identification of the guidewire, completely improves and expands the diagnostic scope of image data from intravascular data collection probes and / or angiographic data.

[0077] In another embodiment, indicator W is used to point to the guidewire image, as shown in Figure 5. In one embodiment, indicator W may be used to identify the guidewire in the GUI or to select and remove it from the image. Figure 6 shows a 3D fly-through. Crimping The bar is shown as a trajectory in front of the user's viewing plane corresponding to the cross-section on the right. The stent struts and the area of ​​interest included in the 3D fly-through view and any other views of the area of ​​interest are also shown. Crimping The area indicator bar 111 remains visible during rotation to alert the user to critical vessel regions during stent planning.

[0078] 7A and 7B show another indicator SB corresponding to the side branch. A rendering of the vessel wall VW is also shown for the side branch. These and other indicators may be used to highlight regions of the 2D and 3D data. As shown in the depicted user interface, such as FIG. 9B, the various circles / line segments C1, C2 in the upper right view may be rotated to navigate through various views of the image. FIGS. 8A-9B show additional interface and control information for navigating the image dataset and performing diagnostics such as stent planning. Various proximal and distal views and other perspective views may be navigated using the tools shown herein. In one or more embodiments, Crimping Indicators such as bar 111 are persistent, so that they remain in view even if navigated away from the area of ​​poor fit.

[0079] Thus, some indicators are rotationally agnostic, so that if an indicator contains a region or length with parameters exceeding a threshold, then even if the rotated view is imperfect, Crimping Even if the image data is altered to obscure an area such as a stented area, that area will still show itself. Crimping In the event of problems, the user remains aware of their location within the blood vessel. Crimping The bar may be displayed as an indicator in one or more views of the angiogram or OCT image or user interface.

[0080] As shown in various figures, Crimping The bar 111 may be subdivided into various regions or lengths to indicate the presence of a stent or the presence of more stents in the vessel, or malposition, or gaps between multiple stents for a multi-stented vessel. The angiography data and associated image frames may be co-registered with the OCT data. Additionally, as shown in the figure, user-selected vertical lines corresponding to specific longitudinal distances on the artery may be set to guide stent planning. The rotationally agnostic or continuous nature of the bar provides further assistance and error reduction during stent planning.

[0081] During the stent delivery planning procedure, clinician-specified landmarks are used to guide the user to the stent site. By providing a stent size selection and a vascular reference, The device may be used to deploy a stent using live angiography. The level and location of the malapposition can be given. This allows users to refer to OCT and annotated angiograms to plan delivery. The stent may be further expanded or displaced as part of the system. For example, this may be implemented using system 3 shown in FIG. 1 and the system of FIG. 10A. .

[0082] FIG. 1 illustrates a system for collecting data or detecting characteristics or sensing conditions of an object 4. various data acquisition subsystems suitable for measuring or otherwise diagnosing subject 4. In one embodiment, the subject can move from a table, bed, to a chair. or other suitable support. Typically, the object 4 is , a human or other animal having a particular region of interest 25.

[0083] The data acquisition system 3 may be a nuclear magnetic resonance, X-ray, computer-assisted tomography, or other suitable This includes non-invasive imaging systems such as suitable non-invasive imaging techniques. As one non-limiting example of a system, to generate cines: A suitable angiography system 21 is shown. The angiography system 21 may be a fluoroscopy system. The angiography system 21 may include, for example, an imaging system such as OCT or IVUS. Angiography is used in one or more imaging techniques to visualize blood vessels within a region 25 of the subject 4. Typically, while a pullback procedure is performed using the probe 30 to be imaged, non-invasively so that frames of angiographic data are generated in the form of frames of image data It is configured to image a subject 4.

[0084] The angiography system 21 is in communication with an angiography data storage and image management system 22. It may be implemented as a workstation or a server in one embodiment. In one embodiment, data processing on the collected angiographic signals includes: The image from the system 21 is then processed directly on the detector of the angiography system 21. The images are stored and managed by the data storage and image management unit 22.

[0085] In one embodiment, the system server 50 or workstation 87 is In one embodiment, the entire system 21 handles the functions of 22. The system 21 also receives such radiation after it has passed through the subject 4. The data processing system 22 then uses the signals from the angiography system 21 to The system images one or more regions, including region 25 of FIG. As described in the Angiographic data, along with the streaks and shadows, are shown on displays 82 and 82. This makes it possible.

[0086] As shown in this particular example, the region of interest 25 may be a region of the vasculature, such as a particular blood vessel, or a peripheral A subset of the vasculature. This can be imaged using OCT. A thermoelectric-based data collection probe 30 is introduced into the subject 4 and measures specific blood vessels, such as the coronary arteries. The probe 30 is placed in the lumen of a certain blood vessel. For example, the probe 30 may be an OCT probe, an FFR probe, or the like. a probe, an IVUS probe, a probe combining two or more of the features of the foregoing; and other probes suitable for intravascular imaging. The probe 30 typically includes a probe tip, one or more radioactive The probe tip includes an opaque 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 foregoing.

[0087] For intravascular probes that include an optical beam director, the optical fiber 33 is The torque wire is an optical fiber that is placed on the probe. In FIG. 1, the optical fiber 33 is shown without a torque wire surrounding it. In addition, the probe 30 may also be made of a polymeric material that forms part of the catheter. In the context of an OCT system, this includes a sheath such as a sample of an interferometer (not shown). The optical fiber 33, which is part of the arm, is connected to the patient interface unit as shown. The optical fiber is optically coupled to a power input / output unit (PIU) 35.

[0088] The patient interface unit 35 receives the end of the probe 30 and optically connects it to Typically, the probe connector is adapted to be coupled to a data collection probe. The probe 30 is disposable. The PIU 35 is used to determine the type of data collection probe being used. Includes appropriate joints and elements based on, for example, OCT and IVUS data acquisition The probe combination requires OCT and IVUS PIU. PIU35 is a typical In effect, the torque wire, the sheath, and the optical fiber 33 disposed therein are pulled back during the procedure. In addition to being retracted, the probe tip also includes a motor suitable for retracting the probe tip. The end is also typically rotated by the PIU 35. In this way, the object 4 The blood vessels can be imaged longitudinally or through a cross-section. The probe 30 can also be used for FFR or may be used to measure specific parameters such as other pressure measurements. The data may be used to generate various 2D and 3D views, which may be , may be navigated as shown in the user interface depiction.

[0089] The PIU 35 is then connected to one or more intravascular data acquisition systems 42. The intravascular data acquisition system 42 may be an OCT system, an IVUS system, or other imaging system. For example, a probe that is an OCT probe. System 42 in the context of block 30 includes a sample arm of an interferometer, a reference arm of an interferometer ( reference arm), photodiode, control system, and patient interface unit. Similarly, as another example, in the context of an IVUS system, intravascular data The acquisition system 42 includes ultrasonic signal generation and processing circuitry, noise filters, a rotatable joystick, In one embodiment, the device may include a drive unit, a motor, and an interface unit. The data acquisition system 42 and the angiography system 21 are connected to an angiography video frame time server. configured to synchronize OCT image frame timestamps and shared A clock or other timing signal may be included.

[0090] In addition to the invasive and non-invasive image data collection systems and devices of FIG. and various other types of data may be collected regarding other parameters of interest of the subject. For example, the data collection probe 30 may include one or more pressure wires. The pressure wire may include a pressure sensor. The pressure wire may be connected to an additional OCT or ultrasound component. Pressure readings may be taken along a segment of a blood vessel within a region 25 of the subject 4. This may also be done.

[0091] Such reading may be by either a wired connection or via a wireless connection. Fractional flow reserve (FFR) data acquisition system As shown in FIG. 1, a wireless transceiver 48 receives pressure readings from the probe 30. , and transmit them to the system to obtain FFR measurements or more positions along the vessel. One or more displays 82, 83 are also configured to generate , angiography frames of data, OCT frames, user interface for OCT and angiography data User interface, shadows, indicators, missing data and other controls and features of interest It may be used to indicate a symptom.

[0092] endovascular data such as frames of endovascular data generated using the data acquisition probe 30 Imaging data is acquired from a data acquisition and processing system coupled to the probe via a PIU 35. 42 along the route. Invasive image data is stored on a co-registration server 50 and workstation 87. transmitted to and stored in one or more servers or workstations, such as The angiographic image data may be acquired from the system 22. A video frame grabber device 55, such as a configured computer board, may be used in various implementations. It may be used in the form.

[0093] In one embodiment, the server 50 includes a processor 80 that stores the Server 5 includes one or more co-written software modules 60 executed by the 0 is another typical component for a processor-based computing server. Alternatively, more databases such as database 90 may be generated. the acquired image data, the subject's parameters, and one or more of the systems shown in FIG. generated by a device or component and received by database 90; or It may also be configured to receive other information that is transferred to database 90. The server 90 is stored in memory in the workstation 87 and is also While shown connected to a bus 50, this is only one exemplary configuration. For example, the software module 60 may be implemented on a processor in the workstation 87. The database 90 may be located in the memory of the server 50. A device or system for operating various software modules may be, for example: The hardware and software described herein in various combinations are provided. The software acquires frames of image data, processes such image data, and It may be used to register various image data.

[0094] As otherwise noted herein, software modules 60 may include software such as pre-processing software, transformations, matrices, lumen detection, stent detection, shadow detection, indicator generators and displays, and other software-based components used to process image data or responsive to patient triggers to facilitate or otherwise perform co-registration of different types of image data by other software-based components 60. Modules include lumen detection using scan line based or image-based techniques, stent detection using scan line based or image-based techniques, indicator generation, and software for stent planning. Crimping May include burr generation, dissection, side branch and guidewire shadow indicators to prevent confusion with missing data, etc.

[0095] The database 90 is generated by the angiography system 21 and is transmitted to the frame grabber 55 Receives and stores angiographic image data 92, such as image data acquired by server 50. The database 90 may be configured to store the data generated by the OCT system 42. The OCT image data is acquired by the frame grabber 55 server 50. It may be configured to receive and store image data 95 .

[0096] Additionally, the subject 4 may be connected to one or more electrodes, such as a monitor 49. The monitor 49 may be electrically coupled to one or more monitors. The heart function is not determined by the heart rate, but is configured to generate data regarding cardiac function, such as systole and diastole. The device may include an electrocardiogram monitor that indicates various conditions of the subject. The shape of the heart is almost the same at a particular cardiac phase, even across different cardiac cycles. ,Knowing the cardiac phase can be used to aid in tracking the vascular centerline.

[0097] Therefore, if the angiographic data spans a few cardiac cycles, the vascular centers at the same cardiac phase First-order matching of the line follows the centerline throughout the pullback In addition, since most of the heart's motion occurs during systole, vasomotion , is expected to be higher near systole and weaken towards diastole. One or more software options may be used as an indicator of the amount of motion expected between imaging frames. Provides data to the module. Knowledge of expected movements allows adaptation based on expected movements. Adaptive constraints improve tracking quality and vascular central line quality. may be used by one or more software modules to improve quality good.

[0098] [Shadow Detection Embodiment] The present disclosure is directed, in part, to a method for detecting a stent shadow resulting in a detected shadow. A method and system for determining the exact offset or position of a strut is provided. Sometimes in the shadows, there is a bright strut bloom or against a dark shadow background in the scan line. There is a single possible strut location that corresponds to the peak. Multiple strut peaks were often detected within the stent struts, indicating the correct positioning of the stent struts. Spurious peaks can be caused by, for example, blood pooling, pullback, Insufficient blood clearing in the zone or imaging optics interacting with metal struts This can be caused by ringing artifacts due to The present disclosure provides a method and system for identifying the best candidate for a true stent within a stent shadow. Provides systems.

[0099] FIG. 10A shows a blood vessel 5, such as an artery, a data collection probe 7, and intravascular data collection and processing. FIG. 10B is a high-level schematic depicting system 10. The method described may also be performed using system 3 of FIG. 1 and other systems. In particular, the system 10 of FIG. 10A may be used in conjunction with other imaging modalities, such as OCT, intravascular ultrasound (IVUS), or Other intravascular imaging systems may be included. A stent 12 is shown within a blood vessel 5. The stent includes a plurality of struts. Some stents can be visualized using an intravascular probe. A shadow or shadow region SR may be generated as part of the process of imaging the blood vessels. 0 is used for side branch detection, stent detection, peak detection, shadow detection, etc. as described herein. Area detection and processing, error correction, indicator bar generation and display, model comparison, lumen detection, parallel and various other processes. Additional details relating to some exemplary stent detection features are provided in FIGS. 18B. System 10 is a A suitable light source that meets the coherence and bandwidth requirements of the application and data collection The system 10 may include an ultrasound imaging system. The probe 7 , a catheter portion having one or more optical fibers 15, and a The catheter 20 may include a probe tip 17. In one embodiment, The probe tip 17 includes a beam director.

[0100] As shown, a catheter 20 is introduced into a lumen 11, such as an arterial lumen. The probe 7 directs light into the lumen L or in a direction perpendicular to the longitudinal axis of the fiber 15. The fiber 15 may include a rotating or slidable fiber 15 that guides the fiber 15 forward. Therefore, for light directed from the side of the probe as the fiber 15 rotates, OC T data is collected about the wall of the blood vessel 5. The wall of the blood vessel 5 defines the lumen boundary. The lumen boundary is detected at the probe tip 17 using the lumen detection software component. The side branches and stems may be detected using distance measurements obtained from the collected optical signals. The tent struts and shadow areas and other features are visible when the probe is pulled back through the artery. may be specified in the scan lines generated between

[0101] In one embodiment, the probe 7 is an OC such as an ultrasound in one embodiment. Other imaging modalities may be included in addition to T. In one embodiment, the luminal / luminal The boundary is optical or ultrasound and intravascular imaging produces signals of interest for imaging blood vessels. This refers to the portion of the blood vessel that is first struck by the ionizing probe when it is present. Image processing in the form of squeezing is used to eliminate any blood flowing within the vessels being removed. In one embodiment, the lumen or lumen boundary is located in front of the blood vessel wall and is located within the blood-containing area of ​​the blood vessel. Refers to the area of ​​tissue facing the target area.

[0102] As shown in FIG. 10A, the probe tip 17 is positioned in the stented region of the blood vessel 5. The probe tip 17 is positioned within the lumen L so as to be distal to the , configured to receive backscattered light from objects such as the stent 12 and the wall of the blood vessel 5. The probe tip 17 and the remaining part of the data collection probe 7 are connected to the lumen L and and pulled through the stented area. As shown in FIG. 10B, the probe 17 are shown before and after insertion into the blood vessel. The probe 7 is connected to an OCT system 10 and an optical The OCT system or subsystem connects to the probe 17 via an optical fiber 15. The system 10 includes a light source, such as a laser, an interferometer having a sample arm and a reference arm, various optical paths, clock generators, photodiodes, and other OCT system components It may also include

[0103] In one embodiment, a photodetector, such as a balanced photodiode-based system, An optical receiver 31 can receive the light leaving the probe 7. A computing device 40, such as a computer, processor, ASIC, or other device, controls the OCT system. 10 or in electrical or optical communication with the OCT system 10. The computing device 40 may be included as a separate subsystem for processing data. memory, storage, buses and other components suitable for side branch detection, stem Selection or identification of stent strut candidates, detection of candidate stent strut shadow regions, stent region detection, stent strut confirmation, correlation and comparison of stent image data and stent visualization, and and an image data acquisition system configured for pullback data acquisition as described below. In one embodiment, the data processing stage 44 may include software. The software 44 operates on the intravascular data to detect stent struts. The pipeline includes various modules such as an automated stent detection module. This module may include a sparse ) Peak detection module, model strut generation module, false positive test module, etc. It may also include various other software modules such as:

[0104] In one embodiment, the computing device 40 includes a side branch detection module, a lumen detection module, , stent detection module, stent strut confirmation module, candidate stent strut software modules or programs, such as application-specific modules and other software Software modules or programs 44 The system 44 includes an image data processing pipeline or its component modules, and one or more may further include a graphical user interface (GUI). The various software-based methods described in the document are software / programs 4 4. Modules may be subsets of each other, They may be arranged and connected through various input, output and data classes. In the present invention, the software module 44 may be an automated stent detection module. The present invention includes a stent detection module.

[0105] One exemplary image processing pipeline and its components includes one or more This may constitute a software program or module 44. 44 is a diagram showing the structure of a blood vessel lumen, a side branch, a guide wire, a guide catheter, a stent strut and a strut. Several image processing algorithms tailored to detect tent regions The present disclosure may include image processing to determine the location of the metal strut within its shadow. Image Data Processing Pipeline and Its Component Software Modules and related methods, as well as any method described herein, stored in memory. and uses one or more computing devices, such as a processor, device, or other integrated circuit. The software module or program 44 receives the image data and Such data is converted into a 2D or 3D view of the vessel and stent and processed by lumen detection software. software module, peak detection, stent detection software module, and side branch detection It may also include software modules and the like.

[0106] As shown in FIG. 10A, the display 46 also displays cross-sectional and longitudinal views of blood vessels generated from OCT or IVUS imaging data, as well as Crimping Bars and other indicators may also be part of the system 10 for displaying information 47. The image processing software algorithms 44 provide data corresponding to detected image features such as stents, side branches, guidewires, etc., which is input to the GUI where these features are displayed in a desired format on the cross-sectional, longitudinal and / or 3D viewing sections of the GUI.

[0107] In addition, the display 46 also displays collected image data, a user interface, , images of the stented vessel generated using various indicators and markings. Information 47 may be shown, such as cross-sectional and longitudinal views. Representation of the stent. For example, the OCT or IVUS image may be presented to the user via display 46. Stent detection involves the display of these features and identifying which may be included in the displayed image. This OCT-based information4 is performed prior to coding or tagging using marks. 7. Displayed using one or more graphic user interfaces 10B, 14A, 14B, and 18B, and the like, as well as those depicted in this specification. Other user interface and its component images are GUI and various 4 is an example of display information 47 that can be displayed and interacted with using an input device. Specifically, it shows a 2D cross-section of a coronary artery containing a metal stent.

[0108] Additionally, the display information 47 may include, but is not limited to, information from the OCT system and data collection platform. Transverse scan data, longitudinal scans, diameter graphs, and image masses acquired using lobes stents, areas of malapposition, luminal boundaries, and other images or representations of blood vessels or The computing device 40 may also include software or programs 44, which may be stored in one or more storage devices 4 5, such as text, arrows, color coding, highlighting, contour lines, or other suitable The stent struts and (e.g., threshold and measured distance) The level of malapposition, the shadow area, and the strut arrangement within the shadow area (based on comparison with the distance) Once the probe is used to obtain the OCT data, the OCT image may be configured to identify other vascular features. is acquired and stored in memory; it is the cross section of the vessel along the length of the pullback region. such as cross-sectional views, longitudinal views and / or three-dimensional views or subsets thereof; These views may be processed to generate information 47. These views may be, for example, as shown in FIGS. As shown in Figures 14A and 14B, may be depicted in any manner, or otherwise as described and depicted herein. This may also be done.

[0109] 10B is a cross-sectional OCT image of a stented vessel in accordance with the present disclosure. The lumen / lumen boundary L is at the center of the image. The guidewire shadow 12 is at the top of the image. 10B. The OCT image shows a number of metallic stent struts 14, which cast a shadow 16 in the OCT image. Coherent light, typically used for CT imaging, penetrates the stent struts. The metal stent struts cast a shadow on the vessel wall because they cannot be reflected. The present disclosure provides an enhanced method for detecting the exact offset of a strut within the strut shadow. Once detected, the shadows and struts in FIG. 10B are It is used to generate the user interface and indicators described in That's fine.

[0110] FIG. 11 is a process flow diagram for detecting struts in OCT image data. The method 100 separates shadows corresponding to stent struts in multiple OCT pullback frames. The method 100 may include one or more steps described herein. Unless otherwise required, these steps may be performed in any order. The metal strut detection method is based on the guidewire (140), side branch (130) and strut. From other image / endovascular data processing modules, such as information about the location of the shadow (110) The process flow and associated method steps and stages are The images were obtained using OCT, IVUS, or other intravascular data acquisition systems. In one embodiment, the endovascular data may operate based on the raw data 120. The data 120 is processed by one or more image processing modules in a pipeline configuration. It is being processed.

[0111] In step 110, whether the shadow can be attributed to a side branch vessel or a guidewire is determined. To determine the side branch detection module 130 and the guide The data input from the wire detection module 140 is compared or correlated. Methods, systems and devices for detecting rat shadows, side branches and guidewires are known. See, for example, U.S. Patent No. 8,412,312; U.S. Patent No. 8,478,387 U.S. Patent No. 8,831,321; U.S. Patent No. 9,138,147; See U.S. Patent No. 9,173,591.

[0112] In step 150, if a given shadow can be attributed to a guidewire or a side branch, If so, the shadow is discarded and the analysis for that shadow ends. whether by direct detection or by a process of elimination. If it is determined that a given shadow can be attributed to a stent strut, the shadow is The shadow boundary is then analyzed to calculate or isolate the shadow interior. The scan lines or A-lines corresponding to the "darkest" areas are split off so that only the scan lines or A-lines are kept. The reason for this is that the shadow area, specifically the shadow onset and and stop scan lines may sometimes include outflow from neighboring lumen pixels. By separating the shadow interior and ignoring the transition scan lines in the shadow margin, This improves the assessment of strut offset.

[0113] In step 170, the shadow interior is calculated by dividing each sample across the scan line that corresponds to the portion of the shadow interior. Each scan line is sampled and analyzed to calculate the projection (or sum) of the In the input OCT image data, each scan The lines refer to data acquired along a particular angular direction centered on the imaging catheter. The scan lines are then radially sampled, with the spacing of pixels or "samples" being Each sample in the OCT data is typically a few microns wide, Generally, the size is uniform. The "projection" sums across each scanline ( In other words, a two-dimensional shadow in {scanline, sample} space is The i-th index is the sum of the i-th sample of each scan line involved in the process. The projection is a one-dimensional signal corresponding to the samples at radius R. and they are drawn from the constituent scanlines at that same radius R. is the sample mean.

[0114] In step 180, the projection is calculated using up to three (e.g., 1, 2, or 3) largest The location or offset of each selected maximum is used as a potential strut. which is the best candidate to be the true strut. Certain characteristics of the selected maximum are then analyzed to determine whether In some embodiments, only the largest maximum is selected. Two or three of the maxima are selected. The initial selection of multiple maxima increases sensitivity. More than three maxima may be selected, but typically the three highest maxima are chosen. This is typically not necessary, as one will indicate the true strut position. The process is illustrated in FIGS.

[0115] FIG. 12 shows an A-line or scan-line OCT image of a stented vessel on a logarithmic scale. The box 155 on the right side of the image shows the shadow under analysis, and Figure 13 shows the The projection graph shows the vessel lumen L, which is the dark area at the top of the image, and the vessel wall VW, which is the dark area at the bottom of the image. The letter L is generally used herein to denote a lumen. The stent 14 and stent shadow 16 can be seen in the image. In this case, the lumen is the boundary between the tissue and the cleared interior of the blood vessel.

[0116] Figure 13 is a graph showing the detection of multiple potential struts in a single shadow. 3 is a plot of the projection across the inner shadow scan line. Two maxima 22a and 22b are These maxima correspond to two potential strut positions in the shadow. These positions are shown in the user interface as stents, as shown herein. To visualize the struts, an intravascular imaging system such as an OCT or IVUS system is used. It may be used by

[0117] An additional filter may be applied to the local maxima to remove false positives. In an embodiment, a local maximum is a value that is one of the global peaks (maximum values ​​along the maximum projection). It is selected only if it has a signal greater than / 10 (i.e., 10%). The maximum peak is the peak with the largest amplitude. The 10% threshold is used to eliminate false positives due to noise. The threshold is set to 5% of the global peak (i.e., 1 / 20) and 10%, for example, 5%, 6%, 7%, 8%, 9%, or 10%. In various embodiments, multiple peaks may be close to each other, with 10% being preferred. If detected, only the largest peak is selected for further analysis.

[0118] In step 190, the selected local maxima are analyzed to determine which maxima have the highest likelihood of being the true strut, based on information available from the strut's immediate neighborhood. A relative score is assigned to each strut based on one or more of the following criteria: 1. Proximity to the lumen: Selected maxima are scored based on their proximity to the lumen boundary: the maxima closest to the lumen around the strut shadow receive the highest score, and the maxima furthest from the lumen around the strut shadow receive the lowest score. 2. Peak Intensity: The selected maxima are scored based on their peak intensity, with the maxima with the highest peak receiving the highest score and the maxima with the lowest peak receiving the lowest score. 3. Degree of malapposition: The selected maximum value indicates the state in juxtaposition to the lumen. Crimping The score is based on apposition. Crimping Struts that are too far from the lumen or vessel wall (as determined by a user-specified threshold using one or more interface screens or based on accepted treatment thresholds) are penalized and receive a lower malapposition score as a potential false positive. In one embodiment, a strut is penalized because it is considered to be malapposition. Crimping A patient may have a poor adhesion score of either 0 or 1 depending on whether or not the patient has been properly fitted.

[0119] These scoring criteria are exemplary and additional criteria based on other strut and shadow features may be used. A scoring criterion may be used. In one embodiment, the candidate stent struts are also Sections of the strut are adjacent to or aligned with other sections in adjacent or nearby frames. If the strut is in a good condition, a cross-frame analysis will be performed to show that the strut is effective. analysis).

[0120] Each maximum gets a combined score which is a linear sum of the above criteria. The local maximum with the highest score is selected as the valid strut. The remaining maxima are considered as alternative or backup struts until further analysis is performed. In the case of a tie, the maximum closest to the lumen and / or the brightest maximum are used. Table 1 shows an example of the maximum values ​​for the stent shadow. Provides a ranking. Table 1: Maximum ranking for stent shadows [Table 1]

[0121] As shown in Table 1, the maximum value 1 has the highest total score and is therefore the candidate effective score. Maximum values ​​2 and 3 are designated as backup struts. It is determined.

[0122] In step 220, all local maxima (active struts and any backup struts) are calculated. rat) undergoes multi-frame validation. In this step, adjacent frames are The active struts in one frame are used to select the active struts for the adjacent frames. The active strut is compared to the other cross frames to ensure it is aligned. If the backup strut is not aligned with the cross frame, If the strut fits the system model better, then the active strut is the backup strut. One embodiment of the multi-frame verification step may be Stent strut geometry and position information may be used. Other embodiments using a set of point and shadow features may also be used for this step. That is, the location and geometry may be based on previous pullback data or other user-supplied data. All may be used as features, along with other features, such as information.

[0123] Once detected, the active or selected strut will be displayed on the user interface. It may be possible to determine the exact location of the stent struts as well as the placement of the stent. Whether adjustments are needed to optimize and / or speed up the process and reduce the risk of side effects The user interface provides important visual aids to the clinician regarding the cross-sectional View images, L-mode images, scan line images, 3D renderings, or detected struts. The user interface may include any other suitable display format for visualizing the user interface. The face also includes indicator bars, angiographic data, and other data described and illustrated herein. The drawings may include other views and features that are depicted.

[0124] The detection algorithm accurately identifies the location of the struts, and its sensitivity is in one embodiment. The detection algorithm detects the strut position over a range of approximately 80%. The sensitivity ranged from about 0.01 to about 0.001 in one embodiment. In one embodiment, sensitivity is measured by the total number of struts (properly located). The number of accurately located struts divided by the number of struts (including missing struts). The positive predictive value is the proportion of cases in which the positive predictive value is In this case, the positive call count is divided by the total positive calls (the sum of correctly detected struts and false positives). The various features described herein are the percentage of struts that are accurately detected. Use with multiple different cath lab systems, such as intravascular imaging and pressure measurement systems The indicators and detection steps described herein are suitable for use by diagnosticians. and provides various benefits to those planning stent deployment or evaluating deployed stents. Glass.

[0125] In part, the invention relates to a computer-aided method for detecting and displaying stented regions. Specifically, the present invention provides methods, systems and devices for treating stented artery disease. In this context, frames refers to a cross section through the vessel being imaged via OCT. The stented area is , the frame and / or its vicinity are consistent with the expected configuration of the stent struts. By iteratively processing OCT image frames to determine whether they exhibit features The stent struts are identified as being separated from soft tissue such as the vessel wall in OCT images. In addition, the straps of a properly expanded stent appear as discernible solid structures. The stent is typically positioned adjacent to the vessel wall. In the cross section of the vessel, multiple stent struts are uniformly distributed around the circumference of the vessel wall. Thus, the deployed stent—for example, multiple stents distributed around the entire vessel wall— The frame showing the OCT characteristics consistent with the struts is used as the stent-containing frame. It is a candidate for designation.

[0126] OCT imaging data shows no cleared blood cells or catheter wall defects. These artifacts may have optical properties similar to those of stent struts. These imaging artifacts are often misinterpreted by software as stent struts. However, background noise is typically It does not have the regular geometric shape of a stent, which is made up of a mesh of fibers. Unassociated blood cells may be clustered within a single region or randomly distributed. The stent may be positioned adjacent to the vessel wall and / or may not be positioned adjacent to the vessel wall. The frame containing the rat is used to include only false positives due to artifacts, and the frame containing the stent is used to include only false positives due to artifacts. The aim is to distinguish it from frames without struts.

[0127] Another challenge is whether there is a valid stented area within the OCT image data. If present, it precisely locates the first and last frames and In one embodiment, the present invention provides a method for imaging a plurality of frames containing the target. The method described in the document applies to metallic and bioabsorbable stents as well as other non-metallic stents. Generally, one or more embodiments of the present disclosure are applicable to end-user US201002222634 - Method for identifying frames and associated representations of endovascular pullbacks displayed to a user - Google Patents The present invention provides a method for accurately detecting stent struts and detecting vessels without stents. pinpoint the area or region of

[0128] [Embodiment of stent detection] In part, the invention relates to a computer-aided method for detecting and displaying stented regions. Specifically, the present invention provides methods, systems and devices for treating stented artery disease. In this context, frames refers to a cross section through the vessel being imaged via OCT. The stented area is , the frame and / or its vicinity are consistent with the expected configuration of the stent struts. By iteratively processing OCT image frames to determine whether they exhibit features The stent struts are identified as being separated from soft tissue such as the vessel wall in OCT images. In addition, the straps of a properly expanded stent appear as discernible solid structures. The stent is typically positioned adjacent to the vessel wall. In the cross section of the vessel, multiple stent struts are uniformly distributed around the circumference of the vessel wall. Thus, the deployed stent, e.g., a plurality of stents distributed around the entire vessel wall, Frames that represent OCT features consistent with struts are designated as stent-containing frames. It is a candidate for being.

[0129] OCT imaging data shows no cleared blood cells or catheter wall defects. These artifacts may have optical properties similar to those of stent struts. These imaging artifacts are often misinterpreted by software as stent struts. However, background noise is typically It does not have the regular geometric shape of a stent, which is made up of a mesh of fibers. Unassociated blood cells may be clustered within a single region or randomly distributed. The stent may be positioned adjacent to the vessel wall and / or may not be positioned adjacent to the vessel wall. The frame containing the rat is used to include only false positives due to artifacts, and the frame containing the stent is used to include only false positives due to artifacts. The aim is to distinguish it from frames without struts.

[0130] Another challenge is whether there is a valid stented area within the OCT image data. If present, it precisely locates the first and last frames and In one embodiment, the present invention provides a method for imaging a plurality of frames containing the target. The method described in the document applies to metallic and bioabsorbable stents as well as other non-metallic stents. Generally, one or more embodiments of the present disclosure are applicable to end-user US201002222634 - Method for identifying frames and associated representations of endovascular pullbacks displayed to a user - Google Patents The present invention provides a method for accurately detecting stent struts and detecting vessels without stents. pinpoint the area or region of

[0131] FIG. 14A shows an L-mode image of a stented vessel region before removal of false-positive struts. The distal end (D) is a longitudinal view. The stent is located to the left of the vessel depicted in the image, and the proximal (P) end is located to the right. The detected area 101 ranges from about 12 mm to about 45 mm in the L-mode image. Area 15 is from about 45 mm to about 52 mm in the L-mode image, and is the area where the actual stent was placed. The false positive region 15 is located directly adjacent to the false positive region 101. This is caused by background noise with similar optical properties. Uncleared blood cells swirling within the stent zone sometimes appear as stent striations in OCT images. Appears as a rat.

[0132] Software programs that analyze these imaging data typically include the false positive region 15 as part of the stented region 101. As one result, the software program may determine that the first stented frame was approximately 12 mm and the last stented frame was approximately 52 mm. Displaying the false positive region 15 as part of the stented region 101 may lead to misinterpretation or confusion in the clinician's understanding of the images, which may further lead to a failed intervention (e.g., an incompletely stented region). Crimping This may lead to unnecessary procedures (e.g., failure to reposition a correctly deployed stent) or unnecessary procedures (e.g., repositioning a correctly deployed stent).

[0133] FIG. 14B shows a stented stent after elimination of the non-stented area 15 according to the present invention. This is an L-mode display of a vascular region. The present invention does not detect individual false-positive struts. rather, it looks at the distribution of detected struts over a fixed longitudinal neighborhood and calculates the strut size. False positive stented areas15 are automatically identified. can be erased, allowing the actual stented area 101 to be detected.

[0134] FIG. 15A shows the neighborhood of a frame for which an evaluation is being performed, such as frame k. 1 is a diagrammatic depiction of one embodiment of a stent region detection algorithm that may be developed. In this embodiment, the frame count includes two adjacent frames k and k+1 (or k and k-1). Obtain the neighborhood of frames, strut angle coverage and geometric shape in frame k The size and rules related to the selection of frames for the neighborhood are , may be varied for a given application. In one embodiment, the stent region detection algorithm The algorithm accumulates struts and calculates the maximum angular gap and subsequently the angular coverage metric. To determine the frame, frames k-1, k, and k+1 are used. For a given neighborhood, the set of frames on either side of k is called a superframe. A given superframe may be summed to create a strapping The strut is fused with other struts on the nearby frame.

[0135] In one embodiment, stent struts 50 are detected in the OCT image data using known techniques, and an estimate of the vessel wall centroid 54 is also pre-calculated by known methods and used by the algorithm. If the stent is correctly deployed and expanded, the stent struts will typically be adjacent to the vessel wall 52 at the luminal boundary; this method ensures that the stent deployment is correctly aligned with the luminal boundary (vessel wall). Crimping It is equally applicable to frames that are not frame-specific. For a given frame k, we combine that strut with struts detected over a fixed neighborhood (in this embodiment, the neighboring frame k+1). The angular position of each strut is determined using the vessel centroid.

[0136] FIG. 15B shows the neighborhood of a frame k, which is a superframe for the neighborhood center on frame k. or other stent region detection algorithms used to create strut fusion. As shown in FIG. 15B, three adjacent The frames k-1, k, and k+1 are the strut angle covers in the three frame neighborhoods. As in Figure 15A, the stage is used to analyze the ledge and geometry. The endovascular struts 50 are detected in the OCT image data using known techniques and are then analyzed to identify the location of the endovascular struts 50 in the vessel wall. An estimate of the center of gravity is also pre-computed by known methods and used by the algorithm.

[0137] If the stent is correctly deployed and expanded, the stent struts will typically abut the vessel wall 52 at the luminal boundary, but this method ensures that the stent deployment is correct relative to the luminal boundary (vessel wall). CrimpingIt is equally applicable to frames that do not have a fixed location. For a given frame k, we combine that strut with struts detected over a fixed neighborhood (in this embodiment, nearby frames k-1 and k+1). The angular position of each strut is determined using the vessel centroid.

[0138] If a given frame belongs to a stented region, then that frame is Struts with near 360 degree coverage around the circumference of the wall 52 Sometimes struts are missing during the OCT imaging process, which would appear as a gap in coverage around the lumen. In a preferred embodiment, the stent information from multiple frames is stacked or assembled. The data are then combined and the gaps between the struts in the combined data are then calculated. Using the struts detected over a neighborhood allows for the plot to be Smoothing and easier thresholding methods to separate true stent regions from false positives This helps the use of thresholding methods and also prevents large shadows from appearing in the image. The presence of the guidewire and side branch leading to lower angular coverage around the periphery These features are identified when analyzing the gaps between the stent struts. may also be taken into consideration.

[0139] Referring again to FIGS. 15A and 15B, the strut information from frame k is multi- To create the stent data for a frame, the stent information from frame k+1 is stacked. In multi-frame analysis, the orientation of each frame is preserved. The angular gap between struts is determined by the circumferential spacing around the vessel lumen in the multi-frame data. The largest angular gap θ between adjacent struts is measured max,k Next is calculated for the vessel centroid for frame k.

[0140] FIG. 15A depicts a multi-frame analysis based on two adjacent frames k and k+1. FIG. 15B shows a multi-frame coding scheme based on three adjacent frames k−1, k, and k+1. Depicts the strut analysis. Combining multiple struts from adjacent frames It provides cross-frame information to the tent region detection method. False positive struts are detected in all frames. therefore, a frame containing only false positives will be The frame and multi-frame images show uniform strut coverage around the circumference of the vessel. Therefore, the effectiveness of stented frames or multi-frames is low. The largest angular gap is the largest angular gap of the non-stented frame or multi-frame. The degree gap is smaller, often much smaller.

[0141] Although larger neighborhoods may be used, the presence of false positives in larger neighborhoods may hinder the approach. Therefore, a small neighborhood (e.g., 2-3 frames) is preferable. In various embodiments, the algorithm analyzes the OCT data from the pullback to: Stent - i.e., θ max,k is within the expected range of the stent area. Cross-frame analysis and cross-neighborhood analysis identify all frames and / or frame neighborhoods that are Using parametric analysis, the algorithm calculates the first and last frames of the stented region. Determine. False positives outside the stented area were associated with the stented area. It is revealed that it is not continuous.

[0142] False positives around the stent ends are calculated by comparing the detected stent length with the known actual stent length. If the detected stent length is greater than the already If the known stent length is exceeded, the detection algorithm will provide a better estimate of the stent area. To achieve this, either the stent area is adjusted or the size of the vicinity is adjusted. This technique may be improved by using a dynamic threshold to detect signal strength. This may also be applied to situations where the length of the packet is shorter than the known length.

[0143] The detection algorithm also compares the geometry and length of the detected stent with that of a known stent. A verification step may be included in which the geometric shape and length of the non-typical geometrical object is compared to the geometric shape and length of the non-typical geometrical object. Frames that represent atypical geometries may be eliminated as false positives, and and / or the atypical frame is clearly part of a contiguous region of multiple frames. It may be deprioritized until it is

[0144] The detection algorithm is not limited to analyzing pairs of frames, but can be used to If the stent contains a sufficiently dense mesh network, it is possible to achieve stenting from a single frame. The tent information may be analyzed, and if the stent being imaged is a sparse mesh network, If the network contains more than two frames (e.g., 3, 4, 5 or more), ) may be analyzed. In addition, The frames do not need to be adjacent (adjoining) frames, but can be separated by just a few frames. In one embodiment, this is done using a sliding window algorithm. It may be implemented using a

[0145] The maximum angular gap derives the angular coverage metric for each multiframe. The angular coverage metric is plotted against the frame number on the graph. Figure 16 shows the frames of two stents in the OCT pullback data. 1 is a graph of the angular coverage plot bounding the frame position. Degree coverage metric Ψ k is defined by the following equation (Equation 3):

number

[0146] Frames with angular coverage metrics below a predetermined threshold are classified as non-stented frames. frames that have an angular coverage metric above a predetermined threshold. The frame is classified as a stented frame. In one preferred embodiment, In this case, the angular coverage metric threshold is, for example, from about 0.25 to about 0.65. The angular coverage threshold may be automatically or dynamically set or calculated by software. Alternatively, it may be user-defined, for example depending on the geometry of a particular stent. In one embodiment, about 0.8 is the angle seen for some stents. In one embodiment, a coverage metric threshold of less than about 0.3 is used to determine whether a frame k is the angular coverage metric threshold found when outside the stent region.

[0147] FIG. 16 is an angular coverage plot for one exemplary OCT pullback. The degree coverage metric threshold is set to 0.4. For frames 0 to 20, the value is lower than 0.4; therefore, these frames are not included in the algorithm. Therefore, it is classified as a non-stented frame. Angular coverage of frames 0 to 20 The metric is less than zero, indicating potential background noise. et al. 125 showed an angular coverage metric between 0.7 and 0.9, well above the 0.4 threshold. Therefore, frames 20 to 125 are selected by the algorithm as the stent. The angular coverage metric is the same as that of frame 125. It then drops sharply to zero and remains below the threshold until frame 140, then rises to 125 and 1 In frame 140, the non-stented region between the stented region and the stented region is shown. The lick increases above the 0.4 threshold and stays above the threshold from frames 140 to 220. Therefore, frames 140 to 220 are classified as stented regions. .

[0148] FIG. 17 is a flow chart showing the stent region detection algorithm 201. Additionally, additional steps or analyses can be introduced without deviating from the base detection algorithm. The detection algorithm 200 can be derived from a preliminary analysis of the OCT pullback data. The obtained guide catheter data 211 and / or stent strut detection data 21 These input data are often in the form of an OCT scan line or a single OCT frame. In step 214, these input data are used to Used to eliminate frame and / or stent strut detection within the tel region This step is optional, but the guide catheter is often used as a stent strut. This is preferable as it can result in imaging artifacts that can be misinterpreted.

[0149] Next, in step 216, the cross-frame or multi-frame information is It is generated by combining strut data from frames k and k+1. In this way, strut data for one frame near other nearby frames can be , fused, aggregated, or combined to perform some kind of cross-frame validation. In one preferred embodiment, frames k and k+1 are immediately adjacent. In another embodiment, the set of frames {kn, k-n+1 ,...k-1,k,k+1,k+n-1,k+n} to find the nearest neighbors of 2n+1 frames. If n=1, frames k-1, k, and k+1 are used. However, as mentioned above, the struts of frame k are spaced apart by a few microns. Additionally, as described above, the detection algorithm may be , stent information from a single frame may be analyzed.

[0150] In step 218, the detection algorithm calculates the angular gap between consecutive struts around the circumference of the vessel lumen in the multi-frame data. In step 221, the maximum angular gap for a given multi-frame is determined. The maximum angular gap is then used to calculate an angular gap metric for each (e.g., frame) in step 222. In step 224, the angular gap metric is then compared against a threshold angular gap metric. If the angular gap metric for a given multi-frame exceeds the threshold angular gap metric, then that multi-frame is flagged as being within the actual stented region. Finally, in step 226, the detection algorithm determines, based on the multi-frame analysis, which OCT frames correspond to the actual stented region. A confirmation step 228 may be performed. The method may further include displaying a mark for the region of the vessel indicating the stented region. Generally, any of the detected and confirmed struts may be displayed as described and depicted herein. Furthermore, in one embodiment, the mark is aligned with the stented region. Crimping It is a bar and Crimping The bar is rotationally agnostic or persistent.

[0151] FIG. 18A shows a stented vessel region 101 before elimination of false-positive struts 18. 1 is a user interface representation showing a longitudinal or L-mode view of a Positive struts were detected around 20 mm and approximately 34 mm. FIG. 1 is an L-mode view of a stented vessel region 101 after clearance of the stent. As shown in Figure 8B, the detection algorithm eliminates false positive struts and identifies real struts. This results in a more accurate representation of the implanted area.

[0152] The use of directional arrowheads, or lack thereof, in a given diagram allows information to flow. It is not intended to limit or require any particular orientation. For example, the orientations shown in Figures 1 and 10A For a given connector, such as the illustrated arrows and lines connecting the elements being connected, the information is Flow may occur in one or more directions, or only in one direction, as appropriate for a given embodiment. The connection may be any suitable connection, such as optical, wired, power, wireless, or electrical connection. It may also include a data transmission connection.

[0153] Some parts of the detailed description refer to operations on data bits in computer memory (e.g., These algorithmic descriptions are presented in terms of algorithms and symbolic representations of the operations. The statements and representations are intended to be used by those skilled in the computer and software related arts. In one embodiment, the algorithm, as used herein and generally, It is considered to be a self-consistent sequence of actions that leads to a result. Actions performed or otherwise described in the specification as method steps may also be included in the product. These quantities are usually, but not necessarily, conserved quantities. being transferred, combined, transformed, compared and otherwise The signals take the form of electrical or magnetic signals that can be manipulated in this manner.

[0154] [Non-limiting software for implementing the interface, detection, and other disclosed features] Features and embodiments of The following description is of an apparatus suitable for carrying out the methods of the present disclosure described herein. It is intended to provide an overview of the hardware and other operating components. The statements are not intended to limit the applicable environments or the scope of the present disclosure. , hardware and other operating components are applicable as part of the equipment described above. This disclosure relates to personal computers, multiprocessor systems, microphones, and the like. processor-based or programmable electronic devices, network PCs, minicomputers , may be practiced using other system configurations, including mainframe computers, etc. The present disclosure also provides a method for communicating with a catheter through a communication network, such as within different rooms of a catheterization or cath lab. A distributed computing environment in which tasks are performed by linked remote processing devices. It may be practiced in

[0155] Some portions of the detailed description refer to operations on data bits within a computer memory. It is presented in terms of algorithms and symbolic representations. These algorithmic descriptions and representations are It can be used by anyone skilled in the art of computers and software. In the embodiments, an algorithm is herein, and generally, a method for producing a desired result. It is considered to be a self-consistent sequence of operations. The operations performed or otherwise described are those requiring physical manipulations of physical quantities. These quantities are typically, but not necessarily, stored, transmitted, and combined. capable of being processed, transformed, compared and otherwise manipulated; It may take the form of an electrical or magnetic signal.

[0156] Unless otherwise specified, as will be apparent from the following description, Therefore, "processing" or "computing" or "searching" or "indicating" or "detecting" or "measuring" or "Calculating" or "Comparing" or "Generating" or " Terms such as "sensing" or "determining" or "displaying" The descriptions that utilize or operations involving Boolean logic or other sets of logic may be implemented in a computer system. or electronic device operations and processes, which operations and processes are implemented by a computer system. manipulate data represented as physical (electronic) quantities in registers and memories of systems or electronic devices; , in electronic memory or register or other such information storage, transmission or display device It is clearly understood that this may be converted to other data similarly expressed as a physical quantity.

[0157] This disclosure also relates in some embodiments to apparatus for performing the operations herein. This equipment may be specially constructed for the required purpose, or it may be Selectively activated or reconfigured by a computer program stored on a computer Various circuits and their components may be used herein. It is used to perform some of the data collection and transformation and processing described in This may also be done.

[0158] The algorithms and displays presented herein may be implemented in a particular computer or other Various general-purpose systems may be used in accordance with the teachings herein. or various general-purpose systems may be used with the program according to the requirements. It may prove advantageous to construct more specialized equipment to perform the method steps. The required structure for a variety of these systems will appear from the description below. In addition, this disclosure is not described with reference to any particular programming language. , and therefore different embodiments may be implemented using different programming languages. In one embodiment, the software instructions are for an intravascular imaging / data acquisition system. It is adapted to run on a microprocessor or ASIC.

[0159] Embodiments of the present disclosure may include a processor (e.g., a microprocessor, a microcontroller, computer for use with a computer (such as a digital signal processor, a field programmable logic, programmable logic devices (e.g., field programmable For use with FPGAs or other programmable logic devices programmable logic, discrete components, integrated circuits (e.g., application-specific integrated circuit (ASIC), or any other means including any combination thereof However, the present invention may be embodied in many different forms and is in no way limited to these. In an exemplary embodiment of the present disclosure, an OCT probe and a processor-based system collected using a system or to generate control signals or user interfaces Some or all of the processing of the data used to initiate the command may be performed by a computer program. The instruction set is implemented as a set of program instructions in a computer-executable format. and itself stored in a computer readable medium, It is executed under the control of a microprocessor.

[0160] Thus, the queries, responses, transmitted probe data, input data and other data, and signals described herein may be used to respond to user interface selections, control the graphical user interface, process control and graphic signals, display cross-sectional information and images from other data collection modalities, and perform other functions, such as: Crimping The data and parameters suitable for display as GUI components or controls or other representations in a graphical user interface include, but are not limited to, malapposition values, occlusion values, and other data suitable for generating and displaying bars and other intravascular data, displaying angiograms, OCT, detecting shadows, detecting peaks, and the like, as part of the graphical user interface and other features and embodiments described above. Crimping This includes bars, stent struts, missing data representation, indicator bars, shadows, angiographic representations, 3D and 2D renders and views, and other features described herein.

[0161] A computer program that implements all or part of the functionality described hereinabove The software may be provided in source code form, computer executable form, and various intermediate forms (e.g., For example, generated by an assembler, compiler, linker, or locator. may be embodied in various forms, including the form Without limitation, the Source Code may be distributed across various operating systems or Various programming languages ​​(e.g., object coding) are available for use in the Assembly language, or Fortran, C, C++, JAVA, or A set of computer programs implemented in one of the following languages: The source code may contain system instructions. The source code defines various data structures and communication messages. Source code may be used for computer execution (e.g., via an interpreter). The source code may be in executable form (e.g., translator, assembler, etc.) The program may be converted into a computer-executable form (via a program, a program block, or a compiler).

[0162] The computer program is stored in a semiconductor memory device (e.g., RAM, ROM, PROM, E EPROM, or flash-programmable RAM), magnetic storage media (e.g., disk hard disks, optical storage devices (e.g., CD-ROMs), PC cards (e.g., In any form, on a tangible storage medium, such as a PCMCIA card, or other storage device. in a permanent form (e.g., in source code form, computer executable form, or intermediate form) Computer programs may be implemented in analogue technology, digital technology, or in a timely manner. technology, optical technology, wireless technology, networking technology, and internetworking technology Using any of a variety of communication technologies, including but not limited to The information may be fixed in any form in a signal that can be transmitted to a computer. The data program can be used to convert printed or electronic documents (e.g., shrink-wrapped documents). ed) Software) may be distributed in any form, such as on a removable storage medium , by using a computer system (e.g., on a system ROM or fixed disk) The software may be loaded onto the computer or distributed over a network.

[0163] Hardware logic (programming) that implements all or part of the functionality previously described herein. (including programmable logic for use with programmable logic devices) They may be designed using manual methods or computer-aided design (CAD), hardware A hardware description language (e.g., VHDL or AHDL), or a PLD programming language (e.g., Electronically designed using various tools such as PALASM, ABEL, or CUPL , may be captured, simulated, or documented.

[0164] Programmable logic is a semiconductor memory device (e.g., RAM, ROM, PROM, E EPROM, or flash-programmable RAM), magnetic storage devices (e.g., disk a hard disk drive (e.g., a hard drive, a USB flash drive, or a hard disk drive), optical storage device (e.g., a CD-ROM), or other storage device The program may be permanently or temporarily fixed in a tangible storage medium, such as a Logic is a technology that combines analog, digital, optical, and wireless technologies (e.g., Bluetooth). (registered trademark), networking technologies, and internetworking technologies. using any of a variety of communication technologies, including but not limited to: The programmable logic may be fixed in a signal that can be transmitted to a computer. Removable storage devices with printed or electronic documents (e.g., shrink-wrapped software) The present invention may be distributed as a storage medium, using a computer system (e.g., a system RO M, or fixed disk) or may be installed in a communication system (e.g., Distributed from a server or bulletin board via the Internet or World Wide Web This may also be done.

[0165] Various examples of suitable processing modules are described in more detail below. When configured, a module is configured to perform a particular data processing or data transmission task. Refers to software, hardware, or firmware suitable for In a preferred embodiment, the module receives instructions, OCT scan data, user input, Interface data, control signals, angiography data, user movements, frequencies, interferometer signals Data, detected stents, candidate stent struts, FFR data, IVUS data , shadow, pixel, intensity pattern, score, projection, side branch data and guidewire data, Various types of data, such as other information of interest as described herein, software routines suitable for receiving, converting, routing, and processing data , a program, or other memory-resident application.

[0166] The computers and computer systems described herein are To store software applications used for processing, storage and / or communication a machine-readable medium, such as a computer-readable medium, operatively associated therewith, such as a memory of Such memory may include a computer or processor with which it is operatively associated. With respect to a computer system, it may be internal, external, remote, or local It will be understood.

[0167] Memory may also be, for example, a hard disk, an optical disk, a floppy disk, or the like. DVD (Digital Versatile Disc), CD (Compact Disc), Memory Stick tick, flash memory, ROM (read-only memory), RAM (random access memory) memory), DRAM (Dynamic Random Access Memory), PROM (Programmable Read Only Memory) EEPROM (Extended Erasable Programmable Read Only Memory), and / or other similar computer any computer-readable medium for storing software or other instructions, including, but not limited to, The present invention may include any means for

[0168] Generally, the computer system applied in connection with the embodiments of the present disclosure described herein The data-readable storage medium is capable of storing instructions that are executed by the programmable device. If applicable, the methods described herein may include any storage medium. The steps may be embodied or implemented as instructions stored on a computer-readable storage medium or memory medium. These instructions can be written in various programming languages ​​such as C++, C, Java, etc. language, and / or various other languages ​​that may be applied to create instructions according to embodiments of the present disclosure. The software may be embodied in any software programming language.

[0169] The term "machine-readable medium" or "computer-readable medium" refers to a medium for execution by a machine. A set of instructions can be stored, encoded and maintained in a machine. Machine-readable media includes any medium that implements any one or more of the methodologies described. Although shown as a single medium in one exemplary embodiment, the term "machine readable" is used interchangeably with "machine readable" to refer to a single medium. A "readable medium" refers to a single medium or multiple media (including, but not limited to, a plurality of media) that store one or more sets of instructions. For example, a database, one or more centralized databases or distributed databases and / or associated caches and servers).

[0170] The storage medium may be non-transitory or may include a non-transitory device. Accordingly, the non-transitory storage medium or device may include a tangible device, It means that something has a specific physical form, although it can change its physical state. So, for example, non-transitory means that something remains tangible despite this change in state. This refers to a device that

[0171] The aspects, embodiments, features, and examples of the present disclosure are considered to be illustrative in all respects. and is not intended to limit the scope of the present disclosure, the scope of which is limited only by the claims. Without departing from the spirit and scope of the claimed disclosure, Other embodiments, modifications and uses will be apparent to those skilled in the art.

[0172] The use of headings and paragraphs in this application is not meant to limit the disclosure. Rather, each paragraph may apply to any aspect, embodiment, or feature of the disclosure.

[0173] Throughout this application, compositions are referred to as having, including, or comprising certain components. When a process is described as having or including specific process steps, When described as including or comprising, the composition of the present teachings consists essentially of the recited components. It is also possible for the process of the present teachings to consist essentially of or consist of the listed components. or consisting of the process steps listed in is also expected.

[0174] In this application, an element or component may be included in an enumerated list of elements or components. And / or when referred to as being selected from a list, the element or component is It can be any one of the listed elements or components, and the listed elements or components It should be understood that the element may be selected from a group consisting of two or more of the elements. Furthermore, the elements and / or features of the compositions, devices, or methods described herein may be: Whether express or implied herein, the spirit and scope of the present teachings It should be understood that the various aspects of the invention may be combined in various ways without departing from the spirit and scope of the invention. do.

[0175] The words "include," "includes," "including," or "have," "having," The use of g) is generally open-ended and non-limiting unless otherwise stated. It should be understood that

[0176] The use of the singular herein includes the plural unless specifically stated otherwise (and vice versa). Moreover, unless the context clearly dictates otherwise, the singular "one, that" is used. "a," ​​"an," "the," or "the" includes plural forms when no limitation on number is made. In addition, the term "about" Where the use of is before a quantitative value, the present teachings will not be applied to a specific The quantitative value itself includes ±10%.

[0177] The order of steps or order for performing certain actions may be changed so long as the present teachings remain operable. It should be understood that the number of the two or more is immaterial as long as the number of the two or more is not significant. Any of these steps or actions may be conducted simultaneously.

[0178] If a range or list of values ​​is provided, the value between the upper and lower limits of the range or list of values Each intervening value is contemplated separately and is treated as if each value were specifically recited herein. In addition, any range between and including the upper and lower limits of a given range is encompassed within the present disclosure. Smaller ranges are anticipated and encompassed within the present disclosure. A list of example values ​​or ranges is given. is not the exclusion of other values ​​or ranges between and including the upper and lower limits of the range.

[0179] The drawings and description of the present disclosure have been omitted for clarity, while other elements have been omitted for clarity. It should be understood that the present invention has been simplified to show relevant elements for clarity of understanding. Those skilled in the art will recognize, however, that these and other factors may be desirable. However, such elements are well known in the art and these elements Because a description of such elements does not facilitate a better understanding of the present disclosure, the description of such elements is not provided herein. The drawings are provided for illustrative purposes and are not intended as construction drawings. It should be understood that omitted details and modifications or alternative embodiments are within the skill of the art. within the knowledge of the

[0180] In certain aspects of the present disclosure, the components may be arranged to provide an element or structure or to provide a given function or A single component may be replaced by multiple components to perform multiple functions. and that multiple components may be replaced by a single component. It is clearly understood that such substitutions may be necessary to implement particular embodiments of the present disclosure. Except where it would be ineffective to do so, such substitutions are considered to be within the scope of the present disclosure.

[0181] The examples presented herein are intended to illustrate potential specific implementations of the present disclosure. These examples are intended primarily for purposes of illustrating the present disclosure for those skilled in the art. It can be clearly understood that without departing from the spirit of this disclosure, There may be variations in these diagrams or the operations described herein. For example, in some cases However, the method steps or actions may be executed or performed in differing order, or actions may be added. , may be deleted or modified.

[0182] Furthermore, since particular embodiments of the present disclosure have been described herein for purposes of illustrating the disclosure and not for purposes of limiting the disclosure, it will be clearly understood by those skilled in the art that numerous changes in the details, materials and configurations of elements, steps, structures and / or parts may be made within the principles and scope of the present disclosure without departing from the disclosure as set forth in the claims. In order to maintain the disclosure of the present application as originally filed, the contents of claims 1 to 22 as originally filed are added below. (Claim 1) 1. A method for detecting a stented region in a blood vessel, the method comprising: receiving optical coherence tomography data for a stented vessel, the optical coherence tomography data including a plurality of image frames; storing the optical coherence tomography data in a storage device of an intravascular data acquisition system; analyzing the plurality of image frames and identifying stent struts on a frame-by-frame basis; demarcating angular offsets of the identified stent struts to create fused angular gap data across adjacent ones of the plurality of image frames; and determining the maximum angular gap between any two adjacent struts in said neighboring frames; A method comprising: (Claim 2) The method of claim 1 , further comprising classifying the frame as a stent-containing frame if the maximum angular gap is less than a threshold angular gap. (Claim 3) further comprising identifying an area containing a stent by identifying a cluster of adjacent frames that contains a maximum angular gap that is less than a threshold angular gap. The method of claim 2. (Claim 4) The method of claim 1 , further comprising determining a centroid for the stented vessel and calculating the maximum angular gap with respect to the vessel centroid for frame k. (Claim 5) The maximum angular gap, θ, for a given frame k max,k is the angular gap metric Ψ for frame k according to (Equation 4). k The method of claim 1, wherein the method is used to calculate

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Claims

1. 1. A system for displaying stent strut coverage in a vessel, comprising: one or more processors; The one or more processors: receiving image data of a stented vessel, the image data including a plurality of image frames; Identifying stent strut locations within the plurality of image frames; generating a three-dimensional view of the stent struts within the vessel; The system provides for display: a first panel including a three-dimensional view of the stent struts within the blood vessel; a second panel including a longitudinal cross-section of the stent struts within the blood vessel and longitudinal indicators positioned relative to the longitudinal cross-section of the stent struts to provide indication of stent strut crimping at one or more longitudinal positions; and a third panel including a transverse cross-section of the blood vessel.

2. 2. The system of claim 1, wherein the longitudinal indicator is a crimping bar and wherein an indicia of the stent strut crimp in the crimping bar is aligned with respect to a longitudinal view of the stent strut such that the indicia correspond to a position of the stent strut crimp in the longitudinal view of the stent strut.

3. 10. The system of claim 1, wherein the incompletely crimped stent struts displayed in the first panel, the second panel, and the third panel are displayed with indicia indicating stent strut crimping.

4. 10. The system of claim 1, wherein the first panel further comprises a circular indicator around the three-dimensional view of the stent struts configured to provide a selected view of the stent struts.

5. The system of claim 4 , wherein the circular indicator is configured to be movable in response to user input.

6. The system of claim 1 , wherein one or more side branches are excluded from the three-dimensional view of the stent struts.

7. The system of claim 1 , wherein the three-dimensional view of the stent struts includes one or more side branch markings.

8. The system of claim 1 , wherein the three-dimensional view is provided based on user input selecting a proximal or distal view of a stent strut within the vessel.

9. 1. A method for displaying stent strut coverage in a vessel, comprising: receiving, by one or more processors, image data of a stented vessel, the image data including a plurality of image frames; the one or more processors identifying the location of the stent struts within the plurality of image frames; generating, by the one or more processors, a three-dimensional view of the stent struts within the vessel; providing, by the one or more processors, for display: a first panel including a three-dimensional view of the stent struts within the vessel; a second panel including a longitudinal cross-section of the stent struts within the vessel and longitudinal indicators positioned relative to the longitudinal cross-section of the stent struts to provide indicia of stent strut crimping at one or more longitudinal locations; and a third panel including a transverse cross-section of the vessel. The method comprising:

10. 10. The method of claim 9, wherein the longitudinal indicator is a crimping bar and wherein indicia of the stent strut crimps in the crimping bar are aligned with respect to a longitudinal view of the stent struts such that indicia correspond to positions of the stent strut crimps in the longitudinal view of the stent struts.

11. 10. The method of claim 9, wherein the incompletely crimped stent struts displayed in the first panel, the second panel, and the third panel are displayed with indicia indicating stent strut crimping.

12. 10. The method of claim 9, wherein the first panel further comprises a circular indicator around the three-dimensional view of the stent struts configured to provide a selected view of the stent struts.

13. The method of claim 12 , wherein the circular indicator is configured to be movable in response to user input.

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